From owner-sci-resources@net.bio.net Sun Jul 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-074 - V24(24) 06/30/95 Date: 3 Jul 1995 14:59:23 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 413 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3t9p7r$ajv@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95074 PA-95-074 P1O1 *************************************** AGING, VASCULAR STIFFNESS, AND CARDIOVASCULAR FUNCTION NIH GUIDE, Volume 24, Number 24, June 30, 1995 PA NUMBER: PA-95-074 P.T. 34; K.W. 0710010, 0715040, 0411005 National Institute on Aging PURPOSE The purpose of this program announcement (PA) is to foster research that will enhance our understanding of vascular stiffness in aging and in cardiovascular disease. Ascertaining the importance of vascular stiffness, as a risk factor for cardiovascular morbidity and mortality, may suggest approaches to prevention and treatment including early modification of risk factors and/or adverse lifestyles to prevent, delay, and/or reverse vascular stiffening and its potential deleterious sequelae as well as novel treatment in persons with established stiffness or cardiac disease. The Geriatrics Program, National Institute on Aging (NIA), invites grant applications on clinically-relevant research focusing on aging and vascular stiffness. 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, Aging, Vascular Stiffness, and Cardiovascular Function, is related to the priority area of heart disease and stroke. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. 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. MECHANISM OF SUPPORT This program will use the NIH investigator-initiated research project grant (R01) and FIRST (R29) award mechanisms. The total project period for an application submitted in response to this program may not exceed five years. Because the nature and scope of the research proposed in response to this program may vary, it is anticipated that the size of awards will vary as well. It is not the intent of this program to encourage submission of large, multi-center, clinical trials. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000 (rev. 4/1/94). RESEARCH OBJECTIVES Background Cardiovascular diseases are the most common cause of death among the elderly and the percentage of deaths due to these diseases increases significantly with age throughout the later years of life. Age is the main risk factor for cardiovascular diseases, including heart attacks and stroke. Age-related changes in cardiac function, circulatory hemodynamics, blood pressure regulation, and lipid metabolism all contribute significantly to morbidity and mortality in the elderly. Although age is a potent risk factor for high blood pressure, stroke, coronary artery disease, and heart failure, the precise reasons for this observation are presently unknown. Other than age per se, a potential risk factor that may underlie cardiovascular morbidity in the elderly is a stiffening of the large and medium-sized elastic arteries (e.g., the aorta). Arterial stiffening increases during aging in healthy persons and is accompanied by an elevation in systolic blood pressure, within the normal range, which averages 25-35 mm Hg between the third and eighth decades of life. In approximately half of older Americans age 65 and beyond, the degree of vascular stiffening may become large enough to lead to the development of isolated systolic hypertension (defined as a systolic blood pressure of 140 mm Hg or greater and a diastolic blood pressure less than 90 mm Hg). This observation is important because high blood pressure is the major risk factor for stroke and is also an important independent risk factor for coronary artery disease, myocardial infarction, and heart failure in older Americans regardless of gender or racial/ethnic background. The increased arterial pressure (i.e., increased afterload) may affect cardiac function in aging. For example, the moderate increase in left ventricular mass in many individuals observed between the third and ninth decades of life may, in part, be mediated by the increased arterial pressure and/or vascular stiffness. Importantly, left ventricular hypertrophy represents a major independent risk factor for morbid cardiovascular events including myocardial infarction and cardiac death. According to The Fifth Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure, African Americans have one of the highest frequencies of high blood pressure in the world. The Third National Health and Nutrition Examination Survey (NHANES III) reports that in non- Hispanic blacks, age 60 and older, high blood pressure is present in approximately 71 percent of the population. Moreover, in comparison to whites, high blood pressure in African Americans is earlier in onset and of greater severity at any decade of life. As a result, African Americans have a greater rate of stroke, heart disease, and end-stage renal disease than whites. Yet, the importance of vascular stiffening during aging, in contributing to the development of these morbid cardiovascular events in African Americans is currently unknown. Taken together, the available data suggest that vascular stiffening may be implicated in the etiology and progression of several cardiovascular disorders that affect a high proportion of older Americans regardless of gender or racial/ethnic background. Vascular stiffening has been considered a part of "normal" aging and neither treatment for increased arterial stiffness nor lifestyle modification nor pharmacologic intervention has been advocated to blunt vascular stiffening and its potential deleterious sequelae. Recent data from the literature, including data from the Baltimore Longitudinal Study of Aging (BLSA) suggest that measurement of aortic pulse wave velocity (i.e., the speed of transmission with which the arterial pulse wave is propagated down the arterial tree) and applanation tonometry (i.e., measurement of late systolic amplification of the carotid artery pressure pulse) are important markers for age-associated changes in vascular stiffness. In a normotensive, carefully screened, healthy population of BLSA volunteers (age range: 21-90), increasing age is associated with progressive vascular stiffening. Importantly, at any age, men and women who have higher aerobic capacity (as indexed by maximal oxygen consumption during exercise), demonstrate lower vascular stiffness than their less aerobically fit peers. Moreover, when compared to their untrained age matched peers, endurance trained older men demonstrate a markedly lower arterial stiffness. These data suggest an important inverse relationship between maximal oxygen consumption and vascular stiffness and also imply that physical conditioning to improve aerobic capacity in older Americans may blunt the arterial stiffening that accompanies aging (Vaitkevicius et al., Circulation 88 (part 1): 1456-1462, 1993). Other ongoing collaborative studies suggest that novel pharmacologic therapy (vasodilators) in older subjects, by decreasing central arterial stiffness, eliminates the age- associated difference in cardiac volumes and ejection parameters seen in older versus younger individuals during maximal exercise. Thus, pharmacologic therapy may have potential for improving both vascular stiffness and cardiac performance in older persons. In other clinical studies, data have accumulated suggesting that differences in chronic dietary salt intake may affect vascular stiffness. In a rural Chinese population who consume approximately 50 percent less salt than an urban Chinese population with a higher prevalence of high blood pressure, arterial pulse wave velocity is consistently lower and increases by a smaller amount with age when compared to the urban group. Moreover, arterial pulse wave velocity is lower in rural group subjects, as compared to age-matched urban group subjects with the same arterial pressure (Avolio et al. Circulation 71: 202-210, 1985). In a different study population, normotensive adult volunteers who follow a low salt diet for an average of two years demonstrate a reduced vascular stiffness, as indexed by arterial pulse wave velocity, when compared to age- and arterial pressure-matched control subjects consuming a regular salt diet (Avolio et al. Arteriosclerosis 6:166-169, 1986). Collectively, these data suggest that differences in dietary salt intake may affect vascular stiffness and moreover, that the effect of salt may be independent of arterial pressure. Thus, modification of diet may also prove beneficial in altering age-associated increases in vascular stiffness. Another focus of this program is to stimulate research on the development of new indices of vascular stiffness and how these new indices compare to well established indices currently in use. Although arterial pulse wave velocity methodology is well established, reproducible, easy to use, and amenable to study in humans due to its non-invasiveness it does, like any other methodology, have its limitations. Ultrasound imaging has gained popularity as a more direct measure of vascular stiffness but suffers >From having the requirement to also measure arterial blood pressure changes concurrently from a different vascular site. It has been suggested that future progress in this field may require a consensus for the best overall measurement of vascular stiffness, including comparisons among various methodologies (both indirect and direct) in prospective clinical studies (Arnett et al., Am. J. Epidemiol. 140(8): 669-682, 1994). This program is particularly interested in the development of new non-invasive measures of aortic impedance. Ascertaining the importance of vascular stiffening in aging, and its potential as a risk factor for cardiovascular morbidity and mortality in older persons, may lead to development of preventive strategies (e.g., early modification of risk factors and adverse lifestyles through exercise and diet interventions) or new therapeutic strategies (e.g., novel pharmacologic therapy) to prevent, delay, and/or reverse vascular stiffening in aging and its potential deleterious sequelae. The potential public health benefit of treating age-associated vascular stiffening, in terms of both cost savings and improving the quality of life of older Americans, may be considerable. Objectives The NIA encourages submission of clinically-relevant research projects on vascular stiffening and the potential for vascular stiffening as a risk factor for cardiovascular morbidity and mortality in aging persons. Topics of interest include, but are not limited to: o Relationship between changes in vascular stiffness, arterial blood pressure, and cardiovascular function with age in heterogenous populations including women and ethnic/minority subgroups; o Relationship between vascular stiffness, arterial blood pressure, and cardiac structure/function including left ventricular mass and ejection parameters (i.e., systolic function) in older populations; o Relationship between vascular stiffness, arterial blood pressure, and diastolic dysfunction in older populations with normal systolic function; o Role of interventions including aerobic exercise, novel pharmacologic agents, dietary modification, and/or smoking cessation in modifying vascular stiffening (and the rate of increase in stiffening), arterial blood pressure, and cardiac performance in older populations; o Importance of vascular stiffness as a predictor of morbid cardiovascular events in aging populations including hypertension, atherosclerosis, stroke, coronary heart disease, and heart failure; o Relationship between vascular stiffness, arterial blood pressure, atherogenic lipoproteins, and susceptibility to atherosclerosis in aging persons; o Physiologic, nutritional, and genetic risk factors affecting the rate of increase in vascular stiffening with age in humans; o Clinico-pathologic studies relating clinical measurements of vascular stiffness to tissue properties of autopsy material or other specimens; o Development of new indices of vascular stiffness; and o Comparisons between established indices of vascular stiffness and newly developed indices in the same study population of older persons. These topics are neither prioritized nor meant to be restrictive. Investigators are encouraged to submit applications in any meritorious area of research responsive to the general research objectives of this program. 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. 5/95) 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 Grants Information Office, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Suite 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301-435-0714. 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 (R29) award must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria o Scientific, technical, or medical significance and originality of the 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 the provisions for the protection of human and animal subjects and safety of the research environment; 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. AWARD CRITERIA Scored applications will compete for available funds with all other scored applications assigned to that Institute/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; and o Program balance among research areas of the program announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Andre J. Premen, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: PremenA@gw.nia.nih.gov Direct inquires regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.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, 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 PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. 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 Sun Jul 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-95-005 - V24(24) 06/30/95 Date: 3 Jul 1995 14:59:20 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 489 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3t9p7o$ajl@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AA95005 AA-95-005 P1O1 *************************************** ROLE OF TOBACCO DEPENDENCE IN ALCOHOLISM TREATMENT NIH GUIDE, Volume 24, Number 24, June 30, 1995 RFA: AA-95-005 P.T. 34; K.W. 0404003, 0404001, 0404019, 0745070 National Institute On Alcohol Abuse And Alcoholism Letter of Intent Receipt Date: October 18, 1995 Application Receipt Date: November 21, 1995 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research applications to study the alcohol tobacco interaction in its implications for alcoholism treatment. The objective of this RFA is to encourage research that will lead to improved strategies for treating alcohol and nicotine dependence in patients receiving care for problem drinking. Such research may identify and test relevant clinical intervention strategies; identify interactions between the two substances that have implications for relapse prevention, or further understanding of the alcoholism treatment process by investigating reinforcement mechanisms underlying conjoint abuse of the two substances. 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, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY 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. MECHANISM OF SUPPORT Research support may be requested through applications for a regular research project grant (R01), FIRST Award (R29), exploratory/developmental grant (R21), and small grant (R03). An applicant for an R01 may request support for up to five years. In FY 1995, 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. Small grants (R03) and exploratory/developmental grants (R21) are limited to two years for up to $50,000/year and $70,000/year, respectively, for direct costs. FIRST Awards, small grants and exploratory/developmental grants cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Potential applicants for FIRST Awards (R29), small grants (R03), and exploratory/developmental grants (R21) should obtain copies of the specific announcement for these programs from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, MD 20852, telephone (301) 468-2600 or 1-800-729-6686. Investigators submitting applications that exceed $500,000 for direct costs in any one year must contact program staff prior to submitting an application. Applicants may also 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 grants (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 $2 million in total costs will be available to support approximately 8 to 10 grants under this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds. The earliest possible award date is July 1, 1996. RESEARCH OBJECTIVES Background Behavioral Research During the past decade many lines of converging data have suggested that alcohol and tobacco consumption are correlated. For example, smokers consume two times as much alcohol per capita as do non- smokers (Carmody et al., 1985) and their risk of excessive drinking is also twice that of non-smokers, a relationship that holds across a broad range of demographic variables (Henningfield et al., 1990; Johnson and Jennison, 1992). Alcoholism itself is estimated as 10 to 14 times more prevalent among those who smoke than those who do not (DiFranza and Guerrera, 1990). In addition, heavy drinking tends to be associated with heavy smoking with 85 percent of currently drinking alcoholics smoking daily. Although smoking has substantially declined in the United States to approximately 30 percent of adults it has diminished very little among alcoholics. Co-occurrence of smoking and excessive drinking has important treatment implications. For example, previous or current problems with alcohol and alcohol treatment bodes negatively for success in smoking cessation (Bobo et al., 1987; DiFranza and Guerrera, 1990; Sandor, 1991). On the other hand, smoking cessation prior to formal alcoholism treatment (Miller et al., 1983) appears to improve subsequent drinking outcome. Conversely, reducing drinking appears to improve the prospects for successful smoking cessation (Burling et al., 1982). Curiously, participation in a stop-smoking program conducted during the course of alcoholism treatment was found to enhance maintenance of sobriety, even though the intervention had little impact on smoking behavior itself (Burling et al., 1991). Discontinuation of smoking and long-term abstinence from drinking are also associated. Alcoholics who maintain sobriety longer have been reported as more successful in smoking cessation (Bobo et al., 1987; Hughes, 1993). Similarly, relapse to drinking may prompt smoking relapse (Shiffman et al., 1985; Sees and Clark, 1993). Several pharmacologic and behavioral mechanisms have been proposed to explain the association between smoking and drinking. At a pharmacologic level some degree of cross-tolerance seems to occur between nicotine and alcohol as sympathetic nervous system agents, each of which has both depressant and stimulant effects. Second, conjoint use of the two substances may also be due to accelerated metabolism of one substance following ingestion of the other. Third, nicotine and alcohol may somewhat counteract the aversive effects of each other, while potentiating reinforcing effects. Basic Science Administration of both alcohol and nicotine together to laboratory animals alters the responses to either drug when administered alone. For example, prior exposure to a low dose of nicotine increases alcohol consumption, whereas a high dose decreases consumption (Gauvin, Morre and Holloway, 1993). Animals respond more for lateral hypothalamic stimulation after nicotine treatment and less after ethanol treatment, compared to controls (Schaefer and Michael, 1992). However, when both agents are given together, responding is higher than after nicotine alone suggesting that alcohol is enhancing the reinforcing properties of nicotine. In discriminative stimulus studies, nicotine enhances the alcohol-like effects of nicotine in alcohol-preferring rats compared to non-preferring rats (Gordon, Meehan and Schecter, 1993). Further evidence of interactions between alcohol and nicotine derives >From comparative sensitivity and cross-tolerance studies suggesting that the sensitivities to alcohol and nicotine are related. Mice selectively bred for alcohol sensitivity are also more sensitive to nicotine compared to alcohol-insensitive mice. In addition, alcohol- sensitive mice rendered tolerant to alcohol are also tolerant to nicotine (de Fiebre and Collins, 1993; Luo, Marks and Collins, 1994 and Majchrzak and Dilsaver, 1992) and nicotine-tolerant, alcohol- sensitive mice display cross-tolerance to alcohol (Collins et al., 1993). These effects are not observed in alcohol-insensitive mice. In other studies, nicotine can antagonize the motor incoordinating effect of alcohol (Dar and Bowman, 1994), whereas a nicotinic receptor antagonist partially blocks increased locomotor activity induced by alcohol (Blomqvist, Soderpalm and Engel, 1992). To better understand the treatment implications of alcohol and tobacco co-dependence, it is necessary to determine the mechanism of interaction of these two agents and how the actions are modified when both drugs are co-administered. Several lines of evidence suggest that although alcohol and nicotine have different molecular structures, they have actions in common. For example, both substances stimulate the release of dopamine in the nucleus accumbens, (Imperato and Di Chiara, 1986a, 1986b) an area of the brain involved with the reinforcing properties of drugs. A role for dopamine is also suggested by the observation that blockade of dopamine receptors increases both alcohol and nicotine intake (Gauvin, et al, 1993; Dawe et al, 1995) . Acetaldehyde is a pyrolysis product of tobacco and has been suggested to play a role in the reinforcing effects of alcohol. The rapid transport of acetaldehyde in an unmetabolized and undiluted form from the lungs through the heart to the brain may enhance the reinforcing properties of smoking. Areas of Research Interest The following list of topics is intended only to illustrate NIAAA interests; topics not specified should not be viewed as excluded from consideration. The primary objective of the RFA is to enhance the efficacy of treatment for nicotine addicted, alcohol dependent patients. To that end, research studies are solicited in the following areas. Research is needed to determine the conditions under which tobacco use serves as a salient risk factor for alcohol relapse. Research suggests several hypothesized mechanisms for the linkage in conjoint alcohol-tobacco use. Studies are needed to more clearly specify these putative mechanisms and understand their interactions. Studies are needed that identify the optimal sequencing of alcohol and smoking cessation in treatment programs. Studies are needed that investigate the use of new/existing pharmacologic agents as adjuncts to alcohol and smoking cessation and in the maintenance of abstinence. Our understanding of treatment issues would be advanced by the identification of the cellular and molecular mechanisms that underlie initiation, maintenance and relapse in conjoint alcohol and tobacco consumption. Studies that seek to advance the transfer of basic research findings toward treatment intervention applications are expressly encouraged. Research is needed that elucidates factors that underlie the joint vulnerability to alcohol and nicotine dependence. Research is needed to develop common assessment methodologies for alcohol and tobacco dependence that will lead to improved treatment efficacy. Research is needed to determine the extent to which alcohol acts through nicotinic receptors and other receptors and whether chronic nicotine exposure can alter those actions. Research is needed using gene knockout technology against the nicotinic receptor, examine the interactions of alcohol and nicotine. Studies are needed that clarify the nature of the discriminative stimuli for alcohol and nicotine and how these stimuli interact. Studies are needed to determine whether conditioned cues associated with smoking enhance alcohol reinforcement. Studies are needed that assess the role of acetaldehyde in alcohol- nicotine interactions. 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 affect 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 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 October 18, 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: RFA: AA-95-005 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 FAX: (301) 443-6077 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) 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, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892, telephone 301-435-0714; and from the NIAAA program administrators listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) 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. 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 reference letters will be considered incomplete and will be returned without 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express mail) At the time of submission, two additional copies of the application must also 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 (20852 for express mail) Applications must be received by November 21, 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 appropriate National Advisory Council or Board. 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 human and animal subjects and the environment. The review criteria for Small Grants (R03), Exploratory/Developmental Grants (R21), and FIRST Awards (R29) are contained in their program announcements. 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 treatment aspects of proposed research to: Joanne Fertig, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0796 FAX: (301) 443-8744 Email: jfertig@willco.niaaa.nih.gov Direct inquiries regarding the neuroscience and behavioral aspects of proposed research to: Walter Hunt, 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: whunt@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 PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. 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 Sun Jul 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-073 - V24(24) 06/30/95 Date: 3 Jul 1995 14:59:15 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 548 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3t9p7j$ajb@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95073 PA-95-073 P1O1 *************************************** MECHANISMS OF ADOLESCENT ALCOHOL ABUSE AND ALCOHOLISM NIH GUIDE, Volume 24, Number 24, June 30, 1995 PA NUMBER: PA-95-073 P.T. 34; K.W. 0404003, 0403001, 0705048 National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant proposals to conduct basic research, using animal models and state-of-the-art imaging techniques in humans, to identify the neurobiological, physiological, and genetic factors that lead to adolescent alcohol abuse and dependence. Despite the fact that alcohol use is high among secondary school students, relatively few studies to date define the neurobiologic and physiologic mechanisms of high alcohol intake or the effects of excessive drinking in adolescents. Studies of neurobiologic mechanisms and risk factors for alcoholism during late childhood through adolescence would increase our ability to predict which individuals will be most likely to develop alcoholism early in life. In addition, evaluation of the effects of alcohol ingestion during postnatal development, particularly during adolescence, would further our understanding of alcohol's immediate consequences and the contribution of early alcohol exposure to excessive drinking and abnormal cognitive and social functioning during subsequent developmental stages. Finally, results obtained will help develop strategies for treatment and prevention of adolescent alcohol abuse and alcoholism. 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, Mechanisms of Adolescent Alcohol Abuse and Alcoholism, is related to the priority area of alcohol abuse and alcoholism. 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 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISM OF SUPPORT Research support may be requested through applications for a regular research project grant (R01), FIRST Award (R29), exploratory/developmental grant (R21), and small grant (R03). Applicants for R01s may request support for up to five years. In FY 1994, the average total cost per year for new and competing renewal R01s funded by the Division of Basic Research was approximately $170,000. 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. Small grants (R03) and exploratory/ developmental grants (R21) are limited to two years for up to $50,000 per year and $70,000 per year, respectively, for direct costs. FIRST Awards, exploratory/developmental grants, and small grants cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Potential applicants for the FIRST Award (R29), exploratory/developmental grant (R21), and small grant (R03) should obtain copies of the specific announcements for these programs from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, MD 20847-2345, telephone 301-468-2600 or 1-800-729-6686. Investigators submitting applications that exceed $500,000 for direct costs in any one year should contact program staff before submitting an application. Applicants may also submit applications for Investigator-Initiated Interactive Research Project Grants (IRPG) (PA-94-086, NIH Guide, 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. RESEARCH OBJECTIVES Alcohol remains the most commonly abused substance among adolescents. According to the National Adolescent Student Health Survey, 75.9 percent of 8th graders and 87.3 percent of 10th graders have used alcohol in their lifetime (Windle, 1990). Of greater significance is the widespread occurrence of heavy drinking (defined as consuming five or more drinks in a row during the past two weeks). Among high school seniors this statistic is 28 percent. Males have consistently reported more frequent and heavier use than females, but this difference has been gradually diminishing over the last decade (Johnston, et al., 1994). This is particularly important since females require less alcohol to achieve blood alcohol concentrations equivalent to males (Frezza, et al, 1990). Thus, if females begin drinking heavily during adolescence and continue throughout life, they may be at enhanced risk for the medical consequences of alcohol abuse including liver disease (Norton, et al, 1987), brain damage (Harper, et al., 1990), and associated behavioral deficits (Glenn & Parsons, 1992). Given the early onset of drinking and its frequency, the consequences of alcohol's acute and chronic effects on physiological growth and maturation, as well as its potential deleterious effects on the development of social and interpersonal competencies, are of major concern. During the period of late childhood and adolescence, development of neurobiologic systems is incomplete. Although final brain size and available neurons are largely fixed early in infancy, plasticity of the brain continues during adolescence through the processes of overproduction and elimination of synapses, progressive myelination, variation in the evolution of neurotransmitter systems, and changes in the rate of brain electrical and metabolic activity (Watkins and Williams, 1992). In addition, hormonal levels change dramatically during adolescence as a result of the onset of puberty. Corresponding to the shifts in brain and hormonal status are significant transitions in cognitive, psychological, and social development (Susman and Petersen, 1992). Adolescence is marked by the emergence of new thinking skills, reassessment of body image, focus on peer relationships, and a desire to establish self identity and distance from parents (Ingersoll, 1992). Thus, environmental influences during adolescence, including alcohol consumption, may interact with unique neurobiological and physiological strengths and weaknesses to predispose or protect an individual from alcohol abuse and/or dependence. A better understanding of alcohol's effects during adolescence on the complicated interaction among genetic, neurobiologic, psychosocial and environmental factors could lead to earlier and more effective prevention and treatment strategies. To date, relatively few studies define the neurobiological and physiological effects of alcohol in adolescents, in part due to ethical considerations that prohibit administering alcohol to youths. Neurobehavioral research in human adolescents has been largely limited to studies of children who are at high risk because of a positive family history of alcoholism. These investigations suggest that there are neurocognitive and neurophysiological abnormalities in children of recovering alcoholics that could be early indicators of risk for alcoholism (Begleiter, et al, 1984; Hill, et al, 1990; Porjesz and Begleiter, 1993; Whipple, et al, 1991). More importantly, the neurophysiological abnormalities are most pronounced during the prepubertal and late adolescent years, are highly dependent on the differential rates of nervous system development in boys and girls, and may reflect maturational lag in children who are at high risk for developing alcoholism (Hill and Steinhauer, 1993; Steinhauer and Hill, 1993). This latter finding underscores the importance of considering developmental stages, particularly adolescence, when trying to identify early risk markers for alcoholism. Evidence from animal studies indicates that unique neurochemical and behavioral changes are occurring during postnatal development, including adolescence, that could mediate the response to alcohol (see Witt, 1994, for review). While the various neurotransmitter systems develop at different rates, the ontogeny of several neurotransmitter systems extends into the adolescent period. For example, in the rat, neurochemical markers of dopamine activity in the striatum, such as levels of postsynaptic receptors and presynaptic dopamine content, show a gradual increase until adult levels are reached around puberty (Coyle and Harris, 1987; Noison and Thomas, 1988). Similarly, in animals and humans, presynaptic cholinergic markers in the cortex do not reach adult levels until the adolescent period (Coyle and Yamamura, 1976; Virgili, et al., 1990; Court et al., 1993). During the 7- to 10-day period just prior to the onset of puberty, referred to as "periadolescence", both male and female rats are behaviorally and pharmacologically distinct from younger and older animals (Spear and Brake, 1983). Periadolescent animals are more "hyperactive" as measured by tests of exploratory behavior and social play, and have difficulty with complex discrimination learning tasks. Pharmacologically, periadolescent animals are less responsive (hyposensitive) to drugs affecting the catecholaminergic system (Spear, et al., 1980; Shalaby and Spear, 1980), which may be due to functional immaturity of self-inhibitory presynaptic dopamine autoreceptors in mesolimbic brain regions during the periadolescent period (Spear et al., 1981). However, whether periadolescent animals drink more alcohol than early postpubertal or adult rats because of an immature dopaminergic system, are more susceptible to alcohol dependence, or fail to attain mature dopamine function following high early intakes are important research questions that need to be explored. Dopamine is one of many neurotransmitter systems that have been implicated in the alcohol addiction process. An understanding of the ontogeny of psychopharmacological responsiveness in neurotransmitter systems related to mechanisms of alcohol reinforcement, alcohol preference, or alcohol's subjective effects could be extremely important in understanding the development of alcohol addiction during adolescence. Finally, animal studies of the ontogeny of alcohol's acute effects on learning and memory have shown early age-dependent changes in alcohol's effect on selective learning tasks (e.g., sensory preconditioning) (Chen, et al., 1992). However, more studies are needed to look at ethanol's influence on age-related changes on other cognitive measures and the neurochemical mechanisms underlying these changes. Similarly, few studies have investigated the effects of chronic ethanol use on cognition and brain function. A recent study of alcohol-abusing teenagers found that both male and female adolescent alcohol abusers were inferior in language skills, but only females were impaired on tests of abstract reasoning and cognitive flexibility (Moss, et al., 1994). Furthermore, chronic ethanol treatment may lead to increased N-methyl-D-aspartate (NMDA)-mediated neurotoxicity (Crews & Chandler, 1993), which could be exacerbated by repeated withdrawals such as during binge drinking (Hunt, 1993). Since the immature brain is more susceptible to NMDA neurotoxicity (Garthwaite & Garthwaite, 1986) and since teenagers are more likely to engage in weekend binge drinking, it would be important to study the effects of such patterns of ethanol exposure on neurochemical parameters and cognitive functioning using adolescent animals models. More basic research is needed in humans and animals to elucidate the neurobiological mechanisms of alcoholism and the effects of alcohol ingestion throughout the period of postnatal maturation. Human studies would also be important to identify neurobiologic and behavioral risk factors for alcoholism during postnatal development, particularly adolescence. For example, with the advent of noninvasive imaging techniques such as PET and SPECT as well as the development of radioactive ligands to label dopamine and benzodiazepine receptors, it may be possible to study the functioning of various neurotransmitter systems in children at risk for developing alcoholism and, more importantly to identify those who are likely to become alcoholic during adolescence. Animal studies will be important for investigating the neurochemical, neuropharmacological, and behavioral mechanisms underlying the variable response to alcohol during ontogeny, examining the consequences of acute and chronic alcohol ingestion on the immature central nervous system, and for controlled studies of gene- environment interactions as they relate to patterns of adolescent drinking. Areas needing further research include, but are not limited to: Development of animal paradigms to study modes of initiation of alcohol-seeking behavior and alcohol's effects on reinforcement, drug discrimination, sensitization, tolerance, and dependence during the juvenile through adolescent period. Ontogenetic studies to compare patterns of alcohol-related behavior (e.g., alcohol reinforcement, sensitivity) as well as their neurochemical, neuropharmacological, neurophysiological, and neuroanatomical mechanisms during each stage of postnatal development through adulthood. Animal studies of the acute and chronic effects of alcohol on brain and behavioral functioning during adolescence, and the effects of early exposure on adult functioning. Studies of recovery of neural and behavioral function following alcohol consumption to determine if the adolescent brain is more or less vulnerable than the adult brain to alcohol's acute and chronic effects. Studies of gender differences in alcohol's effect on normal hormonal activation during puberty, mechanisms of alcohol's effect on neuroendocrine-neurotransmitter interactions, and the relationship of alcohol-induced hormonal/ neurotransmitter disturbances during adolescence on the development of gender differences in behavior (including mood, stress, peer relationships, sexual behavior, aggression, cognitive functioning). Human studies and animal studies using different genetically defined strains to examine the interaction among premorbid temperament/personality, cognitive functioning, neurobiological, environmental, and genetic factors in the development of addictive behaviors in adolescents. Use of noninvasive neuroimaging (MRI, MRS, PET, SPECT), neurophysiological (EEG, ERP, MEG), and neuropsychological/cognitive measures in adolescent humans/animals to study brain mechanisms of craving, intoxication, and withdrawal, and to assess progression of damage and recovery of function following abstinence. 