From owner-sci-resources@net.bio.net Sun Jan 03 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 3 January 1993 Message-ID: Date: 4 Jan 93 17:57:13 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 68 ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: UNDERGRADUATE CURRICULUM AND COURSE DEVELOPMENT PROGRAM -- FY 1992 AWARDS CALCULUS AND THE BRIDGE TO CALCULUS File size (bytes): 10194 STIS Filename: da92clc Title: EHR INSTRUMENTATION AND LABORATORY IMPROVEMENT PROGRAM -- FY 1992 AWARDS File size (bytes): 154049 STIS Filename: da92ili Title: EHR UNDERGRADUATE COURSE AND CURRICULUM DEVELOPMENT PROGRAM -- FY 1992 AWARDS File size (bytes): 36801 STIS Filename: da92ucc Document Type: Program Guideline Title: NSF 92-127 - Collaborative Research in Geosciences, Geography and Mathematical Sciences File size (bytes): 10859 STIS Filename: nsf92127 ------------------------------------------------------------------------ ** 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 nsf92127, the text of your message should be as follows: get nsf92127 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf92127, you would enter: ftp> get nsf92127 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 Mon Jan 04 22:00:00 1993 Path: biosci!uwm.edu!zaphod.mps.ohio-state.edu!moe.ksu.ksu.edu!hobbes.physics.uiowa.edu!news.iastate.edu!IASTATE.EDU!poosala From: poosala@IASTATE.EDU (Poosala Suresh) Newsgroups: bionet.sci-resources Subject: nobel prizes 92 query???? Message-ID: <1993Jan5.133354@IASTATE.EDU> Date: 5 Jan 93 19:33:54 GMT Sender: news@news.iastate.edu (USENET News System) Reply-To: poosala@IASTATE.EDU (Poosala Suresh) Organization: Iowa State University Lines: 5 can someone be kind enough in posting on the net who won the Nobel prizes for science, medicine, biochemistry etc., for 92' and explain briefly their actual inventions and use !! thanks in advance poosala suresh From owner-sci-resources@net.bio.net Thu Jan 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 1, pt. 1, 8 January 1993 Message-ID: Date: 8 Jan 93 03:00:56 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1500 $$XID NIHGUIDE 19930108 V22N01 P1O3 ************************************ X-comment: RFAS described: DK-93-14, CA-93-10, AI-93-05, EY-93-01, AR-93-004, AR-93-005, AR-93-006, GM-93-003, DK-93-19, CA-93- 16, DK-93-15 NIH GUIDE - Vol. 22, No. 1 - January 8, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH, FOOD AND DRUG ADMINISTRATION $$INDEX N3 ********************************************************** COOPERATIVE AGREEMENTS FOR AIDS COMMUNITY-BASED OUTREACH/INTERVENTION RESEARCH National Institute of Drug Abuse INDEX: DRUG ABUSE, AIDS $$INDEX N4 ********************************************************** REVISED PAGE LIMITATIONS FOR SMALL GRANTS National Institute of Dental Research INDEX: DENTAL $$INDEX N5 ********************************************************** CLARIFICATION: RESEARCH INFRASTRUCTURE SUPPORT PROGRAM - PA-93-003 National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX N6 ********************************************************** CHANGE IN FELLOWSHIP RECEIPT DATES National Institutes of Health Agency for Health Care Policy Research INDEX: FELLOWSHIPS, RESEARCH TRAINING NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** CORONARY ARTERY DISEASE RISK DEVELOPMENT IN YOUNG ADULTS - ECHOCARDIOGRAPHY READING CENTER (RFP NHLBI-HC-93-03) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 ********************************************************** IN VITRO ANTIVIRAL SCREEN FOR HERPES AND RESPIRATORY VIRUSES (RFP NIH-NIAID-DMID-93-07) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 ********************************************************** DOMESTIC MASTER CONTRACT FOR HIV VACCINE EFFICACY TRIALS (RFP NIH-NIAID-DAIDS-93-06) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 ********************************************************** INTERNATIONAL MASTER CONTRACT FOR HIV VACCINE EFFICACY TRIALS (RFP NIH-NIAID-DAIDS-93-21) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R5 ********************************************************** INSULATING BIOMATERIALS (RFP NIH-NINDS-93-040) National Institute of Neurological Diseases and Stroke INDEX: NEUROLOGY, STROKE $$INDEX R6 ********************************************************** ELECTRODES FOR FUNCTIONAL NEUROMUSCULAR STIMULATION (RFP NIH-NINDS- 93-05) National Institute of Neurological