From owner-sci-resources@net.bio.net Thu Oct 07 23:00:00 1993 Path: biosci!nsf.gov From: parzberg@nsf.gov (Peter Arzberger) Newsgroups: bionet.sci-resources Subject: Computational Science and Engineering Postdoctoral Associates Message-ID: Date: 8 Oct 93 02:48:29 GMT Sender: kristoff@net.bio.net Lines: 73 Approved: biosci-moderator@net.bio.net The following is extracted from the new program announcement on the Postdoctoral Research Associates in Computational Science and Engineering (CS&E). Complete copies of the program announcment should be attainable at local Sponsored Project Offices or over the network on the NSF Gopher. The CS&E Postdoctoral Associates support individuals in all fields of science and engineering supported by NSF. Please note the deadline of November 29, 1993. Title : NSF 93-150 Postdoctoral Research Associates in Computational Science and Engineering Type : Program Guideline NSF Org: CISE Date : October 5, 1993 File : nsf93150 CISE Postdoctoral Research Associates in Computational Science and Engineering and, in Experimental Science Program Announcement DIVISION OF ADVANCED SCIENTIFIC COMPUTING OFFICE OF CROSS-DISCIPLINARY ACTIVITIES DEADLINE: NOVEMBER 29, 1993 NATIONAL SCIENCE FOUNDATION CISE Postdoctoral Research Associates in Computational Science and Engineering (CS&E) CISE Postdoctoral Research Associates in Experimental Science (ES) The Computer and Information Science and Engineering (CISE) Directorate of the National Science Foundation plans a limited number of grants for support of Postdoctoral Research Associateships contingent upon available funding. The Associates are of two types: - Associateships in Computational Science and Engineering (CS&E Associates) supported by the New Technologies Program in the Division of Advanced Scientific Computing (DASC) in cooperation with other NSF CS&E disciplines (CS&E Associates). The objective of these Associateship awards is to increase expertise in the development of innovative methods and software for applying high performance, scalable parallel computing systems in solving large scale CS&E problems. - Associateships in Experimental Science (ES Associates) supported by the Office of Cross Disciplinary Activities (CDA) . The objective of the ES Associateship awards is to increase expertise in CISE experimental science by providing opportunities for associates to work in established laboratories performing experimental research in one or more of the research areas supported by the CISE Directorate. These awards provide opportunities for recent Ph.D.s to broaden their knowledge and experience and to prepare them for significant research careers on the frontiers of contemporary computational science and engineering and experimental science. It is assumed that CS&E Associates will conduct their research at academic research institutions or other centers or institutions which provide access, either on site or by network, to high performance, scalable parallel computing systems and will be performing research associated with those systems. It is assumed that ES Associates will conduct their research in academic research institutions or other institutions devoted to experimental science in one or more of the research areas supported by the CISE Directorate. From owner-sci-resources@net.bio.net Fri Oct 15 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 10 October 1993 Message-ID: Date: 16 Oct 93 05:07:56 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 170 Approved: sci-resources-moderator@net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: BUL 9310 NSF Bulletin October 1993; Volume 21, No.2 File size (bytes): 87137 STIS Filename: bul1093 Title: BUL 93-09 NSF September 1993 Bulletin Volume 21; No.1 File size (bytes): 45885 STIS Filename: bul9309 Document Type: Press Release Title: NSF EXPANDS COMMITMENT TO TECHNOLOGY TRANSFER BY LINKING SMALL BUSINESSES TO UNIVERSITY RESEARCHERS File size (bytes): 4023 STIS Filename: pr9376 Title: TRACER STUDY REVEALS HOW OCEANS DISPERSE HEAT File size (bytes): 4019 STIS Filename: pr9377 Title: FIVE STATES RECEIVE AWARDS UNDER NEW FEDERAL PROGRAM TO EXPLORE INTERDISCIPLINARY CONNECTIONS File size (bytes): 5455 STIS Filename: pr9378 Document Type: Program Guideline Title: NSF 93-138 - Conferences, Workshops, and Special Years in the Mathematical Sciences File size (bytes): 25217 STIS Filename: nsf93138 Title: NSF 93-139 - Mathematical Sciences Postdoctoral Industrial Research Fellowship Program File size (bytes): 21196 STIS Filename: nsf93139 Title: NSF 93-150 Postdoctoral Research Associates in Computational Science and Engineering File size (bytes): 16304 STIS Filename: nsf93150 Title: NSF 93-67 -- Urban Systemic Initiatives in Science, Mathematis and Technology Education- A new paradigm for Urban Education Reform File size (bytes): 60701 STIS Filename: nsf9367 Title: NSF 93-91 POSTDOCTORAL RESEARCH FELLOWSHIPS IN CHEMISTRY File size (bytes): 28215 STIS Filename: nsf9391 Document Type: Recruit Title: Astronomer (Program Director) File size (bytes): 3154 STIS Filename: vex941 Title: Clerical and Administrative Support Positions File size (bytes): 4141 STIS Filename: vgs943 Title: Secretary (Office Automation) File size (bytes): 4984 STIS Filename: vgs944 Title: Secretary (Office Automation) File size (bytes): 5339 STIS Filename: vgs945 Title: Program Assistant (Office Automation) File size (bytes): 5414 STIS Filename: vgs946 Document Type: STIS Title: FAQ - Accessing STIS and STIS Files File size (bytes): 28887 STIS Filename: accesfaq Title: FAQ - Down load Information from STIS File size (bytes): 9289 STIS Filename: dwnldfaq Title: FAQ - Miscellaneous Information File size (bytes): 10871 STIS Filename: miscfaq ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: CM -PUBLIC NSF Advisory Committee Meetings File size (bytes): 1752 STIS Filename: cmpublic Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 90150 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 99361 STIS Filename: phnorg Document Type: Press Release Title: PR 93-74 THREE MORE STATES RECEIVE AWARDS TO ENHANCE RESEARCH PROGRAMS File size (bytes): 5350 STIS Filename: pr9374 Title: NSF EXPANDS COMMITMENT TO TECHNOLOGY TRANSFER BY LINKING SMALL BUSINESSES TO UNIVERSITY RESEARCHERS File size (bytes): 4299 STIS Filename: pr9375 Document Type: Program Guideline Title: NSF 93-137 BIO Research Training Groups Program File size (bytes): 23513 STIS Filename: nsf93137 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf93137, the text of your message should be as follows: get nsf93137 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf93137, you would enter: ftp> get nsf93137 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 36, pt. 7, 8 October 1993 Message-ID: Date: 23 Oct 93 01:46:46 GMT Sender: kristoff@net.bio.net Lines: 1000 Approved: biosci-moderator@net.bio.net $$XID RFA DK94003 DK-94-003 P1O1 *************************************** KIDNEY DISEASE AND HYPERTENSION IN AFRICAN AMERICANS NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: DK-94-003 P.T. 34, FC; K.W. 0715133, 0715115, 0755015 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: December 21, 1993 Application Receipt Date: January 18, 1994 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), invites cooperative agreement applications from investigators to serve as a clinical center and/or data coordinating center for the full-scale phase of the "African American Study of Kidney Disease and Hypertension" (AASK). The experimental design of the full-scale trial is a multi-center, prospective, double-masked, randomized study examining the impact of three antihypertensive drug regimens with different initial randomized drugs and two different levels of blood pressure (BP) control on the rate of change of the glomerular filtration rate (GFR) in African American subjects with hypertension and established renal insufficiency. The study will follow a three by two factorial design. The first factor will consist of three drug regimens, each initiated by a different agent. The three initial drugs used in these regimens will be a calcium channel blocker, an angiotensin converting enzyme inhibitor, and a beta-blocker. The second factor will be two levels of goal BP as defined by the mean arterial pressure (MAP). One group will have a goal MAP less than or equal to 92 mm Hg and the other group will have a MAP between 102-107 mm Hg inclusive. Study participants in the AASK full-scale trial are restricted to African Americans. The protocol for the ongoing AASK pilot study provides details on inclusion and exclusion criteria and procedures for participants. It is recommended that applicants obtain a copy of this protocol, available upon request from DKUH staff, to assist them in preparing their applications for this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Health People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Kidney Disease and Hypertension in African Americans, is related to the priority areas of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Only U.S. organizations are eligible to apply. Domestic applications may not include international components. Applications may be submitted by for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators and minority institutions are especially encouraged. The expertise appropriate for this research program includes a knowledge of the epidemiological and clinical aspects of kidney disease and hypertension. Experience in carrying out renal and hypertension clinical trials is also essential. Experience and skill in measurement of kidney function (glomerular filtration rate), intervention with anti-hypertensive drugs among a large number of patients, and recruitment and follow-up of study participants, particularly African Americans, in clinical studies are appropriate for Clinical Centers. Skills in management of multi-center clinical trials, establishing and maintaining a large data base, and analysis of complex data sets are appropriate for the Data Coordinating Center. An institution may apply for both a Clinical Center and Data Coordinating Center. However, a specific plan on how the independent operation (i.e., confidentiality of study-wide data) of each unit will be maintained is required. A separate application for each center will be required from an institution applying for both a Clinical Center and Data Coordinating Center. 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. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), which is an assistance mechanism rather than an acquisition mechanism. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is approximately six million dollars. It is anticipated that one award for the Data Coordinating Center for not more than $750,000 (including direct and indirect costs) per year and fourteen awards for Clinical Centers will be made. Funding for a single Clinical Center will be approximately $375,000 in total costs. Although this program is provided for in the financial plans of the NIDDK, awards in response to this RFA are contingent on the availability of funds for this purpose. The total project period for applications submitted in response to the present RFA will be seven years. The anticipated award date is July 1994. At this time, the NIDDK anticipates that there will not be a renewed competition after seven years. If the NIDDK does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. RESEARCH OBJECTIVES Background End-stage renal disease (ESRD) is an important health problem among African Americans. According to the most recent report from the United States Renal Data System, Blacks (African Americans) make up 29 percent of the ESRD cases although only about 12 percent of the U.S. population is Black. In 1990, the ESRD incidence rate for Blacks is nearly four times that of whites (518 per million versus 132 per million). The disparity between Blacks and whites is especially striking for hypertension-related ESRD. The incidence rate of ESRD with a diagnosis of hypertension, the leading cause of renal failure among Blacks, is 6.2 times greater than in whites. For certain age groups, the disease rates are particularly high. For example, among Blacks aged 25-44, the incidence rate of ESRD associated with hypertension is 18 times greater than the rate for whites in 1988-90; the rate for Blacks 45-64 years old is nearly 10 times that of whites. This disease burden prevails despite the fact that improved control of blood pressure has been responsible, in part, for a decrease in incidence of and mortality from myocardial infarction and from stroke among both Black and white Americans during the past decade. The disproportionate number of cases of ESRD among Blacks due to hypertension has been attributed to a number of factors, including higher prevalence of and more severe hypertension, greater susceptibility of the kidney to elevated blood pressure, and difficulty in accessing treatment services, among others. Despite uncertainty about the reason(s) for this preponderance of disease, there are reports that control of blood pressure to 140/90 mm Hg (mean arterial pressure or MAP of 107) or less is beneficial in reducing the progression of kidney disease to end-stage. It is important to note, however, that a rigorously controlled clinical trial has not yet been conducted in persons with established renal impairment resulting from hypertension to determine whether or not one class of antihypertensive agents protects the kidney better than another and to determine the optimum blood pressure level that maximally protects the kidney. Recently, several reports have highlighted the benefits of antihypertensive therapy in preventing loss of renal function among persons with established kidney disease. For example, although only a modest difference in the rate of loss of renal function (as measured by serum creatinine) was observed between the Stepped-Care (SC) and Referred Care (RC) groups (21.7/1,000 in SC survivors and 24.6/1,000 in RC survivors) in the Hypertension and Detection Follow-up Program, a 50 percent relative difference in favor of SC among participants with baseline serum creatinine concentration indicating borderline hypercreatinemia (1.50 - 1.69 mg/dl) was observed. Of particular interest was the significantly greater rate of developing hypercreatinemia in Blacks, men, and older persons (>60 years of age) and among persons with higher diastolic blood pressure at trial entry. An encouraging preliminary report from a single-center clinical trial, which enrolled a high percentage of Blacks and utilized an accurate measure of kidney function, also suggests that lowering blood pressure in patients with hypertensive kidney disease may slow loss of kidney function. However, this study reported results from only a subset of randomized patients, lacked a control or comparison group, and failed to achieve a difference in level of blood pressure control. Since most, if not all, of the antihypertensive clinical trials conducted to date have focused primarily on cerebrovascular and cardiovascular events, a randomized controlled clinical trial is necessary to define the clinical usefulness and possible renal protective effects of long-term therapy with the major blood pressure lowering drugs in patients, especially African Americans, with hypertension associated with the impaired renal function. The benefit to renal function of control of blood pressure to levels below those generally recommended (140/90 mm Hg) also needs to be assessed. AASK Pilot Study The AASK Pilot Study, in which approximately 200 study participants will be enrolled, is currently underway. The anti-hypertensive drugs used in that study along with the two target goals for control of blood pressure are noted below under, "Goal of the Activity". It is anticipated that results from the pilot study, including renal diagnosis made from kidney biopsy, will be available during the summer of 1994. If the results of the Pilot Study indicate a need, modifications will be made to the study protocol for the full-scale trial. At this time two changes to the design and operational aspects of the Pilot Study protocol are anticipated and will be implemented in the full-scale trial; double-masked administration of the randomized anti-hypertensive drugs (ACEi, CCB, and beta-blocker) and use of a distributed data entry system at the Clinical Centers. Goal of the Activity The first goal of this RFA is to initiate a collaborative full-phase trial to test whether one of three anti-hypertensive drug treatment arms significantly reduces the rate of GFR decline better in African Americans with the clinical entity that is now attributed to hypertensive renal disease. A second goal is examining whether one of two levels of blood pressure control (less than 92 mm Hg vs. 102-107 mm Hg) better preserves renal function. The participants will be assigned to one of three randomized regimens: angiotensin converting enzyme inhibitor (ACEi), calcium channel blocker (CCB), or beta-blockers. It is anticipated that treatment by the randomized regimens will be carried out in a double-masked fashion. Subsequent to that assignment, no other ACEis, CCBs, or beta-blockers will be used in any of the participants to achieve blood pressure control. If the BP goal is not reached in a given participant on maximal tolerated doses of the drug assigned, additional anti-hypertensive medications will be added. The Pilot Study protocol recommends that anti-hypertensive medications will be added in the following order: (1) diuretics (furosemide); (2) alpha-blockers (doxazosin); (3) centrally-acting alpha-2 agonists (clonidine); (4) minoxidil or hydralazine. Scope of the Activity Approximately 900 study participants, recruited by fourteen clinical centers, will be required for the full-scale trial. Thus each Clinical Center is expected to randomize at least 65 participants during a two year period of recruitment. The full-scale study will consist of three phases: (1) a 24-month period of recruitment; (2) a 48-month period of intervention and follow-up and (3) 12 months for data analysis, close-out of the Clinical Centers, and reporting of results. Unless otherwise noted in this RFA, applicants should prepare the applications using patient eligibility criteria set forth in the AASK Pilot Study protocol. Major entry and exclusion criteria are briefly described as follows. The study participants in this trial will be exclusively African American men and women age 18-70 years who have hypertension and reduced renal function. Hypertension is defined as sitting blood pressure of 95 mm Hg or more. Reduced renal function is defined as a pre-randomization 125I-iothalamate glomerular filtration rate between 25-70 ml/min/1.73sq m. Selected exclusion criteria include history of malignant or accelerated hypertension within 6 months prior to study entry, known secondary causes of hypertension, known history of diabetes mellitus type I and II, and a ratio of urinary protein (mg/dl) to creatinine (mg/dl) exceeding 1.5 in a 24-hour urine sample. It is anticipated that randomized drugs (ACEi, CCB, and beta-blocker) will be administered in a double-masked fashion in the full-scale trial. Changes to the protocol to accommodate this study design will be considered at the first meeting of the Steering Committee. It is also expected that a distributed data entry system will be established during the full-scale trial. Applicants for the Data Coordinating Center should include a plan to implement (and budget) this system of data transmission. Each applicant should demonstrate the ability to follow an established study protocol and manual of operations. Applicants must also demonstrate the ability to recruit and randomize the required number of study participants, intervene with various anti- hypertensive drugs, and maintain high rates of follow-up during the course of the trial. Study Outline Investigators should develop their applications for the full-scale trial based on the inclusion and exclusion criteria and the general design of the pilot study as outlined in this RFA and the Pilot Study Protocol. It is expected that investigators will carry out the already developed protocol, however, modifications to this protocol may be required based on the results of the pilot study. Study Components 1. Clinical Centers A Clinical Center is an institution that is actively involved in the recruitment, evaluation, and treatment of study participants. It should consist of an interdisciplinary team of clinical investigators and appropriate personnel, such as a research coordinator, recruitment director, blood pressure interventionist, and clerical staff. Applications for Clinical Centers should provide evidence that the investigators are capable of randomizing at least 65 participants into the study during the two-year period of recruitment. Applicants for the Clinical Centers should describe their experience in recruiting from well-defined populations, especially African Americans. Clinical Centers will be required to submit protocol data expeditiously. The Principal Investigator and Co-Investigators in each Clinical Center should be skilled in collaborative clinical investigation, nephrology, and management of hypertension. There should be evidence of strong institutional support for the Clinical Center, including adequate space in which to conduct clinic activities and office space for staff. An organizational structure for the Clinical Center should be set forth in the application delineating lines of authority and responsibility for dealing with problems in all general areas as well as stated willingness to follow the stated common protocol. The applicant should include a succinct discussion of previous relevant investigational efforts. The applicant also should discuss in detail the recruitment strategies to procure the expected number of randomized participants, approaches to attain high levels of adherence to the anti-hypertensive drug regimens, and high rates of follow-up. 2. Central Functions The Data Coordinating Center will have primary responsibility for collecting, editing, storing, and analyzing data generated by the Clinical Centers. It should be prepared to assume a key role in overseeing implementation and adherence to the protocol, and assuring quality control. The Data Coordinating Center will be expected to provide appropriate biostatistical, data management, and coordination expertise. The Data Coordinating Center also will be expected to provide appropriate detailed reports to the Steering Committee and to the External Advisory Committee at regular intervals and will be responsible for the logistics and planning of meetings of these committees and their subcommittees. The NIDDK Project Coordinator will serve as a liaison between the Data Coordinating Center and these committees. Applicants for the Data Coordinating Center should provide a detailed description of prior experience in multi-center studies. The Data Coordinating Center will also be responsible for identifying and supporting a collaborating Drug Distribution Center, and a central laboratory for measurement of kidney function (Central GFR Laboratory), and a Central Biochemistry Laboratory. If these supporting units are not available at the applicant institution, the Data Coordinating Center should include plans to subcontract these functions. The Drug Distribution Center will acquire, store, and distribute study medications on a timely basis to all of the participating clinical centers. The Central GFR Laboratory will be responsible for implementing and coordinating GFR testing, including sample receipt and counting, GFR calculation, and reporting of results to the Data Coordinating Center. The Central GFR Laboratory also will be responsible for training and certification of clinical center GFR personnel. The Central Biochemistry Laboratory (CBL) will be responsible for measurement of relevant laboratory tests as specified in the study protocol and manual of operations. The CBL will coordinate shipping, receipt and testing of samples, and reporting the results directly to the Data Coordinating Center. 3. Steering Committee The primary governing body of the study will be the Steering Committee comprised of each of the Principal Investigators of the Clinical Centers and the Data Coordinating Center, the Chairperson of the Steering Committee, and the NIDDK Project Coordinator (described in detail under Terms and Conditions). 4. External Advisory Committee An independent committee supported by the NIDDK and composed of experts in nephrology, hypertension, biostatistics, clinical trials, and bioethics who are not otherwise involved in the study will be established to review periodically the progress of the study (described in detail under Terms and Conditions). 5. Project Coordinator The Minority Health Program Director, Division of Kidney, Urologic and Hematologic Diseases will be the Project Coordinator for the full-scale trial. The Project Coordinator will assist the Steering Committee and External Advisory Committee in carrying out the study (described in detail under Terms and Conditions). Study Phases The randomized full-scale clinical trial will include fourteen Clinical Centers and one Data Coordinating Center for a period of 84 months. It will have the following three phases: 1. Participant Recruitment: 24 months 2. Intervention and Follow-up: 48 months 3. Study Close-Out and Data Analysis: 12 months It is expected that each Clinical Center will recruit and randomize 65 participants during a 24-month period. The anti-hypertensive drug intervention will be carried out immediately post-randomization. Follow-up procedures, including measurement of blood pressure and GFR, will be carried out during a follow-up period of 48 months. A 12-month period is planned for close-out of Clinical Centers, data analysis, and reporting of results. It is expected that all data will be submitted centrally and that access to data and publications will be by the mechanism(s) defined in the protocol. The External Advisory Committee, will review progress at least semi-annually and provide advice to the NIDDK. Guidelines for Budget Preparation by Study Phases Each applicant for a Clinical Center and for the Data Coordinating Center should submit an adequately justified yearly budget for the entire anticipated project period of 84 months. The budgets for each budget period of the study should be clearly delineated. The following information is provided to assist applicants in the preparation of budgets. Detailed budgets will vary according to policies of the applicant and specific needs identified in the response to this announcement. Budget Period Time Period Activity #1 7/1/94 through 6/30/95 Recruitment, Intervention & F/U #2 7/1/95 through 6/30/96 Recruitment, Intervention & F/U #3 7/1/96 through 6/30/97 Intervention & Follow- Up #4 7/1/97 through 6/30/98 Intervention & Follow-Up #5 7/1/98 through 6/30/99 Intervention & Follow-Up #6 7/1/99 through 6/30/2000 Intervention & Follow-Up #7 7/1/2000 - 6/30/2001 Clinical Center Close-Out, Data Analysis, and Reporting of Results For a Clinical Center, the budget should request support for the minimum number of staff to successfully carry out the trial. A Clinical Center could include a Principal Investigator, Co- Investigator, GFR technician, study coordinator, and data entry clerk. Support for travel for two key investigators to attend quarterly meetings of the Steering Committee should also be included. Steering Committee meetings will be held in the Washington, DC area. Travel for centralized training of the GFR technician, study coordinator, and data entry clerk must also be budgeted (assume central training to be held in the Washington, DC area). For applications for the Data Coordinating Center, the budget should include the time and effort of key personnel needed to conduct the trial and the required number and cost of computers to be used at the Clinical Centers for distributed data entry. Travel to the Washington, DC area for External Advisory Committee meetings (two per year), Steering Committee meetings (three per year), site visits (seven in year 1 and seven in year 2) is also to be included in the budget. The budget should also include travel by the Chairperson of the Steering Committee (if he/she is not a Principal Investigator in the Study) to the External Advisory Committee meetings and the Steering Committee meetings. If the supporting functions of the Drug Distribution Center, the Central Biochemistry Laboratory, and the Central Glomerular Filtration Laboratory are not available at the applicant institution, the budget should reflect subcontracting of these functions. Terms and Conditions of Award The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism" (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the Institute Project Coordinator. These special terms of award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH grant administration policy statements. 1. Awardee Activities The tasks or activities in which awardees (for both the Clinical and Data Centers) will have substantial and lead responsibilities include protocol revision, data collection, quality control, final data analysis and interpretation, and preparation of publications. The awardee agrees to follow the common protocol and manual of operations developed for the Pilot Study and as amended based on the results of that phase of the trial. Specific tasks for the awardees of the Clinical Centers include patient recruitment and follow-up and transmission of all study data to a central Data Coordinating Center for combination and analysis. 2. NIDDK Activities The NIDDK Project Coordinator is the Minority Health Program Director, Division of Kidney, Urologic and Hematologic Diseases whose function will be to assist the Steering Committee and External Advisory Committee in carrying out the trial. The NIDDK Project Coordinator has expertise in clinical nephrology and clinical trials. The individual will assist in quality control, interim data analysis, safety monitoring, and final data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The NIDDK Project Coordinator will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The NIDDK reserves the right to terminate or curtail the study (or an individual award) in the event of (a) a major breach in the protocol or substantial changes in the agreed-upon protocol with which the NIDDK does not agree, (b) human subject ethical issues that may dictate a premature termination, or (c) significant alteration in the availability of resources to support the program. 3. Cooperative Activities A Steering Committee, composed of the principal investigators of each Clinical Center, the principal investigator of the Data Coordinating Center, the NIDDK Project Coordinator and the Chairperson of the Steering Committee will be the main governing board of the study and will have primary responsibility for facilitating the conduct of the trial, monitoring interim measures of trial progress, and reporting trial results. The Principal Investigators from each Clinical Center and the Data Coordinating Center, the Chairperson, and the NIDDK Project Coordinator will have one vote. The Chairperson, who will be someone other than the NIDDK staff member, will be selected by the Steering Committee from among their members, or alternatively, from among experts in the fields of nephrology, hypertension, or clinical trials who are not participating directly in the trial. Subcommittees will be established by the Steering Committee, as it deems appropriate; the NIDDK Project Coordinator will serve on subcommittees as he/she deems appropriate. Any changes to the collaborative protocol will be developed by the Steering Committee. Data will be submitted centrally to the Data Coordinating Center. Protocols will define rules regarding access to data and publications. An independent External Advisory Committee, to be appointed by the NIDDK, will review progress at least annually and report to the Institute. It is anticipated that awardees will have lead responsibilities in all joint tasks and activities. The NIDDK Project Coordinator will have voting membership on the Steering Committee, and as appropriate, its subcommittees. Awardees will be required to accept and implement the common protocol and procedures approved by the Steering Committee. 4. Governance The primary governing body of the study will be the Steering Committee comprised of each of the Principal Investigators of the Clinical Centers and the Data Coordinating Center, the Chairperson of the Steering Committee, and the NIDDK Project Coordinator. The Steering Committee has primary responsibility for developing common clinical protocols, facilitating the conduct and monitoring of the studies, and reporting the study results. Each member of the Steering Committee will have one vote. It is anticipated that the Steering Committee will meet on a quarterly basis during the course of the trial, or more often if deemed necessary. Subcommittees of the Steering Committee may be established as necessary and will meet as necessary. The NIDDK Project Coordinator and the Data Coordinating Center will be represented on each subcommittee. An independent External Advisory Committee supported by the NIDDK and composed of experts in relevant medical, statistical and bioethical fields who are not otherwise involved in the study will be established to review periodically the progress of the study. The committee will oversee participant safety, evaluate results, monitor data quality, and provide operational and policy advice to the Steering Committee and the NIDDK regarding the status of the study. The Principal Investigator of the Data Coordinating Center, the NIDDK Project Coordinator, and the Director of the Division of Kidney, Urologic and Hematologic Diseases may participate as ex-officio, non- voting members of this Committee. Committee members will be appointed by the NIDDK in consultation with members of the Steering Committee. The NIDDK named Project Coordinator will serve as executive secretary of the External Advisory Committee. 5. Arbitration Any disagreement that may arise in scientific-programmatic matters between award recipients and NIDDK may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Steering Committee (with NIDDK member not voting) or by the individual awardees in the event of an individual disagreement, a second member selected by NIDDK, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardees' right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, Subpart D and HHS regulations at 45 CFR part 16. The special terms of award (1-5) described above are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR parts 74 and 92, and other HHS, PHS, and NIH granting policy statements. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis is to be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale is to be provided. In the present study, however, only African Americans are to be enrolled and studied, as explained under "Research Objectives." Gender must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 5, Human Subjects. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. If the required information is not contained within the application, the application will be returned without review. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women in a study design is inadequate to answer the scientific question(s) addressed, AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked, but not required, to submit a letter of intent. This letter is to include the name, telephone number, and mailing address of the Principal Investigator, the names of key personnel, the name of the applicant institution, and the number and title of this RFA. Such a letter of intent is not binding and it will not enter into the review of any application subsequently submitted nor is it a requirement for application. Letters of intent are requested solely for planning purposes. The information contained in these letters is helpful in planning for review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The NIDDK staff will not provide responses to such letters. Letters of intent are to be received no later than December 21, 1993 and are to be addressed to: Dr. Robert D. Hammond Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 406 Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these awards. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7250; and from the NIH program administrators named below. Use the conventional format for research project grant applications and ensure that the points identified in the Review Criteria section below are fulfilled. To identify the application as a response to the RFA, Check "YES" on item 2a of page 1 of the application and enter the title "Kidney Disease and Hypertension in African Americans" and enter the RFA number DK-94-003 in the space provided. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the original completed application form. Failure to use the label could result in delayed processing of the application such that it may not reach the review committee in time for review. Send or deliver the completed, signed application and three complete photocopies to the following office, making sure that the original application with the RFA label attached is on top to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to Dr. Hammond at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants, otherwise the NIDDK cannot guarantee that the application will be reviewed in competition for the RFA. Applications must be received by January 18, 1994. An application not received by this date will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, the Division of Research Grants (DRG) will review the application for completeness. Applications will be reviewed by NIDDK staff for responsiveness to the objectives of this RFA. If an application is judged to be incomplete or unresponsive, it will be returned to the applicant. If the number of applications is large compared to the number of awards to be made, the NIDDK will conduct a preliminary scientific peer review and will withdraw from further competition those applications that are not competitive for award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be both competitive and responsive will be evaluated further according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NIDDK. Subsequently, they will be reviewed by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria The evaluation of applications for both Clinical Centers and the Data Coordinating Center will be based primarily on the scientific merit of the proposed study. If an institution wishes to apply both as a Clinical Center and Data Coordinating Center, separate applications must be prepared. The IRG evaluates the merit of each grant application on the meeting agenda according to specific criteria. The principal criteria for the initial review of research project grant applications, as required in the PHS Scientific Peer Review Regulations include: o scientific, technical, or medical significance and originality of the proposed research; o appropriateness and adequacy of the experimental approach and methodology to be used; o qualifications of the Principal Investigator and staff in the area of the research; o the Principal Investigator's experience and record in previous research activity; o reasonable availability of resources; o reasonableness and adequacy of justification for the proposed budget and duration of support; and o adequacy of the proposed means for protecting against adverse effects upon humans, vertebrate animals, or the environment. Special criteria for review of applications will be as follows: For Clinical Centers: 1. Documentation of access to an African American target population, and women, from which a substantial number of trial participants can be recruited in sufficient numbers to meet the goals specified in the RFA. 2. Understanding and awareness of the scientific, ethical, and practical issues underlying the proposed trial and appropriateness of plans to deal with them. 3. Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the operation of a Clinical Center in the proposed Clinical Trial. Evaluation will include the following: familiarity with and experience in recruiting participants in a randomized trial; providing counseling on antihypertensive drugs; handling laboratory specimens; working in collaboration with other investigators under a common protocol; and meticulous and expeditious handling of study data. Specific experience in the recruitment and antihypertensive drug treatment of African Americans will be emphasized. 4. Responsible budgeting, staffing, and distribution of available resources appropriate for the work proposed. 5. Adequacy of the proposed facility and space. 6. Evidence of the degree of institutional commitment and support for the proposed program, including the relative position of the proposed project staff within the applicant's organizational structure. 7. Willingness to work cooperatively with other centers in the manner summarized in the RFA. For the Data Coordinating Center: 1. Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the operation of a Data Coordinating Center for a collaborative clinical trial, as well as available, on-site medical consultation, and the time these professionals will devote to the project. Prior experience in similar studies in the collection of data and patient specimens from multiple clinical sites, as well as experience in monitoring the quality and timeliness of such data, must be demonstrated. 2. Suitability of proposed data management and data analysis plans. 3. Ability to design, implement and maintain a distributed data entry system for the Clinical Centers. 4. The approach to and likelihood of soliciting cooperation from the participating clinical centers and exercising appropriate leadership in matters of study design and protocol revision, and data acquisition, management, and analysis. 5. Appropriateness of the budget for the work proposed. 6. The adequacy of the proposed facility, technical hardware, and space. 7. The organizational and administrative structure of the proposed program. 8. Evidence of the degree of commitment and support of the organization/institution for the proposed program, including the relative position of the proposed project staff within the applicant's organizational structure. 9. Suitability of the organizational and administrative arrangements for procuring the services of (or subcontracting for) a Central Biochemistry Laboratory, Central GFR Laboratory, and Drug Distribution Center. For the Glomerular Filtration Rate Testing Laboratory: 1. Experience in carrying out GFR assessment with 125I-iothalamate. 2. Experience in handling and testing a large number of urine and blood samples for GFR measurement and in reporting results in a timely fashion to the Data Coordinating Center. 3. Maintenance of internal quality control procedures. 4. Willingness to collaborate with other study investigators to ensure correct collection and shipping of specimens. 5. Ability to train and certify Clinical Center staff for GFR testing. For the Drug Distribution Center: 1. Experience in procuring antihypertensive drugs from the relevant pharmaceutical companies, and other medications that may be necessary for the study. 2. Ability to store and maintain study drugs according to state, local, and federal regulations. 3. Design and implementation of a distribution system for the drugs. 4. Maintaining adequate records to fulfill requirements of Federal and State regulatory agencies and requirements of the study. 5. Providing information to clinical center pharmacists and other team members about pharmacy-related issues pertaining to the study. For the Central Biochemistry Lab: 1. Experience in carrying out relevant routine testing of a large number of samples comprised primarily of body fluids, including urine and blood, as specified in the study protocol and manual of operations. 2. Ability and capability in reporting results in a timely fashion to the Data Coordinating Center. 3. Maintenance of internal quality control procedures. 4. Willingness to collaborate with other study investigators to ensure correct collection and shipping of specimens. 5. Ability to carry out centralized training of clinic staff for proper collection and shipment of specimens to the CBL. AWARD CRITERIA Applications recommended by the National Diabetes and Digestive and Kidney Diseases Advisory Council will be considered for award based upon (a) scientific and technical merit; (b) program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; and (c) availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are encouraged to request a copy of the pilot study protocol. Inquiries regarding programmatic issues may be directed to: Lawrence Y. Agodoa, M.D. Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases Room 3A11, Westwood Building Bethesda, MD 20892 Telephone: (301) 594-7553 FAX: (301) 594-7501 Inquiries regarding fiscal matters may be directed to: Nancy C. Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649B Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 Schedule The timetable for receipt, peer review, and funding of this RFA is as follows: Letter of Intent Receipt Date: December 21, 1993 Application Receipt Date: January 18, 1994 Initial Review: February/March 1994 Review by the NIDDK Advisory Council: May/June 1994 Anticipated Award Date: July 1, 1994 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance No. 93.849-Kidney, Urologic and Hematologic Diseases Research. Awards are made under the authority of the Public Health Service Act, Title IV Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. References 1. U.S. Renal Data System, USRDS 1993 Annual Data Report, The National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, April 1993. 2. Brazy, PC, Fitzwilliam, JF. Progressive renal disease: role of race and antihypertensive medications. Kidney International 37:1113-1119, 1990. 3. National High Blood Pressure Education Program (NHBPEP) Working Group Report on Hypertension and Chronic Renal Failure. U.S. Department of Health and Human Services. Public Health Service. National Institutes of Health. National Heart, Lung and Blood Institute. NIH Publication No. 90-3032. August 1990. 4. Shulman, NB, Ford, CE, Hall, WD, et al. Prognostic value of serum creatinine and effect of treatment of hypertension on renal function. Results from the Hypertension Detection and Follow-Up Program. Hypertension 13:I80-I93, 1989. 5. Eliahou, HE, Cohen, D, Hellberg, B et al. Effect of the calcium channel blocker nisoldipine on the progression of chronic renal failure in man. Am J of Nephrol 8:285-290, 1988. 6. Ruilope, LM, Miranda, B, Morales, JM et al. Converting enzyme inhibition in chronic renal failure. Am J of Kidney Dis 13:120-126, 1989. 7. Brazy, PC, Stead, WW, Fitzwilliam, JF. Progression of renal insufficiency: role of blood pressure. Kidney International 35:670-674, 1989. 8. Pettinger, WA, Lee, HC, Reisch, J et al. Long-term improvement in renal function after short-term strict blood pressure control in hypertensive nephrosclerosis. Hypertension 13:766-772, 1989. 9. Klahr, S. The modification of diet in renal disease study. New England Journal of Medicine 320:864-866, 1989. From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 37, pt. 3, 15 October 1993 Message-ID: Date: 23 Oct 93 01:53:01 GMT Sender: kristoff@net.bio.net Lines: 773 Approved: biosci-moderator@net.bio.net $$XID RFA DK94007 DK-94-007 P1O1 *************************************** HORMONAL REGULATION OF BREAST-SPECIFIC GROWTH FACTORS NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA: DK-94-007 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: January 21, 1994 Application Receipt Date: February 18, 1994 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites investigator-initiated research grant applications to investigate the biology, physiology, and pathophysiology of systemic hormones and their role in regulation of growth factors and cytokines and their receptors in both normal and abnormal endocrine regulatory activity associated with breast tissue. 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), Hormonal Regulation of Breast-Specific Growth Factors, is related to the priority areas of cancer and maternal health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Minority individuals and women are encouraged to submit as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01) or FIRST (R29) awards. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement and this RFA. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total requested project period for applications submitted in response to this RFA may not exceed four years for R01s and five years for R29s. A maximum of three years may be requested for foreign awards. The earliest possible award date will be September 30, 1994. FUNDS AVAILABLE For FY 1994, $2,500,000 will be committed to fund applications submitted in response to this RFA. It is anticipated that up to 12 awards will be made. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Applicants must limit their requests to not more than $160,000 direct costs for the initial budget period. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Breast tissues are significant targets of endocrine actions. A number of hormones such as estrogens, progestins, growth hormone, hydrocortisone, insulin, prolactin and other members of the steroid/thyroid/vitamin hormone superfamily promote in vitro growth of both non-malignant and malignant human breast tissue. Many systemic hormones interact with and/or regulate other intermediates, including growth factors and cytokines to provide multiple stimulatory signals on tissues and cells affecting the growth and function of sensitive breast structures. Although the role(s) of locally active hormones in breast tissue growth, regulation, disease, and/or neoplasia is not fully understood, it is clear that systemic hormones do stimulate tissues to synthesize and release the growth factors (e.g., growth hormone and insulin-like growth factor-I). In other instances, growth factors have been reported present in breast tissue, including gastrin-releasing peptide (GRP), epidermal growth factor (EGF), and insulin-like growth factors (IGF). In addition, EGF is capable of stimulating in vitro growth of breast stromal elements, while IGF-I and TGF appear to mediate certain growth effects of some estrogens on breast epithelium. Still other reports suggest that in cultured breast tissue, stromal elements from either benign or malignant lesions may express a number of mitogenic growth factors including platelet-derived growth factor (PDGF-A chain), fibroblast growth factors (FGF), transforming growth factors and insulin-like growth factors. In addition, breast stromal fibroblasts secrete a form of interleukin-6 (IL6) that stimulates the ability of some human breast cell lines to convert estrone (E1) to the more biologically active 17-beta-estradiol (E2) by an increase in reductive E2- oxidoreductase (EOR) activity. Recent molecular cloning studies have revealed that some growth factor receptors have significant homologies with cellular proto-oncogenes and/or viral oncogenes (e.g., PDGF and v-sis), whose inappropriate expression and/or altered function play roles in the process of breast tissue growth. Moreover, oncogenes and proto-oncogenes often appear to represent altered forms of normal cellular receptors for systemic hormones and/or growth factors whose expression is required for the normal functioning of the same tissues (e.g., EGF and the HER2/neu oncogene). Some hormones, growth factors, and/or cytokines also have cognate binding proteins that may play a role in mediating or regulating their physiological effects and may play a role in various steps associated with cell growth, differentiation and metabolism. With better understanding of the possible interactions among hormones, growth factors, cytokines, or their cognate receptors it may be possible to exploit the respective biologic activities of these substances or their antagonists in developing new therapeutic and preventative agents. For instance, growth factor or cytokine receptor and/or binding proteins and protein segments may have potential therapeutic value as great or greater than that of the cognate cytokines and growth factors. Clearly, further understanding of the role of systemic hormones in the regulation and interaction of growth factors, cytokines, and homologous proto-oncogenes and other endocrine factors with roles in signal transduction in normal and diseased breast tissue structure and function, is required. The rapidly growing clinical applications of the biologic activities of these substances only magnifies this imperative. Scope Some examples of research topics that would be considered responsive to this solicitation include the following: o the regulation, by systemic hormones, of the expression and/or release of growth factors, cytokines, or cognate receptors in breast tissue, in vivo or in vitro o alterations in the expression, production, or function of hormone receptors after stimulation of breast tissues by growth factors or cytokines o hormonal interactions with DNA/RNA regulatory elements (e.g., HREs) involving the production of growth factors, cytokines, and/or cognate receptors (e.g., alternate splicing, tissue specificity, or altered forms) in response to circulating hormones o identification of the effects of hormones on various proto-oncogene/receptors for growth factors or cytokines; mutations that cause dysregulated endocrine function o role(s) of systemic hormone, growth factor and cytokine receptors and/or their homologues (e.g., proto-oncogenes) in ordered and disordered regulation of gene expression in breast tissue o mechanism of action of hormone, growth factor or cytokine receptors in effecting signal transduction in breast; interaction(s) with other signal transduction pathways (i.e., cross-talk) and altered interactions in disease, including altered endocrine/paracrine/autocrine communication o identification and functional significance of genes whose expression is regulated by signal transduction through systemic hormone, growth factor, and cytokine receptors on breast tissues o role and mechanism of action of analogues and/or antagonists to hormones/growth factors/cytokines or their receptors in treatment of breast dysplasia or neoplasia o identification and characterization of orphan receptors in breast epithelium with functions related to those of known receptor tyrosine/serine kinases or phosphatases and/or members of the steroid/thyroid/vitamin hormone superfamily. These areas of interest are not listed in any order or priority. They are only suggested examples of areas of research. Applicants are encouraged to propose other areas that are related to the objectives and scope described above. Applications that propose issues of age-related changes (e.g., menopause) or reproductive biology will be considered non-responsive to this RFA and will have standard DRG referral guidelines relevant to NIA or NICHD, respectively, applied. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample is appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations; i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention [and preventive strategies], diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned without review. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by January 21, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The form is available from most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892; telephone (301) 594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by February 18, 1994. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 and as a component project of a program project, with the proviso that only one could be funded. 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 previously reviewed. Such applications must not only include an introduction addressing the previous critique, but also be responsive to this RFA. FIRST Award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. If the application is not responsive to the RFA, NIDDK staff will contact the applicant to determine whether it should be returned to the applicant or held until the next regular receipt date and reviewed in competition with all other applications. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further competition when they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened by the NIDDK for this RFA. Following this review, the applications will be given a second level review by the NIDDK Advisory Council, unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o scientific/technical merit criteria specific to the objectives of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o if an application involves activities that could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed means for protecting against or minimizing such effects. o for foreign applications: uniqueness of research such that it can be performed only outside of the United States. AWARD CRITERIA Funding decisions will be made based on the initial review group and national advisory council recommendations, program relevance, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: W. Lorenzo Jackson, M.D., Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 621 Bethesda, MD 20892 Telephone: (301) 594-7576 FAX: (301) 594-9011 Inquiries regarding fiscal matters may be directed to: Ms. Kim Law Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649D Bethesda, MD 20892 Telephone: (301) 594-7543 Schedule Letter of Intent Receipt Date: January 21, 1994 Application Receipt Date: February 18, 1994 Initial Review: June 1994 Second Level Review: September 1994 Anticipated Date of Award: September 30, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. 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. $$XID RFA TW94001 TW-94-001 P1O1 *************************************** MINORITY INTERNATIONAL RESEARCH TRAINING GRANTS NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA: TW-94-001 P.T. 44, FF; K.W. 0720005 Fogarty International Center Office of Research on Minority Health Application Receipt Date: March 16, 1994 PURPOSE The Fogarty International Center (FIC) and the Office of Research on Minority Health (ORMH) support a program to provide international research training opportunities for minority undergraduate students, minority graduate students, and minority faculty members in biomedical and behavioral research. Training grant awards will be made for three years to U.S. colleges and universities for the purposes of encouraging minority students to pursue degrees and careers in the biomedical sciences by broadening their undergraduate and graduate education through international experiences; promoting qualities of leadership by expanding cultural perspectives and to help prepare the next generation of scientific leaders to work effectively in a global environment; and establishing linkages between U.S. scientists and institutions and established centers of biomedical research abroad. Some or all of the following three components may be included within each institutional award: first, the international research training program for pre-baccalaureate minority students pursuing life science curricula to conduct short-term research and coursework abroad for approximately 8 to 12 weeks; second, a predoctoral program to enable minority students enrolled in graduate research degree programs to receive research training for 3 to 12 months at foreign institutions; and third, the international faculty development program for individual minority faculty to conduct research at foreign institutions for 3 to 12 months. Applications may be submitted from individual U.S. institutions or from consortia of U.S. institutions with one lead institution. For the purposes of this program, consortia will link institutions that have active international programs with those with limited international research training programs. ELIGIBILITY REQUIREMENTS These institutional training grants will be awarded to U.S. institutions for the purpose of collaborating with one or more foreign research centers that can provide a substantial research training experience for the U.S. minority participants. The applicant institution and any associated institution in a consortium must be a two- or four-year domestic school, college, or university. Minority participants must be from underrepresented minority groups, including African Americans, Hispanic Americans, American Indians, and Pacific Islanders. The program director at the applicant institution will be responsible for the selection and appointment of participants, selection of the foreign training site(s), and the overall direction of the training program. Participating students and faculty members must be members of the minority groups listed above and be U.S. citizens or permanent U.S. residents and be pursuing degrees, studying, and/or conducting research in the biomedical or behavioral sciences at the time of appointment. The foreign research centers should be universities, colleges or other research institutions that have strong, well-established biomedical or behavioral research and research training programs. Close cooperation between the U.S. and foreign institutions and scientists will be needed to provide the trainees with a foreign mentor or collaborator who is recognized as an accomplished investigator and who will participate in their research training. Undergraduate student trainees must be pre-baccalaureate, pursuing a relevant biomedical or behavioral science curriculum and must show evidence of a commitment to obtaining a postgraduate research related degree in a biomedical or behavioral field of science. The foreign training for undergraduate students will usually be for 8 to 12 weeks. One faculty person may accompany each group of four to eight minority students and act as a general advisor/mentor during the study abroad. Faculty members serving this purpose are not required to belong to any minority group. They must hold full-time tenure track or tenured faculty positions at the grantee institution, hold a doctoral level degree and have a biomedical research plan to be conducted at the host institution. Predoctoral students must be enrolled in a U.S. graduate research training program in the biomedical or behavioral sciences. The predoctoral training period may be from 3 to 12 months for the purpose of learning a technique or carrying out a special project or portion of a project related to their doctoral studies. The minority faculty development portion of the training grant will provide support for research and studies for 3 to 12 months at a foreign training site. Participants must have regular full-time faculty appointments at the grantee institutions or an institution in the consortium. The research plan must indicate the expected benefits of the proposed work. Students and faculty must be affiliated with a U.S. college or university at the time of selection; however, the affiliation need not be with the grantee institution. MECHANISMS OF SUPPORT The mechanism of support is the institutional training grant award (T32). Domestic institutions may request up to three years of support. The stipend level during the period of foreign stay is $1,000 per month for undergraduate and graduate students and $3,000 per month for the faculty member. Stipends may be supplemented from non-Federal sources only. Requests may be made for training-related expenses for undergraduate and graduate students and faculty of up to $500 per month each for health insurance, foreign tuition and fees, and other education-related expenses at the foreign training site. Research expenses for use at the foreign training site of up to $500 per month may be requested for each undergraduate student, graduate student, or faculty member. Foreign living expenses will be $1,000 per month for undergraduate and graduate students and $2,000 per month for faculty members. Travel expenses may also be requested from the home institution to the foreign training site and return. Appointments may range from 8 to 12 weeks for undergraduates, 3 to 12 months for the predoctoral students and 3 to 12 months for faculty. Stipends, training and travel expenses are offered only during the time period participants are en route to or working in the foreign country. No expenses are provided for domestic training. If specially justified, the domestic applicant institution may request up to five percent of the requested total direct costs for the support of the Principal Investigator and/or other grant-related personnel for domestic administrative efforts. Indirect costs will be awarded to the grantee institution at a rate of eight percent of the allowable direct costs. Each of the training grant awards will not exceed a total of $400,000 per year, including direct and indirect costs. Additional direct support for the minority student participants on return to the U.S. may be available from the FIC for attendance at scientific meetings to present the results of their foreign research experience. FUNDS AVAILABLE It is expected that 10 to 12 awards will be made in FY 1994. RESEARCH OBJECTIVES The Minority International Research Training grants are designed to offer research training grant awards to enable qualified minority undergraduate students, graduate students, and faculty members to participate in international biomedical and behavioral research programs. This program is designed to supplement the current programs of the FIC available to all scientists. They include the Fogarty International Research Collaboration Award (FIRCA), which supports NIH grantees for the purpose of adding a foreign collaboration with scientists in Central and Eastern Europe, Latin America or Sub-Saharan Africa to their ongoing NIH supported research program and the Senior International Fellowship (SIF), which supports U.S. scientists for up to 12 months at foreign research work sites. The SIF fellowship may be used over three years, taking up to three separate trips for a minimum of three months each. This training grant program is expected to attract students and scientists in the developmental stages of their education and careers, to increase their awareness of international research opportunities and to acquaint them with the full range of career opportunities in biomedical and behavioral research. Minority faculty members are expected to gain experience that will contribute to the research and teaching programs at their U.S. institution. Their association with the foreign institution will, in many cases, provide future undergraduate and graduate research training sites. The components of the training grant may include the following: A. The Undergraduate Research Training Program This component of the training grant will offer a biomedical research experience for minority undergraduate students at research centers abroad where arrangements have been made to house and train students for 8 to 12 weeks, at any appropriate time of the year. The training may include short courses in the language and culture of the host country and/or academic college level courses in the biomedical or behavioral sciences. Also, research training experiences must occupy approximately half of each weekday. Support for the undergraduate students will be available only while abroad. Each group of four to eight students may be accompanied by a faculty member who would also conduct research, preferably at or at least near the location of the students. The faculty member would act as a mentor to the minority students and may receive support from this training grant while with the students. The student research projects might include collection of data, samples, or other information for research purposes but may not involve routine clinical laboratory work without a research component. B. The Predoctoral Program The training grant may include a predoctoral component that will provide support for research training of minority predoctoral students at a foreign institution for 3 to 12 months as part of the requirement for the graduate research degree program (but not professional degree programs such as M.D., O.D., D.D.S., Pharm.D., or D.V.M. programs) in which the student is enrolled. The minority student will receive support from the training grant for the foreign training portion only and the application must demonstrate the benefit of foreign training that may include some course work but must be primarily for the conduct of research, to learn a technique, to participate in a study, or to utilize a unique resource or study population. C. The International Faculty Program Within this institutional training grant, the faculty development program supports minority faculty members employed at U.S. colleges and universities to carry out international collaborative research abroad for periods of from 3 to 12 months. Faculty members will be selected by the grantee institution and will conduct studies and research on a biomedically related topic in collaboration with the foreign laboratory. The U.S. faculty member must have a doctoral-level degree or equivalent experience and training. The purpose of this program is to enhance the current research skills of the investigator by providing a new research direction or an extension of his or her current research activities or for providing a unique site that offers a special research facility or special human or animal study population. The research experience will also benefit the faculty member's ability to communicate new scientific concepts and directions in international developments in science in his/her role as an instructor at the U.S. grantee institution or at his or her home institution. In addition to the conduct of the research, this program may be used to develop a site or sites for the foreign research activities of the undergraduate students. The faculty member may accompany students participating in the undergraduate research program while also conducting research. The FIC and ORMH staff will closely follow the progress of each training grant program through site visits and periodic meetings of program directors. APPLICATION PROCEDURES Applications are to be submitted on the Public Health Service grant application form PHS 398 (rev. 9/91), using the special instructions related to Institutional National Research Services Awards (Section VII). Note the requirement to use NRSA substitute pages MM, NN, and OO to be acceptable for initial review. Application kits are available at most institutional offices of sponsored research and may also be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The title and number of the announcement must be typed in section 2a on the face page of the application. The completed application and three legible copies must be sent or delivered to the following address and received by March 16, 1994: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition, two copies of the complete application must be sent to Dr. David A. Wolff at the address listed under INQUIRIES. REVIEW CONSIDERATIONS All applications responding to this announcement will be reviewed for scientific and technical merit by an NIH initial review group, followed by a second level review by the Fogarty International Center Advisory Board. To be eligible for review, applications must be complete and submitted in accordance with the application procedures stated above. Reviewers will pay particular attention to the proposed method of selecting participating faculty and students, the past or potential capability of the institutions to carry out this type of program, the proposed benefit to the participants and the justification for selecting the foreign training site(s). Letters from the foreign collaborator and their institutional officials indicating their willingness to participate in this training program, must accompany the application. AWARD CRITERIA Applications will compete for funds assigned to the Minority International Research Training Grant Program of the Fogarty International Center. The following will be considered in making funding decisions: how the proposal will contribute to the achievement of the program's objectives; scientific, technical, and educational merit of the application as determined by peer review; and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. David A. Wolff Chief, International Research and Awards Branch Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 FAX: (301) 402-0779 Direct inquiries regarding fiscal matter to: Silvia Mandes International Research and Awards Branch Fogarty International Center Building 31, Boom B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 FAX: (301) 402-0779 AUTHORITY AND REGULATIONS Awards will be made under the authority of the Public Health Service Act, Title III, Part A, Section 307b (42 USC 242l), and administered under PHS grants policies and Federal regulations, most specifically 42 CFR part 61. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 37, pt. 2, 15 October 1993 Message-ID: Date: 23 Oct 93 01:52:15 GMT Sender: kristoff@net.bio.net Lines: 1041 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19931015 V22N37 P2O2 ************************************ the primary responsibility of identifying and recruiting eligible patients at his/her center. He/She will be responsible for the follow up, as specified in the study protocol, of each patient enrolled in the clinical trial and for submitting required data to the resource center(s). The Principal Investigator is also responsible for ensuring that his/her clinic personnel are trained and certified to carry out study procedures. 2. NEI Staff Responsibilities The appropriate NEI extramural program director from the Division of Collaborative Clinical Research whose name appears on the Notice of Grant Award will participate with and assist, but not direct: a. The Study Chairperson and Coordinating Center Director in the nomination and selection of an independent Data and Safety Monitoring Committee. b. The Study Chairperson and, when appropriate, the Executive Committee, in assuring that patient information handbooks, recruitment information, press releases, and publicity exhibits are properly prepared and disseminated. c. The Study Chairperson in the identification of additional participating clinics, if necessary, in order to enhance patient recruitment. d. The Executive Committee in routine performance monitoring of the entire study including matters of quality control within and among various components; and in the determination of inadequate patient recruitment or failure to comply with the protocol on the part of individual clinics. e. The Editorial Committee in the preparation and review of study results for publication. f. The Data and Safety Monitoring Committee as an ex officio member and will participate in all decisions of the Committee, e.g., to proceed from one phase of the study to the next, to implement protocol changes, to evaluate patient recruitment issues, to approve any ancillary studies, to plan data analysis, to announce study findings, and to determine the timing of release of any interim or final reports. The NEI reserves the right to curtail, withhold, or terminate support for the study (or an individual award) in situations involving: inadequate patient recruitment, follow-up, data reporting, or quality control; a major breech of the study protocol; a substantive change in the agreed-upon protocol to which the NEI does not agree; statistical evidence that the major study endpoint has been reached ahead of schedule; or, human subject ethical issues that dictate a premature termination. Prior to taking such actions, NEI will consult with and receive recommendations from the Data and Safety Monitoring Committee. 3. Collaborative Responsibilities Data and Safety Monitoring Committee: A group composed of individuals, not directly involved in patient care or data collection in the trial, who are responsible for periodically reviewing accumulated data for evidence of adverse or beneficial treatment effects; for initiating recommendations for modification of the study protocol, including termination of the treatment when appropriate; and for assessing data quality and clinic performance. Executive Committee: Composed of the Study Chairperson, who serves as Chair, directors of the resource core centers, the NEI representative, and a small group of clinical center Principal Investigators who are elected by the full group of participating clinical center principal investigators for a set term. This committee acts as the administrative and executive arm of the clinical trial. It makes decisions on day-to-day operational issues; considers and adopts changes in study procedures as necessary; reviews and implements recommendations from the Data and Safety Monitoring Committee; reviews progress of the trial in achieving its main goal and takes steps required to enhance likelihood of success; and, reviews data collection practices and procedures as summarized in performance monitoring reports for clinical centers to identify and correct remediable deficiencies. Editorial Committee: This committee has the responsibility for reviewing manuscripts produced by the study investigators and for assisting in the preparation of the main trial results. Its members are the Study Chairperson, coordinating center director, the NEI representative, and several clinical center investigators elected by the full group of participating clinical center Principal Investigators. 4. Arbitration The independent Data and Safety Monitoring Committee will serve as an arbitrator for resolution of potential differences of opinion among the investigators and NEI staff concerning the scientific/technical conduct of the study. This special arbitration procedure in no way affects the awardee's rights to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HHS regulation at 45 CFR Part 16. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Potential applicants are strongly encouraged to contact NEI staff prior to the preparation and submission of an application to discuss NEI's possible interest in supporting the clinical trial and to request additional information that will be helpful in preparing applications. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. For item 2a on the Face Page, enter "NEI Clinical Trial Cooperative Agreement." For item 2b on the Face Page, enter the code "U10." The applicant should provide a statement acknowledging and agreeing to NEI staff post-award involvement in conducting the clinical trial, and should describe plans to accommodate this involvement. The complete, typewritten, signed original of the application, including the Checklist, and three exact copies, in one package with any appendices, must be mailed or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application, and all appendix material, must be sent to: Review and Special Projects Officer National Eye Institute Executive Plaza South, Room 350 6120 Executive Boulevard Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications will be assigned by the Division of Research Grants on the basis of established Public Health Service referral guidelines and reviewed in accordance with standard NIH peer review procedures. Applications assigned to the NEI will be reviewed for scientific merit by an initial review group convened by the NEI Review and Special Projects Officer. Second level program and policy review for applications assigned to NEI will be conducted by the National Advisory Eye Council. All applications will be reviewed using the following standard 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 resources necessary to perform the research; and, o appropriateness of the proposed budget and duration in relation to the proposed research. In addition, the following criteria will also be considered by NEI-convened review groups when assessing the scientific merit of applications: Study Chairperson's Application o the rationale for the clinical trial and the reasonableness of the specific objectives in addressing a major problem in vision research; o the appropriateness of the experimental design for testing the problem/hypothesis and the measures chosen to assess the effect of the intervention, the plans for minimizing bias, and the criteria for the study endpoints; o the study procedures and administrative arrangements for implementing the experimental design/protocol; o the justification for the sample size, the availability of the patient pool, the likelihood of achieving the target sample size in a reasonable time, the reasonableness of the general statistical approach, and the procedures for technical monitoring of the study centers for adherence to protocol and for data monitoring to determine whether protocol changes are needed; and, o the scientific, clinical, and administrative qualifications of the Study Chairperson and other key personnel. Coordinating Center/Other Resource Center Applications o the reliability and accuracy of the center's past performance and the potential of the center's future performance in a clinical trial; o the experience of the Principal Investigator and other key personnel in clinical trials; o the ability of the center to manage and to analyze data for the clinical trial; and, o the appropriateness of the proposed procedures for data management, data storage, and analytical activities. Participating Clinical Center Applications o adequacy of the participating clinical center's procedures for: patient recruitment, patient retention, patient followup, data collection and management, quality control of clinical examinations, and training and certification of personnel; o the qualifications of all key personnel including their experience and track record in clinical trials; and o the sources and numbers of fully-eligible patients, the number of eligible patients likely to have participated in the clinical trial who were seen over a specific period of time, and the clinic's patient recruitment and retention track record in clinical trials. AWARD CRITERIA The following will be considered in making funding decisions for applications assigned to the NEI and recommended by the National Advisory Eye Council: o scientific and technical merit of the proposed clinical trial as determined by peer review; o relevance to NEI program goals and key research questions identified in "Vision Research - A National Plan: 1994-1998;" and o availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. For information regarding this notice and referral to the appropriate NEI program or grants management staff, contact: Dr. Richard L. Mowery Division of Collaborative Clinical Research National Eye Institute Executive Plaza South, Room 350 Telephone: (301) 496-5983 The NEI publication, "Vision Research - A National Plan: 1994-1998," is available from: Office of Science Policy and Legislation National Eye Institute Building 31, Room 6A25 Bethesda, MD 20892 Telephone: (301) 496-4308 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.867, Vision Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PAR-94-004 *********************************************** CANCER EDUCATION NIH GUIDE, Volume 22, Number 37, October 15, 1993 PAR NUMBER: PAR-94-004 P.T. National Cancer Institute PURPOSE The National Cancer Institute (NCI) invites applications to its Cancer Education Grant Program designed to support innovative educational efforts to reduce, directly or indirectly, cancer incidence, morbidity, and mortality. It also wishes to encourage effective programs that promise improvement in the quality of life of cancer patients. 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, Cancer Education, is related to the priority area of educational and community-based programs. Potential applicants may obtain a copy of "Healthy People 2000: (Summary Report: Stock No. 017-001-00473-1 or Full Report: Stock No. 017-001-00474-0) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Any not-for-profit or for-profit organization engaged in health-related education, research, or training and located in the United States or its territories may apply. MECHANISM OF SUPPORT The mechanism of support is the Cancer Education (R25) grant award. In general, allowable costs must be consistent with PHS policy and recommended by peer reviewers. These costs include, but are not limited to, supplies, personnel costs, student compensation, consultant costs, equipment, travel, sub-contractual costs, other expenses, and other student costs when appropriate. Indirect costs are payable at either their actual level or at the rate of eight percent of total direct costs, depending upon which sum is smaller. Tuition and equipment costs are to be excluded from the direct cost base for the computation of the indirect cost amount. All applicants may request up to five years of support in a single grant period in order to develop or maintain a specific education program. RESEARCH OBJECTIVES Reorganized in 1993, the Cancer Education Grant Program (CEGP) plans to accomplish its objectives by providing institutions a wide range of opportunities to develop and sustain unique, innovative curriculum-driven programs that focus on various cancer education activities. These will be projects not normally supported by other NIH grant mechanisms. The target audiences for these programs can range from biomedical researchers; health professionals; medical, dental, nursing, and other health professional students; college and high school students; to members of the lay community. APPLICATION PROCEDURES To apply for a CEGP award, applicants are to use the PHS research grant application form PHS 398 (rev. 9/91) available from the applicant institution's office of sponsored research. Application forms can also be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Ongoing receipt dates for new applications are: 1 February, 1 June, and 1 October each year. Current Guidelines (rev. 04/93) are available from the address listed under INQUIRIES. The title and number of the PA must be typed in Section 2a on the face page of the application. The signed, typewritten original of the application and five signed, exact, clear, and single-sided photocopies, must be sent or delivered in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS All applications will be reviewed for scientific, technical, and educational merit by an appropriate review committee managed by the Grants Review Branch, Division of Extramural Activities, NCI. Second level review will be provided by the National Cancer Advisory Board. Review criteria are listed in the current Guidelines. AWARD CRITERIA The CEGP is supported by the Cancer Education segment of the NCI operating grants budget. Any award decision will be based upon the quality of the proposed project as determined by peer review, availability of funds, and program balance among educational areas of the program. INQUIRIES For current Guidelines and information concerning the objectives and scope of the Cancer Education Grant Program, contact: Dr. Robert C. Adams Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Direct inquiries regarding fiscal matters to: Mr. Robert Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 13 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93.398, Cancer Research Manpower. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A, Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285 and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$XID RFA HL94001 HL-94-001 P1O1 *************************************** ASTHMA ACADEMIC AWARD NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA: HL-94-001 P.T. 34; K.W. 0715013, 0502024, 0795003, 0745027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 13, 1993 Application Receipt Date: February 11, 1994 PURPOSE The primary objective of this Request for Application (RFA) is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of asthma in the United States, with particular emphasis on support of minority schools and minority individuals. HEALTHY PEOPLE 2000 The Public Health Service 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, Asthma Academic Award, is related to the priority areas of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. Although this announcement is not limited to minority institutions or individuals, the intent of the program is to assure representation in the program of minority medical schools and minority individuals, with special emphasis on Black, Hispanic, Native American, Pacific Islander and other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Candidates A candidate for an award must: o be an established physician and medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have demonstrated knowledge and commitment to medical education for medical students, physicians, and patients; o have sufficient clinical training, research, and teaching experience in asthma to develop and implement a high quality curriculum in asthma encompassing current knowledge and methods applicable to the control of asthma in individuals of all ages and to provide leadership in applied research in control of asthma; o have the support of the Dean and educational leadership at the institution; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; and o commit 30 to 50 percent effort for a period of five years. Individuals who have held another NIH career development award (K series) are eligible to apply for the Asthma Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin September 30, 1994. FUNDS AVAILABLE The estimated funds (total costs) for this fiscal year will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. It is the intent of the program to assure representation of minority medical schools and minority individuals, with special emphasis on Blacks, Hispanics, Native Americans, and Pacific Islanders. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested. RESEARCH OBJECTIVES Background Asthma is a serious chronic condition, affecting approximately 10 million Americans. People with asthma experience over 100 million days of restricted activity annually, and costs for asthma care exceed $4 billion a year. Asthma morbidity and mortality rates are increasing. From 1980 to 1987, the prevalence of asthma in the U.S. increased 29 percent, and the number of asthma deaths increased by 31 percent. Recent reports indicate that mortality from asthma has been rising since about 1968 in all age groups. In 1987, the overall death rate from asthma was 1.9/100,000 people with females slightly higher than males. Many of these deaths were considered to be largely preventable. The largest increase in asthma-related mortality has been among blacks, women, and persons over 65 years of age. Additionally, since about 1950 there has been a widening gap in deaths from asthma between blacks and whites. Asthma mortality has been three times higher in black compared to white males and twice as high in black than in white females. Reduction of asthma morbidity has been identified as a new objective in the U.S. Health Objectives for the Year 2000. Considerable national attention is being directed at this problem, including the following major efforts. Considerable behavioral and education research has been conducted in the area of patient/family self management to complement and enhance medical treatment regimens, and these have yielded several effective educational programs for patients and their families. With representation from 30 governmental, professional, and voluntary health organizations, a National Asthma Education Program has been initiated to educate patients, the public, and health care providers about the disease. A major early accomplishment of this Program was the preparation and dissemination of the Guidelines for the Diagnosis and Management of Asthma and the Executive Summary: Management of Asthma During Pregnancy. Yet although asthma is a disease that generally can be controlled with expert medical treatment and self-management, many patients are not receiving state-of-the-art medical care and/or are not following the prescribed treatment plans. Special programs are needed to reach health care providers in areas remote from major medical centers and to reach minority and lower socioeconomic level patients in both inner city and rural areas. Multidimensional research conducted by multidisciplinary teams will be required to improve clinical practice and patient education. Therefore, the aim of this program is to stimulate the development and/or improvement of the quality of medical education, patient and community education, research programs, and clinical practice focused on the control of asthma. Objectives The objectives of the Asthma Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling asthma; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote communication among specialists in primary care, allergy, and obstetrics and gynecology to ensure appropriate treatment of pregnant women with asthma; o encourage applied research in the control of asthma; o promote the development of a faculty capable of providing appropriate diagnosis and management instruction in asthma, with special emphasis on minority faculty; o promote an institutional environment that facilitates an interchange of information and educational evaluation techniques about new diagnostic, therapeutic, and prevention measures in asthma in both children and adult populations; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have asthma, such as minorities, young children, and the elderly; o provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high asthma morbidity, such as inner city minority communities; o facilitate an interchange of ideas among awardees and institutions; o evaluate the impact of the proposed program; o contribute to the public health efforts to control asthma in the United States; and o enhance the teaching of asthma in minority medical schools and promote community asthma education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about asthma and among physicians who are or who will be caring for medically underserved populations. Since this is a medical education program, funds may be requested for technical support staff who have complementary expertise to the principal investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. SPECIAL REQUIREMENTS 1. Awardee Salary The salary requested for the awardee must not exceed the actual institutional salary rates for the effort devoted to the Academic Award, and must not exceed $50,000 plus fringe benefits. A candidate must spend at least 30 percent time on this award. An awardee may devote up to a total of 100 percent effort as an Academic Awardee and as principal or participating investigator on any other NIH-supported grant(s) or contract(s) and may receive remuneration from such grant(s) or contract(s) accordingly. An example of an investigator who receives the Academic Award at a level of effort of 30 percent, who wishes to devote 60 percent of effort to other Federally-sponsored research, and whose institutional salary is $130,000 is as follows: Academic Award 30 percent effort $ 37,500* Other Federally-supported grants and contracts 60 percent effort $ 75,000* Total salary from Federal sources $112,500 Salary contribution from grantee's institution $ 17,500 Total Salary $130,000 *(based on the current ceiling of $125,000) 2. Program Support Program support will be provided up to a maximum of $20,000 per year for the following: o personnel other than the awardee if requested for the development and evaluation of the educational program. Salaries will be allowable for technical and support personnel, e.g., educational and evaluation specialists. Student stipends are allowable for students conducting projects directly related to the award; o equipment costs are not allowable; o consumable supplies essential to the proposed program; o funds for educational development to enable the awardee to develop educational skills; o funds for travel for the Principal Investigator to meet with other awardees and NHLBI staff to exchange ideas, to develop collaborative projects, and to provide for some needed technical support. (Awardees may be requested to meet as a group up to two times a year; $2,000 should be allocated for this purpose.) 3. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures of equipment. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases it may be necessary for the applicant to be relieved of some responsibilities for the five years of the grant award in order to implement the proposed plan. An institution may apply for an award on behalf of a named individual meeting the criteria for this award. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a non-competitive basis depending upon progress being made in meeting the program's objectives. An annual report will be required that summarizes activities relevant to curriculum development at the institution and other elements of the program plan and outlines future plans. This report will serve as the principal basis for renewal of the grant. Awards may not be transferred from one institution to another. If an awardee moves to another institution, the award will continue at the original institution only upon approval by the Division of Lung Diseases of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Although the Asthma Academic Award is not primarily a mechanism to support research, some awardees may implement some research as a part of the overall Academic Award program. If any clinical research is proposed under this program, the policies of the NIH regarding inclusion of women and minority apply. NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group and approximate percentages should be included. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Programs involving educational strategies including the effectiveness of such strategies, such as required by this program, are considered human subject research. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by December 13, 1993, a letter of intent that includes the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the RFA number and title in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 594-7452 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, "RFA: HL-94-001-L Asthma Academic Award" must be typed on Line 2a of the face page of the application form and the "YES" box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Applications must be received at both locations by February 11, 1994 to be assured of review in this competition. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA NHLBI staff will return the application to the applicant. The initial review may include a preliminary evaluation to determine scientific merit relative to the other applications received in response to this program announcement (triage); the NIH will remove from further consideration applications judged to be noncompetitive and promptly notify the Principal Investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures, including, if deemed appropriate, an applicant interview in or near Bethesda at the applicant's expense. The initial review will be conducted by a Special Emphasis Panel, managed by the Division of Extramural Affairs, National Heart, Lung, and Blood Institute. The secondary review will be by the National Heart, Lung, and Blood Advisory Council. Applications for this Asthma Academic Award will be evaluated in terms of the following criteria: o description of the magnitude of the asthma problem and the need for the program in the area to be served; o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula in asthma control; o access to a population with high incidence of asthma; o the qualifications and background of the candidate, including experience in teaching, curriculum development and administration within a medical school, and planning and conduct of clinical research; o the ability and commitment to working cooperatively with other awardees to make innovative asthma curricula and materials available; o the institution's commitment to implement the proposed curriculum and to continue a program in education about asthma control after the termination of the award; o the significant involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with asthma, especially in areas with high morbidity from asthma, such as inner city minority communities; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, family practice, internal medicine, community medicine, and other specialties; o plans for collaborative projects with other organizations that have responsibility for and interest in asthma control, for example, health departments, medical and nursing associations, and voluntary health agencies; o plans for and availability of expertise to implement and evaluate the proposed program, including strategies for both process and impact evaluation; o the potential for the program making an impact on the control of asthma among populations served; o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is September 30, 1994. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Asthma Academic Award, the Division of Lung Diseases will provide funds for a project period up to five years. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, as soon as they receive approval from their institution to apply for this award. Direct inquiries regarding programmatic issues to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CAR 52 and 45 CAR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 37, pt. 1, 15 October 1993 Message-ID: Date: 23 Oct 93 01:51:01 GMT Sender: kristoff@net.bio.net Lines: 1505 Approved: biosci-moderator@net.bio.net NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19931015 V22N37 P1O2 ************************************ X-comment: RFAS described: HL-94-001, HL-94-002, DK-94-007, TW-94-001, DK-94- 006 NIH GUIDE - Vol. 22, No. 37 - October 15, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NRSA INSTITUTIONAL TRAINING GRANTS: SUPPLEMENTAL POLICY STATEMENT National Cancer Institute INDEX: CANCER NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 02/11/94 ************************************************* ASTHMA ACADEMIC AWARD (RFA HL-94-001) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 02/11/94 ************************************************* TUBERCULOSIS ACADEMIC AWARD (RFA HL-94-002) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 02/18/94 ************************************************* HORMONAL REGULATION OF BREAST-SPECIFIC GROWTH FACTORS (RFA DK-94-007) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R4 03/16/94 ************************************************* MINORITY INTERNATIONAL RESEARCH TRAINING GRANTS (RFA TW-94-001) Fogarty International Center Office of Research on Minority Health INDEX: FOGARTY INTERNATIONAL CENTER, MINORITY HEALTH $$INDEX R5 03/31/94 ************************************************* THE PATHOGENESIS OF WASTING IN AIDS (RFA DK-94-006) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** SUPPORT OF CLINICAL TRIALS IN VISION RESEARCH (PAR-94-003) National Eye Institute INDEX: EYE $$INDEX P2 ********************************************************** CANCER EDUCATION (PAR-94-004) National Cancer Institute INDEX: CANCER This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NRSA INSTITUTIONAL TRAINING GRANTS: SUPPLEMENTAL POLICY STATEMENT NIH GUIDE, Volume 22, Number 37, October 15, 1993 P.T. National Cancer Institute A supplemental policy statement for the National Cancer Institute (NCI) Institutional Training Grants (T32) is now available. This policy statement supplements the National Institutes of Health (NIH) general guidelines for T32 grants in the National Research Service Award (NRSA) program (NIH Guide for Grants and Contracts, Vol. 21, No. 11, March 20, 1992) and applies only to Institutional Training Grants assigned to the NCI. This statement outlines three special requirements for NCI Institutional Training Grants. These requirements are based upon current NCI mission objectives for training future cancer research scientists and clinicians. These three special requirements cover the following areas: cancer-related support of preceptors; overlap and coordination with other cancer-related activities; and special cancer curricula and/or other strategies to address issues, approaches, and opportunities in cancer research. This supplemental policy statement affects all new, competing continuation, and noncompeting continuation grants in the program. This policy will be effective with the January 10, 1994 receipt date. For the complete text of the NCI supplemental policy statement, additional information, and questions, contact: Cancer Training Branch National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 30892-4500 Telephone: (301) 496-8580 FAX: (301) 402-4472 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN HL-94-001 FULL-TEXT ************************************** ASTHMA ACADEMIC AWARD NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA AVAILABLE: HL-94-001 P.T. 34; K.W. 0715013, 0502024, 0795003, 0745027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 13, 1993 Application Receipt Date: February 11, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The primary objective of this RFA is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of asthma in the United States, with particular emphasis on support of minority schools and minority individuals. 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, Asthma Academic Award, is related to the priority areas of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. Although this announcement is not limited to minority institutions or individuals, the intent of the program is to assure representation in the program of minority medical schools and minority individuals, with special emphasis on Black, Hispanic, Native American, Pacific Islander and other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Candidates A candidate for an award must: o be an established physician and medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have demonstrated knowledge and commitment to medical education for medical students, physicians, and patients; o have sufficient clinical training, research, and teaching experience in asthma to develop and implement a high quality curriculum in asthma encompassing current knowledge and methods applicable to the control of asthma in individuals of all ages and to provide leadership in applied research in control of asthma; o have the support of the Dean and educational leadership at the institution; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; and o commit 30 to 50 percent effort for a period of five years. Individuals who have held another NIH career development award (K series) are eligible to apply for the Asthma Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin September 30, 1994. FUNDS AVAILABLE The estimated funds (total costs) for this fiscal year will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. It is the intent of the program to assure representation of minority medical schools and minority individuals with special emphasis on Blacks, Hispanics, Native American, and Pacific Islanders. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested. RESEARCH OBJECTIVES The objectives of the Asthma Academic Award are: o to encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others including practicing physician, to learn the principles and practice of preventing, managing, and controlling asthma; o to develop and implement interdepartmental programs with common goals and standardize diagnostic and therapeutic approaches; o to promote communication among specialists in primary care, allergy, and obstetrics and gynecology to ensure appropriate treatment of pregnant women with asthma; o to encourage applied research in the control of asthma; o to promote the development of a faculty capable of providing appropriate instruction in asthma, with special emphasis on minority faculty; o to promote an institutional environment that facilitates an interchange of information and educational evaluation techniques about new diagnostic, therapeutic and prevention measures in asthma in both children and adult populations; o to promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have asthma, such as minorities, young children, and the elderly; o to provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high asthma morbidity, such as inner city minority communities; o to facilitate an interchange of ideas among awardees and institutions; o to evaluate the impact of the proposed program; o to contribute to public health efforts to control asthma in the United States; o to enhance the teaching of asthma in minority medical schools and promote community asthma education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about asthma and among physicians who are or who will be caring for medically underserved populations. Since this is a medical education program, funds may be requested for technical support staff who have complementary expertise to the principal investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by December 13, 1993, a letter of intent that includes the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the RFA number and title in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 594-7452 APPLICATION PROCEDURES Applications must be received by February 11, 1994. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. REVIEW CONSIDERATIONS Applications for this Asthma Academic Award will be evaluated in terms of the following criteria: o description of the magnitude of the asthma problem and the need for the program in the area to be served; o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula in asthma control; o access to a population with high incidence of asthma; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and administration within a medical school, and planning and conduct of clinical research; o the ability and commitment to working cooperatively with other awardees to make innovative asthma curricula and materials available; o the institution's commitment to implement the proposed curriculum and to continue a program in education about asthma control after the termination of the award; o the significant involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with asthma, especially in areas with high morbidity from asthma, such as inner city minority communities; o plans for communication and cooperation between s specialists in adult and pediatric pulmonary medicine, family practice, internal medicine, community medicine, and other specialties; o plans for collaborative projects with other organizations that have responsibility for and interest in asthma control, for example, health departments, medical and nursing associations, and voluntary health agencies; o plans for and availability of expertise to implement and evaluate the proposed program, including strategies for both process and impact evaluation; o the potential for the program making an impact on the control of asthma among populations served; o the potential for replication or adaptation of the program at other sites. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, listed below, as soon as they receive approval from their institution to apply for this award. Direct inquiries regarding programmatic issues and requests for the RFA to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99- 158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CAR 52 and 45 CAR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. $$R1 END ************************************************************ $$R2 BEGIN HL-94-002 FULL-TEXT ************************************** TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA AVAILABLE: HL-94-002 P.T. 34; K.W. 0715165, 0502024, 0795003, 0745027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 13, 1993 Application Receipt Date: February 11, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The primary objective of this RFA is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of Mycobacterial tuberculosis (TB) in the United States, with particular emphasis on support of minority schools and minority individuals. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Tuberculosis Academic Award, is related to the priority areas of immunization and infectious diseases and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. Although this announcement is not limited to minority institutions or individuals, the intent of the program is to assure representation in the program of minority medical schools and minority individuals, with special emphasis on Black, Hispanic, Native American, Pacific Islanders, and other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Candidates A candidate for an award must: o be an established physician and a medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have the unqualified support of the Dean and the educational leadership at the institution and demonstrate knowledge and commitment to medical education for medical students, physicians, patients, and the public; o have sufficient clinical training, research, and teaching experience in the control of TB to develop and implement a high quality curriculum in TB encompassing current knowledge and methods applicable to the control of tuberculosis in individuals of all ages and to provide leadership in research in control of TB; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; o commit 30 to 50 percent effort for a five year period. Individuals who have held another NIH career development award (K series) are eligible to apply for the Tuberculosis Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin September 30, 1994. FUNDS AVAILABLE The estimated funds (total costs) for is fiscal year will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. It is the intent of the program to assure representation of minority medical schools and minority individuals, with special emphasis on Blacks, Hispanics, Native Americans, and Pacific Islanders. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested. RESEARCH OBJECTIVES The objectives of the Tuberculosis Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling TB; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote communication among primary care and other specialists to ensure appropriate control and treatment strategies; o encourage applied research in the control of TB; o promote the development of a faculty capable of providing appropriate instruction in TB with special emphasis on minority faculty; o promote coordinated clinical approaches to the care of patients and various ages and ethnic groups who have TB; o provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high TB morbidity; o contribute to updating the knowledge and skill of practicing physicians and other health care providers in the community; o enhance awareness of health care providers of the unique ethnic, cultural, socioeconomic, and medical dimensions of TB; o coordinate and collaborate with other community organizations to control TB in areas with high incidence of TB; o facilitate an interchange of ideas and methods among awardees and institutions; o contribute to public health efforts to control TB in the community; and o enhance the teaching of tuberculosis in minority medical schools and promote TB education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about tuberculosis and among physicians who are or who will be caring for medically underserved populations. Since this is a medical education programs, funds may be requested for technical support staff who have complementary expertise to the principal investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by December 13, 1993, a letter of intent that includes the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 594-7452 APPLICATION PROCEDURES Applications must be received by February 11, 1994. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7428. "RFA- Tuberculosis Academic Award" must be typed on Line 2a of the face page of the application form and the "YES" box must be marked. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. REVIEW CONSIDERATIONS Applications for this Tuberculosis Academic Award will be evaluated in terms of the following criteria: o description of the magnitude of the tuberculosis problem and the need for the program in the area to be served; o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula on tuberculosis; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and administration in a medical school, and planning and conduct of research; o the ability and commitment to work cooperatively with other awardees to make innovative tuberculosis curricula, materials, and programs available; o the institution's commitment to implement the proposed curriculum and to continue a program in education about tuberculosis control after the termination of the award; o the significant involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with tuberculosis, especially in areas with high incidence of TB; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, infections, and community medicine to ensure optimal treatment; o plan for communication and cooperation between specialists in adult and pediatric pulmonary medicine, infections, and community medicine to ensure optimal treatment; o plans for collaborative projects with other organizations that have responsibility for and interest in tuberculosis control, for example, health departments, medical and nursing associations, and voluntary health agencies; o the potential of the program for making an impact on the control of tuberculosis among populations served; and o the potential for replication or adaptation of the program at other sites. INQUIRIES Written and telephone inquiries concerning this announcement are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, as soon as they receive approval from their institution to apply for this award. Direct inquiries regarding programmatic issues and requests for the RFA to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants will be awarded under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CAR 52 and 45 CAR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. $$R2 END ************************************************************ $$R3 BEGIN DK-94-007 FULL-TEXT ************************************** HORMONAL REGULATION OF BREAST-SPECIFIC GROWTH FACTORS NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA AVAILABLE: DK-94-007 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: January 21, 1994 Application Receipt Date: February 18, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE To promote investigations of the biology, physiology, and pathophysiology of systemic hormones and their role in the regulation of growth factors and their receptors, in both normal and abnormal endocrine regulatory activity of breast tissue. 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, Hormonal Regulation of Breast-Specific Growth Factors, is related to the priority areas of cancer and maternal health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Minority individuals and women are encouraged to submit as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01) or FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and, if R01s, will be reviewed by a DRG study section. The total project period for applications submitted in response to the present RFA may not exceed five years. A maximum of three years may be requested for foreign awards. The earliest possible award date will be September 30, 1994. FUNDS AVAILABLE For FY 1994, the NIDDK intends to commit $ 2,500,000 to fund applications submitted in response to this RFA. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Applicants must limit their requests to not more than $160,000 direct costs for the initial budget period. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES This solicitation is intended to address new issues in molecular endocrinology and medicine that have resulted from recent advances in the understanding of the actions of hormones and growth factors in the physiological regulation of breast tissues. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by January 21, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. A letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91), available in the office of sponsored research of most academic or research institutions and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Detailed instructions on submission procedures are described the full text of the RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIDDK in accordance with the usual NIH peer review procedures. Following review, the applications will be given a secondary review by the NIDDK Advisory Councils unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant or held until the next regular receipt date and reviewed by the Division of Research Grants. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues and requests for the RFA may be directed to: W. Lorenzo Jackson, M.D., Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institutes of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 621 Bethesda, MD 20892 Telephone: (301) 594-7576 FAX: (301) 594-9011 Inquiries regarding fiscal matters may be directed to: Ms. Kim Law Division of Extramural Activities National Institutes of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649D Bethesda, MD 20892 Telephone: (301) 594-7543 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. 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. $$R3 END ************************************************************ $$R4 BEGIN TW-94-001 FULL-TEXT ************************************** MINORITY INTERNATIONAL RESEARCH TRAINING GRANTS NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA AVAILABLE: TW-94-001 P.T. 44, FF; K.W. 0720005 Fogarty International Center Office of Research on Minority Health Application Receipt Date: March 16, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Fogarty International Center (FIC) and the Office of Research on Minority Health (ORMH) support a program to provide international research training opportunities for minority undergraduate students, minority graduate students, and minority faculty members in biomedical and behavioral research. Training grant awards will be made for three years to U.S. colleges and universities for the purposes of encouraging minority students to pursue degrees and careers in the biomedical sciences by broadening their undergraduate and graduate education through international experiences; promoting qualities of leadership by expanding cultural perspectives and to help prepare the next generation of scientific leaders to work effectively in a global environment; and establishing linkages between U.S. scientists and institutions and established centers of biomedical research abroad. Some or all of the following three components may be included within each institutional award: first, the international research training program for pre-baccalaureate minority students pursuing life science curricula to conduct short-term research and coursework abroad for approximately 8 to 12 weeks; second, a predoctoral program to enable minority students enrolled in graduate research degree programs to receive research training for 3 to 12 months at foreign institutions; and third, the international faculty development program for individual minority faculty to conduct research at foreign institutions for 3 to 12 months. Applications may be submitted from individual U.S. institutions or from consortia of U.S. institutions with one lead institution. For the purposes of this program, consortia will link institutions that have active international programs with those with limited international research training programs. ELIGIBILITY REQUIREMENTS These institutional training grants will be awarded to U.S. institutions for the purpose of collaborating with one or more foreign research centers that can provide a substantial research training experience for the U.S. minority participants. The applicant institution and any associated institution in a consortium must be a two- or four-year domestic school, college, or university. Minority participants must be from underrepresented minority groups, including African Americans, Hispanic Americans, American Indians, and Pacific Islanders. The program director at the applicant institution will be responsible for the selection and appointment of participants, selection of the foreign training site(s), and the overall direction of the training program. Participating students and faculty members must be members of the minority groups listed above and be U.S. citizens or permanent U.S. residents and be pursuing degrees, studying, and/or conducting research in the biomedical or behavioral sciences at the time of appointment. The foreign research centers should be universities, colleges or other research institutions that have strong, well-established biomedical or behavioral research and research training programs. Close cooperation between the U.S. and foreign institutions and scientists will be needed to provide the trainees with a foreign mentor or collaborator who is recognized as an accomplished investigator and who will participate in their research training. Undergraduate student trainees must be pre-baccalaureate, pursuing a relevant biomedical or behavioral science curriculum and must show evidence of a commitment to obtaining a postgraduate research related degree in a biomedical or behavioral field of science. The foreign training for undergraduate students will usually be for 8 to 12 weeks. One faculty person may accompany each group of four to eight minority students and act as a general advisor/mentor during the study abroad. Faculty members serving this purpose are not required to belong to any minority group. They must hold full-time tenure track or tenured faculty positions at the grantee institution, hold a doctoral level degree and have a biomedical research plan to be conducted at the host institution. Predoctoral students must be enrolled in a U.S. graduate research training program in the biomedical or behavioral sciences. The predoctoral training period may be from 3 to 12 months for the purpose of learning a technique or carrying out a special project or portion of a project related to their doctoral studies. The minority faculty development portion of the training grant will provide support for research and studies for 3 to 12 months at a foreign training site. Participants must have regular full-time faculty appointments at the grantee institutions or an institution in the consortium. The research plan must indicate the expected benefits of the proposed work. Students and faculty must be affiliated with a U.S. college or university at the time of selection; however, the affiliation need not be with the grantee institution. MECHANISMS OF SUPPORT The mechanism of support is the institutional training grant award (T32). Domestic institutions may request up to three years of support. The stipend level during the period of foreign stay is $1,000 per month for undergraduate and graduate students and $3,000 per month for the faculty member. Stipends may be supplemented from non-Federal sources only. Requests may be made for training-related expenses for undergraduate and graduate students and faculty of up to $500 per month each for health insurance, foreign tuition and fees, and other education-related expenses at the foreign training site. Research expenses for use at the foreign training site of up to $500 per month may be requested for each undergraduate student, graduate student, or faculty member. Foreign living expenses will be $1,000 per month for undergraduate and graduate students and $2,000 per month for faculty members. Travel expenses may also be requested from the home institution to the foreign training site and return. Appointments may range from 8 to 12 weeks for undergraduates, 3 to 12 months for the predoctoral students and 3 to 12 months for faculty. Stipends, training and travel expenses are offered only during the time period participants are en route to or working in the foreign country. No expenses are provided for domestic training. If specially justified, the domestic applicant institution may request up to five percent of the requested total direct costs for the support of the Principal Investigator and/or other grant-related personnel for domestic administrative efforts. Indirect costs will be awarded to the grantee institution at a rate of eight percent of the allowable direct costs. Each of the training grant awards will not exceed a total of $400,000 per year, including direct and indirect costs. Additional direct support for the minority student participants on return to the U.S. may be available from the FIC for attendance at scientific meetings to present the results of their foreign research experience. FUNDS AVAILABLE It is expected that 10 to 12 awards will be made in FY 1994. RESEARCH OBJECTIVES The Minority International Research Training grants are designed to offer research training grant awards to enable qualified minority undergraduate students, graduate students, and faculty members to participate in international biomedical and behavioral research programs. This training grant program is expected to attract students and scientists in the developmental stages of their education and careers, to increase their awareness of international research opportunities and to acquaint them with the full range of career opportunities in biomedical and behavioral research. Minority faculty members are expected to gain experience that will contribute to the research and teaching programs at their U.S. institution. Their association with the foreign institution will, in many cases, provide future undergraduate and graduate research training sites. The FIC and ORMH staff will closely follow the progress of each training grant program through site visits and periodic meetings of program directors. APPLICATION PROCEDURES Applications are to be submitted on the Public Health Service grant application form PHS 398 (rev. 9/91), using the special instructions related to Institutional National Research Services Awards (Section VII). Note the requirement to use NRSA substitute pages MM, NN, and OO to be acceptable for initial review. Application kits are available at most institutional offices of sponsored research and may also be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The title and number of the announcement must be typed in section 2a on the face page of the application. The completed application and three legible copies must be sent or delivered to the following address and received by March 16, 1994: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition, two copies of the complete application must be sent to Dr. David A. Wolff at the address listed under INQUIRIES. REVIEW CONSIDERATIONS All applications responding to this announcement will be reviewed for scientific and technical merit by an NIH initial review group, followed by a second level review by the Fogarty International Center Advisory Board. To be eligible for review, applications must be complete and submitted in accordance with the application procedures stated above. Reviewers will pay particular attention to the proposed method of selecting participating faculty and students, the past or potential capability of the institutions to carry out this type of program, the proposed benefit to the participants and the justification for selecting the foreign training site(s). Letters from the foreign collaborator and their institutional officials indicating their willingness to participate in this training program, must accompany the application. AWARD CRITERIA Applications will compete for funds assigned to the Minority International Research Training Grant Program of the Fogarty International Center. The following will be considered in making funding decisions: how the proposal will contribute to the achievement of the program's objectives; scientific, technical, and educational merit of the application as determined by peer review; and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. David A. Wolff Chief, International Research and Awards Branch Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 FAX: (301) 402-0779 Direct inquiries regarding fiscal matter to: Silvia Mandes International Research and Awards Branch Fogarty International Center Building 31, Boom B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 FAX: (301) 402-0779 AUTHORITY AND REGULATIONS Awards will be made under the authority of the Public Health Service Act, Title III, Part A, Section 307b (42 USC 242l), and administered under PHS grants policies and Federal regulations, most specifically 42 CFR part 61. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN DK-94-006 FULL-TEXT ************************************** THE PATHOGENESIS OF WASTING IN AIDS NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA AVAILABLE: DK-94-006 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 21, 1994 Application Receipt Date: March 31, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites investigator-initiated research grant applications to investigate the pathogenesis of wasting syndromes in acquired immune deficiency syndrome (AIDS) and to develop new approaches for the prevention or reversal of wasting in AIDS. Applications will be encouraged for both basic science and clinical experiments that will provide direction for future treatment. 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), The Pathogenesis of Wasting in AIDS, is related to the priority areas of HIV infection and nutrition. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29). MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01) or FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and, if R01s, will be reviewed by a DRG study section. The total project period for applications submitted in response to the present RFA may not exceed five years. A maximum of three years may be requested for foreign awards. The earliest possible award date will be September 30, 1994. FUNDS AVAILABLE For FY 1994, the NIDDK intends to commit $ 2,500,000 to fund applications submitted in response to this RFA. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Applicants must limit their requests to not more than $160,000 direct costs for the initial budget period. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Involuntary weight loss or wasting indicative of severe protein energy malnutrition is a frequent complication of acquired immune deficiency syndrome (AIDS) and may significantly contribute to the progression of AIDS including death. Mortality from wasting appears to be related to the magnitude of tissue depletion and losses in lean body cell mass and restoration of body cell mass may enhance survival. These losses in AIDS patients are out of proportion to losses of total body weight or fat. While weight loss is variable and occasionally reversible with the treatment of underlying infections and/or easily identifiable reversible causes, the majority of patients do not respond to conventional interventions. The objective of this solicitation is to elucidate the underlying mechanisms responsible for this syndrome and to develop new and more successful approaches to treat it. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by February 21, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91), available in the office of sponsored research of most academic or research institutions and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Detailed instructions on submission procedures are described the RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIDDK in accordance with the usual NIH peer review procedures. Following review, the applications will be given a secondary review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant or held until the next regular receipt date and reviewed by the Division of Research Grants. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues and requests for the RFA may be directed to: W. Lorenzo Jackson, M.D., Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 621 Bethesda, MD 20892 Telephone: (301) 594-7576 FAX: (301) 594-9011 Inquiries regarding fiscal matters may be directed to: Ms. Kim Law Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649D Bethesda, MD 20892 Telephone: (301) 594-7543 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. 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. $$R5 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PAR-94-003 *********************************************** SUPPORT OF CLINICAL TRIALS IN VISION RESEARCH NIH GUIDE, Volume 22, Number 37, October 15, 1993 PAR NUMBER: PAR-94-003 P.T. National Eye Institute PURPOSE The National Eye Institute (NEI) is reannouncing its intention to use the cooperative agreement mechanism (U10) to support future investigator-initiated clinical trials in vision research. This is not an announcement of a new program or initiative. 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, Support of Clinical Trials in Vision Research, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and Local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U10), an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Because the nature and scope of the research proposed in response to this Program Announcement may vary, it is anticipated that the number and sizes of awards will vary also. Details of the responsibilities, relationships, and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." SPECIAL REQUIREMENTS The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional official(s) at the time of award. Terms and Conditions of Cooperative Agreement Award These special Terms and Conditions of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, as applicable, and other HHS, PHS, and NIH Grant Administration policy statements. 1. Awardee Rights and Responsibilities Awardees have primary authorities and responsibilities to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. The design, methods, and procedures of the clinical trial will be detailed in an awardee-prepared and maintained, study-adopted Manual(s) of Operations, and the awardees will have the responsibility of following the protocol. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access, consistent with current HHS, PHS, and NIH policies. The Study Chairperson is responsible for the overall conduct of the clinical trial and for providing scientific, technical, and administrative leadership to the study. He/She will have lead responsibility for planning and directing all phases of the study and for using the study's resources. In carrying out these responsibilities, the Study Chairperson will actively seek advice from all of the study's components, including the representative of the NEI. The Study Chairperson is usually the individual who developed the idea for the clinical trial and was the leader in preparing the Manual of Operations and organizing the study components. The Principal Investigator of each resource core center (e.g., Data Coordinating Center) will play an important role in the design, implementation, and execution of the clinical trial. Each Principal Investigator is responsible for all aspects of the operations of his/her resource center and for the local implementation of the study protocol. The resource core centers are involved in performing specified support functions such as training and certification of clinical center staff, designing and maintaining quality assurance programs, data management, data analysis, and preparing publications. The Principal Investigator of each participating clinical center has From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 37, pt. 4, 15 October 1993 Message-ID: Date: 23 Oct 93 01:53:56 GMT Sender: kristoff@net.bio.net Lines: 1055 Approved: biosci-moderator@net.bio.net $$XID RFA DK94006 DK-94-006 P1O1 *************************************** THE PATHOGENESIS OF WASTING IN AIDS NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA: DK-94-006 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 21, 1994 Application Receipt Date: March 31, 1994 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites investigator-initiated research grant applications to investigate the pathogenesis of wasting syndromes in acquired immune deficiency syndrome (AIDS) and to develop new approaches for the prevention or reversal of wasting in AIDS. Applications will be encouraged for both basic science and clinical experiments that will provide direction for future treatment. 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), The Pathogenesis of Wasting in AIDS, is related to the priority areas of HIV infection and nutrition. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). 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 Support of this program will be through the NIH research project grant (R01) or FIRST (R29) awards. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total requested project period for applications submitted in response to this RFA may not exceed four years. A maximum of three years may be requested for foreign awards. The earliest possible award date will be September 30, 1994. FUNDS AVAILABLE For FY 1994, $2,500,000 will be committed to fund applications submitted in response to this RFA. It is anticipated that up to 12 awards will be made. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Applicants must limit their requests to not more than $160,000 direct costs for the initial budget period. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Involuntary weight loss or wasting indicative of severe protein energy malnutrition is a frequent complication of acquired immune deficiency syndrome (AIDS) and may significantly contribute to the progression of AIDS including death. Mortality from wasting appears to be related to the magnitude of tissue depletion and losses in lean body cell mass and restoration of body cell mass may enhance survival. These losses in AIDS patients are out of proportion to losses of total body weight or fat. While weight loss is variable and occasionally reversible with the treatment of underlying infections and/or easily identifiable reversible causes, the majority of patients do not respond to conventional interventions. The mechanism(s) of weight loss in AIDS has not been clearly elucidated. The etiology is likely to be multifactorial, the result of interactions between decreased caloric intake, malabsorption, and altered energy utilization or expenditure secondary to infection, hormonal and/or metabolic abnormalities. There is already evidence of perturbations in lipid metabolism, cytokine response, and energy/nitrogen balance in the AIDS wasting syndrome as well as indications of gastroenterologic dysfunction from infection or inflammatory cytokines. A number of hormones and cytokines have been implicated in the pathophysiology of HIV-related anorexia/cachexia. Cytokines, such as interleukin-1 (IL1), tumor necrosis factor (TNF), and interferons (IFN) can suppress appetite and disturb normal metabolic activity. HIV wasting syndrome has been associated with inappropriately increased hepatic lipogenesis, hypertriglyceridemia and hypermetabolism with increased resting energy expenditure (REE). There is significant correlation between circulating interferon alpha levels and both triglyceride clearance and de novo hepatic lipogenesis (r=.8). Increased de novo hepatic lipogenesis is an inappropriate and energy wasting response to weight loss. Alimentary impairment is a frequent cause of wasting and occurs when primary or secondary intestinal changes result in decreased intestinal surface area, defects in the mucosal function, or rapid cell turnover producing immature epithelium. Such impairments are frequently associated with idiopathic diarrhea in AIDS patients. Hampered nutrient absorption may also be a complication of the systemic effects of hepatitis, lymphoma or Kaposi sarcoma. Partial villus atrophy, crypt hyperplasia, or increased numbers of intraepithelial lymphocytes suggest microbial or immune mediated intestinal damage may be important factors in AIDS enteropathies and malabsorption. Intestinal injury or damage from protozoal, parasitic, bacterial, or viral infections can result in significant functional impairment. These pathogens include cytomegalovirus, candida, cryptococcus, cryptosporidium, isospora and mycobacterium avium-intracellularae (MAI). Total parenteral nutrition has had variable effects on body composition in AIDS wasting syndrome (AWS), with tissue repletion occurring in patients with eating disorders or malabsorption syndromes and progressive depletion occurring in patients with serious systemic infections. Enteral nutrition also can replete body mass in AIDS patients without severe malabsorption. Both modalities support the concept that adequate nutrition has an essential role in the management of AIDS. Pharmacologic stimulation may provide another means to promote weight gain. There is evidence that hormones, such as growth hormone, progestational agents, growth factors, cytokines and/or factor- cytokine antagonists may have a role in the therapy of AWS. Megestrol acetate, a synthetic, orally active progestational agent, has been reported to stimulate appetite and improve caloric intake. There is evidence that growth hormone administration may produce improved nitrogen balance. The results of these studies indicate that hormonal therapy or nutritional support can improve the physiologic status of selected AIDS patients. Clearly, further understanding of the role of hormones, growth factors, cytokines, and other endocrine factors in AIDS wasting syndrome, within normal and HIV infected tissue is required. The precise roles, interactions and contributions of these factors need further definition. The prospects for clinical application of these substances in the treatment of AIDS magnifies this imperative. Scope Some examples of research topics that would be considered responsive to this solicitation include: o evaluation of body composition, hormonal/growth factor/cytokine secretion, alimentary histopathology, lipid metabolism, caloric intake, nitrogen balance, metabolic rates, and potential therapies in animal models of AIDS o the hormonal regulation of growth factors, cytokines or their receptors and their roles as mediators of wasting in HIV infected individuals o evaluation of potential therapies for AWS including hormonal interventions and their effects on body composition, basal metabolic rate, lipolysis/lipogenesis, resting energy expenditure, and lipoprotein levels in HIV infected patients or animal models of AIDS o evaluations of synergies or antagonisms among growth factors or cytokines that may be important in the alterations of appetite, lipid, protein or carbohydrate metabolism o approaches to the correction of anorexia or metabolic/endocrine aberrations with hormones, growth factors, cytokines or their antagonists o evaluation of body composition in the setting of asymptomatic and symptomatic HIV infection with emphasis on potential mechanisms involved in patient progression to wasting o assessment of metabolic parameters, such as hepatic lipogenesis and REE, in asymptomatic and symptomatic HIV infection o measurement of adaptive mechanisms to conserve lean body mass in the setting of asymptomatic and symptomatic HIV infection o evaluation of various nutritional interventions during the early phases of HIV infection with special emphasis on the impact of such interventions on overall disease process and the efficacy of single versus combined nutritional modalities o mechanisms involved in intestinal malabsorption including mechanisms of malabsorption in intestinal infection in AWS o the regulation of the production and gene expression of gastrointestinal neuropeptides, hormones and cognate receptors in AIDS and HIV infected cells and tissues o the development of new or improved approaches to define the etiology of intestinal dysfunction in HIV infection which may lead to improved diagnosis and treatments These areas of interest are not listed in any order or priority. They are only suggested examples of areas of research. Applicants are encouraged to propose other areas that are related to the objectives and scope described above. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations go that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample is appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations; i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention [and preventive strategies], diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned without review. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by February 21, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 496-7083 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) must be used in applying for these grants. The form is available from most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by March 31, 1994. If an application is received after that date, it will be returned to the applicant without review.. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 and as a component project of a program project, with the proviso that only one could be funded. 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 previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. FIRST Award (R29) applications 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. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. If the application is not responsive to the RFA, NIDDK staff will contact the applicant to determine whether it should be returned to the applicant, or held until the next regular receipt date and reviewed in competition with all other applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further competition when they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following this review, the applications will be given a second level review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally the game as those for unsolicited research grant applications. o scientific/technical merit criteria specific to the objectives of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o if an application involves activities that could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed means for protecting against or minimizing such effects. o for foreign applications: uniqueness of research such that it can be performed only outside of the United States. AWARD CRITERIA Funding decisions will be made based on the initial review group and national advisory council recommendations, program relevance, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: W. Lorenzo Jackson, M.D., Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 621 Bethesda, MD 20892 Telephone: (301) 594-7576 FAX: (301) 594-9011 Inquiries regarding fiscal matters may be directed to: Ms. Kim Law Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649D Bethesda, MD 20892 Telephone: (301) 594-7543 Schedule Letter of Intent Receipt Date: February 21, 1994 Application Receipt Date: March 31, 1994 Initial Review: June 1994 Second Level Review: September 1994 Anticipated Date of Award: September 30, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. 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. $$XID RFA HL94002 HL-94-002 P1O1 *************************************** TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA: HL-94-002 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 13, 1993 Application Receipt Date: February 11, 1994 PURPOSE The primary objective of this Request For Applications (RFA) is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of Mycobacterial tuberculosis (TB) in the United States, with particular emphasis on support of minority schools and minority individuals. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Tuberculosis Academic Award, is related to the priority areas of immunization and infectious diseases and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. Although this announcement is not limited to minority institutions or individuals, the intent of the program is to assure representation in the program of minority medical schools and minority individuals, with special emphasis on Black, Hispanic, Native American, Pacific Islander and other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Candidates A candidate for an award must: o be an established physician and a medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have the unqualified support of the Dean and the educational leadership at the institution and demonstrate knowledge and commitment to medical education for medical students, physicians, patients, and the public; o have sufficient clinical training, research, and teaching experience in the control of TB to develop and implement a high quality curriculum in TB encompassing current knowledge and methods applicable to the control of tuberculosis in individuals of all ages and to provide leadership in applied research in control of TB; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; and o commit 30 to 50 percent effort for a five-year period. Individuals who have held another NIH career development award (K series) are eligible to apply for the Tuberculosis Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin September 30, 1994. FUNDS AVAILABLE The estimated funds (total costs) for this fiscal year will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. It is the intent of the program to assure representation of minority medical schools and minority individuals, with special emphasis on Blacks, Hispanics, Native Americans, and Pacific Islanders. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested. RESEARCH OBJECTIVES Background Despite major advances in our understanding of the pathogenesis, detection and treatment of tuberculosis, nearly 28,000 cases have been reported in the United States since 1984, the year when the lowest number of cases were reported. Currently, TB is spreading rapidly, especially in some population groups. From 1985 through 1990, the number of TB cases increased by 44 percent in the 25-44 year old age group. There was a 12 percent increase among Asians, a 25 percent increase among non-Hispanic whites, a 55 percent increase among blacks, and a 77 percent increase among Hispanics. There is also a high prevalence of TB among HIV infected patients. It is estimated that about 12 percent of all AIDS cases develop TB. HIV-associated TB has occurred in virtually all age groups, both men and women, all race/ethnic groups and in all HIV-transmission categories, although the largest numbers of cases have occurred in intravenous drug users and homosexual/bisexual men. Other groups at high risk for TB include persons living or working in group or institutional settings such as hospitals and correctional facilities. More recently, there have been outbreaks of multi-drug resistant TB. These outbreaks are a dramatic manifestation of serious underlying problems in public and private efforts to control TB. Although considered "curable" since the development of effective chemotherapy in 1950, the TB problem has not been dealt with adequately. This has been attributed to a lack of sufficient awareness of the problem and inadequate resources, as well as clinical management errors and patient nonadherence to treatment regimens. The management errors include failing to diagnose and treat the cases in a timely manner, relying heavily on Isoniazide (INH) therapy even in patients likely to have INH-resistant organisms, using a single drug therapy, prescribing inappropriate drug dosages, and failing to isolate patients appropriately with infectious TB thereby missing opportunities to prevent the spread of the disease. Surveillance has often been slow or incomplete. Noncompliance with treatment regimens for chronic diseases has been a major problem with approximately 50 percent not taking their medicine. A study in 1988 in New York City reported 89 percent of the patients at one hospital failed to complete therapy, more than half failed to keep their first clinic appointment, and within twelve months of discharge 27 percent of the patients had been readmitted at least once with confirmed active TB. The concept for this initiative originated with the Tuberculosis Education Planning Committee convened by the NHLBI in December 1991, which emphasized the need for increased efforts to educate health care workers, patients, and the public on tuberculosis, and recommended that public health officials identify populations and geographic areas in the community where tuberculosis screening programs should be intensified and conduct public education campaigns targeted to high risk populations to encourage symptomatic patients to seek prompt treatment. In addition, in 1987 the Department of Health and Human Services established an Advisory Committee (Council) for the Elimination of TB (ACET), and in 1992 a "National Action Plan to Combat Multidrug Resistant Tuberculosis" was published to complement and supplement the "Strategic Plan for the Elimination of Tuberculosis." These plans indicate the urgency to improve the control of TB in the United States. In summary, TB is spreading in the U.S., despite major advances in our ability to diagnose, treat, and prevent this disease, largely due to inadequate education of health professionals, patients and their families, and the community. Objectives The objectives of the Tuberculosis Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling TB; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote communication among primary care and other specialists to ensure appropriate control and treatment strategies; o encourage applied research in the control of TB; o promote the development of a faculty capable of providing appropriate instruction in diagnosis and management of TB, with special emphasis on minority faculty; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have TB; o provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high TB morbidity; o contribute to updating the knowledge and skills of practicing physicians and other health care providers in the community; o enhance the awareness of health care providers of the unique ethnic, cultural, socioeconomic, and medical dimensions of TB; o coordinate and collaborate with other community organizations to control TB in areas with high incidence of TB; o facilitate an interchange of ideas and methods among awardees and institutions; o contribute to public health efforts to control TB in the United States; and o enhance the teaching of tuberculosis in minority medical schools and promote TB education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about tuberculosis and among physicians who are or who will be caring for medically underserved populations. Since this is a medical education program, funds may be requested for technical support staff who have complementary expertise to the principal investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. SPECIAL REQUIREMENTS 1. Awardee Salary The salary requested for the awardee must not exceed the actual institutional salary rates for the effort devoted to the Academic Award, and must not exceed $50,000 plus fringe benefits. A candidate must spend at least 30 percent time on this award. An awardee may devote up to a total of 100 percent effort as an Academic Awardee and as principal or participating investigator on any other NIH-supported grant(s) or contract(s) and may receive remuneration from such grant(s) or contract(s) accordingly. An example of an investigator who receives the Academic Award at a level of effort of 30 percent, who wishes to devote 60 percent of effort to other Federally-sponsored research, and whose institutional salary is $130,000 is as follows: Academic Award 30 percent effort $ 37,500* Other Federally-supported grants and contracts 60 percent effort $ 75,000* Total salary from Federal sources $112,500 Salary contribution from grantee's institution $ 17,500 Total Salary $130,000 *(based on the current ceiling of $125,000) 2. Program Support Technical support will be provided up to a maximum of $20,000 per year for the following: o personnel other than the awardee if requested for the development, implementation, and evaluation of the program. Salaries will be allowable for technical and support staff and consultants, e.g. educational and evaluation specialists. Students stipends are allowable for students conducting projects directly related to the award; o equipment costs are not allowable; o consumable supplies essential to the proposed program; o funds for educational development to enable the awardee to develop educational skills; o funds for travel for the Principal Investigator to meet with other awardees and NHLBI staff to exchange ideas, to develop collaborative projects, and to provide for some needed technical support. (Awardees may be requested to meet as a group up to two times a year; $2,000 should be allocated for this purpose.) 3. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures of equipment. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases, it may be necessary for the applicant to be relieved of some responsibilities for the five years of the grant award in order to implement the proposed plan. An Institution may apply for an award on behalf of a named individual meeting the criteria for this award. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a non-competitive basis depending upon progress being made in meeting the program's objectives. An annual report will be required that summarizes activities relevant to curriculum development at the institution and other elements of the program plan and outlines future plans. This report will serve as the principal basis for renewal of the grant. Awards may not be transferred from one institution to another. If an awardee moves to another institution, the award will continue at the original institution only upon acceptance by the Division of Lung Diseases of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Although the TB Academic Award is not primarily a mechanism to support research, some awardees may implement research as part of the overall Academic Award Program. If any clinical research is proposed under the program, the policies of the NIH regarding inclusion of women and minorities apply. NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group and approximate percentages should be included. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Programs involving educational strategies including the effectiveness of such strategies, such as required by this program, are considered human subject research. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by December 13, 1993, a letter of intent that includes the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 594-7452 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7428. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, "RFA: HL-94-002-L Tuberculosis Academic Award" must be typed on Line 2a of the face page of the application form and the "YES" box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Applications must be received at both locations by February 11, 1994 to be assured of review in this competition. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will return the application to the applicant. The initial review may include a preliminary evaluation to determine scientific merit relative to the other applications received in response to this program announcement (triage); the NIH will remove from further consideration applications judged to be noncompetitive and promptly notify the Principal Investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures, including, if deemed appropriate, an applicant interview in or near Bethesda at the applicant's expense. The initial review will be conducted by a Special Emphasis Panel, managed by the Division of Extramural Affairs, National Heart, Lung, and Blood Institute. The secondary review will be by the be by the National Heart, Lung, and Blood Advisory Council. Applications for this Tuberculosis Academic Award will be evaluated in terms of the following criteria: o description of the magnitude of the tuberculosis problem and the need for the program in the area to be served; o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula in tuberculosis control; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and administration in a medical school, and planning and conduct of research; o the ability and commitment to work cooperatively with other awardees to make innovative tuberculosis curricula, materials, and programs available; o the institution's commitment to implement the proposed curriculum and to maintain a program in education about tuberculosis control after the termination of the award; o the significant involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with tuberculosis in areas with high incidence of TB; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, infections, and community medicine to ensure optimal treatment; o plans for collaborative projects with other organizations that have responsibility for and interest in tuberculosis control, for example, health departments, medical and nursing associations, and voluntary health agencies; o plans for and availability of expertise to implement and evaluate the proposed program, including strategies for both process and impact evaluation; o the potential of the program for making an impact on the control of tuberculosis among populations served; o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is September 30, 1994. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Tuberculosis Academic Award, the Division of Lung Diseases will provide funds for a project period up to five years. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, listed below, as soon as they receive approval from their institution to apply for this award. Direct inquiries regarding programmatic issues to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CAR 52 and 45 CAR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 36, pt. 2, 8 October 1993 Message-ID: Date: 23 Oct 93 01:42:11 GMT Sender: kristoff@net.bio.net Lines: 1499 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19931008 V22N36 P2O3 ************************************ Americans, Native Americans and Pacific Islanders. The term "science" is used in this RFA to mean the natural, physical, and behavioral sciences and mathematics relevant to biomedical research. Applications must include a partnership between a two year institution ("AA Institution") that offers the Associate degree as the only undergraduate degree in the sciences within the participating departments AND has a significant enrollment of underrepresented minorities, and a college or university offering Baccalaureate degrees in science relevant to biomedical research disciplines. All applications must involve a partnership of at least two colleges or universities, but may involve a consortium of several institutions, and may include several institutions within a single state system. One participating institution must be designated as the applicant institution, must name the program director, and must submit the application. Each participating institution must name one individual to act as its program coordinator. Proposals must include a description of the collaborative arrangement with all participating institutions. Institutions offering both the Associate and Baccalaureate degrees may not use funds from this program for graduates of their own Associate degree programs to enter their own Baccalaureate degree programs, even if the student is moving from one department, school, or college to another. The program seeks to promote and enhance partnerships BETWEEN institutions. For additional requirements see: SPECIAL REQUIREMENTS MECHANISM OF SUPPORT General Awards under this RFA will use the institutional education project (R25) grant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period for applications submitted in response to this RFA may not exceed two years. Requested direct costs are not to exceed $300,000 for the two-year period. Indirect costs will be paid at eight percent of the direct costs, minus appropriate exclusions, or actual indirect costs, whichever is less. A budget for each year must be provided. This RFA is a one-time solicitation. Future unsolicited competing applications will not be accepted. Allowable Costs If appropriate, the budget request may be divided into two phases: a planning phase with its attendant budget for the development, adjustment and/or refinement of the partnership program; and an implementation phase with its attendant budget. The planning phase costs should be minimal and not exceed a period of one year. Faculty release time for planning and implementation of the program and faculty travel related to program development may be requested. The implementation phase may include the costs of administering and coordinating the partnership program within and between each of the participants. Requests for equipment, supplies, travel, and other expenses should be limited to those necessary for program development and should be carefully and specifically justified. Student participation (limited to those matriculated at the AA partner institution(s)) in research experiences may be requested and remunerated through salary/wages and/or other forms of compensation paid in lieu of wages (e.g., tuition remission). These expenditures are allowable provided the student is performing necessary work, there is an employer-employee relationship between the student and the institution, the total compensation is reasonable for the work performed, and it is the institution's practice to provide compensation for all students in similar circumstances, regardless of the source of support for the activity. Stipends, housing, tuition, and fees are not allowable costs under this program. FUNDS AVAILABLE An estimated total of $9 million will be available in Fiscal Year 1994 for supporting awards made in response to this RFA (GM-94-001), RFA GM-94-002, and competing continuation applications, GM-94-003. NIH staff anticipate making a combined total of 20 to 40 new and competing continuation awards for these RFAs using multi-year funding, provided NIH receives sufficient numbers of highly meritorious applications and sufficient funds for this purpose. RESEARCH OBJECTIVES Background This program seeks to promote the initiation and development of new transitional programs as well as the expansion and enhancement of existing programs between those institutions with departments offering only the Associate's degree as the undergraduate academic degree in the sciences, and that have significant enrollments of underrepresented minority students, and colleges and universities with Baccalaureate degree programs. The objective is to facilitate the transition of underrepresented minority undergraduate students into Baccalaureate degree programs after obtaining their Associate's degree. Students receiving their Associate's degree in one field of science may pursue the Baccalaureate degree in a different area if it is in a discipline related to the biomedical sciences with a potential for research careers. Collaborative agreements should take the form that best fits the needs and situations of the institutions involved. The challenge for the program director, with the help of the participating partners, is to design a new partnership program, or enhance an existing program, that will focus attention and adequate resources to the Associate degree- granting institutions to enhance the academic competitiveness of their degree programs and graduates in the sciences. Additional Information These transition programs should be developed to meet the special requirements of underrepresented minority students interested in science. They may include, but are not limited to, the following elements: o providing laboratory research experiences at the baccalaureate institution for students enrolled in the two-year institution (students may receive compensation for these activities); o establishing a mentoring program with faculty at the baccalaureate institution; o providing research opportunities at the baccalaureate institution for faculty of the two-year college; o enriching the curriculum at the two-year institution (e.g., special science courses); o enabling students from the two-year institution to take courses and/or participate in seminar programs at the baccalaureate college; o developing visiting lectureships at the two-year college by science faculty from the baccalaureate institution; o developing courses at the two-year college jointly taught by faculty of both institutions; o guaranteeing acceptance as juniors into the participating baccalaureate program(s) for students who participated successfully in the enhancement program; o academic counseling (e.g., guidance in course selection, tracking and providing assistance to students who express an interest or show special aptitude for science); o additional enrichment activities, such as tutoring, to enhance the student's transition to the baccalaureate college; o nontraditional or other professional degree-granting institutions should describe those modifications or additions to their programs that would provide Bridge students with the potential to enter research career training programs. o other innovative plans to coordinate these programs. It is an expectation of NIGMS and ORMH that students who enter Baccalaureate programs as a result of this enhancement program will receive financial aid packages, if needed, while progressing satisfactorily in B.S. programs. Applicants should describe the type(s) of institutional or other financial aid that would be available to such students. SPECIAL REQUIREMENTS Applicants should describe fully the proposed transition program and explain how its design will meet the goals of this initiative. Applicants should describe the criteria to be used in the selection and retention of the student participants for this program; applicants should also describe the criteria for selecting participating faculty. Applicants with an existing transition program should describe that program and explain how it would be altered to meet the goals of this initiative. Unified Plan To avoid duplication of effort each institution should develop a unified plan (which may include the physical, natural and behavioral sciences and mathematics) to facilitate the transfer of its students from the Associate's degree program to the Baccalaureate degree program at another institution. Applicants should describe how this proposal fits in with the institution's overall transition plan. If an institution is involved in more than one Bridge Program, the applicant or the institution's program coordinator must describe how the various Bridge Programs interact and are consistent with the institution's unified plan. Other Training Programs Colleges with any NIH funding such as the Minority Access to Research Careers (MARC), Minority Biomedical Research Support Program (MBRS), National Research Service Award (NRSA) training grants, and/or project grants, or other sources of funds such as National Science Foundation grants or Howard Hughes Medical Institute grants, should define the relationship between those programs and this transition program. They should delineate how this enhancement program will influence their partnerships with the other participants and the manner in which underrepresented minority students in the transition program will interact with these other sources of support. Consortium Agreements Each applicant institution should delineate appropriate agreements and consortium arrangements with other institutions consistent with its own unified institutional plan. The following statement, accompanied by signatures of the appropriate administrative officials from EACH of the collaborating institutions, must be included as part of the application: "THE APPROPRIATE PROGRAMMATIC AND ADMINISTRATIVE PERSONNEL OF EACH INSTITUTION INVOLVED IN THIS GRANT APPLICATION ARE AWARE OF THE NIH CONSORTIUM GRANT POLICY AND ARE PREPARED TO ESTABLISH THE NECESSARY INTER-INSTITUTIONAL AGREEMENT(S) CONSISTENT WITH THAT POLICY." In addition, letters acknowledging participation in the program are required from each participating institution and must be signed by the program coordinator and the appropriate institutional official. Reporting Requirements A progress report will be required at the end of the planning phase (if any) or at the end of the first year, whichever is shorter. A final report will be required 90 days after the termination date of the award and must include information for each student participant and the benefits derived from the partnership program. For applicants submitting competing renewals the progress report in the competing application may satisfy this requirement. Student Population and Career Tracking The nature and extent of underrepresented minority student participation must be thoroughly delineated. The applicant should also describe the Associate's degree-granting institution's success in training its students in the sciences, including information on the numbers of minority students receiving the Associate's degree and data on subsequent careers or education of their graduates. The applicant should describe a system by which it would monitor and track the students participating in this program, including their future careers, in order to evaluate the success of the program. LETTER OF INTENT Prospective applicants are requested to submit, by November 19, 1993, a letter of intent that includes a descriptive title of the proposed plan, the name, address, and telephone number of the program director, the identities of other key personnel and participating institutions, and the number and title of the RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to the Program Administrator listed below under "INQUIRIES." APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NIGMS program administrator listed under INQUIRIES. The RFA label in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2A of the face page form, the "YES" box must be marked, and "R25" typed in 2B. Submit a signed, typewritten original of the application, including the Checklist, and three photocopies of the signed application in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to Dr. Americo Rivera, Jr. at the address listed under INQUIRIES. Applications must be received by January 20, 1994. Applications received after that date will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be administratively reviewed by NIH staff. Incomplete and/or unresponsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by appropriate peer review groups. The second level of review will be provided by the National Advisory General Medical Sciences Council. Review criteria: o qualifications and experience of the Principal Investigator and staff to carry out the proposed program (extensive publication records may be waived for faculty at primarily teaching institutions); o appropriateness of the plans to develop the transition program to meet the goals of the solicitation; appropriateness of the existing program, if appropriate, and of plans to modify that program; o availability of significant numbers of underrepresented minority students in the participating science department(s) who are interested in studying further in biomedical and health-related fields; o evidence of underrepresented minority students progressing to higher education in the sciences; o appropriateness of the system to track future course of program participants and monitor the effectiveness of the program; o budget and cost-effectiveness of the project including appropriateness to the scope of the program, benefit to the students, number of students involved, appropriateness of the of resources allocated to AA institution(s), and responsible and prudent senior personnel costs; o evidence of institutional commitment, for each institution, and strength of the collaborative efforts between institutions to foster professional development of underrepresented minority faculty and to train underrepresented minority students in the biomedical sciences; o appropriateness of the administrative plan for managing the proposed program, including adequacy of space and other institutional resources. AWARD CRITERIA The anticipated date of award is September 30, 1994. Award decisions will be based on the technical merit of the applications, the geographical distribution of the awardee institutions, and diversity of underrepresented minority student participants. Awards can be made only to institutions with financial management systems and management capabilities that are acceptable under PHS policy. Awards will be administered under the PHS Grants Policy Statement. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Americo Rivera, Jr., Ph.D. National Institute of General Medical Sciences Westwood Building, Room 909 Bethesda, MD 20892 Telephone: (301) 594-7744 FAX: (301) 594-7700 Direct inquiries regarding fiscal matters to: Ms Annette Hanopole Grants Management Specialist National Institute of General Medical Sciences Westwood Building, Room 935 Bethesda, MD 20892 Telephone: (301) 594-7819 AUTHORITY AND REGULATIONS Awards are authorized by sections 301 and 405 of the Public Health Service Act, as amended and administered under PHS grants policies and Federal Regulations 45 CFR Part 74 or 45 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. This program is described in the Catalog of Federal Domestic Assistance No. 93.960, Special Minority Initiatives Program. $$R6 END ************************************************************ $$R7 BEGIN GM-94-002 ************************************************ INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE DOCTORAL DEGREE NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: GM-94-002 P.T. 44, FF; K.W. 0720005, 0710030 National Institute of General Medical Sciences Letter of Intent Receipt Date: November 19, 1993 Application Receipt Date: January 20, 1994 PURPOSE The National Institute of General Medical Sciences (NIGMS) and the Office of Research on Minority Health (ORMH), National Institutes of Health (NIH), re-announce two initiatives directed at increasing the number of underrepresented minorities entering careers in biomedical research. The programs target two different underrepresented minority student populations: those in colleges and universities offering only Master of Science (M.S.) degree programs in biomedically-related sciences and those in two-year junior or community colleges. These have been identified as two key transition points for students considering careers in biomedical research. This is the third year of this program, which seeks to encourage the development of new and innovative programs and the expansion of existing programs to improve the academic competitiveness of underrepresented minority students and facilitate their transition into the next stage towards careers in biomedical research. This Request for Applications (RFA) solicits new applications for a partnership program involving institutions awarding the M.S. degree and universities awarding the Ph.D. degree. A separate RFA (GM-94-001) describes a program targeting the transition from two- year colleges awarding the Associate's degree to institutions awarding the Baccalaureate degree. Former applicants of unfunded Bridge applications are encouraged to submit revised applications that respond to the prior concerns of the National Advisory General Medical Sciences Council. ELIGIBILITY REQUIREMENTS General Applications may be submitted by domestic, private and public, educational institutions. State or local systems of higher education (also hereinafter referred to as institutions) may submit applications as well. An institution may be involved as a partner institution in more than one Bridge Program, but can be the APPLICANT institution for only one Bridges to the Baccalaureate Degree and one Bridges to the Doctoral Degree Program. Institutions with NIGMS Doctoral Bridge Program (R25) grants funded after March 1, 1993 are not eligible to apply for this RFA (GM-94-002). An institution or system of higher education may submit ONLY ONE application for this RFA. Institutions that submit applications in response to this RFA may also apply for support for a Bridge to the Baccalaureate Degree, RFA GM-94-001, if they meet the eligibility requirements. However, a separate application for each RFA is required. Institutions submitting their own applications may participate in programs with other applicant institutions if these interactions are consistent with institutional resources and their unified institutional plans described in BOTH applications (see UNIFIED PLAN under SPECIAL REQUIREMENTS). Institutions participating in more than one application should provided a justification for each. Programs developed or modified under this initiative must be specifically designed to target underrepresented minority graduate students majoring in the sciences. For purposes of this announcement, underrepresented minority students are individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Nationally, individuals who have been found to be underrepresented in biomedical or behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans and Pacific Islanders. The term "science" is used in this RFA to mean the natural, physical, and behavioral sciences and mathematics relevant to biomedical research. Applications must include a partnership between an institution that offers the M.S. degree ("MS Institution") as the only post-graduate degree in the sciences within the participating departments AND has a significant enrollment of underrepresented minorities, and one research university providing Ph.D. degree programs in areas relevant to the biomedical sciences. All applications must involve a partnership of at least two colleges or universities, but may involve a consortium of several institutions, and may include several institutions within a single state system. One participating institution must be designated as the applicant institution, must name the program director, and must submit the application. Each participating institution must name one individual to act as its program coordinator. Applications must include a description of the collaborative arrangement with all participating institutions. Institutions offering both the M.S. and Ph.D. degrees may not use funds from this program for graduates of their own M.S. degree programs to enter their own Ph.D. degree programs, even if the student is moving from one department, school, or college to another. The program seeks to promote and enhance partnerships BETWEEN institutions. For additional requirements see: SPECIAL REQUIREMENTS MECHANISM OF SUPPORT General Awards under this RFA will use the institutional education project (R25) grant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed two years. Requested direct costs are not to exceed $300,000 for the two-year period. Indirect costs will be paid at eight percent of the direct costs, minus appropriate exclusions, or actual indirect costs, whichever is less. A budget for each year should be provided. This RFA is a one-time solicitation. Future unsolicited competing applications will not be accepted. Allowable Costs If appropriate, the budget request may be divided into two phases: a planning phase with its attendant budget for the development, adjustment and/or refinement of the partnership program; and animplementation phase with its attendant budget. The planning phase costs should be minimal and not exceed a period of one year. Faculty release time for planning and implementation of the program and faculty travel related to program development may be requested. The implementation phase may include the costs of administering and coordinating the partnership program within and between each of the participants. Requests for equipment, supplies, travel, and other expenses should be limited to those necessary for program development and should be carefully and specifically justified. Student participation (limited to those matriculated at the MS partner institution(s)) in research experiences may be requested and remunerated through salary/wages and/or other forms of compensation paid in lieu of wages (e.g., tuition remission). These expenditures are allowable provided the student is performing necessary work, there is an employer-employee relationship between the student and the institution, the total compensation is reasonable for the work performed, and it is the institution's practice to provide compensation for all students in similar circumstances, regardless of the source of support for the activity. Stipends, housing, tuition, and fees are not allowable costs under this program. FUNDS AVAILABLE An estimated total of $9 million will be available in Fiscal Year 1994 for supporting awards made in response to this solicitation (GM-93-002), GM-94-001, and applications for competing continuations, GM-94-003. NIH staff anticipate making a combined total of 20 to 40 new and competing continuation awards for these RFAs using multi-year funding, if NIH receives sufficient numbers of highly meritorious applications and sufficient funds for this purpose. RESEARCH OBJECTIVES Background This program seeks to promote the initiation and development of new transitional programs, as well as the expansion and enhancement of existing programs between those institutions with departments offering only the Master's degree as the graduate academic degree in the sciences, and that have significant enrollments of underrepresented minority students, and research universities with Ph.D. degree programs. The objective is to facilitate the transition of underrepresented minority graduate students into Ph.D. programs after obtaining their M.S. degree. Students receiving their M.S. degree in one field of science may pursue a Ph.D. in a different area if it is in a discipline related to the biomedical sciences. Collaborative agreements should take the form that best fits the needs and situations of the institutions involved. The challenge for the project director, with the help of the participating partners, is to design a new partnership program, or enhance an existing program, that will focus attention and adequate resources to the MS Institution(s) to enhance the academic competitiveness of their graduate degree programs and graduates in the sciences. Additional Information The "Bridge" programs must be designed with special attention to the needs and special requirements of the underrepresented minority graduate students enrolled in the M.S. degree program. They may include, but are not limited to, the following elements: o providing research opportunities for M.S. students at the Ph.D. institution or in private industrial laboratories (students may receive compensation for these activities); o establishing a mentoring program for M.S. students with faculty at the Ph.D. institution; o strengthening the research capability of the MS Institution (e.g., by faculty research collaborations, joint seminar programs, etc.); o enhancing the curriculum of the MS Institution (special courses, seminars, etc.); o enabling and encouraging students from either institution to take classes at the other institution; o guaranteeing acceptance into the participating Ph.D. program(s) for students completing the M.S. program; o academic counseling for M.S. students, with a particular focus on encouraging students to pursue research careers in the biomedical sciences. o nontraditional or other professional degree-granting institutions should describe those modifications or additions to their programs that would encourage and facilitate Bridge students to enter research careers. It is an expectation of NIGMS and ORMH that students who enter Ph.D. programs as a result of this enhancement program will receive support, if needed, while progressing satisfactorily in Ph.D. research training programs. Applicants should describe the type(s) of institutional support that would be available to such students. SPECIAL REQUIREMENTS Applicants should describe the proposed transition program in detail and explain how its design will meet the goals of this initiative. Applicants should describe the criteria to be used in the selection and retention of the student participants for this program; applicants should also describe the criteria for selecting participating faculty. Applicants with an existing transition program should describe that program and explain how it would be altered to meet the goals of this initiative. Unified Plan To avoid duplication of effort each institution should develop a unified plan (which may include the biomedically relevant physical, natural and behavioral sciences and mathematics) to facilitate the transfer of its students from the M.S. degree program to the Ph.D. degree program at another institution. Applicants should describe how this proposal fits in with the institution's overall transition plan. If an institution is involved in more than one Bridge Program, the applicant or the institution's program coordinator must describe how the various Bridge Programs interact and are consistent with the institution's unified plan. Other Training Programs Colleges with any NIH funding such as the Minority Access to Research Careers (MARC), Minority Biomedical Research Support Program (MBRS), National Research Service Award (NRSA) training grants, and/or project grants, or other sources of funds such as National Science Foundation grants or Howard Hughes Medical Institute grants, should define the relationship between those programs and this transition program. They should delineate how this enhancement program will influence their partnerships with the other participants and the manner in which underrepresented minority students in the transition program will interact with these other sources of support. Consortium Agreements Each applicant institution should delineate appropriate agreements and consortium arrangements with other institutions consistent with its own unified institutional plan. The following statement, accompanied by signatures of the appropriate administrative officials from EACH of the collaborating institutions, must be included as part of the application: "THE APPROPRIATE PROGRAMMATIC AND ADMINISTRATIVE PERSONNEL OF EACH INSTITUTION INVOLVED IN THIS GRANT APPLICATION ARE AWARE OF THE NIH CONSORTIUM GRANT POLICY AND ARE PREPARED TO ESTABLISH THE NECESSARY INTER-INSTITUTIONAL AGREEMENT(S) CONSISTENT WITH THAT POLICY." In addition, letters, signed by the appropriate institutional official and program coordinator, acknowledging participation in the program are required from each participating institution. Reporting Requirements A progress report will be required at the end of the planning phase (if any) or at the end of the first year, whichever is shorter. A final report will be required 90 days after the termination date of the award and must include information for each student participant and the benefits derived from the partnership program. For applicants submitting competing renewals the progress report in the competing application may satisfy this requirement. Student Population and Career Tracking The nature and extent of underrepresented minority student participation must be thoroughly delineated. The applicant should also describe the MS Institution's success in training its students in the sciences, including information on the numbers of minority students receiving the M.S. degree and data on subsequent careers or education of their graduates. The applicant should describe a system by which it would monitor and track the students participating in this program, including their future careers, in order to evaluate the success of the program. LETTER OF INTENT Prospective applicants are requested to submit, by November 19, 1993, a letter of intent that includes a descriptive title of the proposed plan, the name, address, and telephone number of the program director, the identities of other key personnel and participating institutions, and the number and title of the RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to the Program Administrator listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, NIH, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NIGMS program administrator listed under INQUIRIES. The RFA label in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2A of the face page form, the "YES" box must be marked, and "R25" typed in 2B. Submit a signed, typewritten original of the application, including the Checklist, and three photocopies of the signed application in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to Dr. Americo Rivera, Jr. at the address listed under INQUIRIES. Applications must be received by January 20, 1994. Applications received after that date will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be administratively reviewed by NIH staff. Incomplete and/or unresponsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by appropriate peer review groups. The second level of review will be provided by the National Advisory General Medical Sciences Council. Review criteria o qualifications and experience of the Principal Investigator and staff to carry out the proposed program; o appropriateness of the plans to develop the transition program to meet the goals of the solicitation; appropriateness of the existing program, if appropriate, and of plans to modify that program; o availability of significant numbers of underrepresented minority students in the participating science department(s) who are interested in studying further in biomedical and health-related fields; o evidence of underrepresented minority students progressing to higher education in the sciences; o appropriateness of the system to track future course of program participants and monitor the effectiveness of the program; o budget and cost-effectiveness of the project including appropriateness to the scope of the program, benefit to the students, number of students involved, appropriateness of the of resources allocated to MS institution(s), and responsible and prudent senior personnel costs; o evidence of institutional commitment, for each institution, and strength of the collaborative efforts between institutions to foster professional development of underrepresented minority faculty and to train underrepresented minority students in the biomedical sciences; o appropriateness of the administrative plan for managing the proposed program, including adequacy of space and other institutional resources. AWARD CRITERIA The anticipated date of award is September 30, 1994. Award decisions will be based on the technical merit of the applications, the geographical distribution of the awardee institutions, and diversity of underrepresented minority student participants. Awards can be made only to institutions with financial management systems and management capabilities that are acceptable under PHS policy. Awards will be administered under the PHS Grants Policy Statement. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Americo Rivera, Jr., Ph.D. National Institute of General Medical Sciences Westwood Building, Room 909 Bethesda, MD 20892 Telephone: (301) 594-7744 FAX: (301) 594-7700 Direct inquiries regarding fiscal matters to: Ms Annette Hanopole Grants Management Specialist National Institute of General Medical Sciences Westwood Building, Room 935 Bethesda, MD 20892 Telephone: (301) 594-7819 AUTHORITY AND REGULATIONS Awards are authorized by sections 301 and 405 of the Public Health Service Act, as amended, and administered under PHS grants policies and Federal Regulations 45 CFR Part 74 or 45 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. This program is described in the Catalog of Federal Domestic Assistance No. 93.960, Special Minority Initiatives Program. $$R7 END ************************************************************ $$R8 BEGIN HL-93-019 FULL-TEXT ************************************** GENETICALLY ENHANCED CARDIOVASCULAR IMPLANTS NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA AVAILABLE: HL-93-019 P.T. 34; K.W. 0715040, 0740022, 0740027, 1002019, 1002004 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 14, 1993 Application Receipt Date: January 13, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The objective of this RFA is to stimulate interdisciplinary research leading to the development of implanted cardiovascular devices lined with genetically modified cells. These cell-lined devices would be capable of (1) secreting substances into the local microenvironment that would enhance the biocompatibility of the device or (2) serving as an "organoid" (a hybrid organ composed of a biomaterial lattice coated with secretory cells) that would function as a source for chronic systemic delivery of agents with desirable cardiovascular actions. This research may lead to reduced complications with the use of heart valves, vascular grafts, stents, and circulatory support systems and improved treatment of disorders such as atherosclerosis, diabetes, and hypertension. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. The RFA, Genetically Enhanced Cardiovascular Implants, 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from foreign organizations should be limited to three years. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is August 1, 1994. 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. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE It is anticipated that for FY 94 approximately $750,000 will be available for this RFA from the Advanced Biomaterials program of the Federal Coordinating Council for Science, Engineering, and Technology (FCCSET) initiative, and that four grants will be awarded under this program. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES Biocompatibility problems are encountered with the long-term use of implanted cardiovascular devices such as artificial hearts, ventricular assist devices, heart valves, small diameter vascular grafts, and stents. Recent experimental studies indicate the feasibility of developing an "organoid" consisting of a biomaterial lattice coated with genetically engineered cells. Further studies are needed to determine the function and control of such an organoid over prolonged periods of time. This approach could lead to new modes of prevention and treatment of atherosclerosis, hypertension, diabetes, and other conditions including non- cardiovascular disorders. Implants incorporating genetically modified cells have the potential for continuous delivery of effective concentrations of proteins of therapeutic interest synthesized by the cells. Thus, the potential exists for using these implants in two ways. 1. The biocompatibility problems of implants may be addressed by use of cells that secrete molecules capable of locally controlling or preventing thrombosis and intimal hyperplasia. 2. Alternatively, an organoid comprising genetically modified cells on a polymer matrix might be used to treat various cardiovascular disorders by systemic delivery of antithrombotic, thrombolytic, antiproliferative, vasoactive, angiogenic, or other agents. It is expected that most applications will involve animal models as well as cell cultures. In vivo studies on human subjects will not be supported. Suggested areas of research include, but are not limited to, the following: o Studying genetic modification of endothelial or other cells for the production of recombinant proteins with desired therapeutic effects and investigating mechanisms of control of expression of recombinant genes. o Investigating the long-term function of genetically modified cells seeded on vascular implants. o Studying the parameters that affect the functions of organoids for cardiovascular applications. These may include the chemical nature of the polymer, surface receptor mechanisms on the polymer, the effect of cell adhesion molecules or growth factors coated on the polymer fibers, configuration of the polymer network, and the techniques of implantation. o Defining the conditions under which vascularization of the organoid is reproducible, complete, and long-lasting. o Investigating failure modes: immunologic rejection (if non- autologous cells are used), decline or cessation of expression, malignant change, effects on other genes. Developing strategies for responding to such events. LETTER OF INTENT Prospective applicants are asked to submit, by December 14, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Matthew Starr Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 553A Bethesda, MD 20892 Telephone: (301) 594-7448 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NIH program administrator named below. Applications must be received by January 13, 1994. REVIEW CONSIDERATIONS Applications will be judged on the basis of the scientific merit of the proposed protocols and the qualifications and research experience of the investigators, especially in the area of the proposed research. AWARD CRITERIA The anticipated date of award is August 1, 1994. Criteria for making awards will include priority score, availability of funds, and programmatic priorities. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Paul Didisheim Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue Federal Building, Room 312 Bethesda, MD 20892 Telephone: (301) 496-1586 Direct inquiries regarding fiscal and administrative matters to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 594-7458 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, 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. $$R8 END ************************************************************ $$R9 BEGIN DA-94-001 FULL-TEXT ************************************** DRUG DEPENDENCE RESEARCH CENTER GRANT PROGRAM NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA AVAILABLE: DA-94-001 P.T. 34; K.W. 0404009, 0745070, 0710030 National Institute on Drug Abuse Letter of Intent Receipt Date: December 17, 1993 Application Receipt Date: January 18, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE Grant support from the National Institute on Drug Abuse (NIDA) is available to establish Drug Dependence Research Centers (DDRCs). DDRCs are defined in two categories: (1) Treatment Research Centers (TRCs) or (2) Medications Development Research Centers (MDRCs). DDRCs that primarily conduct interdisciplinary research on the efficacy of treatment of drug dependence will be considered to be Treatment Research Centers (TRCs). DDRCs that primarily conduct interdisciplinary research on medications development for drug dependence will be considered to be Medications Development Research Centers (MDRCs). Applicants are expected to develop proposals that are primarily TRC or MDRC in their integrative research theme, but may choose to include components consistent with either category (e.g., a TRC application may include project(s) that are medications development or vice-versa). 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, Drug Dependence Research Center Grants, is related to the 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 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. However, the proposed TRC or MDRC must be affiliated with an institution, such as a university, medical center, or research center, that has the resources to sustain a long-term, coordinated research program around a central theme relating to maximizing and establishing the efficacy of drug dependence treatment including medications development. An applicant institution must demonstrate the ability to attract high quality scientists from biomedical, behavioral, and/or social science disciplines who are willing to make a long-term commitment to drug dependence treatment research. The proposed TRC or MDRC should have the clear capability to conduct clinical research in existing treatment or medications development programs. Applicants should demonstrate explicitly how this research will be integrated within the treatment program. Applications from minority individuals and women are encouraged. Foreign organizations are ineligible. MECHANISM OF SUPPORT The National Institutes of Health (NIH) center grant (P50) mechanism will be the mechanism of support used under this RFA. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Any applications received after the single receipt date will be returned to the applicant without further review. FUNDS AVAILABLE It is anticipated that up to $14 million will be available to support the first year of this grant program. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will also vary. However, it is anticipated that approximately 8 to 10 new awards will be made under the RFA. Refer to the RFA for additional details. RESEARCH OBJECTIVES This research program is intended to support the establishment of DDRCs (TRCs or MDRCs) to conduct interdisciplinary research on the efficacy of treatment for drug addiction. Effort is to be made to use "state-of-the-science" approaches. Drug dependence treatment efficacy research within a DDRC should involve the systematic development and integration of knowledge derived from a variety of sources, and should utilize a number of designs. The proposed research must be organized around a central theme. The theme of the DDRC (TRC or MDRC) should clearly relate to investigating the efficacy of drug dependence treatments. DDRCs funded under this announcement may conduct research on: TRC o psychobehavioral treatments and/or o currently marketed pharmacological treatments MDRC o medications development. SPECIAL REQUIREMENTS The applicant should provide a detailed plan (for up to five years) describing the DDRC's proposed research program, focused on the central theme. This plan should include specific information on the proposed research projects, identification of scientists who are to be affiliated with the DDRC, and their roles in the program of research. Existing research programs and projects which are essential to the plan should be identified, and arrangements for integrating these into the DDRC's activities delineated. Letters of cooperation should be obtained from principal investigators whose data will be used in DDRC activity, except for those programs whose data bases are in the public domain and routinely made available for public use. Letters of cooperation will also be needed for multi- site investigations where identified programs are to be used for control or manipulation of variables. The nature and mix of investigators will be dependent on the particular theme selected. However, potential is seen for interrelated studies involving scientists in the areas of clinical, counseling and experimental psychology, medical specialties (including psychiatry), clinical pharmacology, clinical toxicology, social work, and statistics as are relevant to the theme of the application. Relationship of individual projects/studies to the core program should be clearly delineated. There must be at least three scored projects and a core which collectively meet the criteria for a Center. There is no maximum limit to the number or projects or cores, however, it must be demonstrated that they are administratively manageable. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by December 17, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIDA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone (301) 594-7248. Submit a signed, typewritten original of the application, including Checklist, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Schedule Letter of Intent Receipt Date: December 17, 1993 Application Receipt Date: January 18, 1994 Initial Review: April 1994 Advisory Council: June 1994 Earliest Award Date: July 1, 1994 Applications received after the receipt date will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications received under this announcement will be assigned to a special review group. The review group, consisting of experts in psychobehavioral and pharmacological drug abuse treatment research, and medications development clinical trials, as warranted by the applications, will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Pre-review site visits will not be made, and applications may not be deferred for site visit; therefore, applications should be complete when submitted. The review criteria are described in the RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applications is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Jack Blaine Division of Clinical Research National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4060 Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A., Chief Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Sections 301 and 464P, and administered under PHS grants policies and Federal Regulations at Title 42 CFR 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. $$R9 END ************************************************************ $$R10 BEGIN DK-94-003 FULL-TEXT ************************************* KIDNEY DISEASES AND HYPERTENSION IN AFRICAN AMERICANS NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA AVAILABLE: DK-94-003 P.T. 34, FC; K.W. 0715133, 0715115, 0755015 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: December 21, 1993 Application Receipt Date: January 18, 1993 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), announces the availability of a RFA for cooperative agreement applications from investigators to serve as a clinical center and/or data coordinating center for the full-scale phase of the clinical trial "African American Study of Kidney Disease and Hypertension" (AASK). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Health People 2000," a PHS-led national activity for setting priority areas. This RFA, Kidney Disease and Hypertension in African Americans, is related to the priority areas of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Only U.S. organizations are eligible to apply. Domestic applications may not include international components. Applications may be submitted by for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators and minority institutions are especially encouraged. An institution may apply for both a Clinical Center and Data Coordinating Center. However, a specific plan on how the independent operation (i.e., confidentiality of study-wide data) of each unit will be maintained is required. A separate application for each center will be required from an institution applying for both a Clinical Center and Data Coordinating Center. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be the cooperative agreement (U01). Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed in the RFA. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is approximately six million dollars. It is anticipated that one award for the Data Coordinating Center for not more than $750,000 (including direct and indirect costs) per year and fourteen awards for Clinical Centers will be made. Funding for a single Clinical Center will be approximately $375,000 in total costs per year. Although this program is provided for in the financial plans of the NIDDK, awards in response to this RFA are contingent on the availability of funds for this purpose. The total project period for applications submitted in response to the present RFA will be seven years. The anticipated award date is July 1994. At this time, the NIDDK anticipates that there will not be a renewed competition after seven years. RESEARCH OBJECTIVES The experimental design of this full-scale trial is a multi-center, prospective, double-masked, randomized study examining the impact of three antihypertensive drug regimens with different initial randomized drugs and two different levels of blood pressure (BP) control on the rate of change of the glomerular filtration rate (GFR) in African American subjects with hypertension and established renal insufficiency. The study will follow a three by two factorial design. The first factor will consist of three drug regimens, each initiated by a different agent. The three initial drugs used in these regimens will be a calcium channel blocker, an angiotensin converting enzyme inhibitor, and a beta-blocker. The second factor will be two levels of goal BP as defined by the mean arterial pressure (MAP). One group will have a goal MAP less than or equal to 92 mm Hg and the other group will have a MAP between 102-107 mm Hg inclusive. Study participants in the AASK full-scale trial are restricted to African Americans. The protocol for the ongoing AASK pilot study will be used for the full-scale study. The full-scale study will include fourteen Clinical Centers (CC) and a Data Coordinating Center (DCC). The expertise appropriate for investigators at the CC includes a knowledge of the epidemiological and clinical aspects of kidney disease and hypertension, experience in carrying out renal and hypertension clinical trials, experience and skill in measurement of kidney function (glomerular filtration rate), intervention with anti- hypertensive drugs among a large number of patients, and recruitment and follow-up of study participants, particularly African Americans, in clinical studies. Skills in management of multi-center clinical trials, establishing and maintaining a large data base, and analysis of complex data sets are appropriate for the Data Coordinating Center. SPECIAL REQUIREMENTS Since the funding mechanism to be used is the cooperative agreement, a number of special terms and conditions are given in the RFA with which each awardee must comply. These involve the relative roles and responsibilities of the clinical centers, the coordinating center, and the government in the conduct and governance of the study. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH policy requires that applicants pay particular attention to inclusion of women and minorities in the study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. However, for this study, only African Americans will be recruited as study participants. Therefore, for this solicitation, special emphasis must be placed on the need for inclusion of women in the study population. A clear compelling rationale must be provided if women are excluded or inadequately accounted for in the application. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked, but not required, to submit a letter of intent. This letter is to include the name, telephone number, and mailing address of the Principal Investigator, the names of key personnel, the name of the applicant institution, and the number and title of this RFA. Such a letter of intent is not binding and it will not enter into the review of any application subsequently submitted nor is it a requirement for application. Letters of intent are requested solely for planning purposes. The information contained in these letters is helpful in planning for review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The NIDDK staff will not provide responses to such letters. Letters of intent are to be received no later than December 21, 1993 and are to be addressed to: Dr. Robert D. Hammond Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 36, pt. 1, 8 October 1993 Message-ID: Date: 23 Oct 93 01:41:26 GMT Sender: kristoff@net.bio.net Lines: 1499 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19931008 V22N36 P1O3 ************************************ X-comment: RFAS described: AA-94-001, AA-94-002, AA-94-003, AA-94-004, AA-94- 005, HL-93-019, DA-94-001, DK-94-003 NIH GUIDE - Vol. 22, No. 36 - October 8, 1993 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 01/24/94 ************************************************* BIOMEDICAL AND BEHAVIORAL RESEARCH ON ALCOHOL AND WOMEN (RFA AA-94-001) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R2 01/12/94 ************************************************* BIOMEDICAL AND BEHAVIORAL RESEARCH ON ALCOHOL AND YOUTH (RFA AA-94-002 National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R3 01/12/94 ************************************************* ALCOHOL AND MINORITIES: BIOMEDICAL AND BEHAVIORAL RESEARCH (RFA AA-94-003) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R4 01/24/94 ************************************************* UNDERDEVELOPED AREAS OF ALCOHOL ABUSE PREVENTION RESEARCH (RFA AA-94-004) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R5 01/24/94 ************************************************* HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS (RFA AA-94-005) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R6 01/20/94 ************************************************* INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE BACCALAUREATE DEGREE (RFA GM-94-001) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX R7 01/20/94 ************************************************* INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE DOCTORAL DEGREE (RFA GM-94-002) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX R8 01/13/94 ************************************************* GENETICALLY ENHANCED CARDIOVASCULAR IMPLANTS (RFA HL-93-019) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R9 01/18/94 ************************************************* DRUG DEPENDENCE RESEARCH CENTER GRANT PROGRAM (RFA DA-94-001) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R10 01/18/94 ************************************************ KIDNEY DISEASES AND HYPERTENSION IN AFRICAN AMERICANS (RFA DK-94-003) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** BEHAVIORAL SCIENCE TRACK AWARD FOR RAPID TRANSITION (PAR-94-002) National Institute of Mental Health INDEX: MENTAL HEALTH This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN AA-94-001 FULL-TEXT ************************************** BIOMEDICAL AND BEHAVIORAL RESEARCH ON ALCOHOL AND WOMEN NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA AVAILABLE: AA-94-001 P.T. 34, II; K.W. 0404003, 0404000, 0414014, 0745027 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: January 12, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to study the health, biological, behavioral, psychosocial, and other consequences of alcohol consumption on women, identify risk and protective factors, and develop more effective identification, treatment and prevention strategies and programs. 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,Biomedical and Behavioral Research on Alcohol and Women, 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, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes and organizations, units of State or local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST Award (R29). Applicants for R01s may request support for up to five years. In FY 1992, the average total cost per year for new R01s funded by NIAAA was approximately $200,000. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FIRST Award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST Awards cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Applicants for FIRST Awards may obtain copies of the FIRST program announcement from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, Maryland 20852, telephone: 301-468-2600 or 1-800-729-6686. Program project grants (P01) will not be accepted for this RFA. Applicants may submit Investigator-Initiated Interactive Research Project Grants (IRPG). 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 the IRGP mechanisms is available in program announcement PA-93-078, NIH Guide for Grants and Contracts, Vol. 22, No. 16, April 23, 1993. FUNDS AVAILABLE It is estimated that up to two million dollars in total will be available for approximately 8 to 10 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objective of this RFA is to foster research that will ultimately lead to the reduction of alcohol abuse, dependence, and consequences among women. Such research may address the etiologic factors (including cellular and molecular mechanisms, unique neurobiological, hormonal, and behavioral vulnerabilities), incidence, prevalence, and natural history of alcohol-related medical consequences; identify risk factors and markers of risk that predict development of alcohol dependence or enhanced vulnerability to specific alcohol induced organ or tissue damage; examine gender differences in the interaction of genetic, individual and environmental factors; document barriers to diagnosis, intervention and treatment specific to women; and develop and test more effective intervention strategies for the prevention and treatment of alcohol-related problems among women across the lifespan from childhood to old age. Areas of research interest include, but are not limited to, studies of the natural history, biological mechanisms, incidence and prevalence of alcohol use, abuse, dependence, and consequences among women and female animals. See the RFA for additional areas of research interest. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of minorities and women in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Applications must be received by January 12, 1994. If an application is received after that date, it will be assigned to the next review cycle and will compete with all investigator-initiated research grant applications. 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 The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Research grant applications will be reviewed based on standard criteria for scientific and technical merit for regular research grants (R01). The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement. AWARD CRITERIA Applications recommended 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 Potential applicants are encouraged to seek preapplication consultation and may contact the individuals listed below for consultation in preparing an application under this RFA. Direct inquiries regarding programmatic issues and requests for the RFA to: Mary C. Dufour, M.D., M.P.H. Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 14C-26 Rockville, MD 20857 Telephone: (301) 443-4897 FAX: (301) 443-8614 Direct inquiries regarding fiscal matters to: Elsie Fleming Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 FAX: (301) 443-3891 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 grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. $$R1 END ************************************************************ $$R2 BEGIN AA-94-002 FULL-TEXT ************************************** BIOMEDICAL AND BEHAVIORAL RESEARCH ON ALCOHOL AND YOUTH NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA AVAILABLE: AA-94-002 P.T. 34, AA; K.W. 0404003, 0404000, 0414014, 0745027 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: January 12, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to study the development of alcohol-related problems among youth, identify risk and protective factors, and develop effective prevention and treatment interventions. This includes studies of the biological, behavioral, and psychosocial causes and consequences of alcohol abuse among youth. 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, Biomedical and Behavioral Research on Alcohol and Youth, 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, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes and organizations, units of State or local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST Award (R29). Applicants for R01s may request support for up to five years. In FY 1992, the average total cost per year for new R01s funded by NIAAA was approximately $200,000. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FIRST Award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST Awards cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Applicants for FIRST Awards may obtain copies of the FIRST program announcement 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. Program project grants (P01) will not be accepted for this RFA. Applicants may submit Investigator-Initiated Interactive Research Project Grants (IRPG). 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 the IRPG mechanism is available in program announcement PA-93-078, NIH Guide for Grants and Contracts, Vol. 22, No. 16, April 23, 1993. FUNDS AVAILABLE It is estimated that up to two million dollars in total will be available for approximately 8 to 10 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objective of this RFA is to foster research that will lead to the reduction in prevalence of alcohol problems among youth. Such research may address the underlying mechanisms through which alcohol affects children and adolescents; identify risk factors and markers predictive of various alcohol-related problems in youth; test models of the development of alcohol-related problems and the mediation of risk through interactions of genetic, individual, and environmental factors; and develop and test interventions for the prevention and treatment of alcohol-related problems in youth. Background While alcohol misuse presents a major risk for health and well-being throughout the life span, the child may be especially vulnerable to adverse effects both from direct exposure to alcohol and from the consequences of others' alcohol abuse. The presence of alcohol abuse within the home environment is an important risk factor for the development of social and behavioral problems, including alcoholism. A variety of physical and behavioral problems follow directly from exposure to alcohol. Attitudes and expectancies regarding alcohol use are established at a very early age, and most persons first experiment with alcohol use during childhood or adolescence. Misuse of alcohol by youth can have immediate devastating effects, including traffic accidents and acute alcohol poisoning; can be associated with other risky behaviors such as engaging in unprotected sex; can interfere with school performance and contribute to a long term pattern of poor social adjustment and failure; and can initiate a lifetime pattern of alcohol abuse and dependence. Genetic, individual, and environmental factors may interact in determining risk for these adverse outcomes. Effective age-appropriate prevention and treatment interventions are essential, and increased understanding of the nature, etiology, and mechanisms of alcohol- related risks for youth is needed to inform such interventions. Areas of Research Interest For the purposes of this announcement, youth is considered to encompass childhood through early young adulthood, or approximately the ages 2 to 21. Specific research methodologies may be appropriate to basic biomedical, neuroscience, and behavioral studies, epidemiology, or prevention and treatment research. This may include the use of immature animals for biomedical, neuroscience, and behavioral studies. Studies that test interventions or seek to advance the transfer of basic research findings toward prevention or treatment intervention applications are encouraged. A list of possible research topics is provided in the RFA. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of minorities and women in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. The RFA label available in the PHS (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Page limits and limits on size of type are strictly enforced. Applicants for FIRST Awards (R29) are reminded that such applications must include three letters of reference. Non conforming applications will be returned without being reviewed. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Applications must be received by January 12, 1994. If an application is received after that date, it will be assigned to the next review cycle and will compete will all other investigator-initiated research grant applications. 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 The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. The second level of review will be provided by the National Advisory Council. Review Criteria Research grant applications will be reviewed based on standard criteria for scientific and technical merit for regular research grants (R01). The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement. 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 Potential applicants are encouraged to seek preapplication consultation and may contact the individuals listed below for consultation in preparing an application under this RFA. Direct inquiries regarding programmatic issues and requests for the RFA to: Gayle Boyd, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 FAX: (301) 443-9334 Direct inquiries regarding fiscal matters to: Elsie Fleming Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 FAX: (301) 443-3891 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, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. $$R2 END ************************************************************ $$R3 BEGIN AA-94-003 FULL-TEXT ************************************** ALCOHOL AND MINORITIES: BIOMEDICAL AND BEHAVIORAL RESEARCH NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA AVAILABLE: AA-94-003 P.T. 34, FF; K.W. 0404003, 0710030, 0404000 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: January 12, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to study the medical and behavioral consequences of alcohol consumption on minority groups and individuals, including development of more effective treatment and prevention programs. The primary purpose of this RFA is to expand the limited information available on alcohol related problems among and within ethnic minority populations of African Americans, Native American/Alaskans, Asian Americans, Pacific Islanders, and Hispanic Americans. Most of these groups are at elevated risk for specific alcohol problems or have patterns of increased alcohol consumption. The NIAAA encourages innovative research on biomedical, behavioral, clinical, socio- cultural, and epidemiological factors associated with the use or abuse of alcohol; the prevention and treatment of alcohol-related problems; and the consequences of these problems in minority groups and individuals. The NIAAA supports alcohol relevant basic and applied research involving a wide array of health science fields and related academic disciplines. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Alcohol and Minorities: Biomedical and Behavioral Research, 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, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST (R29) award. Applicants for R01s may request support for up to five years. In FY 1992, the average total cost per year for new R01s funded by the NIAAA was approximately $200,000. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FIRST Award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST Awards cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Applicants may submit Investigator- Initiated Interactive Research Project Grants (IRPGs). 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. FUNDS AVAILABLE It is estimated that up to two million dollars in total costs will be available for approximately 8 to 10 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The NIAAA has supported studies of variations in drinking patterns and problems among the different racial and ethnic groups. In the past decade attention has become more focused on understanding why these patterns differ and how this information may be used to design and conduct culturally relevant, methodologically sound research. Further information is needed on how these patterns relate to differential biological and behavioral responses to alcohol and how specific responses may explain adverse outcomes of alcohol use. Knowledge of the causes and consequences of alcohol consumption is critical to achievement of the ultimate goal: development and implementation of effective prevention and treatment strategies for specific ethnic populations. Variations in drinking patterns and drinking problems have been noted among different racial and ethnic groups for over 20 years. Many reports provide evidence that the frequency of alcohol problems is distinctly high in some groups. Much of the information regarding alcohol-related problems is based on ethnographic and community studies. Baseline longitudinal studies are needed to better understand consumption patterns and their relationship to chronic alcohol-related diseases. Studies are need to examine the effects of policies and practices that alter the physical, social, or economic availability of alcohol and reduce demand for it among minority ethnic populations. Pre-intervention studies are needed to expand knowledge regarding sociocultural, economic, behavioral, and biological factors related to alcohol use. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applications to give special attention to the inclusion of minorities and women in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Applications must be received by January 12, 1994. If an application is received after that date, it will be assigned to the next review cycle and will compete with all investigator-initiated research grants applications. 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 The DRG serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Research grant applications will be reviewed based on standard criteria for scientific and technical merit for regular research grants (R01). The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement. AWARD CRITERIA Applications recommended 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 Written and telephone inquiries concerning this RFA are encouraged. Potential applicants are encouraged to seek preapplication consultation. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Ernestine Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16C-06 Rockville, MD 20857 Telephone: (301) 443-1273 FAX: (301) 594-0673 Direct inquiries regarding fiscal matters to: Elsie Fleming Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 FAX: (301) 443-3891 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, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN AA-94-004 FULL-TEXT ************************************** UNDERDEVELOPED AREAS OF ALCOHOL ABUSE PREVENTION RESEARCH NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA AVAILABLE: AA-94-004 P.T. 34; K.W. 0404003, 0705035, 0715027 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: January 24, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to conduct studies focused on the prevention of three types of alcohol related problems where prevention has received very little research attention: Fetal Alcohol Syndrome (FAS) and Fetal Alcohol Effects (FAE); alcohol abuse among the elderly; and non-traffic alcohol-related injuries (drownings, burns, falls, rauma to pedestrians, and injuries incurred in crashes of planes, boats, and trains). The major task is to develop and test interventions aimed at preventing these problems before they occur. 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, Underdeveloped Areas of Alcohol Abuse Prevention Research, 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, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST Award (R29). Applicants for R01s may request support for up to five years. In FY 1992, the average total cost per year for new R01s funded by NIAAA was approximately $200,000. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will vary also. FIRST Award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST Awards cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Applicants for FIRST Awards may obtain copies of the FIRST program announcement 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. Program project grants (P01) will not be accepted for this RFA. However, applicants may submit Investigator-Initiated Interactive Research Project Grants. FUNDS AVAILABLE It is estimated that up to two million dollars will be available for approximately 8 to 10 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES FAS/FAE Background. Alcohol is a teratogen capable of damaging the developing fetus. FAS is a cluster of defects that includes growth retardation, central nervous system impairment, and characteristic abnormal facial features. A very conservative estimate of FAS incidence in the U.S. is 0.33 per 1000 live births. Inclusion of more subtle alcohol-related cognitive and behavioral birth defects (FAE) would substantially increase the overall incidence of problematic births. Native Americans and African Americans show higher FAS/FAE incidence rates than Caucasians. NIAAA and groups such as the AMA recommend that pregnant women completely abstain from alcohol use from conception to delivery. Research Areas. Preventive interventions attempt to change the drinking behavior of pregnant women. The following research topics and strategies are suggestive: accessing high-risk women early in their pregnancies, changing attitudes and norms in high-risk populations, message development, use of multi-strategy approaches, involvement of health-providers, server training, screening and assessment of risk, and increased understanding of biobehavioral and cognitive contributors to risk.Older Populations Background. Both episodic and chronic drinking appears to precipitate or aggravate conditions that may be experienced in the later years (e.g., cardiovascular disease, cognitive loss). Tolerance for alcohol is reduced and hazardous interactions with medications pose special risks for the elderly. Although some studies indicate that the prevalence of alcohol problems decreases with age, studies in clinical settings suggest relatively high rates of alcohol problems. Late-onset alcohol abuse, especially, is not well understood. Effective preventive interventions are needed to reduce alcohol problems among the elderly. Research Areas. Primary and secondary prevention and pre- intervention research might focus on: message development, anticipatory guidance, involvement of health care workers, alcohol- related accidents, reaching populations at risk, establishment of normative controls, prevalence of alcohol-related problems, drinking patterns, alcohol effects on the elderly, and identification of risk and protective factors. The heterogeneity of the population must be considered. Non-traffic Injuries Background. Few studies examine the role of alcohol in drownings, falls, fires, poisonings, and trauma to pedestrians and passengers of public transport. These data suggest that alcohol increases risk of these types of injuries and crashes by affecting the ability to operate complex machines. Research Areas. Prevention of alcohol-related non-automotive injuries depends on interventions involving laws and enforcement, education and normative change, and engineering and environmental approaches, and their evaluation. Intervention studies might focus on community-based safety education programs, mandated BAC standards for boaters or their enforcement, and studies of public transport such as "fitness for duty" tests or work-based interventions and/or employee screening practices. Pre-intervention studies might include: epidemiologic studies of the prevalence of and risk factors for alcohol-related falls, poisonings, drownings, burns, and pedestrian injuries; prevalence rates by transport mode and occupational group; "human factor" research on performance limits and capabilities of transportation operators; and attitude studies of drinking in aquatic settings. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of minorities and women in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES Applications must be received by January 24. 1994. If an application is received after that date, it will be held for the next review cycle and will compete with all investigator-initiated research grant applications. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the Institute. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Research grant applications will be reviewed based on standard criteria for scientific and technical merit for regular research grants (R01). The review criteria for FIRST Awards (R29) are contained in the FIRST award program announcement. INQUIRIES Potential applicants are encouraged to seek preapplication consultation and may contact the individuals listed below for consultation in preparing an application under this RFA. Direct inquiries regarding programmatic issues and requests for the RFA to: Kendall Bryant, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 FAX: (301) 443-9334 Direct inquiries regarding fiscal matters to: Elsie Fleming Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 FAX: (301) 443-3891 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 grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. $$R4 END ************************************************************ $$R5 BEGIN AA-94-005 FULL-TEXT ************************************** HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA AVAILABLE: AA-94-005 P.T. 34; K.W. 0404003, 0745027, 0745070, 0730050, 0408006 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: December 20, 1993 Application Receipt Date: January 24, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE This RFA seeks health services research and research training grant applications to develop a knowledge base for improving the accessibility, efficiency, and effectiveness of services for alcohol- related problems. Both prevention interventions and treatment services are important components and provide the research focus for this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Health Services Research on Alcohol-related Problems, 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: 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, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes, insurance or managed care organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST award (R29). Applicants may also submit Investigator-Initiated Interactive Research Project Grants under this RFA. Interactive Research Project Grants require the coordinated submission of related research project grant applications and, to a limited extent, FIRST award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. Program Project Grants applications (P01) will not be accepted under this RFA. The NIAAA also seeks to increase the pool of health services researchers who have expertise in the alcohol field. The NIAAA encourages interested individuals and/or institutions to undertake programs of research training and career development in the area of alcohol-related health services research. Under this RFA, up to $250,000 have been targeted to award one or two Institutional Research Training Grants (T32). A copy of the program announcement PA-92-31 for National Research Service Awards for Institutional Grants and information on other research training and career development opportunities may be obtained from the program contact person listed under INQUIRIES. FUNDS AVAILABLE It is estimated that up to $12 million will be available for approximately 50 to 60 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES This RFA invites research applications related to understanding and improving the financing, organization, management and effectiveness of health services for the prevention and treatment of alcohol- related problems. Applications whose main objective is to establish and support treatment or prevention services are not eligible for funding under this RFA. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for those particular costs and for that period of time required by the research. The following list of research topics is for illustrative purposes: o Investigating the impact of innovative financing and reimbursement approaches on the quality, cost effectiveness, and supply of alcohol treatment and/or prevention services as well as demand for and barriers to those services. o Examining organization and management of all alcohol treatment and prevention services, including social, economic, demographic, legal or health policy, and behavioral factors that facilitate or impede effective and efficient linkage and delivery of those services. o Assessing adequacy and appropriateness of treatment and prevention services to meet needs and demands of different groups such as women, youth, minorities, and the elderly. o Developing and assessing criteria to classify and measure objectives, components, and processes involved in delivering major types of treatment services or prevention interventions for alcohol- related problems. o Improving effectiveness of treatment and prevention services by improving their quality. o Determining the effectiveness of behavioral interventions aimed at alcohol problems; interventions to prevent, for example, drinking and driving, worksite-related alcohol problems, or exposure to HIV or tuberculosis facilitated by alcohol use. o Identifying health service factors and individual characteristics influencing access, adherence, or responsiveness to treatment or preventive interventions. o Determining the extent to which costs of treatment or prevention services are offset by subsequent reductions in health care costs. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of minorities and women in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by December 20, 1993, a Letter of Intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows Institute staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Telephone: (301) 443-4375 FAX: (301) 443-6077 APPLICATION PROCEDURES Applications must be received by January 24, 1994. If an application is received after that date, it will be assigned to the next review cycle and will compete with all investigator-initiated research grant applications. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of alcohol research grant (R01) applications are included in the RFA. The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement. The review criteria for Institutional Research Training Grant (T32) applications are contained in program announcement PA-92-31, National Research Service Awards for Institutional Grants dated January 1992. INQUIRIES Potential applicants are encouraged to seek preapplication consultation and may contact the individuals listed below for consultation in preparing an application under this RFA. Direct inquiries regarding programmatic issues and requests for the RFA to: Cherry Lowman, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 14C-20 Rockville, MD 20857 Telephone: (301) 443-0796 FAX: (301) 443-8774 Direct inquiries regarding fiscal matters to: Elsie Fleming Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 FAX: (301) 443-3891 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, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. $$R5 END ************************************************************ $$R6 BEGIN GM-94-001 *********************************************** INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE BACCALAUREATE DEGREE NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: GM-94-001 P.T. 44, FF; K.W. 0720005, 0710030 National Institute of General Medical Sciences Letter of Intent Receipt Date: November 19, 1993 Application Receipt Date: January 20, 1994 PURPOSE The National Institute of General Medical Sciences (NIGMS) and the Office of Research on Minority Health (ORMH), National Institutes of Health (NIH), re-announce two initiatives directed at increasing the number of underrepresented minorities entering careers in biomedical research. The programs target two different underrepresented minority student populations: those in colleges and universities offering only Master of Science (M.S.) degree programs in biomedically-related sciences and those in two-year junior or community colleges. These have been identified as two key transition points for students considering careers in biomedical research. This is the third year of this program, which seeks to encourage the development of new and innovative programs and the expansion of existing programs to improve the academic competitiveness of underrepresented minority students and facilitate their transition into the next stage towards careers in biomedical research. This Request for Applications (RFA) solicits new applications for a partnership program involving two-year colleges awarding the Associate's degree and institutions awarding the Baccalaureate degree. A separate RFA (GM-94-002) describes a program targeting the transition from the Master's degree granting institutions to universities awarding the Doctoral degree. Former applicants of unfunded Bridge applications are encouraged to submit revised applications that respond to the prior concerns of the National Advisory General Medical Sciences Council. ELIGIBILITY REQUIREMENTS General Applications may be submitted by domestic, private or public, educational institutions. State or local systems of higher education (also hereinafter referred to as institutions) may submit applications as well. An institution may be involved as a partner institution in more than one Bridge program, but can be the APPLICANT institution for only one Bridges to the Baccalaureate Degree and one Bridges to the Doctoral Degree Program. Institutions with NIGMS Baccalaureate Bridge Program (R25) grants funded after March 1, 1993, are not eligible to apply for this RFA (GM-94-001). An institution may submit ONLY ONE application for this RFA. Institutions that submit applications in response to this RFA may also apply for support for a Bridge to the Doctoral Degree (RFA GM-94-002), if they meet the eligibility requirements. However, a separate application for each RFA is required. Institutions submitting their own applications may participate in programs with other applicant institutions if these interactions are consistent with institutional resources and their institutional unified plan described in BOTH applications (see UNIFIED PLAN under SPECIAL REQUIREMENTS). Institutions participating in more than one application should provided a justification for each. Programs developed or modified under this initiative must be specifically designed to target underrepresented minority undergraduates majoring in the sciences. For purposes of this announcement, underrepresented minority students are individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Nationally, individuals who have been found to be underrepresented in biomedical or behavioral research include, but are not limited to, African Americans, Hispanic From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 17 October 1993 Message-ID: Date: 23 Oct 93 01:24:33 GMT Sender: kristoff@net.bio.net Lines: 85 Approved: biosci-moderator@net.bio.net [NOTE - The news system is up and running again at net.bio.net. I am posting this and three issues of the NIH Guide now. - DK] ** NEW DOCUMENTS ON STIS ** Document Type: News Title: PR 93-79 SENATE CONFIRMS PHYSICIST NEAL LANE TO HEAD NATIONAL SCIENCE FOUNDATION File size (bytes): 1238 STIS Filename: pr9379 Document Type: Program Guideline Title: NSF 93-126 EHR ACTIVITIES FOR WOMEN AND GIRLS IN SCIENCE, ENGINEERING, AND MATHEMATICS File size (bytes): 78078 STIS Filename: nsf93126 Title: NSF 93-148 -- Young Investigator Awards FY 1994 Program File size (bytes): 60814 STIS Filename: nsf93148 Document Type: Recruit Title: Selective Placement Talent Bank File size (bytes): 3769 STIS Filename: v941h ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 90241 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 99295 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!genome.wi.mit.edu From: ert@genome.wi.mit.edu (Ert Dredge) Newsgroups: bionet.announce,bionet.genome.chromosomes,bionet.molbio.gene-linkage,bionet.molbio.genome-program,bionet.sci-resources Subject: WI-CGR Genetic map of the mouse, database release 4 Keywords: mouse, map, genetic map, genetic marker Message-ID: <2a4aa8$9aj@senator-bedfellow.MIT.EDU> Date: 20 Oct 93 21:24:24 GMT Sender: kristoff@net.bio.net Organization: Whitehead Institute for Biomedical Research Lines: 63 Approved: bionews-moderator@net.bio.net Xref: biosci bionet.announce:749 bionet.genome.chromosomes:102 bionet.molbio.gene-linkage:252 bionet.molbio.genome-program:590 bionet.sci-resources:827 -- ANNOUNCING THE FOURTH RELEASE OF THE WHITEHEAD INSTITUTE/MIT GENOME CENTER GENETIC MAP OF THE MOUSE Release four of the Whitehead Institute/MIT Genome Center Genetic Map of the Mouse is now available. This map consists of randomly-chosen simple sequence length polymorphisms (microsatellites) that can be analyzed using the polymerase chain reaction, as described in Dietrich, W., et al., Genetics 131:423-447 (1992). Currently the released map contains 2006 markers. The markers fall into 20 linkage groups spanning approximately 1470 cM with an average spacing of less than 1 cM. This data can be obtained in two different ways. 1. Via anonymous ftp to genome.wi.mit.edu. Log in as "anonymous" and use your e-mail address as password. The release can be found in the directory /distribution/mouse_sslp_release/oct93/. The file "README" describes the file format and gives other information about the map. 2. Via internet e-mail using a database e-mail server. Using this service you can obtain locus and assay names of mapped SSLPs, the forward and reverse primer sequences, the genotypes of the loci on the mapping cross, the sizes of the PCR products on selected standard inbred strains, and other useful information. The database can be queried for markers meeting a number of different criteria. For example, you can ask for markers by name, by chromosome, or by position on the map. You can even request a list of markers that are polymorphic between two mouse strains. To obtain copies of the most current query forms, send a message to "genome_database@genome.wi.mit.edu" with either a subject line or body text of "help". You will receive instructions and a query form by return mail. Just fill out the form, send it to "genome_database@genome.wi.mit.edu", and the answer to your query will be mailed back automatically. This project is an ongoing one. As new markers are added to the map they will be released on a quarterly basis on approximately the following schedule: 1 January 1994 1 April 1994 1 July 1994 1 October 1994 etc. Please address questions and comments to Lincoln Stein at: Lincoln Stein, M.D.,Ph.D. lstein@genome.wi.mit.edu MIT Genome Center (617) 252-1916 Whitehead Institute for Biomedical Research (617) 252-1902 FAX 9 Cambridge Center Cambridge, MA 02142 ------------------------------------------------------------------------------- Ert Dredge Thursdays 10:30pm - 12:30am Whitehead Institute's Center for Genome Research WMBR 88.1 FM, Cambridge One Kendall Sq, Cambridge, Bldg 300, 5th floor, 02139 Requests: 253-8810 617-252-1922 (w), 628-2109 (h), 252-1902 (fax) Beauty Canadian tunes, eh? ------------------------------------------------------------------------------- From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 36, pt. 6, 8 October 1993 Message-ID: Date: 23 Oct 93 01:45:55 GMT Sender: kristoff@net.bio.net Lines: 754 Approved: biosci-moderator@net.bio.net $$XID RFA AA94005 AA-94-005 P1O1 *************************************** HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: AA-94-005 P.T. 34; K.W. 0404003, 0745027, 0745070, 0730050, 0408006 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: December 20, 1993 Application Receipt Date: January 24, 1994 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks health services research and research training grant applications to develop a knowledge base that can be used to improve the efficiency and effectiveness of services for alcohol-related problems. Both prevention interventions and treatment services are important components of the health services that a society delivers to its population. To be comprehensive, health services research seeks to evaluate both treatment and prevention services. This Request for Applications (RFA) invites research grant applications related to improving the accessibility, quality, cost effectiveness, impact, and outcome of alcohol-related treatment services and prevention interventions. The research objectives include: (l) determining impacts of financing and reimbursement mechanisms on consumer and provider behavior and on health care accessibility, organization, content, quality, and outcomes; (2) identifying factors that influence organization, management, supply, accessibility, and appropriateness of alcohol treatment and prevention services for alcohol-related problems across regions, populations, and settings; (3) identifying factors influencing the impact of alcohol-related health policies and interventions on outcomes in communities as well as clinical settings; (4) identifying ways to improve the effectiveness of alcohol-related health services (including treatment of medical consequences such as cirrhosis of the liver or alcoholic cardiomyopathy) delivered in general medical as well as alcohol treatment settings; for example, brief interventions and referral, anticipatory guidance, monitoring outcomes, quality assurance, and patient-service matching; (5) identifying ways to improve the effectiveness of preventive interventions for reducing alcohol problems, including educational and media approaches, deterrents for drunk driving and violence, and community-based initiatives; and (6) assessing sources of variation in utilization, cost offsets, and cost effectiveness of treatment services and prevention interventions for problems related to 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 RFA, Health Services Research on Alcohol-related Problems, 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, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes, insurance or managed care organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST award (R29). Applicants may also submit Investigator-Initiated Interactive Research Project Grants under this RFA. Interactive Research Project Grants require the coordinated submission of related research project grant applications and, to a limited extent, FIRST award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. Program Project Grants applications (P01) will not be accepted under this RFA. The NIAAA also seeks to increase the pool of health services researchers who have expertise in the alcohol field. The NIAAA encourages interested individuals and/or institutions to undertake programs of research training and career development in the area of alcohol-related health services research. Under this RFA, up to $250,000 has been targeted to award one or two Institutional Research Training Grants (T32). A copy of the program announcement PA-92-31 for National Research Service Awards for Institutional Grants and information on other research training and career development opportunities may be obtained from the program contact person listed under INQUIRIES. Potential applicants may obtain copies of specific announcements 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. Further information on grant mechanisms and areas of research interest may be obtained from the program staff listed under INQUIRIES. FUNDS AVAILABLE It is estimated that up to $12 million in total will be available for approximately 50 to 60 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES In June 1992, "The ADAMHA Reorganization Act" (Public Law 101-321) directed NIAAA to expand its program of health services research. Health services research is defined in the legislation as "research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care" (Section 409). Health services research also is concerned with identifying factors that influence the effectiveness of health services in "real world" settings. This RFA invites research applications related to understanding and improving the financing, organization, management, and effectiveness of health services for the prevention and treatment of alcohol- related problems. The intent of health services treatment research is to assess the impact of health services and the effects of organizational and financing arrangements in "real world" clinical settings on the quality and outcomes of care provided to patients with alcohol abuse and alcoholism as well as medical problems consequent to alcoholism. Not included in health services treatment research is efficacy research (Public Law 103-43), experimental studies designed to determine how successfully a specific treatment intervention reduces problematic consumption or symptoms related to alcohol use. The intent of health services prevention research is to assess the effectiveness of preventive interventions in reducing alcohol-related problems and/or contributing risk factors. In addition to intervention studies in health care settings, prevention services research may occur in a variety of other settings (e.g., worksites, schools and local communities) and may focus on financing, organization, management, enforcement, and utilization of prevention services as well as their effectiveness. Applications whose main objective is to establish and support treatment or prevention services are not eligible for funding under this RFA. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for those particular costs and for that period of time required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield important generalizable knowledge and/or to make a significant contribution to theoretical concepts. Applicants should adopt the most carefully controlled research designs feasible in conducting treatment and prevention services research/studies (see Lettieri 1992; Sechrest et al. 1991; Cook and Campbell 1979; Holder and Howard 1992). Applicants may wish to consult generic publications in health services research as well as alcohol-specific examples of prevention and treatment research (see References below). The following list of research topics is for illustrative purposes. Topics not mentioned are not necessarily excluded from consideration under this RFA. Financing and Reimbursement of Services o Investigating the impact of innovative financing and reimbursement approaches on the quality, cost effectiveness, and supply of alcohol treatment and/or prevention services as well as demand for and barriers to those services. o Assessing how alternative managed care interventions affect availability, quality, cost, and outcomes of treatment and prevention services. o Developing uniform ways to measure insurance benefits and payments for treatment and prevention of alcohol-related problems in order to compare performance of alternative health plans. Alcohol-related problems include medical consequences of alcohol abuse and alcoholism such as alcohol poisoning, or cardiovascular, gastrointestinal and/or neurological disorders. o Identifying the impacts of changes in compensation incentives on: the behavior of consumers, clinicians, and institutions; treatment appropriateness and outcomes; and the nature and extent of prevention services within the health care system. o Modeling and assessing impacts of health care reform legislation and other policy changes on the organization, management, financing, availability, appropriateness, and cost of alternative alcohol- related health policies and treatment/prevention services. o Assessing the intended and unintended financial incentives (positive and negative) that operate in the proposed or reformed health care system and determining their impact. Organization, Management, and Availability of Resources o Examining organization and management of alcohol treatment and prevention services, including social, economic, demographic, legal or health policy, and behavioral factors that facilitate or impede effective and efficient linkage and delivery of those services. o Determining the impact of system-level, service integration initiatives on the coordination, comprehensiveness and continuity of alcohol treatment and prevention services. o Identifying different organizational models needed for delivery of alcohol treatment and prevention services to different subpopulations such as the elderly or HIV-positive individuals. o Developing and testing innovative management approaches to improve productivity and efficiency of treatment and prevention services. o Examining organizational and provider responses to changes in: (a) financing and reimbursement policies, (b) structural aspects of managed care systems, (c) insurance coverage characteristics of populations in the service area, (d) number and characteristics of other organizations and providers in the area, and (e) demographic factors such as population density, and/or other factors that may lead to changes in organizational and provider behavior with ultimate consequences for access to and outcomes of treatment and prevention services. o Assessing adequacy and appropriateness of treatment and prevention services to meet needs and demands of different groups such as women, youth, minorities, and the elderly. For example, assessing the appropriateness and effectiveness of DWI treatment programs or preventive drinking-driving countermeasures among these groups. o Investigating factors that influence how preventive interventions or treatment services are made available to and utilized by and are implemented with adequate resources. o Assessing the impact of AA membership on treatment utilization, outcome, and cost. Effectiveness of Services o Developing and assessing criteria to classify and measure objectives, components, and processes involved in delivering major types of treatment services or prevention interventions for alcohol- related problems; examining linkages between treatment content, quality of care, and functional as well as alcohol-specific outcomes; and examining linkages (e.g., process evaluations) between prevention content, its method of delivery, and alcohol outcomes. o Improving effectiveness of treatment and prevention services by improving their quality. o Assessing the full range of impacts of brief interventions to treat or prevent problem drinking and its medical and social consequences. Health services treatment research may assess brief interventions in inpatient or outpatient acute and specialty as well as primary care settings. Prevention research may assess the impacts of anticipatory guidance and counselling in health care or other community settings regarding risks of drinking (e.g., server intervention). o Using natural experiments to assess the effectiveness of government policies, interventions, or financing arrangements to prevent or treat alcohol problems (e.g., policies affecting alcohol availability, price, and youth access; or financing arrangements affecting treatment access, quality, and outcome). o Determining the effectiveness of behavioral interventions aimed at alcohol problems; interventions to prevent, for example, drinking and driving, worksite-related alcohol problems, or exposure to HIV or tuberculosis facilitated by alcohol use. o Determining the effectiveness of research-based treatment and prevention interventions when they are delivered to heterogeneous populations in natural rather than experimental settings. These natural settings may include, for example, clinics, hospitals, work sites, schools, or local communities. o Developing classification or measurement systems for use by clinicians to better assign patients to treatment modalities, or to improve outcomes management, particularly prevention and management of post-treatment relapse. o Assessing the effectiveness of preventive services that transcend particular problems (e.g., primary prevention in health care systems or media and educational approaches). Utilization and Cost of Services o Identifying health service factors and individual characteristics influencing access, adherence, or responsiveness to treatment or preventive interventions for alcohol-related problems (including symptomatic medical ones), particularly among underserved, uninsured, and HIV-infected populations. o Identifying care-seeking behavior of people with alcohol problems, including utilization of informal resources (e.g., self-help groups) and alternative (e.g., acupuncture) health resources as well as general medical and specialty services. o Developing standardized criteria for identifying episodes of alcohol treatment to apply in longitudinal analyses of cost and utilization data. o Determining whether prevention programs have significant effects on the utilization and cost of treatment services. o Determining the extent to which costs of treatment or prevention services are offset by subsequent reductions in health care costs. For example, evaluating characteristics of individuals,programs, service systems, and insurance benefits associated with greater cost offsets and cost effectiveness. o Expanding cost effectiveness research to estimate the costs and effectiveness of particular alcohol-related health services (including treatment and prevention) from the perspective of consumers or their families as well as from the perspectives of payers, providers, or employers. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for NIH grants and cooperative agreements are required to include both women and minorities in study populations for clinical research, unless compelling scientific or other justification for not including either women or minorities is provided. This requirement is intended to ensure that research findings will be of benefit to all persons at risk of the disease, disorder, or condition under study. For the purpose of these policies, clinical research involves human studies of etiology, treatment, diagnosis, prevention, or epidemiology of diseases, disorders or conditions, including but not limited to trials; and minorities include U.S. racial/ethnic minority populations (specifically: American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and Hispanics). NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of U.S. racial/ethnic minority populations. However, applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. Applications must include a description of the composition of the proposed study population by gender and racial/ethnic group, and the rationale for the numbers and kinds of people selected to participate. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan and summarized in Section 5, Human Subjects. Applications must incorporate in their study design gender and/or minority representation appropriate to the scientific objectives of the work proposed. If representation of women or minorities in sufficient numbers to permit assessment of differential effects is not feasible or is not appropriate, the reasons for this must be explained and justified. The rationale may relate to the purpose of the research, the health of the subjects, or other compelling circumstances (e.g., if in the only study population available, there is a disproportionate representation in terms of age distribution, risk factors, incidence/prevalence, etc., of one gender or minority/majority group). If the required information is not contained within the application, the review will be deferred until it is complete. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If gender and/or minority representation/ justification are judged to be inadequate, reviewers will consider this as a deficiency in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by December 20, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAAA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Telephone: (301) 443-4375 FAX: (301) 443-6077 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. The RFA label available in the PHS (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Page limits and limits on size of type are strictly enforced. Applicants for FIRST Awards (R29) are reminded that such applications must include three letters of reference. Non-conforming applications will be returned without being reviewed. 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 Center 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 in the application material. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Telephone: (301) 443-4375 FAX: (301) 443-6077 Applications must be received by January 24, 1994. If an application is received after that date, it will be assigned to the next review cycle and will compete with all other investigator-initiated research grant applications. 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 The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of alcohol research grant applications will include the following: 1. The scientific, technical, health, or medical significance and originality of the proposed research. 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the research. 3. The feasibility of implementing the project (including recruitment of subjects, implementation of the intervention or innovation, cooperation of relevant organizations, or availability and quality of necessary data) 4. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 5. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 6. The reasonableness of budget estimates and duration for the proposed research. 7. Where applicable, the adequacy of procedures to protect or minimize effects on human subjects and the environment. 8. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement. The review criteria for Institutional Research Training Grant (T32) applications are contained in program announcement PA-92-31, National Research Service Awards for Institutional Grants dated January 1992. Both are available from staff listed under INQUIRIES. 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 Potential applicants are encouraged to seek preapplication consultation and may contact the individuals listed below for consultation in preparing an application under this RFA. Direct programmatic inquiries regarding health services treatment research to: Cherry Lowman, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 14C-20 Rockville, MD 20857 Telephone: (301) 443-0796 FAX: (301) 443-8774 Direct inquiries regarding fiscal matters to: Elsie Fleming Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 FAX: (301) 443-3891 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, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. References I. Health Services Research Brook, R.H., and McGlynn, E.A. Maintaining quality of care. In: Ginzberg, E., ed. Health Services Research: Key to Health Policy. Cambridge, MA: Harvard University Press, 1991. pp. 284-314 Cook, T.D. and Campbell, D.T. Quasi-Experimentation: Design and Analysis Issues for Field Settings. Boston: Houghton Mifflin, 1979. Drummond, M.F.; Stoddart, G.L.; and Torrance, G.W. Methods for the Economic Evaluation of Health Care Programmes. New York: Oxford University Press, 1987. Ginzberg, E., ed. Health Services Research: Key to Health Policy. Cambridge, MA:Harvard University Press, 1991. Grady, M.L, and Schwartz, H.A., eds. Medical Effectiveness Research Data Methods. Pub. No. 92-0056. Rockville, MD: Agency for Health Care Policy and Research, 1992. Lohr, K.N. (ed.) Advances in health status assessment: Fostering the application of health status measures in clinical settings. Medical Care 30(5):Supplement, 1992. Newhouse, J. P. Controlled experimentation as research policy. In: Ginzberg, E., ed. Health Services Research: Key to Health Policy. Cambridge, MA: Harvard University Press, 1991. pp. 161-194. Pauly, M.V. Effectiveness research and the impact of financial incentives on outcomes. In: Shortell, S.M., and Reinhardt, U.E., eds. Improving Health Policy and Management: Nine Critical Research Issues for the 1990s. Ann Arbor, MI: Health Administration Press, 1992. pp. 151-194. Sechrest, L.; Persin, E.; and Bunker, J., eds. Research Methodology: Strengthening Causal Interpretations of Nonexperimental Data. DHHS Pub. No. (PHS) 90-3454. Rockville, MD: Agency for Health Care Policy and Research, 1990. Shortell, S.M., and Reinhardt, U.E., eds. Improving Health Policy and Management: Nine Critical Research Issues for the 1990s. Ann Arbor, MI: Health Administration Press, 1992. Steinwachs, D.M. Redesign of delivery systems to enhance productivity. In: Shortell, S.M., and Reinhardt, U.E., eds. Improving Health Policy and Management: Nine Critical Research Issues for the 1990s. Ann Arbor, MI: Health Administration Press, 1992. pp. 275-310. Wells, K.B.; Stewart, A.; Hays, R.D.; Burnam, A.; Rogers, W.; Daniels, M.; Berry, M.S.; Greenfield, S.; and Ware, J. The functioning and well-being of depressed patients: Results from the Medical Outcomes Study. Journal of the American Medical Association 262 (7):914-919, 1989. II. Alcohol Health Services Research Ames, G.; Delaney, W.; and Janes C. Obstacles to effective alcohol policy in the workplace: A case study. British Journal of Addiction 87: 1055-1069, 1992. Atkin, C.K. Effects of televised alcohol messages on teenage drinking patterns. Journal of Adolescent Health Care 11:10-24, 1990. Bien, T.H.; Miller, W.R.; and Tonigan, J.S. Brief interventions for alcohol problems: A review. Addiction 88: 315-336, 1993. Booth, B.M.; Yates, W.R.; Petty, F.; and Brown, K. Patient factors predicting early alcohol-related readmissions for alcoholics: Role of alcoholism severity and psychiatric comorbidity. Journal of Studies on Alcohol 52:37-43, 1991. Cooper, M.L. Alcohol and increased behavioral risks for AIDS. Alcohol Health & Research World 16(1):64-72. Finney, J.W., and Moos, R.H. Matching patients with treatments: Conceptual and methodological issues. Journal of Studies on Alcohol 47(2):122-134. Flay, B.R. Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. Preventive Medicine 15:451-474, 1986. Giesbrechet, N.; Conley, P.; Denniston, R.W.; Gliksman, L.; Holder, H., Pederson, A. Room, R. and Shain, M. (eds.) Research, Action, and the Community: Experiences in the Prevention of Alcohol and Other Drug Problems (OSAP Prevention Monograph No. 4) Rockville, MD: Office for Substance Abuse Prevention, 1990. Goodman, A.C.; Holder, H.D.; and Nishiura, E. Alcoholism Treatment Offset Effects. Inquiry 28:168-178, 1991. Hingson, R.W.; Howland, J.; and Levinson, S. Effects of legislative reform to reduce drunken driving and alcohol-related traffic fatalities. Public Health Reports 103: 659-667, 1988. Holder, H., and Blose, J.O. The reduction of health care costs associated with alcoholism treatment: A 14-year longitudinal study. Journal of Studies on Alcohol 53(4):293-302, 1992. Holder, H.D. (ed.) Control Issues in Alcohol Abuse Prevention: Strategies for States and Communities. Greenwich, CT: JAI Press, 1987. Holder, H.D. and Howard, J.M. (eds.) Community Prevention Trials for Alcohol Problems: Methodological Issues. Westport, CT: Praeger, 1992. Institute of Medicine. Prevention and Treatment of Alcohol Problems: Research Opportunities. Washington, D.C.: National Academy of Sciences, 1989. Institute of Medicine. Broadening the Base of Treatment for Alcohol Problems. Washington, D.C.: National Academy of Sciences, 1990. Lettieri, D.J. A Primer of Research Strategies in Alcoholism Treatment Assessment. DHHS Pub. No. (ADM) 92-1882. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism, 1992. Manning, W.G.; Keeler, E.B.; Newhouse, J.P.; Sloss, E.M.; and Wasserman, J. The taxes of sin: Do smokers and drinkers pay their way? Journal of the American Medical Association 261: 1604-1609, 1989. Mattson, M.E., and Allen, J.P. Research on matching alcoholic patients to treatments: Findings, issues and implications. Journal of Addictive Diseases 2(2):33-49, 1991. McLellan, A.T.; O'Brien, C.P.; Metzger, D.; Alterman, A.I.; Cornish, J.; and Urschel, H. How effective is substance abuse treatment-- Compared to what? In: O'Brien, C.P. and Jaffe, J.H., eds. Addictive States. New York: Raven Press, Ltd., 1992. pp. 231-252. Moos, R.H.; Finney, J.W.; and Cronkite, R.C. Alcoholism Treatment: Context, Process and Outcome. New York: Oxford University Press, 1990. Morse, B.J. and Elliott, D.S. The effects of ignition interlock devices on DUI recidivism: Findings from a longitudinal study in Hamilton County, Ohio. Crime and Delinquency 38(2):131-157. Moskowitz, J.M. The primary prevention of alcohol problems: A critical review of the research literature. Journal of Studies on Alcohol 50(1):54-88, 1989. O'Malley, P.M. and Wagenaar, A.C. Effects of minimum drinking age laws on alcohol use, related behaviors, and traffic crash involvement among American youth. Journal of Studies on Alcohol 52: 478-491, 1991. Saltz, R.F. Server intervention and responsible beverage service programs. In: Surgeon General's Workshop on Drunk Driving. Rockville, MD: U.S. Department of Health and Human Services, 1989. pp. 169-179. Schmidt, L., and Weisner, C. Developments in alcoholism treatment systems: A ten year review. In: Galanter, M., ed. Recent Developments in Alcoholism. Vol. 11: Ten Years of Progress. New York: Plenum Press, 1993. Walsh, D.C.; Hingson, R.W.; Merrigan, D.M.; Levinson, S.M.; Cupples, L.A.; Heeren, T.; Coffman, G.A.; Becker, C.A.; Barker, T.A.; Hamilton, S.K.; Maguire, T.G.; and Kelly, C.A. A randomized trial of treatment options for alcohol-abusing workers. New England Journal of Medicine 325(11):775-782, 1991. Weisner, C., and Schmidt, L. Alcohol and drug problems among diverse health and social service populations. American Journal of Public Health 83(6):824-829, 1993. Worden, J.K.; Flynn, B.S.; Merril, D.G.; Waller, J.A.; and Haugh, L.D. Preventing alcohol-impaired driving through community self- regulation training. American Journal of Public Health 79:287-290, 1989. From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 36, pt. 5, 8 October 1993 Message-ID: Date: 23 Oct 93 01:45:10 GMT Sender: kristoff@net.bio.net Lines: 1222 Approved: biosci-moderator@net.bio.net $$XID RFA AA94004 AA-94-004 P1O1 *************************************** UNDERDEVELOPED AREAS OF ALCOHOL ABUSE PREVENTION RESEARCH NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: AA-94-004 P.T. 34; K.W. 0404003, 0705035, 0715027 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: January 24, 1994 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to stimulate studies focused on the prevention of three types of alcohol-related problems where prevention has received very little research attention: Fetal Alcohol Syndrome (FAS) and Fetal Alcohol Effects (FAE), alcohol abuse among the elderly, and non-traffic alcohol-related injuries (drownings, burns, falls, trauma to pedestrians, and injuries incurred in crashes of planes, boats, and trains). The major task is to develop and test interventions aimed at preventing these problems before they occur. Usually, the intervention will be investigator-initiated and controlled. In natural experiments, however, investigators study the impact of interventions that are independently initiated by others, such as governmental bodies (e.g., warning labels). As part of the process of developing appropriate prevention strategies and technologies, investigators may alternatively engage in pre- intervention research that examines questions antecedent to the implementation of prevention research per se. 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), Underdeveloped Areas of Alcohol Abuse Prevention Research, 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, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01) or FIRST Award (R29). Applicants for R01s may request support for up to five years. In FY 1992, 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 the awards will vary also. FIRST Award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST Awards cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Applicants for FIRST Awards may obtain copies of the FIRST program announcement 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. Program project grants (P01) will not be accepted for this RFA. Applicants may submit Investigator-Initiated Interactive Research Project Grants (IRPG). 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 the IRPG mechanism is available in program announcement PA-93-078, NIH Guide for Grants and Contracts, Vol. 22, No. 16, April 23, 1993. FUNDS AVAILABLE It is estimated that up to two million dollars will be available for approximately 8 to 10 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Fetal Alcohol Syndrome (FAS)/Fetal Alcohol Effects (FAE) Background Alcohol is a teratogen capable of damaging the developing fetus. FAS is a cluster of defects that includes growth retardation, central nervous system impairment, and characteristic abnormal facial features. The cost of treatment, rehabilitation, and long-term care for FAS disabilities is estimated to be $1.4 million over one person's lifetime. A very conservative estimate of FAS incidence in the U.S. is 0.33 per 1000 live births. The actual figure is undoubtedly much larger and inclusion of more subtle alcohol-related cognitive and behavioral birth defects (FAE) would substantially increase the overall incidence of problematic births. Native Americans and African Americans show higher FAS/FAE incidence rates than Caucasians. It is not known whether there is a "safe" drinking threshold for pregnant women below which the fetus will not be harmed. Thus, NIAAA and groups such as the American Medical Association recommend that pregnant women completely abstain from alcohol use from conception to delivery. Research Areas Preventive interventions in this area attempt to change the drinking behavior of pregnant women. The following research topics are suggested: 1. Developing and testing strategies to reach high-risk women before they would normally seek prenatal care, generally after the first trimester. 2. Developing and testing strategies to heighten awareness, concern, and action regarding FAS/FAE among vulnerable populations (e.g., high-risk Native American tribes, inner-city African Americans, heavy-drinkers in their child-bearing years). Community-wide strategies might attempt to change drinking norms for pregnant women and to encourage effective social controls. 3. Developing and testing multi-strategy approaches that combine "impersonal" media messages with more personalized sources of influence (e.g., social networks, support groups, and health professionals). 4. Conducting randomized controlled trials of preventive interventions within health-care systems, where the randomized units might be patients, clinics, or physician practices. Interventions might include "anticipatory guidance" before pregnancy occurs as well as counseling during pregnancy. 5. Determining how sellers of alcohol might play more effective roles in reducing drinking by pregnant women (e.g., through server training and warning posters) 6. Developing and testing FAS/FAE components for alcoholism treatment programs. Possible pre-intervention studies in this area may include: 1. Elucidating biobehavioral factors (e.g., maternal nutrition, hormonal changes, stress, co-drug abuse) that combined with alcohol use may increase fetal risk and that should be taken into account in designing preventive interventions. 2. Developing and validating biochemical methods and markers (e.g., carbohydrate-deficient transferrin) to more accurately determine alcohol intake and highest-peak BAC levels among pregnant women over time. Such tools can enhance assessments of risk and determinations of the effectiveness of preventive interventions. 3. Developing or adapting screening instruments and techniques (e.g., self report, laboratory measures) to identify women at high- risk for heavy alcohol use during pregnancy, and testing instrument validity in different subpopulations. 4. Elucidating factors that may help explain differential vulnerability to FAS, as a means of more accurately identifying high- risk pregnancies. 5. Studying decision-making processes of various subgroups of pregnant women regarding alcohol use, and their appraisals of risk to the fetus (their estimates of the nature of fetal damage, its severity, and likelihood). 6. Determining whether and how health professionals who treat pregnant women and women in the child-bearing years deal with FAS/FAE risks. What drinking advice and counseling is provided across different types of practices, settings, specialties, and patient populations? 7. Determining which types of persons in social networks of pregnant women and which types of messages are most likely to be influential in preventing alcohol use/abuse during pregnancy. Older Populations Background Older people are at risk for a variety of alcohol-related problems. Both episodic and chronic drinking appear to precipitate or aggravate a number of conditions that may be experienced in the later years (e.g., cardiovascular disease, stroke, diabetes, cognitive loss, falls and fractures, depression, isolation, and suicide). Additionally, tolerance for alcohol is reduced and hazardous interactions of alcohol with prescription and over-the-counter drugs pose special risks for the elderly. Epidemiologic studies indicate that the prevalence of alcohol problems decreases with age; but the research instruments used are often inappropriate for older populations and alcohol abuse may go undetected. Studies in clinical settings suggest relatively high rates of alcohol problems. Late- onset alcohol abuse, especially, is not well understood. As the older population increases, their alcohol problems will become an increasingly important public health issue. Research Areas Effective primary and secondary preventive interventions are needed to reduce alcohol problems among the elderly. Research and intervention approaches must consider the heterogeneity of the population, e.g., variations in health, life style, and residence. Prevention strategies to be tested might include: specially-focussed messages (e.g., concerning alcohol/medication interactions), anticipatory guidance for persons experiencing major life transitions (e.g., retirement or bereavement counselling), involvement of health- care workers in detection of alcohol problems, interventions to prevent alcohol-impaired driving and other accidents, and normative controls in congregate-living facilities. At risk populations might be reached through electronic media, work sites, the hospitality industry (e.g., server training), health care systems, social services, and community organizations. Pre-intervention research among the elderly is needed to provide more accurate estimates of the prevalence of specific alcohol-related problems; characterize drinking patterns among subgroups; establish whether the elderly are more vulnerable to the effects of alcohol via assessment of cognitive, neuropsychological measures; study age- specific changes in neural function and behavior; identify etiologic, risk, and protective factors and predictors of changes in alcohol use; develop and/or test appropriate instruments for the early detection of alcohol abuse; identify high risk populations, situations, and settings as potential targets of intervention strategies; and identify institutions, groups, and categories of persons that can serve as resources for and facilitators of preventive interventions. Non-traffic Injuries Background In contrast to the abundant research on drinking and driving, there are relatively few studies of the contribution of alcohol to other types and sources of injury, such as drownings, falls, fires, poisonings, and trauma to pedestrians and passengers of public transport. Epidemiologic studies suggest that alcohol significantly increases the risk of falls and burns and that a high percentage of adult drowning victims have consumed alcohol, although it is unclear whether the association is causal. Many laboratory studies indicate that alcohol consumption impairs key skills needed to operate complex machines such as airplanes, trains, and boats, but there are few studies of interventions to reduce the risk of crashes in the transportation industry. Research Areas Prevention of alcohol-related non-automotive injuries must rely on a comprehensive array of interventions drawing on legislation and enforcement, education and normative change, and engineering and environmental approaches, all of which need scientifically-based evaluation. In addition, pre-intervention studies are needed to more fully describe and better understand the role of alcohol in non- automotive accidents and injuries. Possible Intervention studies may include: 1. Assessments of multifaceted community-based safety education programs to prevent non-traffic alcohol-related injuries and deaths. Using experimental and control communities, researchers might implement and test community-wide programs that warn residents that alcohol use can be a risk factor for drownings, boat accidents, burns, and fires (particularly where alcohol abuse is associated with smoking). 2. Studies focused on drownings and aquatic injuries that assess the effects of mandated BAC standards for boaters, and varying levels of enforcement. Drowning and injury rates might be compared across states that do and do not have such standards, or enhanced enforcement might serve as a test intervention. 3. Research related to public transportation that: (a) develops and assesses the validity of practical "fitness for duty" tests or (b) examines the effectiveness of work-based peer intervention strategies, employee assistance programs (EAPs), and/or screening and testing practices for employees. Possible pre-intervention studies include: 1. Case control (event-based) and general population studies to specify the prevalence of and risk factors for alcohol related falls, poisonings, drownings, burns, and pedestrian injuries. Such studies might rely on medical examiner/coroner reports or emergency room records to assess the contribution of alcohol and to determine other risk factors for these injuries. BAC testing data would, of course, enhance research validity. 2. Epidemiologic studies of alcohol use/abuse prevalence rates by transport mode and occupational group, and "human factor" research to improve understanding of the performance limits and capabilities of transportation operators, regarding their attention, vision, perceptual judgment, information processing and overload, vehicle control, and hangover effects. 3. Qualitative and quantitative research on the reasons why people drink while boating or swimming, including examination of attitudes, perceptions of risk, and support for laws prohibiting alcohol consumption at public beaches and pools. Methodological Issues Ideally, studies of the effectiveness of preventive interventions should evaluate effects on the problem at hand (e.g., FAS, drownings). However, where the condition is rare or difficult to measure, proxy indicators of the problem may serve as outcome variables (e.g., drinking by pregnant women). In the case of pre- intervention research, a variety of endpoints are possible (e.g., awareness and perceptions of risk, outcomes of decision making processes, identification of high-risk groups). Any methodological approach appropriate for the discipline involved may be used in applications responsive to this RFA, including qualitative as well as quantitative techniques. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for NIH grants and cooperative agreements are required to include both women and minorities in study populations for clinical research, unless compelling scientific or other justification for not including either women or minorities is provided. This requirement is intended to ensure that research findings will be of benefit to all persons at risk of the disease, disorder, or condition under study. For the purpose of these policies, clinical research involves human studies of etiology, treatment, diagnosis, prevention, or epidemiology of diseases, disorders or conditions, including but not limited to clinical trials; and minorities include U.S. racial/ethnic minority populations (specifically: American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and Hispanics). NIH recognizes that it may not be feasible or appropriate in all clinical research projects to include representation of the full array of U.S. racial/ethnic minority populations. However, applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. Applications must include a description of the composition of the proposed study population by gender and racial/ethnic group, and the rationale for the numbers and kinds of people selected to participate. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan and summarized in Section 5, Human Subjects. Applications must incorporate in their study design gender and/or minority representation appropriate to the scientific objectives of the work proposed. If representation of women or minorities in sufficient numbers to permit assessment of differential effects is not feasible or is not appropriate, the reasons for this must be explained and justified. The rationale may relate to the purpose of the research, the health of the subjects, or other compelling circumstances (e.g., if in the only study population available, there is a disproportionate representation in terms of age distribution, risk factors, incidence/prevalence, etc., of one gender or minority/majority group). If the required information is not contained within the application, the review will be deferred until it is complete. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If gender and/or minority representation/justification are judged to be inadequate, reviewers will consider this as a deficiency in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. The RFA label available in the PHS (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Page limits and limits on size of type are strictly enforced. Applicants for FIRST Awards (R29) are reminded that such applications must include three letters of reference. Non conforming applications will be returned without being reviewed. 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 Center as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator should be included in the application material. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Telephone: (301) 443-4375 FAX: (301) 443-6077 Applications must be received by January 24, 1994. If an application is received after that date, it will be held for the next review cycle and will compete with all investigator-initiated research grant applications. 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 The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. REVIEW CRITERIA Criteria to be used in the scientific and technical merit review of alcohol research grant applications will include the following: 1. The scientific, technical, or medical significance and originality of the proposed research. 2. The appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the Principal Investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 5. The reasonableness of budget estimates and duration for the proposed research. 6. Where applicable, the adequacy of procedures to protect or minimize effects on animal and human subjects and the environment. 7. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement. 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 Potential applicants are encouraged to seek preapplication consultation and may contact the individuals listed below for consultation in preparing an application under this RFA. Direct inquiries regarding programmatic issues to: Kendall Bryant, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 FAX: (301) 443-9334 Direct inquiries regarding fiscal matters to: Elsie Fleming Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 FAX: (301) 443-3891 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 grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA DA94001 DA-94-001 P1O1 *************************************** DRUG DEPENDENCE RESEARCH CENTER GRANT PROGRAM NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: DA-94-001 P.T. 34; K.W. 0404009, 0745070, 0710030 National Institute on Drug Abuse Letter of Intent Receipt Date: December 17, 1993 Application Receipt Date: January 18, 1993 PURPOSE Grant support from the National Institute on Drug Abuse (NIDA) is available to establish Drug Dependence Research Centers (DDRCs). DDRCs are defined in two categories: (1) Treatment Research Centers (TRCs) or (2) Medications Development Research Centers (MDRCs). DDRCs that primarily conduct interdisciplinary research on the efficacy of treatment of drug dependence will be considered to be Treatment Research Centers (TRCs). DDRCs that primarily conduct interdisciplinary research on medications development for drug dependence will be considered to be Medications Development Research Centers (MDRCs). Applicants are expected to develop proposals that are primarily TRC or MDRC in their integrative research theme, but may choose to include components consistent with either category (e.g., a TRC application may include project(s) that are medications development or vice-versa). The Drug Dependence Research Center Grant Program is designed to complement the regular research grant program of NIDA by providing long-term support for interdisciplinary drug dependence treatment research. The program is intended to attract clinical investigators in the behavioral and medical sciences to conduct research designed to (1) maximize the efficacy of behavioral and pharmacologic drug dependence treatment or (2) pursue the identification and development of pharmacologic interventions for drug dependence treatment. One purpose of this program is to provide a stable environment for investigators to engage in drug dependence treatment research. Each DDRC supported is expected to become a significant regional or national research resource. 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), Drug Dependence Research Center Grants, is related to the 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 domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. However, the proposed TRC or MDRC must be affiliated with an institution, such as a university, medical center, or research center, that has the resources to sustain a long-term, coordinated research program around a central theme relating to maximizing and establishing the efficacy of drug dependence treatment including medications development. An applicant institution must demonstrate the ability to attract high quality scientists from biomedical, behavioral, and/or social science disciplines who are willing to make a long-term commitment to drug dependence treatment research. The proposed TRC or MDRC should have the clear capability to conduct clinical research in existing treatment or medications development programs. Applicants should demonstrate explicitly how this research will be integrated within the treatment program. Applications from minority individuals and women are encouraged. Foreign organizations are ineligible. MECHANISM OF SUPPORT The National Institutes of Health (NIH) center grant (P50) will be the mechanism of support used under this RFA. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Any applications received after the receipt date will be returned to the applicant without further review. FUNDS AVAILABLE It is anticipated that up to $14 million will be available to support the first year of this grant program. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will also vary. However, it is anticipated that approximately 8 to 10 new awards will be made under the RFA. Many promising treatment interventions cannot be readily studied due to lack of availability of services necessary to provide comprehensive treatment to research subjects. In such cases research is only possible if financial support is provided to support treatment- related as well as research costs. Under this announcement, support may be provided to DDRCs for comprehensive treatment services essential for carrying out the proposed research. If required in support of research activities, funds may be expended on drug abuse treatment costs, rental and operation of facilities, approved renovation and modification of facilities (subject to limits and conditions specified in Public Health Service grant policy), and other costs normally allowable under existing Public Health Service grants policy. Funds may not be used for new construction or to replace existing treatment funding. In general, funds will not be provided for the purchase and installation of expensive, new equipment. For MDRCs, funds may be requested for subject accrual and recruitment. Once approved, however, reimbursement for patient accrual is for this purpose only and may not be rebudgeted to other categories. RESEARCH OBJECTIVES This research program is intended to support the establishment of DDRCs (TRCs or MDRCs) to conduct interdisciplinary research on the efficacy of treatment for drug addiction. Effort is to be made to use state-of-the-science approaches. Drug dependence treatment efficacy research within a DDRC should involve the systematic development and integration of knowledge derived from a variety of sources and should utilize a number of designs. The proposed research must be organized around a central theme. The theme of the DDRC (TRC or MDRC) should clearly relate to investigating the efficacy of drug dependence treatments. DDRCs funded under this announcement may conduct research on: TRC 1. psychobehavioral treatments and/or 2. currently marketed pharmacological treatments MDRC 3. medications development Applicants for DDRCs may include components in their applications for both treatment and medications development research, but it is expected that each will have a primary emphasis: TRC or MDRC. Treatment Research Centers (TRCs): TRCs may investigate: 1. the efficacy of psychotherapies, behavior therapies, and counseling strategies for all phases of drug dependence treatment. TRCs may also perform work on the development, refinement, and pilot testing of such behavioral therapies; 2. optimizing the efficacy of currently marketed pharmacotherapies for drug dependence; 3. the effects of ancillary services on therapy; 4. the efficacy of well-defined comprehensive treatment approaches; 5. psychobehavioral and neurobiological factors predictive of treatment efficacy, including research aimed at identifying patient characteristics that interact with the therapy or treatment provided; 6. methodological issues related to the proposed clinical research. TRC Research Themes Possible TRC themes may include, but are not limited to, any of the following research areas: 1. Development and efficacy testing of psychobehavioral interventions, complementary adjunctive services, or well-defined comprehensive treatments for special populations of drug addicts, such as: a. Racial and ethnic minorities b. Adolescent drug abusers c. Addicted women, pregnant women and/or mothers d. Individuals at high risk for AIDS or HIV positive individuals e. Dually diagnosed individuals 2. Development and efficacy testing of psychobehavioral interventions, complementary ancillary services, and explicitly described comprehensive treatment approaches designed to: a. Treat specific drug dependence problems/patterns, such as IV drug abuse or poly-drug abuse b. Enhance recruitment into treatment and motivation to achieve sobriety, increase retention, and improve adherence with treatment regimens c. Improve the ability of the drug addict to maintain gains made during the acute treatment period (continuing care) d. Be integrated with and optimize the efficacy of currently approved pharmacotherapies for drug dependence 3. Investigations of marketed drug dependence pharmacotherapies for particular populations of drug addicts, such as the dually diagnosed. 