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 affect 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 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. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Suite 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301-435-0714. 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. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria Criteria for scientific/technical merit review of applications for regular research grants (R01) are as follows: 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. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. The review criteria for Small Grants (R03), Exploratory/Developmental Grants (R21), and FIRST Awards (R29) are contained in their program announcements. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Institute. 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 inquires regarding programmatic issues 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) 443-6545 FAX: (301) 594-0673 Email: EWitt@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley 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) 443-0915 FAX: (301) 443-3891 Email: LHilley@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 authorization of the Public Health Service Act, Sections 301 and 464H, and administered under 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 PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. References Begleiter, H., Porjesz, B., Bihari, B., & Kissin, B. (1984). Event- related brain potentials in boys at risk for alcoholism. Science, 255, 1493-1496. Chen, W., Spear, L. P., & Spear, N. E. (1992). Enhancement of sensory preconditioning by a moderate dose of ethanol in infant and juvenile rats. Behavioral and Neural Biology, 57, 44-57. Coyle, J. T. & Harris, J. C. (1987). The development of neurotransmitters and neuropeptides. In J. D. Noshpitz (Ed.), Basic handbook of child psychiatry (pp. 14-25). New York: Basic Books, Inc. Coyle, J. & Yamamura, H. I. (1976). Neurochemical aspects of the ontogenesis of cholinergic neurons in the rat brain. Brain Research, 118, 429-440. Frezza, M., di Padova, C., Pozzato, G., Terpin, M., Barona, e., & Lieber, C. (1990). The role of decreased gastric alcohol dehydrogenase activity and first-pass metabolism. New England Journal of Medicine, 322, 95-99. Glenn, S. W. & Parsons, O. A. (1992). Neuropsychological efficiency measures in male and female alcoholics. Journal of Studies on Alcohol, 53, 546-552. Harper, C. G., Smith, N. A., & Kril, J. J. (1990). The effects of alcohol on the human brain: A neuropathological study. Alcohol and Alcoholism, 25, 445-448. Hill, S. Y., Steinhauer, S., Park, J., & Zubin, J. (1990). Event- related potential characteristics in children of alcoholics from high density families. Alcoholism: Clinical and Experimental Research, 14, 6-16. Hill, S. Y. and Steinhauer, S. R. (1993). Assessment of prepubertal and postpubertal boys and girls at risk for developing alcoholism with P300 from a visual discrimination task. Journal of Studies on Alcohol, 54, 350-358. Hunt, W. A. (1993). Are binge drinkers more at risk for developing brain damage? Alcohol, 10, 559-561. Ingersoll, G. (1992). Psychological and social development. In E. R. McAnarney, R. E. Kreipe, D. P. Orr, & G D. Comerci (Eds.), Textbook of adolescent medicine (pp. 91-98). Philadelphia: W. B. Saunders Company. Johnston, L. D., O'Malley, P. M., & Bachman, J. G. (1994). National survey results on drug use from monitoring the future study, 1975-1993, Volume 1, secondary students. National Institute on Drug Abuse. NIH Pub. No.94-3809. Washington, D.C.: Supt. of Docs., U. S. Govt. Print. Off. Moss, H. B., Kirisci, L., Gordon, H. W, and Tarter, R. E. (1994) Neuropsychologic profile of adolescent alcoholics. Alcoholism: Clinical and Experimental Research, 18(1), 159-163. Noison, E. L. & Thomas, W. E. (1988). Ontogeny of dopaminergic function in the rat midbrain tegmentum, corpus striatum, and frontal cortex. Developmental Brain Research, 41, 241-252. Norton, R., Dwyer, T., & MacMahon, S. (1987). Alcohol consumption and the risk of alcohol related cirrhosis in women. British Medical Journal, 295, 80-82. Shalaby, I. A., Dendel, P. S., & Spear, L. T. (1981). Differential functional ontogeny of dopamine presynaptic receptor regulation. Developmental Brain Research, 1, 434-439. Shalaby, I. A. and Spear, L. P. (1980). Psychopharmacological effects of low and high doses of apomorphine during ontogeny. European Journal of Pharmacology, 67, 451-459. Spear, L. T. & Brake, S. C. (1983). Periadolescence: age- dependent behavior and psychopharmacological responsivity in the rat. Developmental Psychobiology, 16, 83-109. Steinhauer, S. R. and Hill, S. Y. (1993). Auditory event-related potentials in children at high risk for alcoholism. Journal of Studies on Alcohol, 54, 408-421. Sussman, J. & Petersen, A. C. (1992). Hormones and behavior. In E. R. McAnarney, R. E. Kreipe, D. P. Orr, & G. D. Comerci (Eds.), Textbook of adolescent medicine (pp. 125-130). Philadelphia: W. B. Saunders Company. Watkins, J. M. & Willams, M. E. (1992). Cognitive neuroscience and adolescent development. In E. R. McAnarney, R. E. Kreipe, D. P. Orr, & G. D. Comerci (Eds.), Textbook of adolescent medicine (pp. 99-106). Philadelphia: W. B. Saunders Company. Whipple, S. C., Berman, S. M., & Noble, E. P. (1991). Event- related potentials in alcoholic fathers and their sons. Alcohol, 8, 321-327. Windle, M. (1990). Alcohol use and abuse: some findings from the National Adolescent Student Health Survey. Alcohol Health and Research World, 15, 5-10. Witt, E. D. (1994). Mechanisms of alcohol abuse and alcoholism in adolescents: A case for developing animal models. Behavioral and Neural Biology, 62, 168-177. From owner-sci-resources@net.bio.net Sun Jul 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA/DA-95-013 - V24(24) 06/30/95 Date: 3 Jul 1995 14:59:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 406 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3t9p7f$aj3@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA ADA95013 CA/DA-95-013 P1O1 *********************************** PHARMACO-BEHAVIORAL TREATMENT OF NICOTINE DEPENDENCE NIH GUIDE, Volume 24, Number 24, June 30, 1995 RFA: CA/DA-95-013 P.T. 34; K.W. 0404001, 0710100, 0414015 National Cancer Institute National Institute on Drug Abuse Letter of Intent Receipt Date: August 11, 1995 Application Receipt Date: September 21, 1995 PURPOSE The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) and the Division of Clinical and Services Research at the National Institute on Drug Abuse (NIDA) seek applications for controlled, randomized trials to determine the most effective, generalizable, cost-efficient, and durable adjuvant behavioral therapies to support the pharmacological treatment of nicotine dependence. 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), Pharmaco-Behavioral Treatment of Nicotine Dependence, is related to the priority area of cancer prevention and control. 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. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. 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 four years. The anticipated award date is April 1, 1996. This RFA is 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. FUNDS AVAILABLE Approximately $1.2 million in total costs per year for four years will be committed by the NCI to specifically fund three to five applications submitted in response to this RFA. In addition, $800,000 per year in total costs will be committed by the NIDA to fund two to four applications. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. 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 also vary. The expected number of awards is five to nine. Although this RFA is provided for in the financial plans of the NCI and NIDA, the award of grants pursuant to it is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Tobacco use, although slowly declining in most of the industrialized world, remains a significant public health problem. In the U.S., for example, while the prevalence of smoking has been reduced to approximately 25 percent of the adult population, 46 million adults remain current smokers (MMWR, 1994), accounting for more than 400,000 deaths per year. Worldwide, tobacco smoking accounts for more than three million deaths per year (Peto et al., 1994). Yet, despite such mortality, smoking not only continues in the industrialized countries, but is increasing in the developing world. There is wide agreement (DHHS, 1988; Benowitz, 1988) that nicotine dependence is the primary cause of the maintenance of this behavior. In 1987, the American Psychiatric Association, in the Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R), classified "nicotine dependence" as a psychoactive substance dependence disorder (American Psychiatric Association, 1987). Although a wide variety of approaches to reducing nicotine dependence have been used (e.g., Lichtenstein and Glasgow, 1992; Orleans and Slade, 1993; Richmond, 1994), the most common medical treatment in the U.S. over the past decade (i.e., more than six million users) has been pharmacotherapy - i.e., almost exclusively, either nicotine polacrilex (nicotine- containing gum, or NG) or transdermal nicotine patch (or TNP). The effectiveness of both NG and TNP as treatment aids in smoking cessation has been established in a wide range of research (e.g., Imperial Cancer Research Fund General Practice Research Group, 1993; Silagy et al., 1994; Foulds, 1994; Fiore et al., 1994). An important aspect of this treatment about which there is a lack of clarity, however, is the role of adjuvant counseling or behavioral therapy (defined here as any advice, counseling, or program - whether delivered in person, in print, or through other media - which employs basic behavior change principles in its delivery). As noted by Fiore et al. (1994), many insurers require that smokers who are prescribed NG or TNP participate in an adjuvant behavioral smoking cessation program. The manufacturers themselves encourage such participation (both in package inserts and, in some cases, by providing self-help cessation guides), and the U.S. Food and Drug Administration (FDA) requires that NG and TNP only be prescribed as "part of a comprehensive behavioral smoking cessation program". Yet, there is no consensus about the effectiveness, or the specific, necessary elements, of adjuvant behavioral therapy for smoking cessation (Hajek, in press). There is a great need to establish both the effectiveness and the specific required elements and necessary level of intensity of behavioral therapy when it is provided as an adjuvant to pharmacotherapy aimed at smoking cessation. The importance of smoking cessation as a public health problem, the millions of smokers who are prescribed NG or TNP, the implications for insurers and health care reform efforts, and the need for providers to be able to offer the most effective, cost-efficient, and durable treatment possible requires that this question be addressed. Research Goals The primary goal of the research being solicited is to determine the most effective, generalizable, cost-efficient, and durable adjuvant behavioral therapy in the pharmacological treatment of nicotine dependence. There appears to be general agreement that as the intensity of adjuvant behavioral therapy increases, so also does success in the pharmacological treatment of nicotine dependence (e.g., Fiore et al., 1994). It is not realistic, however, to assume that sufficient intensity for universal effectiveness will be achievable, due to fiscal, time, and/or personnel constraints. Therefore, controlled, randomized studies are sought that will address such questions as: Is there a behavioral therapy that offers the best balance among the four core aims of efficacy, generalizability, cost-efficiency, and durability? Is behavioral therapy a necessary adjuvant to pharmacological treatment of nicotine dependence? What is the minimal behavioral therapy needed to achieve a 10%/25%/etc. difference between control and treatment groups prescribed NG or TNP? Since NG and TNP are physician/dentist- prescribed in the U.S., can physicians and/or dentists, particularly in a primary care setting, deliver a sufficiently effective behavioral therapy to address the four core aims above? What role should other primary care staff, especially nurses, play in the delivery of adjuvant behavioral therapy? Are there elements in adjuvant behavioral therapy that appear to be essential to reduction of nicotine dependence? What components of a primary care intervention could increase rates of patient participation in more intensive adjuvant therapies (which are presumably more effective, but limited by low participation rates)? Other Requirements Several requirements should be observed in preparing applications in response to this RFA: (1) "Pharmaco-therapy" and "pharmacological treatment of nicotine dependence" is defined as treatment with FDA- approved nicotine polacrilex (nicotine gum) and transdermal nicotine patch (subsequent solicitations may focus on other pharmacological treatment approaches); (2) Definitions of the four "core aims" cited above are: (a) efficacy = tobacco use cessation rate; (b) generalizability = ability of the intervention being tested to be adapted to, and used routinely and effectively in, a non-research setting; (c) cost-efficiency = cost comparisons, per successful quitter, of different adjuvant therapies (note: investigators may suggest alternative definitions of cost-efficiency in their proposals); and (d) durability = cessation for at least 6 months; (3) At least one adjuvant behavioral therapy to be tested in any study must be conducted in, or be readily adaptable to, primary care medical or dental settings and all adjuvant therapies should be adaptable to a variety of population characteristics (e.g., women, ethnic minorities, heavy smokers); (4) Minimum patient follow-up should be six months; and (5) At least one measure of treatment "success" shall be continuous non-smoking at all measurement points between the end of treatment (or other measurement point, if the investigator views treatment as an ongoing process) and the final follow-up. SPECIAL REQUIREMENTS Investigators should budget for two, two-day meetings in Bethesda for the PI and one other key staff in Years 1 and 4 and one meeting per year in Years 2 and 3. Additionally, investigators should be prepared to discuss the adoption of data elements and outcome measures common to all studies funded through this RFA. 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 August 11, 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 NCI 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. Thomas J. Glynn at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) 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, 6701 Rockledge Drive, Room 3032, Bethesda, MD 20892-7762, telephone 301/435-0714; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express mail) Applications must be received by September 21, 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 NCI and NIDA. 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 NCI, in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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. 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 found to have significant and substantial merit will be considered for funding by the following criteria: o Quality of the proposed study as determined by peer review; o Availability of funds; and o Responsiveness to the goals and requirements of the RFA. 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: Thomas J. Glynn, Ph.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 320 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8520 FAX: (301) 496-8675 Email: glynnt@dcpcepn.nci.nih.gov Debra Grossman, M.A. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10-A-10 Rockville, MD 20857 Telephone: (301) 443-0107 FAX: (301) 443-8674 Email: dgrossma@aoada.ssw.dhhs.gov Direct inquiries regarding fiscal matters to: Victoria Price Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 252 FAX: (301) 496-8601 Email: PriceV@GAB.NCI.NIH.GOV Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gfleming@aoada2.ssw.dhhs.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399. 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 and Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. 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 Sun Jul 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 24, pt. 1of1, 30 June 1995 Date: 3 Jul 1995 14:59:06 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 325 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3t9p7a$ail@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950630 V24N24 P1O1 ************************************ X-comment: RFAs described: CA/DA-95-013, AA-95-005, PA-95-073, PA-95-074 X-URL: gopher://gopher.nih.gov/11/res/nih-guide/guide-files/95.06.30 NIH GUIDE - Vol. 24, No. 24 - June 30, 1995 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 09/21/95 ************************************************* PHARMACO-BEHAVIORAL TREATMENT OF NICOTINE DEPENDENCE (RFA CA/DA-95-013) National Cancer Institute National Institute on Drug Abuse INDEX: CANCER, DRUG ABUSE $$INDEX R2 11/21/95 ************************************************* ROLE OF TOBACCO DEPENDENCE IN ALCOHOLISM TREATMENT (RFA AA-95-005) National Institute on Alcohol Abuse And Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX P1 ********************************************************** MECHANISMS OF ADOLESCENT ALCOHOL ABUSE AND ALCOHOLISM (PA-95-073) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX P2 ********************************************************** AGING, VASCULAR STIFFNESS, AND CARDIOVASCULAR FUNCTION (PA-95-074) National Institute on Aging INDEX: AGING 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 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) The NIH Guide for Grants & Contracts will not be published on July 7, 1995. The next issue of the NIH Guide will be on July 14, 1995. $$INDEX END ********************************************************* NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN CA/DA-95-013 FULL-TEXT *********************************** PHARMACO-BEHAVIORAL TREATMENT OF NICOTINE DEPENDENCE NIH GUIDE, Volume 24, Number 24, June 30, 1995 RFA AVAILABLE: CA/DA-95-013 P.T. 34; K.W. 0404001, 0710100, 0414015 National Cancer Institute National Institute on Drug Abuse Letter of Intent Receipt Date: August 11, 1995 Application Receipt Date: September 21, 1995 PURPOSE The National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA) announce the availability of a Request for Applications (RFA) to develop controlled, randomized trials to determine the most effective, generalizable, cost-efficient, and durable adjuvant behavioral therapies to support the pharmacological treatment of nicotine dependence. Approximately $2 million in total costs per year for four years will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that up to nine awards will be made. 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, Pharmaco-Behavioral Treatment of Nicotine Dependence, is related to the priority area of cancer prevention and control. 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. Thomas J. Glynn, Ph.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Room 320 Bethesda, MD 20892 Telephone: (301) 496-8520 FAX: (301) 496-8675 Email: glynnt@dcpcepn.nci.nih.gov Debra Grossman, M.A. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A10 Rockville, MD 20857 Telephone: (301) 443-0107 FAX: (301) 443-8674 Email: dgrossma@aoada.ssw.dhhs.gov $$R1 END ************************************************************ $$R2 BEGIN AA-95-005 FULL-TEXT ************************************** ROLE OF TOBACCO DEPENDENCE IN ALCOHOLISM TREATMENT NIH GUIDE, Volume 24, Number 24, June 30, 1995 RFA AVAILABLE: AA-95-005 P.T. 34; K.W. 0404003, 0404001, 0404019, 0745070 National Institute on Alcohol Abuse And Alcoholism Letter of Intent Receipt Date: October 18, 1995 Application Receipt Date: November 21, 1995 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research applications to study the alcohol tobacco interaction in its implications for alcoholism treatment. The objective of this RFA is to encourage research that will lead to improved strategies for treating alcohol and nicotine dependence in patients receiving care for problem drinking. Such research may identify and test relevant clinical intervention strategies; identify interactions between the two substances that have implications for relapse prevention, or further understanding of the alcoholism treatment process by investigating reinforcement mechanisms underlying conjoint abuse of the two substances. It is estimated that up to $2 million in total costs will be available to support approximately 8 to 10 R01, R29, R21, and/or (R03) grants under this RFA. The earliest possible award date is July 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 RFA, Role of Tobacco Dependence in Alcoholism Treatment, 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. Joanne Fertig, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0796 FAX: (301) 443-8744 Email: jfertig@willco.niaaa.nih.gov $$R2 END ************************************************************ $$P1 BEGIN PA-95-073 FULL-TEXT ************************************** MECHANISMS OF ADOLESCENT ALCOHOL ABUSE AND ALCOHOLISM NIH GUIDE, Volume 24, Number 24, June 30, 1995 PA AVAILABLE: PA-95-073 P.T. 34; K.W. 0404003, 0403001, 0705048 National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to conduct basic research, using animal models and state-of-the-art imaging techniques in humans, to identify the neurobiological, physiological, and genetic factors that lead to adolescent alcohol abuse and dependence. Despite the fact that alcohol use is high among secondary school students, relatively few studies to date define the neurobiologic and physiologic mechanisms of high alcohol intake or the effects of excessive drinking in adolescents. Studies of neurobiologic mechanisms and risk factors for alcoholism during late childhood through adolescence would increase our ability to predict which individuals will be most likely to develop alcoholism early in life. In addition, evaluation of the effects of alcohol ingestion during postnatal development, particularly during adolescence, would further our understanding of alcohol's immediate consequences and the contribution of early alcohol exposure to excessive drinking and abnormal cognitive and social functioning during subsequent developmental stages. Finally, results obtained will help develop strategies for treatment and prevention of adolescent alcohol abuse and alcoholism. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement (PA), Mechanisms of Adolescent Alcohol Abuse and Alcoholism, is related to the priority area of alcohol abuse and alcoholism. 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 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. Ellen Witt, 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) 443-6545 FAX: (301) 594-0673 Email: EWitt@willco.niaaa.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-95-074 FULL-TEXT ************************************** AGING, VASCULAR STIFFNESS, AND CARDIOVASCULAR FUNCTION NIH GUIDE, Volume 24, Number 24, June 30, 1995 PA AVAILABLE: PA-95-074 P.T. 34; K.W. 0710010, 0715040, 0411005 National Institute on Aging PURPOSE The purpose of this program announcement (PA) is to foster research that will enhance our understanding of vascular stiffness in aging and in cardiovascular disease. Ascertaining the importance of vascular stiffness, as a risk factor for cardiovascular morbidity and mortality, may suggest approaches to prevention and treatment including early modification of risk factors and/or adverse lifestyles to prevent, delay, and/or reverse vascular stiffening and its potential deleterious sequelae as well as novel treatment in persons with established stiffness or cardiac disease. The Geriatrics Program, National Institute on Aging (NIA), invites grant applications on clinically-relevant research focusing on aging and vascular stiffness. Support for this PA will be the traditional investigator-initiated research project grant (R01) and First Independent Research Support and Transition (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, Aging, Vascular Stiffness, and Cardiovascular Function, is related to the priority area of heart disease and stroke. 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 full text of 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. Andre J. Premen, Ph.D. Geriatrics Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E327, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: PremenA@gw.nia.nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Sun Jul 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-95-004 - V24(23) 06/23/95 Date: 3 Jul 1995 14:59:00 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 728 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3t9p74$aib@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AA95004 AA-95-004 P1O1 *************************************** MODERATE ALCOHOL CONSUMPTION: BENEFITS AND RISKS NIH GUIDE, Volume 24, Number 23, June 23, 1995 RFA: AA-95-004 P.T. 34; K.W. 0404003, 0411005, 1002004, 1002008, 0785055 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: October 18, 1995 Application Receipt Date: November 21, 1995 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking applications for research to determine both the benefits and risks of moderate alcohol use. Several cultural and social definitions for "moderate" alcohol consumption exist, and epidemiological studies refer to a wide range of drinking as moderate. In addition to defining moderate drinking, many important questions remain unanswered. The cellular and molecular mechanisms of the positive association of moderate alcohol use and cardiac health need to be established. Further, any negative effects associated with long term moderate drinking in individuals or subpopulations need to be delineated. Answers to such questions will help identify the tradeoffs involved in an individual's decision about drinking, and will provide a solid base for formulating public health policies. Information obtained about moderate drinking will also provide a better understanding of the mechanisms involved in alcohol effects in general. The purpose of this request for applications (RFA) is to stimulate a wide range of molecular and cellular studies, as well as epidemiological, clinical and psychosocial studies on the benefits and the risks of moderate drinking. These areas include, but are not limited to: (1) coronary artery disease; (2) hypertension; (3) stroke; (4) osteoporosis and breast cancer; (5) interaction with various medications; (6) trade-offs (risk/benefit analysis); and (7) psychosocial issues. 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, Moderate Alcohol Consumption: Benefits and Risks, is related to the priority area of consequences of alcohol abuse and alcoholism. 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 institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) Awards. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01), FIRST (R29) Award, exploratory/developmental grant (R21), and small grant (R03). Applicants for R01s may request support for up to five years. In FY 1995, 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. A FIRST (R29) Award application 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. Small grants (R03) and exploratory/developmental grants (R21) are limited to two years for up to $50,000/year and $70,000/year, respectively for direct costs. FIRST (R29) Awards, small grants (R03) and exploratory/developmental grants (R21) cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Potential applicants for FIRST (R29) Awards, small grants (R03) and exploratory/developmental grants (R21) should obtain copies of the specific announcement for these programs from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, MD 20852, telephone (301) 468-2600 or 1-800-729-6686. Investigators submitting applications that exceed $500,000 for direct costs in any one year should contact program staff prior to submitting an application. 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 grants (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 concurrently 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 $2.0 million in total costs will be available for approximately 10 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. 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. The earliest possible award date is July 1, 1996. RESEARCH OBJECTIVES A review of the psychological benefits of moderate drinking suggests that low levels of alcohol can reduce stress, promote conviviality, and reduce tension and self- consciousness (Baum-Baicker, 1985). This RFA focuses on the benefits and risks associated with moderate drinking. 1. Alcohol and Coronary Artery Disease Numerous epidemiologic studies indicate that moderate drinking is associated with a protective effect against coronary artery diseases (e.g., Klatsky et al., 1990; Rimm et al., 1991; Anderson et al., 1993; Serdula et al., 1995), but not longevity (Criqui and Ringel, 1994). A recent study showed that light to moderate alcohol consumption reduced mortality in women, but this benefit appears largely confined to women at greater risk for coronary heart disease (Fuchs et al., 1995). Most of these epidemiological studies consider the impact of total alcohol consumption over time versus heart disease. However, the influence of various drinking patterns (e.g., lifelong moderate consumption vs. heavy drinking in youth and abstinence later, vs. beginning consumption later in life) is not clear. In addition, the effects of acute versus chronic alcohol consumption and coronary artery disease needs clarification. The contribution of other life style factors (e.g., aspirin consumption, exercise, dietary habits, marital status, smoking, stressful events, and social class) to the observed effect on coronary arteries needs to be elucidated. A recent study has attributed some of the apparent protective effects of moderate drinking to physical activity and other health practices (Barrett et al., 1995). Understanding the cellular and molecular mechanisms by which alcohol reduces the risk of coronary artery disease is important. Research performed hitherto on the mechanisms of the protective effect is suggestive, but not conclusive. While some studies have shown that chronic alcohol consumption increases HDL cholesterol (Hartung et al., 1990; Langer et al., 1992), others have reported that the subspecies HDL3, which is associated with moderate drinking in several studies, has low protective effect (Miller et al., 1981). Yet other studies have shown that both HDL2 and HDL3 are associated with light drinking (Haffner et al., 1985). These studies suggest an effect of alcohol on HDL; however, the mechanism of action has not been firmly established. Some studies hypothesized that this effect is due to an alcohol-induced defect in cholesteryl ester transfer protein (CETP) (Savolainen et al., 1990; Hirano et al., 1992; Hannuksela et al., 1992). Further studies are needed to clarify the effects of alcohol on HDL, CETP and on lipoproteins. Results from a number of studies have demonstrated that acute alcohol consumption reduces platelet aggregation and coagulation (e.g., Renaud and deLorgeril, 1992), which may partly explain the decrease in risk of coronary artery disease associated with moderate drinking. Healthy volunteers who consumed alcohol in sufficient amounts to produce blood alcohol levels less than 100 mg/dL showed an increase in the blood concentration of prostacyclin, which counters the platelet-aggregating effects of thromboxane A2 (Landolfi and Steiner, 1984). The extent to which this effect contributes to the reduction in cardiac risk is unknown. Furthermore, the interaction between alcohol and anticoagulants (aspirin, coumarin derivatives, etc.), and the relative roles of endothelin, nitric oxide, thromboxane A2, prostacyclin and adenosine in the protective effect have not been extensively studied. Also, antioxidants, such as flavonoids (Demrow et al., 1995) or resveratrol (Siemann and Creasy, 1992) are claimed to contribute to the cardio-protective effect of wine, but this issue remains controversial. The role of antioxidants, if any, needs clarification. Epidemiologic studies have shown that all alcoholic beverages, i.e. beer, wine, and distilled spirits (even those that do not contain an appreciable amount of antioxidants) confer protective effects (Seigneur et al., 1990; Klatsky et al., 1992), although a recent study in Copenhagen found decreased risk only with wine (Gronbek, 1995). Other questions that need to be addressed include: Are there gender differences in the extent of alcohol-induced coronary artery protection? If so, what is the relative contribution of alcohol-induced increases in estrogens, especially in post-menopausal women, to the overall effect? What is the role of phytoestrogens that are present in certain drinks (e.g., Bourbon) in producing the observed effect? 2. Alcohol and Hypertension Epidemiological studies from numerous countries have demonstrated that chronic heavy alcohol consumption is associated with hypertension (see review by McMahon, 1987). Although hypertension has not been directly associated with moderate drinking, some studies have shown a positive linear relationship between blood pressure and amount of alcohol consumed, especially in men (Paulin, 1985; Klatsky et al., 1986; Rimm et al., 1991). Does moderate consumption lead to hypertension over time? If so, what is the threshold level of consumption that does not produce hypertension? Women who consume moderate amounts of alcohol did not show tendency for developing hypertension. Why? Whether or not chronic moderate drinking results in hypertension is not clear. However, studies to determine the mechanisms by which heavy alcohol consumption induces hypertension are needed to design effective treatment protocols. 3. Alcohol and Stroke Stroke, both ischemic and hemorrhagic, is the third leading cause of death in the United States. Once stroke occurs, the prognosis is poor. Epidemiologic studies suggest that moderate alcohol consumption reduces the risk of ischemic stroke, especially in Caucasian populations of both genders (Gill et al., 1986, 1988; Stampfer et al., 1988). This effect was not observed in a Japanese population (Tanaka et al., 1982, 1985; Kono et al., 1986). In contrast, moderate alcohol consumption was associated with increases in the risk of hemorrhagic stroke in all populations (Donahue et al., 1986; Stampfer et al., 1988). The cellular and molecular mechanisms by which moderate drinking reduces the risk of ischemic stroke in certain populations, and increases the risk of hemorrhagic stroke are not clear. Are dietary factors involved? Why does alcohol increase risk from hemorrhagic stroke? Does interference with platelet function (Rand et al., 1988; Benistat and Rubin, 1990) play a role? Is alcohol-induced increase in prostacyclin levels (Mikhailidis et al., 1990) involved in this effect? Oral contraceptives use is associated with an appreciable increase in risk of subarachnoid hemorrhage (Petiti et al., 1979). Whether or not moderate alcohol consumption interacts with oral contraceptives to increase the risk of hemorrhagic stroke needs to be clarified? Alcohol intake by women at increased risk has not been examined. 4. Alcohol, Osteoporosis, and Breast Cancer Moderate alcohol consumption is positively correlated with bone mineral density in males and females, especially in post-menopausal women (Laitinen et al., 1991; Holbrook and Barrett-Conner, 1993). This finding suggests that moderate alcohol consumption may help in reducing osteoporosis and, consequently, decrease the risk of fractures. However, other studies indicated the opposite effect (Hernandez-Avila et al., 1991). Carefully designed cellular and molecular studies may elucidate the effects of alcohol on bone homeostasis. The association between moderate alcohol consumption and breast cancer is controversial. While some epidemiological studies have concluded that even modest alcohol consumption is associated with increased risk of breast cancer (Colditz, 1992) in women (Longnecker, 1994, estimated that four percent of the 150,000 cases/year is attributable to alcohol), others did not show such a relationship (Ewertz, 1991). The contribution of alcohol consumption to breast cancer risk needs to be delineated. If indeed moderate drinking increases the risk of breast cancer, what are the cellular and molecular mechanisms of such an effect? Does alcohol-induced increase in estrogen play a role? Do alcohol-induced microsomal enzymes affect the biotransformation of procarcinogens to carcinogens? 5. Interaction Between Moderate Alcohol Consumption and Various Medications Many medications (anesthetics, antibiotics, anticoagulants, antidepressants, oral hypoglycemics, antihistamines, antipsychotics, antiseizure, cardiovascular, narcotics, analgesics, sedatives, etc.) can interact with alcohol leading to serious consequences. Whether moderate drinking results in blood alcohol levels that may adversely interact with medications, especially in the elderly, is an issue of interest. 6. Trade-Offs (Risk/Benefit Analysis) In addition to defining what moderate drinking is, studies aimed at investigating possible trade-offs between the benefits and risks of moderate drinking (in terms of morbidity and mortality) for the population as a whole and for specific subgroups are encouraged. What are the benefits versus risks for different groups of people (e.g., elderly, young adults, smokers). 