Diseases and Stroke INDEX: NEUROLOGY, STROKE $$INDEX R7 ********************************************************** MASTER AGREEMENT FOR THE CLINICAL EVALUATION OF INVESTIGATIONAL ANTIEPILEPTIC DRUGS (RFP NIH-NINDS-93-07) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGY, STROKE $$INDEX R8 ********************************************************** ESTABLISHMENT OF A PERINATAL RESEARCH FACILITY (RFP NICHD-IRP-92-24) National Institute of Child Health and Human Development INDEX: CHILD HEALTH $$INDEX R9 03/25/93 ************************************************* INNOVATIVE APPROACHES TO THE STUDY OF INTERSTITIAL CYSTITIS (RFA DK-93-14) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY $$INDEX R10 04/23/93 ************************************************ SMALL GRANTS FOR CLINICAL TRIALS IN AIDS MALIGNANCIES (RFA CA-93-10) National Cancer Institute INDEX: CANCER $$INDEX R11 07/13/93 ************************************************ INTERNATIONAL COLLABORATIONS IN INFECTIOUS DISEASE RESEARCH (RFA AI-93-05) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R12 03/12/93 ************************************************ CLINICAL CENTERS FOR OCULAR HYPERTENSION TREATMENT STUDY (RFA EY-93- 01) National Eye Institute INDEX: NATIONAL EYE INSTITUTE $$INDEX R13 04/08/93 ************************************************ MYCOPLASMA AND OTHER INFECTIOUS AGENTS AS A CAUSE FOR RHEUMATIC DISEASES (RFA AR-92-004) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Allergy and Infectious Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES, ALLERGY, INFECTIOUS DISEASE $$INDEX R14 04/08/93 ************************************************ RESEARCH ON CAUSAL MECHANISMS IN SYSTEMIC LUPUS ERYTHEMATOSUS (RFA AR-93-005) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Allergy and Infectious Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES, ALLERGY, INFECTIOUS DISEASE $$INDEX R15 04/08/93 ************************************************ SYSTEMIC LUPUS ERYTHEMATOSUS IN WOMEN AND MINORITIES (RFA-93-006) National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES $$INDEX R16 04/27/93 ************************************************ PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS (RFA GM-93-003) National Institute of General Medical Sciences INDEX: FELLOWSHIPS, RESEARCH TRAINING $$INDEX R17 03/25/93 ************************************************ INTERSTITIAL CYSTITIS AND OTHER BLADDER DISORDERS OF WOMEN (RFA DK- 93-19) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: KIDNEY DISEASE $$INDEX R18 04/23/93 ************************************************ SPORE IN GASTROINTESTINAL CANCER (RFA CA-93-16) National Cancer Institute INDEX: CANCER $$INDEX R19 04/21/93 ************************************************ PATHOGENESIS OF INFLAMMATORY BOWEL DISEASE AND CELIAC DISEASE (RFA DK-93-15) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIGESTIVE DISEASE ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** MUCOSAL IMMUNITY IN THE UROGENITAL TRACT (PA-93-034) National Institute of Allergy and Infectious Diseases National Institute on Aging National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases INDEX: ALLERGY, INFECTIOUS DISEASES; AGING; CHILD HEALTH, HUMAN DEVELOPMENT; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P2 ********************************************************** RESEARCH ON SALIVARY GLANDS AND SECRETIONS (PA-93-035) National Institute of Dental Research INDEX: DENTAL ERRATUM $$INDEX E1 ********************************************************** SKIN DISEASES RESEARCH CORE CENTERS (RFA AR-93-03) National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: SKIN DISEASE This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer. Contact Dr. John James at 301/496-7554 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 22, Number 1, January 8, 1993 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health (NIH), Office for Protection from Research Risks (OPRR), is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for FY 1993 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Opportunities will be available through workshops, question periods, and informal discussions for participants to exchange ideas and interests with faculty and OPRR representatives. DATE: JANUARY 21-22, 1993 TOPIC: Science and Animals: Addressing Contemporary Issues LOCATION: Sheraton Grande Torrey Pines 10950 N. Torrey Pines