From owner-sci-resources@net.bio.net Wed Dec 14 22:00:00 1994 Path: biosci!biosci!not-for-mail From: "Karp, Robert" Newsgroups: bionet.sci-resources Subject: RFA on QTL Mapping of Alcohol-Related... Date: 14 Dec 1994 21:49:54 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 656 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <2EEF3251@SMTP2.mm.hub.nih.gov> NNTP-Posting-Host: net.bio.net Attached is a new RFA from NIAAA on QTL mapping of genes influencing alcohol-related behavior in rodents. The receipt date for an optional letter of intent is June 1, 1995, and for applications is July 19, 1995. The earliest possible award date is March 1, 1996. All potential applicants desiring further information are urged to contact me at the address shown below. Robert W. Karp Program Director, Genetics NIAAA rkarp@willco.niaaa.nih.gov DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE NATIONAL INSTITUTES OF HEALTH NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM REQUEST FOR APPLICATIONS RFA AA-95-002 QTL MAPPING OF ALCOHOL-RELATED BEHAVIORAL TRAITS IN RODENTS DECEMBER 1994 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research proposals to map quantitative trait loci (QTL) influencing rat and mouse behavioral traits which model human behavioral traits predisposing to alcoholism. Mapping of such QTL will permit subsequent testing of human homologues of these genes for linkage to alcoholism in human pedigrees. Such a test will help to establish which animal behavioral traits are most relevant to human alcoholism. Mapping of the QTL will also serve as a prologue to the isolation of the relevant genes and the identification of the products they encode. This approach can provide a novel route to elucidating the physiological mechanisms for predisposition to alcoholism and to developing intervention strategies to diminish harmful effects of alcohol. 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) is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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, D.C. 20402-9325 (Telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign, public or private, nonprofit or for-profit organizations, such as universities, colleges, hospitals, research institutes and organizations, units of State or local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or First Independent Research Support and Transition (FIRST) Award (R29). Applicants for R01s may request support for up to 5 years. In FY 1992, the average total cost per year for new R01s funded by NIAAA was approximately $200,000. 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. FIRST Award applications must be for 5 years. Total direct costs for the 5-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST Awards cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Potential applicants for FIRST Awards should obtain copies of the FIRST program announcement (revised February 1994) from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, Maryland 20852, telephone: 301-468-2600 or 1-800-729-6686. Program project grant applications (P01) will not be accepted for this RFA. Applicants may submit applications for Investigator-Initiated Interactive Research Project Grants. Interactive Research Project Grants require the coordinated submission of related research project grant (R01) and, to a limited extent FIRST Award (R29) applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. These applications must share a common theme and describe the objectives and scientific importance of the interchange of, for example, ideas, data, and materials among the collaborating investigators. A minimum of two independent investigators with related research objectives may submit concurrent, collaborative, cross-referenced individual R01 and R29 applications. Applicants may be from one or several institutions. Further information on these and other grant mechanisms may be obtained from the program staff listed in the Inquiries section of this RFA. FUNDS AVAILABLE It is estimated that up to $1.1 million will be available for approximately six grants under this RFA in FY 1996. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. The funds set aside for this RFA are intended to support all aspects of projects funded, except for genotyping of the animals generated during the course of the research, which will be supported by a separately awarded contract (see SPECIAL REQUIREMENTS, below). Although this program is provided for in the financial plan of NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. The earliest possible award date is March 1, 1996. RESEARCH OBJECTIVES Genetic Basis of Alcoholism Alcoholism has been recognized for over a century as a familially transmitted condition. Over the past 25 years, considerable evidence from family, twin, and adoption studies supports important roles for both genes and environment in its etiology in both men (Cloninger, et al., 1981; Merikangas, 1990; McGue, et al. 1992) and women (Kendler, et al. 1992). The specific etiological factors underlying susceptibility to alcoholism remain, however, unknown. Ongoing efforts to discover genes linked to alcoholism in human pedigrees are challenged by the heterogeneous, polygenic nature of alcoholism, along with the incompletely understood role of the environment in its etiology (Aston and Hill, 1990). These efforts could be greatly bolstered by a strategy taking advantage of powerful genetic methods permitting identification of genes influencing ethanol-related behavior in experimental animals (Lander and Botstein, 1989; Gora-Maslak, et al., 1991). Human homologues of these genes could then be tested directly for linkage to alcoholism in human pedigrees. The recent large increase in the density of markers on the mouse genetic map (Copeland, et al., 1993), along with the development of new and more powerful methods of data analysis (Lander and Botstein, 1989), have now made it possible to map individual quantitative trait loci (QTL), the genes contributing jointly to the determination of genetically complex traits (such as behavior) (Gora-Maslak, et al., 1991). Since mapped genes can be isolated and their encoded products characterized, QTL mapping offers a powerful reductionistic approach for dissecting the complex physiological bases of alcohol-related behavior. A detailed human-mouse synteny map can accurately predict the map location of potential human homologues of mouse genes (Nadeau, et al., 1992), so that these predicted loci can then be tested for linkage to alcoholism in human alcoholic pedigrees. This strategy would permit the direct application of knowledge gained from an animal behavior genetic study, for which behavioral measures are precisely defined and powerful genetic techniques can be brought to bear, to a human genetic study of alcoholism. A finding of linkage would, moreover, provide additional evidence for the relevance of the animal behavior under study to human alcoholism. Human Behavioral Indicators of Predisposition to Alcoholism Because family history of alcoholism is a significant risk factor for alcoholism (Cotton, 1979), researchers have examined psychological, biological, and behavioral characteristics that distinguish children of alcoholics from children of non-alcoholics as a means of identifying indicators of vulnerability to alcoholism. The most prominent theories of vulnerability to alcoholism have centered on temperament, baseline sensitivity, and acute tolerance to alcohol. Temperament models of vulnerability to alcoholism propose that deviations in dispositional traits mediate transmission of alcoholism (Tarter, 1991; Cloninger, 1987). According to Tarter, who used Rowe and Plomin's (1977) six dimensions of temperament, children at high risk for developing alcoholism have traits such as high behavioral activity, low attention span and persistence, low soothability, high emotionality, and low sociability. These disturbances of temperament in children of alcoholics are attributed to neurological dysfunction in the prefrontal, limbic, and midbrain areas. This theory is supported by observations of a number of differences between children of alcoholics and children of nonalcoholics, including increased incidence of psychopathology (attention deficit hyperactivity disorder, childhood conduct disorder, anxiety disorders and depression, antisocial personality disorder), behavioral disturbances (impulsiveness, aggression, emotionality), neuropsychological deficits (abstraction/ conceptualization, verbal ability), and neurophysiological variations (reduced amplitude of the P3 component of event- related potentials) (see Tarter, 1991; Sher, 1991 for reviews). In a similar vein, Cloninger's model of Type 1 and Type 2 alcoholism (Cloninger, 1987) is based on temperamental differences (novelty seeking, harm avoidance, reward dependence), which are related to selective neurological substrates and predispose an individual to certain types of alcoholism. For example, Type 2 alcoholics are high in novelty seeking, associated with impulsiveness, distractibility, and positively motivated drinking. Type 1 alcoholics, on the other hand, are high in harm avoidance and reward dependence associated with anxiety, shyness, emotional dependence, and negatively motivated drinking (i.e., escape from dysphoric feelings). The sensitivity hypothesis of vulnerability to alcoholism, first elaborated by Schuckit and his colleagues in the early 1980s, postulated that children of alcoholics are less sensitive to the subjective intoxicating effects of alcohol, and therefore, are susceptible to drinking excessively (Schuckit, 1980, 1984). However, subsequent studies designed to test this hypothesis demonstrated opposite effects, i.e., children of alcoholics were more sensitive to the reinforcing effects of alcohol as measured by muscle relaxing, stress-dampening, electroencephalographic and mood effects (see Sher, 1991 for review). A recent interpretation proposed by Newlin and Thomson (1990) may resolve this conflict. Compared to sons of nonalcoholic fathers, sons of alcoholic fathers show greater acute sensitivity to the reinforcing effects of alcohol (euphoria, muscle relaxation, stress-response dampening) on the ascending limb of the blood alcohol curve, and less sensitivity (greater acute tolerance) to the aversive effects of alcohol (nausea, dysphoria) on the descending limb of the blood alcohol curve. Measuring Animal Behaviors Related to Human Traits Predicting Alcoholism Investigators are now mapping QTL influencing various ethanol-related behaviors in mice, including preference for drinking, sensitivity to sedation, locomotor activation, hypothermia, and withdrawal severity (for review, see Crabbe, et al., 1994). More recently, they have begun mapping genes influencing more complex behaviors, such as acute functional tolerance to ataxia (Crabbe, et al., 1994a) and hypothermia (Crabbe, et al., 1994b), conditioned place preference (a measure of reinforcement) (Cunningham and Malott, 1994), and conditioned taste aversion (a measure of aversive effects) (Risinger and Cunningham, 1994). Aspects of more complex rodent behaviors could conceivably be homologous to human traits predisposing to alcoholism. Some of the corresponding assays could, in principle, be adapted for QTL mapping. Examples are given below. (These examples are for illustrative purposes only, and are not intended to exclude other behavioral tests from this RFA.) Tests that assess intrinsic traits of temperament or personality predisposing humans to alcoholism, such as impulsiveness, novelty seeking, aggression, hyperactivity, emotionality, anxiety, and stress reactivity, can be administered to rodents. Impulsiveness in individuals at risk for alcoholism has been attributed to prefrontal-limbic brain dysfunction (Tarter, 1991) and is comparable to difficulties in response inhibition observed in rodents with prefrontal lesions (see Kolb, 1984 for review). Evidence of impaired response inhibition in rodents has been measured by reversal learning tasks (i.e., the animal first learns to respond to a particular stimulus or location for a reward, and then must reverse its response to a different place or stimulus), tests of response extinction (a previously rewarded response is no longer rewarded), or go/no go tasks (reward is presented for responding to a stimulus on "go" trials, and for not responding on "no go" trials) (Kolb, 1984; Sakurai and Sugimoto, 1985). Animals with deficits in response inhibition have difficulty shifting responses on reversal tasks, continue responding when rewards are no longer presented, and fail to suppress responding on "no go" trials. Research on alcohol and aggression in humans and animals has focused on whether alcohol consumption increases violent/aggressive behavior toward family members, peers, or rivals (see Miczek, et al., 1993 for review). However, whether a history of antisocial personality or aggressive behavior predisposes a person to excessive alcohol consumption has received little study. Measures of aggressive behavior in rodents that might reflect aspects of human antisocial behavior include social interaction/social conflict paradigms, such as isolation-induced aggression between male pairs, resident-intruder encounters, and possibly frustration-induced aggression (omission of reward) (Cairns, et al., 1983; Miczek, et al., 1993; Brain, et al., 1993). Measures of other traits potentially serving as markers of human alcoholism, such as anxiety, emotionality, activity level, and novelty-seeking, could be applied to rodents. Novelty or "sensation-seeking" can be measured by nose-poke or hole board behavior in which the animal places its nose or head into a board with equally spaced holes. Activity level can easily be measured with activity wheels or by the number of boxes crossed in an open field. Hole board behavior and exploratory open field activity, along with number of defecations and rearings in the open field, have also been used to quantitate levels of anxiety and emotionality. Other experimental paradigms for measuring anxiety include conflict paradigms, acoustic startle response, and elevated plus-maze (see Crawley, 1985; Shepard, 1986; Heilig, et al., 1994; Stout and Weiss, 1994 for reviews of all of these paradigms). A further related behavior is stress reactivity, which could be measured by responses to various stressors (social stress, isolation, early weaning), such as changes in vocalization pattern, disruption of circadian rhythms, or autonomic responses such as changes in blood pressure or heart rate (see Pohorecky, 1990; Brown, et al., 1991 for reviews). Acute behavioral tolerance to a single challenge dose of alcohol can be demonstrated in animals by comparing the extent of functional impairment at a given blood alcohol concentration on the ascending limb of the blood alcohol curve with the extent of impairment when the same alcohol concentration is reached on the descending limb. The development of acute tolerance within a single session to alcohol's effects such as motor impairment, hypothermia, and operant responding has been shown by several studies (LeBlanc, et al., 1975; Crabbe, et al., 1994b; Le, et al., 1992; Hiltunen and Jarbe, 1992). Finally, because frequency and amount of alcohol consumed are significant discriminators of alcoholic subtypes (Babor, et al., 1992; Morley and Skinner, 1986), measures of temporal patterns of alcohol consumption in rodents may be informative behavioral markers. Using operant techniques, distinctive temporal patterns of alcohol consumption have been demonstrated in the selectively bred alcohol-preferring and -nonpreferring rats (Schwarz-Stevens, et al., 1991). Such techniques could possibly be adapted to permit QTL mapping. Methodological Considerations Most QTL mapping of behavioral traits has been done in mice because of the well- developed genetic map available for this species. However, the rat genome map is now undergoing rapid development (Yamada, et al., 1994; Serikawa et al., 1992) and has already proven suitable for QTL mapping (Lindpaintner, 1992). Because many interesting behavioral paradigms have been developed in rats to study ethanol-related behaviors, NIAAA encourages investigators studying rat behavior to respond to this RFA. While the choice of animal strains for study is an important feature of experimental design, applicants are encouraged to consider using any of a wide variety of strains, rather than confining their attention only to those already used extensively in alcohol research. Applicants are also encouraged to consider using existing batteries of recombinant inbred (RI) and recombinant congenic (RC) strains. Applicants are encouraged (when cost and experimental considerations permit) to test more than one behavioral paradigm on the same group of animals. Applicants may also wish to consider neurochemical measurements (e.g., receptor binding studies, in situ hybridization, other histological measurements) on the same group of animals. Such studies offer the prospect of a rigorous determination of genetic correlations among multiple behaviors and neurochemical parameters, as well as mapping of the genes responsible for those correlations. Some behavioral paradigms of great potential interest may be so complex as to preclude measurements on the hundreds of animals required for QTL mapping. Investigators working with such paradigms are strongly encouraged to attempt modifying them so as to permit measurements on hundreds of animals, without degrading their informativeness about the principal aspect of the behavior under study. SPECIAL REQUIREMENTS This RFA is intended to support the genetic analysis of animal behaviors not previously analyzed, in the hope that these behaviors may usefully model human traits related to predisposition to alcoholism. Investigators wishing to respond to this RFA who lack expertise in genetic analysis should seek collaboration with investigators experienced in QTL mapping, insofar as such experience will prove essential for proper study design and data analysis. To support as economically as possible the large amount of genotyping required for this research, NIAAA will award a separate contract for genotyping of animals generated by the research supported under this RFA. Awardees under this RFA who desire NIAAA funding for the genotyping of the animals they generate are expected to use the services provided under this contract. Awardees will be expected to attend one joint meeting per year in or near Washington, D.C., in order to review progress, and should request sufficient funds in their budgets to support such attendance. LETTER OF INTENT Prospective applicants are asked to submit, by June 1, 1995, 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 or 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 a subsequent application, the information that it contains allows Institute staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Mark Green, Ph.D. Chief, Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Blvd. MSC 7003 Bethesda, Maryland 20892-7003 Telephone: 301-443-4375 FAX: 301-443-6077 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 Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone 301-594-7248; and from the NIAAA program administrators named below under Inquiries. The RFA label available in the PHS (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. Page limits and limits on size of type are strictly enforced. Applicants for FIRST Awards (R29) are reminded that such applications must include three letters of reference. Non-conforming applications will be returned without being reviewed. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies in one package to: Division of Research Grants, NIH Westwood Building, Room 240 5333 Westbard Avenue Bethesda, Maryland 20892* * (If using express mail or overnight carrier, the zip code is 20816.) At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Chief, Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409 MSC 7003 Bethesda, Maryland 20892-7003 Telephone: 301-443-4375 FAX: 301-443-6077 Applications must be received by July 19, 1995. 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 RFA 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 be prepared as a revised application and include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the Institute. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG 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 that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Institute in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non- competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. REVIEW CRITERIA Criteria to be used in the scientific and technical merit review of alcohol research grant applications will include the following: 1. The scientific, technical, or medical significance and originality of the proposed research. 2. The appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 5. The reasonableness of budget estimates and duration in relation to the proposed research. 6. Where applicable, the adequacy of procedures to protect or minimize effects on animal and human subjects and the environment. The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement (revised February 1994). AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the proposal as determined by peer review, NIAAA programmatic needs and balance, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding genetic aspects of proposed research to: Robert W. Karp, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, Maryland 20892-7003 Telephone: 301-443-4223 FAX: 301-594-0673 Internet: rkarp@willco.niaaa.nih.gov Direct inquiries regarding behavioral aspects of proposed research to: Ellen Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, Maryland 20892-7003 Telephone: 301-443-4223 FAX: 301-594-0673 Internet: ewitt@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Joseph Weeda Chief, Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard MSC 7003 Bethesda, Maryland 20892-7003 Telephone: 301-443-4703 FAX: 301-443-3891 Internet: jweeda@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 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. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES Aston CE, Hill SY (1990): Segregation analysis of alcoholism in families ascertained through a pair of male alcoholics. Am J Hum Genet 46:879-887. Babor TF, Hofmann M, DelBoca FK, Hesselbrock V, Meyer RE, Dolinsky ZS, Rounsaville B (1992): Types of alcoholics, I. Evidence for an empirically derived typology based on indicators of vulnerability and severity. Arch Gen Psychiatry 49:599-608. Brain PF, Miras RL, Berry MS (1993): Diversity of animal models of aggression: their impact on the putative alcohol/aggression link. J Stud Alc Supp No. 11, pp. 140-145. Brown MR, Koob GF, Rivier C (1991): Stress: Neurobiology and Neuroendocrinology. New York: Marcel Dekker. Cairns RB, MacCombie DJ, Hood KE (1983): A developmental-genetic analysis of aggressive behavior in mice: I. Behavioral outcomes. J Comp Psych 97:69-89. Cloninger CR, Bohman M, Sigvardsson (1981): Inheritance in alcohol abuse. Arch Gen Psychiatry 38:861-868. Cloninger CR (1987): Neurogenetic adaptive mechanisms in alcoholism. Science 236:410-416. Copeland NG, Jenkins NA, Gilbert DJ, Eppig JT, Maltais LJ, Miller JC, Dietrich WF, Weaver A, Lincoln SE, Steen RG, Stein LD, Nadeau JH, Lander ES (1993): A genetic linkage map of the mouse: current applications and future prospects. Science 262:57-66. Cotton NS (1979): The familial incidence of alcoholism. J Stud Alcohol 40:89-116. Crabbe JC, Belknap JK, Buck KJ (1994a): Genetic animal models of alcohol and drug abuse. Science 264:1715-1723. Crabbe JC, Belknap JK, Mitchell SR, Crawshaw LI (1994b): QTL mapping of genes influencing sensitivity and tolerance to ethanol hypothermia in mice. Alcohol Clin Exp Res 18:451, abstract no. 191. Crawley JN (1985) Exploratory behavior models of anxiety in mice. Neurosci Biobehav Rev 9:37-44. Cunningham CL, Malott DH (1994): Ethanol-induced conditioned place preference in the BXD RI strains: behavioral and QTL analyses. Alcohol Clin Exp Res 18:451, abstract no. 188. Gora-Maslak G, McClearn GE, Crabbe JC, Phillips TJ, Belknap JK, Plomin R (1991): Use of recombinant inbred strains to identify quantitative trait loci in psychopharmacology. Psychopharmacology 104:413-424. Heilig M, Koob GF, Ekman R, Britton KT (1994): Corticotropin-releasing factor and neuropeptide Y: role in emotional integration. Trends Neurosci 17:80-85. Hiltunen AJ, Jarbe TUC (1992): Acute and chronic ethanol tolerance: operant behavior in naive and ethanol tolerant rats. Psychopharmacology 107:511-516. Kendler KS, Heath AC, Neale MC, Kessler RC, Eaves LJ (1992): A population- based twin study of alcoholism in women. JAMA 268:1877-1882. Kolb B (1984): Functions of the frontal cortex of the rat: a comparative review. Brain Res Rev 8:65-98. Lander ES, Botstein D (1989): Mapping Mendelian factors underlying quantitative traits using RFLP linkage maps. Genetics 121:185-199. Le AD, Mana M, Quan B, Kalant H (1992): Differential development of acute tolerance to the motor impairment and anticonvulsant effects of ethanol. Psychopharmacology 109:107-111. LeBlanc AE, Kalant H, Gibbins RJ (1975): Acute tolerance to ethanol in the rat. Psychopharmacologia 41:43-46. Lindpaintner K (1992) Genetic linkage analysis in hypertension: principles and practice. J Hypertens 10:121-124. McGue M, Pickens RW, Svikis DS (1992): Sex and age effects on the inheritance of alcohol problems: A twin study. J Abnorm Psych 101:3-17. Merikangas KR (1990): The genetic epidemiology of alcoholism. Psychological Med 20:11-22. Miczek KA, Weerts EM, DeBold JF (1993): Alcohol, aggression, and violence: biobehavioral determinants. In Martin SE (ed), NIAAA Research Monograph No. 24, Alcohol and Interpersonal Violence: Fostering Multidisciplinary Perspectives. NIH Publication No. 93-3496, National Institutes of Health, Rockville, MD. Morley LC, Skinner HA (1986): Empirically derived classifications of alcohol-related problems. In Galanter M (ed), Recent Developments in Alcoholism, Vol. 5. New York: Plenum Press, pp. 145-168. Nadeau JH, Davisson MT, Doolittle DP, Grant P, Hillyard AL, Kosowsky MR, Roderick TH (1992): Comparative map for mice and humans. Mamm Genome 3:480-536. Newlin DB, Thomson JB (1990): Alcohol challenge with sons of alcoholics: a critical review and analysis. Psychological Bulletin 108:383-402. Pohorecky LA (1990): Interaction of ethanol and stress: research with experimental animals -- an update. Alcohol Alcoholism 25:263-276. Risinger FO, Cunningham CL (1994): Identification of genetic markers associated with sensitivity to ethanol-induced conditioned taste aversion. Alcohol Clin Exp Res 18:451, abstract no. 187. Rowe D, Plomin R (1977): Temperament in early childhood. J Pers Assess 41:150- 156. Sakurai Y, Sugimoto S (1985): Effects of lesions of prefrontal cortex and dorsomedial thalamus on delayed go/no-go alternation in rats. Behav Brain Res 17:213-219. Sher KJ (1991): Children of Alcoholics. Chicago: University of Chicago Press. Schuckit MA (1980): Self-rating of alcohol intoxication by young men with and without family histories of alcoholism. J Stud Alcohol 41:242-249. Schuckit MA (1984): Subjective responses to alcohol in sons of alcoholics and controls. Arch Gen Psychiatry 41:879-884. Schwarz-Stevens K, Samson HH, Tolliver GA, Lumeng L, Li TK (1991): The effects of ethanol initiation procedures on ethanol reinforced behavior in the alcohol- preferring rat. Alcoholism Clin Exp Res 15:277-285. Serikawa T, Kuramoto T, Hilbert P, Mori M, Yamada J, Dubay CJ, Lindpainter K, Ganten D, Guenet JL, Lathrop GM, et al. (1992): Rat gene mapping using PCR-analyzed microsatellites. Genetics 131:701-21. Shepard RA (1986): Neurotransmitters, anxiety, and benzodiazepines: a behavioral review. Neurosci Biobehav Rev 10:449-461. Stout JC, Weiss JM (1994): An animal model for measuring behavioral responses to anxiogenic and anxiolytic manipulations. Pharmacol Biochem Behav 47:459- 465. Tarter RE (1991): Developmental behavior-genetic perspective of alcoholism etiology. In Galanter M (ed), Recent Developments in Alcoholism, Volume 9. New York, Plenum Press, pp. 69-85. Yamada J, Kuramoto T, Serikawa T (1994): A rat genetic linkage map and comparative maps for mouse or human homologous rat genes. Mamm Genome 5:63-83. From owner-sci-resources@net.bio.net Wed Dec 14 22:00:00 1994 Path: biosci!biosci!not-for-mail From: GROUP PRESS 202-260-4355 Newsgroups: bionet.sci-resources Subject: NTC NEW PROGRAM FOR A NEW PROGRAM OF GRANTS AND FELLOWSHIPS Date: 14 Dec 1994 21:50:35 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 39 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3colfb$39t@net.bio.net> NNTP-Posting-Host: net.bio.net FOR RELEASE: MONDAY, DECEMBER 12, 1994 The U.S. EPA today announced plans for a new program of grants and fellowships for environmental research to be carried out by U.S. universities. The new program will double the Agency's existing research grants program in fiscal 1995 with the addition of $22 million. Greater interaction with the university scientific community is an integral part of EPA's commitment to seek the best talent to develop and maintain the Agency's scientific excellence. Universities are a proven source of expertise and innovative ideas on environmental research. EPA's Office of Research and Development (ORD) will be soliciting applications from universities and not-for-profit, research-intensive institutions. EPA will work with the National Science Foundation (NSF) to jointly solicit and evaluate proposals. The augmented grants program will fund research in the areas of ecosystems, environmental technologies, global change and socio-economic issues. ORD will also seek applications from graduate students under a new fellowship program for environmentally-related studies. ORD expects to issue 100 fellowships totalling $4 to $5 million in fiscal 1995. The fellowships will provide two-year support for masters students, and three- year support for students in a doctoral program. The program was created to support the development of a new generation of experts with the training and skills to address increasingly complex environmental challenges. Solicitations for the fellowships will be issued in mid-December 1994, and solicitations for the grants will be issued in early January 1995. For additional information about these initiatives, call the EPA Office of Research and Development at 202-260-7473. R-311 From owner-sci-resources@net.bio.net Thu Dec 15 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 4 December 1994 Date: 15 Dec 1994 22:06:25 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 164 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3crap1$am1@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Form Title: FM 1030s - (Revised) GPG Summary Proposal Budget Form Sample File size (bytes): 244 STIS Filename: fm1030s Also available: fm1030s.ps Document Type: General Publication Title: NSF 94-74 Connections File size (bytes): 62742 STIS Filename: nsf9474 Document Type: News Title: TIP41118 - Media Tipsheet November 18, 1994 File size (bytes): 5174 STIS Filename: tip41118 Title: TIP41129 - Media Tipsheet November 29, 1994 File size (bytes): 5043 STIS Filename: tip41129 Document Type: Press Release Title: PR 94-71 SCIENTISTS STUDY HOW PLANTS RESPOND TO ENVIRONMENTAL SIGNALS File size (bytes): 5879 STIS Filename: pr9471 Title: PR 94-73 1994 YOUNG INVESTIGATORS AWARD RECIPIENTS File size (bytes): 67601 STIS Filename: pr9473 Also available: pr9473.doc Title: PR 94-75 NATIONAL SCIENCE BOARD APPROVES NEW $365 MILLION TOTAL PRICETAG FOR LIGO File size (bytes): 4360 STIS Filename: pr9475 Title: NSF-FUNDED RESEARCHER USES NEW MICROSCOPY TECHNIQUE TO DISCOVER HOW CELLS SYNTHESIZE PROTEINS File size (bytes): 3425 STIS Filename: pr9476 Title: MARINE SCIENTISTS BEGIN EXPEDITION TO ARABIAN SEA AND INDIAN OCEAN; AREA’S MONSOONS MAY PROVIDE CLUES TO GLOBAL CLIMATE File size (bytes): 5133 STIS Filename: pr9477 Document Type: Program Guideline Title: NSF 94-136-- State/Industry/University Cooperative Research Centers File size (bytes): 51720 STIS Filename: nsf94136 Document Type: SRS Report Title: SFFRDC94 Master Government List of Federally Funded Research and Development Centers Fiscal Year 1995 (FFRDCs) File size (bytes): 6442 STIS Filename: sffrdc94 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Form Title: FM 1030 - (Revised) GPG Summary Proposal Budget Form File size (bytes): 235 STIS Filename: fm1030 Also available: fm1030.ps Title: GPG Package of NSF-style Smart Forms File size (bytes): 811 STIS Filename: fmgpg Also available: fmgpg.zip Title: NSF 94-3 - Grant Proposal Guide Forms Kit(Revised) File size (bytes): 1476 STIS Filename: nsf943 Also available: nsf943.zip Document Type: Letter Title: Current List of REU Sites File size (bytes): 86021 STIS Filename: reulist Title: Current List of REU Sites File size (bytes): 86021 STIS Filename: reulist Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 96391 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 99853 STIS Filename: phnorg Document Type: Program Guideline Title: NSF 94-153 -- NSF-NATO POSTDOCTORAL FELLOWSHIPS IN SCIENCE AND ENGINEERING File size (bytes): 62892 STIS Filename: nsf94153 Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 45058 STIS Filename: sesvac ------------------------------------------------------------------------ ** 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). 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 stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac 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 "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Thu Dec 15 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 11 December 1994 Date: 15 Dec 1994 22:06:31 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 105 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3crap8$amc@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: TIP41202 - Media Tipsheet December 2, 1994 File size (bytes): 4124 STIS Filename: tip41202 Document Type: Press Release Title: OXYGEN A COMPONENT OF EARTH’S CORE? File size (bytes): 2043 STIS Filename: pr9478 Document Type: Recruit Title: Director, Division of Materials Research File size (bytes): 7860 STIS Filename: vep952c Title: Director, Division of Materials Research File size (bytes): 5428 STIS Filename: vep952i Title: Director, Division of Materials Research File size (bytes): 7531 STIS Filename: vep952l Title: Director, Division of Social, Behavioral and Economic Research File size (bytes): 5929 STIS Filename: vep953 Title: Chemist (Associate Program Director) File size (bytes): 4318 STIS Filename: vex951 Title: Chemist (Associate Program Director) File size (bytes): 5505 STIS Filename: vex953 Title: Program Clerk (Office Automation) File size (bytes): 6039 STIS Filename: vgs9533 Title: Secretary (Office Automation) File size (bytes): 5919 STIS Filename: vgs9534 Document Type: SRS Data Brief Title: NSF 94-314 Science & Engineering Doctorate Awards are at an All-Time High File size (bytes): 4233 STIS Filename: db94314 Title: NSF 94-326 S&E Manufacturing Jobs Down- Changes Vary Greatly by Industry and Occupation File size (bytes): 4400 STIS Filename: db94326 ------------------------------------------------------------------------ ** 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). 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 stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve db94326, the text of your message should be as follows: get db94326 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve db94326, you would enter: ftp> get db94326 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 "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-95-001 - V23(43) 12/09/94 Date: 16 Dec 1994 16:45:47 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 855 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcbr$a04@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI95001 AI-95-001 P1O1 *************************************** STD DIAGNOSTIC DEVELOPMENT GROUPS NIH GUIDE, Volume 23, Number 43, December 9, 1994 P.T. 34; K.W. 0715182, 0745020 RFA: AI-95-001 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: January 9, 1995 Application Receipt Date: March 23, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for the establishment of Sexually Transmitted Disease (STD) Diagnostic Development Groups (SDDG) for the research development, manufacturing development, and evaluation of diagnostic tests that are simple, easy-to-use, rapid and inexpensive. The specific focus of this initiative is the development and evaluation of tests for the diagnosis of cervicitis and urethritis due to Neisseria gonorrhoeae or Chlamydia trachomatis. This solicitation for cooperative agreements is designed to encourage and support joint for-profit and non-profit research groups in development and evaluation of these diagnostic tests. 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), STD Diagnostic Development Groups (SDDG), is related to the priority areas of STD and 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 for-profit and non-profit organizations, public and private organizations such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U01), an assistance mechanism, rather than an acquisition mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of a study funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total project period 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. The anticipated award date is September 1995. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $2.0 million. In Fiscal Year 1995, the NIAID plans to fund three applications: two for diagnostic test development and one for test evaluation. Depending upon the stage of development of the diagnostic test proposed, it is anticipated that the first year development awards will range from $300,000 to $850,000 (total cost). Applications for test evaluation activities will be limited to $300,000 first-year total costs. Applicants proposing budgets larger than these amounts must obtain approval, prior to submission, from Dr. Hitchcock (see INQUIRIES below). In recognition of the highly specialized scientific expertise needed, it is anticipated that applications for test development will focus on either N. gonorrhoeae or C. trachomatis; for evaluation applications, it is anticipated that the applicants will have the capability to evaluate tests for both infections. 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. The usual PHS policies governing grant administration and management will apply. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. 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 The HIV pandemic has focused attention on STDs, both because HIV infection is a fatal STD and because other STDs are implicated as risk factors for sexual transmission of HIV. Current global estimates indicate that 14 million people are infected with HIV, the cause of Acquired Immunodeficiency Syndrome (AIDS). The majority of these infections were acquired through sexual intercourse. Unless effective prevention measures to stop sexual transmission of HIV are implemented, the number of AIDS cases will continue to grow. Several clear lines of experimental evidence indicate that STDs increase sexual transmissibility of HIV infection. Recent studies indicate that both discharge STDs (chlamydial infection, gonorrhea, and trichomoniasis) and ulcerative STDs (genital herpes, syphilis, and chancroid) increase HIV transmission. Although individual risk associated with the genital ulcer diseases appears to be higher (up to nine fold) compared to the discharge diseases (ranging from three to five fold), the higher prevalence of the discharge diseases means the population attributable risk for the discharge diseases is greater than that of the ulcerative diseases. Several mechanisms of action are likely to play a role in altered susceptibility/ infectiousness. These include disruption of mucosal epithelium (providing opportunities for bidirectional trafficking of HIV), alteration of normal (protective) flora, cellular inflammation including the recruitment of CD4+ target cells to the mucosal surface, molecular interactions between the pathogens, and immune suppression/stimulation. Significant reductions in the rates of HIV transmission are likely to result from a focused effort to control the spread of these more common STDs, particularly those due to N. gonorrhoeae or C. trachomatis. Separate and apart from the HIV epidemic, STDs cause significant morbidity and mortality and contribute greatly to increasing health care costs. In the United States in 1993, an estimated 12 million cases of STDs occurred; people less then 24 years old accounted for 64 percent of these and three million were in teenagers. In 1992, costs associated with these infections approached $6 billion. STDs disproportionately affect the female, the fetus, and the newborn. Gonococcal and chlamydial infections cause pelvic inflammatory disease, infertility, and ectopic pregnancy. These STDs adversely affect pregnancy and result in spontaneous abortion, stillbirth, chorioamnionitis, premature rupture of membranes, pre- term delivery, and postpartum endometritis. Neonatal infections include gonococcal/chlamydial conjunctivitis, which may lead to blindness, and chlamydial pneumonia, which may lead to chronic respiratory disease. The importance of STD prevention as a means to prevent HIV infection, as well as the morbidity and mortality associated with the major sequelae of STDs in women and infants, are compelling reasons for the development of simple, easy-to-use, rapid, and inexpensive diagnostic tests. These will enable effective screening and antibiotic therapy for infections caused by N. gonorrhoeae or C. trachomatis. Ideally, the needed tests would be administered to a patient without the need to obtain invasive specimens and would be so rapid that an etiological diagnosis would be obtained before the end of the clinic visit. These tests are needed for both high and low prevalence settings and therefore must have appropriate (i.e., high) sensitivity and specificity. Several new and innovative tests have recently been developed. For example, PCR and similar methods have been applied. While these tests are highly specific and sensitive, the unrelenting problem with the application of these technologies is that they are complicated, relying on sophisticated technical equipment and highly trained technical staff. Finally, it is important to highlight that the tests must be inexpensive; a manufacturing cost of less than $1.00 per test is the target. The availability of a sensitive, accurate, inexpensive test will enable/encourage screening and case finding - a critical approach to controlling these asymptomatic infections, preventing HIV infection, chronic sequelae, and decreasing health care costs. In a 1991 workshop on STD Diagnostics, co-sponsored by the National Institute of Allergy and Infectious Diseases, STD researchers and representatives from funding agencies, health care delivery agencies, and industry convened to examine the potential for and constraints on developing STD diagnostics. The participants considered the special requirements of such tests and recommended that useful STD diagnostic tests should be similar in format and simplicity to the occult fecal blood card or the urine glucose dipstick; no such STD diagnostic tests exist that have the required sensitivity and specificity. The workshop participants reviewed the available biotechnology, and concluded that the principal obstacle for the development of these tests was in the application of technological innovation to obtain appropriate tests. Recent advances and possible modifications of older diagnostic approaches may lead to tests that are useful. Most promising are inexpensive biochemical tests for enzymes and metabolites and immunodiagnostics, including antigen detection tests and serological assays, using newer, simpler formats. Research Objective and Scope The objective of this RFA is to develop and evaluate tests for gonorrhea and chlamydial infection through collaborative research between private sector and academic scientists. The collaboration will facilitate the research development, manufacturing development and evaluation of new diagnostic tests for sexually transmitted discharge diseases through original and innovative approaches focused on the antigens, nucleic acids, biochemical metabolites of and immune responses to chlamydial infection and gonorrhea. Ultimately this research should lead to commercially available diagnostic tests for gonorrhea or chlamydial infection that: o utilize a non-invasive or minimally invasive clinical sample, i.e., urine or a finger stick sample of blood would be acceptable) that requires minimal processing; o utilize stable, inexpensive, and readily available reagents; o are simple to use and provide results within 10 to 20 minutes of application of the clinical sample; o have sensitivities and specificities to detect cervicitis/urethritis due to gonorrhea and chlamydial infection comparable to culture; and o are small and simply packaged. SPECIAL REQUIREMENTS Applicants may apply for either a test development or the test evaluation award, but not both. Applicants who wish to develop tests for gonorrhea and for chlamydial infection must submit a separate application for each test development effort. Test Development The scope of test development includes all activities required to improve the basic test system such that it has the desired performance characteristics and all activities required to take the prototype test format through the complete manufacturing development phase including all steps involved in the scale up, quality control assessment, and the production of three lots of 10,000 tests. The budget should reflect this research effort. Test Evaluation The scope of test evaluation includes all activities required to determine and report the characteristics of experimental/prototype tests including: (a) determination of sensitivity and specificity of the test using a panel of prepared laboratory specimens; (b) determination of the sensitivity and specificity of the test using appropriate human clinical specimens, such as blood, urine, cervical swabs, saliva or other suitable specimens; and (c) comparison of the experimental test results to those obtained by culture of the appropriate sample from the same patient. (If the results are discrepant, a confirmatory test that is based on a different target should be used.) The budget should reflect this effort. A. Minimum Requirements Test Development: o The applicant should describe, in detail, the basic assay concept and the marker that will be used as well as the functional test system. o A description of the sensitivity and specificity of the prototype tests determined by evaluating a limited number of clinical specimens. The other characteristics of the prototypes and the appropriateness of different types of clinical specimens (e.g., urine or vaginal secretions) should be included. o If discrepancies exist between performance characteristics of the prototypes at the time of submission of the application and required characteristics of the final tests, the applicant should provide a justification and a research plan for achieving the desired characteristics in the final product. o The applicant should describe the capabilities for production of tests by a manufacturing process that can be fully validated for regulatory approval. o Plans for establishing good manufacturing procedures (GMP) standards and placing the tests on real time and accelerated stability schemes using appropriate protocols should be included by the applicant. o The applicant should include plans for the final component specifications including raw materials, work-in-progress, finished goods, and unit costing. Test Evaluation: o Applicants should describe the capability to conduct laboratory evaluations of diagnostic tests for gonorrhea and chlamydial infection using laboratory prepared and human clinical specimens and conduct "gold standard" diagnostic tests (i.e., culture) using human clinical specimens. o The applicant should describe, identify, and demonstrate access to appropriate populations as a source of clinical specimens. These populations should include: symptomatic and asymptomatic women and men with gonorrhea and/or chlamydial infection; and sub-populations with ranges in disease burden to support evaluation of chlamydial and gonococcal diagnostic tests in high, intermediate and low prevalence settings. For gonorrhea, low prevalence is defined as less than 2%, intermediate as 2-8%, and high as greater than 8%. For chlamydial infection, these are defined as less than 4%, 4-7% and greater than 7%, respectively. Additionally, NIH policies for inclusion of women and minorities in the clinical studies must be met (see STUDY POPULATIONS - Inclusion of Women and Minorities in Research involving human subjects below). o The diagnostic laboratory should have access to a minimum of 7500 subjects per year. For the purpose of determining the budget, in year 1 it is anticipated that 3000 tests will be evaluated and in years 2-5 that 7500 tests per year will be evaluated. o The applicant should include detailed examples of (1) protocols for culture and confirmatory test; (2) consent forms; (3) reports of test results and other information on test performance characteristics. o Letters of collaboration from all participating clinics/clinicians are necessary. These letters shall describe in detail the agreed upon plans for obtaining informed consent of the patients, assuring confidentiality of the patient, for the collection of additional/different samples, collecting appropriate information about the patient, and the procedures for handling, labeling, storing, and transporting the clinical samples. o Since it is theoretically possible that the requirements for the experimental or prototype tests will include application of the sample to the test format at the time of specimen collection, the abilities of the collaborating clinics/clinicians to accommodate the evaluation of the test "at the bedside" (i.e., in the clinical setting) should be described. o The applicant should include a plan for administration of the diagnostic test evaluations, specifying methods to record and report the results of the diagnostic test evaluations, to calculate the sensitivity and specificity of the tests. This may include developing the specifics of the protocols; purchasing of commercially available tests (supplies for years 1 and 2 should include the purchase of 1000 commercially available tests at $5/test); receiving and shipping of reagents and samples; coding of patients, reagents, and samples, and coordinating all of the collaborators' activities (and subcontractors', if applicable). This may also include development of an organized, complete system for entering and tracking data on test results; and documentation of the conduct of all clinical evaluations. B. Definitions 1. SEXUALLY TRANSMITTED DISEASES DIAGNOSTIC DEVELOPMENT GROUP (SDDG): In this RFA, the terms Sexually Transmitted Diseases Diagnostic Development Group, SDDG and "Group" are synonymous. An SDDG is composed of a test development awardee and the test evaluation awardee. Each SDDG will have a scientific steering committee. 