7. Psychosocial Issues Even modest amounts of alcohol may increase morbidity from existing physical disorders, cause relapse among abstaining alcoholics, affect performance or judgment in critical situations, increase accidents and falls among low tolerance populations (e.g., the elderly), and exacerbate existing family and work problems. For groups who do drink moderately, more detailed information is required to formulate appropriate advice. In particular, health care professionals are increasingly encouraged to advise patients about "safe drinking" limits. This may include selective advice to at-risk groups such as anticipatory guidance to adolescents and the elderly. Research is needed to: (a) understand how vulnerable populations, the population at large, and health-care professionals interpret moderate drinking messages of various types (e.g., promoting cardiovascular risk reduction, reduction of behavioral consequences of heavy drinking); (b) examine how patients respond to different types of advice from their health-care providers concerning the benefits and risks of moderate drinking; (c) increase knowledge on the psychosocial and environmental contexts in which moderate drinking occurs, how context mediates the consequences of moderate drinking, and what changes might be implemented to make moderate drinking patterns less hazardous 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 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 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 October 18, 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 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: RFA: AA-95-004 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 FAX: (301) 443-6077 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) 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, 6701 Rockledge Drive, Room 3032, msc 7762, Bethesda, MD 20892, telephone 301-435-0714; and from the NIAAA program administrators listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) 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. 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 reference letters will be considered incomplete and will be returned without 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 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also 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 (20852 for express mail) Applications must be received by November 21, 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 NIAAA in accordance with the review criteria stated below. As part of the initial merit review, a triage process 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 Alcoholism and Alcohol Abuse Council. Review Criteria Criteria to be used in the scientific and technical merit review of alcohol research grant applications are 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 human and animal subjects and the environment. The review criteria for FIRST Awards (R29), Small Grants (R03) and Exploratory/Developmental Grants (R21) are contained in their program announcements. 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 application 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 biomedical aspects of proposed research to: Sam Zakhari, 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) 443-0799 FAX: (301) 594-0673 Email: SZakhari@Willco.NIAAA.NIH.Gov Direct inquiries regarding epidemiological aspects of proposed research to: Mary C. Dufour, M.D., M.P.H. Deputy Director National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 400 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-3851 FAX: (301) 443-7043 Email: MDufour@Willco.NIAAA.NIH.Gov Direct inquiries regarding psychosocial aspects of proposed research to: Kendall Bryant, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8820 FAX: (301) 443-8774 Email: KBryant@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 PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. References Anderson P, Cremona A, Paton A, Turner C, Wallace P: The risk of alcohol. Addiction, 11:1493-508, 1993. Barrett DH, Anda RF, Croft JB, Serdula MK, Lane MJ: The association between alcohol use and health behaviors related to the risk of cardiovascular disease: The South Carolina Cardiovascular Disease Prevention Project. J Stud Alcohol, 56:0-15, 1995. Baum-Baicker, C: The psychological benefits of moderate alcohol consumption: A review of the literature. Drug and Alcohol Dependence, 15:305-322, 1985. Benistant C, Rubin R: Ethanol inhibits thrombin-induced secretion by human platelets at a site distinct from phospholipase C or protein kinase. C.Biochem J, 269:489, 1990. Colditz G: Diet and breast cancer in the Harvard Nurses Study. Presented at Dietary Factors in Breast Cancer: Epidemiologic Controversies, San Diego, CA November 20, 1992. Criqui, MH, Ringel BL: Does diet or alcohol explain the French paradox? Lancet, 344:1719-1723, 1994. Demrow HS, Slane PR, Folts JD: Administration of wine and grape juice inhibits in vivo platelet activity and thrombosis in stenosed canine corodnaryd arteries. Circulation, 91:1182-1188, 1995. Donahue RP, Abbott RD, Reed DM, Yano K: Alcohol and hemorrhagic stroke. The Honolulu Heart Study. JAMA, 225:2311-2314, 1986. Ewertz M: Alcohol consumption and breast cancer risk in Denmark. Cancer Causes Control, 2:247-252, 1991. Fuchs CS, Stampfer MJ, Colditz GA, Giovannucci EL, Manson JE, Kawachi I, Hunter DJ, Hankinson SE, Hennekens CH, Rosner B, Speizer FE, Willett WC: Alcohol consumption and mortality among women. N Eng J Med, 332:1245-1250, 1995. Gill JS, Zezulka AV, Shipley MJ, Gill SK, Beevers DG: Stroke and alcohol consumption. N Engl J Med, 315:1041-1046, 1986. Gill JS, Shipley MJ, Hornby RH, Gill SK, Beevers DG: A community case-control study of alcohol consumption in stroke. Int J Epidemiol, 17:542-547, 1988. Gronbek M, Deis A, Sorensen TIA, Becker U, Schnohr P, and Jensen G: Mortality associated with moderate intakes of wine, beer, or spirits. British Medical Journal, 310:1165-1169, 1995. Haffner S, Applebaum-Bowen D, Wahl PW, Hoover JJ, Warnick GR, Albers JJ, Hazzard WR. Epidemiological correlates of high-density lipoprotein subfractions, apolipoproteins A-1, A-11, and D, and lecithin cholesterol acyltransferase. Effects of smoking alcohol, and adioposity. Arteriosclerosis, 5:169-177, 1985. Hannuksela M, Marcel YL, Kesaniemi YA, Savolainen MJ: Reduction in the concentration and activity of plasma cholesteryl ester transfer protein by alcohol. J Lipid Res, 33:737-744, 1992. Hartung GH, Foreyt JP, Reeves RS, Krock LP, Patsch W, Patsch JR Gotto AM: Effect of alcohol dose on plasma lipoprotein subfraction and lipolytic enzyme activity in active and inactive men. Metabolism, 39:81, 1990. Hernandez-Avila M, Colditz GA, Stampfer MJ, Rosner B, Spetzer FE, Willett WC: Caffeine, moderate alcohol intake, and risk of fractures of the hip and forearm in middle-aged women. American Journal of Clinical Nutrition, 54:157-163, 1991. Hirano K, Matsuzawa Y, Sakai N, Hiraoka H, Nozaki S, Funahashi T, Yamashita S, Kubo M, Tarui S: Polydisperse Low-Density Lipoproteins in Hyperalphalipoproteinemic Chronic Alcohol Drinkers in Association With Marked Reduction of Cholestery Ester Transfoer Proten Activity. Metabolism, 41:1313- 1318, 1992. Holbrook TL, Barrett-Connor EA: A prospective study of alcohol consumption and bone mineral density. Br J Med, 306:1506-1509, 1993. Klatsky AL, Friedman GD, and Armstrong MA: The relationship between alcoholic beverage use and other traits to blood pressure: A new Kaiser-Permanente study. Circulation, 73:628-636, 1986. Klatsky AL, Armstrong MA, Friedman GD: Risk of cardiovascular mortality in alcohol drinkers, ex-drinkers and nondrinkers. American Journal of Cardiology, 66:1237-1242, 1990. Klatsky AL, Armstrong MA, Friedman GD: Alcohol and Mortality. Ann Intern Med, 117:6646-6654, 1992. Kono S, Ikeda M, Tokudome S, Nishizumi M, Kuratsune M: Alcohol and mortality, A Cohort study of male Japanese physicians. Int J Epidemiol, 15:527-532, 1986. Laitinen K, Valimaki M, Keto P: Bone mineral density measured by dual-energy X-ray absorptiometry in healthy Finish women. Calcif Tissue Int, 48:224-231, 1991. Landolfi R, Steiner M: Ethanol raises prostacyclin in vivo and in vitro. Blood, 64:679-682, 1984. Langer RD, Criqui MH, Reed DM: Lipoproteins and blood pressure as biologic pathways for the effect of moderate alcohol consumption on coronary artery disease. Circulation, 85:910-915, 1992. Longnecker, M: Alcohol and breast cancer. Cancer Causes and Control 5:73-82, 1994. MacMahon S: Alcohol consumption and hypertension. Hypertension, 9:111-121, 1987. Mikhailidis DP, Barradas MA, Jeremy JY: The effect of ethanol on platelet function and vascular prostanoids. Alcohol, 7:171-180, 1990. Miller NE, Hammett F, Saltissi S: Relation of angiographically defined coronary artery disease to plasma lipoprotein subfractions and apolipoproteins. British Medical Journal , 282:1741-1744, 1981. Paulin JM: Alcohol consumption and blood pressure in a New Zealand community study. The New Zealand Medical Journal, 98:425-428, 1985. Petitti WB, Wingerd J, Pellegrin F, Ramcharan S: Risk of vascular disease in women: Smoking, oral contraceptives, noncontraceptive estrogens, and other factors. JAMA, 242:1150-1154, 1979. Rand ML, Packham MA, Kinlough-Rathbone RL, Mustard JF: Effects of ethanol on pathways of platelet aggregation in vitro. Thromb Haemost, 59:383-387, 1988. Renaud S, deLorgeril M: Wine, Alcohol, platelets, and the French paradox for coronary heart disease. Lancet, 339:1523-1526, 1992. Rimm EB, Giovannucci EL, Willett WC, Colditz GA, Ascherio A, Rosner B, Stampfer MJ: Prospective study of alcohol consumption and risk of coronary disease in men. The Lancet, 338:464-468, 1991. Savolainen MJ, Hannuksela M, Sepp nen S, Kervinen K, and Kes niemi YA: Increased high density lipoprotein cholesterol concentration in alcoholics is related to low cholesteryl ester transfer protein activity. Eur. J. Clin. Invest. 20:593-599, 1990. Seigneur M, Bonnet J, Dorian B, et al: Effect of consumption of alcohol, white wine and red wine on platelet function and serum lipids. J Appl Cardiol 5:215- 222, 1990. Serdula MK, Koong SL, Williamson DF, Anda RF, Madans JH, Kleinman JC, Byers T: Alcohol Intake and Subsequent Mortality, Findings from the NHANES I Follow-up Study. J Stud. Alcohol, 56:233-239, 1995. Siemann EH, Creasy LL: Concentration of the phytoalexin reseratrol in wine. Am J Enol Vitic, 43:49-52, 1992. Stampfer MJ, Colditz GA, Willett WC, Speizer FE, Hennekens CH: A prospective study of moderate alcohol consumption and the risk of coronary disease and stroke in women. New England Journal of Medicine, 319:267-273, 1988. Tanaka H, Ueda Y, Hayashi M: Risk factor for cerebral hemorrhage and cerebral infarction in a Japanese rural community. Stroke, 13:62-73, 1982. Tanaka H, Hayashi M, Date C, Imai K, Asada M, Shoji H, Okazaki K, Yamamoto H, Yoshikawa K, Shimada T, Lee SI: Epidemiologic studies of stroke in Shibata, a Japanese provincidal city. Preliminary report on risk factors for derebral infarction. Stroke, 16:773-780, 1985. From owner-sci-resources@net.bio.net Sun Jul 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 23, pt. 1of1, 23 June 1995 Date: 3 Jul 1995 14:58:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 667 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3t9p6t$ahv@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950623 V24N23 P1O1 ************************************ X-comment: RFAs described: AA-95-004 X-URL: gopher://gopher.nih.gov/11/res/nih-guide/guide-files/95.06.23 NIH GUIDE - Vol. 24, No. 23 - June 23, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** AVAILABILITY OF THE NIMH ALZHEIMER'S DISEASE GENETICS DATASET National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX N2 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N3 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** NIH GUIDE---DISTRIBUTION POLICY AND PROCEDURES FOR ONLINE ACCESS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 11/21/95 ************************************************* MODERATE ALCOHOL CONSUMPTION: BENEFITS AND RISKS (RFA AA-95-004) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** AVAILABILITY OF THE NIMH ALZHEIMER'S DISEASE GENETICS DATASET NIH GUIDE, Volume 24, Number 23, June 23, 1995 P.T. 34; K.W. 1002019, 0715180, 0780030 National Institute of Mental Health The National Institute of Mental Health (NIMH), recognizing the major public health implications of identifying genes responsible for severe neuropsychiatric disorders, has funded a multi-site Genetics Initiative. The goal of this Initiative is to establish a national resource of demographic, clinical, and genetic data from individuals with Alzheimer's disease (AD), schizophrenia, or bipolar disorder to aid researchers in defining the genetic bases for these disorders. This notice announces the availability on July 1, 1995 of clinical data and DNA from the NIMH AD Genetics Dataset to qualified investigators studying the genetics of Alzheimer's disease. As of May 31, 1995, the NIMH AD Genetics Dataset contained clinical data and DNA on 238 sib-pairs. The Alzheimer's disease genetics catalog will be available via Internet (http://nimh.sratech.com). Genotyping results will become available at a later date. Alzheimer's disease sib-pairs are identified via cooperative agreements to the University of Alabama at Birmingham, Johns Hopkins University, and Massachusetts General Hospital. Data being collected consist of clinical information, including demographics, symptomatology, and eventually autopsy data, which are being stored in a central Data Management Center, and genetic materials stored at the NIMH Cell Repository. These latter resources have been established through contract mechanisms. Data collection from AD sib-pairs and unaffected siblings has been coordinated among the three university-based Diagnostic Centers using an agreed-upon protocol that has included uniform assessments, extensive interview data on risk factors and medical history, and shared rules for extension of pedigrees through affected members. There have been two methods of ascertainment employed by each site. The first method is systematic, e.g., all patients evaluated within a clinical population are screened for the possible availability of a secondary proband within the family. The second method is opportunistic. This method uses several mechanisms to identify families: referral from other clinicians, contacting local AD associations, and media advertising. There is a preferential ascertainment scheme based on family structure, which is dictated by the methods of linkage analysis. The order of preference is (1) those families with living affected sib-pairs; (2) those families with one living affected sib and one deceased sib with recoverable tissue for DNA genotyping and with another living affected relative no more distantly related than biological first-cousins; (3) those families with a proband and an affected relative no more distantly related than biological first-cousins with living affected relatives in the line of descent; (4) same as 3 but with deceased affected relatives in the line of descent. These Centers have the ability to follow subjects longitudinally, track changes in diagnoses, and compare and update diagnoses by autopsy, thus avoiding false positives, a major pitfall to genetic studies. To be eligible for inclusion in the study, primary probands must meet NINCDS-ADRDA criteria for probable Alzheimer's disease on initial evaluation and show deterioration in cognitive function by longitudinal assessment or history for at least one year. The secondary proband must meet NINCDS-ADRDA criteria for probable or possible AD at the onset of disease and have evidence of progressive decline in cognitive function. One of the above must have a Mini-Mental State Examination score less than 27 and history of difficulties with activities of daily living. Families with evidence of bilineal inheritance will be noted. Probands with depression will be kept as subjects. Access to National Resource Data and DNA Clinical information and DNA will be distributed only to experienced, qualified investigators who are conducting research on the genetics of Alzheimer's disease and are associated with a recognized biomedical research facility. This NIMH Genetics Initiative clinical information and DNA obtained by the investigator cannot be transferred in any manner, with or without charge, to anyone outside the direct supervision of the principal investigator, without the express written permission from the NIMH Cell Repository project officer. Investigators may request grant funding and access to the clinical data and DNA by submitting a research grant application to NIMH for peer review using investigator initiated grant application mechanisms. If funding is not requested, contact Dr. Mary Farmer for information on how to obtain the AD clinical data and DNA. The cost of DNA for investigators not funded by an NIMH grant is $50 per 50 microgram vial. (DNA is shipped only in 50 microgram vials.) INQUIRIES For further information, contact: Mary Farmer, M.D., M.P.H. Division of Epidemiology and Services Research National Institute of Mental Health Parklawn Building, Room 10C-09 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3774 FAX: (301) 443-4045 Email: MFARMER@AOAMH2.SSW.DHHS.GOV $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 24, Number 23, June 23, 1995 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 the following: DATES: September 18-19, 1995 TITLE: Contemporary Human Subject Issues in Academic Research LOCATION The University of Mississippi, Oxford, MS SPONSORS The University of Mississippi Jackson State University REGISTRATION Mr. D. Russell Cooper OPRR Conference Registration c/o Center for Public Service and Continuing Studies The University of Mississippi P.O. Box 879 University, MS 38677 Telephone: (601) 232-7282 FAX: (601) 232-5138 REGISTRATION FEE: $95 ($115 after September 5) DESCRIPTION: The biomedical and behavioral research currently being conducted within academic institutions promises exciting advances in scientific knowledge, as well as unprecedented opportunities for the betterment of individual and societal life. Increasingly, however, these dramatic achievements and opportunities are accompanied by scientific, ethical, regulatory, and legal intricacies, and dilemmas. Within the academic community, understanding these rapidly changing complexities is central to the IRBs ability to protect the rights and welfare of human research subjects while supporting scientific endeavor and its potential benefits to humankind. This conference is designed to examine a broad range of contemporary scientific, ethical, regulatory, and legal issues relating to biomedical, social, behavioral, and anthropological research involving human subjects. Each of these issues will be discussed within the framework of the academic research environment, and presentations will focus on the unique challenges presented to IRBs, researchers, subjects, and administrators in academic institutions. Designed for both experienced and novice participants, the workshop will provide opportunities for greater depth and specificity on contemporary IRB issues. Along with sessions on examining common IRB issues - including liability, informed consent, and deception - the conference will feature special focus sessions on issues related to historical perspectives, issues in mental health, the establishment, structure, and management of IRBs, computerized management information systems for the IRB office, FDA regulations for clinical trials, guidelines on inclusion of minorities and women, research involving genetic/DNA testing, and research involving special populations, including American Indians children, and elderly research subjects. Sessions will feature issues particularly pertinent to historically black colleges and universities and institutions newer to the IRB process. Speakers will include representatives from OPRR and FDA, including Dr. Gary B. Ellis, Mr. Paul Goebel, Jr., and Dr. Gary Chadwick, and other Federal agencies such as the Congressional Office of Technology Assessment, the Office of Research on Women's Health at NIH, and the National Institute of Mental Health. Distinguished members of the academic and clinical research community will also include Dr. William L. Freeman of the Indian Health Service, Dr. Diane Brown from the University of California at Berkeley, Dr. Ernest D. Prentice of the University of Nebraska, and Dr. John Estrada of Meharry Medical College. The format will encourage audience participation and informal information exchanges, with ample question and answer opportunities throughout the program. 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 x233 FAX: (301) 402-0527 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 24, Number 23, June 23, 1995 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office of Extramural Research (OER), Office for Protection from Research Risks (OPRR) is continuing to cosponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1995 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and information discussions. DATES: September 14-15, 1995 TOPIC: Internal Audits of the Animal Care and Use Program LOCATION Radisson Riverfront Hotel Two Tenth Street Augusta, GA 30910 Telephone: (706) 721-3967 FAX: (706) 721-4642 SPONSORS National Institutes of Health; Medical College of Georgia; Albany State College REGISTRATION Ms. Katrinka Akeson Department of Continuing Education HM100 Medical College of Georgia Augusta, GA 300912 Telephone: (706) 721-3967 FAX: (706) 721-4642 FEE: $150.00 DESCRIPTION: The Workshop will address processes whereby Institutional Animal Care and Use Committees (IACUC) can effectively evaluate their institution's animal care and use program. The PHS Animal Welfare Policy and USDA Regulations state that at least once every six months the institution's program for humane care and use of animals is to be evaluated by the IACUC using the Guide and USDA Regulations (Title 9, Chapter 1, subchapter A-Animal Welfare) as a basis. Topics to be included in the Workshop include: A review of the program as described in the Guide; institutional policy issues such as the occupational health and safety program, personnel training, and the activities of the IACUC and how effectively does it meet its mandates. Other program issues to be included are veterinary care, the animal environment, and record reviews. Reports of the IACUC semiannual program and facility reviews will also be discussed. Approaches useful to IACUC's serving both small and large institutions will be included. INQUIRIES For further information concerning these workshops and future NIH/OER/OPRR Animal Welfare Education 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 ext. 233 FAX: (301) 402-0527 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NIH GUIDE---DISTRIBUTION POLICY AND PROCEDURES FOR ONLINE ACCESS NIH GUIDE, Volume 24, Number 23, June 23, 1995 P.T. 34; K.W. 1014006 National Institutes of Health The NIH Guide for Grants and Contracts is published in one printed and several electronic editions. One copy of the printed edition, which includes notices regarding NIH policy and notices of the availability of Program Announcements, Requests for Applications, and Requests for Proposals is provided to the office of sponsored research or equivalent of any interested organization. The electronic editions and procedures for obtaining them are provided below. NOTE: The address for subscribing to the full text LIST has been changed, effective June 23. Current subscriptions (subscribed to on listserv@jhuvm.hcf.jhu.edu or LISTSERV@JHUVM) will be transferred automatically to the new server (listserv@list.nih.gov or LISTSERV@NIHLIST), but subscribers should note the new address for future reference. 1. NIHGDE-L The NIHGDE-L is the electronic version of the full text of the NIH Guide for Grants and Contracts. Individual subscriptions are available. Subscribing and unsubscribing to/from a LIST is done via email. To subscribe to the LIST, send mail to listserv@list.nih.gov or LISTSERV@NIHLIST. The text of the mail should read ONLY: SUBSCRIBE NIHGDE-L First-name Last-name The First & Last names should be in upper & lower case; e.g.: SUBSCRIBE NIHGDE-L Bill Jones This will subscribe the email address from which the mail was sent. To subscribe an address from which mail cannot be sent (e.g., an internal distribution list), send mail to wkj@cu.nih.gov. To remove an address from this LIST, send mail to listserv@list.nih.gov or LISTSERV@NIHLIST from that address. The text of the mail should read ONLY: UNSUBSCRIBE NIHGDE-L 2. NIHTOC-L. The NIHTOC-L list contains only the Table of Contents of each issue of the NIH Guide. The full text version of any notice, program announcement (PA), or request for applications (RFA) must be obtained through other means such as the NIH GOPHER, the NIH Grant Line Bulletin Board, or via ftp. To subscribe to the NIHTOC-L, send mail to LISTSERV@list.nih.gov. The text of the mail should read ONLY: SUBSCRIBE NIHTOC-L First-name Last-name To unsubscribe, the command is: UNSUBSCRIBE NIHTOC-L Each issue of the TOC contains the URL that may be used via Gopher to access that issue of the E-Guide and/or the full text of a Program Announcement or Request for Applications on the NIH Gopher server. (see also item 4., below) 3. NIH GRANT LINE BULLETIN BOARD The NIH Grant Line includes information about NIH extramural programs, including the NIH Guide for Grants and Contracts. Files can be emailed or downloaded via the modem and communications software. To access the NIH Grant Line, the terminal emulator must be configured as follows: 1200 or 2400 baud, even parity, 7 data bits, 1 stop bit, half duplex. Using the procedure specified in the communication software, dial 1-301-402-2221. When a response indicates that a connection has been made, type ,GEN1 (the comma is mandatory) and press ENTER; the NIH system will prompt for INITIALS?. Type BB5 and press ENTER. A prompt will ask for ACCOUNT? Type CCS2 and press ENTER. Messages and a menu will be displayed that allow one to read Bulletins and download Files. Back issues of the NIH Guide are found in different Directories. GUIDE90 has issues going back to July 6, 1990; GUIDE91, GUIDE92, and GUIDE93 have all issues for each year. Type F (for FILES) to access any of the files that are arranged into directories. To get an overview of the kinds of information available, type D (for Directory). Access to the NIH Grant Line via the Internet To access the NIH Grant Line in an interactive Internet session, Telnet to wylbur.cu.nih.gov and, when a message has been received that the connection is open, type VT100. At the INITIALS? prompt, type BB5 and at the ACCOUNT? prompt, type CCS2. This puts the user into the NIH Grant Line. 4. WORLD WIDE WEB (WWW) Current and past issues of the NIH Guide for Grants and Contracts may be accessed via the World Wide Web. The NIH gopher server, which contains the printed edition of the NIH Guide in ASCII text format and the full text of Program Announcements, Requests for Applications, and Notices, is accessible through the NIH Home Page, URL http://www.nih.gov. Select "Grants and Contracts" from that page to access the NIH Guide. 5. INDIVIDUAL ANNOUNCEMENTS AND BACK ISSUES FROM THE LIST ARCHIVES Each mailing distributed via the NIHGDE-L LIST is automatically archived by LISTSERV. All issues after 1/19/90 have been saved with the text of each RFA and PA as a separate document. Retrieving files >From the LISTSERV archives is a two step process: a list of the available archive files is obtained by sending an INDEX NIHGDE-L command to listserv@list.nih.gov. These files can then be retrieved by means of a ET NIHGDE-L filetype command or by using the database search facilities of LISTSERV. Send an INFO DATABASE command for more information on the latter. The following is a sample of the INDEX command file information: filename filetype GET PUT -fm lrecl nrecs date time Remarks -------- -------- --- --- --- ----- ----- -------- ----------- NIHGDE-L 90-00027 PRV OWN V 80 969 90/01/18 16:12:44 -> NIH Guide, Vol. 19, No. 3, January 19, 1990 The information for each entry consists of two lines. The first line contains information necessary for retrieval and the beginning of the Remarks, and the second contains the rest of the Remarks. The important information is the number (90-xxxxx) and the Remarks. The Remarks field is the subject line of the mail distributed and shows which documents can be retrieved. The number is the value used in the GET command. To retrieve files, send mail (to listserv@list.nih.gov) that contains one line for each document as follows: GET NIHGDE-L number For example, to get the main body of the NIH Guide for 1/19/90, the mail would contain the line: GET NIHGDE-L 90-00027 The documents referenced in the GET commands will be sent back as files. It is possible to use any of the publicly available LISTSERV commands with the NIHGDE-L list. More information on LISTSERV commands can be found in the "General Introduction Guide," which can be retrieved by sending an INFO GENINTRO command to listserv@list.nih.gov. 6. ANONYMOUS FTP The NIH Guide is available via Anonymous ftp at the NIH Computer Utility. The files contain both the main body of the printed edition of the NIH Guide and the full text of the Program Announcements and Requests For Applications. The format of the delimited records is slightly different and is explained in the README file. The file names are of the form Gmmddyy, where mmddyy is the month/day/year of the date of the NIH Guide. To access the NIH Guide via Anonymous ftp: ftp to ftp.cu.nih.gov (specify ANONYMOUS as the userid and GUEST as the password) cd nih-eguide All normal ftp commands are available. The output will look quite different from other installations because the NIH implementation is under MVS. The NIH SERVER facility can be used to get back issues via ftp. Send mail to SERVER@cu.nih.gov and specify in the subject: GET FTP NIH-EGUIDE.Gmmddyy The appropriate issue of the NIH Guide will be mailed. To see a list of the file names available, send mail as above, but specify in the subject: INDEX FTP DIR=NIH-EGUIDE To get a copy of the document that describes the delimiters for the electronic edition of the NIH Guide, send mail to SERVER as above with a subject of: GET FTP NIH-EGUIDE.HEADERS.DESCR INQUIRIES Claudia Blair, Ph.D. or Myra Brockett Institutional Affairs Office, NIH Building 31, Room 5B35 Bethesda, MD 20892 Telephone: (301) 496-5366 FAX: (301) 402-2831 Email: claudia_blair@nih.gov or q2c@cu.nih.gov For additional information about the NIH Grant Line Bulletin Board, direct inquiries to: John C. James, Ph.D. Assistant Director for Special Projects Division of Research Grants Email: JQJ@cu.nih.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN AA-95-004 FULL-TEXT ************************************** MODERATE ALCOHOL CONSUMPTION: BENEFITS AND RISKS NIH GUIDE, Volume 24, Number 23, June 23, 1995 RFA AVAILABLE: AA-95-004 P.T. 34; K.W. 0404003, 0411005, 1002004, 1002008, 0785055 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: October 18, 1995 Application Receipt Date: November 21, 1995 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking applications for research to determine both benefits and risks of moderate alcohol use. Several cultural and social definitions for "moderate" alcohol consumption exist, and epidemiological studies refer to a wide range of drinking as moderate. In addition to defining moderate drinking, many important questions remain unanswered. The cellular and molecular mechanisms of the positive association of moderate alcohol use and cardiac health need to be established. Further, any negative effects associated with long term moderate drinking in individuals or subpopulations need to be delineated. Answers to such questions will help identify the tradeoffs involved in an individual's decision about drinking, and will provide a solid base for formulating public health policies. Information obtained about moderate drinking will also provide a better understanding of the mechanisms involved in alcohol effects in general. The purpose of this request for applications (RFA) is to stimulate a wide range of molecular and cellular studies, as well as epidemiological, clinical and psychosocial studies on the benefits and the risks of moderate drinking. These areas include, but are not limited to: (1) coronary artery disease; (2) hypertension; (3) stroke; (4) osteoporosis and breast cancer; (5) interaction with various medications; (6) trade-offs (risk/benefit analysis); and (7) psychosocial issues. It is estimated that up to $2.0 million in total costs will be available for approximately 10 grants (R01, R03, R21, R29) under this RFA in FY 1996. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. 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. The earliest possible award date is July 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 RFA, Moderate Alcohol Consumption: Benefits and Risks, is related to the priority area of consequences of alcohol abuse and alcoholism. 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. Sam Zakhari, 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) 443-0799 FAX: (301) 594-0673 Email: SZakhari@Willco.NIAAA.NIH.Gov $$R1 END ************************************************************ From owner-sci-resources@net.bio.net Sun Jul 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 2 July 1995 Date: 3 Jul 1995 14:51:13 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 165 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3t9ooh$a90@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: General Publication Title: NSF 95-68 Planning for the Challenges Ahead in the Mathematical and Physical Sciences, NSF 9568 File size (bytes): STIS Filename: nsf9568.txt Document Type: Letter Title: NSF 95-105 Mathematical Science Dear Colleague Letter File size (bytes): STIS Filename: nsf95105.txt Document Type: News Title: Media Tipsheet June 30, 1995 File size (bytes): STIS Filename: tip50630.txt Document Type: Press Release Title: UNCONVENTIONAL ENVIRONMENTS HARBOR BACTERIA WITH “EXTREMOZYMES” File size (bytes): STIS Filename: pr9543.txt Title: GEOPHYSICISTS EXPLORE INTERIOR OF MARS--FROM EARTH File size (bytes): STIS Filename: pr9544.txt Title: ARCTIC OCEAN PROVIDES CLUES TO GLOBAL CLIMATE AND ENVIRONMENTAL CHANGES File size (bytes): STIS Filename: pr9545.txt Title: NSF GRANTS SERVE AS CATALYST FOR UNDERGRADUATE CHEMISTRY REFORM File size (bytes): STIS Filename: pr9546.txt Document Type: Program Guideline Title: NSF 95-101s INSTITUTO INTERAMERICANO PARA LA INVESTIGACION DEL CAMBIO GLOBAL (IAI) File size (bytes): STIS Filename: ns95101s.txt Title: NSF 95-108 POSTDOCTORAL RESEARCH FELLOWSHIPS IN CHEMISTRY File size (bytes): STIS Filename: nsf95108.txt Title: NSF 95-109 ENGINEERING FACULTY EARLY CAREER DEVELOPMENT (CAREER) PROGRAM File size (bytes): STIS Filename: nsf95109.txt Also available: nsf95109.doc Document Type: Recruit Title: Science Assistant, AD-1 File size (bytes): STIS Filename: vex9527.txt Title: Clerical and Administrative Support Positions File size (bytes): STIS Filename: vgs95104.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 5015 STIS Filename: cmmtg.txt Document Type: General Publication Title: NSF 94-2a Grant Proposal Guide - Appendix A File size (bytes): 14470 STIS Filename: nsf942a.txt Also available: nsf942a.doc Title: NSF 94-2c Grant Proposal Guide - Appendix C File size (bytes): 2504 STIS Filename: nsf942c.txt Also available: nsf942c.doc Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 107862 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 110911 STIS Filename: phnorg.txt Title: NSF Organization Directory File size (bytes): 110911 STIS Filename: phnorg.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 50793 STIS Filename: sesvac.txt Title: Secretary (Office Automation) File size (bytes): 7675 STIS Filename: vgs95106.txt Document Type: STIS Title: Document Types on STIS File size (bytes): 1778 STIS Filename: stistype.txt ------------------------------------------------------------------------ ** 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 stistype.txt, the text of your message should be as follows: get stistype.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve stistype.txt, you would enter: ftp> get stistype.txt 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 Sun Jul 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 25 June 1995 Date: 3 Jul 1995 14:51:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 111 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3t9oo6$a8n@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: TIP50616 -- Media Tipsheet June 16, 1995 File size (bytes): STIS Filename: tip50616.txt Document Type: Program Guideline Title: NSF 95-88 International Opportunities for Scientists and Engineers File size (bytes): STIS Filename: nsf9588.txt Title: NSF 95-92 - Science & Technology Studies Program File size (bytes): STIS Filename: nsf9592.txt Document Type: Recruit Title: Deputy General Counsel, Office of the General Counsel File size (bytes): STIS Filename: vep9511.txt Title: Program Assistant (OA), GS-303-5/6 File size (bytes): STIS Filename: vgs95102.txt Title: Computer Specialist, GS-334-5/7/9 File size (bytes): STIS Filename: vgs95105.txt Title: Secretary (Office Automation), GS-318-7/8 File size (bytes): STIS Filename: vgs95106.txt Title: Secretary (OA), GS-318-5/6 File size (bytes): STIS Filename: vs95103.txt Title: Secretary (OA), GS-318-9/10 File size (bytes): STIS Filename: vs95109.txt Document Type: Report Title: NSF 94-165 RESEARCH PRIORITIES IN NETWORKING AND COMMUNICATIONS File size (bytes): STIS Filename: nsf94165.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: News Title: MPSLECT -- Intelligent Gels and Molecular Recognition File size (bytes): 2143 STIS Filename: mpslect.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 41328 STIS Filename: sesvac.txt ------------------------------------------------------------------------ ** 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.txt, the text of your message should be as follows: get sesvac.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac.txt, you would enter: ftp> get sesvac.txt 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 Sat Jul 15 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 9 July 1995 Date: 15 Jul 1995 21:59:38 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 82 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ua6bq$q4i@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: International Document Title: INT 95-016 - . JAPAN'S B-ISDN AND FIBER-TO-THE-HOME PROJECTS File size (bytes): STIS Filename: int95016.txt Document Type: News Title: FS-50607 June/July Feature Service File size (bytes): STIS Filename: fs50607.txt Document Type: Recruit Title: Oceanographer (Science Assistant, Assistant or Associate Program Officer) File size (bytes): STIS Filename: vex9528.