Road La Jolla, CA 92037 Telephone: (619) 558-1500 FAX: (619) 558-1131 SPONSORS: Scripps Clinic and Research Foundation Salk Institute REGISTRATION: Janie Partridge Scripps Clinic and Research Foundation/MB 10666 North Torrey Pines Road La Jolla, CA 92037-000 Telephone: (619) 554-8048 FAX: (619) 554-8841 INQUIRIES For further information concerning these workshops and future NIH National Animal Welfare Education programs contact: Ms. Roberta Sonneborn Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-7163 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 22, Number 1, January 8, 1993 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: SOUTHEASTERN WORKSHOP DATES: January 14 and 15, 1993 LOCATION: Sheraton Sand Key Resort 1160 Gulf Boulevard Clearwater Beach, FL 33515 Telephone: (813) 595-1611 SPONSORS: University of South Florida Florida A & M University REGISTRATION: Ms. Eileen Highsmith Executive Secretary University of South Florida 4202 E. Fowler Avenue (MP.FAO-126) Tampa, FL 33620-7900 Telephone: (813) 974-2897 TITLE: Barriers to Informed Consent: Language, Age Factors, Trauma, and Women/Minority Issues DESCRIPTION: Today's researchers face numerous barriers to obtaining an informed consent. Such issues as age, language, mental capacity, and sobriety may affect the ability of subjects to give a truly informed consent. Many of these barriers oftentimes impact the pool of subjects which an investigator is willing (or able) to use in a research project. In addition, recent legislation from the Congress was designed to address the issue of inadequate numbers of women and minorities in research projects. This conference has been designed to address three main areas in which barriers to informed consent may exist: mental competence, ethnic and gender issues, and research with children and the elderly. The conference program is designed to be of value to physicians, nurses, pharmacists, scientific investigators, and other health care professionals. All IRB members, students in health care areas and administrators will also benefit from the conference. Attention will be given to Federal regulations governing research on human subjects, with special emphasis placed on the assessment of risks---medical, legal, and psychosocial. Ample opportunities will be provided to exchange ideas and interests, through question and answer sessions and informal discussions. SOUTHWESTERN WORKSHOP DATES: February 12 and 13, 1993 LOCATION: Sheraton Tempe Mission Palms Hotel 60 East 5th Street Tempe, AZ 85281 Telephone: (602) 894-1400 SPONSORS: Arizona State University Northern Arizona University REGISTRATION: Ms. Carol Jablonski IRB Coordinator Office of the Assistant Vice President for Research Arizona State University Tempe, AZ 85287-3403 Telephone: (602) 965-6788 TITLE: Contemporary Issues in Human Subject Research: Challenges for Today's IRBs DESCRIPTION: This program is designed to be a practical working session to explore contemporary issues in human subjects protection including regulations and assurances, categorization of research protocols, uses of special populations, experimental design and scientific merit, fetal tissue research, ethical/legal issues in human subjects research, and conflict of interest. As appropriate, topics will be discussed from the perspective of the clinical researcher and the behavioral/social science researcher. Issues will be discussed in a panel format with ample time for audience questions. An outstanding faculty has been assembled. This program should be of interest to researchers in clinical medicine and the behavioral and social sciences. Institutional Review Board members, university and hospital administrators, lawyers, ethicists, health care practitioners, students, and other persons with interests in human subject protection issues. INQUIRIES For further information regarding these workshops and future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Division of Human Subject Protections Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** COOPERATIVE AGREEMENTS FOR AIDS COMMUNITY-BASED OUTREACH/INTERVENTION RESEARCH NIH GUIDE, Volume 22, Number 1, January 8, 1993 P.T. 34; K.W. 0715008, 0403004, 0404009, 0411005 National Institute on Drug Abuse The National Institute on Drug Abuse, (NIDA), wishes to alert the research community that the last date for acceptance of cooperative agreements in