2. SCIENTIFIC STEERING COMMITTEE: For each SDDG, a steering committee comprised of the Principal Investigators from the development and evaluation cooperative agreements, the NIAID Scientific Coordinator, and two to three peers from the scientific community will be established. The role of the Steering Committee is to provide direction and oversight of the Group's activities and is defined below under Terms and Conditions of Award. 3. NIAID SCIENTIFIC COORDINATOR: This is a Senior Scientist of the NIAID extramural staff who coordinates NIAID's participation in the STDG. Within NIAID, this individual oversees the entire research program on sexually transmitted diseases, maintains the overall scientific balance in NIAID's diagnostic development program commensurate with new research, field observations and emerging research opportunities, and ensures that the diagnostic development program is consistent with NIAID's missions and goals. For role in the SDDG, see NIAID Staff Responsibilities, below. C. Patent Coverage Because the discovery of innovative, non-invasive, rapid, sensitive, specific and reliable diagnostic tests to identify active infection due to N. gonorrhoeae or C. trachomatis is the goal of this effort, and since active involvement by the private sector is facilitated by the existence of adequate patent coverage, it is essential that applicants provide plans to ensure such coverage. With the potential for involvement of several institutions, the patent situation could be complicated. Each applicant for a test development award must, therefore, provide a detailed description of the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. Each applicant must provide a detailed description of the procedures to be followed for the resolution of legal problems that may develop. Attention is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 52.227-11. Instructions were also published in the NIH Guide for Grants and Contracts, Vol. 19, No. 23, June 22, 1990. 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. It is also noted that 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. As a result of this memorandum, the relationships among industrial organizations and other participants are simplified, since all Group members can now be full partners in the research and in any inventions resulting therefrom. The specific patenting arrangements among institutions may vary and could include joint patent ownership, exclusive licensing arrangements, etc. Applicants are encouraged to develop an arrangement that is most suitable for their own particular circumstances. 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, 9000 Rockville Pike, Bethesda, MD 20892. D. Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the Cooperative Agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the Cooperative Agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the study will be shared among the awardees and the NIAID Scientific Coordinator. Under the cooperative agreement, a relationship will exist between the award recipient(s) and the NIAID in which the performers of the activities (1) are responsible for the requirements and conditions described below and (2) agree to accept program assistance from the named NIAID Scientific Coordinator in achieving project objectives. Failure of an awardee to meet the performance requirements, including these special terms and conditions of award, or significant changes in the level of performance, may result in a reduction in budget, withholding of support, or suspension and/or termination of the award. 1. Awardee Rights and Responsibilities The awardee is responsible for: a. Research design and development, including definition of objectives and approaches, planning, implementation, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results. b. Establishing a mandatory Steering Committee to coordinate and manage the test development and test evaluation studies. c. Implementing the data collection strategy and methods collectively decided upon by the Steering Committee. For each study involving multiple institutions, it is the responsibility of each awardee/site to ensure that data will be collected and submitted in a timely way following such procedures as agreed to by the Steering Committee. d. Establishing mechanisms for quality control and monitoring. Awardees are responsible for ensuring the accurate and timely assessment of the progress of the study, including development of procedures to ensure that data collection and management are adequate for quality control and analysis. e. Preparing and submitting interim progress reports, when requested (not more than quarterly), to the NIAID Scientific Coordinator including, as a minimum, summary data on diagnostic test performance results. Such reports are in addition to the annual awardee noncompeting continuation progress reports. f. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. g. Cooperating in the reporting of the study findings. The NIAID will have access to and may periodically review all data generated under an award. Where warranted by appropriate participation, plans for joint publication with NIAID of pooled data and conclusions, are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIAID staff will apply in all cases. In general, to warrant co-authorship, NIAID staff must have contributed to each of following areas: (a) design of the experiments or concepts being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts. The awardee will retain custody of and have primary rights to the data developed under these awards, subject to Government right of access consistent with current HHS, PHS, and NIH policies. Contents of reports of study results are solely the responsibility of the authors and do not necessarily represent the views of NIAID. 2. NIAID Staff Responsibilities It is expected that the dominant role and prime responsibility for the activity will reside with the awardee(s) for the project as a whole. However, specific tasks and activities will be shared among the awardee(s) and the NIAID Scientific Coordinator. As required for the coordination of activities and to expedite progress, the NIAID Scientific Coordinator may designate additional NIAID staff to provide advice or assistance to the awardee(s) on specific scientific, technical, or management issues. The NIAID Scientific Coordinator shall retain overall programmatic responsibility for the award(s) and will clearly specify to the awardee(s) the name(s) and role(s) of any such additional individuals and the lines of reporting authority. a. Interacting with the principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: (a) regular communications with the principal investigator and staff, (b) periodic site visits for discussions with awardee research teams, (c) observation of laboratory, manufacturing, data collection and management techniques, quality control, fiscal review, and other relevant matters, as well as (d) attendance at and participation in Scientific Steering Committee. b. Convening the first meeting of and subsequent participation in the Scientific Steering Committee that oversees study conduct. The NIAID Scientific Coordinator will be a full participant and voting member of the Scientific Steering Committee. c. Serving as a resource with respect to ongoing NIAID activities that may be relevant to the research to facilitate compatibility and avoid unnecessary duplication. d. Substantial assistance in the design and coordination of research activities for awardees including: 1. Assisting by providing advice on the management and technical performance of the investigations. 2. Providing access to and use of, when appropriate, reagents and assays, and other resources available through NIAID contractors and awardees. 3. Technical advice and assistance with meeting FDA requirements. 4. Reviewing and approving study designs to insure that they are within the scope of peer review and for adequacy of safety, human subjects, and representation of women and minorities, as required by Federal regulations. 5. Reviewing and providing advice regarding the establishment of mechanisms for quality control and study monitoring. e. Making recommendations for continued funding based on: (1) overall study progress, including study subject and/or data accrual; (2) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with terms of award and reporting requirements); and/or (3) maintenance of a high quality of research which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements. 3. Joint Responsibilities In addition to the interactions defined above, awardees and NIAID staff shall share responsibility for the organization of and participation on a Scientific Steering Committee. A Scientific Steering Committee for each SDDG organized by the Principal Investigators of a test development awardee and the test evaluation awardee and the NIAID Scientific Coordinator will be the main oversight body of the study. The steering committee will be comprised of the Principal Investigators from a development and the evaluation cooperative agreements, the NIAID Scientific Coordinator, and two to three peers from the scientific community. The peers from the scientific community shall be selected jointly by the Principal Investigators and the NIAID Scientific Coordinator. The Steering Committee has primary responsibility to design joint research activities, establish priorities, develop common methods and procedures including data recording forms, establish and maintain quality control among awardees, review progress, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIAID Scientific Coordinator and will provide periodic supplementary reports upon NIAID request. An initial meeting of the Steering Committee will be convened early after award by the NIAID Scientific Coordinator. The final structure of the Steering Committee will be established at the first meeting. The NIAID Program Officer will have voting membership on the Steering Committee. After the initial meeting, the Steering Committee will meet 1-2 times per year. A Chairperson, other than the NIAID Program Officer, will be selected by vote of the members. The Chairperson is responsible for coordinating the Committee activities, for preparing meeting agendas, for scheduling and chairing meetings, and for preparing and disseminating a concise summary of each meeting to members of the Committee. 4. Arbitration Process Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one awardee designee, one NIAID designee, and a third designee with expertise in the relevant area and chosen by the other two. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, March 18, 1994, Volume 23, Number 11. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 9 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the number and title of this RFA, and 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 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 Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the program administrator listed under INQUIRIES. Applications must address the items stated in the section "SPECIAL REQUIREMENTS" above and must specifically agree to the Terms and Conditions of Award presented in the SPECIAL REQUIREMENTS section. Should the Group wish to place all inventions and discoveries resulting from these studies within the public domain, a letter to that effect must be submitted to Dr. Hitchcock in lieu of the patent agreement prior to submission of the application. The letter must be co-signed by the Principal Investigator and each of the business officials representing the respective institutions. 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. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-spaced 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, also submit two additional exact copies of the application, and five sets of the appendix and reprints directly to Dr. Olivia Preble at the address listed under INQUIRIES. Applications must be received by March 23, 1995. If an application is received after that date, it will be returned to the applicant without review. The DRG will not accept any application in response to this RFA 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 a substantial revision of an application already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAID. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG will return the application to the applicant. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria Based on the PURPOSE, RESEARCH OBJECTIVES, and SPECIAL REQUIREMENTS of this Request for Applications, the following review criteria will apply: o scientific, technical, and manufacturing merit or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental/methodological and manufacturing approaches proposed to carry out the research; o qualifications and research/manufacturing experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Awards 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. It is anticipated that one award will be made for test development for gonorrhoea, one award will be made for test development for chlamydial infection, and one award will be made for evaluation of tests. 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: Dr. Penelope J. Hitchcock Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A16 6003 Executive Boulevard Bethesda, MD 20892-7630 Telephone: (301) 402-0443 FAX: (301) 402-0659 or 1456 Email: penny@exec.niaid.pc.niaid.nih.gov Direct letters of intent, and inquiries regarding application preparation and review to: Dr. Olivia T. Preble 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 FAX: (301) 402-2638 Email: olivia preble@exec.niaid.pc.niaid.nih.gov Direct inquiries regarding fiscal matters to: Ms. Sharie Bernard 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 FAX: (301) 480-3780 Email: sharie bernard@exec.niaid.pc.niaid.nih.gov Schedule Letter of Intent Receipt Date: January 9, 1995 Application Receipt Date: March 23, 1995 Scientific Review Date: July 1995 Advisory Council Date: September 1995 Anticipated Award Date: September 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.856 - Microbiology and Infectious Diseases Research and No. 93.855 - Immunology, Allergic and Immunologic Diseases Research. 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 Parts 52 and 45 CFR Part 74 [and Part 92 when applicable for State and Local governments]. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-014 - V23(43) 12/09/94 Date: 16 Dec 1994 16:45:39 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 519 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcbj$9vb@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95014 HL-95-014 P1O1 *************************************** GENETIC MAP AND LARGE INSERT LIBRARY FOR THE RAT GENOME NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFA: HL-95-014 P.T. 34; K.W. 1002019, 0755044 National Heart, Lung and Blood Institute National Center for Human Genome Research National Cancer Institute National Institute of Mental Health National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases National Center for Research Resources National Institute on Drug Abuse National Institute on Alcohol Abuse and Alcoholism National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Environmental Health Sciences Letter of Intent Receipt Date: February 15, 1995 Application Receipt Date: March 15, 1995 PURPOSE The purpose of this Request for Application (RFA) is to solicit applications to construct a genetic map of the rat genome with a resolution of 0.43 cM or better and a large-insert DNA clone library of rat genomic DNA. 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), Genetic Map and Large Insert Library for the Rat Genome, is related to many priority areas. 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, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from social/ethnic minority individuals, women, and persons with disabilities are encouraged. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. Collaborations and consortia are encouraged. In such collaborations, the respective contributions should be well-integrated into the design of the application to encourage cross-fertilization of ideas and rapid application of the research to practical purposes. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) mechanism. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is September 30, 1995. This RFA is a one-time solicitation. This RFA is an initiative of the Institutes and Centers listed above. However, the awards will be made by the National Heart, Lung, and Blood Institute (NHLBI) and managed through the NHLBI with the collaboration of the participating Institutes and Centers. FUNDS AVAILABLE A maximum of about $11.06 million (including direct and indirect costs) over a five year period will be awarded. Approximately $3.2 million may be available for the first year, $2.4 million for the second year, $1.82 million for the third year, $1.82 million for the fourth year, and $1.82 million for the fifth year. Funding is subject to the availability of funds. It is anticipated that one to two awards will be made. Applications for building either the genetic map or the large insert clone library alone will be accepted, as well as those proposing to accomplish both aims of this RFA. RESEARCH OBJECTIVES Background For many years, the rat has been an important experimental model for studying human diseases such as hypertension, cancer, behavioral disorders, diabetes, drug abuse, alcoholism, cranio-facial and dental disorders, and obesity, among others. The rat offers many advantages in this regard because of the existing body of knowledge about physiological mechanisms, the ease of breeding, and the ability to generate inbred congenic rat strains. Because of its large size in comparison with the mouse, the rat is widely used in studies of anatomy, physiology and pharmacology of the chemical senses and more generally, of intricate neuronal pathways in the brain. The usefulness of the rat as a model system is hampered, however, by the lack of high-resolution genetic and physical maps of the rat genome. A number of groups working with the rat as a model system have constructed useful genetic maps, but only in genomic regions of interest. Investigators attempting to locate particular genes in an unmapped region must construct detailed maps, thus slowing the progress of their research. Such extensive individual mapping efforts would no longer be required if a high resolution genetic map were available. The technology to construct such maps has been developed through efforts that have developed 5,000 marker genetic maps of the human and mouse genomes respectively. This technology can now be applied in a cost-effective and efficient way to construct maps of the genomes of other mammals. Similar progress has also been made in the technology for building another genomic resource that is useful in gene analysis, a large insert clone library. A number of vectors have been developed for making libraries of large DNA fragments. Additionally, there is considerable information about the depth of coverage needed to maximize the usefulness of a clone library and the best ways to format it for wide usage. The present initiative, to build a genetic map and a large-insert clone library for the rat genome, is intended to take advantage of recent technological advances and experience in mapping and library construction in order to begin constructing mapping resources of use for studies involving the rat. Objectives and Scope The first objective of this RFA is to solicit applications for research projects that will use state-of-the-art methods, and will develop any necessary new technologies, to construct a genetic map of the rat genome consisting of 6,000 easy-to-use polymorphic markers, and to do so rapidly, efficiently and at low cost. Applications are also being sought to construct a high quality, large-insert clone library of the rat genome that can be generally used by many investigators as a physical resource for obtaining DNA in any region of interest. Applications submitted in response to this RFA to accomplish either one or both of these goals will be investigator-initiated and should be forward-thinking, proposing a project design that will rapidly incorporate new approaches to map and library construction. In developing the research strategy, applicants should consider and address the following: Construction of the Genetic Map The rat strains to be used for constructing the map. As this RFA is an interdisciplinary effort involving several of the Institutes and Centers of the NIH, rat strains that will be most useful to the widest community of researchers should be selected. A clear justification for selection of the strains and how they will be used must be presented. After the map has been constructed, applicants may wish to consider genotyping the one available battery of recombinant inbred rats (J. Kunes and J. Zicha, Physiol Res 42:225-233, 1993) with a subset of markers at intervals of 5 cM or less; The strategy for map construction. The completed map should consist of at least 6,000 polymorphic markers displaying a high degree of variation among strains that are commonly used in biomedical research, yielding a map of 0.43 cM or less average resolution. The research plan should include a rationale for the type of marker that will be used, the number of markers that will be mapped at high odds and a realistic and well-justified estimate of the unit cost for making and mapping a genetic marker in the rat. Although the human and mouse genetic mapping efforts have been highly successful in making maps of microsatellite repeats, applications for this RFA are not limited microsatellites. Other types of markers are currently being developed and a plan to build a useful map of the rat genome using such markers would be appropriate as long as completion of a high quality, widely useful genetic map of the rat that meets the criteria described above is a reasonable expectation during the five- year period of the proposed grant and the technology for assaying the markers is or can be economically made available to the rat research community. The current status of the rat genome map should be discussed and the possibility of integrating existing markers addressed. The overall mapping plan must include a discussion of expected, quantifiable milestones that can be used to assess yearly progress, e.g., the number of markers that can be generated and mapped each year; Data management. Projects of this magnitude require informatics support for management of the data and map construction. A thorough description of the informatics plan for the project will be critical in evaluation of the proposal. Construction of a Large Insert Library The strategy for construction of a large insert clone library. Selection of the vector and source of DNA with which this library will be built should be justified in terms of its usefulness to research employing the rat model. Issues of library depth, representation, and format should also be discussed. Prior experience in building such libraries and the rationale for the strategy selected should be thoroughly discussed. Data and Resource Sharing Plans for the availability and distribution of the data and resources developed through the grant. The sharing of materials and data in a timely manner has been an essential element in the rapid progress made in construction and use of the human and mouse genetic maps. Public Health Service (PHS) policy requires that investigators make the results and accomplishments of funded activities publicly available. The advisors to the NIH and the DOE genome programs have developed a set of "NIH-DOE Guidelines for Access to Mapping and Sequencing Data and Material Resources" that address the special needs of genome research. These guidelines call for material and information from genome research to be made available within six months of the time the data or materials are generated; more rapid sharing is encouraged and has become the norm in the genome community. Applications submitted in response to this RFA should include detailed plans for sharing data and materials generated through the grant. Where appropriate, grantees may work with the private sector in making unique resources available to the larger biomedical research community at a reasonable cost. The plans proposed for sharing and data release will be reviewed for adequacy by NIH staff prior to award of the grant and the proposed sharing plan will be made a condition of the award. Investigators may request funds to defray the costs of sharing materials or submitting data in their application. Such requests must be adequately justified. Post-award Management During the course of the grant period, mapping and cloning technologies will improve, genomic technologies will evolve, and the rate of progress and focus of work supported by the grant(s) may change. It is expected that the Principal Investigator will make any necessary adjustment in scientific direction to accommodate the changing environment. In order to ensure that the project(s) remains focused on appropriate goals, incorporates new technological advances and makes sufficient progress, scientific and programmatic visits to the grantee will be conducted at a frequency to be negotiated with the awardee. In addition, Applications should include travel funds for the P.I. and the other investigators in the grant to meet yearly with NIH staff in the Washington area. LETTER OF INTENT Prospective applicants are asked to submit, by February 15, 1995, 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. Any applicant planning to submit an application for more than $500,000 direct cost per year must have contacted one of the NIH staff listed under INQUIRIES before submitting the application or it will be returned to the applicant. 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 IC 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: James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 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 Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. 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. 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. Scheirer at the address listed under INQUIRIES. Applications must be received by March 15, 1995. 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 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 for completeness by DRG and for responsiveness to the RFA by NIH program staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIH 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. 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 NHLBI and the NCHGR. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. All applicants will receive a summary statement consisting of the reviewer's written comments essentially unedited. Summary Statements for competitive applications will also contain a summary of the review committee's discussion. The second level of review will be provided by the National Heart, Lung, and Blood Advisory Council and by the National Advisory Councils/Boards of the other Institutes and Centers involved. Review criteria will include the following: o scientific and technical merit of the research proposed to meet the objectives of this RFA; o the value of the proposed map to the scientific community; 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 the resources and technology necessary to perform the research; o adequacy of facilities and resources and the level of institutional commitment; o appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The anticipated date of award is September 30, 1995. Factors that will be used to make award decisions are as follows: o Quality of the proposed project as determined by peer review; o Promise of the proposed program to accomplish the goals of this RFA and address the needs of the participating Institutes and Centers as regards their interest in the rat as a model organism; o Nature and extent of the plans for sharing distributing data and resources in a timely manner; o 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 inquiries regarding programmatic issues to: Stephen C. Mockrin, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 4C10 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1613 FAX: (301)402-2044 Email: SM60d@nih.gov Jane L. Peterson, Ph.D. Mammalian Genomics Branch National Center for Human Genome Research Building 38A, Room 610, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: jane_peterson@occhost.nlm.nih.gov Grace L. Shen, Ph.D, Hematology and Oncology for Extramural Program National Cancer Institute Executive Plaza North, Room 501 6130 Executive Boulevard, MSC 7381 Rockville, MD 20892-8531 Telephone: (301) 496-7815 FAX: (301) 496-8656 Email: sheng@dcbdcep.nci.nih.gov Ljubisa Vitkovic, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11C-06 Rockville, MD 20857 Telephone: (301) 443-5288 FAX: (301) 443-4822 Email: lv5@cu.nih.gov Steven Kaminsky, Ph.D. Developmental Biology Genetics and Teratology Branch National Institute of Child Health and Human Development Building 61E, Room 4B01D, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: tky@cu.nih.gov Joan T. Harmon, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN-18G, MSC 6401 Bethesda, MD 20892-6401 Telephone: (301) 594-7565 FAX: (301) 594-9011 Email: joanh@dvsgate.niddk.nih.gov Louise Ramm, Ph.D. Deputy Director National Center for Research Resources Building 12A, Room 4009, MSC 5662 Bethesda, MD 20892-5662 Telephone: (301) 496-6023 or (301) 594-7906 FAX: (301) 402-0006 Email: louiser@ep.ncrr.nih.gov Theresa Lee, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-19 Rockville, MD 20857 Telephone: (301) 443-6300 FAX: (301) 594-6043 Email: tlee@aoada.ssw.dhhs.gov Robert Karp, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4223 FAX: (301) 594-0673 Email: rkarp@willco.niaaa.nih.gov Ralph F. Naunton, M.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite 400C 6120 Executive Boulevard, MSC 7180 Rockville, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: nauntonr%nidcd-eps%nih@fedtcp.ninds.nih.gov Norman S. Braveman, Ph.D. Assistant Director for Program Development National Institute of Dental Research Building 45, Room 4AN24B, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8381 Email: bravemann@de45.nidr.nih.gov William A. Suk, Ph.D., M.P.H. 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 FAX: (919) 541-2843 Email: suk@niehs.nih.gov Direct inquiries regarding fiscal matters to: Mr. Thomas G. Turley Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A12B Bethesda, MD 20892 Telephone: (301) 594-7434 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837, Heart and Vascular Diseases. 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. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-95-002 - V23(43) 12/09/94 Date: 16 Dec 1994 16:45:33 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 707 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcbd$9ui@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AA95002 AA-95-002 P1O1 *************************************** QTL MAPPING OF ALCOHOL-RELATED BEHAVIORAL TRAITS IN RODENTS NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFA: AA-95-002 P.T. 34; K.W. 0404003, 0414015, 1002019 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: June 1, 1995 Application Receipt Date: July 19, 1995 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research applications to map quantitative trait loci (QTL) influencing rat and mouse behavioral traits that model human behavioral traits predisposing to alcoholism. Mapping of such QTL will permit subsequent testing of human homologues of these genes for linkage to alcoholism in human pedigrees. Such a test will help to establish which animal behavioral traits are most relevant to human alcoholism. Mapping of the QTL will also serve as a prologue to the isolation of the relevant genes and the identification of the products they encode. This approach can provide a novel route to elucidating the physiological mechanisms for predisposition to alcoholism and to developing intervention strategies to diminish harmful effects of alcohol. 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), QTL Mapping of Alcohol-Related Behavioral Traits in Rodents, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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, 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) (R29) Awards. MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST (R29) Award. Applicants for R01s may request support for up to five years. In FY 1994, the average total cost per year for new R01s funded by the NIAAA was approximately $200,000. 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. FIRST Award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST Awards cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Potential applicants for FIRST Awards should obtain copies of the FIRST program announcement (revised February 1994) from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, Maryland 20852, telephone: 301-468-2600 or 1-800-729-6686. Program project grant applications (P01) will not be accepted for this RFA. Applicants may submit applications for Investigator-Initiated Interactive Research Project Grants (IRPG) (refer to PA-94-086, Vol. 23, No. 28, July 29, 1994). Interactive Research Project Grants require the coordinated submission of related research project grant (R01) and, to a limited extent FIRST Award (R29) applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. These applications must share a common theme and describe the objectives and scientific importance of the interchange of, for example, ideas, data, and materials among the collaborating investigators. A minimum of two independent investigators with related research objectives may submit concurrent, collaborative, cross-referenced individual R01 and R29 applications. Applicants may be from one or several institutions. Further information on these and other grant mechanisms may be obtained from the program staff listed under INQUIRIES. FUNDS AVAILABLE It is estimated that up to $1.1 million in total costs will be available for approximately six grants under this RFA in FY 1996. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. The funds set aside for this RFA are intended to support all aspects of projects funded, except for genotyping of the animals generated during the course of the research, which will be supported by a separately awarded contract (see SPECIAL REQUIREMENTS, below). Although this program is provided for in the financial plan of NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. The earliest possible award date is March 1, 1996. RESEARCH OBJECTIVES Genetic Basis of Alcoholism Alcoholism has been recognized for over a century as a familially transmitted condition. Over the past 25 years, considerable evidence from family, twin, and adoption studies supports important roles for both genes and environment in its etiology in both men (Cloninger, et al., 1981; Merikangas, 1990; McGue, et al. 1992) and women (Kendler, et al. 1992). The specific etiological factors underlying susceptibility to alcoholism, however, remain unknown. Ongoing efforts to discover genes linked to alcoholism in human pedigrees are challenged by the heterogeneous, polygenic nature of alcoholism, along with the incompletely understood role of the environment in its etiology (Aston and Hill, 1990). These efforts could be greatly bolstered by a strategy taking advantage of powerful genetic methods permitting identification of genes influencing ethanol-related behavior in experimental animals (Lander and Botstein, 1989; Gora- Maslak, et al., 1991). Human homologues of these genes could then be tested directly for linkage to alcoholism in human pedigrees. The recent large increase in the density of markers on the mouse genetic map (Copeland, et al., 1993), along with the development of new and more powerful methods of data analysis (Lander and Botstein, 1989), have now made it possible to map individual quantitative trait loci (QTL), the genes contributing jointly to the determination of genetically complex traits (such as behavior) (Gora-Maslak, et al., 1991). Since mapped genes can be isolated and their encoded products characterized, QTL mapping offers a powerful reductionistic approach for dissecting the complex physiological bases of alcohol-related behavior. A detailed human-mouse syntony map can accurately predict the map location of potential human homologues of mouse genes (Nadeau, et al., 1992), so that these predicted loci can then be tested for linkage to alcoholism in human alcoholic pedigrees. This strategy would permit the direct application of knowledge gained from an animal behavior genetic study, for which behavioral measures are precisely defined and powerful genetic techniques can be brought to bear, to a human genetic study of alcoholism. A finding of linkage would, moreover, provide additional evidence for the relevance of the animal behavior under study to human alcoholism. Human Behavioral Indicators of Predisposition to Alcoholism Because family history of alcoholism is a significant risk factor for alcoholism (Cotton, 1979), researchers have examined psychological, biological, and behavioral characteristics that distinguish children of alcoholics from children of non-alcoholics as a means of identifying indicators of vulnerability to alcoholism. The most prominent theories of vulnerability to alcoholism have centered on temperament, baseline sensitivity, and acute tolerance to alcohol. Temperament models of vulnerability to alcoholism propose that deviations in dispositional traits mediate transmission of alcoholism (Tarter, 1991; Cloninger, 1987). According to Tarter, who used Rowe and Plomin's (1977) six dimensions of temperament, children at high risk for developing alcoholism have traits such as high behavioral activity, low attention span and persistence, low soothability, high emotionality, and low sociability. These disturbances of temperament in children of alcoholics are attributed to neurological dysfunction in the prefrontal, limbic, and midbrain areas. This theory is supported by observations of a number of differences between children of alcoholics and children of nonalcoholics, including increased incidence of psychopathology (attention deficit hyperactivity disorder, childhood conduct disorder, anxiety disorders and depression, antisocial personality disorder), behavioral disturbances (impulsiveness, aggression, emotionality), neuropsychological deficits (abstraction/conceptualization, verbal ability), and neurophysiological variations (reduced amplitude of the P3 component of event-related potentials) (see Tarter, 1991; Sher, 1991 for reviews). In a similar vein, Cloninger's model of Type 1 and Type 2 alcoholism (Cloninger, 1987) is based on temperamental differences (novelty seeking, harm avoidance, reward dependence), which are related to selective neurological substrates and predispose an individual to certain types of alcoholism. For example, Type 2 alcoholics are high in novelty seeking, associated with impulsiveness, distractibility, and positively motivated drinking. Type 1 alcoholics, on the other hand, are high in harm avoidance and reward dependence associated with anxiety, shyness, emotional dependence, and negatively motivated drinking (i.e., escape from dysphoric feelings). The sensitivity hypothesis of vulnerability to alcoholism, first elaborated by Schuckit and his colleagues in the early 1980s, postulated that children of alcoholics are less sensitive to the subjective intoxicating effects of alcohol, and therefore, are susceptible to drinking excessively (Schuckit, 1980, 1984). However, subsequent studies designed to test this hypothesis demonstrated opposite effects, i.e., children of alcoholics were more sensitive to the reinforcing effects of alcohol as measured by muscle relaxing, stress-dampening, electroencephalographic and mood effects (see Sher, 1991 for review). A recent interpretation proposed by Newlin and Thomson (1990) may resolve this conflict. Compared to sons of nonalcoholic fathers, sons of alcoholic fathers show greater acute sensitivity to the reinforcing effects of alcohol (euphoria, muscle relaxation, stress-response dampening) on the ascending limb of the blood alcohol curve, and less sensitivity (greater acute tolerance) to the aversive effects of alcohol (nausea, dysphoria) on the descending limb of the blood alcohol curve. Measuring Animal Behaviors Related to Human Traits Predicting Alcoholism Investigators are now mapping QTL influencing various ethanol-related behaviors in mice, including preference for drinking, sensitivity to sedation, locomotor activation, hypothermia, and withdrawal severity (for review, see Crabbe, et al., 1994). More recently, they have begun mapping genes influencing more complex behaviors, such as acute functional tolerance to ataxia (Crabbe, et al., 1994a) and hypothermia (Crabbe, et al., 1994b), conditioned place preference (a measure of reinforcement) (Cunningham and Malott, 1994), and conditioned taste aversion (a measure of aversive effects) (Risinger and Cunningham, 1994). Aspects of more complex rodent behaviors could conceivably be homologous to human traits predisposing to alcoholism. Some of the corresponding assays could, in principle, be adapted for QTL mapping. Examples are given below. (These examples are for illustrative purposes only, and are not intended to exclude other behavioral tests from this RFA.) Tests that assess intrinsic traits of temperament or personality predisposing humans to alcoholism, such as impulsiveness, novelty seeking, aggression, hyperactivity, emotionality, anxiety, and stress reactivity, can be administered to rodents. Impulsiveness in individuals at risk for alcoholism has been attributed to prefrontal- limbic brain dysfunction (Tarter, 1991) and is comparable to difficulties in response inhibition observed in rodents with prefrontal lesions (see Kolb, 1984 for review). Evidence of impaired response inhibition in rodents has been measured by reversal learning tasks (i.e., the animal first learns to respond to a particular stimulus or location for a reward, and then must reverse its response to a different place or stimulus), tests of response extinction (a previously rewarded response is no longer rewarded), or go/no go tasks (reward is presented for responding to a stimulus on "go" trials, and for not responding on "no go" trials) (Kolb, 1984; Sakurai and Sugimoto, 1985). Animals with deficits in response inhibition have difficulty shifting responses on reversal tasks, continue responding when rewards are no longer presented, and fail to suppress responding on "no go" trials. Research on alcohol and aggression in humans and animals has focused on whether alcohol consumption increases violent/ aggressive behavior toward family members, peers, or rivals (see Miczek, et al., 1993 for review). However, whether a history of antisocial personality or aggressive behavior predisposes a person to excessive alcohol consumption has received little study. Measures of aggressive behavior in rodents that might reflect aspects of human antisocial behavior include social interaction/social conflict paradigms, such as isolation-induced aggression between male pairs, resident-intruder encounters, and possibly frustration-induced aggression (omission of reward) (Cairns, et al., 1983; Miczek, et al., 1993; Brain, et al., 1993). Measures of other traits potentially serving as markers of human alcoholism, such as anxiety, emotionality, activity level, and novelty-seeking, could be applied to rodents. Novelty or "sensation- seeking" can be measured by nose-poke or hole board behavior in which the animal places its nose or head into a board with equally spaced holes. Activity level can easily be measured with activity wheels or by the number of boxes crossed in an open field. Hole board behavior and exploratory open field activity, along with number of defecations and rearings in the open field, have also been used to quantitate levels of anxiety and emotionality. Other experimental paradigms for measuring anxiety include conflict paradigms, acoustic startle response, and elevated plus-maze (see Crawley, 1985; Shepard, 1986; Heilig, et al., 1994; Stout and Weiss, 1994 for reviews of all of these paradigms). A further related behavior is stress reactivity, which could be measured by responses to various stressors (social stress, isolation, early weaning), such as changes in vocalization pattern, disruption of circadian rhythms, or autonomic responses such as changes in blood pressure or heart rate (see Pohorecky, 1990; Brown, et al., 1991 for reviews). Acute behavioral tolerance to a single challenge dose of alcohol can be demonstrated in animals by comparing the extent of functional impairment at a given blood alcohol concentration on the ascending limb of the blood alcohol curve with the extent of impairment when the same alcohol concentration is reached on the descending limb. The development of acute tolerance within a single session to alcohol's effects such as motor impairment, hypothermia, and operant responding has been shown by several studies (LeBlanc, et al., 1975; Crabbe, et al., 1994b; Le, et al., 1992; Hiltunen and Jarbe, 1992). Finally, because frequency and amount of alcohol consumed are significant discriminators of alcoholic subtypes (Babor, et al., 1992; Morley and Skinner, 1986), measures of temporal patterns of alcohol consumption in rodents may be informative behavioral markers. Using operant techniques, distinctive temporal patterns of alcohol consumption have been demonstrated in the selectively bred alcohol- preferring and -nonpreferring rats (Schwarz-Stevens, et al., 1991). Such techniques could possibly be adapted to permit QTL mapping. Methodological Considerations Most QTL mapping of behavioral traits has been done in mice because of the well-developed genetic map available for this species. However, the rat genome map is now undergoing rapid development (Yamada, et al., 1994; Serikawa et al., 1992) and has already proven suitable for QTL mapping (Lindpaintner, 1992). Because many interesting behavioral paradigms have been developed in rats to study ethanol related behaviors, NIAAA encourages investigators studying rat behavior to respond to this RFA. While the choice of animal strains for study is an important feature of experimental design, applicants are encouraged to consider using any of a wide variety of strains, rather than confining their attention only to those already used extensively in alcohol research. Applicants are also encouraged to consider using existing batteries of recombinant inbred (RI) and recombinant congenic (RC) strains. Applicants are encouraged (when cost and experimental considerations permit) to test more than one behavioral paradigm on the same group of animals. Applicants may also wish to consider neurochemical measurements (e.g., receptor binding studies, in situ hybridization, other histological measurements) on the same group of animals. Such studies offer the prospect of a rigorous determination of genetic correlations among multiple behaviors and neurochemical parameters, as well as mapping of the genes responsible for those correlations. Some behavioral paradigms of great potential interest may be so complex as to preclude measurements on the hundreds of animals required for QTL mapping. Investigators working with such paradigms are strongly encouraged to attempt modifying them so as to permit measurements on hundreds of animals, without degrading their informativeness about the principal aspect of the behavior under study. SPECIAL REQUIREMENTS This RFA is intended to support the genetic analysis of animal behaviors not previously analyzed, in the hope that these behaviors may usefully model human traits related to predisposition to alcoholism. Investigators wishing to respond to this RFA who lack expertise in genetic analysis should seek collaboration with investigators experienced in QTL mapping, insofar as such experience will prove essential for proper study design and data analysis. To support as economically as possible the large amount of genotyping required for this research, NIAAA will award a separate contract for genotyping of animals generated by the research supported under this RFA. Awardees under this RFA who desire NIAAA funding for the genotyping of the animals they generate are expected to use the services provided under this contract. Awardees will be expected to attend one joint meeting per year in or near Washington, DC, in order to review progress, and should request sufficient funds in their budgets to support such attendance. LETTER OF INTENT Prospective applicants are asked to submit, by June 1, 1995, 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 of 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 a subsequent application, the information that it contains allows NIAAA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Mark Green, Ph.D. Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 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 Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrators named below under INQUIRIES. The RFA label available in the PHS (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. Page limits and limits on size of type are strictly enforced. Applicants for FIRST Awards (R29) are reminded that such applications must include three letters of reference. Non-conforming applications will be returned without being reviewed. 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: Mark Green, Ph.D. National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Applications must be received by July 19, 1995. 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 RFA 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 be prepared as a revised application and include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG 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 that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Institute in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of alcohol research grant applications will include the following: 1. The scientific, technical, or medical significance and originality of the proposed research. 2. The appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 5. The reasonableness of budget estimates and duration in relation to the proposed research. 6. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 7. Where applicable, the adequacy of procedures to protect or minimize effects on animal subjects and the environment. The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement (revised February 1994). AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the proposal as determined by peer review, NIAAA programmatic needs and balance, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding genetic aspects of proposed research to: Robert W. Karp, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4223 FAX: (301) 594-0673 Email: rkarp@willco.niaaa.nih.gov Direct inquiries regarding behavioral aspects of proposed research to: Ellen Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4223 FAX: (301) 594-0673 Email: ewitt@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Joseph Weeda Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Email: jweeda@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 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. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References Aston CE, Hill SY (1990): Segregation analysis of alcoholism in families ascertained through a pair of male alcoholics. Am J Hum Genet 46:879-887. Babor TF, Hofmann M, DelBoca FK, Hesselbrock V, Meyer RE, Dolinsky ZS, Rounsaville B (1992): Types of alcoholics, I. Evidence for an empirically derived typology based on indicators of vulnerability and severity. Arch Gen Psychiatry 49:599-608. Brain PF, Miras RL, Berry MS (1993): Diversity of animal models of aggression: their impact on the putative alcohol/aggression link. J Stud Alc Supp No. 11, pp. 140-145. Brown MR, Koob GF, Rivier C (1991): Stress: Neurobiology and Neuroendocrinology. New York: Marcel Dekker. Cairns RB, MacCombie DJ, Hood KE (1983): A developmental genetic analysis of aggressive behavior in mice: I. Behavioral outcomes. J Comp Psych 97:69-89. Cloninger CR, Bohman M, Sigvardsson (1981): Inheritance in alcohol abuse. Arch Gen Psychiatry 38:861-868. Cloninger CR (1987): Neurogenetic adaptive mechanisms in alcoholism. Science 236:410-416. Copeland NG, Jenkins NA, Gilbert DJ, Eppig JT, Maltais LJ, Miller JC, Dietrich WF, Weaver A, Lincoln SE, Steen RG, Stein LD, Nadeau JH, Lander ES (1993): A genetic linkage map of the mouse: current applications and future prospects. Science 262:57-66. Cotton NS (1979): The familial incidence of alcoholism. J Stud Alcohol 40:89-116. Crabbe JC, Belknap JK, Buck KJ (1994a): Genetic animal models of alcohol and drug abuse. Science 264:1715-1723. Crabbe JC, Belknap JK, Mitchell SR, Crawshaw LI (1994b): QTL mapping of genes influencing sensitivity and tolerance to ethanol hypothermia in mice. Alcohol Clin Exp Res 18:451, abstract no. 191. Crawley JN (1985) Exploratory behavior models of anxiety in mice. Neurosci Biobehav Rev 9:37-44. Cunningham CL, Malott DH (1994): Ethanol-induced conditioned place preference in the BXD RI strains: behavioral and QTL analyses. Alcohol Clin Exp Res 18:451, abstract no. 188. Gora-Maslak G, McClearn GE, Crabbe JC, Phillips TJ, Belknap JK, Plomin R (1991): Use of recombinant inbred strains to identify quantitative trait loci in psychopharmacology. Psychopharmacology 104:413-424. Heilig M, Koob GF, Ekman R, Britton KT (1994): Corticotropin- releasing factor and neuropeptide Y: role in emotional integration. Trends Neurosci 17:80-85. Hiltunen AJ, Jarbe TUC (1992): Acute and chronic ethanol tolerance: operant behavior in naive and ethanol tolerant rats. Psychopharmacology 107:511-516. Kendler KS, Heath AC, Neale MC, Kessler RC, Eaves LJ (1992): A population-based twin study of alcoholism in women. JAMA 268:1877-1882. Kolb B (1984): Functions of the frontal cortex of the rat: a comparative review. Brain Res Rev 8:65-98. Lander ES, Botstein D (1989): Mapping Mendelian factors underlying quantitative traits using RFLP linkage maps. Genetics 121:185-199. Le AD, Mana M, Quan B, Kalant H (1992): Differential development of acute tolerance to the motor impairment and anticonvulsant effects of ethanol. Psychopharmacology 109:107-111. LeBlanc AE, Kalant H, Gibbins RJ (1975): Acute tolerance to ethanol in the rat. Psychopharmacologia 41:43-46. Lindpaintner K (1992) Genetic linkage analysis in hypertension: principles and practice. J Hypertens 10:121-124. McGue M, Pickens RW, Svikis DS (1992): Sex and age effects on the inheritance of alcohol problems: A twin study. J Abnorm Psych 101:3-17. Merikangas KR (1990): The genetic epidemiology of alcoholism. Psychological Med 20:11-22. Miczek KA, Weerts EM, DeBold JF (1993): Alcohol, aggression, and violence: biobehavioral determinants. In Martin SE (ed), NIAAA Research Monograph No. 24, Alcohol and Interpersonal Violence: Fostering Multidisciplinary Perspectives. NIH Publication No. 93-3496, National Institutes of Health, Rockville, MD. Morley LC, Skinner HA (1986): Empirically derived classifications of alcohol-related problems. In Galanter M (ed), Recent Developments in Alcoholism, Vol. 5. New York: Plenum Press, pp. 145-168. Nadeau JH, Davisson MT, Doolittle DP, Grant P, Hillyard AL, Kosowsky MR, Roderick THE (1992): Comparative map for mice and humans. Mamm Genome 3:480-536. Newlin DB, Thomson JB (1990): Alcohol challenge with sons of alcoholics: a critical review and analysis. Psychological Bulletin 108:383-402. Pohorecky LA (1990): Interaction of ethanol and stress: research with experimental animals--an update. Alcohol Alcoholism 25:263-276. Risinger FO, Cunningham CL (1994): Identification of genetic markers associated with sensitivity to ethanol induced conditioned taste aversion. Alcohol Clin Exp Res 18:451, abstract no. 187. Rowe D, Plomin R (1977): Temperament in early childhood. J Pers Assess 41:150-156. Sakurai Y, Sugimoto S (1985): Effects of lesions of prefrontal cortex and dorsomedial thalamus on delayed go/ no-go alternation in rats. Behav Brain Res 17:213-219. Sher KJ (1991): Children of Alcoholics. Chicago: University of Chicago Press. Schuckit MA (1980): Self-rating of alcohol intoxication by young men with and without family histories of alcoholism. J Stud Alcohol 41:242-249. Schuckit MA (1984): Subjective responses to alcohol in sons of alcoholics and controls. Arch Gen Psychiatry 41:879-884. Schwarz-Stevens K, Samson HH, Tolliver GA, Lumeng L, Li TK (1991): The effects of ethanol initiation procedures on ethanol reinforced behavior in the alcohol-preferring rat. Alcoholism Clin Exp Res 15:277-285. Serikawa T, Kuramoto T, Hilbert P, Mori M, Yamada J, Dubay CJ, Lindpainter K, Ganten D, Guenet JL, Lathrop GM, et al. (1992): Rat gene mapping using PCR-analyzed microsatellites. Genetics 131:701-21. Shepard RA (1986): Neurotransmitters, anxiety, and benzodiazepines: a behavioral review. Neurosci Biobehav Rev 10:449-461. Stout JC, Weiss JM (1994): An animal model for measuring behavioral responses to anxiogenic and anxiolytic manipulations. Pharmacol Biochem Behav 47:459-465. Tarter RE (1991): Developmental behavior-genetic perspective of alcoholism etiology. In Galanter M (ed), Recent Developments in Alcoholism, Volume 9. New York, Plenum Press, pp. 69-85. Yamada J, Kuramoto T, Serikawa T (1994): A rat genetic linkage map and comparative maps for mouse or human homologous rat genes. Mamm Genome 5:63-83. From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA RR-95-003 - V23(43) 12/09/94 Date: 16 Dec 1994 16:45:28 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 448 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcb8$9tl@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA RR95003 RR-95-003 P1O1 *************************************** EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFA: RR-95-003 P.T. 02; K.W. 0710030 National Center for Research Resources Letter of Intent Receipt Date: January 20, 1995 Application Receipt Date: March 9, 1995 PURPOSE The National Center for Research Resources (NCRR) is authorized under Public Law (PL) 103-43, Sections 481A and 481B of the Public Health Service Act (PHS), as amended by the National Institutes of Health (NIH) Revitalization Act, to "make grants to public and nonprofit private entities to expand, remodel, renovate or alter existing research facilities or construct new research facilities" for biomedical and behavioral research and research training. The Appropriations Act for the Department of Health and Human Services for Fiscal Year 1995 (PL 103-333) provides $20 million in the budget of the NCRR of the NIH for extramural facilities construction grants, to be awarded competitively, with special provisions made for institutions of emerging excellence, designated under section 739 of the PHS Act as revised in PL 102-408, and the Regional Primate Research Centers (RPRCs). The NCRR is issuing a Request for Applications (RFA) RR-95-003 for support of construction and renovation of facilities for biomedical and behavioral research and research training. ELIGIBILITY REQUIREMENTS Under Section 481A of the PHS Act, domestic, non-Federal, public and private non-profit institutions, organizations, and associations that conduct or support biomedical or behavioral research are eligible to apply, including, for example, allied health professional schools. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Only applications submitted in response to this RFA will be eligible for possible award under this RFA. Applications submitted previously to the NIH, but not awarded, must be submitted again to compete for these awards. In addition to any applications submitted from RPRCs or recipients of Fiscal Year 1994 PHS Centers of Excellence awards, an institution may submit only one application in response to this specific announcement. For example, two components of the same institution, e.g., a medical school and a dental school, even if separated geographically, may not submit separate applications. MECHANISM OF SUPPORT This RFA is a one-time solicitation that will use the NIH research facilities construction grant (C06). 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 this RFA may not exceed one year and no indirect costs or continuation costs will be awarded. The anticipated award date is September 30, 1995. Matching funds will be required. Under Section 481A, up to 50 percent of the necessary and allowable costs of a project may be awarded, or 40 percent of costs proportionate to use in a multi- purpose facility. Under Section 481B, RPRCs may receive up to 80 percent of necessary and allowable costs. The maximum award amount will be $2.5 million. Applications proposing a Federal share of less than $500 thousand or more than $2.5 million will not be accepted. Because the nature and scope of the activities proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FUNDS AVAILABLE Based on the Fiscal Year 1995 appropriation, up to $20 million will be available for this initiative. Up to 25 percent of these funds are targeted for institutions of emerging excellence, and up to $2.5 million of the total amount available is set aside for the purpose of improving the research facilities of the RPRCs as outlined in Section 481B of Title IV of the PHS Act as amended. It is anticipated that ten to 20 new awards at different levels will be made. RESEARCH OBJECTIVES The main objective of this program is to facilitate the conduct of PHS-supported biomedical and behavioral research by supporting the costs of designing and constructing non-Federal basic and clinical research facilities to meet the biomedical or behavioral research, research training, or research service needs of an institution or a research group at an institution, and for the purchase of essential associated fixed research equipment. Applications are particularly encouraged from institutions of emerging excellence as defined in the PHS Act, Section 739 as amended by PL 102-408, as are applications that propose to (a) broaden the scope of research and research training programs of the institutions by promoting interdisciplinary research; research on emerging technologies (including those involving novel analytical techniques or computation methods); or other novel research mechanisms or programs; (b) broaden the scope of research and research training programs of qualified institutions by promoting genomic research with an emphasis on interdisciplinary research, including research related to pediatric investigations, oral health, and eye research. Specialized research support facilities such as cell repositories will also be considered for support. Facility construction that may be supported under this program includes construction of new facilities, additions to existing buildings, completion of uninhabitable "shell" space in new or existing buildings, and major alterations and renovations. Support for instrumentation or equipment that usually would be requested as part of a research project grant will not be provided, and neither land acquisition nor off-site improvements will be supported. LETTER OF INTENT Prospective applicants are asked to submit, by January 20, 1995, a letter of intent that includes a brief description of the type of facility proposed and the areas of research or research support to be conducted in the proposed facility, the name, address, and telephone number of the Principal Investigator, 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 a subsequent application, the information that it contains allows NCRR staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Charles L. Coulter Director, Research Facilities Improvement Program National Center for Research Resources 5333 Westbard Avenue, Room 8A15 Bethesda, MD 20892 Telephone: (301) 594-7952 APPLICATION PROCEDURES Applicants must use Standard Form 424, "Application for Federal Assistance." Application forms and special instructions for completing them must be requested from the grants management official listed under INQUIRIES. Individuals considering applying are advised to consult with appropriate officials at their institution before completing the application forms. Submit a signed, typewritten original of the application, including appendices, and two signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Applications must be received by March 9, 1995. 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 RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. o Intergovernmental Review -- Executive Order 12372 Applicants are required to comply with Executive Order (E.O.) 12372 as supplemented by DHHS 45 CFR Part 100, Intergovernmental Review of Department of Health and Human Services Programs and Activities. E.O. 12372 sets up a system for State and local government review of proposed Federal assistance applications. Applicants (other than federally-recognized Indian tribal governments) should contact their State Single Point of Contact (SPOCs) as early as possible to alert them to the prospective applications and receive any necessary instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC of each affected State. A current list of SPOCs is included in the application kit. The SPOC must be given 60 days to review a construction grant application. Applicants are to provide the SPOC with a copy of the application NOT LATER THAN the time the application is submitted to the Division of Research Grants, NIH. Applications submitted to NIH in response to this solicitation must contain either SPOC comments or documentation indicating the date on which the application was submitted to the SPOC for review. The SPOC comment period ends 60 days after the application receipt date. The granting agency does not guarantee to "accommodate or explain" for State process recommendations it receives after that date. All SPOC comments must be forwarded to both the applicant and to the NCRR fiscal contact given below. If comments are provided by the SPOC, the applicant may wish to submit to the NIH a statement of its reaction to the comments and any appropriate changes to its application. If no response is received from the SPOC by the end of the 60 days allotted for review of the application, the applicant must notify the NIH that no response was received. o Public Disclosure Applicants must also make a public disclosure of the project by publication and describe its environmental impact at the time the SPOC is notified. It is suggested that the notice be published in a large-circulation newspaper in the area. This public disclosure is required by Section 102 of the National Environmental Policy Act (NEPA) of 1969 and by Federal Executive Order 11514. One example of a suitable disclosure statement follows: "PUBLIC NOTICE" "Notice is hereby given that the Uptown Medical School proposes to construct additional space, partially utilizing Federal funds. The proposed construction project is the addition of 2,700 square feet connected to the existing Allen Building, which is located at 5333 Main Street, Downtown, Ohio. "The Medical School has evaluated the environmental and community impact of the proposed construction. There will be construction noise and increased construction traffic during the construction period. No significant permanent environmental impacts are foreseen. All building permits and zoning approvals have been obtained. "In accordance with Federal Executive Order 11514, which implements the NEPA of 1969, any individual or group may comment on, or request information concerning, the environmental implications of the proposed project. Communications should be addressed to the Office of Planning, Uptown Medical School, and be received by (date). The Federal grant application may be reviewed at the Office of the Dean, School of Medicine, 5333 Main Street, during working hours." o Design Standards Design requirements are imposed to protect the health and safety of persons using the proposed facility, assure that the new facility is accessible to and useable by the physically handicapped, control the project's impact on the natural environment, conserve energy resources, achieve economy in construction costs, and protect against natural disasters such as earthquake and flood. Therefore, the documents listed under REFERENCES at the end of the RFA must be consulted, and the design requirements incorporated in the development, review, and evaluation of all drawings and specifications. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants and responsiveness by NCRR. Those applications judged to be unresponsive, incomplete, or ineligible will be returned to the applicant. Applications that are complete and responsive will be reviewed for scientific and technical merit by the Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities established for this purpose by the NCRR. The second level of review will be conducted by the National Advisory Research Resources Council. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria Applications will be evaluated on the basis of criteria intended to assess the following overall questions: (1) How will the proposed change in the research environment facilitate the applicant institution's ability to conduct, expand, improve, or maintain biomedical/behavioral research? (2) How will the proposed project meet national unmet health needs for biomedical/behavioral research, training and/or research support facilities? Thus, reviewers will consider the following factors: o The overall scope of the ongoing PHS-supported biomedical and behavioral research and/or research support activities that will be impacted by the proposed construction, as well as the expanded or proposed future biomedical/behavioral research and/or research support activities. o Appropriateness and suitability of the proposed facilities for the research to be conducted and/or research support to be provided. o The applicant's consideration of safety and biohazard issues in planning the construction and administering the facilities. o Specific deficiencies in the existing research facilities that would be remedied. o Impact of the proposed project on current and future research activities, particularly for institutions of emerging excellence. o The appropriateness of the proposed physical location and layout of the new facility. o Reasonableness of the proposed time-course, cost and sequence for the construction. o Adequacy of the proposed administrative arrangements with respect to: a. Institutional commitment to use the space for biomedical/behavioral research and/or research support. b. Institutional safety and biohazard issues. c. Capabilities of the Principal Investigator and staff for scientific and fiscal administration of the facility. AWARD CRITERIA Factors considered in making awards include the merit of the proposal; the needs of the institution, with special consideration for RPRCs and for institutions designated as institutions of emerging excellence; the commitment of the institution; the availability of funds; and overall programmatic priorities including geographic distribution of the awards. Award Conditions Prior to award, an applicant must provide an assurance that required matching funds are available and that additional funds will be secured to meet project costs in excess of the Federal award and non- Federal matching amounts. Advertisement for construction bids and construction can be initiated only after receipt of the construction grant award and subsequent approval of the working drawings and specifications by NIH staff. Therefore, no requests to initiate construction, consistent with Public Health Service policy, will be entertained prior to receipt of a construction grant award from NIH and subsequent approval of working drawings and specifications by NIH staff. The Principal Investigator should be a highly placed institutional official, at the level of Dean or equivalent, who has the responsibility for allocation of space for the program(s) of biomedical or behavioral research and research training addressed in the submitted application. The facility must be utilized for biomedical or behavioral research purposes for which it was constructed for at least 20 years beginning 90 days following completion of the construction project. The NIH staff will evaluate use of the facility periodically to assure its continued use for the approved purposes. Failure to comply with the 20 year utilization requirement will result in recovery of the Federal share of the value of the facility in accordance with Federal regulation 45 CFR Part 74, Subpart O. INQUIRIES 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: Dr. Charles L. Coulter Director, Research Facilities Improvement Program National Center for Research Resources 5333 Westbard Avenue, Room 8A15 Bethesda, MD 20892 Telephone: (301) 594-7952 Email: charlesc@ep.ncrr.nih.gov Direct inquiries regarding fiscal matters and requests for application Standard Form 424 and special application instructions, to: Ms. Katherine A. Springmann Office of Grants and Contract Management National Center for Research Resources 5333 Westbard Avenue, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 Email: kspringmann@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.214. 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 and Public Law 103-43, 42 USC 241, 285, and 481) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. Applicants are required to comply with Executive Order 12372 as supplemented by DHHS 45 CFR Part 100, Intergovernmental Review of Health and Human Services Programs and Activities. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES A. PHS Policy. The project shall meet the PHS policies as described in the "Public Health Service Grants Policy Statement," DHHS Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994 as updated. B. The design of facilities to be constructed or altered with PHS grant funds will be evaluated for compliance with design requirements contained in the most recent edition of Technical Handbook 2.1, "Information for Project Applicants and State Agencies on Design and Construction Related Activities." The Handbook is part of the Department's Facilities Engineering and Construction Manual and is available from the Office of Engineering Services. Applicants from Regions I, II, III and V should write to: Director of the Regional Office of Engineering Services Office of the Regional Health Administrator, PHS, DHHS Jacob K. Javits Federal Building 26 Federal Plaza, Room 3309 New York, NY 10278 Telephone: (212) 264-3600 Applicants from Regions IV, VI, VII, and IX should write to: Director of the Regional Office of Engineering Services Office of the Regional Health Administrator, PHS, DHHS 1200 Main Tower Building, Room 1900 Dallas, TX 75202 Telephone: (214) 767-3491 Applicants from Regions VIII and X should write to: Director of the Regional Office of Engineering Services Office of the Regional Health Administrator, PHS, DHHS Blanchard Plaza Building 2201 6th Avenue, M/S RX24 Seattle, WA 98121 Telephone: (206) 615-2452 Where State and local codes or requirements exceed the design requirements set forth in Technical Handbook 2.1 or standards incorporated in it, the more stringent requirement will be applied. State or local codes may be used as a basis for facility design in lieu of the design requirements in Technical Handbook 2.1 but a prior determination must be made by HHS that the specific State or local code is equivalent to, or exceeds, HHS requirements. From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 43, 9 December 1994 Date: 16 Dec 1994 16:45:21 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 902 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcb1$9sr@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941209 V23N43 P1O1 ************************************ X-comment: RFAs described: RR-95-003, HL-95-014, AI-95-001, AA-95-002 NIH GUIDE - Vol. 23, No. 43 - December 9, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** AVAILABILITY OF DRUG USE DATA National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N2 ********************************************************** NIAID AWARD AND APPLICATION POLICIES National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** NHLBI MULTIDISCIPLINARY COURSE ON THE GENETICS OF HEART, LUNG, AND BLOOD DISEASE (RFP NHLBI-HC-95-2) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 ********************************************************** FEMALE CONTROLLED METHODS--DEVELOPMENT OF NOVEL VAGINAL PRODUCTS TO MAINTAIN THE INTEGRITY OF THE VAGINAL ECOSYSTEM (RFP NICHD-CD-95-8) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 ********************************************************** MAINTENANCE AND SUPPLY OF SCHISTOSOME INFECTED SNAILS AND MAMMALS (RFP NIH-NIAID-DMID-95-09) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 ********************************************************** SIMIAN VACCINE EVALUATION UNITS (RFP NIH-NIAID-DAIDS-96-05) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R5 ********************************************************** ANIMAL MODELS OF HUMAN VIRAL INFECTIONS FOR EVALUATION OF EXPERIMENTAL THERAPIES (RFP NIH-NIAID-DMID-96-06) National Institutes of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R6 03/09/95 ************************************************* EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS (RFA RR-95-003) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX R7 03/15/95 ************************************************* GENETIC MAP AND LARGE INSERT LIBRARY FOR THE RAT GENOME (RFA HL-95-014) National Heart, Lung, and Blood Institute National Center for Human Genome Research National Cancer Institute National Institute of Mental Health National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases National Center for Research Resources National Institute on Drug Abuse National Institute on Alcohol Abuse and Alcoholism National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Environmental Health Sciences INDEX: HEART, LUNG, BLOOD; HUMAN GENOME RESEARCH; CANCER; MENTAL HEALTH; CHILD HEALTH, HUMAN DEVELOPMENT; DIABETES, DIGESTIVE, KIDNEY DISEASES; RESEARCH RESOURCES; DRUG ABUSE; ALCOHOL ABUSE, ALCOHOLISM; DEAFNESS, OTHER COMMUNICATIONS DISORDERS; DENTAL RESEARCH; ENVIRONMENTAL HEALTH SCIENCES $$INDEX R8 03/23/95 ************************************************* STD DIAGNOSTIC DEVELOPMENT GROUPS (RFA AI-95-001) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R9 07/19/95 ************************************************* QTL MAPPING OF ALCOHOL-RELATED BEHAVIORAL TRAITS IN RODENTS (RFA AA-95-002) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM ERRATUM $$INDEX E1 ********************************************************** TROPICAL MEDICINE RESEARCH CENTERS (RFA AI-95-002) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES This publication is available electronically via BITNET or INTERNET by subscription, and is also on the NIH GOPHER (gopher.nih.gov). Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** AVAILABILITY OF DRUG USE DATA NIH GUIDE, Volume 23, Number 43, December 9, 1994 P.T. 34; K.W. 0404009, 0755018 National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) announces the availability of the public use data disk and documentation for the Washington, DC Metropolitan Area Drug Study (DC*MADS) Homeless and Transient Population Study: 1991. To order, write to: National Technical Information Service 5285 Port Royal Road Springfield, VA 22161 Telephone: (703) 487-4650 FAX: (703) 321-8547 Order # PB95-500351; $90.00 + $6.00 S&H INQUIRIES Elizabeth Lambert, Ph.D. Division of Epidemiology and Prevention National Institute on Drug Abuse Parklawn Building, Room 9A-53 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6637 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIAID AWARD AND APPLICATION POLICIES NIH GUIDE, Volume 23, Number 43, December 9, 1994 P.T. 34, 44; K.W. 1014006 National Institute of Allergy and Infectious Diseases This is an addendum to the notice NIAID AWARD AND APPLICATION POLICIES, which appeared in the NIH Guide for Grants and Contracts, Vol. 23, No. 40, November 18, 1994. These new award and application policies arose from recommendations made by the National Advisory Allergy and Infectious Disease Council. In addition to the policies described in that notice, NIAID will also implement the following one: Limited Reimbursement of Tuition Costs on Training Grants Rising tuition costs on NRSA institutional training grants seriously impair the NIAID's ability to fund new outstanding training programs. Therefore the NIAID will only reimburse 70 percent of recommended tuition costs on all new and competing NRSA training grants (T32), beginning in FY 1996. Under rare circumstances, the NIAID Director or his designee may permit exceptions from these policies. INQUIRIES John J. McGowan, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 3C20 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: john_mcgowan@exec.niaid.pc.niaid.nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NHLBI-HC-95-2 ******************************************** NHLBI MULTIDISCIPLINARY COURSE ON THE GENETICS OF HEART, LUNG, AND BLOOD DISEASE NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFP AVAILABLE: NHLBI-HC-95-2 P.T. 34; K.W. 0715040, 0715032, 0715165, 0710030, 1002058 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) requires a contract to provide a model for the development, organization, implementation, and evaluation of a comprehensive, interdisciplinary training course on the molecular genetics of cardiovascular, pulmonary, and hematologic diseases. Performance includes the development and formulation of the course curriculum, format for the course including any interactive elements, the scheduling, announcement, and conduct of three offerings of the course, and evaluation of the performance and impact of the course. The course will provide an intensive introduction to the use of molecular tools to elucidate the genetic and non-genetic determinants of complex diseases of interest to the NHLBI. This course will assist the participants to (1) understand the principles, methodologies, uses, and implications of population and molecular genetic approaches in investigating complex disease states; (2) evaluate critical clinical, statistical, and genetic evidence concerning the causation and prevention of complex cardiovascular, pulmonary and hematologic diseases; (3) develop appropriate molecular genetic study designs; (4) establish contact with internationally recognized investigators in the areas of molecular genetics; and (5) form professional relationships for future interdisciplinary collaborative research efforts. The period of performance is four years. This is an announcement for a Request For Proposal (RFP). The RFP was issued on November 30, 1994, and proposals are due February 28, 1995. One award is anticipated to be made about September 1, 1995. Award of a contract for these services will be made only to an offeror who is located in the United States of America. Interested organizations should request either a streamlined or full RFP package. If no selection is made, a streamlined version of the RFP will be provided, which includes only the Statement of Work, Deliverables and Reporting Requirements, and Technical Evaluation Criteria. After examination of these documents, any organization interested in responding to this RFP must request the entire RFP in writing or by FAX request (301-496-0075). Telephone requests will only be honored if confirmed by FAX or written request. All requests for RFP must cite RFP No. NHLBI-HV-95-2. INQUIRIES Requests for copies of the RFP may be directed to: Patricia A. Smith ECA Contracts Section National Heart, Lung, and Blood Institute Federal Building, Room 3C16 Bethesda, MD 20892 FAX: (301) 496-0075 $$R1 END ************************************************************ $$R2 BEGIN NICHD-CD-95-8 ******************************************** FEMALE CONTROLLED METHODS--DEVELOPMENT OF NOVEL VAGINAL PRODUCTS TO MAINTAIN THE INTEGRITY OF THE VAGINAL ECOSYSTEM NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFP AVAILABLE: NICHD-CD-95-8 P.T. 34, II; K.W. 0705075, 1002061 National Institute of Child Health and Human Development The Contraceptive Development Branch of the Center for Population Research, National Institute for Child Health and Human Development (NICHD), is interested in stimulating investigations into the development of novel products that are capable of maintaining low vaginal pH and bacterial microflora. The goals are to obtain novel vaginal products that: (a) are capable of maintaining low pH and the integrity of the vaginal ecosystem, (b) do not cause vaginal irritation, (c) may inactivate STD pathogens while producing only a transient effect on normal human vaginal flora, (d) are inexpensive, and (e) are aesthetically pleasing (e.g., colorless, odorless). Organizations must have adequate facilities to carry out the proposed syntheses and biological testing. The Government estimates the effort to be approximately 4.0 technical person-years annually. The principal investigator should devote approximately 20 percent effort to this project. All responsible sources may submit a proposal that will be considered by the agency. It is anticipated that three cost- reimbursement incrementally funded type contracts will be awarded as a result of the RFP for a period of 36 months. This announcement is not a request for proposals (RFP). RFP No. NICHD-CD-95-8 will be available on or about January 5, 1995. Proposals will be due approximately 75 days thereafter. INQUIRIES Copies of the RFP may be obtained by sending a written request to the address listed below. Requests may also be made by FAX. Requests for the RFP must cite the above RFP number. Paul J. Duska Contracts Management Branch, OGC National Institute of Child Health and Human Development Executive Building, Suite 7A07 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 FAX: (301) 402-3676 $$R2 END ************************************************************ $$R3 BEGIN NIH-NIAID-DMID-95-09 ************************************* MAINTENANCE AND SUPPLY OF SCHISTOSOME INFECTED SNAILS AND MAMMALS NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFP AVAILABLE: NIH-NIAID-DMID-95-09 P.T. 34; K.W. 0780005 National Institute of Allergy and Infectious Diseases The Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for the maintenance and supply of vectors and mammals with Schistosoma mansoni, S. hematobium, and S. japonicum. The offeror must have the capabilities and facilities to maintain all of the life-cycles of Schistosoma mansoni, Schistosoma hematobium and Schistosoma japonicum, and to distribute the infected mammals and infected or uninfected vectors to qualified investigators and to rapidly deliver parasite materials to the NIAID intramural laboratories. Stock supplies of snails and parasites may be provided by the Government. Any contract awarded will be subject to DHHS regulations regarding the animal welfare assurance in research. It is expected that this NIAID sponsored project will have a seven-year period of performance. A cost-reimbursement type contract is anticipated. One contract may be awarded as a result of this solicitation. The issuance of this Request for Proposal (RFP) will be on or about December 1, 1994, with a closing date of February 1, 1995. INQUIRIES To receive a copy of the RFP, provide this office with two self- addressed mailing labels. Any responsible offeror may submit a proposal for consideration by the Government. Interested organizations should request either a streamlined version or full RFP package. If no selection is made, a streamlined version of the RFP will be provided, which includes only the Statement of Work, deliverable and reporting requirements, special requirements, and mandatory qualifications, if any, and the Technical Evaluation Criteria. After examination of the abbreviated document, any organization interested in responding to the RFP must request the entire package in writing or by FAX request. This advertisement does not commit the Government to award a contract. Telephone inquiries will not be honored and all inquiries must be in writing and addressed to: Dawn Kotzen Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 FAX: (301) 480-5253 $$R3 END ************************************************************ $$R4 BEGIN NIH-NIAID-DAIDS-96-05 ************************************ SIMIAN VACCINE EVALUATION UNITS NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFP AVAILABLE: NIH-NIAID-DAIDS-96-05 P.T. 34; K.W. 0740075, 0755020 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID), NIH has a requirement to establish Simian Vaccine Evaluation Units for evaluation of SIV and HIV vaccine approaches in support of preclinical AIDS vaccine research and development. This project will take approximately five years to complete. A cost reimbursement contract is anticipated. It is anticipated that three awards will be made. This is an announcement for an anticipated Request for Proposal (RFP). RFP No. NIH-NIAID-DAIDS-96-05 will be issued on or about December 20, 1994 with a closing date tentatively set for April 1, 1995. INQUIRIES To receive a copy of the RFP, provide this office with three self- addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. FAX requests are acceptable. A short-form version of the RFP will be provided first, which includes only the Work Statement, Reporting Requirements and the Evaluation Criteria, used for selection of the awardee. After examining this, the full-text version of the RFP must be requested if your organization chooses to submit a proposal. All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the Government to award a contract. Requests for the RFP are to be directed in writing to: Ms. Grace A. Bruce Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 FAX: (301) 402-0972 $$R4 END ************************************************************ $$R5 BEGIN NIH-NIAID-DMID-96-06 ************************************ ANIMAL MODELS OF HUMAN VIRAL INFECTIONS FOR EVALUATION OF EXPERIMENTAL THERAPIES NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFP AVAILABLE: NIH-NIAID-DMID-96-06 P.T. 34; K.W. 1002045, 0755020 National Institutes of Allergy and Infectious Diseases The Antiviral Research Program of the Virology Branch of the Division of Microbiology and Infectious Diseases, National Institutes of Allergy and Infectious Diseases (NIAID) is seeking investigators to employ appropriate animal model systems of human viral infections to evaluate the efficacy of antiviral therapies and provide basic information on the natural history and pathogenesis of viral infections. The primary objective of these Animal Models will be to evaluate experimental therapies for potential clinical efficacy and toxicity in animal models of clinically important human viral infections. In addition, the animal models are used to study disease pathogenesis and host response to infection. When appropriate, these models will also be used for a limited amount of vaccine evaluation and pharmacokinetic studies. Basic studies on model development will be encouraged as an adjunct to the primary focus on therapeutic evaluation. Models for cytomegalovirus, herpes simplex, respiratory syncytial virus, and influenza infections are a priority for NIAID, but offerors are also encouraged to propose models for other viral infections as well, except models for retrovirus, hepatitis B and D, and papillomavirus infections. Request for Proposals (RFP) NIH- NIAID-DMID-96-06 will be available on or about December 19, 1994 and proposals will be due at COB on April 10, 1995. It is anticipated that up to five cost reimbursement, completion type contracts will be awarded for a period of five years. INQUIRIES Interested organizations should request either a streamlined or full RFP package. If no selection is made, a streamlined version of the RFP will be provided, which includes only the Statement of Work, deliverables and reporting requirements, special requirements and mandatory qualifications, if any, and the Technical Evaluation Criteria. After examination of these documents, any organization interested in responding to the RFP must request the entire RFP in writing, by telephone, or by FAX request. This advertisement does not commit the Government to award a contract. To receive a copy of this RFP, supply this office with one self-addressed mailing label. Telephone inquiries will not be honored and all inquires must be in writing and addressed to: Mr. Frank Murphy Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 $$R5 END ************************************************************ $$R6 BEGIN RR-95-003 FULL-TEXT ************************************** EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFA AVAILABLE: RR-95-003 P.T. 02; K.W. 0710030 National Center for Research Resources Letter of Intent Receipt Date: January 20, 1995 Application Receipt Date: March 9, 1995 PURPOSE The National Center for Research Resources (NCRR) is authorized under Public Law (PL) 103-43, Sections 481A and 481B of the Public Health Service Act, as amended by the National Institutes of Health (NIH) Revitalization Act to "make grants to public and nonprofit private entities to expand, remodel, renovate or alter existing research facilities or construct new research facilities" for biomedical and behavioral research and research training. The Appropriations Act for the Department of Health and Human Services for Fiscal Year 1995 (PL 103-333) provides $20 million in the budget of the NCRR of the NIH for extramural facilities construction grants to be awarded competitively, with special provisions made for institutions of emerging excellence, designated under section 739 of the Public Health Service (PHS) Act as revised in PL 102-408, and the Regional Primate Research Centers (RPRCs). It is anticipated that ten to 20 new awards (C06) at different levels will be made. INQUIRIES The RFA, which describes the objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Dr. Charles L. Coulter Director, Research Facilities Improvement Program National Center for Research Resources 5333 Westbard Avenue, Room 8A15 Bethesda, MD 20892 Telephone: (301) 594-7952 Email: charlesc@ep.ncrr.nih.gov $$R6 END ************************************************************ $$R7 BEGIN HL-95-014 FULL-TEXT ************************************** GENETIC MAP AND LARGE INSERT LIBRARY FOR THE RAT GENOME NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFA AVAILABLE: HL-95-014 P.T. 34; K.W. 1002019, 0755044 National Heart, Lung, and Blood Institute National Center for Human Genome Research National Cancer Institute National Institute of Mental Health National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases National Center for Research Resources National Institute on Drug Abuse National Institute on Alcohol Abuse and Alcoholism National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Environmental Health Sciences Letter of Intent Receipt Date: February 15, 1995 Application Receipt Date: March 15, 1995 PURPOSE The purpose of this Request for Applications (RFA) is to solicit applications to construct a genetic map of the rat genome with a resolution of 0.43 cM or better and a large-insert DNA clone library of rat genomic DNA. A maximum of about $11.06 million (including direct and indirect costs) over a five year period will be awarded. Approximately $3.2 million may be available for the first year, $2.4 million for the second year, $1.82 million for the third year, $1.82 for the fourth year, and $1.82 million for the fifth year. Funding is subject to the availability of funds. It is anticipated that one to two new awards will be made. Applications for building either the genetic map or the large insert clone library alone will be accepted, as well as those proposing to accomplish both aims of this RFA. This RFA will use the National Institutes of Health (NIH) individual research grant (R01) mechanism. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is September 30, 1995. This RFA is a one-time solicitation. 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, Genetic Map and Large Insert Library for the Rat Genome, is related to many priority areas. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from any of the program contacts listed below. Stephen C. Mockrin, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 4C10 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1613 FAX: (301) 402-2044 Email: SM60d@nih.gov Jane L. Peterson, Ph.D. Mammalian Genomics Branch National Center for Human Genome Research Building 38A, Room 610, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: jane_peterson@occhost.nlm.nih.gov Grace L. Shen, Ph.D, Hematology and Oncology for Extramural Program National Cancer Institute Executive Plaza North, Room 501 6130 Executive Boulevard MSC 7381 Rockville, MD 20892-8531 Telephone: (301) 496-7815 FAX: (301) 496-8656 Email: sheng@dcbdcep.nci.nih.gov Ljubisa Vitkovic, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11C-06 Rockville, MD 20857 Telephone: (301) 443-5288 FAX: (301) 443-4822 Email: lv5@cu.nih.gov Steven Kaminsky, Ph.D. Developmental Biology Genetics and Teratology Branch National Institute of Child Health and Human Development Building 61E, Room 4B01D, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: tky@cu.nih.gov Joan T. Harmon, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN-18G, MSC 6401 Bethesda, MD 20892-6401 Telephone: (301) 594-7565 FAX: (301) 594-9011 Email: joanh@dvsgate.niddk.nih.gov Louise Ramm, Ph.D. Deputy Director National Center for Research Resources Building 12A, Room 4009, MSC 5662 Bethesda, MD 20892-5662 Telephone: (301) 496-6023 or (301) 594-7906 FAX: (301) 402-0006 Email: louiser@ep.ncrr.nih.gov Theresa Lee, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-19 Rockville, MD 20857 Telephone: (301) 443-6300 FAX: (301) 594-6043 Email: tlee@aoada.ssw.dhhs.gov Robert Karp, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4223 FAX: (301) 594-0673 Email: rkarp@willco.niaaa.nih.gov Ralph F. Naunton, M.