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Bulletin Title: BUL 95-06 June/July/August Bulletin Vol. 22; No. 10 File size (bytes): 44005 STIS Filename: bul9506.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 105076 STIS Filename: phnalpha.txt Also available: phnalpha.dlm ------------------------------------------------------------------------ ** 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 phnalpha.txt, the text of your message should be as follows: get phnalpha.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnalpha.txt, you would enter: ftp> get phnalpha.txt 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 Sat Jul 15 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-075 - V24(25) 07/14/95 Date: 15 Jul 1995 21:59:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 345 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ua6c3$q5d@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95075 PA-95-075 P1O1 *************************************** TRANSIT FROM CARDIAC HYPERTROPHY TO OVERT HEART FAILURE NIH GUIDE, Volume 24, Number 25, July 14, 1995 PA NUMBER: PA-95-075 P.T. 34; K.W. 0705037, 0715040, 1002004, 1002008, 0765014 National Heart, Lung, and Blood Institute PURPOSE This program announcement solicits applications for research on a molecular and cellular approach to elucidation of the signaling mechanisms that coordinate the events that lead to deterioration of cardiac structure and function. Appropriate studies may include mechanisms of action of mediators derived from myocardial, interstitial, endothelial, endocrine, or immune cells and the respective receptors for those mediators, as well as the factors that affect altered gene expression of these mediators and their receptors. 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, Transit from Cardiac Hypertrophy to Overt Heart Failure, is related to the priority area of heart disease and stroke. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Research support mechanisms include traditional research project grants (R01) and FIRST (R29) awards. Traditional research project grants (R01) provide support for up to five years. Applications for FIRST (R29) awards must request support for five years and are limited to $350,000 in direct costs over the entire project period. RESEARCH OBJECTIVES Congestive heart failure (CHF) is estimated to affect three million people in the United States. It is the final common pathway of a variety of primary cardiovascular disease entities, such as coronary artery disease, hypertension, valvular heart disease, genetic disorders, diabetes and the sequelae of infection or toxin exposure, among others. Hospitalizations and mortality from CHF have increased steadily since 1968, despite the overall improvement in mortality >From cardiovascular disease. Heart failure is now the underlying cause of death in over 39,000 persons annually. In 1992, it was the first listed diagnosis in 822,000 persons and is the most common hospital discharge diagnosis in persons over 65 years of age. The incidence of death from CHF is 1.5 times as high in black Americans as in whites. The estimated direct economic cost of CHF in the United States is reported to be $10.2 billion annually. At present, the only cure for end-stage CHF is cardiac transplantation. One fundamental question that needs to be answered before progress can be made in the prevention and treatment of heart failure is how the compensated, hypertrophied heart progresses to failure. In recent years, research on the natural history of heart failure has benefitted from the application of cell and molecular biology techniques. Physiological studies on the development of pathological hypertrophy have led to the view that hypertrophy is compensatory, but while providing a short-term adaptive response to maintain cardiac output, it eventually becomes maladaptive. Studies have shown that the mechanism of hypertrophic growth involves remodeling of all cardiac tissue compartments: myocytes, matrix, and vasculature, and is associated in cardiac myocytes with a molecular expression profile bearing much similarity to the fetal phenotype. Mechanisms such as the immediate/early gene response and peptide growth factor expression have been implicated in this molecular switching, but little is known about their role in the overall ventricular remodeling that occurs in vivo. A variety of studies suggest that the physiological function of the myocardium is modified through complex cross-talk among vascular, interstitial and myocyte compartments of the heart. Thus, locally produced mediators can act in autocrine and paracrine fashions to modify function or induce cell death. Research is required to understand the mechanisms of this cross-talk which has important consequences in the transition to heart failure. For example, several studies suggest a role for the endogenous vascular peptide, endothelin. Experiments employing the rapid pacing model demonstrated a two-fold increase in circulating endothelin that correlated well with known physiological markers of CHF. Interestingly, elevated circulating endothelin levels have also been reported in human heart failure. Receptors for endothelin have been identified in cultures of rat cardiac myocytes, and the peptide has been demonstrated to have potent positive inotropic activity in rat ventricular myocytes. Angiotensin II (AII) levels are elevated in CHF. This potent vasoconstrictor peptide is produced in renal tissue and activated both systemically and in myocardial tissue by angiotensin converting enzyme (ACE). The active peptide is also a secretogogue for endothelin. A recent report demonstrates that the AII-stimulated release of endothelin from human endothelial cells is inhibited by atrial natriuretic peptide (ANP). In the adult human, ANP is normally made and secreted only by atrial myocytes and ventricular conduction cells. ANP synthesis and secretion from ventricles is stimulated in the failing heart. A recent study has correlated the expression of ANP in the ventricle with increasing end-diastolic pressure or volume and worsening New York Heart Association functional class. The release of ANP is also stimulated by endothelin. Thus angiotensin, endothelin and ANP may be partners in a feedback loop which is important in determining the functional status of the myocardium. Research is needed to understand how these factors mediate the changes in vascular impedance and fluid volume in the presence of a failing heart. Other lines of investigation suggest that the immune system, acting through cells of the myocardium, may play a role in the transition to heart failure but how the immune system is recruited and how it mediates maladaptive cardiac growth and altered function is not understood. Similarly, such factors as impairment of alpha and beta adrenergic receptor function, and altered phospholamban and heat shock protein expression are associated with heart failure but the stimulus to effect these changes is not understood. Genetically altered animals offer much promise to study the basic mechanisms responsible for heart failure and to develop therapy. Information now available on genes involved with abnormal cardiac growth may be utilized to develop new models. Discovery of new genes altered in the transition to heart failure may also be the source of exciting approaches. Proposed Research Examples of studies that could be included under this initiative are listed below. The list is not meant to be exhaustive, and many other types of studies would certainly be appropriate. o Elucidation of the mechanisms underlying the growth response of the overloaded heart. o Identification of the origins of the peptide growth factors, TGF-betaF, alpha-FGF and beta-FGF and their role in ventricular wall remodeling in the adult. o Elucidation of the mechanisms whereby ACE inhibitors lower peripheral vascular resistance in heart failure patients and appear to reverse hypertrophy of damaged myocardium. o Elucidation of the mechanisms whereby beta-blockers have beneficial effects on myocardial remodeling. o Investigations of the pathophysiological consequences of immune cytokines in heart failure. o Studies of the interactions between cytokine action, neuroendocrine activation, and growth abnormalities in the failing heart should be investigated. o The development and use of genetically altered animals to explore the molecular and physiological factors and processes responsible for heart failure and to devise and test new therapeutic modalities. While it is recognized that heart failure commonly occurs in the setting of neuroendocrine excess, applications that focus exclusively on the classical role of the neuroendocrine system in heart failure are not encouraged. However, studies of the effects of the neuroendocrine system on cellular and molecular processes in the failing myocardium would be responsive. Strategies that employ neonatal cardiac myocytes must demonstrate a clear relationship to heart failure beyond descriptive similarities between the onset of cardiac hypertrophy in the adult and fetal cardiac gene expression in order to be considered responsive; such studies, for example, could highlight differences in the growth responses to overload of proliferating and terminally differentiated myocytes. 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 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. 5/95) 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, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892, telephone 301/435-0714. 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 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) 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 and technical review, the applications will receive a second-level review by the appropriate national advisory council. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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. 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: Isabella Liang, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Two Rockledge Center Suite 9044 6701 Rockledge Drive Bethesda, MD 20892-7940 Telephone: (301) 435-0520 FAX: (301) 480-1335 Email: ISABELLA_LIANG@NIH.GOV Direct inquiries regarding fiscal matters to: William W. Darby Grants Operations Branch National Heart, Lung, and Blood Institute Two Rockledge Center Suite 7128 6701 Rockledge Drive Bethesda, MD 20892-7128 Telephone: (301) 435-0177 FAX: (301) 480-3310 Email: WILLIAM_DARBY@NIH.GOV AUTHORITY AND REGULATIONS This program 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 Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. 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 Sat Jul 15 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 25, pt. 2of2, 14 July 1995 Date: 15 Jul 1995 21:59:44 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 115 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ua6c0$q53@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950714 V24N25 P2O2 ************************************ costs excludes indirect consortium costs. INQUIRIES Dr. Creighton H. Phelps Dementias of Aging Branch National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307 - MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: phelps%nihniagw.bitnet@cu.nih.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$P1 BEGIN PA-95-075 FULL-TEXT ************************************** TRANSIT FROM CARDIAC HYPERTROPHY TO OVERT HEART FAILURE NIH GUIDE, Volume 24, Number 25, July 14, 1995 PA AVAILABLE: PA-95-075 P.T. 34; K.W. 0705037, 0715040, 1002004, 1002008, 0765014 National Heart, Lung, and Blood Institute PURPOSE This program announcement (PA) solicits applications for research on a molecular and cellular approach to elucidation of the signaling mechanisms that coordinate the events that lead to deterioration of cardiac structure and function. Appropriate studies may include mechanisms of action of mediators derived from myocardial, interstitial, endothelial, endocrine, or immune cells and the respective receptors for those mediators, as well as the factors that affect altered gene expression of these mediators and their receptors. Research support mechanisms include traditional research project grants (R01) and First Independent Research Support and Transition (FIRST) (R29) 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. This PA, Transit from Cardiac Hypertrophy to Overt Heart Failure, is related to the priority area of heart disease and stroke. 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. Isabella Liang, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Two Rockledge Center, Suite 9044 6701 Rockledge Drive Bethesda, MD 20892-7940 Telephone: (301) 435-0520 FAX: (301) 480-1335 Email: ISABELLA_LIANG@NIH.GOV $$P1 END ************************************************************ ERRATA $$E1 BEGIN R4 19950303 APPEND RFA AI-95-012 BOTH *********************** HEPATITIS C COOPERATIVE RESEARCH CENTERS - APPLICATION RECEIPT DATE NIH GUIDE, Volume 24, Number 25, July 14, 1995 RFA: AI-95-012 P.T. 34; K.W. 0715125, 1002045, 0765033, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 7, 1995 Application Receipt Date: September 13, 1995 (Revised) The application receipt date for RFA AI-95-012, which was published in the NIH Guide, Vol. 24, No. 8, March 3, 1995 is revised from July 18, 1995 to September 13, 1995. The other schedule dates are changed as follows: Application Receipt Date: September 13, 1995 (Revised) Scientific Review Date: March 1996 Advisory Council Date: June 1996 Earliest Award Date: August 1, 1996 INQUIRIES Dr. Leslye Johnson Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-22 MSC 7630 6003 Executive Boulevard Bethesda, MD 20892-7630 Telephone: (301) 496-7051 Email: lj7m@nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Sat Jul 15 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 25, pt. 1of2, 14 July 1995 Date: 15 Jul 1995 21:59:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ua6bt$q4n@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950714 V24N25 P1O2 ************************************ X-comment: RFAs described: PA-95-075 X-URL: gopher://gopher.nih.gov/11/res/nih-guide/guide-files/95.07.14 NIH GUIDE - Vol. 24, No. 25 - July 14, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** OBJECTIVITY IN RESEARCH Public Health Service INDEX: PUBLIC HEALTH SERVICE $$INDEX N2 ********************************************************** COMPLETION OF INVESTIGATION Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N3 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N4 ********************************************************** ADDENDUM - ALZHEIMER'S DISEASE CORE CENTER GRANTS (RFA AG-95-004) National Institute on Aging INDEX: AGING NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX P1 ********************************************************** TRANSIT FROM CARDIAC HYPERTROPHY TO OVERT HEART FAILURE (PA-95-075) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD ERRATA $$INDEX E1 ********************************************************** HEPATITIS C COOPERATIVE RESEARCH CENTERS - APPLICATION RECEIPT DATE (RFA AI-95-012) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** OBJECTIVITY IN RESEARCH NIH GUIDE, Volume 24, Number 25, July 14, 1995 P.T. 34; K.W. 1014006 Public Health Service The following is a reprint of the final rule on "Objectivity in Research," which was published in the Federal Register of July 11, 1995 with an effective date of October 1, 1995. The National Science Foundation has published a similar policy in the same issue of the Federal Register. The requirements are almost identical. ACTION: Final rule. SUMMARY: The Public Health Service (PHS) and the Office of the Secretary, HHS, are promulgating regulations establishing standards and procedures to be followed by institutions that apply for research funding from the PHS to ensure that the design, conduct, or reporting of research funded under PHS grants, cooperative agreements or contracts will not be biased by any conflicting financial interest of those investigators responsible for the research. Under the rules, investigators are required to disclose to an official(s) designated by the institution a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that would reasonably appear to be affected by the research proposed for funding by the PHS. The institutional official(s) will review those disclosures and determine whether any of the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research and, if so, the institution must, prior to any expenditure of awarded funds, report the existence of such conflicting interests to the PHS Awarding Component and act to protect PHS-funded research from bias due to the conflict of interest. EFFECTIVE DATE: October 1, 1995. FOR FURTHER INFORMATION CONTACT: Dr. George J. Galasso, Associate Director for Extramural Affairs, National Institutes of Health, Building 1, Room 152, 9000 Rockville Pike, MSC 0154, BETHESDA, MD 20892-0154. The telephone number is (301) 496-5356 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: On June 28, 1994 the Department of Health and Human Services (HHS) published proposed regulations (59 FR 33242) to ensure that PHS- funded research would not be compromised by financial interests of investigators that could be reasonably expected to bias the design, conduct or reporting of the research. In addition to setting forth proposed rules requiring institutional procedures for the disclosure and management, reduction or elimination of Significant Financial Interests that would reasonably appear to be directly and significantly affected by the research funded by PHS, or proposed for funding, the Notice of Proposed Rulemaking (NPRM) raised several specific questions about alternatives for implementing the pertinent statutes and for ensuring that PHS-funded research is not compromised by any financial conflicts of interest. The NPRM was published in the Federal Register at the same time the National Science Foundation (NSF) published its Investigator Financial Disclosure Policy and reflected coordination between the two agencies. Since that time, we have continued to work closely with the NSF to ensure that the NSF policy and our regulations do not impose disparate requirements upon the many institutions that receive funding from both agencies. Elsewhere in this Federal Register, the NSF is issuing changes in its policy necessary to maintain consistency with this final rule, and the changes we have made to conform to the NSF policy are referenced in the discussion that follows. The agencies intend to continue their cooperation by working together to develop common guidance, including a set of questions and answers, to help institutions implement conflict of interest policies that comply with both HHS and NSF requirements. During the 60 day comment period that ended on August 28, 1994, the PHS received 102 comments on the NPRM. Most of the comments were generally supportive of giving the applicant institutions primary responsibility for identifying and resolving financial conflicts of interest that could directly and significantly affect the PHS-funded research. The comments are summarized below under the headings: Changes in the NPRM; Comments Not Resulting in Any Changes; and Responses to Questions on Alternatives. Changes in the NPRM A summary of the changes made in the regulations as proposed on June 28, 1994, follows. Only the sections in 42 CFR Part 50 are referenced. Similar changes have been made in the regulations at 45 CFR 94 which apply to contracts. 1. In the section titles, 50.601, 50.602, 50.605 and several other sections, references to "Significant Financial Interests" or "Significant Financial Interests of the type described in 50.605," have been changed to refer to a conflict of interest or conflicting financial interests. This change has been made in response to many of the comments. It was pointed out that this change will make the HHS regulations consistent with the NSF regulations and that the institutions can only manage the conflict, not the financial interests. 2. In response to several comments, the "Purpose" sections in the grants and the contracts regulations have been rewritten to make them more concise and parallel. 3. A reference to 50.604(a) has been added to the "Applicability" section. As explained more fully in paragraph 6 below, this change and the change in 50.604(a) clarify that the regulations apply to Investigators carrying out the PHS-funded research for subgrantees or contractors of the awardee institution. 4. In response to several comments, the definition of "Investigator," has been amended to delete the phrase "at the Institution." 5. The definition of "Significant Financial Interest" in 50.603 has been changed in several respects. Clause (i) has been split so that ownership interests are now referenced in a new clause (ii). Some commentors felt that it was not clear whether the requirement that an institution be an applicant under the SBIR program modified both ownership interest and salary, royalties or other remuneration. The exception for financial interests in business enterprises has been split to clarify that the per annum measurement applies only to salary, royalties or other payments not reasonably expected to exceed $10,000 per annum. In addition, the dollar limits have been changed >From $5,000 to $10,000 and the applicability of the alternative measures of $10,000 in value or five percent ownership interest, has been clarified. These changes have been made in response to a large number of comments stating that the $5,000 limit was too low. A majority of those comments indicated that $10,000 would be an appropriate figure, particularly since the experience of state universities in California, and some other universities, is that interests up to this amount do not raise conflict of interest concerns. The reference to determining the value of equity interests on the basis of public prices or other reasonable measures of fair market value was adapted from a similar provision in the proposed FDA rule on conflict of interest (59 FR 48708 et seq., September 22, 1994). 6. Section 50.604(a) has been revised to clarify that the Institution must maintain an appropriate written, enforced conflict of interest policy (this parallels NSF language) and that the Institution must make reasonable efforts to ensure compliance with the regulations by Investigators working for subgrantees and contractors, either by including those Investigators in the Institution's policy or by receiving appropriate assurances from their employers. This latter change was recommended in several comments and is consistent with current regulations and policies on the applicability of grant terms and conditions to subgrantees and contractors. 7. In response to many comments, paragraph (a)(3) (redesignated as paragraph (c)) of 50.604 has been changed from requiring the institution to "ensure" that investigators have disclosed all Significant Financial Interest to simply "require" disclosures by each investigator. In addition, in response to several comments and for uniformity with the NSF guidelines, this paragraph has been revised to require disclosure, by the time an application is submitted to PHS, of those Significant Financial Interests attributable to the Investigator that would reasonably appear to be affected by the research, including interests in entities whose financial interests would reasonably appear to be affected by the research. This change eliminates the need to cross-reference the description of a conflict interest in 50.605(a). Also, the changes in this section and in 50.604(c) and 50.605(a) will result in a slightly broader disclosure by the Investigator than under the NPRM. The institutional official(s) will review the disclosures and determine which disclosed interests could directly and significantly affect the design, conduct or reporting of the research, necessitating the management, reduction or elimination of the conflict of interest. In addition, in response to a significant number of comments, the reference to "pendency" of the award has been changed to "period" of the award. Paragraph (a)(5) of 50.604 (redesignated as paragraph (e)) has been changed to delete the requirement that records be identifiable to each award, and to refer to the applicable retention requirements in the HHS grants administration regulations. The former change has been made for conformity with the NSF policy, and the latter change clarifies that the recordkeeping requirements of these regulations are intended to be consistent with the HHS grants administration regulations. The change in paragraph (f) of 50.604 (formerly paragraph (a)(6)) has also been made for conformity with the NSF policy. 8. In response to many comments, 50.604(a)(7)(ii), now redesignated as (g)(2), has been revised to reduce the burden on institutions and ensure that the application does not have to state whether a conflict of interest has been found. Rather, the provision now requires the applicant to certify that action will be taken, prior to the institution's expenditure of any funds under the award, to report to the PHS awarding component the existence of a conflicting interest and assure that the interest has been managed, reduced or eliminated in accordance with the regulations. The commentors felt that review of an application would be biased if the application indicated there was a conflict of interest and that, in any case, it would not be feasible for an institution to review the disclosed financial interests and determine whether a conflict of interest was present in the limited time available prior to submission of the application. In addition, the previous 50.604(a)(8)(i) has been incorporated into 50.604(g)(2) with minor changes. Many commentors felt that the 60 day period for management of a conflict of interest found after the award should be doubled. However, the 60 day period does not seem unreasonable, since we have clarified that it is measured >From the time the institution identifies the conflict of interest and that only interim action is required by the end of the 60 day period. As stated in the NPRM, section 493A of the PHS Act imposes a continuing obligation on awardees to identify conflicts of interest in clinical research projects and report their management, reduction or elimination. This and other statutory requirements for clinical research have been applied to all PHS-funded research in order to avoid confusion and provide for uniform PHS reporting requirements. We would not expect this reporting requirement to be burdensome, as only a few conflicts of interest are likely to be identified after the award. Section 50.604(a)(8)(ii) has been incorporated into 50.606(b), because the review of records referenced in the former section is directly related to the inquiry into actions regarding conflicts of interest addressed in the latter section. Section 50.604(a)(8)(iii) has been deleted as duplicative of the statement in the definition of "Significant Financial Interest" ( 50.603), that salary, royalties or other remuneration from the institution is not considered a Significant Financial Interest. Under current regulations and policies governing applications for PHS research grants, if the applicant receives non-PHS grant support for the same project to be supported by the PHS award, the grant must be listed in the "Other Support" section of the application for PHS support. 9. Section 50.605(a) has been revised to clarify that the institutional official(s) must identify and manage, reduce or eliminate any conflicts of interest. Consistent with the language in the NSF guidelines, this provision states that a conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. As noted above in the discussion of the changes to 50.604(c), Investigators must disclose those Significant Financial Interests that would reasonably appear to be affected by the research and the institutional official must decide which of those interests are conflicting under the standard prescribed in 50.605(a). This change is intended to more clearly define and limit the types of financial interests that must be managed, reduced or eliminated because they are considered to be conflicting interests. In response to a few comments, the clause introducing the examples of methods for managing, reducing or eliminating conflicts has been clarified by adding after "include," the phrase "but are not limited to." 10. In 50.606, the first sentence has been deleted because it essentially duplicated the provision in proposed 50.604(a)(6). In the next sentence, the term "employee" has been changed to the defined term "Investigator" and, in response to a comment, the phrase "or to be taken" has been added at the end of the sentence. In addition, paragraph (b) has been rewritten to incorporate 50.604(b), because the two provisions were somewhat duplicative. 11. Many commentors were concerned about what they considered to be a significant underestimation of the annual reporting and recordkeeping burden. In response, burdens have been further reduced by raising the dollar threshold for financial interests that are considered Significant Financial Interests subject to the regulations, and by amending 50.604(g)(2) to require the reporting of a conflict of interest and its management, reduction or elimination only after an award has been made (but before any expenditure of funds). In addition, the estimated annual reporting and record keeping burden has been recalculated in light of these changes and the public comments. 12. Many commentors urged uniformity with the NSF guidelines, but indicated the pursuit of that end should not interfere with necessary changes to the NPRM. As noted above, many of the changes result in greater uniformity between these regulations and the NSF guidelines. The few remaining differences between these regulations and the NSF guidelines are based upon requirements in section 493A of the PHS Act, 42 U.S.C. 289b-1, and differences between the grant programs and experiences under those programs. The effective date for these regulations, October 1, 1995, is the same as the effective date for the NSF guidelines. Although some commentors felt that a longer lead time would be necessary to enable institutions to prepare for implementation of the regulations, we believe the time period provided is ample, particularly because institutions have had since June 28, 1994, to prepare for implementation of the similar provisions of the NSF guidelines and because many institutions already have conflict of interest procedures. Comments Not Resulting in Any Changes 1. Title. Two commentors felt that the title of the regulations should be changed to focus upon investigator financial disclosure or conflict of interest. These are not inappropriate titles, but we have chosen to focus the title upon the desired outcome of the review of investigator financial disclosures, that is, objectivity in the design, conduct and reporting of the research. 2. 50.602 Applicability. Several commentors recommended that the regulations be limited to clinical research. As explained in the preamble to the NPRM, experience indicates that financial conflicts of interest can arise in all types of research. It is expected that the risk of a conflict of interest will be higher in clinical research than in other types of research, but we have concluded that the latter risk is sufficiently likely that pertinent financial interests should be disclosed and reviewed. In response to a specific request for comments on the NSF exemption >From its conflict of interest policy for grantees employing fifty persons or less, it was generally agreed by those responding that PHS-funded investigators working for small entities may be just as subject to conflicts of interest as investigators working at large institutions. This view is consistent with the PHS experience referred to in the preamble of the NPRM. The NSF experience has differed, apparently because of the differences between the research funding that is provided to small entities by HHS and NSF. 3. 50.603 Definitions. Investigator. There were diverse comments on the definition of the term, "Investigator." Although one commentor supported the approach of the NPRM of leaving it to the institutions to determine who are persons "responsible for the design, conduct, or reporting" of the PHS funded research, others felt that the definition should offer more guidance on who would fall within that category. It was recommended that the term be limited to Principal Investigators, Co- Principal Investigators, and faculty collaborators and that students and technical staff be excluded. It was also recommended that administrators be excluded by limiting the definition to the "scientific design" of the research. The definition of Investigator has not been changed, except for deleting the phrase "at the institution," as explained above. The degree to which individuals are responsible for the design, conduct, or reporting of the PHS- funded research will vary. In some circumstances students, technical personnel and administrators may not be "responsible," but in other circumstances, they may be, in that they are given responsibility for a task that could have a significant effect on the design, conduct or reporting of the research. Based on their knowledge of the specific circumstances, we believe the institutions are in the best position to determine who is responsible for the design, conduct or reporting of the research to such a degree that his/her financial interests should be reviewed. Significant Financial Interest. As noted above, the public comments led to several changes in this definition. There were a number of other detailed comments that were not adopted, primarily because they would have: complicated the definition and its application (e.g., have different threshold levels for publicly traded equity interests and those not so traded, differentiate between large and small companies, and adopt criteria for determining reasonably anticipated future value); led to a long, cumbersome list of additional exclusions (e.g., exclude copyright that is not licensable, mutual funds, pensions, and reimbursement for expenses); or were based upon a misunderstanding of the definition and its effect (some apparently did not understand that any remuneration an investigator receives >From the applicant institution was excluded). Some commentors questioned the exclusion of ownership interests in SBIR applicants. No change has been made in response to that comment because we believe such ownership interests are apparent to PHS funding agencies based on the application. Furthermore, the exclusion does not prohibit institutions from adopting more rigorous standards, if they wish to do so. The definition of Significant Financial Interest alone does not delineate what the investigator must disclose or what the institution must manage, reduce or eliminate. The Investigator must consider all Significant Financial Interests, but need disclose only those that would reasonably appear to be affected by the research proposed for funding by the PHS, including the Investigator's financial interest in entities whose interests would be affected. Following this disclosure, the institutional official must determine, on the basis of the regulatory standard, whether there are conflicting interests that need to be managed, reduced, or eliminated. We think it is appropriate to have a relatively broad range of financial interests considered by the Investigator in making his/her determination of those that must be disclosed. In this manner, broad consideration of possibly conflicting interests is assured with minimal burdens, since only a limited number of interests need to be disclosed and an even smaller number will need to be managed, reduced or eliminated. There were a number of comments recommending different thresholds than those that were adopted, including a threshold adjusted for inflation. The threshold amounts adopted were recommended in many comments and seem to represent a reasonable balance between the need to consider a broad range of financial interests and the burdens imposed upon the investigators and the institutions. 4. 50.604. Many commented that the requirement for updating financial disclosures (in 50.604(c) of these regulations) needed to be clarified. The provision, which has not been changed, except for a minor word change, states that financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained. We believe this language is reasonably clear in conveying that the institutions have the option of adopting either of two methods for investigators to report changes in financial interests during the period of the PHS award: reporting on an annual basis any changes in the previously reported financial interests; or requiring investigators to update disclosures as new reportable Significant Financial Interests are obtained. An annual reporting requirement would serve as a reminder for investigators to review their prior disclosures, but it might be burdensome if in fact there are no changes and it could result in delayed reporting as compared to the alternative. This burden would be eliminated by the other reporting alternative, but there would be no annual reminder to investigators to review and update their disclosures. The weighing of these factors and the decision are left to the institutions. The reference to "new reportable Significant Financial Interests" is intended to include financial interests that become reportable due to an increase in value that meets the reporting threshold, as well as the acquisition of new interests that are reportable. Of course, both types of interests are subject to disclosure by the investigator only if they meet the criteria in 50.604(c). It was recommended that the requirement in 50.604(g)(2) for the reporting to the PHS Awarding Component of the existence of a conflicting interest be changed to conform with the NSF approach that requires such reporting only "if the institution finds that it is unable to satisfactorily manage an actual or potential conflict of interest." As stated in the NPRM, section 493A of the Public Health Service Act requires that institutions report conflicting interests for clinical research projects. To avoid disparate requirements for clinical and nonclinical research, the regulations apply this reporting requirement to all PHS-funded research. 5. 50.606. One commentor felt that the notification required in paragraph (a) should go to HHS, rather than to the PHS Awarding Component. Because PHS Awarding Components are responsible for the award and have delegated authority, it is appropriate for those components to receive notifications and to act on them. On the other hand, paragraph (b) refers to HHS inquiries into institutional procedures and actions because such audit type activities may be conducted by HHS components other than the awarding agencies. As is made clear in the definitions, the term HHS encompasses all components of the Department, including the PHS Awarding Components. A number of commentors objected to the requirement for submission of records to the HHS, fearing that the confidentiality of such records could not be assured. 