response to DA-90-02, "A COOPERATIVE AGREEMENT FOR AIDS COMMUNITY-BASED OUTREACH/INTERVENTION RESEARCH," will be January 3, 1993. After that date, and until further notice, no applications in response to this program announcement will be accepted. This program announcement was originally published in the NIH Guide for Contracts and Grants, Volume 19, No.2, January 12, 1990. Volume Current cooperative agreement grantees should contact the Project Officer regarding submission of competing supplements focusing on emerging research related to evaluating the effectiveness of innovative community-level behavior change strategies to prevent the spread of HIV in a documented high risk, unreached or understudied "hidden" populations of out-of-treatment injection drug abusers, non-injection cocaine/crack users. Newly proposed supplements are expected to be consistent with the original purposes of the cooperative agreement. INQUIRIES Dr. Richard Needle Community Research Branch Division of Clinical Research National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: 301) 443-6720 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** REVISED PAGE LIMITATIONS FOR SMALL GRANTS NIH GUIDE, Vol. 22, No. 1, January 8, 1993 P.T. 34; K.W. 1014006 National Institute of Dental Research The purpose of this notice is to modify the National Institute of Dental Research, Small Grant Announcement (PA-91-36), that appeared in the NIH Guide - Volume 20, Number 12, March 22, 1991. Changes in the reporting requirements for "Other Support" in form PHS 398 (Revised 9/91) have rendered impractical the 25 page limitation for small grant applications. Effective with the April 3, 1993 receipt date, the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed ten pages. No appendix, including reprints or manuscripts, may be submitted. Graphs, diagrams, tables, charts and photographs must be included in the body of the application. Original glossy photographs should be included in the original application sent to Division of Research Grants, National Institutes of Health, and in the two copies sent to the Scientific Review Office, National Institute of Dental Research. The introduction included in revised applications may not exceed one page. Applicants are reminded that the type size limitations specified in the General Instructions, form PHS (Rev. 9/91) must be observed. All other instructions in Program Announcement-91-36 remain in effect. Applications not conforming to the revised instructions will be returned to the applicant without review. INQUIRIES Director, Extramural Program Westwood Building - Room 503 National Institute of Dental Research Bethesda, MD 20892-4500 Telephone (301)496-7723 (Effective 4/1/93 (301)594-7723) $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** CLARIFICATION: RESEARCH INFRASTRUCTURE SUPPORT PROGRAM - PA-93-003 NIH GUIDE, Vol. 22, No. 1, January 8, 1993 National Institute of Mental Health Program Announcement PA-93-003 (Research Infrastructure Support Program) was published in the October 2 "NIH Guide to Grants and Contracts." The purpose of this program is "to stimulate the development of new resources at institutions capable of developing and maintaining programs of clinical and services research directed at the major mental health disorders." An eligibility requirement was included that stated that "applications may be submitted by public and private, non-profit and for-profit organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, except for those institutions with NIMH research support exceeding $3,000,000 (in total costs) in fiscal year 1991." Potential applicants have asked NIMH staff about this restriction and its interpretation. Based upon the above, thirty one institutions are ineligible. Eligible institutions must apply directly, however, and not in conjunction with an ineligible one; e.g. subcontracting is NOT acceptable. Thus, eligible institutions affiliated with ineligible institutions may apply, as long as the eligible institution is awarded the entire grant. Ineligible applications submitted to DRG will be immediately administratively withdrawn. $$N5 END ************************************************************ $$N6 BEGIN ********************************************************** CHANGE IN FELLOWSHIP RECEIPT DATES NIH GUIDE, Vol. 22, No. 1, January 8, 1993 P.T. 22; K.W. 0720005, 1014006 National Institutes