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite 400C 6120 Executive Boulevard, MSC 7180 Rockville, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: nauntonr%nidcd-eps%nih@fedtcp.ninds.nih.gov Norman S. Braveman, Ph.D. Assistant Director for Program Development National Institute of Dental Research Building 45, Room 4AN24B, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8381 Email: bravemann@de45.nidr.nih.gov William A. Suk, Ph.D., M.P.H. 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 FAX: (919) 541-2843 Email: suk@niehs.nih.gov $$R7 END ************************************************************ $$R8 BEGIN AI-95-001 FULL-TEXT ************************************** STD DIAGNOSTIC DEVELOPMENT GROUPS NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFA AVAILABLE: AI-95-001 P.T. 34; K.W. 0715182, 0745020 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: January 9, 1995 Application Receipt Date: March 23, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for the establishment of Sexually Transmitted Disease (STD) Diagnostic Development Groups (SDDG) for the research development, manufacturing development, and/or evaluation of diagnostic tests that are simple, easy-to-use, rapid and inexpensive. The specific focus of this initiative is the development and evaluation of tests for the diagnosis of cervicitis and urethritis due to Neisseria gonorrhoeae or Chlamydia trachomatis. This solicitation for cooperative agreements (U01) is designed to encourage and support joint for-profit and non-profit research groups in development and evaluation of these diagnostic tests. The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $2.0 million. In Fiscal Year 1995, the NIAID plans to fund three applications: two for diagnostic test development and one for test evaluation. Depending upon the stage of development of the diagnostic test proposed, it is anticipated that the first year development awards will range from $300,000 to $850,000 (total cost). 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), STD Diagnostic Development Groups (SDDG), is related to the priority areas of STDs and 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and Email from the program contact listed below: Dr. Penelope J. Hitchcock Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A16 Bethesda, MD 20892 Telephone: (301) 402-0443 FAX: (301) 402-0659 or 1456 Email: penny@exec.niaid.pc.niaid.nih.gov $$R8 END ************************************************************ $$R9 BEGIN AA-95-002 FULL-TEXT ************************************** QTL MAPPING OF ALCOHOL-RELATED BEHAVIORAL TRAITS IN RODENTS NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFA AVAILABLE: AA-95-002 P.T. 34; K.W. 0404003, 0414015, 1002019 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: June 1, 1995 Application Receipt Date: July 19, 1995 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research applications to map quantitative trait loci (QTL) influencing rat and mouse behavioral traits that model human behavioral traits predisposing to alcoholism. Mapping of such QTL will permit subsequent testing of human homologues of these genes for linkage to alcoholism in human pedigrees. Such a test will help to establish which animal behavioral traits are most relevant to human alcoholism. Mapping of the QTL will also serve as a prologue to the isolation of the relevant genes and the identification of the products they encode. This approach can provide a novel route to elucidating the physiological mechanisms for predisposition to alcoholism and to developing intervention strategies to diminish harmful effects of alcohol. Research support may be obtained through applications for a regular research grant (R01) or First Independent Research Support and Transition (FIRST) (R29) award. It is estimated that up to $1.1 million in total costs will be available for approximately six grants under this RFA in FY 1996. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. The funds set aside for this RFA are intended to support all aspects of projects funded, except for genotyping of the animals generated during the course of the research, which will be supported by a separately awarded contract. Although this program is provided for in the financial plan of NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. The earliest possible award date is March 1, 1996. 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), QTL Mapping of Alcohol-Related Behavioral Traits in Rodents, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Robert W. Karp, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4223 FAX: (301) 594-0673 Email: rkarp@willco.niaaa.nih.gov $$R9 END ************************************************************ ERRATUM $$E1 BEGIN R15 19941118 APPEND RFA AI-95-002 BOTH ********************** TROPICAL MEDICINE RESEARCH CENTERS NIH GUIDE, Volume 23, Number 43, December 9, 1994 RFA: AI-95-002 P.T. 04; K.W. 0715151, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: February 17, 1995 Application Receipt Date: May 16, 1995 The following correction is issued for RFA AI-95-002, which was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 40, November 18, 1994: Change Letter of Intent Receipt Date from December 19, 1994 to February 17, 1995. INQUIRIES Michael Gottlieb, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard Solar Building, Room 3A03 Bethesda, MD 20892-7630 Telephone: (301) 496-7115 FAX: (301) 402-0804 Email: mg35s@nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-009 - V23(42) 12/02/94 Date: 16 Dec 1994 16:45:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 311 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcat$9sc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95009 PA-95-009 P1O1 *************************************** PREDICTION AND DETERMINATION OF HEARING AID BENEFIT NIH GUIDE, Volume 23, Number 42, December 2, 1994 PA NUMBER: PA-95-009 P.T. 34; K.W. 0740030, 0745070 National Institute on Deafness and Other Communication Disorders PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for the support of basic and applied research studies on issues related to predicting and measuring the benefit received from hearing aids. No widely accepted measures of hearing aid benefit are currently available, nor is there a universally accepted definition of hearing aid benefit. In addition, clinical measures currently used for fitting hearing aids provide little of value in predicting user benefit, especially over the long term. Clinicians and researchers agree that many more individuals than currently use hearing aids could benefit from their use. Rational approaches to designing and providing hearing aids to millions of hearing-impaired individuals require clinically valid measures for predicting and determining the benefit received from hearing aids. 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 PA, Prediction and Determination of Hearing Aid Benefit, is related to the priority area of 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 20402-9325 (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 or 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, women, and individuals with disabilities are encouraged. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the individual investigator-initiated research project grant (R01) and the FIRST (R29) award. RESEARCH OBJECTIVES A variety of cosmetically acceptable hearing aids, with a wide range of processing capabilities, is available to millions of hearing- impaired people. Anatomical, physiological, and psychophysical studies have provided a better understanding of the abilities and limitations of the normal and impaired auditory system. Clinical tools such as real ear acoustic measures and hearing aid prescriptive procedures have made the fitting of hearing aids a more precise process. Although these advances have facilitated the provision of high-quality hearing aids, most clinicians are uncertain to what extent a given hearing aid will benefit a given individual, especially over the longterm. Lack of knowledge about what constitutes or defines benefit for a given person contributes to this problem. Hearing aid benefit has been defined in many ways, including: any reported improvement in a person's quality of life related to the use of a hearing aid; a measurable improvement in the ability to understand speech; a perceived improvement in the quality of sound; the number of hours of actual hearing aid use; and a decision by a hearing aid candidate to keep or return a hearing aid. The two main approaches to assessing hearing aid benefit have been self-report inventories and speech intelligibility measures. Although each of these approaches has provided useful information, neither has led to widely accepted valid evaluation endpoints for the prediction or determination of hearing aid benefit. Measures of definitive evaluation endpoints, or definitive outcome measures, are those that define the actual long-term benefit received from a hearing aid. Surrogate evaluation endpoints are intended to be related to or predictive of the definitive evaluation endpoint. Measures of both definitive and surrogate evaluation endpoints are needed. Surrogate measures allow clinical practice and research to continue and advance as better tests are developed and as the relationship between outcome on tests and benefit is further elucidated. For example, surrogate measures are important in clinical practice for determining candidacy for a hearing aid and for differentiating between hearing aids with respect to expected benefit. A continuum of evaluation endpoints probably exists. A set of measures more time-intensive than a typical clinical measure, but less so than a definitive research measure, might be used in clinical research studies of hearing aid benefit. Studies of evaluation endpoints along the entire continuum are needed. Previous studies indicate that many factors may contribute to hearing aid benefit. Such factors include: individual characteristics such as performance on psychoacoustic tests, personality traits, and cognitive factors; aspects of the acoustic environment such as noise and reverberation; the degree and type of hearing loss; the type of communication tasks required of the individual hearing aid wearer; and factors related to the performance of the hearing aid itself, such as audibility, distortion, and signal processing. Other parameters, such as learning and adaptation effects associated with hearing aid use over time, may also affect hearing aid benefit. Not only do the factors contributing to hearing aid benefit need to be identified and characterized systematically, but the interaction among these factors also needs to be explored. This initiative encourages both basic and applied research designed to contribute to the understanding of and to the development of measures for the prediction and determination of hearing aid benefit. An important factor in such studies is the ability to generalize findings to hearing-impaired individuals with respect to degree and type of hearing loss and to age. Since some or all of the variables described above may vary for different subgroups of the hearing- impaired population, this should be taken into account in study designs, as appropriate. A variety of approaches to the research problems is encouraged, and topics may include, but are not limited to those listed below: o development of a clear, rational, and evidence-based characterization of hearing aid benefit, based on valid definitive evaluation endpoints (e.g., communication benefit, comfort, ease of use, perceived impairment) capable of predicting and measuring hearing aid benefit o determination of surrogate evaluation endpoints that relate to and are predictive of definitive evaluation endpoints in both clinical and research settings o development of valid and reliable tests to measure surrogate and definitive evaluation endpoints in both clinical and research settings o determination of both the auditory and nonauditory factors that contribute to hearing aid benefit, including those related to the individual hearing aid wearer, to the acoustic environment, to the hearing aid, and to learning or adaptation effects o characterization of the relationships between the auditory and nonauditory factors that contribute to hearing aid benefit o development of valid and reliable tests to measure the factors that contribute to hearing aid benefit, with a special emphasis on measures that are predictive of long-term benefit o development of measures of hearing aid benefit appropriate to children and other special populations (i.e., measures that are maximally sensitive to sensory processes, but minimally affected by cultural, linguistic and cognitive status) INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Application kits are available from most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The title and number of the announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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** REVIEW CONSIDERATIONS 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, 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. As part of the initial merit review, a process (triage) will be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the PA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications will compete for available funds with all other applications assigned to that Institute or Center. 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 priorities among research areas of the program 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 scientific content to: Lynn E. Huerta, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3461 FAX: (301) 402-6251 E-Mail: Lynn_Huerta%NIDCD-EPS%NIH@FEDTCP.NINDS.NIH.GOV Direct inquiries regarding fiscal matters to: Sharon Hunt Grants Management Office National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. 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. The Public Health Service strongly encourages all grant recipients to provide a smokefree workplace and promote the nonuse of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-010 - V23(42) 12/02/94 Date: 16 Dec 1994 16:45:13 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 297 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcap$9rs@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95010 PA-95-010 P1O1 *************************************** ENHANCING CLINICAL CARE THROUGH NURSING INFORMATICS NIH GUIDE, Volume 23, Number 42, December 2, 1994 PA NUMBER: PA-95-010 P.T. 34; K.W. 0710078, 0785130, 0785035 National Library of Medicine National Institute of Nursing Research PURPOSE The National Library of Medicine (NLM) and the National Institute of Nursing Research (NINR) invite applications for grants to support research in nursing informatics. Of particular interest is investigation that addresses improvements in the delivery of clinical nursing care through the use of information systems. The intent of this program announcement is to generate research that will examine systems to manage and process data, information and knowledge with the goal of facilitating appropriate and effective clinical care. Although NLM's existing program in medical informatics addresses the application of informatics to health care broadly defined, this program announcement has the specific purpose of calling the attention of those interested in informatics research to the set of issues of particular concern and importance to the nursing profession. 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. The program announcement, Enhancing Clinical Care Through Nursing Information, is related to the priority area of surveillance and data systems. 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, public and private organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Topics studied by foreign applications must have direct relevance to U.S. populations. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). MECHANISM OF SUPPORT The mechanisms of support will be the National Institutes of Health research project grant (R01) and FIRST award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Though the length of individual studies will vary, support will be provided for a period of up to five years, based on availability of funds and sufficient scientific progress. Applicants must plan for five years of support for the R29 award. Costs of individual projects will vary. Direct costs for R29 awards are capped at $100,000 in any one year and $350,000 across all years. The average direct cost of a R01 award in FY 1993 was $186,000. RESEARCH OBJECTIVES This initiative builds directly on the work of a panel of scientific experts on nursing informatics convened as part of the development of the National Nursing Research Agenda. The work of this panel was published in a 1993 report entitled, "Nursing Informatics: Enhancing Patient Care". This report is available from NINR; see INQUIRIES section. The goal of this PA is to encourage proposals of innovative research that focus on the use of nursing information systems to strengthen the quality of clinical care. The term nursing informatics combines the scientific areas related to computers, information and nursing. Nursing informatics assists in the management and processing of nursing data, information, and knowledge to support clinical practice and the provision of nursing care. Well designed studies are needed to develop, expand, or test a variety of nursing informatic areas. These include, but are not limited to nursing clinical data, processes and outcomes of care, and clinical decision making. Some examples of possible topics are: o Examine methods to integrate existing terminologies representing nursing concepts, patient problems and nursing interventions into larger and broader based systems. o Test the reliability and validity of clinical language for nursing related assessments, diagnoses, interventions and outcomes. o Determine the validity of existing data sets of clinical terms with emphasis on the continuum of care. o Explore processes to link clinical conditions, nursing interventions and treatments with measures of clinical end points. o Ascertain the effectiveness of existing information strategies that support the decision process by nurses in clinical practice. o Examine information systems designed to improve quality of care by defining optimal sequencing and timing of interventions, detailing expected outcomes and determining resource use such as data bases supporting clinical pathways or care mapping focusing on particular patient cohorts frequently requiring concentrated nursing care, eg. CVAs, multiple traumas, or patients who may make frequent transitions across health care settings such as children or older adults. o Analyze the relationship of patient assessment, processes of diagnostic development and clinical inference, and choice of related treatments and intervention alternatives. o Explore the processes of clinical decision making, the extent and influence of participation of patients and their family members in decision making. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion Of Women And Minorities As Subjects In Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. 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 (rev. 9/91) instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of this program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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** REVIEW CONSIDERATIONS Applications received under this program announcement will be assigned to an initial review group (IRG) on the basis of established Public Health Service referral guidelines. The IRG will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Applications will receive a second-level review by the appropriate national advisory council. Only applications recommended for further consideration by the Council may be considered for funding. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications recommended for further consideration will be considered for available funds on the basis of the scientific and technical quality of the proposed project determined by peer review, appropriateness of budget estimates, program needs and balance, policy considerations, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. To receive a copy of "Nursing Informatics: Enhancing Patient Care," direct your inquiries to: Office of Information and Legislative Affairs National Institute of Nursing Research Building 31, Room 5B13 31 Center Drive MSC 2178 Bethesda, MD 20892-2178 Telephone: (301) 496-0207 Direct inquiries regarding scientific programmatic issues to: Dr. Patricia Moritz Nursing Systems Branch National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5966 FAX: (301) 480-8260 Dr. Milton Corn Division of Extramural Programs National Library of Medicine Building 38A, Room 5N-505 Bethesda, MD 20894 Telephone: (301) 496-4621 FAX: (301) 402-0421 E-Mail: CORN@NLM.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Sally A. Nichols Grants Management Office National Institute of Nursing Research Building 45 Room 3AN-32 45 Center Drive MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8256 Ms. Ruth E. Bortz Division of Extramural Programs National Library of Medicine Building 38A, Room 5N-515 Bethesda, MD 20894 Telephone: (301) 496-4253 FAX: (301) 402-0421 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.879 and 93.361. Awards are made under authorization of the PHS Act, Title III, Part A, Section 301, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and Part D, Subpart 2, Sections 472-476, as amended, Public Law 100-607, 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. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HG-95-001 - V23(42) 12/02/94 Date: 16 Dec 1994 16:45:06 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 499 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcai$9qr@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HG95001 HG-95-001 P1O1 *************************************** IMPROVED ELECTROPHORETIC DNA SEQUENCING TECHNOLOGY NIH GUIDE, Volume 23, Number 42, December 2, 1994 RFA: HG-95-001 P.T. 34; K.W. 0755045, 1215018 National Center for Human Genome Research Letter of Intent Receipt Date: February 1, 1995 Application Receipt Date: March 17, 1995 PURPOSE The National Center for Human Genome Research (NCHGR) invites applications for research projects to develop novel automated sequencing technology suitable for large-scale genomic sequencing through the reduction in scale and increased parallelization of existing approaches utilizing Sanger sequencing reactions coupled with electrophoretic separation of fragments. The Request For Applications (RFA) encompasses front end sample preparation, separation, detection, and data acquisition and handling. Technologies solicited include a spectrum of approaches ranging from capillary and ultrathin gel electrophoresis to microfabricated and microelectro mechanical systems (MEMS) that could yield reductions in scale and increased throughput. 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, Improved Electrophoretic DNA Sequencing Technology, is related to several priority areas, including cancer, heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. 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, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Collaborations between scientists in academia and industry are encouraged, as are applications from minority individuals and women. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. Applications are particularly encouraged from scientists, such as engineers and physicists, and institutions, such as for-profit institutions and biotechnology companies, that have not traditionally requested research support from the NCHGR. Applicants whose expertise is primarily nonbiological are especially encouraged to interact closely with biologists during the development of the research plan. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health (NIH) individual research project grant (R01), pilot project/feasibility study (R21), research program project (P01), and exploratory grant (P20) mechanisms. The R21 mechanism is used to support highly creative approaches for which substantial preliminary data is not yet available. R21 awards will be limited to $100,000 direct costs per year and to a maximum of three years of support, although the funding limit may be waived under exceptional circumstances. The P20 mechanism is used to support groups of outstanding investigators who wish to develop interdisciplinary research programs. P20 awards will be limited to three years at $750,000 direct costs per year. R21 and P20 grants are not renewable, but future project continuation is possible through other grant mechanisms such as R01 or P01. The levels and time frames for support of R21 and P20 awards indicated here are specific to this solicitation. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. 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. The total project period for applications submitted in response to the present RFA may not exceed three years. The anticipated award date is September 30, 1995. FUNDS AVAILABLE It is anticipated that $3,000,000 (direct and indirect costs) per year for up to three years will be available beginning in fiscal year 1995. It is anticipated that between five and ten awards will be made, representing a mix of research topics and mechanisms. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of awards will also vary. The number of awards may be increased if a large number of highly meritorious applications are received and if funds are available. The number of awards made will be contingent upon the quality of applications received and the availability of funds. RESEARCH OBJECTIVES Background The NCHGR sponsors basic and applied research concerned with the development and application of new technologies for the characterization and analysis of the human genome and the genomes of selected model organisms. The activities encompassed by the NCHGR program include genetic and physical mapping, DNA sequencing, informatics related to mapping and sequencing, gene identification, and technology development that will facilitate all of these efforts. The NCHGR, in conjunction with the Department of Energy, recently formulated a new five-year plan (Science Vol. 262, pp. 43-46, 1993) that states that significant technological advances will need to be made in the area of DNA sequencing if the demanding goals of the Human Genome Project are to be met. A major long-term goal of the Human Genome Program is to identify all the genes encoded in the three billion base pairs of human DNA. The first step in this process is to assemble detailed genetic and physical maps of the human genome. Subsequently, the complete sequence of human DNA must be determined. In order to attain this second objective, DNA sequencing technology must be further developed so that the cost will be significantly decreased and the rate significantly increased. In 1994, the cost of sequencing performed by highly skilled researchers in laboratories devoted to genomic DNA sequencing was estimated to be about $1 per finished base. The state-of-the-art approach for large-scale sequencing includes isolation of sample DNA from a biological source followed by amplification of the DNA and the synthesis of fluorescently tagged replicate ladders of the template DNA in a Sanger sequencing reaction. Biochemistry for DNA sequencing is currently performed in volumes that range from multiple microliters to hundreds of microliters, and only modest parallelization and automation has been achieved. The DNA ladders are resolved on a separation medium through slab gel electrophoresis and ladder composition is evaluated by laser-based detection technology. Software tools are then utilized for identification of the four bases, assembly of contiguous sequences from individual reads, and sequence finishing, including resolution of ambiguities. Current sequence throughput from automated electrophoresis instruments is approximately 7,000,000 bases (raw) per instrument year. Application of these instruments in sequencing approaches based on a combination of shotgun and directed strategies results in a throughput of about 700,000 finished bases per year. Even at this relatively modest throughput, sequence assembly and finishing limitations result in a systems bottleneck. Current efforts to optimize genomic sequencing technology focus on the development of a fully automated, integrated, modular system, that accounts for sample flow in a way that eliminates bottlenecks and maximally utilizes each step of the system from the front end of sample isolation through to data collection and analysis. Recent advances suggest that dramatically improved DNA sequencing technology can be developed through the application of existing miniaturization and automation technologies to state-of-the-art genomic sequencing. A continuum of approaches exists that creates a path to a substantially reduced scale for sequencing devices with associated throughput increase and cost decrease. Further development of these approaches requires several technological advances that are expected to be addressable based on existing scientific principles. Capillary Electrophoresis and Ultrathin Gels Recent work in ultrathin (capillary or slab) gel electrophoresis has demonstrated the potential for greatly increased separation speed due to improved heat transfer. These approaches are also expected to yield cost savings by reduction in sample size if small volume robotic reaction systems are developed concurrently. Although preliminary data suggest that these formats will be successful in improving sequence throughput, technological challenges remain to the development of dependable, exportable systems. Remaining challenges include the need to identify new separation matrices that will allow for increased reproducibility of separation and easy manipulation in these formats, small volume loading technology, reduced volume sample preparation chemistry, improved detection technology, and systems automation to attain maximal sustainable throughput. Microfabricated Devices and MEMS It is anticipated that further reductions in scale and increases in throughput could be achieved through the application of existing microfabrication and MEMS to DNA sequencing. It is anticipated that successful application of this technology could increase the speed of sequencing by two to three orders of magnitude. Technological challenges that are likely to be encountered are related to the nature of the sample and include reduced volume sample preparation chemistries, improved sample loading technologies, optimizing surface chemistries to minimize sample and reagent loss, and microscale fluidics and detection issues. Systems Integration, Data Acquisition and Handling A key component of high-throughput automated systems will be improved software tools for base calling, sequence assembly, and sequence finishing, as well as for overall systems integration. Even in current approaches, sequence finishing is a bottleneck and requires manual intervention to achieve sequence closure as well as resolution of ambiguities. Therefore, if order of magnitude improvements in finished sequence throughput are to be achieved, this component will require substantial attention and creative approaches for full automation. Objectives The purpose of this RFA is to encourage applications from individuals and groups interested in developing novel automated sequencing technology suitable for large-scale electrophoresis-based genomic sequencing through the reduction in scale of existing approaches utilizing Sanger sequencing reactions coupled with electrophoretic separation of fragments. Applications are encouraged that will provide technology that can ultimately achieve the sequencing goals of the Human Genome Project. Therefore applications should address the development of sequencing technology that when fully developed will allow: o the large-scale sequencing of DNA at a cost significantly below 50 cents per base pair, and o increased large-scale genomic DNA sequence throughput, by at least 10-fold over current methods. Novel sequencing technologies based on reductions in scale that will be considered include, but are not limited to, capillary and ultrathin electrophoresis separation systems, and microfabricated and MEMS systems. Applications to develop such systems should consider front-end sample preparation through separation and detection, aiming for a fully automated, integrated, modular system. Support for individual components of an integrated system will be considered, given indications of a vision towards a fully integrated system or appropriate collaborations. It is important for applicants to demonstrate an appreciation of bottlenecks that arise in the application of existing technology to large-scale genomic DNA sequencing, and to indicate how these bottlenecks will be overcome in the proposed system. In this context, collaboration with large-scale genomic sequencing efforts is encouraged. It is also important for applicants to discuss plans for exportation and support of the technology developed. As the development of a fully functional integrated system is largely dependent on successful data handling, it is anticipated that proposals will deal with this issue in detail. Applications for the development of improved tools for data acquisition, data handling, sequence assembly, and finishing are encouraged, as these steps represent the greatest bottlenecks in current systems and additional improvements in these areas are required to unleash the full power of systems with a capacity for higher throughput. It is crucial that the development of new data acquisition and handling tools be closely linked to large-scale sequencing efforts using current technology and existing data sets, and should also be well connected to ongoing efforts toward reductions in scale to ensure adaptability of ensuing products to higher throughput systems under development. Applications to pursue DNA sequencing projects using state-of-the-art techniques, or improved non-electrophoretic-based technology such as hybridization-based approaches or scanning probe microscopy will not be considered responsive to this request for applications. However, the NCHGR welcomes applications in those areas, as well as other new approaches to DNA sequencing, through program announcements PA-92-50 and PA-90-21. Applications that are solely directed toward the development of databases to support large-scale sequencing projects, or development of algorithms and analytical tools for the annotation of genomic information, should be submitted under program announcement PA-92-50. LETTER OF INTENT Because of the specialized interest of this NCHGR program, it is strongly recommended that potential applicants contact NCHGR staff to discuss research objectives and appropriate mechanisms. Prospective applicants are asked to submit, by February 1, 1994, 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 NCHGR 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: Sample Preparation and/or Separation Devices Carol A. Dahl, Ph.D. Sequencing Technology Branch National Center for Human Genome Research Building 38A, Room 610 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 E-mail: xd2@cu.nih.gov Systems Integration, Data Acquisition and Handling Robert L. Strausberg, Ph.D. Sequencing Technology Branch National Center for Human Genome Research Building 38A, Room 610 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 E-mail: cxr@cu.nih.gov 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 Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NIH program administrator listed under INQUIRIES. 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. 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 the review process, at the time of submission, send two additional copies of the application to: Office of Scientific Review National Center for Human Genome Research Building 38A, Room 609 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Applications must be received by March 17, 1994. 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 RFA 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 for completeness by DRG and for responsiveness to the RFA by the NCHGR program staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCHGR 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. 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 NCHGR. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. All applicants will receive a summary statement consisting of the reviewer's written comments essentially unedited. Summary statements for competitive applications will also contain a summary of the review committee's discussion. The second level of review will be provided by the National Advisory Council for Human Genome Research. Review criteria for RFAs are generally the same as those for unsolicited research grant applications, and include the following: 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; Additional scientific/technical merit criteria specific to this RFA include: o likelihood that the proposed technology will serve as a technology that can support the completion of the goals of the Human Genome Project for sequencing of genomic DNA. o degree to which the project contributes to a fully integrated, automated, modular system for the sequencing of genomic DNA; o degree to which the proposed technology considers and effectively overcomes existing bottlenecks in large-scale sequencing of genomic DNA; o degree to which the proposed system addresses data acquisition and handling issues; o degree to which the proposal considers exportation and support of the ensuing technology; AWARD CRITERIA The anticipated date of award is September 30, 1995. The following criteria will be considered in making funding decisions. o the quality of the proposed project as determined by peer review; o balance among the projects in addressing the issues related to the development of a fully integrated, automated, miniaturized, highly parallel system for sequencing of genomic DNA with associated tools for data acquisition and handling, as specified in this RFA; o 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 inquiries regarding programmatic issues to: Sample Preparation and/or Separation Devices Carol A. Dahl, Ph.D. Program Director, Sequencing Technology Branch National Center for Human Genome Research Building 38A, Room 610 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 E-mail: xd2@cu.nih.gov Systems Integration, Data Acquisition and Handling Robert L. Strausberg, Ph.D. Chief, Sequencing Technology Branch National Center for Human Genome Research Building 38A, Room 610 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 E-mail: cxr@cu.nih.gov Direct inquiries regarding fiscal matters to: Jean M. Cahill Grants and Contracts Management Section National Center for Human Genome Research Building 38A, Room 613 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 402-0733 FAX: (301) 402-1951 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. 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 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 42, pt. 1of1, 2 December 1994 Date: 16 Dec 1994 16:45:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 864 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcac$9q3@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941202 V23N42 P1O1 ************************************ X-comment: RFAs described: HG-95-001, PA-95-009, PA-95-010 NIH GUIDE - Vol. 23, No. 42 - December 2, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** RESPONSIBILITIES OF NIH AND AWARDEE INSTITUTIONS FOR THE RESPONSIBLE CONDUCT OF RESEARCH National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** CHANGE OF PROCEDURES FOR IMPLEMENTING NO-COST EXTENSIONS APPROVED BY GRANTEES UNDER EXPANDED AUTHORITIES OR FEDERAL DEMONSTRATION PROJECT TERMS AND CONDITIONS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** SINGLE NOTICE OF GRANT AWARD National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** NATIONAL CENTER ON SLEEP DISORDERS RESEARCH National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX N5 ********************************************************** HAZARDOUS MATERIALS WORKER HEALTH AND SAFETY TRAINING National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX N6 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N7 ********************************************************** SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BEHAVIORAL RESEARCH CAREERS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 03/17/95 ************************************************* IMPROVED ELECTROPHORETIC DNA SEQUENCING TECHNOLOGY (RFA HG-95-001) National Center for Human Genome Research INDEX: HUMAN GENOME RESEARCH $$INDEX P1 ********************************************************** PREDICTION AND DETERMINATION OF HEARING AID BENEFIT (PA-95-009) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATIONS DISORDERS $$INDEX P2 ********************************************************** ENHANCING CLINICAL CARE THROUGH NURSING INFORMATICS (PA-95-010) National Library of Medicine National Institute of Nursing Research INDEX: NATIONAL LIBRARY OF MEDICINE; NURSING RESEARCH ERRATA $$INDEX E1 ********************************************************** HAZARDOUS MATERIALS WORKER HEALTH AND SAFETY TRAINING (ES-95-001) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES This publication is available electronically via BITNET or INTERNET by subscription and is also on the NIH GOPHER (gopher.nih.gov). Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, MD 20816 $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** RESPONSIBILITIES OF NIH AND AWARDEE INSTITUTIONS FOR THE RESPONSIBLE CONDUCT OF RESEARCH NIH GUIDE, Volume 23, Number 42, December 2, 1994 P.T. 34; K.W. 1014006, 1014004 National Institutes of Health The responsible conduct of research is an important public policy issue. Cases of misconduct in science present a serious threat to continued public confidence in the integrity of the scientific process and the stewardship of Federal funds. The Public Health Service (PHS) has set forth regulations and policies (42 CFR Part 50, Subpart A) for handling misconduct in science. The purpose of this notice is to provide guidance on the responsibilities of awardee institutions under current regulations when misconduct in science affects the design, conduct, or reporting of research funded by the NIH. DEFINITION Misconduct in science is defined as fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgements of data. (42 CFR Part 50.102) Copies of the regulation pertaining to misconduct in science are available from the Office of Research Integrity (ORI) at the address listed below. POLICY 1. It is the policy of PHS to maintain high ethical standards in research and investigate and resolve promptly and fairly all instances of alleged or apparent misconduct. The NIH places responsibility on awardee institutions to assure that each NIH funded program, function, or activity is progressing toward its respective goals (45 CFR Part 74.81) and that awarded funds are expended solely for the purpose of the award in accordance with the approved application and budget, applicable regulations, the terms and conditions of the award, and the applicable cost principles. These responsibilities must be carried out with extra care where misconduct in science has been found or where a misconduct in science investigation has been initiated. 2. Where a misconduct in science investigation has been initiated that involves alleged misconduct affecting an ongoing project, the awardee institution, consistent with its responsibilities under applicable regulations, is responsible for taking whatever steps are necessary to protect the scientific integrity of the project; protect human or animal subjects; provide reports to ORI; ensure that awarded funds are properly expended; and ensure the continuation of the project, to the extent such continuation is consistent with the foregoing objectives and the need to ensure a prompt, fair investigation. Affirmative obligations are imposed in each of these areas by 42 CFR 50.103 and 50.104. The institution should consult with the ORI and the funding agency as necessary to accomplish these objectives. Appointment of a qualified institutional official not previously connected with the research project to oversee the scientific and/or financial aspects of the project is an example of an action that may be necessary, depending upon the circumstances. 3. When a finding of misconduct in science has been made against an individual or individuals working on the funded project by the ORI, the awardee institution must assess the effect of that finding upon the qualifications of the Principal Investigator (PI) or other staff named in the application. Proposed changes must be reported promptly to the awarding agency. In accord with 42 CFR Parts 52.2 and 52.5(a), the awarding agency may withdraw its approval of the PI or other staff named in the application against whom a finding of misconduct has been made, and require the appointment of acceptable substitutes before the project may continue. If PHS or HHS has imposed administrative actions based on an ORI finding of misconduct, such as debarment of an investigator from Federal funding, the awardee institution is expected to make any changes necessary on the funded project to comply with such actions. 4. A finding of misconduct in science that has a significant effect upon the conduct of a funded project may constitute grounds for the withholding of additional awards and the suspension and/or termination of current funding under 45 CFR Parts 74.114 and 74.115. 5. Under 45 CFR 74.170, et seq., and the cost principles referenced therein, expenditures of awarded funds for research that is invalid or unreliable because of misconduct in science may be considered unallowable costs for which the awardee institution is liable for repayment to the awarding agency. This is decided on a case-by-case basis. This and any other determination of unallowable costs is appealable under 42 CFR Part 50, Subpart D and 45 CFR Part 16. 6. Where the validity or reliability of data has been affected by misconduct in science, the awardee institution and its employee authors are responsible for submitting a correction or retraction of data to a journal, as appropriate, and/or for republishing the corrected data. Such corrections or retractions may be required as a PHS administrative action. If the institution does not meet its responsibilities, the awarding agency may invoke its rights to access the data (45 CFR Part 74.211) and to use copyrightable material developed under the award (45 CFR Part 74.145), have the data reviewed, and submit the correction. COOPERATION AND TECHNICAL ASSISTANCE Staff of the ORI are available to assist awardee institutions in responding to misconduct in science. Staff of the NIH awarding agencies are available to provide technical assistance to protect funded projects from the adverse effects of misconduct in science. The joint responsibilities of the awarding agencies and the awardee institutions are the protection of human and animal subjects, proper stewardship of public funds, and ensuring the integrity of the scientific data from the project. INQUIRIES Written, telephone, and email requests for additional information or clarification of the issues addressed in this notice are welcome. Questions concerning technical assistance to protect funded projects should be directed to: NIH Agency Extramural Research Integrity Officer National Institutes of Health Building 1, Room 152 Bethesda, MD 20892 Telephone: (301) 496-5356 Email: gg9i@nih.gov Questions concerning the conduct of institutional or ORI inquiries or investigations should be directed to: Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (310) 443-5330 FAX: (301) 594-0039 Email: dmacfarlane@oash.ssw.dhhs.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** CHANGE OF PROCEDURES FOR IMPLEMENTING NO-COST EXTENSIONS APPROVED BY GRANTEES UNDER EXPANDED AUTHORITIES OR FEDERAL DEMONSTRATION PROJECT TERMS AND CONDITIONS NIH GUIDE, Volume 23, Number 42, December 2, 1994 P.T. 34; K.W. 1014006 National Institutes of Health Under expanded authorities (PHS Grants Policy Statement, Revised April 1, 1994, Page 8-6) and Federal Demonstration Project terms and conditions, a grantee may extend the final budget period of a research project one time for a period of up to one year beyond the original expiration date shown on the Notice of Grant Award (NGA). Effective October 1, 1994, the National Institutes of Health (NIH) has revised its internal procedures to expedite the administrative processing of no-cost extensions approved by grantees subject to these terms and conditions. This procedural change is intended to reduce NIH processing costs, as well as address concerns raised by grantees about the timeliness of issuing no-cost extensions and the potential for delays to result in Financial Status Reports inappropriately appearing on reports of those past due. Under the new procedure, grantees will continue to submit an appropriately signed no-cost extension notification to the NIH awarding Institute or Center (IC) grants management office. This notification will serve as the authorizing document from which the NIH awarding IC will administratively process the extension to reflect the change in internal NIH systems and the Payment Management System. Under this expedited process, grantees will no longer receive a revised NGA. However, an acknowledgement that the no-cost extension has been processed will be sent by the awarding IC to the grantee organization's administrative official (individual identified in item number 6 on the PHS 2590 application face page, or item number 15 on the PHS 398 application face page). Grantees are reminded that the NIH awarding IC grants management office must be notified of the extension 10 days prior to the expiration date of the project period. No-cost extensions requiring NIH awarding IC prior approval, e.g., grants and cooperative agreements not subject to expanded authorities or Federal Demonstration Project terms and conditions, will continue to be processed through revised NGAs. INQUIRIES Questions concerning the revised procedures for no-cost extensions should be addressed to NIH IC grants management staff identified on the NGA. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** SINGLE NOTICE OF GRANT AWARD NIH GUIDE, Volume 23, Number 42, December 2, 1994 P.T. 34; K.W. 1014006 National Institutes of Health Recently, the awarding Institutes and Centers of the National Institutes of Health (NIH), implemented a new procedure for routinely mailing the original Notice of Grant Award (NGA) only to the administrative official identified in item number 15 on the PHS 398 application face page and item number 6 on the PHS 2590 application face page. This procedural change was implemented under a streamlining and cost savings initiative. Specifically, it has been estimated that NIH can reduce its mailing costs associated with distribution of NGAs by almost two-thirds. Consultation with grantee administrative officials indicates that this procedural change has had minimal impact at the grantee level, since organizations typically have internal distribution procedures in place. Since NIH grants are awarded to organizational entities on behalf of principal investigators, NIH expects that the administrative official identified on the application face page will immediately forward to the principal investigator a copy of the NGA, along with any special terms and conditions. It is essential that, when submitting applications to NIH, the applicant organization provide the complete name and address of the administrative official so that the NGA and other important information will be received by the grantee organization. This new procedure will routinely apply to the mailing of all types of NGAs, except Notices of Fellowship Award, which will continue to be mailed to the fellow and the sponsoring institution. NIH Institutes and Centers may elect to send additional copies of the NGA for certain award mechanisms or where other special circumstances apply. INQUIRIES Questions concerning the distribution of NGAs may be addressed to the NIH Institute or Center grants management staff identified on the award. $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL CENTER ON SLEEP DISORDERS RESEARCH NIH GUIDE, Volume 23, Number 42, December 2, 1994 P.T. 34; K.W. 0715187 National Heart, Lung, and Blood Institute The purpose of this notice is to inform the scientific community and public of the establishment and goals of the National Center on Sleep Disorders Research. Sleep disorders and disturbances of sleep constitute a major public health problem. The National Commission on Sleep Disorders Research estimated that as many as 40 million Americans may suffer from chronic or intermittent disorders of sleep and sleep deprivation. The consequences of which include reduced productivity, lowered cognitive performance, excessive daytime sleepiness, increased likelihood of accidents, higher risk of morbidity and mortality, and decreased quality of life. As part of the 1993 National Institutes of Health (NIH) Revitalization Act (Public Law 103-43), the National Heart, Lung, and Blood Institute (NHLBI) was authorized to establish the National Center on Sleep Disorders Research (NCSDR). The mission of the NCSDR is to support research, scientist training, the dissemination of health information, and other activities with respect to sleep disorders and sleep related research. It is also responsible for coordination of activities in sleep research with all NIH components, other Federal agencies, public entities, and nonprofit organizations. The Center will serve four key functions: coordination, support of crosscutting basic and clinical research, training of scientists, technology transfer to health professionals, policymakers, patients, and the public. To accomplish these goals, the Center has an Advisory Board to advise, assist, consult and make recommendations to the Director, NHLBI, and Director, NIH, on scientific activities, research directions, priorities, and policy matters to be carried out by and through the Center. The Advisory Board consists of 12 appropriately qualified representatives and 10 ex officio members. The NCSDR serves as a focal point for the Federal Government's efforts on sleep and sleep disorders research, but will not become the single funding organization for all sleep research, or supplant ongoing sleep research programs at the NIH. Rather, it will work closely with other Institutes and Government Agencies to facilitate, support and foster a wide range of activities in sleep and sleep disorders. NIH referral guidelines will be used to assign grant applications to the most appropriate NIH Institute based on the scientific focus of the application. Through this coordinated effort, the NCSDR hopes to improve communication among scientists, policymakers, and health care professionals, accelerate the speed of scientific discovery and disseminate findings to health professionals, patients, and the public. INQUIRIES Written and telephone inquiries are encouraged and may be directed to: National Center on Sleep Disorders Research National Heart, Lung and Blood Institute 31 Center Drive, Room 4A11 MSC 2490 Bethesda, MD 20892-2490 Telephone: (301) 496-7443 FAX: (301) 402-8307 AUTHORITY AND REGULATIONS This project is described in the Catalog of Federal Domestic Assistance No. 93.837. 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 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** HAZARDOUS MATERIALS WORKER HEALTH AND SAFETY TRAINING NIH GUIDE, Volume 23, Number 42, December 2, 1994 P.T. 34; K.W. 0725020, 0502017 National Institute of Environmental Health Sciences Request for Applications (RFA) ES-95-001 was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 38, October 28, 1994. An open meeting was held on November 16, 1994 with potential applicants to clarify issues relating to the RFA. A summary of the issues discussed is now available. The National Institute of Environmental Health Sciences (NIEHS) plans to hold a technical workshop entitled, Environmental Job Training for Inner City Youth, in Cleveland, Ohio on January 5-6, 1995. The purpose of the workshop is to address major issues regarding training programs in this area and for interested parties to engage in dialogue that may help these training programs improve. Participants will be encouraged to join together in consortia for the minority worker part of the RFA referenced above. Additionally, the following change is made to the RFA: The application receipt date is changed from January 20, 1995 to February 17, 1995. INQUIRIES For further information on either of these items, contact: Denny Dobbin Worker Education and Training Program National Institute of Environmental Health Sciences 111 Alexander Drive, MD WC-04 Research Triangle Park, NC 27709-2233 Telephone: (919) 541-0752 FAX: (919) 541-0462 Email: dobbin@niehs.nih.gov $$N5 END ************************************************************ $$N6 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 23, Number 42, December 2, 1994 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 subjects. The meetings should be of special interest to those persons 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: DATES: February 23 & 24, 1995 LOCATION Kellogg Conference Center, Columbia University, New York, NY SPONSORS Columbia University, New York, NY Harlem Hospital Center, New York, NY The John Conley Foundation for Ethics and Philosophy in Medicine, Inc., New York, NY REGISTRATION David J. Rothman, Ph.D. Bernard Schoenberg Professor of Social Medicine and Director College of Physicians and Surgeons Columbia University 630 West 168th Street, Black 101 New York, NY 10023 Telephone: (212) 305-4184 FAX: (212) 305-6416 REGISTRATION FEE: $200 TITLE: Regulating Human Experimentation in the United States: The Lessons of History DESCRIPTION: The current organization and operation of Institutional Review Boards (IRBs) cannot be understood apart from the history of human experimentation. During the 1950s and 1960s, a series of exposes and scandals created the pressure for reform and oversight of clinical research. Over the 1970s, regulations were enacted that reflected an increased public awareness of the atrocities committed by Nazi doctors during World War II and such American incidents as Tuskegee, Willowbrook, and those described by henry Beecher in his whistle-blowing 1966 New England Journal of Medicine article. Today, exposes of experiments with radioactive materials and mind altering chemical substances of American citizens during the Cold War are now prominent in the media. Once again, reform must be like to an understanding of history. The past record is of primary relevance to the design of an effective public policy in human experimentation for the 21st century. Hence, this two day conference will explore the history of human experimentation in the United States in the 20th century and analyze its critical implication for IRB performance and policy today. The first day of the conference will address such important and heretofore unexplored questions as who were the primary sponsors of clinical research in the period preceding 1950. It will devote significant attention to why the first subjects for human experimentation were so often recruited from minorities and institutionalized populations. It will also analyze the changing norms for informing subjects about clinical research and the place of human experimentation in popular culture and the media. The second day will examine cold war research and draw out its implications for current IRB operations and policy. In light of the historical record, the discussion will place particular emphasis on the use of vulnerable populations as human subjects in clinical research. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 FAX: (301) 402-0527 $$N6 END ************************************************************ $$N7 BEGIN ********************************************************** SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BEHAVIORAL RESEARCH CAREERS NIH GUIDE, Volume 23, Number 42, December 2, 1994 PA NUMBER: PA-94-067 P.T. 34; K.W. 0710030 National Institutes of Health The following addendum is issued for PA-94-067, Supplements to Promote Reentry Into Biomedical and Behavioral Research Careers, which was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 18, May 13, 1994. The National Institute of Mental Health (NIMH) is added to the list of participating Institutes and Centers. The program contact for NIMH is: Delores L. Parron, Ph.D. Associate Director for Special Populations National Institute of Mental Health Parklawn Building, Room 17C-14 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2847 FAX: (301) 443-8552 $$N7 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HG-95-001 FULL-TEXT ************************************** IMPROVED ELECTROPHORETIC DNA SEQUENCING TECHNOLOGY NIH GUIDE, Volume 23, Number 42, December 2, 1994 RFA AVAILABLE: HG-95-001 P.T. 34; K.W. 0755045, 1215018 National Center for Human Genome Research Letter of Intent Receipt Date: February 1, 1995 Application Receipt Date: March 17, 1995 PURPOSE The National Center for Human Genome Research (NCHGR) invites applications for research projects to develop novel automated sequencing technology suitable for large-scale genomic sequencing through the reduction in scale and increased parallelization of existing approaches utilizing Sanger sequencing reactions coupled with electrophoretic separation of fragments. The Request For Applications (RFA) encompasses front end sample preparation, separation, detection, and data acquisition and handling. Technologies solicited include a spectrum of approaches ranging from capillary and ultrathin gel electrophoresis to microfabricated and micro-electro mechanical systems (MEMS) that could yield reductions in scale and increased throughput. It is anticipated that $3,000,000 (direct and indirect costs) per year for up to three years will be available beginning in fiscal year 1995. It is anticipated that between five and ten awards will be made, representing a mix of research topics and mechanisms. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of awards will also vary. 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, Improved Electrophoretic DNA Sequencing Technology, is related to several priority areas, including cancer, heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Carol A. Dahl, Ph.D. Sequencing Technology Branch National Center for Human Genome Research Building 38A, Room 610 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 E-mail: xd2@cu.nih.gov $$R1 END ************************************************************ $$P1 BEGIN PA-95-009 FULL-TEXT ************************************** PREDICTION AND DETERMINATION OF HEARING AID BENEFIT NIH GUIDE, Volume 23, Number 42, December 2, 1994 PA AVAILABLE: PA-95-009 P.T. 34; K.W. 0740030, 0745070 National Institute on Deafness and Other Communication Disorders PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for the support of basic and applied research studies on issues related to predicting and measuring the benefit received from hearing aids. No widely accepted measures of hearing aid benefit are currently available, nor is there a universally accepted definition of hearing aid benefit. In addition, clinical measures currently used for fitting hearing aids provide little of value in predicting user benefit, especially over the long term. Clinicians and researchers agree that many more individuals than currently use hearing aids could benefit from their use. Rational approaches to designing and providing hearing aids to millions of hearing-impaired individuals require clinically valid measures for predicting and determining the benefit received from hearing aids. The support mechanisms for grants in this area will be the individual investigator-initiated research project grant (R01) and the FIRST (R29) award. 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 PA, Prediction and Determination of Hearing Aid Benefit, is related to the priority area of diabetes and chronic disabling conditions. 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). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Lynn E. Huerta, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3461 FAX: (301) 402-6251 E-Mail: Lynn_Huerta%NIDCD-EPS%NIH@FEDTCP.NINDS.NIH.GOV $$P1 END ************************************************************ $$P2 BEGIN PA-95-010 FULL-TEXT ************************************** ENHANCING CLINICAL CARE THROUGH NURSING INFORMATICS NIH GUIDE, Volume 23, Number 42, December 2, 1994 PA AVAILABLE: PA-95-010 P.T. 34; K.W. 0710078, 0785130, 0785035 National Library of Medicine National Institute of Nursing Research PURPOSE The National Library of Medicine (NLM) and the National Institute of Nursing Research (NINR) invite applications for grants to support research in nursing informatics. Of particular interest is investigation that addresses improvements in the delivery of clinical nursing care through the use of information systems. The intent of this program announcement is to generate research that will examine systems to manage and process data, information and knowledge with the goal of facilitating appropriate and effective clinical care. Although NLM's existing program in medical informatics addresses the application of informatics to health care broadly defined, this program announcement has the specific purpose of calling the attention of those interested in informatics research to the set of issues of particular concern and importance to the nursing profession. The mechanisms of support will be the National Institutes of Health research project grant (R01) and FIRST award (R29). 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. The program announcement, Enhancing Clinical Care Through Nursing Information, is related to the priority area of surveillance and data systems. 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). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Patricia Moritz Nursing Systems Branch National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5966 FAX: (301) 480-8260 Dr. Milton Corn Division of Extramural Programs National Library of Medicine Building 38A, Room 5N-505 Bethesda, MD 20894 Telephone: (301) 496-4621 FAX: (301) 402-0421 E-Mail: CORN@NLM.NIH.GOV $$P2 END ************************************************************ ERRATA $$E1 BEGIN R1 19941028 APPEND RFA ES-95-001 BOTH *********************** HAZARDOUS MATERIALS WORKER HEALTH AND SAFETY TRAINING NIH GUIDE, Volume 23, Number 42, December 2, 1994 RFA: ES-95-001 P.T. 34; K.W. 0725020, 0502017 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: November 18, 1994 Application Receipt Date: February 17, 1995 The following correction is issued for RFA ES-95-001, which was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 38, October 28, 1994. The application receipt date is changed to: February 17, 1995. INQUIRIES Direct inquiries regarding programmatic issues to: Denny Dobbin Worker Education and Training Program National Institute of Environmental Health Sciences 111 Alexander Drive, MD WC-04 Research Triangle Park, NC 27709-2233 Telephone: (919) 541-0752 Email: dobbin@niehs.nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 44, 16 December 1994 Date: 16 Dec 1994 16:45:53 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 794 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcc1$a0u@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941216 V23N44 P1O1 ************************************ X-comment: RFAs described: HS-95-001, PAR-95-011, PAR-95-012 NIH GUIDE - Vol. 23, No. 44 - December 16, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** REINVENTION ACTIVITIES RELATED TO NIH EXTRAMURAL PROGRAMS STATUS REPORT: DECEMBER 1994 National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** RESPONSIBILITIES OF NIH AND AWARDEE INSTITUTIONS FOR THE RESPONSIBLE CONDUCT OF RESEARCH National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 03/16/95 ************************************************* RESEARCH ON EMERGENCY MEDICAL SERVICES FOR CHILDREN (RFA HS-95-001) Agency for Health Care Policy and Research Health Resources and Services Administration INDEX: HEALTH CARE POLICY, RESEARCH; HEALTH RESOURCES AND SERVICES ADMINISTRATION $$INDEX P1 ********************************************************** FOGARTY INTERNATIONAL RESEARCH COLLABORATION AWARD (PAR-95-011) Fogarty International Center INDEX: FOGARTY INTERNATIONAL CENTER $$INDEX P2 ********************************************************** HIV, AIDS AND RELATED ILLNESSES COLLABORATION AWARD (PAR-95-012) Fogarty International Center INDEX: FOGARTY INTERNATIONAL CENTER This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** REINVENTION ACTIVITIES RELATED TO NIH EXTRAMURAL PROGRAMS STATUS REPORT: DECEMBER 1994 NIH GUIDE, Volume 23, Number 44, December 16, 1994 P.T. 34; K.W. 1014006 National Institutes of Health Vice President Gore's National Performance Review (NPR) outlined a plan to reinvent the Federal government to work better and cost less. In response to this directive and the accompanying mandate to reduce the size of the Federal workforce, the NIH extramural programs have been designated one of several Executive Branch "Reinvention Laboratories," to lead the process of change for grants administration in the Public Health Service (PHS). The imprimatur of this status has facilitated the efforts of the Office of Extramural Research (OER) to reevaluate NIH policies and procedures. As a consequence, both the momentum to make changes and the opportunity to effect them have increased. A large number of initiatives are currently underway at NIH. Some are new and directly responsive to the mandate of reinvention; others are a continuation of ongoing efforts to improve the way NIH does business. Some address issues specific to extramural activities, while others address overarching issues at the NIH, PHS, or HHS level that potentially have impact on extramural programs. They emanate from ideas contributed by individuals and groups, both within and outside of NIH. When feasible, pilot studies are being conducted. The activities are coordinated by the Extramural Reinvention Committee (ERC), which operates under the auspices of the OER and ensures sharing of knowledge and prevents duplication of effort. An essential feature of this coordination is that it does not serve a "gatekeeping" function, i.e., it does not serve as a bureaucratic impediment to the free flow of ideas, activities of working groups, or development of pilot experiments. The reinvention activities outlined below are organized into three sections: those which directly impact on the submission of competing applications and the peer review process; those which deal with post- award issues; and those which aim to improve the efficiency and cost- effectiveness of internal NIH processes. The reinvention activities discussed below range from those that are fully developed to those that are still in the conceptual phase. They represent the present state of an evolving operation, which will continue to rely on the valued input of all interested parties. This report is one of a series in which the state of reinvention activities will be updated. PEER REVIEW AND PROCESSING OF APPLICATIONS: Triage - (full implementation beginning February 1995) - Beginning with the February 1995 round of review (i.e., review of applications submitted October/November 1994), all DRG study sections will employ the triage process routinely, and Initial Review Groups (IRGs) within Institutes and Centers (ICs) may use it at their option. This represents an extension across NIH of a triage process that had been used successfully for a number of years by the ICs for the review of applications received in response to Requests for Applications (RFAs). In triage, peer reviewers are asked to identify the pending applications (approximately half) that are "unrealistic candidates for funding in the present budgetary environment" (not to be equated with "disapproval" or "not recommended for further consideration"). Those applications are not discussed at the study section meeting, and are not given priority scores. If even one member of the study section believes that the application has some chance of being funded, the application is fully discussed and scored. A pilot study has been conducted. The first phase of the pilot study, performed during the February 1994 review round, included four study sections within the DRG; participating review groups designated 30 to 50 percent of the applications as not to be discussed, and reviewers consistently indicated that there was more time for discussion of the applications that were scored, and that meetings ended earlier than usual. Expanded pilot studies were conducted in the June and October 1994 rounds of review. While triage can now be considered to be fully implemented, the process will nonetheless continue to evolve, with adjustments and modifications if necessary. Modified Summary Statement - (full implementation beginning February 1995) - The first-phase triage study incorporated a streamlined format for the expedited production of summary statements. Applicants whose projects were unscored received a critique that was essentially unabridged comments from the reviewers, with the intent that this would allow for a quicker return of the critiques and provide the applicant more time to amend and resubmit the application, if desired. Feedback from applicants involved in the first-phase study (and others) indicated that, in general, receiving essentially unedited reviewers' comments is preferable to receiving a synthesis of the critiques prepared by NIH staff. In the expanded triage study, the use of essentially unabridged reviewers' critiques was extended to all applications. For the scored applications, a "Resume and Summary of Discussion" was included to convey the highlights of the discussion at the study section meeting leading to the final rating, plus a paragraph detailing budgetary recommendations as appropriate. The modified summary statement format will be used for all applications reviewed by DRG study sections beginning with the February 1995 round of review (i.e., those submitted in October or November 1994). Expedited Release of Summary Statements to Applicants - (concept under discussion) - In current practice, summary statements prepared by Scientific Review Administrators (SRAs) are routed to Program staff at the ICs, who review and then release them to the applicants. This introduces a time lag, sometimes substantial, between preparation of the document and receipt by the applicant. Now that full implementation of triage and the use of modified summary statements are in place, it has been suggested that summary statements for unscored applications, which consist of the essentially unedited reviewers' comments, might be released to applicants directly from DRG. This would provide considerably faster feedback to investigators whose applications were unscored. Retrospective versus Prospective Review - (concept under discussion) - The usual NIH peer review process is primarily prospective in that it typically focuses on a detailed proposal of the specific research studies for which the applicant is seeking support. However, some contend that a retrospective review, focussing primarily on the investigator's recent accomplishments, would be advantageous. Researchers would be relieved of the burden of writing detailed plans that are likely to change in the course of conducting their investigations, and could instead spend the saved time on research; evaluation of past scientific record could afford the precision of hindsight and is believed by some to be the best predictor of continued creativity and accomplishment; and success could be less dependent on grantsmanship skills. On the other hand, there are concerns that investigators just beginning their careers or at career turning-points may not be well served by retrospective review. Ongoing discussion is focused on the question of under what circumstances a retrospective-based review might be appropriate. Historical data on funding patterns and information derived from examination of precedents for retrospective peer review at NIH and other Federal agencies are being considered in these discussions. Further deliberations, involving both NIH staff and extramural researchers, are clearly needed. Restructuring DRG Review Groups: - (concept under discussion) - Ideas are being considered about how the new Initial Review Group-based organization of DRG can be exploited to broaden the range of expertise represented on individual study sections without sacrificing focus. In addition, discussions are under way to identify mechanisms for periodic review of the organization and function of IRGs and their constituent study sections, to ensure that they evolve in pace with scientific advances. "Just in Time" - (pilot experiments currently under way) - "Just-in- Time" postpones the collection of a fairly substantial amount of information that currently must be provided for all competitive applications. Data on other support and complete budget detail would not be requested at the time of application, and the biographical sketch would instruct applicants to provide only information related to research background and experience, including, at the option of the applicant, the sponsored support relevant to the proposed research. This approach would simplify and reduce the administrative burden associated with the NIH grant application without compromising the initial review group determination of scientific merit or the reasonableness of the proposed budget. Detailed information relevant to the award of the project would be exchanged "just in time" prior to award. This delayed request and receipt of information should relieve administrative and paperwork burdens for the approximately 70-75 percent of applicants who will not receive an award. In order for "Just-in-Time" to be effective, it is essential that applicants and their institutions be prepared to provide the detailed information quickly, if a decision were made to fund an application. "Just-in-Time" pilot tests are being conducted through a number of RFAs and Program Announcements from several ICs. This provides an opportunity to explain the requirements to a defined set of applicants and to evaluate the results. Identification of High Risk/High Impact (HR/HI) Research Applications - (implementation in place since June 1994) - Since June/July, 1994, reviewers serving on DRG study sections have been asked to identify those applications that both involve high risk research and have the potential for high scientific impact. This identification occurs after the merit review and assignment of priority scores, and will require agreement of at least two members of the IRG. The goal is to determine whether IRGs can better identify HR/HI applications when specifically asked to, and if the information they provide will aid program staff and the National Advisory Councils to better identify special research opportunities for consideration. Amended Applications - (concept under discussion) - Currently, there is no limit to the number of times an unsuccessful application can be resubmitted in an amended version. This impacts on review burden, and can result in inefficiency, particularly in cases where the original application is either fairly weak overall or for the most part quite strong. Applicants with intrinsically weak proposals have been known to incorporate reviewers' specific suggestions into amended versions, cycle after cycle after cycle, with the expectation that eventually this will suffice to merit a fundable score. On the other hand, applications that are very strong overall, but for which reviewers have raised a few relatively minor questions or criticisms (the sort that could easily be dealt with by a one or two page response from the applicant), are frequently voted scores that put them beyond the nominal payline for funding. Those applicants must then resubmit an amended version, which is then subjected to the lengthy review process all over again. This introduces delays in the initiation of worthwhile research activities. Such delays can be deleterious to the careers of beginning investigators, and can result in serious inefficiencies of both cost and time when the delay results in a funding discontinuity for a renewal project. Discussions are focusing on a proposal to limit the maximum number of amended versions permitted to two (i.e., no more than three submissions of the same project), and on ways in which time-consuming resubmission of promising applications might be avoided (e.g., by increased use of deferral and request for additional information by study sections and/or by Program staff for presentation to National Advisory Councils). Cost Management: budgeting for total costs rather than direct costs - (concept under discussion) - The usual current practice is for applicants to request, and for reviewers and program staff to recommend, grant budgets in terms of direct costs. Indirect costs usually increase total costs by approximately 30 percent. However, indirect cost amounts may vary unpredictably over the duration of a multi-year grant, as institutional indirect cost rates change as a result of negotiations or as direct-cost spending patterns vary (e.g., if funds originally budgeted for equipment are instead used for supplies, or vice-versa). Thus, it is difficult to estimate true out-year funding commitments for budget projection purposes. An alternative approach, which is standard practice in several other Federal agencies, is to consider the requested and recommended budgets at all stages of the process in terms of total costs. In addition to accurately reflecting the total cost of the research and stabilizing the out-year budget commitments, this provides cost management incentives to the grantee institution and investigator. Modular Grants - (pilot experiments under way) - The concept of the modular grant is based on a return to the underlying principle of a grant as an assistance mechanism that does not necessarily provide full-cost reimbursement for the research project. In the modular grant model, applications would be submitted and/or awards would be made with direct (or possibly total) costs in modules of a given amount, e.g., $50,000, with work proposed within these incremental categories. Alternatively, a limited series of capped award levels (e.g., $100,000, $200,000) might be used. The modular grant is envisioned as eliminating the need for submission or review of detailed budgets. Fiscal accountability for individual projects could largely be shifted to the recipient organizations, with NIH retaining responsibility for oversight of the organizations' monitoring systems and remaining accountable for the scientific progress of the projects it supports. A feasibility test of the modular grant mechanism is being undertaken by the National Heart, Blood, and Lung Institute (NHLBI) through a Request for Applications (RFA) for R01 applications that was issued in the Fall of 1994, with applications due in January 1995. A second pilot is planned, also at NHLBI, in conjunction with an RFA for multi-project applications. This concept could be extended to address total costs. Post-Council Notification - (limited implementation in place) - Several ICDs have eliminated routine use of post-council letters. Instead, all applicants are informed of the status of their pending applications in the letters that accompany the summary statements and that they will be notified if the National Advisory Council makes any recommendation that differs from or alters the recommendation of the IRG. The use of post-council letters is thus reserved for only the small group of applicants for whom the National Advisory Council takes a separate action, such as addressing a rebuttal or recommending deferral, or to inform the applicant of funding or possible funding (NHLBI only). Full implementation of this reinvention would eliminate the mailing of more than 25,000 letters from the NIH each year. Electronic Research Administration - (in planning stage; some pilot experiments under way) - Electronic research administration initiatives are based on the concept that electronic files would be created to serve as the repository for all information generated during the life cycle of each grant. This data base would be accessible to authorized institutional and NIH staff, who could each review and add information as required. When fully implemented, this should streamline the administration of research grants and cooperative agreements. One major initiative involves the electronic submission of grant applications. A feasibility experiment in which R01 applications were submitted electronically in their entirety, using software provided by NIH (Automated Grant Application System, AGAS), was carried out for five review cycles (February 1993 through July 1994) in cooperation with seven major grantee institutions. Analysis of the results of the experiment have not yet been completed. However, the experiment was limited by the fact that internal NIH procedures for the post-receipt handling of applications are not yet electronic and therefore require the use of paper documents. These trials illuminated the diversity in the way applicant organizations use automation to create applications and to capture relevant data for use within their inhouse systems. Therefore, NIH has adjusted its plan to emphasize the publication of transmission stream specifications. This will open up opportunities for independent software vendors to develop grant application creation software, which can create data streams compatible with NIH processing systems. Another experiment (Limited Electronic Submission System, LESS) was begun in October 1994 in cooperation with two major grantee institutions, in which the face page, second (Abstract) page, certain budget items, and personal data for the Principal Investigator for R01 applications are submitted electronically, with the remainder of the application submitted as paper copies. The aim is to feed the electronically-submitted information directly into NIH's internal data base (IMPAC), without the need for intervening paper copies or manual re-keying of the data. In the near future, this process will be further simplified through an initiative to provide each institution with a unique, assigned number that would be used to link the application with administrative information already contained in IMPAC, e.g., institutional assurances and certifications, names of institutional officials. By using these institutional profiles, the need to provide data repeatedly on a project-by-project basis would be eliminated. Increased electronic availability of information about extramural research programs - (planned enhancement of current implementation) - Access to the NIH Guide and telephone directory has been provided on both the NIH Gopher and NIH Grantline; the PHS Grants Policy Statement will soon be available on the NIH Gopher; and the CRISP database, which lists all NIH grant and contract awards, is available on the NIH Gopher. The full text of the NIH Guide and the Table of Contents is available through separate LISTSERV subscription lists (NIH Guide, Vol. 23, No. 20, May 27, 1994). Efforts are underway to add several items, such as a subscription list for information from the Office for Protection from Research Risks (OPRR); rosters of advisory groups including initial review groups; the minutes of the public portions of the National Advisory Council meetings; the NIH Extramural Programs; and descriptions of ongoing programs such as the First Independent Research Support and Transition (FIRST) Awards, the National Research Service Act (NRSA) Awards, and the Minority Supplement Program. POST-AWARD MANAGEMENT OF GRANTS: Notice of Grant Awards (NGA) - (full implementation announced in NIH GUIDE, Vol. 23, No. 42, December 2, 1994) - The awarding Institutes and Centers (ICs) have recently implemented a new procedure whereby only a single copy of the NGA is mailed to the grantee institution's administrative official, with the instruction that the institution distribute copies to the Principal Investigator and other interested parties. This eliminates the mailing of copies to several offices from NIH, and will serve as a phase-in to the longer-term goal of electronic transmission of NGAs. Streamlining the Non-Competing Award Process - (implementation begun October 1994) - The goal is to create a process that is more efficient and less burdensome for all parties involved. One guiding principle is that, to the extent possible, the financial and administrative information required for the responsible award and administration of a grant should be obtained at the time of the competing award; the noncompeting applications could then focus on the scientific progress of the research. Toward this end, beginning October 1, 1994, financial reporting for Type 5 applications has been streamlined. All out-year budgets are provided to NIH program staff at the time of initial award. Therefore, instead of submitting four different financial documents each year (year "x" budget, estimate of year "x-1" expenses, Financial Status Report, and quarterly Federal Cash Transaction Reports), only the Financial Status Report and the Federal Cash Transaction Reports are required. Annual reports are still required, but these should focus on scientific progress, changes in scientific direction, changes in other support, and other matters relevant to the programmatic management of the grant. This streamlined approach had been tested for two years under the Federal Demonstration Project. Further streamlining is under consideration, notably the possibility of eliminating the annual Financial Status Report. NIH INTERNAL STREAMLINING: A number of experiments and other activities are underway to improve the efficiency and cost-effectiveness of internal NIH processes. For example, the NIH Extramural Research Reinvention Laboratory has requested redelegation of authorities related to advisory committee administration and grants administration policy and regulation, with the goal of reducing paperwork, effort, and delay related to obtaining clearances at several levels within the DHHS. Other internal reinvention activities at various stages of development include: streamlining the DRG process for nominating study section members; expedited assignment of applications in DRG for renewals and amended applications; evaluation of new staffing patterns to identify ways to accomplish more work with fewer staff; reinventing aspects of National Advisory Council activities; streamlining internal clearance and approval of cooperative agreement RFAs; streamlining internal review for non-competing awards; reinvention of contracts management procedures; and simplification of other grants management-related processes. (Suggestions may be submitted to Dr. Wendy Baldwin, Deputy Director for Extramural Research, National Institutes of Health, Building 1, Room 152, Bethesda, MD 20892, or via e-mail: DDER@NIHOD1.BITNET or DDER%NIHOD1.BITNET@cu.nih.gov) $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** RESPONSIBILITIES OF NIH AND AWARDEE INSTITUTIONS FOR THE RESPONSIBLE CONDUCT OF RESEARCH NIH GUIDE, Volume 23, Number 44, December 16, 1994 P.T. 34; K.W. 1014006, 1014004 National Institutes of Health The responsible conduct of research is an important public policy issue. Cases of misconduct in science present a serious threat to continued public confidence in the integrity of the scientific process and the stewardship of Federal funds. The Public Health Service (PHS) has set forth regulations and policies (42 CFR Part 50, Subpart A) for handling misconduct in science. The purpose of this notice is to provide guidance on the responsibilities of awardee institutions under current regulations when misconduct in science affects the design, conduct, or reporting of research funded by the NIH. DEFINITION Misconduct in science is defined as fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgements of data. (42 CFR 50.102) Copies of the regulation pertaining to misconduct in science are available from the Office of Research Integrity (ORI) at the address listed below. POLICY 1. It is the policy of PHS to maintain high ethical standards in research and investigate and resolve promptly and fairly all instances of alleged or apparent misconduct. The NIH places responsibility on awardee institutions to assure that each NIH funded program, function, or activity is progressing toward its respective goals (45 CFR 74.81) and that awarded funds are expended solely for the purpose of the award in accordance with the approved application and budget, applicable regulations, the terms and conditions of the award, and the applicable cost principles. These responsibilities must be carried out with extra care where misconduct in science has been found or where a misconduct in science investigation has been initiated. 2. Where a misconduct in science investigation has been initiated that involves alleged misconduct affecting an ongoing project, the awardee institution, consistent with its responsibilities under applicable regulations, is responsible for taking whatever steps are necessary to protect the scientific integrity of the project; protect human or animal subjects; provide reports to ORI; ensure that awarded funds are properly expended; and ensure the continuation of the project, to the extent such continuation is consistent with the foregoing objectives and the need to ensure a prompt, fair investigation. Affirmative obligations are imposed in each of these areas by 42 CFR 50.103 and 50.104. The institution should consult with the ORI and the funding agency as necessary to accomplish these objectives. Appointment of a qualified institutional official not previously connected with the research project to oversee the scientific and/or financial aspects of the project is an example of an action that may be necessary, depending upon the circumstances. 3. When a finding of misconduct in science has been made against an individual or individuals working on the funded project by the ORI, the awardee institution must assess the effect of that finding upon the qualifications of the Principal Investigator (PI) or other staff named in the application. Proposed changes must be reported promptly to the awarding agency. In accord with 42 CFR 52.2 and 52.5(a), the awarding agency may withdraw its approval of the PI or other staff named in the application against whom a finding of misconduct has been made, and require the appointment of acceptable substitutes before the project may continue. If PHS or HHS has imposed administrative actions based on an ORI finding of misconduct, such as debarment of an investigator from Federal funding, the awardee institution is expected to make any changes necessary on the funded project to comply with such actions. 4. A finding of misconduct in science that has a significant effect upon the conduct of a funded project may constitute grounds for the withholding of additional awards and the suspension and/or termination of current funding under 45 CFR 74.114 and 74.115. 5. Under 45 CFR 74.170, et seq., and the cost principles referenced therein, expenditures of awarded funds for research that is invalid or unreliable because of misconduct in science may be considered unallowable costs for which the awardee institution is liable for repayment to the awarding agency. This is decided on a case-by-case basis. This and any other determination of unallowable costs is appealable under 42 CFR 50, Subpart D and 45 CFR 16. 6. Where the validity or reliability of data has been affected by misconduct in science, the awardee institution and its employee authors are responsible for submitting a correction or retraction of data to a journal, as appropriate, and/or for republishing the corrected data. Such corrections or retractions may be required as a PHS administrative action. If the institution does not meet its responsibilities, the awarding agency may invoke its rights to access the data (45 CFR 74.211) and to use copyrightable material developed under the award (45 CFR 74.145), have the data reviewed, and submit the correction. COOPERATION AND TECHNICAL ASSISTANCE Staff of the ORI are available to assist awardee institutions in responding to misconduct in science. Staff of the NIH awarding agencies are available to provide technical assistance to protect funded projects from the adverse effects of misconduct in science. The joint responsibilities of the awarding agencies and the awardee institutions are the protection of human and animal subjects, proper stewardship of public funds, and ensuring the integrity of the scientific data from the project. INQUIRIES Written, telephone, and email requests for additional information or clarification of the issues addressed in this notice are welcome. Questions concerning technical assistance to protect funded projects should be directed to: NIH Agency Extramural Research Integrity Officer National Institutes of Health Building 1, Room 152 Bethesda, MD 20892 Telephone: (301) 496-5356 Email: gg9i@nih.gov Questions concerning the conduct of institutional or ORI inquiries or investigations should be directed to: Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (310) 443-5330 FAX: (301) 594-0039 Email: dmacfarlane@oash.ssw.dhhs.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HS-95-001 FULL-TEXT ************************************** RESEARCH ON EMERGENCY MEDICAL SERVICES FOR CHILDREN NIH GUIDE, Volume 23, Number 44, December 16, 1994 RFA AVAILABLE: HS-95-001 P.T. 34, AA; K.W. 0730007, 0408006, 0730005 Agency for Health Care Policy and Research Health Resources and Services Administration Application Receipt Date: March 16, 1995 PURPOSE This announcement solicits applications to conduct research on (1) Severity and Acuity Measures for Illness and Injury for Children; (2) Child and Adolescent Patient Outcomes and Outcome Measures; (3) Costs of Emergency Medical Services for Children; and (4) Emergency Medical Services for Children (EMSC) System Organization, Configuration, and Operation. This solicitation represents a collaboration between the Maternal and Child Health Bureau, Health Resources and Services Administration (HRSA), and the Agency for Health Care Policy and Research (AHCPR). The AHCPR and HRSA expect that up to $500,000 will be available in Fiscal Year 1995 for first year support of two to three awards. 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. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contacts listed below. Elinor Walker Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street Rockville, MD 20852 Telephone: (301) 594-1352, ext. 108 FAX: (301) 594-2155 Email: ewalker@PO3.AHCPR.GOV Jean Athey, Ph.D. Division of Maternal, Infant, Child, and Adolescent Health Maternal and Child Health Bureau, HRSA 5600 Fishers Lane, Room 18-A-39 Rockville, MD 20857 Telephone: (301) 443-4026 FAX: (301) 443-1296 $$R1 END ************************************************************ $$P1 BEGIN PAR-95-011 FULL-TEXT ************************************* FOGARTY INTERNATIONAL RESEARCH COLLABORATION AWARD NIH GUIDE, Volume 23, Number 44, December 16, 1994 PA AVAILABLE: PAR-95-011 P.T. 34; K.W. 0710030, 0404000 Fogarty International Center Receipt Dates: March 25, July 25, November 25 PURPOSE The Fogarty International Research Collaboration Award (FIRCA) is available to facilitate collaborative research between U.S. biomedical scientists supported by the National Institutes of Health and investigators in the developing world. The FIRCA will extend and enhance the research program of the U.S. scientist, while at the same time benefiting the scientific interests of the collaborating foreign scientist. Awards (R03) are made to the U.S. applicant institution to support a collaborative research project that will be carried out mainly at the foreign collaborator's research site. Up to $20,000 in direct costs per year is available for up to three years. Funds are available to purchase supplies for the foreign collaborator's laboratory and to support travel for the U.S. and foreign collaborators and their research associates, as justified by the needs of the collaborative research. If the foreign collaborator does not have significant biomedical research infrastructure support, the FIRCA will provide small pieces of equipment necessary to the research project. All biomedical and behavioral research topics supported by the NIH are eligible for inclusion under this program. However, investigators working on topics related to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) or related illnesses should apply for the Fogarty International Center's HIV, AIDS and Related Illnesses Collaboration Award (AIDS-FIRCA), which is available to U.S. investigators and their collaborators in most countries of the world: see Program Announcement number PAR-95-012. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Dr. Mirilee Pearl International Research and Awards Branch Fogarty International Center Building 31, Room B2C39 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: vnp@cu.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-95-012 FULL-TEXT ************************************* HIV, AIDS AND RELATED ILLNESSES COLLABORATION AWARD NIH GUIDE, Volume 23, Number 44, December 16, 1994 PA AVAILABLE: PAR-95-012 P.T. 34; K.W. 0715008 Fogarty International Center Receipt Dates: January 2, May 1, September 1 PURPOSE The Fogarty International Center (FIC) is expanding its AIDS International Research and Training Program to provide small individual research grants (R03) for collaboration between U.S. and foreign scientists in any country, consistent with U.S. foreign policy considerations. Support is available for research on human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), and for research related to AIDS. Up to $20,000 per year for a maximum of three years is available for U.S. investigators and their foreign collaborators to conduct research mainly at the foreign site. U.S. investigators holding currently active NIH grants for research related to HIV infections, AIDS and other related health problems are eligible to apply with their foreign collaborator for the AIDS Fogarty International Research Collaboration Award (AIDS-FIRCA). A similar program of Fogarty International Research Awards (FIRCA) is available in all non-AIDS biomedical sciences research topics for collaborative projects involving U.S. scientists and investigators in developing countries: see Program Announcement number PAR-95-011. Grants will provide funds to the foreign collaborator, through the U.S. grantee institution, for supplies at the foreign institution; for expenses incurred at the U.S. institution to support the collaboration; and for research-related travel and subsistence expenses for both the U.S. and foreign investigators. If the foreign collaborator is in a developing country, applicants may also request funds for small pieces of equipment necessary to the AIDS-FIRCA project at the foreign site. For the purpose of this program, developing countries are considered to include those in the following regions: Africa, Asia (except Hong Kong, Japan, Singapore, South Korea and Taiwan), Central and Eastern Europe, Latin America and the non-U.S. Caribbean, the Middle East (except Israel and the Persian Gulf states), and the Pacific Ocean Islands (except Australia and New Zealand). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Dr. Mirilee Pearl International Research and Awards Branch Fogarty International Center Building 31, Room B2C39 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: vnp@cu.nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-012 - V23(44) 12/16/94 Date: 16 Dec 1994 16:46:14 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 316 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctccm$a3e@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95012 PAR-95-012 P1O1 ************************************* HIV, AIDS AND RELATED ILLNESSES COLLABORATION AWARD NIH GUIDE, Volume 23, Number 44, December 16, 1994 PA NUMBER: PAR-95-012 P.T. 34; K.W. 0715008 Fogarty International Center Receipt Dates: January 2, May 1, September 1 PURPOSE The Fogarty International Center (FIC) is expanding its AIDS International Research and Training Program to provide small individual research grants for collaboration between U.S. and foreign scientists in any country, consistent with U.S. foreign policy considerations. Support is available for research on human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS) and for research related to AIDS. Up to $20,000 per year for a maximum of three years is available for U.S. investigators and their foreign collaborators to conduct research mainly at the foreign site. U.S. investigators holding currently active NIH grants for research related to HIV infections, AIDS, and other related health problems are eligible to apply with their foreign collaborator for the AIDS Fogarty International Research Collaboration Award (AIDS-FIRCA). A similar program of Fogarty International Research Awards (FIRCA) is available in all non-AIDS biomedical sciences topics for collaborative projects involving U.S. scientists and investigators in developing countries: see Program Announcement number PAR-95-011. Grants will provide funds to the foreign collaborator, through the U.S. grantee institution, for supplies at the foreign institution; for expenses incurred at the U.S. institution to support the collaboration; and for research-related travel and subsistence expenses for both the U.S. and foreign investigators. If the foreign collaborator is in a developing country, applicants may also request funds for small pieces of equipment necessary to the AIDS-FIRCA project at the foreign site. For the purpose of this program, developing countries are considered to include those in the following regions: Africa, Asia (except Hong Kong, Japan, Singapore, South Korea and Taiwan), Central and Eastern Europe, Latin America and the non-U.S. Caribbean, the Middle East (except Israel and the Persian Gulf states), and the Pacific Ocean Islands (except Australia and New Zealand). ELIGIBILITY REQUIREMENTS Applications may be submitted by U.S. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. To be eligible for the AIDS-FIRCA program, the following conditions must be met: o The proposed U.S. Principal Investigator must be the Principal Investigator (Project Director) of an NIH-sponsored AIDS or AIDS-related research grant project (R, P, or U01 series) that will be active and funded during the proposed grant award period (up to three years). Under exceptional circumstances, after consultation with program officials, some research contracts (N01 series) may be eligible "parent" funding for the AIDS-FIRCA. On submission of an application, at least 18 months of active research support must remain on the listed parent grant. Investigators may request the full three years of support in the FIRCA application in cases where less than three future years remain on the parent grant, presuming that the renewal application will be submitted and awarded. o The foreign collaborator must hold a position at an institution in a foreign country that will allow him or her adequate time and provide appropriate facilities to conduct the proposed research. o The application must demonstrate that the award will enhance the scientific contributions of both the U.S. and foreign scientists and will enhance or expand the contribution of the NIH-sponsored research project (parent grant). MECHANISM OF SUPPORT The small grants (R03) will provide up to $20,000 per year in direct costs for up to three years. Funds may be used for materials and supplies necessary to conduct the collaborative research in the foreign scientist's research laboratory or site, and for costs related to the AIDS-FIRCA project at the U.S. institution. Equipment requests are limited to items for use in the AIDS-FIRCA project at foreign institutions in developing countries. Travel and subsistence-related expenses may be requested for the U.S. Principal Investigator, the foreign collaborator, and/or their colleagues for visits directly related to the subject of the collaborative research. All proposed expenditures must be well justified and clearly related to the research objectives of the proposed project. Applicants should request support to conduct research not already being supported by the U.S. investigator's parent grant; however, the research proposal must be an extension of or related to the research project currently funded by the NIH. The awards will be made to U.S. institutions that will be responsible for the expenditures. The minimum FIRCA project period will be for one year; the maximum will be for three years. Continuation of the FIRCA project depends upon research progress, availability of funds, and continuation of appropriate NIH support of the Principal Investigator's AIDS-related research. Since the research supported under this award is mainly to occur at the foreign site, indirect costs will be calculated on the basis of the off-site rate of the U.S. sponsoring institution. RESEARCH OBJECTIVES The main objective of this AIDS-FIRCA program is to facilitate unique and highly promising collaborative basic and applied research efforts between U.S. and foreign scientists that will both expand and enhance the HIV- and AIDS-related NIH-supported research program of the U.S. Principal Investigator and benefit the scientific interests of the collaborating foreign scientist. All areas of research directly and indirectly related to HIV infection and AIDS are eligible for consideration. Examples of topics include, but are not limited to: o Research related to the development of HIV/AIDS vaccines; o Research on antiviral and other interventions for HIV/AIDS; o Research on HIV and infection by the virus; o Research on other retroviruses related to HIV; o Studies of maternal/pediatric HIV infections; o Cofactors involved in HIV infection; o Studies on the spread of HIV infection and AIDS into new locales; o The natural history of HIV infection; o Research on opportunistic infections and other disorders that result from immunosuppression by the AIDS virus; o Studies of emerging/reemerging microbes and diseases linked to factors known or suspected to relate to the spread of HIV; and o Research on the social and behavioral factors that affect HIV risk and transmission. Applicants should be aware that applicable provisions for protection of human research subjects and laboratory animals must be met in both domestic and foreign settings. See Title 45 CFR, Part 46, for information concerning the Department of Health and Human Services regulations for the protection of human subjects and the PHS Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard MSC 7507, Rockville, MD 20892-7507. Information on these assurances is included in the special application instructions available from the FIC program contact listed under INQUIRIES. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES o Special application instructions are required and are available from the International Research and Awards Branch, FIC (address below). o The application consists of a portion to be completed by the U.S. Principal Investigator, and a separate portion to be completed by the foreign collaborator. Both portions of this application must be submitted as a single package, by the U.S. grantee institution. o Applications must be submitted by the U.S. Principal Investigator on standard form PHS 398 (rev. 9/91), which is available from most U.S. institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Receipt dates for completed applications are September 1, January 2 and May 1. If the deadline falls on a weekend or a holiday, it is automatically extended to the following workday. Applications received on these dates will be reviewed using the mandated AIDS-Expedited Review schedule. REVIEW CONSIDERATIONS Applications will be assigned to the Fogarty International Center. Applications will be reviewed for scientific and technical merit by the AIDS and Related Research Initial Review Group in the Division of Research Grants (DRG), NIH. Following scientific-technical review, the applications will receive a second level review by the Fogarty International Center Advisory Board. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the program announcement. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria o likelihood that the proposed research extends or enhances the ongoing funded research of the U.S. Principal Investigator; o ability of the foreign collaborator to undertake and direct the foreign research efforts; o appropriateness of the proposed collaborative effort as a format for accomplishing the stated aims; o appropriateness of the proposed budget and duration in relation to the proposed research; 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 availability of the resources necessary to perform the research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Fogarty International Center. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Special application instructions are necessary to apply for this program. To obtain further information write, FAX, or telephone the Fogarty International Center. Direct inquiries regarding programmatic issues to: Dr. Mirilee Pearl International Research and Awards Branch Fogarty International Center Building 31, Room B2C39 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: vnp@cu.nih.gov For grants management and fiscal matters, contact: Ms. Susan Bettendorf Grants Management Specialist Fogarty International Center Building 31, Room B2C39 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: sn5@cu.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.934. 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. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-011 - V23(44) 12/16/94 Date: 16 Dec 1994 16:46:09 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 298 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctcch$a2m@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95011 PAR-95-011 P1O1 ************************************* FOGARTY INTERNATIONAL RESEARCH COLLABORATION AWARD NIH GUIDE, Volume 23, Number 44, December 16, 1994 PA NUMBER: PAR-95-011 P.T. 34; K.W. 0710030, 0404000 Fogarty International Center Receipt Dates: March 25, July 25, November 25 PURPOSE The Fogarty International Research Collaboration Award (FIRCA) is available to facilitate collaborative research between U.S. biomedical scientists supported by the National Institutes of Health and investigators in the developing world. The FIRCA will extend and enhance the research program of the U.S. scientist, while at the same time benefiting the scientific interests of the collaborating foreign scientist. Awards are made to the U.S. applicant institution to support a collaborative research project that will be carried out mainly at the foreign collaborator's research site. Up to $20,000 in direct costs per year is available for up to three years. Funds are available to purchase supplies for the foreign collaborator's laboratory and to support travel for the U.S. and foreign collaborators and their research associates, as justified by the needs of the collaborative research. If the foreign collaborator does not have significant biomedical research infrastructure support, the FIRCA will provide for the purchase of small pieces of equipment necessary to the research project. All biomedical and behavioral research topics supported by the NIH are eligible for inclusion under this program. However, investigators working on topics related to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) or related illnesses should apply for the Fogarty International Center's HIV, AIDS and Related Illnesses Collaboration Award (AIDS-FIRCA), which is available to U.S. investigators and their collaborators in most countries of the world: see Program Announcement number PAR-95-012. ELIGIBILITY REQUIREMENTS For the purpose of this program, eligible countries are considered to include those in the following regions: Africa, Asia (except Hong Kong, Japan, Singapore, South Korea and Taiwan), Central and Eastern Europe, Latin America and the Caribbean, the Middle East, and the Pacific Ocean Islands (except Australia and New Zealand). It is anticipated that the U.S. scientist will apply as principal investigator with a colleague from a single laboratory or research site in an eligible country. Occasionally, however, scientific opportunities may arise that warrant a formal collaborative effort between the U.S. investigator and individuals from more than one country. Such applications may be considered if well justified and only after consultation with program staff at the FIC. Applications may be submitted by U.S. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. In order to be eligible for a FIRCA, the following requirements must be met: o U.S. applicants must already be principal investigators or project directors on NIH research project grants (referred to as the "parent grant") that will be active and funded during the proposed FIRCA budget period (R, P, or U series with the following exceptions: Center Core Grants (P30), Shannon Awards (R55), and Small Grants (R03)). The parent grant must have a minimum of 19 months of funding remaining at the time of application to be eligible for FIRCA funding. Grants in a no-cost extension period are not eligible to act as a parent grant for a FIRCA project. o The FIRCA research proposal must be for work which will be an extension of or a new direction of the parent grant, not supported by other sources. o The foreign collaborator must hold a position at a public or private non-profit institution that will allow him or her adequate time and provide appropriate facilities to conduct the proposed research. o Applicants may submit only one FIRCA application per review cycle. MECHANISM OF SUPPORT The small grants (R03) will provide up to $20,000 per year in direct costs for up to three years. Funds may be used for materials and supplies necessary to conduct the collaborative research in the foreign scientist's research laboratory or site and for travel directly related to the research project. Equipment requests will be considered from applicants with strong justification. Travel may be requested up to 25 percent of the total direct costs (up to $5,000) for the U.S. Principal Investigator, the foreign collaborator, and/or their colleagues for visits directly related to the subject of the collaborative research. All proposed expenditures must be well justified and clearly related to the research objectives of the proposed project. No salaries or stipends for any of the collaborators, students, or technical assistants will be offered under these awards. Applicants must request support to conduct research not already being supported by the U.S. investigator's parent grant; however, the research proposal must be an extension of or related to the currently funded research project. The awards will be made to U.S. institutions which will be responsible for the expenditures. The minimum small grant project period will be for one year; the maximum will be for three years. Continuation of the FIRCA project depends upon research progress, availability of funds, and continuation of appropriate NIH support for the U.S. Principal Investigator's research. Starting with fiscal year 1995, the FIC will accept applications for competing continuation of FIRCA grants. Since the research supported under this award is mainly to occur at the foreign site, indirect costs will be calculated on the basis of the off-site rate of the U.S. sponsoring institution. RESEARCH OBJECTIVES An important role of the FIC is to foster discovery through the support of international cooperation across the continuum of basic, clinical and applied biomedical, behavioral and health sciences. The opportunity to collaborate internationally provides a means of access to new information and perspectives; innovative concepts and methods; emerging research technologies; or unique populations and environments. The main objective of the FIRCA program is to facilitate collaborative research efforts between U.S. and foreign scientists that extend or enhance the NIH-supported research program of the U.S. Principal Investigator, while at the same time benefiting the scientific interests of the collaborating foreign scientist. Applicants should be aware that applicable provisions for protection of human research subjects and laboratory animals must be met in both domestic and foreign settings. See Title 45 CFR, Part 46, for information concerning the Department of Health and Human Services regulations for the protection of human subjects and the PHS Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20892-7507. Information on these assurances is included in the special application instructions available from the FIC program contact listed under INQUIRIES. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES o Special application instructions are required and are available from the International Research and Awards Branch, FIC (address below). o The application consists of a portion to be completed by the U.S. Principal Investigator, and a separate portion to be completed by the foreign collaborator. Both portions of this application must be submitted as a single package, by the U.S. grantee institution. o Applications must be submitted by the U.S. Principal Investigator on standard form PHS 398 (rev. 9/91), which is available from most U.S. institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Receipt dates for completed applications are November 25, March 25, and July 25. If the deadline falls on a weekend or a holiday, it is automatically extended to the following workday. Applications received on these dates will be reviewed using an expedited review schedule. REVIEW CONSIDERATIONS Applications will be assigned to the Fogarty International Center. Applications will be reviewed for scientific and technical merit by the International and Cooperative Projects study section, a broadly multidisciplinary review group in the Division of Research Grants (DRG), NIH. Following scientific-technical review, the applications will receive a second level review by the Fogarty International Center Advisory Board. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the program announcement. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria o likelihood that the proposed research extends or enhances the ongoing funded research of the U.S. Principal Investigator; o ability of the foreign collaborator to undertake and direct the foreign research efforts; o appropriateness of the proposed collaborative effort as a format for accomplishing the stated aims; o appropriateness of the proposed budget and duration in relation to the proposed research; 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 availability of the resources necessary to perform the research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Fogarty International Center. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority, which may include regional balance. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Special application instructions are necessary to apply for this program. To obtain further information write, fax or phone the Fogarty International Center. Direct inquiries regarding programmatic issues to: Dr. Mirilee Pearl International Research and Awards Branch Fogarty International Center Building 31, Room B2C39 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: vnp@cu.nih.gov For grants management and fiscal matters, contact: Ms. Susan Bettendorf Grants Management Specialist Fogarty International Center Building 31, Room B2C39 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: sn5@cu.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.934. 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. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Dec 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-95-001 - V23(44) 12/16/94 Date: 16 Dec 1994 16:46:03 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 389 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ctccb$a21@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HS95001 HS-95-001 P1O1 *************************************** RESEARCH ON EMERGENCY MEDICAL SERVICES FOR CHILDREN NIH GUIDE, Volume 23, Number 44, December 16, 1994 RFA: HS-95-001 P.T. 34, AA; K.W. 0730007, 0408006, 0730005 Agency for Health Care Policy and Research Health Resources and Services Administration Application Receipt Date: March 16, 1995 PURPOSE This announcement solicits applications to conduct research on (1) Severity and Acuity Measures for Illness and Injury for Children; (2) Child and Adolescent Patient Outcomes and Outcome Measures; (3) Costs of Emergency Medical Services for Children; and (4) Emergency Medical Services for Children (EMSC) System Organization, Configuration, and Operation. This solicitation represents a collaboration between the Maternal and Child Health Bureau, Health Resources and Services Administration (HRSA), and the Agency for Health Care Policy and Research (AHCPR). 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. The AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-004374-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. The AHCPR, by statute, can support only non-profit organizations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Grant funds are additive, not substitutive; they are not to be used to replace existing resources. Also, they may not be used for delivery of services. This RFA is a one-time solicitation. The total requested project period for applications submitted in response to this RFA may not exceed three years. Applications may request a maximum total of $250,000 direct and indirect costs per year. The earliest possible award date will be September 1, 1995. Annual progress reviews by AHCPR and HRSA, and the availability of funds especially designated for this research, will determine the continuation of grants up to the three year limit. FUNDS AVAILABLE The AHCPR and HRSA expect that up to $500,000 will be available in Fiscal Year 1995 for first year support of two to three awards. RESEARCH OBJECTIVES Background The Maternal and Child Health Bureau (MCHB), HRSA, and the AHCPR have joined in a partnership to address research needs of pediatric emergency medicine. The EMSC program, authorized by the Congress in 1984, is an activity of MCHB that addresses the emergency-care needs of sick and injured children that are different from those of adults. The need for such special attention to children is supported by the report of the Institute of Medicine (IOM) Committee on Pediatric Emergency Medical Services issued in 1993 (Institute of Medicine, Emergency Medical Services for Children, Washington, DC: National Academy Press 1993). In this report, the Committee cited relative neglect of research on pediatric emergencies, and outlined a research agenda for EMSC. From that agenda, MCHB and AHCPR have selected for this RFA, four topics that fall most clearly within the area of interest common to both agencies. Research Issues Listed below are the four broad topics selected to advance knowledge about the provision of emergency medical services (EMS) to children. Examples of specific issues are provided under each broad topic. 1. Severity and Acuity Measures for Illness and Injury o Development and validation of generic scales or indexes for children, with special attention to use (1) for triage in the prehospital or emergency department (ED) setting; and (2) to adjust case mix for purposes of research or performance evaluation. o Development and validation of specific severity scales, such as measures of abdominal and chest trauma. o Development and evaluation of methods to triage patients more accurately in the field and in EDs, with particular attention to young children with possible serious illness. 2. Patient Outcomes and Outcome Measures o Development and validation of outcome measures based on functional status/disability, suitable for use in planning and evaluating rehabilitation care. o Development and validation of outcome measures suitable for research and performance evaluation. o Employing innovative approaches to longitudinal study of outcomes with a follow-up to post-hospital care. 3. Costs o Assessment of the marginal incremental cost of different approaches to improving EMSC. o Evaluation of the cost-effectiveness of different EMSC program configurations, with attention to impacts on emergency systems and the health care system, and considering a broad set of program benefits and outcomes. Examples of such configurations would be different approaches to medical control, categorization, and regionalization. o Determination of the economic consequence of pediatric trauma or severe illness to families and to taxpayers, taking into account direct and indirect costs and all types and settings of EMSC. 4. System Organization, Configuration, and Operation o Evaluation of effectiveness of interventions to upgrade EMS system components to improve care of children. Examples of such components would be equipment, protocols, and telephone advice capabilities. o Study of effectiveness and efficiency of variations in EMSC care, highlighting special population subgroups or groups in special circumstances (homeless, migrant, military, rural/urban/suburban, minority, managed care, uninsured, Medicaid, inner city). o Formulation of methods for developing population-based estimates of need for ED and pediatric intensive care unit (PICU) beds for local and regional areas, for purposes of planning and resource allocation. Applicants are encouraged to take full advantage of opportunities for efficient enhancements of available expertise, data, and other research resources. This might include collaboration with researchers and practitioners outside their own institutions, creative use of existing data, or "piggybacking" on other data collection activities. Another possibility for leveraging research resources is to conduct comparisons of outcomes where existing practice patterns or structures are known to differ (e.g., across care settings, geographical areas, insurers, or providers). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR/HRSA that women and members of minority groups must be included in all AHCPR/HRSA supported health services research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains some provisions that are substantially different from the 1990 policies. AHCPR plans to publish guidelines specific to AHCPR. In the interim, AHCPR will follow the NIH guidelines, as applicable. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the NIH policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this policy. APPLICATION PROCEDURES The application receipt date is March 16, 1995. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). State and local government agencies may use form PHS 5161 and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and for AHCPR applications from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX 301-652-5264). 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. In addition, 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 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** At the time of submission, two additional copies of the application must be sent to: Ms. Elinor Walker Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Completed applications must be received by the Division of Research Grants by March 16, 1995. If an application is received after that date, it will be returned to the applicant without review. Conference for Prospective Applicants A conference of one to two days is planned for prospective applicants, if there is sufficient interest from prospective applicants. This conference would provide programmatic and administrative information and respond to questions concerning this RFA. If convened, the conference is planned for January 13, 1995 in the Washington, DC area. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. Individuals with questions concerning this conference may contact Ms. Elinor Walker at telephone (301) 594-1352, ext. 108. Those interested in attending the conference should, no later than December 30, 1994, mail or FAX their names, addresses, and telephone numbers to: Outreach Department National Center for Education in Maternal and Child Health 2000 15th Street, North Arlington, VA 22201-2617 Telephone: (703) 524-7802 FAX: (703) 524-9335 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Referral Office, Division of Research Grants, NIH, for completeness, and by AHCPR/HRSA staff for responsiveness to the RFA. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications may undergo triage by an appropriate peer review group on the basis of relative competitiveness. The AHCPR/HRSA will withdraw from further consideration 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 peer review for scientific merit by a review committee of experts convened by the AHCPR. When an application is reviewed, the peer review committee may recommend further consideration for funding or no further consideration. The committee also assigns priority scores to the applications for which further consideration is recommended. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council for Health Care Policy, Research, and Evaluation. Review Criteria The general review criteria for these AHCPR/HRSA grant applications are: o significance and originality from a scientific and technical viewpoint; o adequacy of the proposed method(s); o availability of data or proposed plan to collect data required for the project; o adequacy of the plan for organizing and carrying out the project; o qualifications and experience of the Principal Investigator and proposed staff; o reasonableness of the proposed budget; o adequacy of the facilities and resources available to the applicant; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of experimental subjects, and the safety of the research environments. Special Review Criteria In addition to the review criteria noted above, special scientific and technical review criteria also apply. A major review criterion for evaluating applications under this solicitation is the likelihood of obtaining convincing, new information that has the potential for use to improve the delivery of emergency medical services to children. It is the task of the applicant to justify the need for the research and the potential impact of the findings on emergency medical services to children. To the extent that the proposed research is descriptive rather than analytic, investigators must justify the importance of the expected results to understanding and improving EMS services for children. Investigators are encouraged to consider the validity and implications of the major assumption underlying this RFA: that aspects of the emergency care system and products of emergency care research pertaining to adults are inadequate to the needs of children. Applications to explore or test this assumption are not ruled out, and applications based on this assumption will be strengthened by incorporating evidence in its support. AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, and availability of funds. The earliest anticipated date of award for applications will be September 1, 1995. INQUIRIES Inquiries concerning this RFA are encouraged. AHCPR and HRSA staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct programmatic inquiries to: Elinor Walker Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street Rockville, MD 20852 Telephone: (301) 594-1352, ext. 108 FAX: (301) 594-2155 Email: ewalker@PO3.AHCPR.GOV Jean Athey, Ph.D. Division of Maternal, Infant, Child, and Adolescent Health Maternal and Child Health Bureau, HRSA 5600 Fishers Lane, Room 18-A-39 Rockville, MD 20857 Telephone: (301) 443-4026 FAX: (301) 443-1296 Direct inquiries regarding fiscal matters to: Ralph L. Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street Rockville, MD 20852 Telephone: (301) 594-1447 FAX: (301) 594-3210 Email: rsloat@PO7.AHCPR.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Nos. 93.180, 93.226, and 93.127. Awards are made under authorization of the Public Health Service Act, Title IX (42 U.S.C. 299-299c-6) and Title XIX, Section 1910, as amended (42 U.S.C. 300w-9); and Section 1142 of the Social Security Act (42 U.S.C. 1320b-12). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Dec 19 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 18 December 1994 Date: 19 Dec 1994 16:53:33 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 123 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3d59ud$mn0@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: NSF 94-169 Dear Colleague Letter File size (bytes): 4588 STIS Filename: ns94169a Title: NSF 94-169 Dear Colleague Letter File size (bytes): 4587 STIS Filename: ns94169b Title: NSF 94-169 Dear Colleague Letter File size (bytes): 4587 STIS Filename: ns94169c Title: NSF 94-169 Dear Colleague Letter File size (bytes): 4587 STIS Filename: ns94169d Title: NSF 94-169 Dear Colleague Letter File size (bytes): 4587 STIS Filename: ns94169e Title: NSF 94-168 CISE Dear Colleague Letter File size (bytes): 13992 STIS Filename: nsf94168 Document Type: News Title: Tip 41216 Media Tipsheet December 16, 1994 File size (bytes): 4081 STIS Filename: tip41216 Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 97101 STIS Filename: phnalpha Document Type: Press Release Title: PR 94-79 HISTORIC FCC AUCTION USES NEW ECONOMIC DESIGN File size (bytes): 3741 STIS Filename: pr9479 Document Type: Program Guideline Title: NSF 94-166 Human Dimensions of Global Change File size (bytes): 27254 STIS Filename: nsf94166 Title: NSF 94-172 Global Oscillation Network Group Project File size (bytes): 6428 STIS Filename: nsf94172 Document Type: Recruit Title: Computer Specialist File size (bytes): 6145 STIS Filename: vgs9540 Title: Program Specialist File size (bytes): 6064 STIS Filename: vgs9541 Title: Program Analyst File size (bytes): 6311 STIS Filename: vgs9542 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Organizational Directory File size (bytes): 100152 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). 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 stisserve@nsf.gov (Internet). 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 "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Dec 19 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-009 - V23(45) 12/23/94 Date: 20 Dec 1994 15:58:53 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 406 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3d7r3t$1vh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95009 HD-95-009 P1O1 *************************************** PERINATAL EMPHASIS RESEARCH CENTERS NIH GUIDE, Volume 23, Number 45, December 23, 1994 RFA: HD-95-009 P.T. 04; K.W. 0775013, 0775020, 0775025 National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 13, 1995 Application Receipt Date: March 22, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators to develop multidisciplinary research efforts that will advance knowledge about diseases and disorders of pregnancy and infancy with the aim of reducing infant morbidity and mortality in rural populations. The resulting grant will be part of the Perinatal Emphasis Research Centers (PERC) program. These centers are intended for the support of hypothesis- testing research efforts; they are not intended to support service or demonstration projects. PERCs are organized around problem/need themes and are established where research can be coordinated with existing programs of health care to ensure the rapid assimilation of new scientific knowledge into health care delivery. Active PERCs are addressing issues in high-risk pregnancies (diabetes, hypertension), prevention of prematurity, fetal hypoxia, intrauterine growth retardation, and infant sleep physiology. A PERC works closely with NICHD in participating in the center network and in carrying out its objectives in a manner consistent with NICHD goals and missions. 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), Perinatal Emphasis Research Centers, is related to the priority area of maternal and infant 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 The need for continuous and active communication among centers mandates that only institutions in the United States will be eligible for participation. Domestic, non-profit organizations and institutions are eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. As stated in the NICHD Center Guidelines, the NICHD will not support more than one NICHD center grant (P50) in a given department or specialty unit. MECHANISM OF SUPPORT Grants will be awarded using the National Institutes of Health (NIH) specialized research center grant (P50) mechanism. Review of applications and management of grants will be subject to applicable policies for NIH research center (P50) grants. The P50 is an institutional award, made in the name of a principal investigator, and awarded competitively. It provides support for both research projects and the core services used by those projects. FUNDS AVAILABLE The estimated funds available for the first year of support will not exceed $500,000 for direct costs and $750,000 total costs. The initial award will be made for a period of five years. Budget increments for subsequent years generally will be limited to increases not to exceed four percent. Budgets of applications will be stringently reviewed within these guidelines. It is expected that one award will be made in response to this RFA in the area of rural maternal/infant health. RESEARCH OBJECTIVES Background A major goal of the Pregnancy and Perinatology (PP) Branch of the Center for Research for Mothers and Children (CRMC) of the NICHD is the prevention of diseases and disorders during pregnancy and infancy. Too many infants are born too soon, too small for their gestational age, or with an abnormality in development initiated prior to birth or shortly thereafter that causes immediate or delayed abnormality in structure or function. If all newborns were free of defects and were mature enough to cope during the first month of life, much of this nation's infant mortality and morbidity could be eliminated. This RFA invites applications for a research center to develop new knowledge about diseases and disorders of pregnancy and infancy with the aim of reducing infant morbidity and mortality in rural populations. Areas of Research Interest By issuing this RFA, the CRMC is indicating its wish to encourage investigator interest in developing multidisciplinary research efforts that will advance knowledge in areas important to its mission and specifically as it relates to health of mothers and infants in rural areas. A PERC grant is used to promote and support multidisciplinary research efforts in areas where (a) knowledge gaps are not being sufficiently addressed by ongoing research, or (b) there are needs to stimulate and intensify efforts in promising research areas. Research areas for PERC grants have been and will continue to be identified by CRMC and PP in consultation with outside advisors. Through the PERC programs for mothers and infants, NICHD has undertaken concerted biomedical and behavioral research efforts directed toward improving pregnancy outcome and ensuring infant survival and well-being. PERCs are located throughout the United States and presently are addressing the issues listed in the PURPOSE paragraph above. In addition to the areas addressed in the current PERCs, which continue to be of interest, it is recognized that other medical problems need to be approached in the same multidisciplinary fashion. Clinical studies may include etiologic mechanisms, improvement of diagnostic techniques, and various aspects of prevention and management. All investigative approaches can be used from molecular biology to cellular, organ or whole organism physiology, epidemiology as well as clinical evaluations. The PERC in rural health may address, among other problems, distance to available medical facilities and the effect on rates of preventable illnesses and disease. Supported research may be carried out in experimental animals. A minimum of one subproject must address issues in patients. Research interests include, but are not necessarily limited to, the following: 1. High-Risk Pregnancies (e.g., diabetes, hypertension, drug abuse) - Effects upon pregnancy, fetal development, and neonatal adaptation. 2. Intrauterine Growth - All aspects that may contribute to the regulation of fetal growth such as role of growth factors, hypoxia, nutrients, hormones, infections; placental function; regulation of maternal blood volume and uterine and umbilical blood flow; methodology to assess fetal health and development. 3. Initiation of Labor - Normal and abnormal mechanisms and outcomes in term, preterm, and/or postterm births. 4. Neonatal Disorders - Adaptation, response to external stimuli, unique nutritional requirements, response to acute and chronic injury (including asphyxia, ROP, BPD, NEC), remodeling and repair, immune function and development. 5. Perinatal epidemiology and clinical research addressing the special needs of rural populations. Overall goals are similar to the ones stated above; developing and testing interventions to reduce infant mortality, low birth weight, intrauterine growth retardation, and preterm delivery as they apply to stable and statewide rural populations. SPECIAL REQUIREMENTS The PERC program holds an annual meeting of the Principal Investigators to assess progress. A budget request must be included in the application for this purpose. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. These new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 13, 1995, 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 in the review. The letter of intent is to be sent to Dr. Charlotte Catz 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 Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the program administrator listed under INQUIRIES. Detailed guidelines are found in "NICHD Research Center Programs" P50 Specialized Research Center guidelines (hereafter called NICHD Center Guidelines). The guidelines include the following restrictions: (1) a five-year total program funding period, (2) at least three projects at all times, and (3) each core serving as a resource for at least three projects at all times. The NICHD Center Guidelines may be obtained from Dr. Charlotte Catz at the address listed under INQUIRIES. 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. 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 and any appendix material must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Executive Building, Room 5E03F 6100 Executive Boulevard, MSC 7510 Rockville, MD 20852-7510 Telephone: (301) 496-1485 Email: StreufeS@HD01.NICHD.NIH.GOV Applications must be received by March 22, 1995. 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 RFA 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 for completeness by DRG and responsiveness by the NICHD. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications judged to be noncompetitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review procedures and criteria are detailed in the P50 Specialized Research Center Grant Guidelines. Applications will be reviewed under the criteria indicated below: 1. Significance of the proposed research program to the CRMC perinatal research mission. 2. Scope and breadth of the center's program, the component research projects, and core units. 3. Suitability of the program's central theme for a cooperative research effort. 4. Multidisciplinary scope of the program and provisions for coordinating the research projects and core units. 5. Leadership and scientific stature of the program director and his/her ability to meet the program's demands of time and effort. 6. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 7. Academic and physical environment as it bears on patients, space, and equipment, and on the potential for interaction with scientists from other departments and institutions. 8. Arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, and internal communication and cooperation among the investigators in the program. 9. Presence of an administrative and organizational structure conducive to attaining the objectives of the proposed program. The existence of an external advisory board and a description of its function are necessary. The review of the projects and core units will consider: 1. Scientific merit of each project and the relation of the project to the central theme of the overall program (a simple compilation of several R01-type projects loosely related will not be acceptable). 