45 CFR 74.53 already gives the HHS a right of access to all records pertinent to grants, which would include the records relating to financial conflicts of interest of investigators carrying out the PHS-funded research. It is expected that the PHS funding agencies will not often require the submission of records or retain copies from audits at the institution, but when that occurs the records will be maintained confidentially. In addition, although a few commentors objected to the reference to suspension of funding pending the resolution of a conflicting interest determined by the PHS awarding agency as biasing the objectivity of the research, that provision has been retained and a reference to the regulatory authority for the suspension has been added. Such suspension action would be necessary to protect Federal funds only in unusual situations, but we believe awardees subject to the regulations should be notified of the potential for such action. Responses to Questions on Alternatives. The NPRM requested specific comments on the following issues: (1) whether the regulations should address institutional conflicts of interest, as well as individual conflicting interests and, if so, how; (2) what types of financial interests should be disclosed; (3) whether the disclosed financial interests should include financial interests in products that would compete with the product or potential product of the PHS-funded research; (4) whether an employee's equity or other nonsalary financial interests in an applicant institution should be excluded from the definition of Significant Financial Interest; and (5) whether there should be an exemption for all compensation other than that tied to the outcome of the research. Most of the commentors addressed at least some of these issues. Those comments are summarized below. Institutional Conflicts Those addressing this issue were nearly unanimous in concluding that the regulations should not address the institutional conflict of interest issue because of the need to carefully consider that issue through a separate process. We agree with that conclusion. The comments on the alternatives for addressing institutional conflicts of interest will be considered separately from this rulemaking. Competing Products Over 30 commentors opposed any requirement for disclosing financial interests in entities or products that would compete with the PHS- funded research. Twelve commentors supported investigator disclosure of such competing entities or products, but some felt that the disclosure should be limited to those financial interests in competitors or competing products known to the investigator. As revised, the regulation would not specifically require the disclosure of such interests, but, depending upon the circumstances, those interests might come within the definition of the financial interests that must be disclosed. In clinical research, it is probable that a financial interest in a product that competes with the product being evaluated could reasonably appear to be affected by the PHS-funded research. Such a relationship is much less probable where the PHS funding is for basic research. Types of Financial Interests Disclosed Most of the comments on this issue are summarized above in the discussion of comments on the definition of Significant Financial Interests and on the financial interests that must be disclosed. The financial interests to be disclosed must be known to the investigator and determined by him/her to be a financial interest that would reasonably appear to be affected by the PHS-funded research or to be a financial interest in an entity whose financial interest would reasonably appear to be affected by the research. This criterion would, in most cases, require that the financial disclosure be relevant to biomedical research or health care, as was recommended by one commentor, but the disclosure would not necessarily be limited to those fields, because other types of financial interests could reasonably appear to be affected by the PHS-funded research. Exclusion of Financial Interests There were few specific comments on the questions relating to the exclusion from the definition of Significant Financial Interest of equity interests in, or compensation from, the applicant institution. The general comments on the definition emphasized the need for limiting disclosures to financial interests related to the research proposed for PHS funding. We are retaining the exclusion for all remuneration paid to an investigator by an applicant institution and the exclusion of any ownership interest in the applicant institution if it is an applicant under the SBIR or STTR program. We have not expanded the exclusion for ownership interests to encompass all institutions, because we believe there may be situations in which an ownership interest in a for-profit applicant could be in conflict with the investigator's responsibility for the conduct of the PHS- funded research and that ownership interest should be subject to appropriate institutional review. Experience under the regulations may prove this reasoning to be incorrect. If so, we will consider appropriate amendments to the regulations. Regulatory Impact The Department has concluded that this rule is not economically significant under Executive Order 12866 and that it thus does not require the development of a comprehensive benefit-cost analysis. While we agree with comments received that the initial estimate of implementation costs was low, none of these comments indicated that the costs would exceed $100 million annually; in addition, changes made in the final regulations will reduce implementation costs. Commentors did not provide any evidence that the rule will hamper desirable research or otherwise have an adverse effect on the conduct of research under PHS-funded grants or on the consequent technological progress that is so important to the Nation's economy. Executive Order 12866 requires that the Office of Management and Budget (OMB) review all regulations that may create a serious inconsistency with or otherwise interfere with an action taken or planned by another Federal agency. This rule was thus reviewed by OMB and coordinated with the policy of the NSF on this subject (see the notice of technical changes in NSF policy published elsewhere in this issue of the Federal Register). The Department prepares a regulatory flexibility analysis, in accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. chapter 6), if a rule is expected to have a significant impact on a substantial number of small entities. Although we have not followed the NSF approach of exempting entities with 50 or fewer employees, we have concluded that the regulation will not have a significant impact on small entities. Any such effect is mitigated by the provisions of the regulations and the fact that the regulations impose obligations primarily on those receiving grants that can be used, in part (amounts for indirect costs), to offset the costs of compliance with the regulatory requirements. The regulations do not apply to SBIR and STTR Phase I applications. These programs are for small businesses and the Phase I grants are for limited amounts. Phase II grants are for larger amounts and thus more funds would be available for meeting the costs of compliance. Furthermore, we have changed the regulations to reduce burdens and costs of compliance for all entities subject to the regulations by eliminating more financial interests from consideration and by reducing burdens upon institutions through changes in the certification requirements. Institutions do not have to take action to identify, report and manage conflicting interests until after being notified by the PHS Awarding Agency of its decision to award funds. For the same reasons, this rule will not create an unfunded mandate on State-owned institutions and thus would not trigger the requirements of Executive Order 12875 on "Enhancing the Intergovernmental Partnership." The proposed rule has been changed to significantly reduce burdens on institutions and, as noted above, institutions will be able to use amounts awarded for indirect costs to meet the costs of implementing the regulations. Paperwork Reduction Act The final rules contain information collection requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1980. The title, description, and respondent description applicable to the information collection are shown below with an estimate of the annual reporting and record- keeping burden. These estimates have been revised in light of the comments on the proposed rules and the changes in the regulations. Consistent with the comments and a thorough consideration of the potential burdens imposed by the reporting, recordkeeping and disclosure requirements of the regulations, the statement of the burden has been reduced from that stated in the NPRM, based upon changes in the regulations that will significantly reduce the burdens on institutions and upon more accurate estimates of the burdens imposed by specific requirements. The mean hours per response for initial reports of conflicts of interest have been significantly increased to account for the review by the institution of all the financial disclosures relating to an award. Although not more than 200 reports of conflicts of interest are expected, the institutions will need to review all financial disclosures associated with PHS funding awards to determine whether or not any conflicts of interest exist. Thus, the total burden of 16,000 hours is based on estimates that it will take, on the average, four-fifths of an hour to review each of the 20,000 financial disclosures associated with PHS funding awards. If the number of disclosures is reduced because of the increase in the amount of the threshold for significance, the burden may be an overestimate. The burden for subsequent reports of conflicts (made during the twelve month period after the initial report) is significantly less, because we do not expect many additional reportable conflicts and there will be only a limited number of disclosures to review. We have significantly reduced the respondent number for reporting that failure of an investigator to comply with the institution's conflict of interest policy has biased the design, conduct or reporting of the research ( 50.606(a)). We have estimated there will be no more than five such instances and we think that is a generous estimate. For recordkeeping, we have listed the number of files expected to be necessary, rather than the number of institutions, because it will result in a more accurate estimation. The 20,000 figure is based upon 35,000 awards annually, reduced to account for those investigators who will not have any disclosures (no files are required to be established) and those investigators with more than one award. We have estimated it will take four hours, on the average, for the establishment and maintenance of each file. Although we believe this to be a very generous estimate, we note that it will include the time of both administrative and clerical personnel. The burden figures for informing each investigator of the institution's policy are based upon 2,000 recipient institutions and 20 hours for the performance of this function. This time burden could be reduced even further if institutions choose to inform investigators through a notice in the grant application procedures. This method of notification would be acceptable because the regulations do not specify the method of notification. The financial disclosures burden estimate ( 50.604(c)) is based upon an investigator figure of 35,000 with an average response time of one hour. We believe experience may show that the number of disclosures will be significantly less because of the increases in the reporting threshold. Note that we have not attempted to calculate the overall hours spent by the institution to establish the necessary administrative mechanisms to comply with the regulations. The estimates are for burdens imposed by disclosure, reporting and recordkeeping requirements, not all activities of an institution that may result from the regulations. Title: Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought. Description: The regulations would require each applicant/offeror Institution to establish procedures to identify and manage, reduce, or eliminate any conflicting financial interest of an Investigator involved in the design, conduct or reporting of the research for which PHS funding is sought. Description of Respondents: Public and private non-profit institutions, small business, and other for-profit organizations and investigators working for such institutions, businesses and organizations. ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN 42CFR 45CFR # Hrs Hrs Hrs tot Rspdnts p/rsp 42CFR 45CFR Reporting: 50.604(g)(2) 94.4(g)(2) 200 80.0 14,000 2,000 16,000 50.604(g)(2) 94.4(g)(2) 30 2.0 54 6 60 50.606(a) 94.6(a) 5 10.0 40 10 50 TOTAL: 16,110 Recordkeeping: 50.604(e) 94.4(e) 20,000 4 72,000 8,000 80,000 TOTAL: 80,000 Disclosure: 50.604(a) 94.4(a) 2,000 20.0 36,000 4,000 40,000 50.604(c) 94.4(c) 35,000 1 31,600 3,400 35,500 TOTAL: 75,000 TOTAL BURDEN: 171,110 In accordance with the requirements of the Paperwork Reduction Act of 1980, the Department of Health and Human Services has submitted the information collection requirements cited above to OMB for review and approval. Organizations and individuals desiring to submit comments on the information collection requirements and the estimated burden should direct such comments to the information address cited above and to: NIH/PHS Desk Officer, Office of Information and Regulatory Affairs, OMB, New Executive Office Building, room 10235, 725 17th St., N.W., Washington, DC 20503. Catalogue of Federal Domestic Assistance The rule will affect all extramural research, research and development, and research and development support funded by the Public Health Service. Questions about the rule should be directed to Dr. George J. Galasso, Associate Director for Extramural Affairs, National Institutes of Health, Building 1, Room 152, 9000 Rockville Pike, MSC 0154, BETHESDA, MD 20892-0154. The telephone number is (301) 496-5356 (this is not a toll-free number). List of Subjects 42 CFR Part 50 - Grant programs-health; Conflict of interest; Medical research; Behavioral, biological, biochemical, psychological and psychiatric research. 45 CFR Part 94 - Government procurement. Dated: Philip R. Lee, M.D. Assistant Secretary for Health Approved: Donna E. Shalala, Ph.D. Secretary Accordingly, 42 CFR Part 50 and 45 CFR Subtitle A are amended as set forth below: 1. Subpart F is added to 42 CFR Part 50 to read as follows: Subpart F--Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought 50.601 Purpose. 50.602 Applicability. 50.603 Definitions. 50.604 Institutional Responsibility Regarding Conflicting Interests of Investigators. 50.605 Management of Conflicting Interests. 50.606 Remedies. 50.607 Other HHS regulations that apply. Authority: 42 U.S.C. 216, 289b-1, 299c-3. 50.601 Purpose. This subpart promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator. 50.602 Applicability. This subpart is applicable to each Institution that applies for PHS grants or cooperative agreements for research and, through the implementation of this subpart by each Institution, to each Investigator participating in such research (see 50.604(a)); provided, that this subpart does not apply to SBIR Program Phase I applications. In those few cases where an individual, rather than an institution, is an applicant for PHS grants or cooperative agreements for research, PHS Awarding Components will make case-by-case determinations on the steps to be taken to ensure that the design, conduct, and reporting of the research will not be biased by any conflicting financial interest of the individual. 50.603 Definitions. As used in this subpart: "HHS" means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated. "Institution" means any domestic or foreign, public or private, entity or organization (excluding a Federal agency). "Investigator" means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding. For purposes of the requirements of this subpart relating to financial interests, "Investigator" includes the Investigator's spouse and dependent children. "PHS" means the Public Health Service, an operating division of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated. "PHS Awarding Component" means the organizational unit of the PHS that funds the research that is subject to this subpart. "Public Health Service Act" or "PHS Act" means the statute codified at 42 U.S.C. 201 et seq. "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development. As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority. "Significant Financial Interest" means anything of monetary value, including but not limited to, salary or other payments for services (e.g.,consulting fees or honoraria); equity interests (e.g.,stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include: (1) salary, royalties, or other remuneration from the applicant institution; (2) any ownership interests in the institution, if the institution is an applicant under the SBIR Program; (3) income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; (4) income from service on advisory committees or review panels for public or nonprofit entities; (5) an equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; or (6) salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000. "Small Business Innovation Research (SBIR) Program" means the extramural research program for small business that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564. 50.604 Institutional Responsibility Regarding Conflicting Interests of Investigators. Each Institution must: (a) Maintain an appropriate written, enforced policy on conflict of interest that complies with this subpart and inform each Investigator of that policy, the Investigator's reporting responsibilities, and of these regulations. If the Institution carries out the PHS-funded research through subgrantees, contractors, or collaborators, the Institution must take reasonable steps to ensure that Investigators working for such entities comply with this subpart, either by requiring those Investigators to comply with the Institution's policy or by requiring the entities to provide assurances to the Institution that will enable the Institution to comply with this subpart. (b) Designate an institutional official(s) to solicit and review financial disclosure statements from each Investigator who is planning to participate in PHS-funded research. (c) (1) Require that by the time an application is submitted to PHS each Investigator who is planning to participate in the PHS-funded research has submitted to the designated official(s) a listing of his/her known Significant Financial Interests (and those of his/her spouse and dependent children): (i) that would reasonably appear to be affected by the research for which PHS funding is sought; and (ii) in entities whose financial interests would reasonably appear to be affected by the research. (2) All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained. (d) Provide guidelines consistent with this subpart for the designated official(s) to identify conflicting interests and take such actions as necessary to ensure that such conflicting interests will be managed, reduced, or eliminated. (e) Maintain records of all financial disclosures and all actions taken by the Institution with respect to each conflicting interest for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR 74.53(b) for different situations. (f) Establish adequate enforcement mechanisms and provide for sanctions where appropriate. (g) Certify, in each application for the funding to which this subpart applies, that; (1) there is in effect at that Institution a written and enforced administrative process to identify and manage, reduce or eliminate conflicting interests with respect to all research projects for which funding is sought from the PHS, (2) prior to the Institution's expenditure of any funds under the award, the Institution will report to the PHS Awarding Component the existence of a conflicting interest (but not the nature of the interest or other details) found by the Institution and assure that the interest has been managed, reduced or eliminated in accordance with this subpart; and, for any interest that the Institution identifies as conflicting subsequent to the Institution's initial report under the award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification. (3) the Institution agrees to make information available, upon request, to the HHS regarding all conflicting interests identified by the Institution and how those interests have been managed, reduced, or eliminated to protect the research from bias; and (4) the Institution will otherwise comply with this subpart. 50.605 Management of Conflicting Interests. (a) The designated official(s) must: review all financial disclosures; and determine whether a conflict of interest exists and, if so, determine what actions should be taken by the institution to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the PHS- funded research. Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to: (1) public disclosure of significant financial interests; (2) monitoring of research by independent reviewers; (3) modification of the research plan; (4) disqualification from participation in all or a portion of the research funded by the PHS; (5) divestiture of significant financial interests; or (6) severance of relationships that create actual or potential conflicts. (b) In addition to the types of conflicting financial interests described in this paragraph that must be managed, reduced, or eliminated, an Institution may require the management of other conflicting financial interests, as the Institution deems appropriate. 50.606 Remedies. (a) If the failure of an Investigator to comply with the conflict of interest policy of the Institution has biased the design, conduct, or reporting of the PHS-funded research, the Institution must promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the funded project. (b) The HHS may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in PHS-funded research, including a requirement for submission of, or review on site, all records pertinent to compliance with this subpart. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records and/or other information that may be available, the PHS Awarding Component may decide that a particular conflict of interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that the Institution has not managed, reduced, or eliminated the conflict of interest in accordance with this subpart. The PHS Awarding Component may determine that suspension of funding under 45 CFR 74.62 is necessary until the matter is resolved. (c) In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not disclosed or managed as required by this subpart, the Institution must require the Investigator(s) involved to disclose the conflicting interest in each public presentation of the results of the research. 50.607 Other HHS regulations that apply. Several other regulations and policies apply to this subpart. They include, but are not necessarily limited to: 42 CFR Part 50, Subpart D---Public Health Service grant appeals procedure 45 CFR Part 16---Procedures of the Departmental Grant Appeals Board 45 CFR Part 74---Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Non- Profit Organizations, and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments and Indian Tribal Governments 45 CFR Part 76---Government-wide debarment and suspension (non- procurement) 45 CFR Part 79---Program Fraud Civil Remedies 45 CFR Part 92---Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments 2. A new Part 94 is added to 45 CFR, Subtitle A, to read as follows: 45 CFR Part 94--Responsible Prospective Contractors 94.1 Purpose. 94.2 Applicability. 94.3 Definitions. 94.4 Institutional Responsibility Regarding Conflicting Interests of Investigators. 94.5 Management of Conflicting Interests. 94.6 Remedies. Authority: 42 U.S.C. 216, 289b-1, 299c-3. 94.1 Purpose. This part promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research to be performed under PHS contracts will be biased by any conflicting financial interest of an Investigator. 94.2 Applicability. This part is applicable to each Institution that seeks PHS funding for research and, through the implementation of this part, to each Investigator who participates in such research (see 94.4(a)); provided that this part does not apply to SBIR Program Phase I applications. 94.3 Definitions. As used in this part: "Contractor" means an entity that provides property or services for the direct benefit or use of the Federal Government. "HHS" means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated. "Institution" means any public or private entity or organization (excluding a Federal agency) (1) that submits a proposal for a research contract whether in response to a solicitation from the PHS or otherwise, or (2) that assumes the legal obligation to carry out the research required under the contract. "Investigator" means the principal investigator and any other person who is responsible for the design, conduct, or reporting of a research project funded by PHS, or proposed for such funding. For purposes of the requirements of this part relating to financial interests, "Investigator" includes the Investigator's spouse and dependent children. "PHS" means the Public Health Service, an operating division of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated. "Public Health Service Act" or "PHS Act" mean the statute codified at 42 U.S.C. 201 et seq. "PHS Awarding Component" means an organizational unit of the PHS that funds research that is subject to this part. "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development. As used in this part, the term includes any such activity for which funding is available from a PHS Awarding Component, whether authorized under the PHS Act or other statutory authority. "Significant Financial Interest" means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include: (1) salary, royalties, or other remuneration from the applicant institution; (2) any ownership interests in the institution, if the institution is an applicant under the SBIR program; (3) income from seminars, lectures, or teaching engagements sponsored by pubic or nonprofit entities; (4) income from service on advisory committees or review panels for public or nonprofit entities; (5) an equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; or (6) salary, royalties or other payments that when aggregated for the investigator and the investigator's spouse and dependent children over the next twelve months, are not reasonably expected to exceed $10,000. "Small Business Innovation Research (SBIR) Program" means the extramural research program for small business that is established by the awarding components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this part, the term SBIR Program includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564. 94.4 Institutional Responsibility Regarding Conflicting Interests of Investigators. Each Institution must: (a) Maintain an appropriate written, enforced policy on conflict of interest that complies with this part and inform each Investigator of that policy, the Investigator's reporting responsibilities, and of these regulations. If the Institution carries out the PHS-funded research through subcontractors, or collaborators, the Institution must take reasonable steps to ensure that Investigators working for such entities comply with this part, either by requiring those Investigators to comply with the Institution's policy or by requiring the entities to provide assurances to the Institution that will enable the Institution to comply with this part. (b) Designate an institutional official(s) to solicit and review financial disclosure statements from each Investigator who is planning to participate in PHS-funded research. (c) (1) Require that by the time an application is submitted to PHS, each Investigator who is planning to participate in the PHS-funded research has submitted to the designated official(s) a listing of his/her known Significant Financial Interests (and those of his/her spouse and dependent children): (i) that would reasonably appear to be affected by the research for which PHS funding is sought; and (ii) in entities whose financial interests would reasonably appear to be affected by the research. (2) All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained. (d) Provide guidelines consistent with this part for the designated official(s) to identify conflicting interests and take such actions as necessary to ensure that such conflicting interests will be managed, reduced, or eliminated. (e) Maintain records of all financial disclosures and all actions taken by the Institution with respect to each conflicting interest for three years after final payment or, where applicable, for the other time periods specified in 48 CFR Part 4 Subpart 4.7. (f) Establish adequate enforcement mechanisms and provide for sanctions where appropriate. (g) Certify, in each contract proposal, that: (1) there is in effect at that Institution a written and enforced administrative process to identify and manage, reduce or eliminate conflicting interests with respect to all research projects for which funding is sought from the PHS; (2) prior to the Institution's expenditure of any funds under the award, the Institution will report to the PHS Awarding Component the existence of any conflicting interest (but not the nature of the interest or other details) found by the Institution and assure that the interest has been managed, reduced or eliminated in accordance with this part; and, for any interest that the Institution identifies as conflicting subsequent to the Institution's initial report under the award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification. (3) the Institution agrees to make information available, upon request, to the HHS regarding all conflicting interests identified by the Institution and how those interests have been managed, reduced, or eliminated to protect the research from bias; and (4) the Institution will otherwise comply with this part. 94.5 Management of Conflicting Interests. (a) The designated official(s) must: review all financial disclosures and determine whether a conflict of interest exists, and if so, what actions should be taken by the institution to manage, reduce, or eliminate such conflict of interest. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the PHS- funded research. Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to: (1) public disclosure of significant financial interests; (2) monitoring of the research by independent reviewers; (3) modification of the research plan; (4) disqualification from participation in all or a portion of the research funded by the PHS; (5) divestiture of significant financial interests, or; (6) severance of relationships that create actual or potential conflicts. (b) In addition to the types of conflicting financial interests described in this paragraph that must be managed, reduced, or eliminated, an Institution may require the management of other conflicting financial interests, as the Institution deems appropriate. 94.6 Remedies (a) If the failure of an Investigator to comply with the conflict of interest policy of the Institution has biased the design, conduct, or reporting of the PHS-funded research, the Institution must promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the funded project. (b) The HHS may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in PHS-funded research, including a review of all records pertinent to compliance with this part. HHS may require submission of the records or review them on site. To the extent permitted by law HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records and/or other information that may be available, the PHS Awarding Component may decide that a particular conflict of interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that the Institution has not managed, reduced, or eliminated the conflict of interest in accordance with this part. The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved. (c) In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not disclosed or managed as required by this part, the Institution must require disclosure of the conflicting interest in each public presentation of the results of the research. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** COMPLETION OF INVESTIGATION NIH GUIDE, Volume 24, Number 25, July 14, 1995 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 completed an investigation and DOES NOT find scientific misconduct in the following case: David Plotkin, M.D., Memorial Cancer Research Foundation of Southern California: The Division of Research Investigations (DRI), Office of Research Integrity (ORI), investigated allegations that clinical trial data forms submitted from the Memorial Cancer Research Foundation of Southern California (MCRF), Los Angeles, California, contained falsified and fabricated information. The data forms were submitted to the Statistical Office of the National Surgical Adjuvant Breast and Bowel Project (NSABP) located at the University of Pittsburgh. The NSABP project at MCRF received funding from the National Cancer Institute (NCI), with Dr. David Plotkin as Principal Investigator. In mid April 1994, the Chicago Tribune obtained a copy of an April 1990 NSABP Audit Report that indicated there was a ~serious problem . . . with respect to the accuracy of the data reported to the NSABP~ >From the MCRF. A Chicago Tribune reporter reviewed records on some subjects entered on NSABP trials at MCRF and found apparent discrepancies between reported data and medical records. Much of the questioned data was related to the B-06 clinical trial which compared lumpectomy (with or without radiation therapy) to total mastectomy for the treatment of breast cancer. ORI reviewed records and data on 59 patients reported to NSABP between 1973 and 1994 and did not find falsification, fabrication, or deliberate misrepresentation on the part of Dr. Plotkin or his staff. ORI found that many of the discrepancies originally identified by the NSABP and the Chicago Tribune were the result of a review of incomplete records, honest error on the part of one or more of the participating parties, or differences in interpretations or judgments of the facts. 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 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 24, Number 25, July 14, 1995 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: Gloria Clayton, R.N., Ed.D., Medical College of Georgia: The Division of Research Investigations (DRI) of the Office of Research Integrity (ORI) reviewed an investigation report, forwarded by the Medical College of Georgia, into possible scientific misconduct on the part of Gloria Clayton, R.N., Ed.D., Professor of Adult Nursing at the Medical College of Georgia. ORI found that Dr. Clayton fabricated the existence of subjects and associated data under a subcontract with the Gerontology Center at the University of Georgia for research entitled "Adaptation and Mental Health of the Oldest Old," supported by the National Institute of Mental Health. Dr. Clayton, who has admitted this fabrication, has accepted the ORI findings and agreed to a Voluntary Exclusion Agreement. Under the Agreement, Dr. Clayton is not eligible to apply for or receive any Federal grant or contract funds or to serve on any Public Health Service Advisory Committee, Board or peer review committee for a three-year period beginning May 25, 1995. In addition, Dr. Clayton has agreed to cooperate with the University of Georgia and the Medical College of Georgia in the submission of letters of correction to appropriate journals for publications shown to contain the fabricated data. Barbara Jones, St. Mary's Hospital, Montreal: The Office of Research Integrity (ORI) conducted an investigation into possible scientific misconduct on the part of Ms. Barbara Jones while a data coordinator at St. Mary's Hospital, Montreal, Quebec. ORI concluded that Ms. Jones committed scientific misconduct by falsifying and fabricating the dates of tests or examinations required prior to study entry for two women entered on the Breast Cancer Prevention Trial (BCPT). The BCPT is coordinated by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and supported by the National Cancer Institute and the National Heart, Lung, and Blood Institute. Because the BCPT is still in progress, no conclusions or results have been published and no clinical recommendations have been based on the results of the study. Ms. Jones did not contest the ORI findings or administrative actions which require that, for a period of three years, any institution which proposes Ms. Jones' participation in PHS-supported research must submit a supervisory plan designed to ensure the scientific integrity of her contribution. Ms. Jones is also prohibited from serving in any advisory capacity to the PHS for a period of three years. Farooq A. Siddiqui, Ph.D., Roswell Park Cancer Institute: The Division of Research Investigations (DRI) of the Office of Research Integrity (ORI) completed an investigation into possible scientific misconduct on the part of Dr. Siddiqui while he was an employee of Roswell Park Memorial Institute. ORI finds that Dr. Siddiqui committed scientific misconduct by misrepresenting data in a published article. The research was supported by a grant award from the National Cancer Institute, National Institutes of Health, Public Health Service (PHS). Dr. Siddiqui agreed not to appeal the misconduct finding as part of a Voluntary Settlement Agreement under which, for a period of two years, he will not apply as a principal or coprincipal investigator in any nonprocurement transactions (grants and cooperative agreements) or as a principal or coprincipal in any contract or subcontract with the United States Government. Dr. Siddiqui also is prohibited from serving on any Public Health Service advisory committee, board, and/or peer review committee for a period of two years. Also, for a two-year period the institution where he is employed will supervise his performance of work on any covered transaction including a periodic review of primary data, and certify the accuracy of any such data used in any United States Government Public Health Service grant application, contract proposal, or which is otherwise publicly reported. He has agreed to submit a letter to the journal Biochemica et Biophysica Acta (BBA) to retract the article entitled "Purification and Immunological Characterization of DNA Polymerase-alpha from Human Acute Lymphoblastic Leukemia Cells" (BBA, 745:154-161, 1983). 