of Health Agency for Health Care Policy Research Effective April 1, 1993, there will be a change in receipt dates for applications to the PHS for individual National Research Service Awards (NRSAs -- fellowships, the F-series awards). This change was made subsequent to the merger of the former Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) research Institutes with the NIH. The three new Institutes,, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the National Institute of Mental Health, will now expedite the review of NRSA fellowship applications in accordance with this longstanding NIH practice. The new receipt dates will apply to all individual fellowship applications (F- series) to the NIH Institutes and Centers as well as to the Agency for Health Care Policy and Research. The new receipt dates will be: April 5 (instead of May 10) August 5 (instead of September 10) December 5 (instead of January 10) NOTE: Implementation of the new receipt date schedule will begin with the April 5, 1993, receipt date; the January 10, 1993, receipt date remains the same. Institutional Training Grant (T 32) applications are not affected. Their receipt dates remain January 10, May 10, and September 10. $$N6 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NHLBI-HC-93-03 ******************************************* CORONARY ARTERY DISEASE RISK DEVELOPMENT IN YOUNG ADULTS - ECHOCARDIOGRAPHY READING CENTER NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFP AVAILABLE: NHLBI-HC-93-03 P.T. National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) Epidemiology and Biometry Research program, seeks an Echocardiography Reading Center for the Coronary Artery Disease Risk Development in Young Adults (CARDIA) project. CARDIAs four field centers will continue to examine and follow a total of 5000 men and women who were aged 18 to 30 years at the baseline examination in 1985 in a longitudinal study of the evolution of coronary heart disease risk factors in young adults. The Echocardiography Reading Center will direct, with the assistance of the study Steering Committee, the development of a final protocol for repeating the echocardiographic examination in two of the four field centers. The protocol will perform M-mode, 2-dimensional and Doppler echocardiography. The Echocardiography Reading Center is the only competitive Request for Proposals (RFP) anticipated for the CARDIA study. This is an announcement for an RFP. RFP NHLBI-HC-93-03 will be available on or about December 22, 1992, with proposals due about February 23, 1993. One award is anticipated. Written requests for the RFP must include three self-addressed mailing labels and cite RFP NHLBI-HC-93-03. INQUIRIES Requests for copies of the RFP are to be sent to: Cheryl A. Jennings, Contracting Officer Contracts Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Federal Building, Room 3C16 Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN NIH-NIAID-DMID-93-07 ************************************* IN VITRO ANTIVIRAL SCREEN FOR HERPES AND RESPIRATORY VIRUSES NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFP AVAILABLE: NIH-NIAID-DMID-93-07 P.T. 34; K.W. 1002045, 0755060, 0740012, 0760035 National Institute of Allergy and Infectious Diseases The Antiviral Research Branch of the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), has a requirement for investigators to perform in vitro screening of compounds for their ability to inhibit the growth and/or replication of herpes viruses (HSV, CMV, VZV, EBV) and respiratory viruses (influenza, parainfluenza, respiratory syncytial virus, measles). The contractor(s) will provide the necessary equipment, personnel, facilities, and materials to screen 200 compounds annually. The contractor(s) will be responsible for determining a compound's antiviral activity, cytotoxicity, and selective index. Research on the development of improved screening methodology, studies on mechanism of action, and studies of efficacy of drug combinations will be encouraged as an adjunct to the primary antiviral evaluation. It is anticipated that either one cost-reimbursement, completion, contract covering all virus classes or two cost-reimbursement, completion, contracts covering the virus classes individually will be awarded for a period of five years. This is an announcement for an anticipated Request for Proposals (RFP). RFP NIH-NIAID-DMID-93-07 will be