2. Technical merit, cost effectiveness, and quality control of each core unit (each core must be used by at least three research projects). 3. The appropriateness of the research projects' use of core services. 4. Qualifications, experience, and commitment of the investigators responsible for the research projects or core units and their ability to devote the required time and effort to the program. 5. Appropriateness of budgetary requests. 6. The adequacy of the means proposed for protecting against risks to human subjects, animals, and/or environment. 7. Participation of a suitable number of responsible, experienced investigators. 8. Institutional commitment to the requirements of the program. AWARD CRITERIA Applications will be considered for award on the basis of their scientific and technical merit, as determined by peer review, and upon allocation of appropriated funds for this purpose. Furthermore, the NICHD will not support more than one NICHD center grant (P50) in a given department or specialty unit. The anticipated award date is September 1995. INQUIRIES Inquiries regarding this RFA are encouraged. The staff welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues, requests for the program guidelines, and address the letter of intent to: Dr. Charlotte Catz Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Building, Room 4B03 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5575 Email: CatzC@HD01.NICHD.NIH.GOV Direct inquiries regarding budgetary issues to: Mr. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 8A17F 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 Email: ShawverD@HD.NICHD.NIH.GOV 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, Sections 1004, 301 and 444, and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke free workplace and promote the non use of all tobacco products. This is consistent with the PHS mission to protect in advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Dec 19 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 45, pt. 1of1, 23 December 1994 Date: 20 Dec 1994 15:58:46 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 914 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3d7r3m$1v7@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941223 V23N45 P1O1 ************************************ X-comment: RFAS described: HD-95-009, HD-95-010, AG-95-002, PAR-95-013, PA-95 -014 NIH GUIDE - Vol. 23, No. 45 - December 23, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N3 ********************************************************** REVISION TO NIH IMPLEMENTATION OF EXPANDED AUTHORITIES National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** DYNAMICS OF HEALTH, AGING AND BODY COMPOSITION - FIELD CENTER (RFP NIH-AG-95-04) National Institute on Aging INDEX: AGING $$INDEX R2 ********************************************************** EVALUATION OF CHEMOPREVENTIVE AGENTS BY IN VITRO TECHNIQUES (MAA NCI- CN-55079-63) National Cancer Institute INDEX: CANCER $$INDEX R3 03/22/95 ************************************************* PERINATAL EMPHASIS RESEARCH CENTERS RFA HD-95-009) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R4 05/16/95 ************************************************* PAIN MANAGEMENT FOR PERSONS WITH PHYSICAL DISABILITIES (RFA HD-95-010) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R5 05/23/95 ************************************************* CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS (RFA AG-95-002) National Institute on Aging INDEX: AGING $$INDEX P1 ********************************************************** NCRR MINORITY INITIATIVE: K-12 TEACHERS AND HIGH SCHOOL STUDENTS (PAR-95-013) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P2 ********************************************************** BASIC AND CLINICAL RESEARCH ON SLEEP AND WAKEFULNESS (PA-95-014) National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Child Health and Human Development National Institute on Drug Abuse National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research INDEX: AGING; ALCOHOL ABUSE, ALCOHOLISM; CHILD HEALTH, HUMAN DEVELOPMENT; DRUG ABUSE; HEART, LUNG, BLOOD; MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE; NURSING RESEARCH This publication is available electronically via BITNET or INTERNET, by subscription, and is also on the NIH GOPHER (gopher.nih.gov). Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221); contact Dr. John James at 301/594- 7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. HAVE A JOYOUS HOLIDAY!! $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT PUBLISHED ON DECEMBER 30 AND JANUARY 6. THE NEXT ISSUE WILL BE ON JANUARY 13, 1995. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 23, Number 45, December 23, 1994 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following cases: Gerald Leisman, Ph.D., New York Chiropractic College: The Division of Research Investigations (DRI) of the Office of Research Integrity (ORI) reviewed an investigation conducted by the New York Chiropractic College (NYCC) into possible scientific misconduct on the part of Gerald Leisman, Ph.D., formerly Director of Research and Institutes at NYCC. ORI found that Dr. Leisman committed scientific misconduct by misrepresenting his academic credentials and professional experience and awards in a grant application (T32 AR07564-01A1) for Public Health Service (PHS) research funds submitted on December 29, 1988. Based upon information obtained by ORI during its oversight review, the ORI found that Dr. Leisman falsely claimed: (1) to have earned an M.D. degree from the University of Manchester (Manchester, England) in 1972; (2) to have held the position of Professor, Neurology and Biomedical Engineering, Harvard University Medical School (June 1982 to January 1987); and (3) to have been awarded inventorship or co-inventorship of 13 U.S. Patents. Dr. Leisman accepted the ORI findings and agreed to a Voluntary Exclusion agreement under which he is not eligible to apply for or receive any Federal funds in non-procurement transactions (e.g., grants and cooperative agreements) and is not eligible to contract or subcontract with any Federal government agency for a three-year period beginning November 28, 1994 and ending November 27, 1997. In addition, Dr. Leisman is prohibited from serving on PHS Advisory Committees, Boards, or peer review groups for a three-year period beginning November 28, 1994 and ending November 27, 1997. John L. Ninnemann, Ph.D. On July 22, 1994, the Office of Research Integrity (ORI) settled scientific misconduct charges against John L. Ninnemann, Ph.D., formerly of the University of Utah and the University of California, San Diego, that will result in his retraction or correction of several articles related to immunosuppression. Although Dr. Ninnemann has not admitted guilt to ORI's allegations that he falsified and misrepresented scientific experiments in grant applications and publications in the 1970s and 1980s, he has agreed to: 1. Be excluded from eligibility for all federal grants, contracts and cooperative agreements for three years. 2. Be excluded from serving on any Public Health Service advisory committees, boards or peer review committees for three years. 3. Submit letters of retraction for five scientific articles. 4. Submit letters of correction for four additional scientific articles. Following the settlement, Dr. Ninnemann has submitted the required letters of correction and retraction and ORI entered the remaining administrative actions into the PHS ALERT System. Dr. Ninnemann submitted letters of retraction for the following five articles: Ninnemann, J.L., "Melanoma-Associated Immunosuppression Through B Cell Activation of Suppressor T Cells," Journal of Immunology, 120: 1573-1579 (1978). Ninnemann, J.L., Stockland, A.E., and Condie, J.T., "Induction of Prostaglandin Synthesis-Dependent Suppressor Cells with Endotoxin: Occurrence in Patients with Thermal Injuries," Journal of Clinical Immunology, 3:142-150 (1983). Ninnemann, J.L., "Immunosuppression Following Thermal Injury through B Cell Activation of Suppressor T Cells," Journal of Trauma, Vol. 20, 3:206-213 (1980). Ninnemann, J.L., Condie, J.T., Davis, S.E., and Crockett, R.A., "Isolation of Immunosuppressive Serum Components Following Thermal Injury," The Journal of Trauma, Vol. 22, 10:837-844 (1982). Ninnemann, J.L. and Stockland, A.E., "Participation of Prostaglandin E in Immunosuppression Following Thermal Injury," The Journal of Trauma, Vol. 24, 3:201-7 (1984). Dr. Ninnemann submitted letters of correction for the following four articles: Ninnemann, J.L., Ozkan, A.N. and Sullivan, J.J., "Hemolysis and Suppression of Neutrophil Chemotaxis by a Low Molecular Weight Component of Human Burn Patient Sera," Immunology Letters, 10:63-69 (1985). Ozkan, A.N., and Ninnemann, J.L., "Reversal of SAP-induced Immunosuppression and SAP Detection by a Monoclonal Antibody," The Journal of Trauma, Vol. 27, 2:123-6 (1987). Ninnemann, J.L., and Ozkan, A.N., "Definition of a Burn Injury- induced Immunosuppressive Serum Component." The Journal of Trauma, Vol. 25, No. 2:113-7 (1985). Ninnemann, J.L., and Ozkan, A.N., "Immunosuppression Activity of C1Q Degradation Peptides," Journal of Trauma, Vol. 27, :119-122 (1987). INQUIRIES For further information, contact: Director Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** REVISION TO NIH IMPLEMENTATION OF EXPANDED AUTHORITIES NIH GUIDE, Volume 23, Number 45, December 23, 1994 P.T. 34; K.W. 1014006 National Institutes of Health Effective October 1, 1994, the National Institutes of Health (NIH) has revised its implementation of Expanded Authorities (PHS Grants Policy Statement Section 8 pages 5-8). The implementation is based on recent revisions to OMB Circular A-110 and Department of Health and Human Services Regulations at 45 CFR Part 74, Administration of Grants, which waive the following prior approval requirements (expanded authorities) for awards that support research unless the Federal awarding agency provides otherwise in the award notice or in the agency's regulations: (1) Incur preaward costs 90 calendar days prior to award. Preaward costs more than 90 calendar days prior to award requires the prior approval of the Federal awarding agency. All preaward costs are incurred at the recipient's risk (i.e., the Federal awarding agency is under no obligation to reimburse such costs if for any reason the recipient does not receive an award or if the award is less than anticipated and inadequate to cover such costs). (2) Initiate a one-time extension of the expiration date of the award of up to 12 months unless one or more of the following conditions apply. For one-time extensions, the recipient must notify the Federal awarding agency in writing with the supporting reasons and revised expiration date at least 10 days before the expiration date (project period end date) specified in the award. This one-time extension may not be exercised merely for the purpose of using unobligated balances, nor may grantees extend project periods previously extended by the NIH awarding office. Such extensions are not permitted where: (i) The terms and conditions of award prohibit the extension. (ii) The extension requires additional Federal funds. (iii) The extension involves any change in the approved objectives or scope of the project. (3) Carry forward unobligated balances to subsequent funding periods. (4) Waives cost-related (rebudgeting) and administrative prior written approvals required by OMB Circulars A-21 and A-122. (5) Authorizes program income earned during the project period to be added to funds committed to the project by the Federal awarding agency and recipient and used to further eligible project or program objectives. The application of expanded authorities is intended to eliminate unnecessary administrative burdens of sponsored research for both grantee and awarding office staff. Consistent with the revised Circular and HHS Regulations, the new NIH implementation expands the routine coverage of grants awarded under expanded authorities to include Program Project grants (P01s), Research Career Awards (Ks), Minority High School Student Research Apprentice Program awards (S03s), and all Research Project grants (Rs), except Phase I Small Business Innovation Research (R43) and Small Business Technology Transfer (R41) awards. Individual awards may be excluded from the routine inclusion under expanded authorities based on the following criteria: o Grants that require close project monitoring or technical assistance, e.g., clinical trials, exceptional grantees, or certain large multi-project grants, may be excluded. o Grantees that have a consistent pattern of failure to adhere to appropriate reporting or notification deadlines may be excluded. o In accordance with 45 CFR Part 74, except for awards issued under the Small Business Innovation Research or Small Business Technology Transfer programs, awards to for-profit organizations are excluded from the additional cost alternative for general program income (item 5 above). On individual awards to non-profit institutions, awarding office discretion may be used to specify an alternative disposition for general program income, i.e., the deductive or combination alternative. Although the Circular authorizes all NIH grant activities as eligible for expanded authorities, NIH staff have determined that certain grant activities, e.g., centers and training grants, should not automatically receive expanded authorities, in whole or in part, due to the routine requirement for close project monitoring or technical assistance. In addition, because of substantial programmatic involvement, cooperative agreements will also be routinely excluded from expanded authorities. However, awarding office discretion may be used to authorize expanded authorities for these grant activities and cooperative agreements on an individual or group award basis. With recent revisions to the PHS Grants Policy Statement (April 1, 1994) and OMB Circular A-110, grants awarded with the expanded authorities described above will be subject to NIH Institute or Center (IC) staff review under the following conditions: o PHS policy (PHS Grants Policy Statement page 8-6) requires that when a grantee reports on the annual Financial Status Report a balance of unobligated funds in excess of 25 percent of the total amount awarded, or $250,000, whichever is less, IC staff shall review the circumstances resulting in such balances to assure that the funds are necessary to complete the project. Based on the outcome of the review, the Grants Management Officer may take appropriate action, e.g., authorize approval of the unobligated balance as carryover; restrict on future Notices of Grant Award the authority to automatically carryover unobligated balances; use the balance as an offset against a subsequent award; or allow the carryover, but reduce the next budget period award level. o PHS policy (PHS Grants Policy Statement pages 8-1 and 8-7) requires that when significant rebudgeting occurs, the grantee shall consult with the awarding IC Grants Management Officer and Program Official for a decision as to whether the rebudgeting constitutes a change of scope. As a guideline, significant rebudgeting as defined by PHS occurs when the cumulative amount of transfers among direct cost categories for the current budget period exceeds 25 percent of the total amount awarded, or $250,000, whichever is less. o OMB Circular A-110 requires grantees to seek prior approval from the awarding agency when anticipating a 25 percent reduction in time (e.g., percent effort reduction from 40 to 30 percent) devoted to the project by the approved project director or principal investigator. Each Notice of Grant Award issued with budget period begin dates after October 1, 1994, will carry a term and condition to indicate whether or not the award is subject to expanded authorities. Questions concerning the new NIH implementation should be addressed to the NIH IC grants management staff identified on the Notice of Grant Award. $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-AG-95-04 ********************************************* DYNAMICS OF HEALTH, AGING AND BODY COMPOSITION - FIELD CENTER NIH GUIDE, Volume 23, Number 45, December 23, 1994 RFP AVAILABLE: NIH-AG-95-04 P.T. 34; K.W. 0785055, 1002061, 0710010 National Institute on Aging The National Institute on Aging (NIA) will support through a research contract, an epidemiologic study, Dynamics of Health, Aging and Body Composition (HEALTH ABC). The primary objective of the study is to examine the incidence of physical disability in relation to body composition and weight-related health conditions in healthier older persons. Change in body composition in old age, particularly loss of muscle mass and bone, may be a common pathway by which several diseases contribute to risk of disability. The reasons for changes in weight and body composition in old age and the influence of these changes on health outcomes are not fully understood. The HEALTH ABC will include a total of 3,000 noninstitutionalized white and African- American men and women aged 70-79. Incident change in physical function and related disability are the major outcomes. Serial measurement of body composition using dual energy x-ray absorptiometry will be accompanied by measures of anthropometry, strength, fitness, and physical function. A key component of the study is the assessment by objective measures of weight-related health conditions including osteoarthritis, cardiovascular disease, osteoporosis, pulmonary disease, diabetes, selected cancers, and depression. An eight-year cost-reimbursement type contract is anticipated. Two awards are expected. The solicitation is scheduled to be issued on or about December 28, 1994. Proposals will be due 90 days after the date of issuance of the solicitation. All responsible sources may submit a proposal that will be considered by the Government. INQUIRIES Copies of the solicitation may be obtained by sending a written request to: Donna Winters Division of Contracts and Grants National Institutes of Health 6100 Executive Boulevard, Room 6E01 (MSC 7540) Bethesda, MD 20892-7540 Telephone: (301) 496-4487 $$R1 END ************************************************************ $$R2 BEGIN NCI-CN-55079-63 ****************************************** EVALUATION OF CHEMOPREVENTIVE AGENTS BY IN VITRO TECHNIQUES NIH GUIDE, Volume 23, Number 45, December 23, 1994 MAA AVAILABLE: NCI-CN-55079-63 P.T. 34; K.W. 0745003 National Cancer Institute The Chemoprevention Branch, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), in its annual requirement to seek new sources, is soliciting proposals for the Evaluation of Chemopreventive Agents by In Vitro Techniques to increase the number of Master Agreement (MA) Holders. Current MA Holders for this program are not required to submit a proposal. This Master Agreement Announcement (MAA) is issued to solicit MA Holders who have adequate capabilities and technical expertise to screen and evaluate the activity of chemopreventive agents in various in vitro assays of cell transformation. Agents with potential chemopreventive activity are identified by epidemiologic surveys, initial laboratory (experimental) findings, observations in the clinical setting, or structural homology with agents having known chemopreventive activity. A rigorous and systematic evaluation of these candidate agents is necessary before their efficacy can be examined in clinical trials for cancer prevention. In vitro screening and evaluation techniques measuring the ability of these chemopreventive agents to inhibit transformation provides a relatively rapid and efficient means of qualifying these agents for further evaluation for the prevention of cancer in humans. Some of the agents to be used in this project are potentially hazardous. The in vitro systems may involve the use of carcinogens, tumor cells, or tumor viruses. Laboratory practices will be employed that will keep any element of risk to personnel at an absolute minimum. Where indicated, tissue and compound handling must be performed in (at least) Class I laminar flow cabinets, which must meet NIH specifications for work with these agents. The offeror will comply with NCI safety standards for research involving chemical carcinogens (DHHS Publication No. NIH 76-900). It will be required that the facilities have operating tissue culture/cell biology and chemistry laboratories that are suitable for using hazardous and/or carcinogenic materials as test materials. The contractor must have or be able to obtain all equipment necessary to accomplish the studies including, but not limited to, laminar flow hoods, CO2 incubators, equipment for sterility testing, isotope counters, spectrophotometer, hazardous chemical storage cabinets and refrigerators, equipment such as microscopes and miscellaneous laboratory equipment. The laboratory must have or have access to appropriate terminal and computer facilities and equipment for data collection and storage. The period of performance of the Master Agreement (MA) pool will be three years. It is estimated that up to four Master Agreement Orders per year will be issued to the Master Agreements. INQUIRIES Requests for this solicitation must be in writing and reference MAA No. NCI-CN-55079-63. The MAA will be available approximately January 9, 1995 and due approximately February 10, 1995. Requests are to be addressed to: Ms. Tina Huyck Research Contracts Branch, PCCS National Cancer Institute 6120 Executive Boulevard MSC 7226 Bethesda MD 20892-7226 Telephone: (301) 496-8603 $$R2 END ************************************************************ $$R3 BEGIN HD-95-009 FULL-TEXT ************************************** PERINATAL EMPHASIS RESEARCH CENTERS NIH GUIDE, Volume 23, Number 45, December 23, 1994 RFA AVAILABLE: HD-95-009 P.T. 04; K.W. 0775013, 0775020, 0775025 National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 13, 1995 Application Receipt Date: March 22, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators to develop multidisciplinary research efforts that will advance knowledge about diseases and disorders of pregnancy and infancy with the aim of reducing infant morbidity and mortality in rural populations. The resulting grant will be part of the Perinatal Emphasis Research Centers (PERC) program. These centers are intended for the support of hypothesis testing research efforts; they are not intended to support service or demonstration projects. PERCs are organized around problem/need themes and are established where research can be coordinated with existing programs of health care to ensure the rapid assimilation of new scientific knowledge into health care delivery. Active PERCs are addressing issues in high-risk pregnancies (diabetes, hypertension), prevention of prematurity, fetal hypoxia, intrauterine growth retardation, and infant sleep physiology. A PERC works closely with NICHD in participating in the center network and in carrying out its objectives in a manner consistent with NICHD goals and missions. This center will be awarded to an application focused on special health problems of mothers and children living in rural areas. It is anticipated that one specialized center (P50) grant will be made at a cost not exceed $500,000 for direct costs and $750,000 total costs. 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, Perinatal Emphasis Research Centers, is related to the priority area of maternal and infant 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and e-mail from the program contact listed below. Dr. Charlotte Catz, Chief Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Building, Room 4B03 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5575 FAX: (301) 496-3790 Email: CatzC@HD01.NICHD.NIH.GOV $$R3 END ************************************************************ $$R4 BEGIN HD-95-010 FULL-TEXT ************************************** PAIN MANAGEMENT FOR PERSONS WITH PHYSICAL DISABILITIES NIH GUIDE, Volume 23, Number 45, December 23, 1994 RFA AVAILABLE: HD-95-010 P.T. 34; K.W. 0715150, 0415003, 0745070 National Institute of Child Health and Human Development Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: May 16, 1995 PURPOSE The National Center for Medical Rehabilitation Research (NCMRR) invites applications for program projects (P01)to conduct rehabilitation research to improve the prevention and management of chronic pain experienced by persons with designated physical impairments. The chronic pain of interest is a secondary condition associated with the primary impairments of spinal cord injury, amputation, cerebral palsy, spina bifida, or traumatic brain injury. Program project applications are encouraged that take into account the pathophysiological, subjective, behavioral, cognitive, and social manifestations of chronic pain as a secondary condition. The award of at least two program projects is anticipated. Approximately $1 million direct cost for the first year will be committed to fund applications submitted in response to this RFA. 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), Pain Management for Persons with Physical Disabilities, is related to the priority areas of other 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 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Louis A. Quatrano, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Executive Building, Room 2A03 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 Email: quatranl@hd01.nichd.nih.gov $$R4 END ************************************************************ $$R5 BEGIN AG-95-002 FULL-TEXT ************************************** CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS NIH GUIDE, Volume 23, Number 45, December 23, 1994 RFA AVAILABLE: AG-95-002 P.T. 34; K.W. 0710010, 0404000, 0417000 National Institute on Aging Letter of Intent Receipt Date: April 10, 1995 Application Receipt Date: May 23, 1995 PURPOSE The National Institute on Aging (NIA) invites applications for support of Claude D. Pepper Older Americans Independence Centers (OAICs). The purpose of these centers is to increase independence in older Americans. OAICs will provide support for research to develop and test clinical interventions, and core laboratories in the basic sciences. OAICs will also train individuals in research approaches to develop and test methods of maintaining and increasing independence, and enhance expertise in aging research through the provision of training in the relevant fundamental scientific disciplines. They will conduct demonstration projects and information dissemination concerning the applications of such research. Centers should promote linkages between mechanistic and outcome research and thereby foster the capacity of new investigators to develop better clinical treatments and preventive approaches. It is recognized that the balance between support devoted to intervention studies and fundamental science will differ among Centers to take advantage of areas of strength in geriatric and gerontologic research available at different institutions. In those instances where applications request significant core resources to enhance ongoing projects, the number and quality of externally funded peer-reviewed studies will be of special importance. Plans are to make up to one award in FY 1995 and up to 3 new and/or competing renewal awards in FY 1996, depending upon availability of funds. Up to $1.2 million (total cost) for first-year expenses, and additional approved expenses for up to five years, will be committed in Fiscal Year 1995 and up to $3.6 million in Fiscal Year 1996, to fund applications submitted in response to this RFA, subject to receipt of high-quality applications and availability of funds. Budget increments for subsequent years generally will be limited to no more than one percent. 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, Claude D. Pepper Older Americans Independence Centers, is related to the priority area of 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 20402-9325 (telephone 202/783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Stanley L. Slater, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E-327 Bethesda, MD 20892 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: slater%nihniagw.bitnet@cu.nih.gov $$R5 END ************************************************************ $$P1 BEGIN PAR-95-013 FULL-TEXT ************************************* NCRR MINORITY INITIATIVE: K-12 TEACHERS AND HIGH SCHOOL STUDENTS NIH GUIDE, Volume 23, Number 45, December 23, 1994 PA AVAILABLE: PAR-95-013 P.T. 34, FF; K.W. 0710030, 0404000, 0720005 National Center for Research Resources Application Receipt Date: March 29, 1995 PURPOSE The National Center for Research Resources (NCRR) announces the availability of a program announcement aimed at increasing the pool of underrepresented minority high school students who are interested in pursuing careers in biomedical/behavioral research and the health professions. The program will include both K-12 teachers and minority high school students. This announcement represents the third and final phase of the NCRR transition from the S03 "Minority High School Student Research Apprentice Program" (MHSSRAP). Awards under this PA will use the education project (R25) grant mechanism. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Health People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, NCRR Minority Initiative: K-12 Teachers and High School Students, is related to many of the areas discussed in this publication. 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). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Dr. Marjorie A. Tingle Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 848 Bethesda, MD 20892 Telephone: (301) 594-7947 Email: BRSPK12@EP.NCRR.NIH.GOV $$P1 END ************************************************************ $$P2 BEGIN PA-95-014 FULL-TEXT ************************************** BASIC AND CLINICAL RESEARCH ON SLEEP AND WAKEFULNESS NIH GUIDE, Volume 23, Number 45, December 23, 1994 PA AVAILABLE: PA-95-014 P.T. 34; K.W. 0715187, 0710085, 1002030, 0755030, 0765035 National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Child Health and Human Development National Institute on Drug Abuse National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research PURPOSE Sleep disturbances affect a wide range of age groups and practically every segment of society is profoundly affected by the absence of healthful patterns of sleep and wakefulness. It is now apparent that sleep disorders, disturbances of sleep, and sleep deprivation are major public health concerns. Recent estimates suggest that as many as 40 million people may suffer from chronic or intermittent disorders of sleep. Many of these people remain undiagnosed and untreated, the consequences of which include reduced productivity, lowered cognitive performance, increased likelihood of accidents, higher risk of morbidity and mortality and decreased quality of life. Research in sleep and sleep disorders has increased steadily over the past decade and basic research is rapidly becoming relevant to clinical problems. However, despite this growth in sleep research, the neurobiological mechanisms underlying sleep and wakefulness and many of the clinical manifestations affected by sleep remain largely unknown. It is recognized that the sleeping brain is not in an inactive phase of existence, but rather is undergoing a complex set of active physiological and behavioral processes. Improved understanding of the fundamental nature of sleep, how sleep affects neural function, and how the central nervous system is modified by sleep can begin to provide a means to primary prevention of sleep disorders to reduce the economic and social impact of sleep/wake disturbances, and to significantly improve life expectancy and overall quality of life of all people across the lifespan. The purpose of this broad based sleep research program announcement is to inform the scientific community of the interests of the various Institutes at the National Institutes of Health (NIH) in order to stimulate, foster, and coordinate a wide range of basic and clinical studies on sleep and wakefulness as they relate to the missions of these Institutes. These areas include, but are not limited to: (1) the neuroscience and behavioral science of sleep; (2) the molecular and cellular mechanisms of sleep and circadian rhythms across the life span; (3) the development of sleep from fetal life through infancy; (4) the neurobiologic role of dreaming in humans; (5) the etiologic factors and pathophysiology of transient or persistent insomnia; and (6) the treatment of sleep disorders. 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, Basic and Clinical Research on Sleep and Wakefulness, is related to the fundamental research areas of the Decade of the Brain, and to the priority areas of chronic disabling conditions, mental health and disorders, and clinical prevention 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). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contacts listed below. Andrew A. Monjan, Ph.D., M.P.H. Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 Bethesda, MD 20892 Telephone: (301) 496-9350 Email: MonjanA:NIA-GW:NIH Ellen D. Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard Rockville, MD 20892 Telephone: (301) 443-4223 Email: ewitt@willco.niaaa.nih.gov Marian Willinger, Ph.D. Pregnancy and Perinatology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03 Bethesda, MD 20892 Telephone: (301) 496-5575 Email: willingm@hd01.nichd.nih.gov James R. Cooper, M.D. Medical Affairs Branch National Institute on Drug Abuse Parklawn Building, Room 10A-12 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4877 Email: jcooper@aoada.ssw.dhhs.gov James P. Kiley, Ph.D. Division of Lung Diseases National Heart, Lung and Blood Institute Westwood Building, Room 6A15 Bethesda, MD 20892 Telephone: (301) 594-7443 Email: james_kiley@nihh311.Bitnet Richard K. Nakamura, Ph.D. Coordinator for Sleep Research National Institute of Mental Health 5600 Fishers Lane, Room 11-102 Rockville, MD 20857 Telephone: (301) 443-1576 Email: NRN@CU.NIH.GOV Charlotte McCutchen, M.D. Epilepsy Branch, DCDND National Institute of Neurological Disorders and Stroke Federal Building, Room 114 Bethesda, MD 20892 Telephone: (301) 496-1917 Email: c5m@cu.nih.gov Mary Lucas Leveck, Ph.D. Acute and Chronic Illnesses Branch National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 Email: mleveck@ep.ninr.nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Mon Dec 19 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Peter Arzberger Newsgroups: bionet.sci-resources Subject: Multidisciplinary Challenge - Dear Colleague Letter, An HPCC activity Date: 19 Dec 1994 19:11:06 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 101 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3d5i0a$3lr@net.bio.net> NNTP-Posting-Host: net.bio.net Dear Colleague: The National Science Foundation (NSF) intends to announce opportunities for support of multidisciplinary group-oriented research for Fiscal Year 1995 in connection with the U.S. High Performance Computing and Communications (HPCC) Program, including the new Information Infrastructure Technology and Applications (IITA) component and the National Information Infrastructure (NII). This activity builds on the success of the Grand Challenge Application Groups and National Challenge Groups competitions held previously to include five distinct but interrelated components: GRAND CHALLENGES: to prepare the groundwork for the HPCC goal of sustained teraflop computing on important application problems utilizing parallel, distributed and heterogeneous computing systems and high performance networks; NATIONAL CHALLENGES: to demonstrate the solution of problems beneficial to a broad spectrum of society which contain an extensive information processing component, and which could benefit greatly by building an underlying information infrastructure; ENABLING TECHNOLOGIES: to accelerate progress in developing those technologies that will enable the community to take full advantage of high performance computing and communications systems in solving problems represented by the Grand Challenges and Natonal Challenges. Computer Science Challenges: focus is on the development of computing technology ranging from computer architecture through systems software to algorithms. Mathematical Sciences Challenges: focus is on advances in the mathematical sciences ranging from algorithms through the development of tools to the essential use of computation in extending mathematical frontiers. Problem Solving Environments: focus is on the development of computational environments that take advantage of unique characteristics of specific problems in order to shorten the problem solving cycle. Pre-proposals will be required. It is anticipated that deadline for submission of pre-proposals will be February 13, 1995. Details will be given in the announcement which will be available on STIS shortly; it will be referenced in the NSF Mosaic home page accessible via http://www.nsf.gov. Until then, inquiries should be directed to Robert G. Voigt, rvoigt@nsf.gov. Robert G. Voigt Acting HPCC Coordinator The National Science Foundation (NSF) provides awards for research in the sciences and engineering. The awardee is wholly responsible for the conduct of such research and preparation of the results for publication. The Foundation, therefore, does not assume responsibility for such findings and their interpretation. The Foundation welcomes proposals on behalf of all qualified scientists and engineers, and strongly encourages women, minorities and persons with disabilities to compete fully in any of the research and research-related programs described in this document. In accordance with Federal statutes and regulations and NSF policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, denied the benefits of, or be subject to discrimination under, any program or activity receiving financial assistance from the National Science Foundation. Facilitation Awards for Handicapped Scientists and Engineers provide funding for special assistance or equipment to enable persons with disabilities (investigators and other staff, including student research assistants) to work on an NSF project. See program announcement NSF 91-54, or contact the Facilitation Awards Coordinator, Directorate for Education and Human Resources, Washington, DC 20550, (703) 306-1636. The Foundation has TDD (Telephonic Device for the Deaf) capability, which enables individuals with hearing impairment to communicate with the Division of Personnel and Management about NSF programs, employment, or general information. The telephone number is (703) 306-0090 This program is described in the Catalog of Federal Domestic Assistance categories: 47.074, BIO; 47.070, CISE; 47.041, ENG; 47.049, MPS; and 47.075, SBE. Electronic Dissemination You can get information fast through STIS (Science and Technology Information System), NSF's online publishing system, described in NSF 94-4 the "STIS flyer" (elsewhere in this publication). To get more copies of the flyer, call the NSF Publications Section at (703) 306-0214. For an electronic copy, send an e-mail message to stisfly@nsf.gov . Ordering by Electronic Mail If you are a user of electronic mail and have access to the Internet, you may order publications electronically by sending requests to pubs@nsf.gov. In your request, include the NSF publication number and title, number of copies, your name, and a complete mailing address. Publications should be received within three weeks after placement of your order. From owner-sci-resources@net.bio.net Mon Dec 19 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-010 - V23(45) 12/23/94 Date: 20 Dec 1994 15:58:58 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 452 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3d7r42$1vt@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95010 HD-95-010 P1O1 *************************************** PAIN MANAGEMENT FOR PERSONS WITH PHYSICAL DISABILITIES NIH GUIDE, Volume 23, Number 45, December 23, 1994 RFA: HD-95-010 P.T. 34; K.W. 0715150, 0415003, 0745070 National Institute of Child Health and Human Development Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: May 16, 1995 PURPOSE The National Center for Medical Rehabilitation Research (NCMRR) invites applications for program projects to conduct rehabilitation research to improve the prevention and management of chronic pain experienced by persons with designated physical impairments. The chronic pain of interest is a secondary condition associated with the primary impairments of spinal cord injury, amputation, cerebral palsy, spina bifida, or traumatic brain injury. Program project applications are encouraged that take into account the pathophysiological, subjective, behavioral, cognitive, and social manifestations of chronic pain as a secondary condition. The award of at least two program projects is anticipated. 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), Pain Management for Persons with Physical Disabilities, is related to the priority areas of other 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 20402-9325 (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, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) program project (P01). Applicants should be familiar with NICHD program project guidelines. A copy may be obtained from the NICHD office listed under INQUIRIES. Responsibility for the planning, direction, and execution of the proposed program will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (rev. April 1994). The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated award date is December 1, 1995. 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. This RFA is a one-time solicitation for applications for new awards. Future unsolicited continuation applications will compete with other applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1 million direct cost for the first year will be committed to fund applications submitted in response to this RFA. It is anticipated that two applications will be funded. The number of awards is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this RFA is provided for in the financial plans of the NCMRR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background This initiative builds directly on recommendations emanating from an NCMRR workshop on management of chronic pain that was conducted in March of 1993. A panel of experts evaluated the state of science, determined research needs and opportunities, and made recommendations for rehabilitation research in the area of chronic pain. To receive a copy of the panel report ("Chronic Pain Management: Developing A Treatment System For People with Disabilities," March 1-3, 1993, National Center For Medical Rehabilitation Research, Bethesda, Maryland (Unpublished Report)), send a mailing label and request to the program administrator listed under INQUIRIES. This RFA is focused on research to improve the prevention and management of chronic pain experienced by people with spinal cord injury, amputation, cerebral palsy, spina bifida or traumatic brain injury. This RFA encompasses the five domains of investigation that are identified in the "Research Plan for the National Center for Medical Rehabilitation Research" as being relevant to medical rehabilitation (Research Plan for the National Center for Medical Rehabilitation Research, March 1993, National Institutes of Health, Bethesda, MD, NIH Publication No. 93-3509). These are: pathophysiology, impairment, functional limitation, disability, and societal limitation. Scope The objectives of this RFA are to stimulate the establishment of program projects that are multidisciplinary research approaches to chronic pain and to bring together, on a cooperative basis, clinical and basic science investigators in a manner that will foster communication, innovation, and high quality research. To accomplish these objectives, the applicant institution or collaborating institution must be conducting an ongoing program of excellence in biomedical research related to the study of chronic pain. This research should be in the form of NIH-funded research projects (R01), FIRST Awards (R29), program projects (P01), or other peer reviewed research supported by federal or non-federal sources. Applications on behalf of more than one institutions should include documentation demonstrating the capacity of each to participate in the program and their willingness to implement common protocols targeting rehabilitation- specific research questions. The theoretical bases for proposed studies must be clearly explicated. Interventions to be tested must be clearly defined in terms of their purpose, sample composition, means of implementation and anticipated effects. Particular attention should be paid to ensuring that the anticipated effects are linked with well defined outcome measures. These might include but are not limited to: reduced medication dependency, reduced psychosocial disruption, increased functional activity, fewer reports of pain, reduced health care costs, and a return to age-appropriate activities. Applications must address one or both of the following research themes. 1. Examining the effectiveness of specific treatments (either pharmacological or non- pharmacological) that are currently used to manage different types of chronic pain in different populations of people with physical disabilities. 2. Developing and evaluating new or improved treatments (either pharmacological or non-pharmacological) to manage different types of chronic pain in different populations of people with physical disabilities. Current Treatments Subprojects to evaluate interventions (e.g., pharmacological, surgical, physiotherapeutic, or behavioral) that are used currently to manage different types of chronic pain in different populations may include, but are not limited to: o evaluating the pathophysiology of different types of pain from a basic science perspective to elucidate relationships among pathology, pain intensity, and potential treatments of pain; o developing and testing conceptual models to specify the mechanisms responsible for the prevention and management of chronic pain; and, o investigating effects of interventions on functional, psychosocial or quality-of-life issues for persons with disabilities who experience chronic pain. New or Improved Treatments Subprojects to evaluate new or improved interventions (e.g., pharmacological, surgical, physiotherapeutic, or behavioral) to prevent or manage different types of chronic pain may include, but are not limited to: o evaluating the pathophysiology of different types of pain from a basic science perspective to elucidate relationships among pathology, pain intensity, and potential treatments of pain; o developing and testing conceptual models to specify the mechanisms responsible for the prevention and management of chronic pain; and, o investigating effects of interventions on functional, psychosocial, or quality-of-life issues for persons with disabilities who experience chronic pain. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 15, 1995, 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 a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Louis A. Quatrano, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Executive Building, Room 2A03 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used to prepare the application. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248, and from the program administrator listed under INQUIRIES. Grant applications will be supported through the program project (P01) mechanism. The application should be prepared in a manner consistent with the general guidelines in the publication "NICHD P01 PROGRAM PROJECT GUIDELINES," which are available from the NICHD office listed under INQUIRIES. 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. 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: Susan Streufert, Ph.D. Acting Director Division of Scientific Review National Institute of Child Health and Human Development Executive Building,Room 5E01 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 Applications must be received by May 16, 1995. 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 RFA 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 for completeness by DRG and responsiveness by the NICHD. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may 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 that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score, and will also receive a second level of review by the NICHD Council. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator/Program Director and the official signing for the applicant organization will be notified. Peer Review Criteria The scientific and technical merit peer review of program projects focuses on two areas: (1) review of the overall program as an integrated, synergistic effort; and, (2) review of the component research projects and core units. Overall Program Criteria The criteria for reviewing the program as an integrated effort are: o the coordination, interrelationship, cohesiveness, and synergism among the individual research projects and core components; relationship of the program objectives to the common theme; the advantages of pursuing the proposed research as a program project rather than through individual research grants; o relevance of the program to the NCMRR mission; o leadership ability and scientific stature of the program director and his/her ability to meet the program's demands of time and effort; o participation of a suitable number of responsible, experienced investigators; o an appropriate organizational and administrative structure for effective attainment of program objectives; o arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, and internal communication and cooperation among program investigators; o the institutional environment in which the research will be conducted, including the availability of space, equipment and subjects; physical proximity of investigators and the potential for interaction with scientists from other areas; o the appropriateness of the program size: small enough to afford effective interaction focused on a specific central theme and large enough to achieve synergy and economies not provided by regular research grants; o institutional commitments to the program requirements. Individual Projects and Core Unit Criteria The review criteria for the component research projects and core units are: o the scientific merit of each individual project in the program context; o the specific scientific objectives of each project that will benefit significantly from or depend upon, collaborative interactions with other P01 projects (e.g., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness, and/or economy of effort); o accomplishments and progress to date of the component research projects, if appropriate; o qualifications, experience, and commitment of the investigators and their ability to devote the required time and effort to the program; o the appropriateness of the budget for each component research project and core unit; cost effectiveness and quality control of core units; o the appropriateness of the research projects use of core services; o the adequacy of the means proposed for protecting against risks to human subjects, animals, and the environment; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The review of program project applications assigned to NICHD may include a site visit or applicant interview. However, these are not review requirements and should not be depended upon to supplement an incomplete written application. If a site visit is planned, the principal investigator will be contacted by the Scientific Review Administrator. AWARD CRITERIA 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 geographical location of the applicant organization; o program balance among research areas of this announcement; and, o relevance to medical rehabilitation. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquires regarding programmatic issues to: Louis A. Quatrano, PhD National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Executive Building, Room 2A03 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 Email: quatranl@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 8A17G 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 Email: colvinm@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.929-Medical Rehabilitation 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 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. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Dec 19 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-95-002 - V23(45) 12/23/94 Date: 20 Dec 1994 15:59:13 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 776 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3d7r4h$20s@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AG95002 AG-95-002 P1O1 *************************************** CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS NIH GUIDE, Volume 23, Number 45, December 23, 1994 RFA: AG-95-002 P.T. 34; K.W. 0710010, 0404000, 0417000 National Institute on Aging Letter of Intent Receipt Date: April 10, 1995 Application Receipt Date: May 23, 1995 PURPOSE The National Institute on Aging (NIA) invites applications for support of Claude D. Pepper Older Americans Independence Centers (OAICs). These centers are for the purpose of increasing independence in older Americans. OAICs will provide support for research to develop and test clinical interventions, and for core laboratories in the basic sciences. OAICs also will train individuals in research approaches to develop and test methods of maintaining and increasing independence, and to enhance expertise in aging research through the provision of training in the relevant fundamental scientific disciplines. They will conduct demonstration projects and information dissemination concerning the applications of such research. Centers should promote linkages between mechanistic and outcome research and thereby foster the capacity of new investigators to develop better clinical treatments and preventive approaches. It is recognized that the balance between support devoted to intervention studies and fundamental science will differ among Centers to take advantage of areas of strength in geriatric and gerontologic research available at different institutions. In those instances where applications request significant core resources to enhance ongoing projects, the number and quality of externally funded peer-reviewed studies will be of special importance. OAICs may support a broad range of geriatric and aging research. However, applications with a predominant focus in neuroscience or the behavioral and social sciences are more appropriate for other NIA centers programs that have a primary focus in these disciplines. 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), Claude D. Pepper Older Americans Independence Centers, is related to the priority area of 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 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Only U.S. organizations are eligible to apply. Applications may be submitted by 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Older Americans Independence Centers will be supported through the comprehensive center grant (P60) mechanism. The awarding of funds pursuant to this RFA is contingent on availability of funds. All pertinent DHHS, PHS, and NIH grant regulations, policies and procedures are applicable. First year budgets may not exceed $1,200,000 (direct plus indirect costs). Budget increments for subsequent years generally will be limited to no more than one percent. Awards are made initially for no less than five years and may be renewed for five-year periods. FUNDS AVAILABLE Although it is anticipated that up to $1.2 million will be directed to the support of competing OAICs in Fiscal Year 1995, and that one award will be made, issuance of an Older Americans Independence Center award is contingent upon the receipt of scientifically meritorious applications and allocation of appropriated funds for this purpose. In addition to the FY 1995 award, it is anticipated that up to $3.6 million will be directed to the support of OAICs in Fiscal Year 1996 and that three awards will be issued to applicants responding to this RFA, depending on the quality of applications and the availability of funds. RESEARCH OBJECTIVES Millions of older Americans suffer from loss of abilities needed to live fully independently. Loss of independence imposes enormous personal and financial burdens on older persons and their families. The annual cost to the Nation for care of dependent older persons totals billions of dollars. Dependence is not inevitable in old age. It results from disabling conditions which are potentially, if not currently, preventable or reversible. The development and testing of interventions to reduce disability and increase independence thus offers immense benefits and potential savings in health care costs. To date efforts to develop such interventions and test their efficacy in maintaining and increasing independence have been modest, and the number of researchers with the abilities to conduct such research has been small. There is a need for more researchers and research teams with the ability to: 1. Conduct controlled clinical trials of promising interventions against disabling conditions of older persons. 2. Fill gaps in the knowledge of the pathophysiology of disabling conditions, and of the mechanisms affecting their responses to treatment, and develop and test improved treatments based on this knowledge. 3. Develop and test ways of applying independence-enhancing advances in treatment within the American health care system. The combination of these three abilities would allow the conduct of concerted research programs to increase independence for older Americans. The Claude D. Pepper OAIC program is designed to expand this research and the number of researchers capable of conducting it. Specifically, as authorized under amendments to Section 445A of the Public Health Service Act, each OAIC will conduct: "research into the aging processes and into the diagnosis and treatment of diseases, disorders, and complications related to aging, including menopause, which includes research on such treatments, and on medical devices and other medical interventions regarding such diseases, disorders and complications that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals and programs to develop individuals capable of conducting research in these areas." As defined by Section 445A of the Public Health Service Act, "the term independence, with respect to diseases, disorders, and complications of aging, means the functional ability of individuals to perform activities of daily living or instrumental activities of daily living without assistance or supervision." The overall goals of the OAIC program are: 1. To facilitate the development and testing of interventions to increase or maintain abilities needed for independence of older persons. 2. To use knowledge gained in these intervention studies in developing and testing improved interventions. 3. To strengthen core laboratories in the basic sciences as they relate to aging research and to train researchers in the techniques of fundamental research relevant to studies in aging and geriatric medicine. 4. To train researchers capable of leading and conducting research programs as described in 1, 2, and 3 above. OAIC research projects should provide opportunities to train such researchers. 5. To translate OAIC research findings into improvements in health care practice through demonstration and dissemination projects. The components of OAICs derive from these goals. OAICs will support: Intervention Studies (IS) and Intervention Development Studies (IDS) At least one Intervention Study or Intervention Development Study that utilizes older persons as subjects must be eligible for funding following peer review to qualify as an OAIC. Intervention Studies. Proposed intervention studies must test the efficacy of interventions to prevent or ameliorate functional impairments contributing to loss of independence. Studies may be of effects on long-term disability and/or temporary disability following illness or injury. In studies of prevention interventions, a focus on subgroups at high risk for disability is encouraged where appropriate. All Intervention Studies should measure direct effects on functional status and have adequate statistical power to determine important intervention effects on functional abilities. Central in the evaluation of these studies will be the adequacy and appropriateness of the plans for measurements of changes in functional status. Measures of related medical and physiologic endpoints are encouraged wherever pertinent. Because older persons with multiple health problems are at especially high risk for disability, determinations of the efficacy of interventions in such persons, and analyses of the effects of different health problems on treatment efficacy, are encouraged where feasible. Tests of interventions specifically designed against disabilities resulting from the interaction of two or more comorbid conditions are also encouraged. Besides measurements of intervention effects on the above outcomes, each proposed intervention study must also include planned investigations of: o Mechanisms underlying the interventions' effects on functional status, to provide a basis for further improvements in interventions. Intervention interactions with intermediary response variables such as underlying disease mechanisms, symptoms, and behavioral factors should be measured and analyzed as needed for this purpose. o Factors affecting recruitment into the study and participants' compliance, to provide data for potential wider applications of the interventions are considered pertinent and must be included. o Cost-effectiveness and effects on health care utilization (e.g., hospitalizations, nursing home admissions and stays, use of home care services) of the intervention(s) tested. Proposals for intervention studies that do not contain the above elements will be returned to applicants. Examples of types of interventions for study include, but are not limited to: o Interventions to prevent or reduce frailty and increase physical performance abilities. Exercise, nutritional, pharmacologic, rehabilitative, surgical, and other interventions against disorders such as osteoarthritis, congestive heart failure, chronic pulmonary disease, pathologic loss of muscle mass and/or strength, protein- calorie malnutrition, dizziness, and gait and balance problems are encouraged. o Interventions to reduce risk of disabling events such as hip fractures and strokes, and to reduce impairments following these events. Studies of interventions against osteoporosis and to prevent hip fracture, and studies of techniques to improve functional status after hip fracture and strokes are encouraged. o Interventions to prevent or reduce disabling side effects from medication use. Examples include drug withdrawal studies and testing of non-pharmacologic therapeutic alternatives, as well as testing improved pharmacologic agents or regimens. o Interventions to prevent, lessen, or shorten temporary disability from exacerbation or complications of chronic diseases of older persons. Examples include transient disability associated with exacerbations of chronic pulmonary disease, deconditioning during hospitalization, and acute confusional states. o Interventions to prevent or reduce disabling sequelae of menopause and associated estrogen deficiency. Examples include osteoporotic fractures and urge incontinence. o Combined intervention strategies to prevent or ameliorate disabilities in older persons with multiple impairments. The above list is not exhaustive and its order is not intended to reflect NIA priorities. All studies of promising interventions to enhance independence in older persons are encouraged. No priority is placed on having a diversity of intervention topics associated with a single OAIC. Applicants may find it advantageous to concentrate on one or a few topics in which their strengths are greatest. Subjects for these studies may include older persons living at home, recipients of home care, nursing home residents, hospitalized patients, and those in other pertinent clinical settings, as appropriate to each intervention study. Organizational liaisons involving one or more medical centers, nursing homes, home care services, and other care organizations are encouraged wherever appropriate for the conduct of OAIC activities. All activities to be performed by proposed cores as part of Intervention Studies should be clearly described in the plans for the Intervention Study itself. Examples include functional assessment and biostatistical support. Intervention Development Studies. The OAIC center grant may support other studies to identify, develop, or refine potential interventions to preserve or increase independence. Each proposed Intervention Development Study should present a complete plan for conduct of the proposed research, analogous in the level of detail to an individual research project grant application. It should be presented in sufficient detail to allow for full scientific review. Types of such studies include: o Tests of therapies on physiologic factors known to affect functional status. Both beneficial and adverse effects may be studied. o Studies to identify or confirm reversible or preventible risk factors for disability and/or disabling events. Examples include diseases, and previously unidentified pathophysiologic changes leading to functional impairment and/or disabling events. Large- scale epidemiologic studies are outside the scope of this RFA. o Studies of experimental therapeutics directed at the prevention or treatment of morbid conditions associated with aging. Research utilizing animal and/or human subjects is appropriate. (If a study utilizing animal subjects is proposed, another study utilizing older persons as subjects must be included in the IS/IDS section to satisfy the requirements of this RFA.) All activities to be performed by proposed cores as part of Intervention Development Studies should be clearly described in the plans for the Intervention Development Study itself. Examples include functional assessment, biostatistical support, etc. Research Resources Cores (RRC) Applicants may request core resource support to enhance the quality of OAIC research projects, i.e., Intervention Studies, Intervention Development Studies and Pilot Research Projects. RRCs for the support of laboratories in the fundamental sciences as they relate to aging research or geriatric medical subspecialties may be requested as well. RRCs may also provide support for research projects relevant to the mission of OAICs whose major support is independent of the OAIC. Opportunities to participate in the scientific activities of RRCs should serve to enhance the development of research skills of new investigators and where appropriate should encourage linkages between fundamental science and clinical intervention research. Applicants should not propose a core unless its services/resources are required by at least two projects (otherwise the core could simply be included in the one project it supports). The justification for proposed cores (including the merit and number of projects they would support) will be evaluated by peer reviewers. Routine patient care costs may not be requested, but research-related patient care costs are eligible for support. Examples of possible RRCs include: o Recruitment/screening/assessment/registry units for subjects for different OAIC intervention study research protocols. o Functional assessment units to monitor functional status of subjects in OAIC studies. o Diagnostic and pathophysiologic units for studies of mechanisms of treatment response and interactions with disease. o Basic science laboratories providing state of the art technologies and training to center investigators. o Biostatistical/data management units. o Cost-effectiveness analysis units. o Veterinary Units for the support of laboratory animals used in aging research and the development of animal models of age-associated diseases. The above list is not intended to describe the full range of activities to be supported, nor to direct applicants towards these areas. Inclusion of research resources cores of any or all these types in a single proposed OAIC is neither required nor necessarily advisable. Innovative organizational approaches are encouraged. Institutions that are recipients of NIH General Clinical Research Center awards who wish to apply for an (OAIC) award are encouraged to use core resources from these Centers for support of OAIC projects where appropriate. For each Research Resources Core proposed, a core leader should be named, and plans for the scientific and administrative functioning must be presented. The method for prioritizing access to core resources requested by multiple projects should be described. Research Development Core (RDC) The Research Development Core is a required component of all OAICS. The RDC will provide salary and other support for junior faculty and research associates to acquire abilities in research to enhance the independence of older persons. This includes all phases of research to develop interventions to enhance independence, including clinical trials, studies of mechanisms of treatment response, and cost- effectiveness/health care utilization studies. The development of persons who will have the necessary breadth and depth of experience needed to lead teams spanning this range of research is of high priority. The career development of individuals acquiring skills in fundamental aging research related to the mission of OAICs may also be supported here. The research development core should promote linkages between mechanistic and outcome research. This will enhance the capacity of young scientists to develop better clinical treatments and preventive approaches. This goal may be achieved in a variety of ways including periodic meetings of center staff and other scientists and most importantly through the provision of suitable training opportunities. While the creation of these linkages is an important overall function of the RDC, it is recognized that this will not in all cases be feasible. However, the plan for the educational program of the RDC as a whole should describe the approach to be followed and the training plan for at least one (preferably more) of the individuals receiving support under the RDC should document how training opportunities will be utilized to achieve the goal of creating these linkages. The components of the Research Development Core are: Junior Faculty Development Support. Support may be requested for salary and fringe benefits for junior faculty participating in OAIC Intervention Studies and other OAIC research. The Research Development Core should present a plan for achieving development of junior faculty supported under this component, including a mechanism for monitoring their scientific progress and development toward independent research. Applicants should clearly specify the role of senior mentors in training and supervising junior faculty and research associates. A biographical sketch (two pages maximum), a list of active research support, and a brief description of the mentor's role in proposed OAIC activities should be provided for all proposed mentors. Though applicants are not required to identify individual junior faculty, research associates, and their specific roles in advance, they are encouraged to do so if possible, since this information is useful to peer reviewers. If support is requested for "to-be-named" junior faculty or research associates, applicants should present their plans for recruiting, training, and supervising these persons. The Research Development Core may also serve to encourage the research career development of other junior faculty and research associates (in addition to those receiving salary support from this core) by coordinating the participation in OAIC research projects of other junior faculty and research associates whose salary support may come from other sources, such as NIA's Geriatric Academic Program Award (GAP), Geriatric Research Institutional Training Award (GRIT), Physician Scientist Award (PSA), NIA Academic Award, and Clinical Investigator Award (CIA). The overall contribution of the OAIC to the development of researchers throughout the grantee institution who can contribute to the development of independence-enhancing interventions will be considered in the evaluation of OAIC proposals. Didactic Training. Support may be requested for didactic training in such topics as clinical trials methodology, biostatistics, pertinent topics in disease mechanisms and related basic sciences, behavioral sciences, health services research, etc. Such support is not restricted to individuals receiving salary support from the core, but may be provided to other personnel on OAIC research projects or OAIC Intervention Development Studies. Pilot Research Projects. Support may be requested for pilot projects on topics related to the activities of the OAIC. Examples of project topics include pilot studies of new interventions, and probes of disease mechanisms and their interactions with interventions. The procedures by which awardees will solicit, select, monitor and evaluate the results of pilot projects should be specified in the application, but applicants are not required to present specific pilot projects as part of the application. Pilot projects are limited to a maximum of one year in duration, a maximum of $25,000 (direct costs) per pilot project, and a maximum of $100,000 (direct costs) per year for the total allocated to all pilot projects contained in an OAIC. Pilot project funds may be used for salaries, equipment, and supplies. Research Development Core Leader. Support may be requested for a core leader who will be responsible for coordination of the above activities and must report annually on the progress of all individuals supported thorough this core, and other core activities. A maximum of $250,000 in total (direct plus indirect) first-year costs may be requested for the Research Development Core. Budget increments in future years will generally be limited to one percent. Demonstration and Information Dissemination Core (DIDC) OAICS must include a DIDC that supports activities to translate findings from their research into health care practice. A maximum of $80,000 annual total (direct plus indirect) costs may be requested for these activities. Specific projects for demonstration/ information dissemination activities should be described. The staffing plan and a rationale for the organization of this core should be presented. The methods and techniques to be employed for information dissemination and the audience targeted and size should be defined. Attention should be directed to issues of cultural sensitivity with regard to the target audience. Where appropriate, the information should be structured so that it can effectively reach minority populations, including non-English-speaking older people. Examples of projects that may be supported include dissemination of research results to the public, professionals, and paraprofessionals, through symposia and in-service training. Planning and pilot activities for larger scale demonstration projects to evaluate the practicability of interventions tested in OAICs within various health care settings are also appropriate. Leadership/Administrative Core Applicants may include a Leadership/Administrative Core that requests funds for the OAIC director, OAIC administrator, and support staff. The OAIC director should be a scientist who can provide effective administrative and scientific leadership and coordination with OAIC Intervention Studies. An OAIC administrator, who will assist the director in managing the Center, addressing issues of fiscal management and compliance with institutional, PHS, NIH, and NIA policies, should be identified. A maximum of $120,000 (direct plus indirect costs) per year for this core, for salary, travel, and other expenses of the director, administrator and appropriate administrative staff may be requested. Future year annual increases will generally be limited to no more than one percent. OAIC Advisory Panel. OAIC applications, regardless of whether a Leadership/Administrative Core is requested, must describe a plan and budget for the selection of experts from outside the OAIC who will meet yearly to review the progress of the OAIC and provide a written report to the OAIC Director. Potential outside experts should not be selected or named. The outside experts' review will be included in the annual OAIC Progress Report to the NIA. (A member of the NIA extramural staff assigned to each Center will routinely attend the Advisory Panel meetings. It will be the OAIC Director's responsibility to notify NIA Staff well in advance of the date scheduled). Coordination Among OAICs. OAICs are expected to meet together yearly to compare research results and to explore possibilities for collaborative efforts. Funds should be requested to permit travel of the OAIC director, administrator and on all OAIC Intervention Studies, and Intervention Development Studies for meetings with NIA staff and staff from other OAICs. Responsibility for organizing these meetings will rotate among OAIC sites. Required Components of an OAIC. The minimum required components that must be determined to be eligible for funding by the peer reviewers in order to qualify for an OAIC Award are (1) at least one Intervention Study or Intervention Development study that utilizes older persons as subjects (2) a Research Development Core, and (3) a Demonstration and Information Dissemination Core. All required components must be recommended for the full five years in order for the application to be eligible for funding. The total first year budget may not exceed $1,200,000 (direct plus indirect costs) and the total first year budget for the sum of the Research Resources Cores, Research Development Core, Demonstration and Information Dissemination Core and the Leadership/Administrative Core may not exceed $825,000. Thus, a center application requesting the full $1,200,000 will have an Intervention Study/Intervention Development Study first year total budget request of at least $375,000. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 10, 1995, 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 NIA 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 Dr. Stanley L. Slater 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 Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The application should be prepared using the OAIC (P60) Guidelines available from the program administrator listed under INQUIRIES. 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. 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: Michael Oxman, Ph.D., Chief, SRO National Institute on Aging Gateway Building, Room 2C212 Bethesda, MD 20892 Complete applications must be received by May 23, 1995. 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 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. Applications may not exceed a total of 25 pages for parts 1-4 of the Research Plan for each project and 10 pages for parts 1-4 of the Research Plan for each core section. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIA. Incomplete applications will be returned to the applicant without further consideration. The applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA in accordance with the review criteria stated below. Applications judged by the NIA Program Staff to be non-responsive (those that fail to include all required components, request amounts that exceed allowable limits, or are not directed at the goals of this RFA) will be returned to the applicant without review. Because no site visits will be conducted, each application must be thorough and complete enough to stand on its own. Additional materials or revisions will not be accepted after the receipt date. It is strongly recommended that Institutional Review Board and, if appropriate, Institutional Animal Care and Use Committee approval be secured before the application is submitted. Otherwise, it is the applicant's responsibility to ensure these certifications are sent to the Scientific Review Office, NIA, within 60 days of the receipt date, unless an earlier date is set by the Scientific Review Administrator. Applications failing to comply with this requirement well be returned without review. There will be no further notifications on this issue. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria The primary criterion for review by the NIA review committee in evaluating each OAIC grant application will be the effectiveness of the proposed program in contributing to increasing independence for older Americans through the conduct of research, demonstration, and dissemination projects; and development of academic leaders in geriatrics with effective research, teaching and clinical capabilities. Specific criteria related to this standard include: 1. Scientific merit of the proposed research and its expected impact on the maintenance of independent functioning of older persons. 2. Contribution of Research Resources Cores, where included, to enhancement of research, training and pilot projects. Where major resources are requested for the RRCs, the number and quality of externally-funded peer-reviewed studies will of considerable importance. 3. Role of the Research Development Core in providing educational and other career development opportunities for fellows, junior faculty and other professional and paraprofessional personnel associated with the Center. The quality of the plans to promote linkages between mechanistic and applied research are an important aspect in the evaluation of the RDC. Other review criteria are: 1. Leadership ability and scientific stature of the program director and his/her ability to meet the program's demands of time and effort. 2. Qualifications, experience, and commitment of the investigators responsible for core units and their ability to devote the required time and effort to the program. 3. Presence of an administrative and organizational structure conducive to attaining the objectives of the proposed program. 4. Arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, the internal communication and cooperation among investigators in the program. 5. Quality of proposed external review process. 6. Appropriateness of the total budget and budgetary requests for the individual components. 7. Academic and physical environment as it bears on patients, space and equipment and on the potential for interaction among scientists within the center and with scientists from other departments, institutions and Claude D. Pepper Centers. 8. Institutional commitment to the requirements of the program. 9. The adequacy of the means for protecting against risks to human subjects, animals and the environment. 10. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA The award criteria are: o priority score o availability of funds o programmatic priorities 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: Stanley L. Slater, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E-327 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: slater%nihniagw.bitnet@cu.nih.gov Direct inquiries regarding fiscal matters to: Margaret Kuhn Grants Management Office National Institute on Aging Gateway Building, Room 2N-212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Email: kuhn%nihniagw.bitnet@cu.nih.gov 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. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Dec 19 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-014 - V23(45) 12/23/94 Date: 20 Dec 1994 15:59:09 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 588 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3d7r4d$20h@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95014 PA-95-014 P1O1 *************************************** BASIC AND CLINICAL RESEARCH ON SLEEP AND WAKEFULNESS NIH GUIDE, Volume 23, Number 45, December 23, 1994 PA NUMBER: PA-95-014 P.T. 34; K.W. 0715187, 0710085, 1002030, 0755030, 0765035 National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Child Health and Human Development National Institute on Drug Abuse National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research PURPOSE Sleep disturbances affect a wide range of age groups and practically every segment of society is profoundly affected by the absence of healthful patterns of sleep and wakefulness. It is now apparent that sleep disorders, disturbances of sleep, and sleep deprivation are major public health concerns. Recent estimates suggest that as many as 40 million people may suffer from chronic or intermittent disorders of sleep. Many of these people remain undiagnosed and untreated, the consequences of which include reduced productivity, lowered cognitive performance, increased likelihood of accidents, higher risk of morbidity and mortality and decreased quality of life. Research in sleep and sleep disorders has increased steadily over the past decade and basic research is rapidly becoming relevant to clinical problems. However, despite this growth in sleep research, the neurobiological mechanisms underlying sleep and wakefulness and many of the clinical manifestations affected by sleep remain largely unknown. It is now recognized that the sleeping brain is not in an inactive phase of existence, but rather is undergoing a complex set of active physiological and behavioral processes. Improved understanding of the fundamental nature of sleep, how sleep affects neural function, and how the central nervous system is modified by sleep can begin to provide a means to primary prevention of sleep disorders to reduce the economic and social impact of sleep/wake disturbances, and to significantly improve life expectancy and overall quality of life of all people across the lifespan. The purpose of this broad based sleep research program announcement is to inform the scientific community of the interests of the various Institutes at the National Institutes of Health (NIH) and to stimulate, foster, and coordinate a wide range of basic and clinical studies on sleep and wakefulness as they relate to the missions of these Institutes. These areas include, but are not limited to: (1) the neuroscience and behavioral science of sleep; (2) the molecular and cellular mechanisms of sleep and circadian rhythms across the life span; (3) the development of sleep from fetal life through infancy; (4) the neurobiologic role of dreaming in humans; (5) the etiologic factors and pathophysiology of transient or persistent insomnia; and (6) the treatment of sleep disorders. 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, Basic and Clinical Research on Sleep and Wakefulness, is related to the fundamental research areas of the Decade of the Brain, and to the priority areas of chronic disabling conditions, mental health and disorders, and clinical prevention 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 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. Foreign institutions are not eligible for small research grants (R03s), First Independent Research Support and Transition (FIRST) (R29) awards (R29s), and research program project (P01) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanisms of support will be the investigator initiated research project grant (R01), FIRST award (R29), and small research grants (R03). To apply for support of a more broadly based multidisciplinary research program, the research program project (P01) mechanism is suggested. Policies that govern the research grants programs of the NIH will prevail. Details of eligibility for the different funding mechanisms vary. Applicants are strongly advised to contact the program official listed under INQUIRIES for additional information, particularly related to P01s and other specific application procedures. RESEARCH OBJECTIVES There are a number of research directions that could be pursued to provide new insights on the underlying neurobiological mechanisms and clinical manifestations of sleep and wakefulness. This program announcement seeks to stimulate and encourage ideas that can compete successfully for support through grants-in-aid from the NIH. The following examples of research topics, many of which may lend themselves to studies in humans as well as in animal models and in vitro systems, are intended to reflect the breadth of interests of the NIH programs. Neurophysiological, behavioral, neuroanatomical, pharmacological, cellular, molecular and genetic techniques or combinations of these approaches are appropriate. All of the areas identified cut across Institutes and programs and should not be viewed as restricted to only one specific Institute. Current NIH referral guidelines will be used to assign grant applications to the most appropriate NIH Institute based on the scientific focus of the application. The National Center on Sleep Disorders Research (NCSDR) plans to coordinate sleep related activities at the NIH. The following topic areas are not intended to be comprehensive or exclusive: Neuroscience and Behavioral Science of Sleep. o Elucidate neural structures and mechanisms that control states of sleep and wakefulness. o Examine how neural circuits controlling sleep are modulated through emotions and stress, ethanol use or abuse, diseases or other disorders. o Obtain a better understanding of behavioral and physiological adaptations to sleep/wake cycles, hibernation, circadian and biological rhythms. o Determine neural correlates of cognition during sleep including learning and memory. o Utilize neural network models and theoretical approaches to understand the transitions between wakefulness and different stages of sleep. o Determine the homeostatic regulation of brain functions through interactions of sleep-promoting circuits in the brain. o Examine the role of sleep in understanding the basic neurobiology of substance and ethanol abuse. o Investigate the effects of drugs on the neurochemistry and determination of sleep onset, dreaming, awakening and transition between sleep and wakefulness. o Explore possible social factors and the development of sleep in children and adolescents as a model for acquiring behavioral control of homeostatic processes. Molecular and Cellular Mechanisms of Sleep and Circadian Rhythms Across the Life Span. o Identify genes, genetic mechanisms and heritable determinants in controlling sleep or circadian systems. o Isolate and characterize gene products that are expressed during sleep in order to identify molecules that alter intrinsic properties of neurons during this state of altered awareness. o Elucidate the mechanisms through which various stimuli, such as light, exercise, or endogenous factors (e.g., monoamines and melatonin) entrain sleep and circadian rhythms in mammalian and nonmammalian species, and any other sleep regulators such as the immune system and the suprachiasmatic nucleus. o Identify age related molecular, cellular and structural changes in the aging nervous system related to sleep and circadian systems. o Explore interventions, such as transplants of neuronal tissue, hormone or growth factor replacements to understand underlying mechanisms of age related alterations of sleep and circadian rhythms. o Apply noninvasive brain imaging techniques such as PET and MRI to identify changes in metabolism in specific brain areas, localize brain regulator mechanisms, and correlates of transitions between sleep states, dreaming and wakefulness during development and in the sleeping brain of older people. Development of Sleep from Fetal Life Through Infancy. o Determine the role of sleep and sleep state organization during fetal and infant development. o Identify potentially life threatening sleep disorders and dysfunctions which emanate specifically from chronic maternal use of alcohol, cigarette smoking and narcotic drugs. o Determine possible interactions between the developing immune system and the organization of sleep/wake state that occur in the first few months of life. o Explore the mechanisms underlying prenatal development of biological clocks and the relationship between maternal and fetal/neonatal behaviors necessary for establishing circadian rhythms. Neurobiologic Role of Dreaming in Humans. o Investigate the biological and behavioral functions and significance of dreams, including the role of REM sleep in mammalian evolution and memory. o Examine the role of non-REM sleep dreams and whether these are a qualitatively different type of brain activity than REM sleep dreams. Determine perceptual and cognitive influences on dream content. o Determine neural correlates of, and interactions between, sexual or other motivational systems, the content of dreams and sensory processing. o Employ multidisciplinary approaches utilizing metabolic and electrophysiologic methods to correlate events that occur during REM sleep with dreams involving non-visual sensory modalities. o Develop improved and more precise methods for identifying specific sleep stages, and the occurrence, onset and termination of dreams independent of waking recollections. o Correlate patterns of neuronal activity during REM sleep with dreams having other sensory modalities such as audition, olfaction or temperature regulation. o Develop better approaches to correlate subjective passage of time in a dream with real time duration. Etiologic Factors and Pathophysiology of Transient or Persistent Insomnia. o Investigate the role of the thalamus and other brain substrates in mediating insomnia. o Determine the relationship of insomnia to other medical conditions such as neurological, cardiovascular and psychiatric diseases. Determine physiological mechanisms that may account for the potential link between poor sleep, insomnia and cardiovascular disease, and whether insomnia may be predictive for future cardiovascular events. Examine the relationship of insomnia with other sleep disorders such as periodic movements of sleep and restless leg syndrome. o Investigate the role of persistent insomnia as a risk factor for development of depression and anxiety disorders. Determine the prognostic aspects of sleep for depression, alcoholism and other disorders; and the role of various sleep stages in predicting relapse following successful treatment of depression. Determine the mechanisms underlying the anti-depressant effect of sleep deprivation and changes associated with a night of recovery sleep. o Examine the effects of benzodiazepines on central nervous system acquisition or encoding of new information and the process of memory storage and recall. o Utilize sleep deprived, restricted, or disrupted models to understand the fundamental mechanisms of insomnia and effects on daytime function. Treatment of Sleep Disorders and Co-Morbidity with Other Conditions o Investigate the interactions between brainstem control of respiration and the neural mechanisms specific to sleep and wakefulness, and the source of the respiratory variations during sleep. o Investigate underlying autonomic mechanisms and physiological interrelations between snoring, obesity, sleep apnea, hypertension, and the regulation of sleep. o Determine the cellular and molecular basis of excessive daytime sleepiness, particularly as it relates to sleep apnea. o Explore the pharmacology and role of hormones in respiratory disorders of sleep. o Conduct studies on the efficacy of pharmacologic, behavioral and psychotherapeutic interventions for specific types of insomnia. o Investigate the risks, benefits, long term safety, and efficacy of hypnotic agents (i.e., benzodiazepines). Examine the long term efficacy of hypnotic agents in treating insomnia, especially whether the long term use renders them ineffective or if prolonged use actively disturbs sleep. Investigate the role of hypnotic agents on respiratory drive and autonomic function. o Determine the mechanisms underlying rebound insomnia and whether or not long term use of hypnotic agents leads to risk of physical dependence. o Develop and evaluate the best outcome variables and parameters to assess the clinical significance for insomnia therapy. o Understand co-morbidity of sleep disorders with neurological disorders to include but not limited to epilepsy, stroke, and movement disorders. o Examine the effects of ethanol use on respiratory function during sleep (e.g., sleep apnea). o Investigate the effects of sleep deprivation and use of ethanol and other drugs of abuse on daytime drowsiness and behavioral performance. o Understand co-morbidity of sleep and mental disorders o Explore mechanisms of environmental causes of sleep disturbances such as drug abuse, stressors, toxins, or artificial zeitgebers. o Investigate sleep disorders in underserved and understudied populations. o Investigate therapies that will ameliorate or eliminate sleep disorders due to disruptions of circadian rhythms. o Characterize sleep disturbances in persons with physical disabilities that result from traumatic injuries or chronic disease and how they influence the course of rehabilitation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justifications is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) 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 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 should be included with 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** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit 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 or board. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria The following criteria will be considered when assessing the scientific/technical merit review of a research grant application: o Scientific, technical, or medical significance and originality of proposed research; o Appropriateness and adequacy of the experimental approach and methodology; 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 the resources necessary to perform the research. o Appropriateness of the proposed budget and duration in relation to the proposed research; The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that IC. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Andrew A. Monjan, Ph.D., M.P.H. Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 Bethesda, MD 20892 Telephone: (301) 496-9350 Email: MonjanA:NIA-GW:NIH Ellen D. Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard Rockville, MD 20892 Telephone: (301) 443-4223 Email: ewitt@willco.niaaa.nih.gov Marian Willinger, Ph.D. Pregnancy and Perinatology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03 Bethesda, MD 20892 Telephone: (301) 496-5575 Email: willingm@hd01.nichd.nih.gov James R. Cooper, M.D. Division of Clinical Research National Institute on Drug Abuse Parklawn Building, Room 10A-12 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4877 Email: jcooper@aoada.ssw.dhhs.gov James P. Kiley, Ph.D. Division of Lung Diseases National Heart, Lung and Blood Institute Westwood Building, Room 6A15 Bethesda, MD 20892 Telephone: (301) 594-7443 Email: james_kiley@nihh311.Bitnet Richard K. Nakamura, Ph.D. Coordinator for Sleep Research National Institute of Mental Health 5600 Fishers Lane, Room 11-102 Rockville, MD 20857 Telephone: (301) 443-1576 Email: NRN@CU.NIH.GO