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 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** ADDENDUM - ALZHEIMER'S DISEASE CORE CENTER GRANTS NIH GUIDE, Volume 24, Number 25, July 14, 1995 RFA: AG-95-004 P.T. 04; K.W. 0715180, 0710030, 0755030, 0765033, 0745020, 0745070 National Institute on Aging Letter of Intent Receipt Date: August 1, 1995 Application Receipt Date: September 15, 1995 The National Institute on Aging (NIA) announces the following modification to RFA AG-95-004, which was published in the NIH Guide, Vol. 24, No. 14, April 14, 1995. FUNDS AVAILABLE The direct costs requested in the first year for new applications may not exceed $600,000. Competing renewal applications may not request more than a 10 percent increase over the final year of funding in the current award or $600,000, whichever is higher. The cap on direct From owner-sci-resources@net.bio.net Sun Jul 16 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 16 July 1995 Date: 17 Jul 1995 11:57:55 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 134 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3uebrj$r6d@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: International Document Title: INT 95-017 - . Computers at Japanese Public Primary and Secondary Schools File size (bytes): STIS Filename: int95017.txt Also available: int95017.doc Title: INT 95-018 - Japan's Inter-Ministry Research Information Network File size (bytes): STIS Filename: int95018.txt Also available: int95018.doc Title: INT 95-19 NEDO'S INDUSTRIAL TECHNOLOGY RESEARCHER PROGRAM File size (bytes): STIS Filename: int95019.txt Also available: int95019.doc Title: INT 95-15-20 -1995 Summer Institute Program in Japan File size (bytes): STIS Filename: int95020.txt Also available: int95020.doc Document Type: Press Release Title: ONE OF EARTH’S GREAT CRUSTAL PLATES CRACKING IN TWO File size (bytes): STIS Filename: pr9547.txt Document Type: Program Guideline Title: NSF 95-116 - Multidisciplinary Research in Optical Science and Engineering File size (bytes): STIS Filename: nsf95116.txt Document Type: Recruit Title: Director, Division of Earth Sciences File size (bytes): STIS Filename: vep9511c.txt Title: Director, Division of Earth Sciences File size (bytes): STIS Filename: vep9511i.txt Title: Director, Division of Earth Sciences File size (bytes): STIS Filename: vep9511l.txt Title: Biologist (Science Assistant) File size (bytes): STIS Filename: vex9529.txt Title: Legal Analyst (FOIA, Ethics and Information) File size (bytes): STIS Filename: vgs95111.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: General Publication Title: NSF 94-91 -- Guide to Programs Fiscal Year 1995 File size (bytes): 15691 STIS Filename: nsf9491a.txt Title: NSF 94-91--Guide to Programs Fiscal Year 1995 File size (bytes): 55408 STIS Filename: nsf9491b.txt Title: NSF 94-91 -- Guide to Programs Fiscal Year 1995 File size (bytes): 86069 STIS Filename: nsf9491e.txt Document Type: Program Guideline Title: NSF 93-131 -- Elementary, Secondary, and Informal Education File size (bytes): 163035 STIS Filename: nsf93131.txt Title: NSF 95-109 ENGINEERING CAREER Matching & Base Funds Guidelines File size (bytes): 10090 STIS Filename: nsf95109.txt Also available: nsf95109.doc ------------------------------------------------------------------------ ** 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 nsf95109.txt, the text of your message should be as follows: get nsf95109.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf95109.txt, you would enter: ftp> get nsf95109.txt 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 Jul 24 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 26, pt. 1of1, 21 July 1995 Date: 24 Jul 1995 13:35:52 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 270 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3v1078$ons@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950721 V24N26 P1O1 ************************************ X-comment: RFAs described: PA-95-076, PAR-95-077 X-URL: gopher://gopher.nih.gov/11/res/nih-guide/guide-files/95.07.21 NIH GUIDE - Vol. 24, No. 26 - July 21, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIAAA ADDITIONAL INFORMATION TO THE NIH CAREER DEVELOPMENT PROGRAM ANNOUNCEMENTS (K AWARDS) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX P1 ********************************************************** MARIJUANA/CANNABIS ABUSE RESEARCH (PA-95-076) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY (PAR-95-077) National Cancer Institute INDEX: CANCER 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 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIAAA ADDITIONAL INFORMATION TO THE NIH CAREER DEVELOPMENT PROGRAM ANNOUNCEMENTS (K AWARDS) NIH GUIDE, Volume 24, Number 26, July 21, 1995 P.T. 34; K.W 0404003, 0710030 National Institute on Alcohol Abuse and Alcoholism This addition to the National Institutes of Health (NIH) career development program announcements (K Awards) provides additional information for potential applicants on the unique aspects of National Institute on Alcohol Abuse and Alcoholism (NIAAA) career development programs. The NIH program announcements addressed in this supplement are PA-95-049, Mentored Research Scientist Development Award (K01); PA-95-050, Independent Scientist Award (K02); PA-95-051, Senior Scientist Award (K05); PA-95-052, Academic Career Award (K07); and PA-95-053, Mentored Clinical Scientist. Development Award (K08). The guidelines and procedure outlined in the NIH program announcements must be followed closely when an application is being prepared for submission to the NIAAA. Particular attention should be paid to the purpose of each award mechanism, its eligibility requirements, and its review considerations. The NIAAA supports only the development, not the leadership award, aspect of the K07 Award and only for clinical faculty to develop careers in clinical research and teaching. NIAAA Program Guidelines for the K07 Award are essential for one to develop a competitive application and must be obtained from NIAAA staff. Potential applicants should contact appropriate NIAAA staff for further information on this and other K Awards. The RESEARCH OBJECTIVES section of each program announcement should be followed carefully during the preparation of an application. Note especially that differences exist among various NIH Institutes regarding allowable costs. The unique aspects of NIAAA allowable costs, specifically in the categories of salary (all Ks) and research development support (K01, K07, K08) or research support (K02, K05), are listed below. Salary (all Ks) The NIAAA contribution to the Principal Investigator's salary is geared to the institutional base salary as follows: Institutional Base Salary NIAAA Contribution o Up to $45,000 100% of institutional base o $45,001 to $60,000 $45,000 o $60,001 and over 75% of institutional base salary, up to $75,000 Research Development Support (K01, K07, K08) The NIAAA allows up to $50,000 per year for the expenses outlined in each program announcement. Research Support (K02, K05) The NIAAA allows requests for funds up to $25,000 per year for those applications from individuals who are engaged in predominantly theoretical work, such as modeling or computer simulation, as outlined in each program announcement. INQUIRIES Consultation with NIAAA staff is encouraged, especially during the planning phase of the application. Below are the names of the NIAAA staff who can provide further information: Dr. Ernestine Vanderveen, 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) 443-1273 FAX: (301) 594-0673 Email: Tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8774 Email: Fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: Mdufour@willco.niaaa.nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$P1 BEGIN PA-95-076 FULL-TEXT ************************************** MARIJUANA/CANNABIS ABUSE RESEARCH NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA AVAILABLE: PA-95-076 P.T. 34; K.W. 0404001, 0710030, 0414015, 0404009 National Institute on Drug Abuse PURPOSE This program announcement encourages research across the broad area of marijuana/cannabis abuse. The abuse of marijuana is a significant problem, shows little evidence of abatement, and may still be increasing in scope. Based on a review of information available and the research supported by the National Institute on Drug Abuse (NIDA), this program announcement identifies many areas of research that are particularly in need of development. Investigators from many scientific disciplines are encouraged to apply either individually (R01, R03, R29) or collectively (P01). HEALTHY PEOPLE 2000 The 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, Marijuana/Cannabis Abuse Research, is related to priority area of alcohol and other drugs. 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 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. Lynda Erinoff, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A20 Rockville, MD 20857 Telephone: (301) 443-1263 Email: LERINOFF@AOADA.SSW.DHHS.GOV $$P1 END ************************************************************ $$P2 BEGIN PAR-95-077 FULL-TEXT ************************************* SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA AVAILABLE: PAR-95-077 P.T. 34; K.W. 0715035, 0785055 National Cancer Institute PURPOSE The Division of Cancer Etiology, National Cancer Institute, invites small grant (R03) applications relating to cancer epidemiology. These are short-term awards, not to exceed three years, intended to provide support for pilot projects, testing of new techniques, or development of innovative or high-risk projects that could provide a basis for more extended research. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Small Grants Program for Epidemiology, is related to the priority areas of cancer and chronic diseases. 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 consideration, 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. A. R. Patel Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 535, MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Email: Jason@EPNDCE.NCI.NIH.GOV $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Mon Jul 24 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 26, pt. 1of1, 21 July 1995 Date: 24 Jul 1995 13:49:04 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 270 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3v1100$phf@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950721 V24N26 P1O1 ************************************ X-comment: RFAs described: PA-95-076, PAR-95-077 X-URL: gopher://gopher.nih.gov/11/res/nih-guide/guide-files/95.07.21 NIH GUIDE - Vol. 24, No. 26 - July 21, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIAAA ADDITIONAL INFORMATION TO THE NIH CAREER DEVELOPMENT PROGRAM ANNOUNCEMENTS (K AWARDS) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX P1 ********************************************************** MARIJUANA/CANNABIS ABUSE RESEARCH (PA-95-076) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY (PAR-95-077) National Cancer Institute INDEX: CANCER 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 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIAAA ADDITIONAL INFORMATION TO THE NIH CAREER DEVELOPMENT PROGRAM ANNOUNCEMENTS (K AWARDS) NIH GUIDE, Volume 24, Number 26, July 21, 1995 P.T. 34; K.W 0404003, 0710030 National Institute on Alcohol Abuse and Alcoholism This addition to the National Institutes of Health (NIH) career development program announcements (K Awards) provides additional information for potential applicants on the unique aspects of National Institute on Alcohol Abuse and Alcoholism (NIAAA) career development programs. The NIH program announcements addressed in this supplement are PA-95-049, Mentored Research Scientist Development Award (K01); PA-95-050, Independent Scientist Award (K02); PA-95-051, Senior Scientist Award (K05); PA-95-052, Academic Career Award (K07); and PA-95-053, Mentored Clinical Scientist. Development Award (K08). The guidelines and procedure outlined in the NIH program announcements must be followed closely when an application is being prepared for submission to the NIAAA. Particular attention should be paid to the purpose of each award mechanism, its eligibility requirements, and its review considerations. The NIAAA supports only the development, not the leadership award, aspect of the K07 Award and only for clinical faculty to develop careers in clinical research and teaching. NIAAA Program Guidelines for the K07 Award are essential for one to develop a competitive application and must be obtained from NIAAA staff. Potential applicants should contact appropriate NIAAA staff for further information on this and other K Awards. The RESEARCH OBJECTIVES section of each program announcement should be followed carefully during the preparation of an application. Note especially that differences exist among various NIH Institutes regarding allowable costs. The unique aspects of NIAAA allowable costs, specifically in the categories of salary (all Ks) and research development support (K01, K07, K08) or research support (K02, K05), are listed below. Salary (all Ks) The NIAAA contribution to the Principal Investigator's salary is geared to the institutional base salary as follows: Institutional Base Salary NIAAA Contribution o Up to $45,000 100% of institutional base o $45,001 to $60,000 $45,000 o $60,001 and over 75% of institutional base salary, up to $75,000 Research Development Support (K01, K07, K08) The NIAAA allows up to $50,000 per year for the expenses outlined in each program announcement. Research Support (K02, K05) The NIAAA allows requests for funds up to $25,000 per year for those applications from individuals who are engaged in predominantly theoretical work, such as modeling or computer simulation, as outlined in each program announcement. INQUIRIES Consultation with NIAAA staff is encouraged, especially during the planning phase of the application. Below are the names of the NIAAA staff who can provide further information: Dr. Ernestine Vanderveen, 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) 443-1273 FAX: (301) 594-0673 Email: Tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8774 Email: Fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: Mdufour@willco.niaaa.nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$P1 BEGIN PA-95-076 FULL-TEXT ************************************** MARIJUANA/CANNABIS ABUSE RESEARCH NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA AVAILABLE: PA-95-076 P.T. 34; K.W. 0404001, 0710030, 0414015, 0404009 National Institute on Drug Abuse PURPOSE This program announcement encourages research across the broad area of marijuana/cannabis abuse. The abuse of marijuana is a significant problem, shows little evidence of abatement, and may still be increasing in scope. Based on a review of information available and the research supported by the National Institute on Drug Abuse (NIDA), this program announcement identifies many areas of research that are particularly in need of development. Investigators from many scientific disciplines are encouraged to apply either individually (R01, R03, R29) or collectively (P01). HEALTHY PEOPLE 2000 The 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, Marijuana/Cannabis Abuse Research, is related to priority area of alcohol and other drugs. 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 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. Lynda Erinoff, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A20 Rockville, MD 20857 Telephone: (301) 443-1263 Email: LERINOFF@AOADA.SSW.DHHS.GOV $$P1 END ************************************************************ $$P2 BEGIN PAR-95-077 FULL-TEXT ************************************* SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA AVAILABLE: PAR-95-077 P.T. 34; K.W. 0715035, 0785055 National Cancer Institute PURPOSE The Division of Cancer Etiology, National Cancer Institute, invites small grant (R03) applications relating to cancer epidemiology. These are short-term awards, not to exceed three years, intended to provide support for pilot projects, testing of new techniques, or development of innovative or high-risk projects that could provide a basis for more extended research. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Small Grants Program for Epidemiology, is related to the priority areas of cancer and chronic diseases. 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 consideration, 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. A. R. Patel Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 535, MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Email: Jason@EPNDCE.NCI.NIH.GOV $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Mon Jul 24 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 26, pt. 1of1, 21 July 1995 Date: 24 Jul 1995 16:57:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 270 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3v1c0n$4qi@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950721 V24N26 P1O1 ************************************ X-comment: RFAs described: PA-95-076, PAR-95-077 X-URL: gopher://gopher.nih.gov/11/res/nih-guide/guide-files/95.07.21 NIH GUIDE - Vol. 24, No. 26 - July 21, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIAAA ADDITIONAL INFORMATION TO THE NIH CAREER DEVELOPMENT PROGRAM ANNOUNCEMENTS (K AWARDS) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX P1 ********************************************************** MARIJUANA/CANNABIS ABUSE RESEARCH (PA-95-076) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY (PAR-95-077) National Cancer Institute INDEX: CANCER 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 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIAAA ADDITIONAL INFORMATION TO THE NIH CAREER DEVELOPMENT PROGRAM ANNOUNCEMENTS (K AWARDS) NIH GUIDE, Volume 24, Number 26, July 21, 1995 P.T. 34; K.W 0404003, 0710030 National Institute on Alcohol Abuse and Alcoholism This addition to the National Institutes of Health (NIH) career development program announcements (K Awards) provides additional information for potential applicants on the unique aspects of National Institute on Alcohol Abuse and Alcoholism (NIAAA) career development programs. The NIH program announcements addressed in this supplement are PA-95-049, Mentored Research Scientist Development Award (K01); PA-95-050, Independent Scientist Award (K02); PA-95-051, Senior Scientist Award (K05); PA-95-052, Academic Career Award (K07); and PA-95-053, Mentored Clinical Scientist. Development Award (K08). The guidelines and procedure outlined in the NIH program announcements must be followed closely when an application is being prepared for submission to the NIAAA. Particular attention should be paid to the purpose of each award mechanism, its eligibility requirements, and its review considerations. The NIAAA supports only the development, not the leadership award, aspect of the K07 Award and only for clinical faculty to develop careers in clinical research and teaching. NIAAA Program Guidelines for the K07 Award are essential for one to develop a competitive application and must be obtained from NIAAA staff. Potential applicants should contact appropriate NIAAA staff for further information on this and other K Awards. The RESEARCH OBJECTIVES section of each program announcement should be followed carefully during the preparation of an application. Note especially that differences exist among various NIH Institutes regarding allowable costs. The unique aspects of NIAAA allowable costs, specifically in the categories of salary (all Ks) and research development support (K01, K07, K08) or research support (K02, K05), are listed below. Salary (all Ks) The NIAAA contribution to the Principal Investigator's salary is geared to the institutional base salary as follows: Institutional Base Salary NIAAA Contribution o Up to $45,000 100% of institutional base o $45,001 to $60,000 $45,000 o $60,001 and over 75% of institutional base salary, up to $75,000 Research Development Support (K01, K07, K08) The NIAAA allows up to $50,000 per year for the expenses outlined in each program announcement. Research Support (K02, K05) The NIAAA allows requests for funds up to $25,000 per year for those applications from individuals who are engaged in predominantly theoretical work, such as modeling or computer simulation, as outlined in each program announcement. INQUIRIES Consultation with NIAAA staff is encouraged, especially during the planning phase of the application. Below are the names of the NIAAA staff who can provide further information: Dr. Ernestine Vanderveen, 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) 443-1273 FAX: (301) 594-0673 Email: Tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8774 Email: Fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: Mdufour@willco.niaaa.nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$P1 BEGIN PA-95-076 FULL-TEXT ************************************** MARIJUANA/CANNABIS ABUSE RESEARCH NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA AVAILABLE: PA-95-076 P.T. 34; K.W. 0404001, 0710030, 0414015, 0404009 National Institute on Drug Abuse PURPOSE This program announcement encourages research across the broad area of marijuana/cannabis abuse. The abuse of marijuana is a significant problem, shows little evidence of abatement, and may still be increasing in scope. Based on a review of information available and the research supported by the National Institute on Drug Abuse (NIDA), this program announcement identifies many areas of research that are particularly in need of development. Investigators from many scientific disciplines are encouraged to apply either individually (R01, R03, R29) or collectively (P01). HEALTHY PEOPLE 2000 The 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, Marijuana/Cannabis Abuse Research, is related to priority area of alcohol and other drugs. 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 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. Lynda Erinoff, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A20 Rockville, MD 20857 Telephone: (301) 443-1263 Email: LERINOFF@AOADA.SSW.DHHS.GOV $$P1 END ************************************************************ $$P2 BEGIN PAR-95-077 FULL-TEXT ************************************* SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA AVAILABLE: PAR-95-077 P.T. 34; K.W. 0715035, 0785055 National Cancer Institute PURPOSE The Division of Cancer Etiology, National Cancer Institute, invites small grant (R03) applications relating to cancer epidemiology. These are short-term awards, not to exceed three years, intended to provide support for pilot projects, testing of new techniques, or development of innovative or high-risk projects that could provide a basis for more extended research. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Small Grants Program for Epidemiology, is related to the priority areas of cancer and chronic diseases. 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 consideration, 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. A. R. Patel Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 535, MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Email: Jason@EPNDCE.NCI.NIH.GOV $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Mon Jul 24 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 26, pt. 1of1, 21 July 1995 Date: 24 Jul 1995 17:13:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 270 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3v1cvh$5kg@net.bio.net> $$XID NIHGUIDE 19950721 V24N26 P1O1 ************************************ X-comment: RFAs described: PA-95-076, PAR-95-077 X-URL: gopher://gopher.nih.gov/11/res/nih-guide/guide-files/95.07.21 NIH GUIDE - Vol. 24, No. 26 - July 21, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIAAA ADDITIONAL INFORMATION TO THE NIH CAREER DEVELOPMENT PROGRAM ANNOUNCEMENTS (K AWARDS) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX P1 ********************************************************** MARIJUANA/CANNABIS ABUSE RESEARCH (PA-95-076) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY (PAR-95-077) National Cancer Institute INDEX: CANCER 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 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIAAA ADDITIONAL INFORMATION TO THE NIH CAREER DEVELOPMENT PROGRAM ANNOUNCEMENTS (K AWARDS) NIH GUIDE, Volume 24, Number 26, July 21, 1995 P.T. 34; K.W 0404003, 0710030 National Institute on Alcohol Abuse and Alcoholism This addition to the National Institutes of Health (NIH) career development program announcements (K Awards) provides additional information for potential applicants on the unique aspects of National Institute on Alcohol Abuse and Alcoholism (NIAAA) career development programs. The NIH program announcements addressed in this supplement are PA-95-049, Mentored Research Scientist Development Award (K01); PA-95-050, Independent Scientist Award (K02); PA-95-051, Senior Scientist Award (K05); PA-95-052, Academic Career Award (K07); and PA-95-053, Mentored Clinical Scientist. Development Award (K08). The guidelines and procedure outlined in the NIH program announcements must be followed closely when an application is being prepared for submission to the NIAAA. Particular attention should be paid to the purpose of each award mechanism, its eligibility requirements, and its review considerations. The NIAAA supports only the development, not the leadership award, aspect of the K07 Award and only for clinical faculty to develop careers in clinical research and teaching. NIAAA Program Guidelines for the K07 Award are essential for one to develop a competitive application and must be obtained from NIAAA staff. Potential applicants should contact appropriate NIAAA staff for further information on this and other K Awards. The RESEARCH OBJECTIVES section of each program announcement should be followed carefully during the preparation of an application. Note especially that differences exist among various NIH Institutes regarding allowable costs. The unique aspects of NIAAA allowable costs, specifically in the categories of salary (all Ks) and research development support (K01, K07, K08) or research support (K02, K05), are listed below. Salary (all Ks) The NIAAA contribution to the Principal Investigator's salary is geared to the institutional base salary as follows: Institutional Base Salary NIAAA Contribution o Up to $45,000 100% of institutional base o $45,001 to $60,000 $45,000 o $60,001 and over 75% of institutional base salary, up to $75,000 Research Development Support (K01, K07, K08) The NIAAA allows up to $50,000 per year for the expenses outlined in each program announcement. Research Support (K02, K05) The NIAAA allows requests for funds up to $25,000 per year for those applications from individuals who are engaged in predominantly theoretical work, such as modeling or computer simulation, as outlined in each program announcement. INQUIRIES Consultation with NIAAA staff is encouraged, especially during the planning phase of the application. Below are the names of the NIAAA staff who can provide further information: Dr. Ernestine Vanderveen, 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) 443-1273 FAX: (301) 594-0673 Email: Tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8774 Email: Fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: Mdufour@willco.niaaa.nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$P1 BEGIN PA-95-076 FULL-TEXT ************************************** MARIJUANA/CANNABIS ABUSE RESEARCH NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA AVAILABLE: PA-95-076 P.T. 34; K.W. 0404001, 0710030, 0414015, 0404009 National Institute on Drug Abuse PURPOSE This program announcement encourages research across the broad area of marijuana/cannabis abuse. The abuse of marijuana is a significant problem, shows little evidence of abatement, and may still be increasing in scope. Based on a review of information available and the research supported by the National Institute on Drug Abuse (NIDA), this program announcement identifies many areas of research that are particularly in need of development. Investigators from many scientific disciplines are encouraged to apply either individually (R01, R03, R29) or collectively (P01). HEALTHY PEOPLE 2000 The 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, Marijuana/Cannabis Abuse Research, is related to priority area of alcohol and other drugs. 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 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. Lynda Erinoff, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A20 Rockville, MD 20857 Telephone: (301) 443-1263 Email: LERINOFF@AOADA.SSW.DHHS.GOV $$P1 END ************************************************************ $$P2 BEGIN PAR-95-077 FULL-TEXT ************************************* SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA AVAILABLE: PAR-95-077 P.T. 34; K.W. 0715035, 0785055 National Cancer Institute PURPOSE The Division of Cancer Etiology, National Cancer Institute, invites small grant (R03) applications relating to cancer epidemiology. These are short-term awards, not to exceed three years, intended to provide support for pilot projects, testing of new techniques, or development of innovative or high-risk projects that could provide a basis for more extended research. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Small Grants Program for Epidemiology, is related to the priority areas of cancer and chronic diseases. 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 consideration, 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. A. R. Patel Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 535, MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Email: Jason@EPNDCE.NCI.NIH.GOV $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Mon Jul 24 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-077 - V24(26) 07/21/95 Date: 24 Jul 1995 17:13:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 248 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3v1cvh$5kh@net.bio.net> $$XID RFA PAR95077 PAR-95-077 P1O1 ************************************* SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA NUMBER: PAR-95-077 P.T. 34; K.W. 0715035, 0785055 National Cancer Institute Purpose The Division of Cancer Etiology, National Cancer Institute (NCI), invites small grant (R03) applications relating to cancer epidemiology. These are short-term awards intended to provide support for pilot projects, testing of new techniques, or development of innovative or high-risk projects that could provide a basis for more extended research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Small Grants Program for Epidemiology, is related to the priority area of cancer and chronic diseases. 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 not-for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, eligible agencies of Federal government, and small businesses. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support of this program announcement will be through individual research project grants (R03). This is a revision of a program announcement. This program was initiated in 1986, and modified in 1988 to increase the funding for individual grants from $25,000 to $50,000 in direct costs for the entire project. The total project period for applications submitted in response to this program announcement may not exceed three years. RESEARCH OBJECTIVES Investigators may apply for a small grant to support research on a topic relevant to cancer etiology for the purpose of: o Planning a complex epidemiologic investigation; o Developing or validating a laboratory or statistical procedure that has the potential for improving the quality of cancer epidemiologic research; o Obtaining support to study a question relevant to cancer epidemiology in situations in which rapid funding is needed, such as the availability of special personnel for limited time periods, rapidly evolving research leads on topics such as AIDS, or time- limited access to an important resource; o Analyzing previously collected data for epidemiologic purposes, such as combining data from several studies to examine consistency or strength of observed associations; o Resolving methodologic problems, such as documenting the accuracy of a customary procedure in preparation for use in epidemiologic research or evaluating the effect of cancer diagnosis and/or treatment on risk factor estimates derived from case-control studies; or o Obtaining funding for investigations of urgent or emergent issues in cancer epidemiology. o Applications for support of dissertation research may receive a small grant. Applications for support of purposes other than those stated will be returned to the proposed Principal Investigator without undergoing committee review. 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 on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication and reprinted in the NIH Guide for Grants and Contracts of March 18, 1994, Volume 23, Number 11. Investigators also may obtain copies of the policy from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning this policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) 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, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Submit a signed, typewritten original of the application, including the checklist, and three exact photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) In addition, in order to expedite the review of the application, submit two additional exact photocopies, of the application to: Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636, MSC 7405 6130 Executive Boulevard Bethesda, MD 20892-7405 REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score. Review Criteria o The significance of the goal of the proposed research; o The practicality and likelihood of accomplishing the small grant aims; o The value of the information the investigator proposes to derive >From the small grant, in the context of the research goal; o The adequacy and appropriateness of the methodology for achieving the purposes of the small grant; o The investigator's background and training for carrying out the proposed activities; o The appropriateness of the research team and the evidence of their effective interaction for the proposed research; o The adequacy of the facilities and resources available to the project; o The adequacy of specific budget justifications; 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 human subjects and animal welfare and the safety of the research environment. AWARD CRITERIA Applications will compete for funds with other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; and o Program priority and balance INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. A. R. Patel Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 535, MSC 7395 6130 Executive Boulevard Bethesda, MD 20892-7395 Telephone: (301) 496-9600 FAX: (301) 402-4279 Email: Jason@EPNDCE.NCI.NIH.GOV Direct inquiries regarding fiscal matters to: Mr. E. C. Melvin Grants Management Branch National Cancer Institute Executive Plaza South, Suite 243, MSC 7150 6120 Executive Boulevard Bethesda, MD 20892-7150 Telephone: (301) 496-7800, EXT 258 FAX: (301) 496-8601 Email: MELVINE@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, Cancer Cause and Prevention 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 990158, 42 USC 241 and 285) and administered under HHS policies and grant regulations. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. 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 Jul 24 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-076 - V24(26) 07/21/95 Date: 24 Jul 1995 17:13:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 460 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3v1cvh$5ki@net.bio.net> $$XID RFA PA95076 PA-95-076 P1O1 *************************************** MARIJUANA/CANNABIS ABUSE RESEARCH NIH GUIDE, Volume 24, Number 26, July 21, 1995 PA NUMBER: PA-95-076 P.T. 34; K.W. 0404001, 0710030, 0414015, 0404009 National Institute on Drug Abuse PURPOSE This program announcement encourages research across the broad area of marijuana/cannabis abuse. The abuse of marijuana is a significant problem, shows little evidence of abatement, and may still be increasing in scope. Based on a review of information available and the research supported by the National Institute on Drug Abuse (NIDA), this program announcement identifies many areas of research that are particularly in need of development. Investigators from many scientific disciplines are encouraged to apply either individually (e.g., as individual projects) or collectively (e.g., as a program project). 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, Marijuana/Cannabis Abuse Research, is related to priority area of alcohol and other drugs. 