issued on or about December 28, 1992, with a closing date tentatively set for March 5, 1993. INQUIRIES Requests for the RFP are to be directed in writing to: Sara Southard, Contract Specialist, Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 To receive a copy of the RFP, supply this office with two self-addressed mailing labels. All responsible sources may submit a proposal that will be considered by the government. This advertisement does not commit the government to award a contract. $$R2 END ************************************************************ $$R3 BEGIN NIH-NIADI-DIADS-93-06 ************************************ DOMESTIC MASTER CONTRACT FOR HIV VACCINE EFFICACY TRIALS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFP AVAILABLE: NIH-NIAID-DAIDS-93-06 P.T. 34; K.W. 0715008, 0755015, 0755018, 0740075, 0785055 National Institute of Allergy and Infectious Diseases The Vaccine Trials and Epidemiology Branch (VTEB), Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals from organizations with the capacity to serve as the Domestic Master Contractor (DMC) for: (1) preparation of sites for efficacy trials and (2) phase III trials of Human Immunodeficiency Disease (HIV) vaccines and other methods for preventing HIV infection in high-risk populations in the United States and its territories. The proposed contract requires expertise in the following areas: coordination and management of multicenter, longitudinal epidemiologic, vaccine, or clinical trials; coordination, training and site monitoring of Phase III vaccine trials; experience with populations at high risk of HIV infection; and solicitation and management of subcontracts. Specifically, the selected contractor will be responsible for the operation and maintenance of a master contract that will provide: (1) subcontracts to sites that are currently conducting baseline epidemiologic studies to ascertain the feasibility of conducting future Phase III HIV vaccine trials; (2) solicitation of proposals from, and monitoring of, additional sites to conduct baseline/feasibility studies; (3) solicitation of proposals from, and monitoring of, sites to conduct Phase III HIV vaccine trials; (4) development of protocols to test HIV vaccines and other biomedical interventions in high-risk seronegative individuals; and (5) an orderly and efficient transition of the proposed contract to a successor, if necessary, at the expiration of the contract. This is an announcement for an anticipated Request for Proposals (RFP). RFP NIH-NIAID-DAIDS-93-06 will be issued on or about January 20, 1993, with a closing date tentatively set for March 19, 1993. INQUIRIES Requests for the RFP are to be directed in writing to: Jacqueline C. Holden Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C-07 6003 Executive Boulevard Bethesda, MD 20892 FAX: (301) 402-0972 Requests sent via overnight mail service should use Rockville, MD 20852 instead of the Bethesda zip code To receive a copy of the RFP, supply this office with three self-addressed mailing labels. Telephone inquiries will not be honored, and all inquiries must be in writing. A short-form version of the RFP will be provided first. It includes only the Statement of Work and Evaluation Criteria to be used for selection of the awardee. After examining this, a full text version of the RFP must be requested, in writing, for those offerors interested in responding. FAX requests are acceptable for the full-text version only. All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the government to award a contract. $$R3 END ************************************************************ $$R4 BEGIN NIH-NIAID-DAIDS-93-21 ************************************ INTERNATIONAL MASTER CONTRACT FOR HIV VACCINE EFFICACY TRIALS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFP AVAILABLE: NIH-NIAID-DAIDS-93-21 P.T. 34; K.W. 0715008, 0755015, 0755018, 0740075, 0785055 National Institute of Allergy and Infectious Diseases The Vaccine Trials and Epidemiology Branch (VTEB), Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals from organizations with the capacity to serve as the International Master Contractor (IMC) for: (1) preparation of sites for efficacy trials, (2) Phase I/II trials, and (3) Phase III trials of HIV vaccines and other methods for preventing HIV infection in high-risk populations in countries outside of the United States and its territories. The