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