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, research institutions, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) Awards or program project grants (P01). MECHANISM OF SUPPORT Support mechanisms are research project grants (R01), small grants (R03), FIRST (R29) awards, and program project grants (P01). Because the nature and scope of the research proposed in this program announcement may vary, it is anticipated the size of an award will vary also. RESEARCH OBJECTIVES The term "marijuana abuse" is used to describe a variety of drug abuse behaviors that include the use of cannabis and its derivatives in all forms and in combination with other drugs. Research areas of interest include, but are limited to, the following: I. Etiology: Genetic, Social, Cultural, Behavioral,Neurobiological, and Environmental Research is needed to determine the interactions of neurobiologic, genetic, behavioral, social and cultural, and environmental factors and processes in association with the initiation, continuation, and, discontinuation of marijuana abuse and dependence in both cross sectional and longitudinal designs. Investigators are encouraged to use a physiological, sociocultural and behavioral developmental perspective in these studies, recognizing the differential impact of factors at various stages of human development and the impact of cannabis abuse at these different developmental stages. Research opportunities exist to investigate the neurobiological bases for the behavioral risk factors leading to the development of marijuana abuse especially with respect to initiation, compulsive use and dependence, and withdrawal. Also, the elucidation of biobehavioral factors involved in the discontinuation of marijuana abuse is necessary to more fully understand the process of abuse for this drug. Studies could focus on the genetic and/or other neurobiological factors contributing to drug-seeking behavior, as well as other neurobiological correlates involved in placing an individual at risk of initiating and maintaining marijuana use, and in turn, leading to possible dependence. Conversely, studies on the neurobiological factors that might "protect" an individual from the typical pathogenesis of drug addiction are important. Also of particular importance are studies to examine the contribution of the use of tobacco and alcohol and other possible early causal determinants on the simultaneous or subsequent use of cannabis, especially the changes that these substances might have on brain systems leading to drug vulnerability. Where possible, to examine the contribution of marijuana use to the use of other both licit and illicit substances. Studies could focus on how such factors as lack of family support, family violence, abuse and neglect, lack of positive role models, poor parental supervision, parental drug use, breakdown of the extended family system, association with peer groups and the socioeconomic status as well as medical illnesses/disabilities (e.g., ADHD, ADD, and other psychiatric disorders) affect initiation, continuation, and escalation of marijuana use among individuals, particularly among children and adolescents. Moreover, factors that mitigate or protect against drug involvement should also be considered for study. Studies could also focus on cultural values and attitudes toward marijuana use, acculturation related stress, or loss of cultural identification of minority individuals, of the existence of subcultures of marijuana use, crosscultural etiology (local, endemic or worldwide). In addition environmental factors such as drug availability and distribution networks, recreational and employment opportunities, negative social sanctioning and attitudes within society, gangs, religion on the use of marijuana/cannabis should be considered. The impact of negative psychological, developmental, and psycho- pathological factors, such as self-esteem, depression, aggressive behavior, coping styles should be studied as they influence the use of drugs. Of particular interest are studies of factors that establish resiliency and protection for children at high risk but who do not abuse drugs such as marijuana. Such studies might lead to the early identification of those at risk of marijuana use or identify motivating factors responsible for the cessation of marijuana use. II. Epidemiology Studies are needed to provide a definitive understanding of the patterns and prevalence of marijuana use through cross-sectional and natural history methods among high-risk youth, school drop-outs, gang members, children of drug users, and homeless youth. Research is needed to determine the prevalence of marijuana use among children, adolescents and young adults in various settings including primary care settings (HMOs, hospital-based and community-based clinics, and emergency rooms), social service agencies, college campuses, etc.. Moreover, these studies should focus on the short- and long-term social, behavioral, and health consequences of marijuana use on the individual users, their families, and on the community. The interrelationship between marijuana abuse and other deviant behaviors should be examined as well as school performance and attendance, the dynamics associated with different consequences relative to marijuana abuse, bases for endemic patterns of abuse and diminished use of marijuana. Furthermore, studies need to be conducted to assess users' values, beliefs, and routines and their perceptions as to the social, behavioral, and health consequences of their marijuana using behaviors. III. Prevention Intervention Marijuana abuse prevention intervention research scientifically approaches the causes, onset and progression of marijuana use in order to design, develop, and test theory-based prevention interventions focused upon the individual, family, peer group, and community (school, workplace, neighborhood). These studies may focus on intervening in early childhood behaviors and characteristics found to be associated with high risk users and abusers such as attention deficit disorders, conduct disorders, hyperactivity, and learning deficits. Primary goals of intervention research are to develop a scientifically-sound knowledge base concerning the effectiveness of marijuana use and abuse prevention policies and programs, and develop and test innovative intervention strategies that can be delivered in a variety of settings to include the school, communities, and the workplace. Special settings such as school based health clinics and in primary care settings would require methods for the detection of children who are at risk of drug abuse. Randomized controlled and quasi-experimental designs are encouraged. Prevention intervention research should focus on one of three strategies: universal (which focus on populations not identified on the basis of individual risk to drug use/abuse), selective (which target populations at risk) and, indicated (which target groups who have detectable signs, symptoms or behaviors indicative of drug use). Methodological studies are encouraged to develop valid and reliable markers and measures of key variables; unified approaches to the collection and utilization of both qualitative and quantitative data; accurate measures of both cost and benefits of prevention programming; data analysis procedures suitable to measure changes in key variables over time; and, innovative techniques to assess diffusion of preventive practices. IV. Treatment Treatment of marijuana abuse and dependence has not been adequately studied. Only a few therapies have been adapted for treating marijuana abuse and dependence and studied for efficacy mostly in adults. Therefore, investigators should give increased attention to developing new strategies and improving existing therapeutic approaches. Studies should focus on treatment designed specifically for primary marijuana abuse or dependence as well as dependence secondary to alcohol or other drug abuse or dependence. Subgroups of interest include children and adolescents, and women who are pregnant, individuals with co-occurring medical and/or mental disorders, and those involved in criminal activities. Investigators should scientifically study the efficacy of behavioral therapies including counseling, psychotherapy, relapse prevention, family and group therapy, social skills training, as approaches for the treatment of marijuana abuse and dependency and associated correlative health and social consequences. Because many marijuana users do not want treatment or do not believe they need to control their marijuana consumption, increased attention should be given to developing therapies that focus on individuals that incorporate precontemplation and contemplation stages of change as well as developing therapies for the action and maintenance stages as well as stepped care models of treatment. Attention should be given to therapies for use in settings distinct from standard drug abuse treatment programs such as primary health care or office-based mental health settings. Outreach strategies, alone and in combination with case management, should be examined in terms of enlisting and maintaining marijuana abusers in treatment and rehabilitation programs. Related research might also examine the form and extent to which professional, legal, economic, and administrative factors relate to the accessibility and effectiveness of therapeutic programs and supportive services that are already available. Additionally, research should be directed toward developing screening and assessment techniques that would include biological, self-report and other diagnostic tools related to criteria specific to marijuana abuse. Other studies should identify pre-existing and co-existing neurobiological, psychosocial and environmental factors that significantly impact on treatment outcomes. Furthermore, additional research is needed on the prevalence of marijuana use among clients in treatment for other drugs of abuse and the role marijuana abuse plays on progress in treatment and in relapse after treatment. V. Clinical and Basic Science Short- and long-term sequelae have been correlated with marijuana abuse, including cognitive impairment, cardiac disease, pulmonary disorders, endocrine and reproductive disorders, as well as cancer. However, many of these observations are based on case reports or studies that have methodological limitations. Further research needs to evaluate medical sequelae and neuropsychological/neuropsychiatric and neurobiological consequences of marijuana abuse incorporating epidemiologic, clinical and natural history approaches; evaluate associated learning difficulties and other consequences of cognitive impairment as well as alteration in motivation as both a cause and a consequence of marijuana use, and clarify the role of psychiatric disorders as both a cause and a consequence of marijuana abuse. The impact of duration of use and chronicity of use also needs to be clarified. Opportunities exist to study the neurobiological effects of marijuana and its active component, delta-9- tetrahydrocannabinol, on the brain anatomy, physiology and chemistry. Brain imaging and other noninvasive techniques allow for the direct study of marijuana abuse on specific brain systems, and direct correlations now can be made between marijuana's effects on the brain and behavioral changes. Particularly important are human studies assessing the effects of chronic, long-term marijuana use on structure and function of the brain. HIV infection, sexually transmitted diseases, tuberculosis, and hepatic disease, (e.g., hepatitis B, C) are prevalent among illicit drug abusers and have been linked with both needle use and risky sexual practices. As drug abusers have polydrug patterns that often include marijuana, investigations of relationships between marijuana abuse and the transmission and pathophysiology of these diseases are needed. There is a strong interest in assessing the association of marijuana use, particularly chronic use, and impaired immune function. Studies are needed to examine chronic use of marijuana and exacerbation of medical and health consequences in immune-compromised individuals such as in cases of HIV infection, cancer, and organ transplantation. Animal studies of marijuana consequences should attempt to model human exposure and should include studies of marijuana smoke (containing many different constituent compounds including cannabinoids and tars) as well as drug interactions. Given that marijuana use is frequently accompanied by alcohol use, studies on this interaction are particularly encouraged. Studies in animals should evaluate potential adverse consequences of marijuana exposure such as effects on fetal development, pulmonary function, immune function, and carcinogenicity. Animal research should explore CNS effects of both acute and chronic exposure to marijuana and related compounds, including THC and anandamide. These studies should identify the neural pathways, receptor subtypes mediating cannabinomimetic effects, and mechanism of action. The biological and environmental factors contributing to vulnerability to marijuana abuse should also be explored in animal and human laboratory studies. Studies of interest also include parallel animal and human behavioral and biological evaluations of the effects of marijuana exposure on learning, memory, and performance across the life span. This includes developmentally appropriate measures of cognitive and performance effects of acute and chronic marijuana use in human and animal studies on learning and memory, motor function, and perception. Additional behavioral developmental studies should address effects on motivational and emotional states as well as social interaction. 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 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 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. 5/95) 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. 5/95) instructions. Application kits are available at most institutional offices of sponsored research and from the Office of Grant Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone (301) 435-0714. The title and number of the program announcement must be typed in Section 2a on the face page of the application. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be reviewed for scientific and technical merit by a peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score and receive a second level review by the appropriate national advisory council. Review Criteria o scientific, technical, or clinical 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 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 Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of 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: Lynda Erinoff, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A20 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1263 Email: LERINOFF@AOADA.SSW.DHHS.GOV Direct inquiries regarding fiscal matters to: Dr. Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-55 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," Title 45 CFR part 74 & 92, "Administration of Grants," and 45 CFR Part 46, "Protection of Human Subjects." Title 42 CFR Part 2 "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Awards must be administered in accordance with the PHS Grants Policy Statement, (rev. 4/94), which may be available from your office of sponsored research. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. 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 Tue Jul 25 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 23 July 1995 Date: 25 Jul 1995 17:08:26 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 132 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3v411q$uv@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: International Document Title: INT 95-022 Japan's Science and Technology Week File size (bytes): STIS Filename: int95022.txt Also available: int95022.doc Document Type: News Title: Media Tipsheet July 14, 1995 File size (bytes): 4823 STIS Filename: tip50714.txt Document Type: Press Release Title: HIGH-ABILITY COLLEGE STUDENTS OFFERED NSF GRADUATE RESEARCH FELLOWSHIPS File size (bytes): STIS Filename: pr9548.txt Title: OUTSTANDING SCIENCE STUDENTS AWARDED NSF MINORITY GRADUATE FELLOWSHIPS File size (bytes): STIS Filename: pr9549.txt Document Type: Program Guideline Title: NSF 95-111 Grant Opportunities for Academic Liaison with Industry File size (bytes): STIS Filename: ns95111a.txt Title: NSF 95-111 Grant Opportunities for Academic Liaison with Industry File size (bytes): STIS Filename: ns95111b.txt Title: NSF 95-111 Grant Opportunities for Academic Liaison with Industry File size (bytes): STIS Filename: ns95111c.txt Title: NSF 95-107 POSTDOCTORAL RESEARCH FELLOWSHIPS IN CHEMISTRY File size (bytes): STIS Filename: nsf95107.txt Title: NSF 95-112 - Grant Opportunities for Academic Liaison with Industry File size (bytes): STIS Filename: nsf95112.txt Title: NSF 95-117 - Conferences, Workshops, and Special Years in the Mathematical Sciences File size (bytes): STIS Filename: nsf95117.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: News Title: Media Tipsheet July 14, 1995 File size (bytes): 4823 STIS Filename: tip50714.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 108111 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 105161 STIS Filename: phnorg.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 51075 STIS Filename: sesvac.txt Title: Biologist (Science Assistant) File size (bytes): 5406 STIS Filename: vex9529.txt ------------------------------------------------------------------------ ** 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 vex9529.txt, the text of your message should be as follows: get vex9529.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vex9529.txt, you would enter: ftp> get vex9529.txt 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 Jul 28 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 27, pt. 1of1, 28 July 1995 Date: 28 Jul 1995 17:36:45 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 660 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3vbvqt$gtr@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950728 V24N27 P1O1 ************************************ X-comment: RFAs described: PAR-95-078, PA-95-079, PA-95-080 X-URL: gopher://gopher.nih.gov/11/res/nih-guide/guide-files/95.07.28 NIH GUIDE - Vol. 24, No. 27, - July 28, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** REVISED PHS 398 GRANT APPLICATION FORM AVAILABLE National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N3 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N4 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX P1 ********************************************************** SMALL GRANTS FOR CLINICAL TRIALS IN DIGESTIVE AND NUTRITIONAL DISORDERS (PAR-95-078) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P2 ********************************************************** PATHOPHYSIOLOGY OF ANOREXIA IN DISEASE AND AGING (PA-95-079) National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Deafness and Other Communication Disorders National Institute on Aging National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute of Mental Health INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; DEAFNESS, OTHER COMMUNICATIONS DISORDERS; AGING; CHILD HEALTH, HUMAN DEVELOPMENT; ALLERGY, INFECTIOUS DISEASES, MENTAL HEALTH $$INDEX P3 ********************************************************** INFORMED CONSENT IN CLINICAL MENTAL HEALTH RESEARCH (PA-95-080) National Institute of Mental Health INDEX: MENTAL HEALTH 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 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** REVISED PHS 398 GRANT APPLICATION FORM AVAILABLE NIH GUIDE, Volume 24, Number 27, July 28, 1995 P.T. 34; K.W. 1014006 National Institutes of Health The revised (5/95) PHS 398 grant application form is now available, and should be used for receipt dates beginning September 1,1995, and must be used for the receipt date of January 1, 1996, and thereafter. A major change in the new PHS 398 is the format of the application kit. The form pages are not attached to the instruction booklet. Therefore, applicants are encouraged to retain the instruction booklet for use with future applications. The instruction booklet has been reformatted so that the specific instructions for completing the application appear first, followed by sample form pages and general information about submitting an application. The third section contains definitions, assurances, and other relevant information, including the Division of Research Grants, NIH, Grants Information Office publication list. The last two sections contain additional information about research career awards and institutional training grants. Other major changes include: (1) stating that applicants are not to contact consultants (page 22); (2) having the applicant organization signature on the face page certify compliance with all applicable assurances and certifications in the application; (3) clarifying the Other Support format page by redefining terms and providing sample items; (4) deleting several personnel items (e.g., birthdate and SSN) for new applications; (5) expanding the additional instructions (Section IV) to include all research career awards (K series); (6) providing a new receipt date chart (page 21); (7) expanding the foreword to include information about the NIH Guide for Grants and Contracts, the Grants Information Office, the PHS Grants Policy Statement, the NIH Grant Line, and other items; (8) reformatting the face page and including a sample form page indicating character length restrictions; (9) stressing the importance of including preliminary results (page 16); and (10) explaining more fully gender and minority inclusion policy (page 28), fetal tissue policy (page 28), and clinical trials policy (page 29). There are also some corrections to the new application kit: (1) Address (page 6)-- The correct address in the top of the left column is: "Chief, Referral Office, Division of Research Grants, National Institutes of Health, Suite 2130, 6701 Rockledge Drive MSC 7720, Bethesda, Maryland 20892-7720"; (2) Competitive Supplements (page 15)--Line 7 in the right column should read: "A supplemental application will not be accepted..."; (3) Contacts (page 23)--The contacts at the bottom of the left column should read: "CENTERS FOR DISEASE CONTROL AND PREVENTION, National Institute for Occupational Safety and Health (404) 639-3343, Procurement and Grants Office (404) 842-6630; (4) Letters of Reference (Research Career Awards, page IV-3)-- Reference letters are not required for K02, K05 or for experienced K07 applicants. (5) Section II of the Research Career Award application (see Research Career Awards, pages IV-3, IV-6, and the Table of Contents) must not exceed 25 pages, exclusive of letter of reference; statements by sponsors, consultants, and collaborators; and the environment description and institutional commitment. The allocation of these 25 pages to items b, c, and d of the Candidate's Section and the Research Plan is left to the applicant. To request two or more copies of the new PHS 398, contact: ADMINISTRATIVE SERVICES OFFICE DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE MSC 7760 BETHESDA MD 20892-7760 EMAIL: AMRG@DRGPO.DRG.NIH.GOV To request one copy, contact: GRANTS INFORMATION OFFICE DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE MSC 7762 BETHESDA MD 20892-7762 EMAIL: GIRG@DRGPO.DRG.NIH.GOV Provide a complete mailing address, the number of copies needed, and an email address or telephone number. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 24, Number 27, July 28, 1995 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: James Urban, M.D., Ph.D., California Institute of Technology: The Office of Research Integrity (ORI) has found that James L. Urban, M.D., Ph.D., engaged in scientific misconduct. This finding is based on an investigation by the California Institute of Technology (CIT) which concluded that Dr. Urban committed serious errors in judgment and serious scientific misconduct in connection with fabricating certain research data in two scientific papers that were published in the journal Cell. The first paper is J. Urban, V. Kumar, D. Kono, C. Gomez, S. Horvath, J. Clayton, D. Ando, E. Sercarz, and L. Hood, "Restricted Use of T Cell Receptor V Genes on Murine Autoimmune Encephalomyelitis Raises Possibilities for Antibody Therapy," Cell 54: 577-592 (1988). The second paper at issue is J. L. Urban, S. J. Horvath and L. Hood, "Autoimmune T Cells: Immune Recognition of Normal and Variant Peptide Epitopes and Peptide-based Therapy," Cell 59: 257-271 (1989). Specifically, the CIT Report states that Dr. Urban admitted that he fabricated two control lanes reported in Figure 5 of the Cell 54 paper. With respect to the Cell 59 paper, the CIT Report states that Dr. Urban admitted that he circulated draft copies of the manuscript that contained fabricated data in order to circumvent both the internal and external review processes. Dr. Urban has accepted the ORI findings and agreed to exclude himself voluntarily, for a period of three years beginning June 2, 1995, from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government as defined in 45 CFR Part 76 and 48 CFR Subparts 9.4 and 309.4 (Debarment Regulations). This voluntary exclusion does not apply to Dr. Urban's current or future practice of clinical medicine or training, whether as a resident, fellow, or licensed practitioner, unless that practice involves the proposing, conducting, or reporting of biomedical or behavioral research or research training. Dr. Urban also agreed to exclude himself voluntarily from serving on any Public Health Service Advisory Committees, Boards, and/or peer review committees for the same three- year period. The ORI acknowledges that Dr. Urban cooperated with the CIT Investigation Committee during its investigation of allegations of scientific misconduct and with ORI in its resolution of this matter. 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 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 24, Number 27, July 28, 1995 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 the following: DATES: September 18-19, 1995 TITLE: Contemporary Human Subject Issues in Academic Research LOCATION: The University of Mississippi, Oxford, MS SPONSORS: The University of Mississippi; Jackson State University REGISTRATION Mr. D. Russell Cooper OPRR Conference Registration c/o Center for Public Service and Continuing Studies The University of Mississippi P.O. Box 879 University, MS 38677 Telephone: (601) 232-7282 FAX: (601) 232-5138 REGISTRATION FEE: $95 ($115 after September 5) DESCRIPTION: The biomedical and behavioral research currently being conducted within academic institutions promises exciting advances in scientific knowledge, as well as unprecedented opportunities for the betterment of individual and societal life. Increasingly, however, these dramatic achievements and opportunities are accompanied by scientific, ethical, regulatory, and legal intricacies, and dilemmas. Within the academic community, understanding these rapidly changing complexities is central to the IRBs ability to protect the rights and welfare of human research subjects while supporting scientific endeavor and its potential benefits to humankind. This conference is designed to examine a broad range of contemporary scientific, ethical, regulatory, and legal issues relating to biomedical, social, behavioral, and anthropological research involving human subjects. Each of these issues will be discussed within the framework of the academic research environment, and presentations will focus on the unique challenges presented to IRBs, researchers, subjects, and administrators in academic institutions. Designed for both experienced and novice participants, the workshop will provide opportunities for greater depth and specificity on contemporary IRB issues. Along with sessions on examining common IRB issues - including liability, informed consent, and deception - the conference will feature special focus sessions on issues related to historical perspectives, issues in mental health, the establishment, structure, and management of IRBs, computerized management information systems for the IRB office, FDA regulations for clinical trials, guidelines on inclusion of minorities and women, research involving genetic/DNA testing, and research involving special populations, including American Indians children, and elderly research subjects. Sessions will feature issues particularly pertinent to historically black colleges and universities and institutions newer to the IRB process. Speakers will include representatives from OPRR and FDA, including Dr. Gary B. Ellis, Mr. Paul Goebel, Jr., and Dr. Gary Chadwick, and other Federal agencies such as the Congressional Office of Technology Assessment, the Office of Research on Women's Health at NIH, and the National Institute of Mental Health. Distinguished members of the academic and clinical research community will also include Dr. William L. Freeman of the Indian Health Service, Dr. Diane Brown from the University of California at Berkeley, Dr. Ernest D. Prentice of the University of Nebraska, and Dr. John Estrada of Meharry Medical College. The format will encourage audience participation and informal information exchanges, with ample question and answer opportunities throughout the program. 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 x233 FAX: (301) 402-0527 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 24, Number 27, July 28, 1995 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office of Extramural Research (OER), Office for Protection from Research Risks (OPRR) is continuing to cosponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1995 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and information discussions. DATES: September 14-15, 1995 TOPIC: Internal Audits of the Animal Care and Use Program LOCATION Radisson Riverfront Hotel Two Tenth Street Augusta, GA 30910 Telephone: (706) 721-3967 FAX: (706) 721-4642 SPONSORS: National Institutes of Health; Medical College of Georgia; Albany State College REGISTRATION Ms. Katrinka Akeson Department of Continuing Education HM100 Medical College of Georgia Augusta, GA 300912 Telephone: (706) 721-3967 FAX: (706) 721-4642 FEE: $150.00 DESCRIPTION: The Workshop will address processes whereby Institutional Animal Care and Use Committees (IACUC) can effectively evaluate their institution's animal care and use program. The PHS Animal Welfare Policy and USDA Regulations state that at least once every six months the institution's program for humane care and use of animals is to be evaluated by the IACUC using the Guide and USDA Regulations (Title 9, Chapter 1, subchapter A-Animal Welfare) as a basis. Topics to be included in the Workshop include: A review of the program as described in the Guide; institutional policy issues such as the occupational health and safety program, personnel training, and the activities of the IACUC and how effectively does it meet its mandates. Other program issues to be included are veterinary care, the animal environment, and record reviews. Reports of the IACUC semiannual program and facility reviews will also be discussed. Approaches useful to IACUC's serving both small and large institutions will be included. INQUIRIES For further information concerning these workshops and future NIH/OER/OPRR Animal Welfare Education 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 ext. 233 FAX: (301) 402-0527 $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$P1 BEGIN PAR-95-078 FULL-TEXT ************************************* SMALL GRANTS FOR CLINICAL TRIALS IN DIGESTIVE AND NUTRITIONAL DISORDERS NIH GUIDE, Volume 24, Number 27, July 28, 1995 PA AVAILABLE: PAR-95-078 P.T. 34; K.W. 0755915, 0715085, 0710095, 0715145, 0745027 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The Division of Digestive Diseases and Nutrition (DDDN), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces a small grants (R03) program to encourage the submission of small grant applications for clinical trials of digestive diseases and nutritional disorders. These clinical trials may use pharmacologic, dietary, surgical, or behavioral interventions given for disease therapy or prevention. New and experienced investigators in relevant fields and disciplines (clinical and surgical) may apply for small grants to test new treatment strategies or do pilot clinical studies or to plan a larger clinical trial. Investigators are encouraged to take advantage of recent laboratory developments. Areas of special interest are obesity, eating disorders and other nutritional disorders; Helicobacter pylori and dyspepsic conditions; gastroesophageal reflux disease and Barrett's esophagus; biliary atresia and neonatal hepatitis; primary biliary cirrhosis, autoimmune hepatitis, sclerosing cholangitis; inflammatory bowel disease (IBD), irritable bowel syndrome (IBS); gallstone disease and chronic pancreatitis. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," in a PHS-led national activity for setting priority areas. This PA, Small Grants for Clinical Trials in Digestive Diseases, 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 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. Tommie Sue Tralka Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN/12K - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8879 Email: tt30m@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-95-079 FULL-TEXT ************************************** PATHOPHYSIOLOGY OF ANOREXIA IN DISEASE AND AGING NIH GUIDE, Volume 24, Number 27, July 28, 1995 PA AVAILABLE: PA-95-079 P.T. 34; K.W. 0765035, 0710010, 0715091 National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Deafness and Other Communication Disorders National Institute on Aging National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute of Mental Health PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Aging (NIA), National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), and National Institute of Mental Health (NIMH) are interested in receiving research grant applications for support of research on pathophysiologic mechanisms that mediate the loss of appetite seen in disease and in aging. Applications covering a broad range of activities in this area, including both basic and clinical research are encouraged. This program announcement is issued in order to encourage investigator-initiated research projects (R01 and R29) in these areas of special programmatic interests. This PA complements an existing NIMH-sponsored PA, Anorexia Nervosa and Bulimia Nervosa: Basic Brain, Behavioral, and Clinical Studies (PA-91-79) by its coverage of appetite disturbance phenomena without restriction to currently defined psychiatric disorders of anorexia nervosa and bulimia nervosa. 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, Pathophysiology of Anorexia in Disease and Aging, is related to the priority area of nutrition. 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 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. Susan Z Yanovski M.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-18 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8882 FAX: (301) 480-8300 Email: yanovskis@niddkep.nih.gov. $$P2 END ************************************************************ $$P3 BEGIN PA-95-080 FULL-TEXT ************************************** INFORMED CONSENT IN CLINICAL MENTAL HEALTH RESEARCH NIH GUIDE, Volume 24, Number 27, July 28, 1995 PA AVAILABLE: PA-95-080 P.T. 34; K.W. 0715129, 0785035, 1014004 National Institute of Mental Health PURPOSE The purpose of this program announcement (PA) is to stimulate investigations into the informed consent process in research involving individuals with mental disorders. Voluntary informed consent is an integral and defining aspect of interactions between researchers and subjects. There is an ethical as well as a legal duty to ensure that individuals both consent to and understand their participation in research, particularly since an investigation may benefit future generations rather than the subjects themselves. Little empirical work exists to document the degree of understanding achieved by research participants regarding: (1) comprehension of a study's methods and procedures; (2) relative risks and benefits of participation; (3) confidentiality and any exceptions to confidentiality; and (4) the right to withdraw from a study and any risks associated with withdrawing. Such data should be useful in designing informed consent procedures that are readily comprehended by prospective participants yet impart all critical information. Since individuals with mental disorders may experience cognitive difficulties, research to assess comprehension and remediate difficulties in this population can be particularly important. The goal of the present initiative is to identify and validate methods for improving the informed consent process in research involving individuals with mental disorders. The mechanisms available for support of this program announcement are the research project grant (R01), small grant (R03), FIRST award (R29), and cooperative clinical research grant (R10). Competitive supplements to existing R01, R10, and research program projects and centers (P01, P20, P30, P50) will also be available. 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, Informed Consent Process in Clinical Mental Health Research, is related to the priority areas of reducing the prevalence of mental disorders and improving assessment of patient mental status. 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. John K. Hsiao, M.D. Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 18C-14 Bethesda, MD 20857 Telephone: (301) 443-3525 FAX: (301) 443-6000 EMAIL: jhsiao@helix.nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Fri Jul 28 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-079 - V24(27) 07/28/95 Date: 28 Jul 1995 17:37:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 427 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3vbvrl$gur@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95079 PA-95-079 P1O1 *************************************** PATHOPHYSIOLOGY OF ANOREXIA IN DISEASE AND AGING NIH GUIDE, Volume 24, Number 27, July 28, 1995 PA NUMBER: PA-95-079 P.T. 34; K.W. 0765035, 0710010, 0715091 National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Deafness and Other Communication Disorders National Institute on Aging National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute of Mental Health PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Aging (NIA), National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), and National Institute of Mental Health (NIMH) are interested in receiving research grant applications for support of research on pathophysiologic mechanisms that mediate the loss of appetite seen in disease and in aging. Applications covering a broad range of activities in this area, including both basic and clinical research, are encouraged. This program announcement (PA) is issued in order to encourage investigator-initiated research projects in these areas of special programmatic interest. This PA complements an existing NIMH- sponsored PA, Anorexia Nervosa and Bulimia Nervosa: Basic Brain, Behavioral, and Clinical Studies (PA-91-79) by its coverage of appetite disturbance phenomena without restriction to currently defined psychiatric disorders of anorexia nervosa and bulimia nervosa. 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, Pathophysiology of Anorexia in Disease and Aging, is related to the priority area of nutrition. 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support of this program will be by research project grant (R01) and FIRST awards (R29). Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of award will vary also; however, the average size of grants funded by NIDDK is estimated to be approximately $200,000, total costs. RESEARCH OBJECTIVES This program announcement is intended to stimulate research on pathophysiologic mechanisms leading to loss of appetite, which is observed in association with many disorders, including AIDS; end- stage cardiac, renal, and liver disease; cancer; tuberculosis; and major depressive disorder. Appetite disturbances may also be reported among individuals with anorexia nervosa and bulimia nervosa. In children, loss of appetite associated with many chronic disorders or infections often impedes normal growth. Loss of appetite is also commonly observed in the elderly. While there has been a great deal of interest in the understanding of cachexia, wasting is a result of a number of factors, including decreased energy intake, malabsorption, and increased energy utilization. Little research has been conducted investigating the causes of loss of appetite that contribute to this end result. Further understanding of the metabolic and physiologic bases for anorexia could lead to improved means of preventing the secondary wasting and other consequences of poor nutritional status, such as depressed immune function, associated with these conditions. Improved understanding of the mechanisms leading to loss of appetite in chronic disease or in some elderly persons may have profound implications for understanding anorexia associated with other illnesses, or for intervening in dysregulation of eating behavior in other disorders, such as bulimia nervosa, binge eating disorder, and obesity. Anorexia appears to be the end-result of a modification of central regulation of feeding behavior. It can occur as a distinct symptom or as part of a cluster of behavioral and motivational symptoms as in the syndrome of depression. There is some indication that aging results in impairment in ability to control food intake following underfeeding in both humans and animals, which can result in decreased energy intake and weight loss among the elderly. In addition, decreased food intake is associated with certain alterations of smell and taste function. A number of physiologic changes have been noted in loss of appetite in humans and animals, although it is often difficult to differentiate primary from secondary phenomena. In animal studies, loss of appetite has been associated with increased brain tryptophan and serotonin levels. Observations of elevated levels of brain tryptophan and serotonin may be a partial explanation for the development of loss of appetite in patients with chronic liver disease or chronic renal failure. In fact, some of the therapeutic interventions for these diseases have been developed to minimize the availability of nutrients that could be metabolized to tryptophan and serotonin (i.e., branched-chain amino acid therapy). The role of deficiencies of micronutrients such as zinc in causing anorexia in both animal models and humans is inconclusive. Tumor- bearing rats have also been found to have decreased hypothalamic neuropeptide Y (NPY), a neurotransmitter that increases nutrient intake, particularly intake of carbohydrate. Elderly humans also have been found to have low cerebrospinal fluid (CSF) and plasma levels of beta endorphins compared with younger controls, and also show differences in amino acid concentrations in the CSF. The role of corticotropin releasing hormone (CRF) in the loss of appetite associated with disease and aging also deserves exploration. Other neural and/or hormonal factors, such as cholecystokinin (CCK) and corticotropin (ACTH), have also been hypothesized to play a causative role in loss of appetite in diseases ranging from AIDS to chronic liver disease. Nutrient intake may play a role in modulating these factors, such as a relationship found in animals between chronic ethanol consumption and sensitivity to the anorectic effects of CCK-8. Novel substances, such as a glycoprotein found in Mung bean sprouts, have been found to reduce food intake in animals. With increased knowledge about the mechanisms leading to the development of loss of appetite, specific therapeutic interventions, such as the use of pharmacologic agents, food flavor enhancement, or dietary manipulation, could be considered. Since anorexia is also associated with early satiety, a major factor contributing to reduced food intake, it is likely that innovative approaches to control food intake could be achieved. Better understanding of factors responsible for early satiety might allow the development of therapeutic approaches to prevent and treat obesity and other eating disorders. Specific examples of research topics appropriate for inclusion in applications responsive to this program announcement include, but are not limited to: o Studies characterizing primary endocrine, metabolic, cellular and related pathophysiologic mechanisms that contribute to loss of appetite in disease, aging or associated with use of certain medications. This includes determination of the potential role of peptides, neurotransmitters, hormones, and cytokines in the development or maintenance of loss of appetite o Studies investigating neural function and networks within the neural system (using a variety of probes or assessment techniques, such as brain imaging, cognitive testing, etc.) related to the anorexia of disease and/or aging o Studies on the role of alterations in olfaction and gustation in anorexia associated with disease and/or aging o Studies on the association of anorexia with other motivational, behavioral, affective, and cognitive factors or symptoms o Studies of molecular mechanisms in the infection process and host defense that lead to the initiation, maintenance, and/or exacerbation of the anorectic state observed in chronic infectious diseases such as AIDS and tuberculosis o Studies on the role of factors such as vagal tone and gastric motility on early satiety in loss of appetite o Studies of the role micronutrient and/or macronutrient deficiencies or excesses in the development or maintenance of loss of appetite o Studies of specific taste and smell aversions in loss of appetite 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. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda MD 20892-7762, telephone 301/435-0714. The title and number of the program announcement must be typed in item 2 on the face page of the application. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) Applications for FIRST awards (R29) must include at least three letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW 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. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment. o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries that are not readily available in the United States or which provide augmentation of existing U.S. resources. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the relevant Institute. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Susan Z Yanovski M.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-18 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8882 FAX: (301) 480-8300 Email: yanovskis@niddkep.nih.gov. Jack Pearl, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3464 FAX: (301) 402-6251 Email: Jack_Pearl@nih.gov Pamela E. Starke-Reed, Ph.D. Office of Nutrition National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-4603 FAX: (301) 402-0010 Email: PS39P@NIH.GOV Gilman Grave, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 411B - MSC 7510 Bethesda, MD 20892-7510 Email: graveg@hd01.nichd.nih.gov Eugene M. Zimmerman, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A42 Bethesda, MD 20892 Telephone: (301) 496-8973 FAX: (301) 402-2571 Email: ez1b@nih.gov Matthew V. Rudorfer, M.D. Clinical Treatment Research Branch National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Email: mr118r@nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Sharon Bourque Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-49H - MSC 6600 Bethesda, MD 20982-6600 Telephone: (301) 594-8846 Email: bourques@ep.niddk.nih.gov Mr. Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B35 Bethesda, MD 20892 Telephone: (301) 496-7075 Voicemail: (301) 402-5512 FAX: (301) 480-3780 Email: tb22i@nih.gov Mr. E. Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 411B - MSC 7510 Bethesda, MD 20892-7510 Email: shawverd@hd01.nichd.nih.gov Ms. Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-B - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: sh79f@nih.gov Ms Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 Email: dt21a.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. 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 Jul 28 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-078 - V24(27) 07/28/95 Date: 28 Jul 1995 17:37:01 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 483 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3vbvrd$gud@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95078 PAR-95-078 P1O1 ************************************* SMALL GRANTS FOR CLINICAL TRIALS IN DIGESTIVE AND NUTRITIONAL DISORDERS NIH GUIDE, Volume 24, Number 27, July 28, 1995 PA NUMBER: PAR-95-078 P.T. 34; K.W. 0755915, 0715085, 0710095, 0715145, 0745027 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The Division of Digestive Diseases and Nutrition (DDDN), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), announces a small grants program to encourage the submission of small grant applications for clinical trials relating to digestive diseases and nutritional disorders. These clinical trials may use pharmacologic, dietary, surgical, or behavioral interventions given for disease therapy or prevention. New and experienced investigators in relevant fields and disciplines (clinical and surgical) may apply for small grants to test new treatment strategies or do pilot clinical studies or plan a larger clinical trial. Investigators are encouraged to take advantage of recent laboratory developments. Areas of special interest are obesity, eating disorders and other nutritional disorders; Helicobacter pylori and dyspepsic conditions; gastroesophageal reflux disease and Barrett's esophagus; biliary atresia and neonatal hepatitis; primary biliary cirrhosis, autoimmune hepatitis, sclerosing cholangitis; inflammatory bowel disease (IBD), irritable bowel syndrome (IBS); gallstone disease; and chronic pancreatitis. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," in a PHS-led national activity for setting priority areas. This PA, Small Grants for Clinical Trials in Digestive Diseases, 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 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. An application may be >From one institution or several institutions (collaborating institutions or consortia), if appropriate. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this Program Announcement will be through the NIH small grants (R03) mechanism. However, specific application instructions have been modified to reflect streamlining efforts being examined by the NIH. It is hoped that these changes will relieve the burden for the applicants, reviewers, and institute staff. The small grants research program provides limited funds (maximum of $50,000 direct costs per year) for short-term (up to two years) research projects. Only limited budget information will be requested and the Initial Review Group can make budget recommendations concerning level of effort (e.g., if the IRG recommends reduction of personnel, those funds could be shifted to other categories). Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page will be requested by NIDDK Staff only if and when an application is considered for an award. The APPLICATION PROCEDURES section of this PA provides specific details of modifications to standard application instructions. These grants are non-renewable, but continuation of projects developed under this program can be supported by the regular research project grant (R01) program. Applicants will be responsible for the planning, direction, and execution of the proposed project. Applications submitted in response to this PA will compete for funds with all other R03 and regular research project (R01 and R29) grant applications assigned to NIDDK. 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. Applicants are encouraged to collaborate with the Directors of the Silvio O. Conte Digestive Diseases Centers, Clinical Nutrition Research Centers, and Obesity/Nutrition Research Centers for consultation in experimental design, intervention, and methodology, as well as use of core facilities appropriate for carrying out the proposed projects. Information describing the centers and their cores may be requested from the person listed under INQUIRIES. The award of grants in response to this PA is also contingent upon the availability of funds. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement (rev. 4/94). Projects with substantial scientific merit that are not funded by the NIDDK are eligible for support by the American Digestive Health Foundation (ADHF). Principal investigators will be responsible for forwarding copies of their summary statements and applications to the ADHF for consideration for award. The amount of ADHF support will be determined by project scope, and duration of funding will be limited to two years. No funds for indirect costs will be provided. RESEARCH OBJECTIVES Background The NIDDK supports an extensive network of clinical and laboratory research studies related to digestive diseases and nutritional disorders, mostly through the R01 and R29 funding mechanisms. At present, there is no mechanism targeted to stimulate the communication of promising and potentially relevant new developments >From the laboratory to the clinical setting. There is a need for a mechanism to fund short-term studies and obtain preliminary clinical data rapidly. It is expected that these R03 grants will serve as a basis for planning future clinical research project grant applications (R01) or cooperative clinical trial group studies. The small grants (R03) mechanism provides research support specifically limited in time and amount for studies in categorical program areas (see Research Goals and Scope). Small grants provide flexibility for initiating preliminary, short-term studies and are non-renewable. Furthermore, the time interval from application to funding is shortened under the R03 mechanism, thus allowing new ideas to be investigated in a more expeditious manner. Support is needed to encourage new as well as experienced investigators to apply new treatment approaches. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy 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 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 applications 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. 5/95). 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 Institute of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714. The title and number of this program announcement must be typed in Item 2 on the face page of the application. Applications will be accepted at the regular application deadlines indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 (rev. 5/95) instructions. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) Special Instructions for Completion of PHS 398 Application The NIH has been designated a "reinvention laboratory" by the Public Health Service. One effort to streamline NIH operations is to simplify the grant application and review process. Therefore, an experiment is being conducted to test ways to reduce the administrative burden of applying for an NIH grant without compromising those elements needed by the initial scientific peer review group to assess the scientific merit of the application and the reasonableness of the proposed budget. The following are specific instructions for sections of the PHS 398 application form (rev. 5/95) that should be completed differently >From usual, in response to this PA. Some sections are modified, and others do not need to be completed for the submission of the application, but WILL be requested if the application receives a priority score in the fundable range. For items in the application not identified here, follow the instructions on pages 5-20 of the PHS 398 booklet. FACE PAGE (Form AA) - The title and number of the PA must be typed in Item 2. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for review. FORM DD - PAGE 4 - DETAILED BUDGET PAGE FOR INITIAL BUDGET PERIOD Enter the following information without the associated costs: o Only personnel and level of effort of each should be itemized in the Personnel section. o In addition, list consultants, equipment, supplies, travel (especially for personnel assisting in preparation of the Manual of Procedures), patient care activities, and other items as appropriate. However, the costs associated with the individual items or categories must not be listed. Enter only the total direct costs. Applications that do not conform to these special instructions will be returned to the applicant without further review. Form EE - Page 5 - BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD - Do not complete this page. The budget for the second year will be the same as that for the first year. Form FF - Page 6 - BIOGRAPHICAL SKETCH - For each KEY person only, provide a two-page biographical sketch. Name, Position Title, Education - Identify the research background and experience relevant to the research proposed. Specifically, provide: o A list of previous research positions that are felt to be of significance or relevance for the review of the proposed research; o Complete references, titles, and authors on all peer-reviewed publications representative of the research career or pertinent to the research proposed of each key person. o The title and funding source of all active research grants or contracts on which each key person is principal investigator, co- investigator, or project leader. Indicate current percent effort for each award. o The title and length of service on any peer review group, council, or program advisory committee. The purpose of this section is to demonstrate the professional credentials of the organizers, as briefly as possible, indicating experience in such areas as: o The problem under study o Clinical trial administration o Methodology o Adequate and similar patient recruitment potential o The proposed procedures. o Professional credentials of the participating center investigators in the clinical problem and in clinical trial participation. Verification of the cooperating investigators and their institutions will be required later, if the application is considered for funding. Form GG - Page 7 - OTHER SUPPORT - Do not complete. Other Support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Current information will be requested by NIDDK staff from only those applicants being considered for funding. Form HH - Page 8 - RESOURCES - Complete item(s) only if proposed research requires specialized resources unique for the proposed research. RESEARCH PLAN (Booklet Pages 15-19) - Applications in response to this PA should be concise and substantially shorter than regular research project grant applications. Items a-d may not exceed a total of 16 pages. (a) - Specific Aims - Within one page, list in order of priority, the broad, long-range objectives. Describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. (b) - Background and Significance - Within three pages, describe (1) how the proposed research will contribute to meeting the goals and objectives of the PA; and, (2) explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. (c-d) - Preliminary Studies/Progress Report, Research Design and Methods - Within twelve pages, complete as instructed on pages 16-17 of the PHS 398 (rev. 5/95) booklet, that with the modification that the clinical protocol(s) and up to three publications, manuscripts submitted or accepted for publication, patents, or invention reports can be included in the Appendix (see below). The investigator may use this section to address, even though briefly, issues such as the following: o Merit of the study design. o Appropriateness of intervention groups. o Plans to minimize bias through randomization, stratification, choice of controls, and masking of treatment or results. o Identification of appropriate primary and secondary outcomes for the trial. o Recognition of possible problems inherent in the design and the adequacy of plans for dealing with them. o Quality of plans (even if broadly described) for recruitment and retention of patients, identification of eligibility and exclusion criteria, and standardization and maintenance of quality control among participating centers. o Patient protection, including informed consent and monitoring data for safety and efficacy. Plans for early termination if it becomes necessary. o Documentation of potential availability of patients at each of the participating centers. o Plans for the preparation of a Manual of Procedures that must be submitted with any future application for support of the actual conduct of the randomized controlled trials. o Preliminary studies pertinent to the application; o The study group's suitability for providing the necessary supporting data for preliminary studies. o The feasibility of the study group, particularly in conducting preliminary studies. o Rationale and hypothesis for the clinical trial and laboratory studies such as the following: Clinical importance of the disease or condition being studied, rationale for therapy being applied, ethical considerations of treatment. o General methods that will be utilized; provide specific details for those techniques that are unique or where a significant departure >From a generally accepted technique is important for reviewers to know; o Plans for the rigorous data management and verification of research data including rationale and validity of sample size and general methods to be used for data analyses. o Potential pitfalls in the experimental design and alternative studies that will be done if the proposed experiments fail. (e-f) - Human Subjects, Vertebrate Animals - Complete as described on pages 17-18. State clearly the plans for early detection of and protection against adverse effects on human subjects. (g) - Literature Cited - Within two pages, give full literature citations including the title of each article. (h) - Consortium/Contractual Arrangements - Within one page, provide a brief explanation of the programmatic, fiscal, and administrative arrangements made with collaborating organizations. (i) - Consultants - Biographical sketches should conform to the brief format described previously for key personnel on Form FF. APPENDIX (Page 19) - Up to three publications, manuscripts submitted or accepted for publication, patents, and invention reports should be provided. Clinical protocol(s) must be included in this section. Other than this change, complete as instructed. CHECKLIST (Form II and JJ) - Do not complete. Information will be requested by NIDDK staff from only those applicants being considered for funding. If the applicant or the institutional business office has any questions regarding these instructions, contact the program staff listed under INQUIRIES. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate peer review group convened by the NIDDK, 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. 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 approved applications assigned to the NIDDK. 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 priority INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Administrative suggestions for preparing an R01 clinical trial grant application that include review criteria for full-scale clinical trials are available. These could be useful in preparing the small grant application because the proposed research may be the first phase of a subsequent larger full-scale clinical trial. Direct inquiries regarding programmatic issues to: Ms. Tommie Sue Tralka Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN/12K - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8879 Email: tt30m@nih.gov Direct inquiries regarding fiscal matters to: Ms. Sharon Bourque Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS/49H - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8846 Email: sb114@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. 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 Jul 28 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-080 - V24(27) 07/28/95 Date: 28 Jul 1995 17:36:54 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 377 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3vbvr6$gu1@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95080 PA-95-080 P1O1 *************************************** INFORMED CONSENT IN CLINICAL MENTAL HEALTH RESEARCH NIH GUIDE, Volume 24, Number 27, July 28, 1995 PA NUMBER: PA-95-080 P.T. 34; K.W. 0715129, 0785035, 1014004 National Institute of Mental Health PURPOSE The purpose of this program announcement (PA) is to stimulate investigations into the informed consent process in research involving individuals with mental disorders. Voluntary informed consent is an integral and defining aspect of interactions between researchers and subjects. There is an ethical as well as a legal duty to ensure that individuals both consent to and understand their participation in research. Little empirical work exists to document the degree of understanding achieved by research participants regarding: (1) comprehension of a study's methods and procedures; (2) relative risks and benefits of participation; (3) confidentiality and any exceptions to confidentiality; and (4) the implications of withdrawal from a study. Such data should be useful in designing informed consent procedures that are readily comprehended by prospective participants and impart all critical information. Since individuals with mental disorders may experience cognitive difficulties, research to assess comprehension and remediate difficulties in this population can be particularly important. The goal of the present initiative is to identify and validate methods for improving the informed consent process in research involving individuals with mental 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 PA, Informed Consent in Clinical Mental Health Research, is related to the priority area of reducing the prevalence of mental disorders. 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 First Independent Research Support and Transition (FIRST) awards (R29) and small grants (R03). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms available for support of this program announcement are the research project grant (R01), small grant (R03), FIRST award (R29), and cooperative clinical research grant (R10). Competitive supplements to existing R01, R10, and research program projects and centers (P01, P20, P30, P50) will also be available. Because small grants, FIRST awards, and Cooperative Clinical Research grants have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. RESEARCH OBJECTIVES Background Full consideration of the components of informed consent is an essential part of every research project involving human subjects. Indeed, the Code of Federal Regulations (45 CFR, Subtitle A (10-1-90 Edition), Part 46.116) requires that "...no investigator may involve a human being as a subject in research...unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative." As stated in 45 CFR 46: (a) ...in seeking informed consent, the following information shall be provided to each subject: 1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; 2) A description of any reasonably foreseeable risks or discomforts to the subject; 3) A description of any benefits to the subject or to others which may reasonably be expected from the research; 4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; 5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; 6) For research involving more than minimal risk, an explanation as to whether any compensation and any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained; 7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; 8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall be provided to each subject: 1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; 2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; 3) Any additional costs to the subject that may result from participation in the research; 4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; 5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and 6) The approximate number of subjects involved in the study. While 45 CFR 46 is quite specific about the content of informed consent, the responsibility for ensuring that such complex information is fairly presented and understood is left to the researcher and his or her Institutional Review Board. It is clear that informed consent involves much more than a signature on a consent form. Willingness to participate in research may wax and wane depending on a subject's expectations and satisfaction. For studies of mental disorders, this may be further complicated by changes in cognitive abilities and judgment over time. In some instances, obtaining consent from a legally authorized representative may be a requirement, as with research on children or older subjects with advanced dementias. The issues of substituted judgment and surrogate consent can be germane to the mental disorders as well, if an individual's competency to consent is in question. Finally, the research setting may play a role in the informed consent process. For instance, the degree of risk is affected by whether a study involves inpatients or outpatients, how closely these participants are monitored, and by different legal requirements in community, clinical, and institutional research settings. Research Goals and Topics Since a number of complex issues have an impact on informed consent, there is much to be learned and understood about this process. Modern cognitive science has greatly increased our understanding of how humans learn, process, comprehend, and retain information, and these advances in knowledge can be applied to the informed consent process. The purpose of this program announcement is to gather empirical data on the informed consent process, particularly with respect to studies involving subjects with mental illnesses. Inclusion of subjects with non-psychiatric illness for comparison purposes would be appropriate in many instances. This program announcement is focused on clinical research populations, but the application of research methods developed to study normal cognitive processes will play an important role in meeting the goals of this initiative. The following list contains possible research topics, but should not be considered exhaustive: o Evaluating the degree of comprehension and reasoning ability required to understand and consent to specific experimental procedures, and to differentiate between clinical research and individualized treatment o Applying existing knowledge in cognitive neuroscience to develop methods for efficiently assessing comprehension and reasoning ability in a research mental health setting o Identifying the cognitive processes underlying complex decision making by individuals with mental disorders. (If impairments in these processes can be detected, are they stable or do they change over time and with the course of the mental disorder? Can impairments be remediated?) o Identifying the determinants for subject participation in mental health research (e.g., altruism, hopes for new or better treatment, closer follow up, free care, interest in science) o Determining which, if any, aspects of the informed consent process predict subsequent subject retention and satisfaction o Developing and assessing innovative methods for clearly and efficiently conveying consent information (e.g., audio-visual aids, computer-assisted instruction) o Assessing whether a participant understands experimental procedures over time, including assessment throughout the full duration of participation and over possible changes in mental status o Determining how specific changes in affective or cognitive state in patients with mental illness affect the informed consent process and interactions with treatments o Determining if appropriate inclusion of a patient's relatives or friends in the consent process changes participation and retention rates within a study or alters the reported satisfaction with participation in research o Determining the impact of proxy or surrogate consent as well as durable powers of attorney and advance directives on research participation and outcomes o Identifying and determining the impact of special issues related to informed consent in research involving children and adolescents (e.g., parental responsibilities and consent, autonomy issues in adolescents, emancipated minors, additional protections from risk) o Identifying and determining the impact of special issues related to informed consent in geriatric research (e.g., worsening of dementia over the course of a study, durable power of attorney, methods for proxy consent) o Examining the role of ethnicity and gender on participation in clinical mental health research and the informed consent process o Examining how research setting, timing, and the individual obtaining informed consent affect the process 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 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. 5/95) 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, 6701 Rockledge Drive, Room 3034 - MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714. The title and number of the program announcement must be typed in Section 2 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight mail service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. Review Criteria for Research Project Grant Applications o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of 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 subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: John K. Hsiao, M.D. Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 18C-14 Rockville, MD 20857 Telephone: (301) 443-3525 FAX: (301) 443-6000 Email: jhsiao@helix.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 EMAIL: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. 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. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (rev. 4/94). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. 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 Jul 31 23:00:00 1995 Path: biosci!biosci!not-for-mail From: "Dr. Harold T. Safferstein" Newsgroups: bionet.sci-resources Subject: Wanted: Organization to do Software Development Collaboration with NIH Date: 31 Jul 1995 17:32:27 -0700 Organization: National Heart, Lung and Blood Institute, National Institutes of Health Lines: 58 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3vj3of$2sf@news.us.net> NNTP-Posting-Host: net.bio.net The National Institutes of Health (NIH) seeks a software development firm to enter into a Cooperative Research and Development Agreement (CRADA). The goal of the CRADA will be to develop seamless electronic systems for commodity identification and product/service acquisition for NIH intramural scientists, extramural program managers, and their support staff. Specific goals include providing a forum for the identification of appropriate vendors and location of needed equipment, supplies, and services. The system must also facilitate compliance with federal procurement regulations and interact with NIH administrative systems including accounting, procurement, and property management systems. This project is consistent with the reengineering/reinvention activities currently taking place at the NIH. Design strategies might include the creation of an electronic "mall" which will provide a controlled environment for offering goods and services to the NIH community. Such a forum might consist, in whole or in part, of a multimedia presentation on the goods and services offered. The systems could provide for compliance with federal regulations and electronic entry in the NIH procurement system or allow for the direct placement of orders with the vendor in a secure manner. It should also allow for the feedback of order status to the end user and approval of internal clearance of orders prior to placement. The system must provide interface to budget tracking and accounts payable systems. The Collaborator will provide the expertise to integrate the appropriate software components and develop software where needed to interface with existing NIH systems. The Collaborator will provide a means for publishing vendor information, possibly utilizing existing vendor catalogs. This system should also include browsers for viewing multimedia online catalogues, systems for order placement and tracking, as well as fiscal accountability. The Collaborator will ensure that the developed systems comply with federal procurement law and regulations and integrate seamlessly with existing NIH systems as described above. Collaborator's proposal should include a time line for completion. NIH will provide information on government procurement regulations, ordering, and budget processes and will provide expertise on commodity and service requirements. NIH will also provide technical expertise on interfacing with existing systems and access to a prototype system which illustrates procurement compliance requirements, ordering procedures, budget tracking, and user notification. The Collaborator will have the ability to utilize and integrate the existing system to achieve the CRADAs objectives. Both the Collaborator and NIH shall derive resources for undertaking this project independent of one another. Collaborator shall derive specific licensing rights under the CRADA to allow for the adequate commercialization of this system to other Government agencies and academic institutions. In addition, Collaborator will be expected to provide services for fee to effect any maintenance of or upgrades to the system as may be required by each implementing organization. Proposals shall be submitted to the address below on or before the close of business on September 1, 1995: Dr. Harold T. Safferstein, Technology Transfer and Commercialization Team, National Heart, Lung and Blood Institute, National Institutes of Health, 31 Center Drive MSC 2490, Building 31, Room 1B32, Bethesda, Maryland, 20892-2490 or E-mail: hs11a@nih.gov. From owner-sci-resources@net.bio.net Mon Jul 31 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 30 July 1995 Date: 31 Jul 1995 18:30:28 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 93 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3vk03k$lul@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: IAI Newsletter Title: IAI-0493 IAI/IC NEWSLETTER File size (bytes): STIS Filename: iai0493.txt Title: IAIISP IAI Initial Science Program Announcement File size (bytes): STIS Filename: iaiisp.txt Document Type: Letter Title: NSF 95-119 Dear Colleague LETTER File size (bytes): STIS Filename: nsf95119.txt Title: NSF 95-122 Dear Colleague LETTER (ATM) File size (bytes): STIS Filename: nsf95122.txt Document Type: Press Release Title: NEW REPORT SAYS SEVERAL ASIAN NATIONS CLOSING THE HIGH-TECH GAP File size (bytes): STIS Filename: pr9550.txt Document Type: Program Guideline Title: NSF 94-100 - University-Industry Cooperative Research Programs in the Mathematical Sciences File size (bytes): STIS Filename: nsf94100.txt Title: NSF 95-114 - BIO Research Training Groups Program File size (bytes): STIS Filename: nsf95114.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: STIS Title: Document Types on STIS File size (bytes): 1807 STIS Filename: stistype.txt ------------------------------------------------------------------------ ** 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 stistype.txt, the text of your message should be as follows: get stistype.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve stistype.txt, you would enter: ftp> get stistype.txt 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).