proposed contract requires expertise in the following areas: coordination and management of multicenter, longitudinal epidemiologic studies, coordination of Phase I/II and Phase III trials; coordination, training and site monitoring of Phase III vaccine trials; experience with populations at high risk of HIV infection; and solicitation and management of subcontracts. Specifically, the selected contractor will be responsible for the operation and maintenance of a master contract that will provide: (1) subcontracts to sites that are currently conducting baseline epidemiologic studies to ascertain the feasibility of conducting future Phase III HIV vaccine trials; (2) solicitation of proposals from, and monitoring of, additional sites to conduct baseline/feasibility studies; (3) solicitation of proposals from, and monitoring of, sites to conduct Phase I/II and Phase III HIV vaccine trials; (4) development of protocols to test HIV vaccines and other biomedical interventions in high risk seronegative individuals; and (5) an orderly and efficient transition of the proposed contract to a successor, if necessary at the expiration of the contract. This is an announcement for an anticipated Request for Proposals (RFP). RFP NIH-NIAID-DAIDS-93-21 will be issued on or about January 20, 1993, with a closing date tentatively set for March 19, 1993. INQUIRIES Requests for the RFP are to be directed in writing to: Cyndie Cotter Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C-07 6003 Executive Boulevard Bethesda, MD 20892 FAX: (301) 402-0972 Requests sent via overnight mail service should use Rockville, MD 20852 instead of the Bethesda zip code To receive a copy of the RFP, supply this office with three self-addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. A short-form version of the RFP will be provided first. It includes only the Statement of Work and Evaluation Criteria to be used for selection of the awardee. After examining this, a full text version of the RFP must be requested, in writing for those offerors interested in responding. Fax requests are acceptable for the full-text version only. All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the government to award a contract. $$R4 END ************************************************************ $$R5 BEGIN NIH-NINDS-93-04 ****************************************** INSULATING BIOMATERIALS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFP AVAILABLE: NIH-NINDS-93-04 P.T. 34; K.W. 0740050, 0750005 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, is seeking a contract for the development of biomaterials for the long-term insulation of implantable stimulating and recording microelectrodes and interconnect cables. In-vitro and in-vivo studies will be conducted. Insulating biomaterials, intended to protect implanted probes and cables over the lifetime of an implant recipient, will be developed and tested. The focus of the work shall be on finding and characterizing insulating biomaterials. A research team with expertise in materials science, biomaterials, microelectronic packaging, and animal testing will be required to successfully conduct this research. It is anticipated that one (1) award will be made for a period of three (3) years in September 1993. INQUIRIES This notice is not the Request for Proposals (RFP). To receive a copy of the RFP, please submit a written request to the following address, and supply this office with two (2) self-addressed mailing labels. All responsible sources shall be considered by the agency. A RFP will be issued on or about January 29, 1993, with proposals due on March 31, 1993. Contracting Officer Federal Building, Room 901 National Institute of Neurological Disorders and Stroke Bethesda, MD 20892 Attention: RFP No. NIH-NINDS-93-04 $$R5 END ************************************************************ $$R6 BEGIN NIH-NINDS-93-05 ****************************************** ELECTRODES FOR FUNCTIONAL NEUROMUSCULAR STIMULATION NIH GUIDE, Vol. 22, No. 1, January 8, 1993 RFP AVAILABLE: NIH-NINDS-93-05 P.T. 34; K.W. 0745047, 0750005 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, is seeking a contract to develop stimulating electrodes that permit safe, reliable, and graded activation of selected muscles for use in functional neuromuscular stimulation (FNS). The studies will concentrate on developing electrodes that are capable of