4. Relationship of psychobehavioral and/or neurobiological factors to therapy/treatment efficacy Medications Development Research Centers (MDRCs) MDRCs may emphasize the study and development of new pharmacotherapeutic medications to: 1. block the effects of abused drugs; 2. reduce the craving for abused drugs; 3. moderate or eliminate withdrawal symptoms; 4. block or reverse the toxic effects of abused drugs; 5. prevent relapse in persons who have been detoxified from drugs of abuse; 6. be used in special populations such as racial or ethnic minorities, adolescent drug abusers, addicted women, or pregnant women. Identified pharmacologic agents for the treatment of drug dependence, primarily for the treatment of cocaine and opiate addiction, may be assessed in clinical pharmacologic paradigms and/or in clinical trials. Such studies can include clinical pharmacologic assessments including human laboratory assessments and/or clinical trials at one or more sites designed to comply with Good Clinical Practice (GCP) standards of the Food and Drug Administration (FDA). Documentation of GCP is available from the program officer of the MDRC. Development and integration of new methods and technology for the study of new pharmacotherapeutic agents for drug dependence treatment are encouraged. The range of studies envisioned can include: 1. clinical concept confirmation studies; 2. studies designed to address pharmacokinetic parameters; 3. studies designed to assess conclusively (by appropriate methodology and rigorous statistical analysis) questions of efficacy of new potential pharmacotherapeutic agents for drug dependence treatment; 4. studies that develop and evaluate rapid and efficient clinical methods to predict efficacy of new pharmacologic agents to treat drug dependence; 5. studies to develop methods that advance or improve the development of new medications for drug dependence treatment. MDRC Research Themes MDRC applications can incorporate theme(s) from a range of clinical pharmacologic and clinical trials topics. Applicants are encouraged to include studies that seek to: 1. determine in both drug abusers and normal volunteers the pharmacokinetic profile of a new or novel investigational agent with available preclinical testing data for use in drug dependence treatment including safety and toxicity profiles; 2. evaluate in cocaine and opiate dependent patients the efficacy and safety of new or novel investigational compounds with available preclinical testing results; 3. evaluate the combined efficacy of potential investigational pharmacotherapeutic agents and other treatment parameters such as behavioral interventions or cross subject comparisons. 4. evaluate or develop laboratory parameters that may correlate with or predict pharmacotherapeutic response; 5. evaluate the potential abuse liability and effects on performance of investigational compounds in cocaine and opiate dependent patients; 6. evaluate pharmacotherapy in selected populations of cocaine and opiate dependent patients including neonates, adolescents, females and HIV seropositives. The major emphasis will be on clinical pharmacologic evaluations and clinical trials, including clinical concept confirmation studies, to evaluate the dose-response, efficacy and safety profiles for further medication development. These clinical trials can include studies initiated by the MDRC as well as relevant multisite trials sponsored by NIDA or pharmaceutical sponsors or both. Applicants should indicate their willingness to participate in such trials in letters appended to their applications. SPECIAL REQUIREMENTS The applicant should provide a detailed plan (for up to five years) describing the DDRC's proposed research program, focused on the central theme. This plan should include specific information on the proposed research projects, identification of scientists who are to be affiliated with the DDRC, and their roles in the program of research. Existing research programs and projects that are essential to the plan should be identified and arrangements for integrating these into the DDRC's activities delineated. Letters of cooperation should be obtained from Principal Investigators whose data will be used in DDRC activity, except for those programs whose data bases are in the public domain and routinely made available for public use. Letters of cooperation will also be needed for multi-site investigations where identified programs are to be used for control or manipulation of variables. The nature and mix of investigators will be dependent on the particular theme selected. However, potential is seen for interrelated studies involving scientists in the areas of clinical, counseling and experimental psychology, medical specialties (including psychiatry), clinical pharmacology, clinical toxicology, social work, and statistics as are relevant to the theme of the application. Relationship of individual projects/studies to the core program should be clearly delineated. There must be at least three scored projects and a core which collectively meet the criteria for a Center. There is no maximum limit to the number or projects or cores, however, it must be demonstrated that they are administratively manageable. Upon initiation of the program, the Clinical and Experimental Therapeutics Branch, Division of Clinical Research, and the Clinical Trials Branch, Medications Development Division, NIDA, will sponsor periodic meetings for TRCs and MDRCs to encourage exchange of information among investigators who participate in this program, and to stimulate collaboration. Applicants should request additional travel funds for one or two one-day meetings each year, to be held in the Bethesda/Rockville Maryland area. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. Facilities and Environment Each applicant must demonstrate that it has available adequate laboratory, clinical, and office facilities suitable for carrying out the objectives of the proposed DDRC program. Components of the treatment and/or medications development research facility should be identified and arrangements for integrating clinical research into the DDRC's facilities explicitly described. Although not required, it is desirable that sufficient contiguous space be committed to give the DDRC a high degree of cohesion and visibility. In addition, adequate reference facilities that will afford access to the relevant drug abuse literature must be readily available. It is expected that such reference facilities will be the primary repository of additional reference materials that may be obtained through the DDRC. Relevant support services and adequate data processing facilities must also be readily accessible within or through the institution. Reasonable assurances of such support must be included with the application. Organization and Administration An applicant must designate an individual to serve both as Principal Investigator (PI) for the DDRC grant and Director of the DDRC. This person must have eminent scientific credentials and be capable of providing the leadership essential to the success of the research program. The PI and Director of the DDRC will have overall scientific responsibility, responsibility for planning and coordination of the DDRC program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of administration and operation of the DDRC. This individual will be responsible and accountable to the recipient institution for the proper conduct of the DDRC program. The recipient institution is, in turn, responsible to the Public Health Service for the performance and financial aspects of the grant supported activity. The PI will be responsible for assuring interaction and collaboration among scientists conducting research within the DDRC, in order to promote a concerted approach to the research theme of the DDRC. The PI will be invited to participate in NIDA's periodic research coordination meetings. The PI also will be responsible for the direct monitoring of ongoing research and for identifying (with the assistance of his or her colleagues) research activities to be expanded or decreased and needs for additional resources or reallocation of resources. The applicant may also designate a DDRC Coordinator, who will be responsible to the DDRC Director and provide assistance to the Director in budget preparation, oversight of financial aspects, and administrative duties essential to the smooth operation of the DDRC. In order to ensure an institutional commitment for space, staffing, and other resources essential to the DDRC, including active collaboration with clinical leaders, a letter of commitment from the applicant institution is required as part of the application. A DDRC must be an identifiable organizational unit, and it must have an administrative structure and lines of authority which will facilitate coordination among DDRC personnel and assure maximum accountability and efficiency in DDRC operations. It is expected that the nature of investigators' affiliations with the DDRC will reflect the applicant institution's policies on appointments. Research Training While the primary function of each DDRC is the conduct of high quality interdisciplinary research, an important, but non-mandatory, component related to the DDRC and its research efforts is the training of research personnel. It is anticipated that efforts made to produce well-trained drug dependence therapy researchers will enhance the overall DDRC program. The applicant institution must give evidence of the capacity to train predoctoral and postdoctoral students for careers in research on drug dependence. The DDRC need not have formal training programs of its own, but must make specific provision for coordination between the DDRC and training programs of the applicant institution and/or affiliated institution. While DDRC grant funds may not be used to pay stipends or other trainee costs, DDRC staff may participate in the development of training programs and DDRC resources may be made available for the use of trainees. Applicants are encouraged to seek training support from other funding sources within and outside NIDA. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for clinical research grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all researcH projects to include representation of the full array of United States racial/ethnic minorities populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well-explained and justified. The NIH funding components will not make awards of grants, cooperative agreements or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects in the non-competing competitive application. LETTER OF INTENT Prospective applicants are asked to submit, by December 17, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIDA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label in the PHS 398 application kit must be affixed to the bottom of the original face page. Failure to use the RFA label and to follow instructions 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 in Item 2a of the face page and YES box marked. Submit a signed, typewritten original of the application, including Checklist, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Schedule Letter of Intent Receipt Date: December 17, 1993 Application Receipt Date: January 18, 1994 Initial Review: April 1994 Advisory Council: June 1994 Earliest Award Date: July 1, 1994 Applications received after the receipt date will be returned to the applicant without review. REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary DHHS grant programs. Applications received under this RFA will be assigned to a special review group convened by the NIDA. The review group, consisting of experts in psychobehavioral and pharmacological drug abuse treatment research, and medications development clinical trials, as warranted by the applications, will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Pre-review site visits will not be made, and applications may not be deferred for site visit; therefore, applications must be complete when submitted. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate Advisory Council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended for further consideration by the initial review group and Council may be considered for funding. The review criteria are: 1. Program as an Integrated Effort o The significance of the overall program goals and the development of a well-defined central research focus of importance and relevance to the goals and mission of NIDA. o The multidisciplinary or multifaceted character of the program, i.e., its coordination, cohesiveness, interrelationship of the components and relationship to the central theme, and synergistic potential among the individual projects and core. o The justification for, and usefulness of the core facilities to the research projects. Each core unit must provide essential facilities or services for three or more approved individual projects. o The scientific stature of the investigators and the extent to which each contributes to the overall program goals as well as their commitment to the program. o Capacity to provide a variety of quality training opportunities. o Potential of the proposed DDRC to become or continue as a regional and national resource as appropriate to research objectives of this RFA. o Administrative arrangements and organizational structure, through the administrative core, to facilitate and monitor the attainment of objectives and internal quality control. For example, these factors will include plans to enhance communication and cooperation among the investigators involved in the program and mechanisms for the allocation of funds for day-to-day management, long-term planning and periodic evaluation, contractual agreements, and procedures for the replacement of key personnel, e.g., the Principal Investigators, if required on an interim or permanent basis. o Reasonableness of the overall budget for the proposed work. o In addition, applications from currently funded grantees who are applying for competing continuation support under this RFA will be evaluated in terms of the degree to which they have achieved the originally stated goals, with special attention to the following: the scientific merit of completed research, implementation of innovative research areas, recruitment of new scientists into drug abuse research and the training of young scientists, development of a multidisciplinary research team, coalescence of the Center staff into an effective team, and increase of professional and public awareness of drug abuse problems. 2. Individual Projects and Core Units o The scientific and technical merit of each research project, merit and justification of each core unit. o The qualifications, experience, and commitment of the investigators responsible for the research projects or core units, including their ability to devote adequate time and effort to the project. o The appropriateness of the budget for each of the proposed projects and core units. 3. Resources and Environment o The academic climate and physical environment in which the research will be conducted, including the availability of space, equipment, research subjects, etc., and the potential for interaction with scientists from other departments and/or institutions. o Adequacy of the clinical and research facilities to perform the proposed research including access to subjects, instrumentation, and data management systems when needed. o The institutional strength, stability, and commitment to research and support for the proposed Center and its ability to attract highly qualified scientists. AWARD CRITERIA Applications recommended for further consideration by an National Drug Abuse Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the application as determined by peer review, appropriateness of budget estimates, program needs and balance, policy considerations, adequacy of provisions for the protection of human subjects, and availability of funds. Funding for the MDRC applications will also be considered on the basis of: (1) demonstrated ability to comply with FDA guidelines for Good Clinical Practice (GCP) and (2) demonstrated capacity to recruit evaluable patients and submit acceptable data in appropriate time frames to permit optimal analysis of clinical trial results. The anticipated date of award is July 1, 1994. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applications is welcome. Direct inquiries regarding programmatic issues to: Dr. Jack Blaine Division of Clinical Research National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4060 Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Sections 301 and 464P, and administered under PHS grants policies and Federal Regulations at Title 42 CFR 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. From owner-sci-resources@net.bio.net Fri Oct 22 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 36, pt. 4, 8 October 1993 Message-ID: Date: 23 Oct 93 01:44:10 GMT Sender: kristoff@net.bio.net Lines: 998 Approved: biosci-moderator@net.bio.net $$XID RFA AA94002 AA-94-002 P1O1 *************************************** BIOMEDICAL AND BEHAVIORAL RESEARCH ON ALCOHOL AND YOUTH NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: AA-94-002 P.T. 34, AA; K.W. 0404003, 0404000, 0414014, 0745027 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: January 12, 1994 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to study the development of alcohol-related problems among youth, identify risk and protective factors, and develop effective prevention and treatment interventions. This includes studies of the biological, behavioral, and psychosocial causes and consequences of alcohol abuse among youth. 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), Biomedical and behavioral Research on Alcohol and Youth, 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, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes and organizations, units of State or local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST Award (R29). Applicants for R01s may request support for up to five years. In FY 1992, the average total cost per year for new R01s funded by NIAAA was approximately $200,000. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FIRST Award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST Awards cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Applicants for FIRST Awards may obtain copies of the FIRST program announcement from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, Maryland 20852, telephone: 301-468-2600 or 1-800-729-6686. Program project grants (P01) will not be accepted for this RFA. Applicants may submit Investigator-Initiated Interactive Research Project Grants (IRPG). 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 the IRPG mechanisms is available in program announcement PA-93-078, NIH Guide for Grants and Contracts, Vol. 22, No. 16, April 23, 1993. FUNDS AVAILABLE It is estimated that up to four million dollars in total will be available for approximately 8 to 10 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objective of this RFA is to foster research that will lead to the reduction in prevalence of alcohol problems among youth. Such research may address the underlying mechanisms through which alcohol affects children and adolescents; identify risk factors and markers predictive of various alcohol-related problems in youth; test models of the development of alcohol-related problems and the mediation of risk through interactions of genetic, individual, and environmental factors; and develop and test interventions for the prevention and treatment of alcohol-related problems in youth. Background While alcohol misuse presents a major risk for health and well-being throughout the life span, the child may be especially vulnerable to adverse effects both from direct exposure to alcohol and from the consequences of others' alcohol abuse. The presence of alcohol abuse within the home environment is an important risk factor for the development of social and behavioral problems, including alcoholism. A variety of physical and behavioral problems follow directly from exposure to alcohol. Attitudes and expectancies regarding alcohol use are established at a very early age and most persons first experiment with alcohol use during childhood or adolescence. Misuse of alcohol by youth can have immediate devastating effects, including traffic accidents and acute alcohol poisoning; can be associated with other risky behaviors such as engaging in unprotected sex; can interfere with school performance and contribute to a long term pattern of poor social adjustment and failure; and can initiate a lifetime pattern of alcohol abuse and dependence. Genetic, individual, and environmental factors may interact in determining risk for these adverse outcomes. Effective age-appropriate prevention and treatment interventions are essential, and increased understanding of the nature, etiology, and mechanisms of alcohol- related risks for youth is needed to inform such interventions. Areas of Research Interest For the purposes of this announcement, youth is considered to encompass childhood through early young adulthood, or approximately the ages 2 to 21. Specific research methodologies may be appropriate to basic biomedical, neuroscience, and behavioral studies, epidemiology, or prevention and treatment research. This may include the use of immature animals for biomedical, neuroscience, and behavioral studies. Studies that test interventions or seek to advance the transfer of basic research findings toward prevention or treatment intervention applications are encouraged. The following list of topics is intended only to illustrate NIAAA interests; topics not mentioned are not necessarily excluded from consideration. o Strategies to Prevent or Reduce Access to Alcohol by Youth and Change Norms Regarding Its Use Studies may examine the institution or change in level of enforcement of laws, regulations and policies as they affect youth access to alcohol and the acceptability of alcohol use. This includes, but is not limited to, price changes, sales restrictions, enforcement of minimum drinking age, per se laws, sanctions against drunk driving, and campus and school policies. Interventions not involving legislative action may be investigator-initiated or interventions may be naturally occurring through government or community initiation. o Neurobiology and Physiology of Alcohol in Youth and Adolescence Studies are needed to develop animal models of the neurobiological mechanisms of alcohol abuse and alcoholism in the developing organism through its adolescence. Studies are needed utilizing immature animals for examining the cellular and molecular mechanisms of alcohol seeking behavior, the acute and chronic consequences of alcohol ingestion on the immature central nervous system, on the neuroendocrine system (neuroendocrine-neurotransmitter interactions), effects on hormonal activation, behavioral effects, and for controlled studies of gene-environment interactions as they relate to patterns of adolescent drinking. o Risk Taking Behaviors and Decision-Making Studies may focus on the development of attitudes and expectancies regarding alcohol use and their relationship to behavior; judgements of risk by youth according to age and setting, and the meaning of risk-taking for the individual; the role of alcohol in decisions regarding risk-taking (e.g., sexual activity; driving after drinking); and the development of interventions that will impact adolescent decision-making regarding alcohol use and other risk behaviors. o Evolution of Risk for Alcohol Problems Across Maturational Stages and Development of Appropriate Interventions Studies could address the incidence and prevalence of alcohol problems according to family history, individual, and environmental characteristics; the identification of risk and protective factors specific to age or maturational level; the identification of biological, behavioral, and environmental markers of risk; behavioral genetic models of the evolution of risk as a cumulative and dynamic interaction of genetic heritage, individual characteristics, and environmental factors; and development and evaluation of prevention interventions appropriate for specific age and risk levels (e.g., children of alcoholics; conduct disorder). o Development of Appropriate Interventions Studies are needed to determine whether assessment methodologies and behavioral strategies developed with alcoholic adults work with adolescents who abuse alcohol. Research topics could include development of methodologies to detect and assess early onset alcoholism in adolescence, evaluation of whether there are specific opportunity points to engage adolescents in alcoholism treatment, evaluation of potential pharmacologic interventions that may deter the development of alcohol dependence in problem drinking youth, further understanding the role of the family in enhancing treatment efficacy with adolescent alcohol abusers; identification of risk factors and the responsivity of these factors to different intervention strategies; and the development and evaluation of treatment interventions for alcohol-dependent youth. o Role of the Family in Development and Moderation of Alcohol-Related Risk Studies could focus on identification of mechanisms for inter- and intra-generational transmission of norms regarding alcohol use; development of effective interventions to strengthen the family's protective role; identification of high-risk families, based on individual characteristics (e.g., presence of an alcoholic family member) or demographic variables; development of appropriate prevention or treatment interventions for high-risk families; and the development of family-based prevention and treatment interventions for high risk youth. o Alcohol-Related Violence and Youth Studies could address the role of alcohol use in domestic violence, including use by victims and perpetrators; effect of experiencing or witnessing domestic or other violence on the child's subsequent risk for alcohol-related problems; the role of alcohol in youth involvement in violence outside the family, including sexual aggression and victimization; biobehavioral, individual, and social factors mediating alcohol-related violence; and the development of prevention and treatment interventions to reduce alcohol-related violence and to address special alcohol-related risks of young victims of violence. o Effects of Alcohol Exposure in Youth Research is needed to assess the extent of organ damage (e.g., liver, heart, brain, pancreas, endocrine system, immune system, digestive tract) and on other effects of alcohol on the developing child. Further understanding of the mechanisms by which and the level of drinking beyond which organ damage becomes irreversible is especially important. Given the prevalence of drinking among adolescents, information is needed on the long-term effects of alcohol on fertility and reproductive capability; interactions of alcohol exposure with neurochemical, endocrine and neuroanatomical developmental changes (e.g., onset of puberty); the interaction of biological effects of alcohol and individual characteristics on alcohol-seeking behavior (e.g., role of stress and corticosteroids); the effects of alcohol on the central nervous system, including cognitive and motor performance; indirect effects of alcohol use on intellectual and social development as part of a constellation of increasing risk, including the role of alcohol use in conduct disorder, high-risk sexual activity, future alcohol use, and other risk taking behaviors; treatments for acute alcohol intoxication in youth; and methodologies to identify short-term symptomatic responses to heavy alcohol consumption. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for NIH grants and cooperative agreements are required to include both women and minorities in study populations for clinical research, unless compelling scientific or other justification for not including either women or minorities is provided. This requirement is intended to ensure that research findings will be of benefit to all persons at risk of the disease, disorder, or condition under study. For the purpose of these policies, clinical research involves human studies of etiology, treatment, diagnosis, prevention, or epidemiology of diseases, disorders or conditions, including but not limited to clinical trials; and minorities include U.S. racial/ethnic minority populations (specifically: American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and Hispanics). NIH recognizes that it may not be feasible or appropriate in all clinical research projects to include representation of the full array of U.S. racial/ethnic minority populations. However, applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. Applications must include a description of the composition of the proposed study population by gender and racial/ethnic group, and the rationale for the numbers and kinds of people selected to participate. This information must be included in the form PHS 398 in SectionS 1-4 of the Research Plan and summarized in Section 5, Human Subjects. Applications must incorporate in their study design gender and/or minority representation appropriate to the scientific objectives of the work proposed. If representation of women or minorities in sufficient numbers to permit assessment of differential effects is not feasible or is not appropriate, the reasons for this must be explained and justified. The rationale may relate to the purpose of the research, the health of the subjects, or other compelling circumstances (e.g., if in the only study population available, there is a disproportionate representation in terms of age distribution, risk factors, incidence/prevalence, etc., of one gender or minority/majority group). If the required information is not contained within the application, the review will be deferred until it is complete. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If gender and/or minority representation/justification are judged to be inadequate, reviewers will consider this as a deficiency in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. The RFA label available in the PHS (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Page limits and limits on size of type are strictly enforced. Applicants for FIRST Awards (R29) are reminded that such applications must include three letters of reference. Non-conforming applications will be returned without being reviewed. 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 Center 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 in the application material. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Telephone: (301) 443-4375 FAX: (301) 443-6077 Applications must be received by January 12, 1994. If an application is received after that date, it will be assigned to the next review cycle and will compete with all investigator-initiated research grant applications. 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 The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of alcohol research grant applications will include: 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 for the proposed research. 6. Where applicable, the adequacy of procedures to protect or minimize effects on animal and human subjects and the environment. 7. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. Research grant applications will be reviewed based on standard criteria for scientific and technical merit for regular research grants (R01). The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement. 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 Potential applicants are encouraged to seek preapplication consultation and may contact the individuals listed below for consultation in preparing an application under this RFA. Direct inquiries regarding programmatic issues to: Gayle Boyd, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 FAX: (301) 443-9334 Direct inquiries regarding fiscal matters to: Elsie Fleming Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 FAX: (301) 443-3891 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 grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. $$XID RFA AA94003 AA-94-003 P1O1 *************************************** ALCOHOL AND MINORITIES: BIOMEDICAL AND BEHAVIORAL RESEARCH NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: AA-94-003 P.T. 34, FF; K.W. 0404003, 0710030, 0404000 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: January 12, 1994 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to study the medical and behavioral consequences of alcohol consumption on minority groups and individuals, including development of more effective treatment and prevention programs. The primary purpose of this Request for Applications (RFA) is to expand the limited information available on alcohol related problems among and within ethnic minority populations of African Americans, Native American/Alaskans, Asian Americans, Pacific Islanders, and Hispanic Americans. Most of these groups are at elevated risk for specific alcohol problems or have patterns of increased alcohol consumption. The NIAAA encourages innovative research on biomedical, behavioral, clinical, socio-cultural, and epidemiological factors associated with the use or abuse of alcohol; the prevention and treatment of alcohol-related problems; and the consequences of these problems in minority groups and individuals. The NIAAA supports alcohol relevant basic and applied research involving a wide array of health science fields and related academic disciplines. Research on alcohol problems among ethnic minority groups should be directed toward better understanding of how variations in drinking patterns and responses to alcohol among diverse cultural and ethnic sub-groups can serve as the basis for development of more effective treatment and intervention strategies for specific populations, and to do research on the implementation of such approaches. 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, Alcohol and Minorities: Biomedical and Behavioral Research, 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, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST (R29) award. Applicants for R01s may request support for up to five years. In FY 1992, the average total cost per year for new R01s funded by the NIAAA was approximately $200,000. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FIRST Award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST Awards cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Applicants for FIRST Awards may obtain copies of the FIRST program announcement 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. Program project grants (P01) will not be accepted for this RFA. Applicants may submit Investigator-Initiated Interactive Research Project Grants (IRPG). 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 the IRPG mechanism is available in program announcement PA-93-078, NIH Guide for Grants and Contracts, Vol. 22, No. 16, April 23, 1993. FUNDS AVAILABLE It is estimated that up to two million dollars in total costs will be available for approximately 8 to 10 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The United States encompasses a great number of minority groups. Indeed, one out of every four Americans belongs to a racial or ethnic minority. Many of the alcohol-related problems that affect the majority population also are prevalent in ethnic minority groups. However, national surveys have found disproportionately high levels of alcohol consumption and alcohol-related problems among some minority groups. In the United States, about 100,000 deaths per year are attributed to alcohol-related causes, and alcohol-related problems affect approximately 1 in 10 adults and several million adolescents and children. These problems have been found to be more extensive among some groups of African Americans, Hispanic Americans, Native Americans and Alaska Natives than in the general U.S. population. Although it tends to be lower for Asian Americans/Pacific Islanders, recent evidence indicates that alcohol consumption may be increasing among these two groups. African Americans account for 12 percent of the total population and are the largest minority group in the United States. African Americans are at high risk for alcohol related diseases such as cirrhosis, alcoholic fatty liver, hepatitis, heart disease, and certain cancers. Although overall rates of alcohol consumption are similar among Caucasian and African American males, they differ with respect to age of onset of heavy drinking (later in African American), economic status of heavy drinkers, and other factors. Although African-American women tend to drink less on the average than Caucasian women, those who are heavy drinkers may be more prone to develop alcohol-related problems, including having children with fetal alcohol syndrome. The Hispanic population comprises nine percent of the U.S. population and consists of several distinct groups; Mexican Americans, Puerto Ricans, Cuban Americans, and persons from other countries in South and Central America and the Caribbean. Studies suggest that Hispanic males have higher rates of alcohol dependence and other alcohol- related problems that continue throughout adulthood than Caucasian males. Hispanic women abstain or drink infrequently, however, Hispanic women born in the U.S. have rising consumption rates. The Native American/Alaskan population is approximately two million people representing over 300 distinct tribal and ethnic groupings. It is a young, diverse, rapidly growing population living in urban, rural, and reservation settings. Alcohol abuse is a contributing factor in death from accidents, chronic liver disease and cirrhosis, homicide and suicide. Alcohol use patterns vary markedly among tribes, regions and communities. In general, women drink less than men, however, prevalence of drinking among women is growing rapidly in some groups, and the incidence of fetal alcohol syndrome is high in some populations. Death from alcohol related causes are particularly prevalent in the 25 to 44 age group. The size of the Asian/Pacific Islander American population has more than doubled during the last decade, growing to approximately 2.9 percent of the U.S. population. There is increasing diversity among Asian American groups as well. Research on Asian American alcohol use and abuse indicates that they have low rates of alcohol-related problems even among those identified as heavy drinkers. This has been attributed to ethnic differences in physiological reactions (i.e., the "flushing response") as well as socio-cultural and environmental factors. Nevertheless, recent findings suggest an increase in drinking problems among recent Asian immigrants as they assimilate into the American value system. The NIAAA has supported studies of variations in drinking patterns and problems among the different racial and ethnic groups. In the past decade attention has become more focused on understanding why these patterns differ and how this information may be used to design and conduct culturally relevant, methodologically sound research. Further information is needed on how these patterns relate to differential biological and behavioral responses to alcohol and how specific responses may explain adverse outcomes of alcohol use. Knowledge of the causes and consequences of alcohol consumption is critical to achievement of the ultimate goal: development and implementation of effective prevention and treatment strategies for specific ethnic populations. Areas of Research Interest The following list of topics is intended only to illustrate NIAAA interests; topics not mentioned are not necessarily excluded from consideration. Variations in drinking patterns and drinking problems have been noted among different racial and ethnic groups for over 20 years. Many reports provide evidence that the frequency of alcohol problems is distinctly high in some groups. Much of the information regarding alcohol-related problems is based on ethnographic and community studies. Baseline longitudinal studies are needed to better understand consumption patterns and their relationship to chronic alcohol-related diseases. These studies include, but are not limited to: o Studies to identify genetic and environmental factors associated with excessive alcoholic cirrhosis mortality among Native Americans and African Americans. o Studies to identify the factors, either genetic or environmental, associated with increased risk for fetal alcohol syndrome among some Native Americans and African Americans. o Epidemiologic studies of alcohol consumption and alcohol related problems that focus on subgroups of each of the ethnic and racial minority groups. o Studies to identify and assess age, ethnicity and gender associated with the onset of alcohol consumption and development of alcohol-related problems. Studies are needed to examine the effects of policies and practices that alter the physical, social, or economic availability of alcohol and reduce demand for it among minority ethnic populations. Such studies might investigate the effects of: o The impacts of existing alcohol beverage control (ABC) regulations as they pertain to minorities; impacts of price on alcoholic beverage consumption among minorities; and the effects of other culturally appropriate interventions designed to alter social or physical environment in bars. o Advertising and counter advertising focused on particular ethnic groups and on age, gender, and socioeconomic subpopulations within them. o Prevention programs operated through key social institutions in ethnic minority communities, such as churches, schools, recreational organizations, and business organizations. o Minority group appropriate: school-based programs focused on reaching children of alcoholics; family-based interventions designed for adolescent and young women to facilitate abstinence during pregnancy; special programs to reach "not in school" young people. Pre-intervention studies are needed to expand knowledge regarding sociocultural, economic, behavioral, and biological factors related to alcohol use. Such studies include: o Studies of the coping resources and protective factors that have been shown to reduce alcohol problems among minority individuals who are exposed to "high-risk" environments. o Studies of the effects of immigration, urbanization, assimilation, and acculturation, or the phenomenon of bicultural membership and stresses associated with it, as mediators of problematic drinking practices. o Studies to establish the validity of standard tests and instruments for measuring consumption among relevant ethnic populations. o Research on the norms and values related to alcohol use and risk- taking behavior identified with specific age and generational cohorts in specific ethnic minority populations, (e.g., the role of cultural values in the definition of "heavy drinking" and "alcohol abuse" among Hispanic youth) or more broadly applied to cultural definitions of "inappropriate" alcohol use. o Studies of the role of the family in socializing youth to drinking norms and behaviors in different groups. o Studies to examine the influences of the family, peer group, and gender role (particularly the relationship of "machismo" or masculinity) on alcohol consumption among various sub-groups and its contributions to alcohol-related violence. o Studies to identify and characterize biological factors, including cellular and molecular mechanisms, that may account for differences in metabolism and elimination of alcohol among racial groups. o Studies to determine the biological, genetic, behavioral, and environmental effects that specifically relate to a minority population that may interact in contributing to alcoholism and related pathologies such as organ damage. o Research to determine the extent to which alcohol consumption contributes to prevalence of hypertension in African Americans. o Controlled, randomized treatment studies that match on various dimensions related to culture, age, and gender are needed to demonstrate if outcomes for minority populations receiving culture/age/gender-specific treatments differ from outcomes obtained through treatments not specific to culture, age, or gender. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for NIH grants and cooperative agreements are required to include both women and minorities in study populations for clinical research, unless compelling scientific or other justification for not including either women or minorities is provided. This requirement is intended to ensure that research findings will be of benefit to all persons at risk of the disease, disorder, or condition under study. For the purpose of these policies, clinical research involves human studies of etiology, treatment, diagnosis, prevention, or epidemiology of diseases, disorders or conditions, including but not limited to clinical trials; and minorities include U.S. racial/ethnic minority populations (specifically: American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and Hispanics). NIH recognizes that it may not be feasible or appropriate in