selectively activating specific functional muscle groups required by a collaborating clinical group. In order to encourage the broadest competition, the particular muscles to be stimulated are not specified. The offeror will define this focus in association with a collaborating clinical research group. Personnel with established expertise in physiology, biomedical engineering, electrode development, and animal testing are needed. It is anticipated that one award will be made for a period of three years in September 1993. This notice is not the Request for Proposals (RFP). To receive a copy of the RFP, please submit a written request to the address indicated above, and supply this office with two self addressed mailing labels. A RFP will be issued on or about January 11, 1993 with proposals due on March 10, 1993. All responsible sources shall be considered by the agency. Contracting Officer Federal Building, Room 901 National Institute of Neurological Disorders and Stroke Bethesda, MD 20892 Attention: RFP No. NIH-NINDS-93-05 $$R6 END ************************************************************ $$R7 BEGIN NIH-NINDS-93-07 ****************************************** MASTER AGREEMENT FOR THE CLINICAL EVALUATION OF INVESTIGATIONAL ANTIEPILEPTIC DRUGS NIH GUIDE, Vol. 22, No. 1, January 8, 1993 RFP AVAILABLE: Master Agreement Announcement/RFP NIH-NINDS-93-07 P.T. 34; K.W. 0740010 National Institute of Neurological Disorders and Stroke (NINDS) The NINDS intends to reissue its Master Agreement Announcement/Request for Proposals (MAA/RFP) entitled: "Master Agreement for the Clinical Evaluation of Investigational Antiepileptic Drugs," with the intent of seeking new sources to add to the current pool of qualified Master Agreement (MA) holders. In May 1991 the NINDS issued MAA/RFP No. NIH-NINDS-91-10 to renew its Master Agreement Program for performance of future clinical evaluation studies of investigational antiepileptic drugs through January 1997. In an effort to continually enlarge the pool of qualified holders under this program, the NINDS, each year, reissues the MAA/RFP. Current Master Agreement (MA) holders are not required to compete at this time. MA's will be awarded to those sources determined to be technically capable of performing clinical evaluations of investigational antiepileptic drugs in tolerability and preliminary efficacy studies, controlled efficacy and safety trials, or both, in patients with epilepsy. Only MA holders will be eligible to compete for future Master Agreements Orders (MAOs) that fund for the actual clinical evaluation of specific drugs as they become available for testing. INQUIRIES This notice is not the Master Agreement Announcement/Request for Proposals (MAA/RFP). MAA/RFP No. NIH-NINDS-93-07 will be issued on or about January 15, 1993 with a tentative closing date set for receipt of proposals on March 31, 1993. The award of any MA under this RFP will be valid through January 31, 1997. It is anticipated that as a result of this MAA/RFP, a number of new sources will be added to the current pool of MA holders. All responsible sources may submit a proposal that shall be considered by the Government. To receive a copy of MAA/RFP No. NIH-NINDS-93-07, please submit a written request to the following address, and supply two (2) self- addressed mailing labels: Contracting Officer Federal Building, Room 901 National Institute of Neurological Disorders and Stroke Bethesda, MD 20892 Attention: MAA/RFP No. NIH-NINDS-93-07 $$R7 END ************************************************************ $$R8 BEGIN NICHD-IRP-92-24 ****************************************** ESTABLISHMENT OF A PERINATAL RESEARCH FACILITY NIH GUIDE, Vol. 22, No. 1, January 8, 1993 RFP AVAILABLE: NICHD-IRP-92-24 P.T. 34; K.W. 0785135, 0785170, 0775025 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) seeks a contractor to provide the space, patient population, personnel, and support services required by the Intramural Perinatology Research Branch to perform the research associated with this project. The following mandatory qualification criteria are conditions that must be met at the time of proposal submission: (1) the prime contractor must be a University-based medical center with an appropriate environment to support clini- cal and laboratory research. Subcontractor institu- tion(s) are not required to be University-based medical institutions; (2) the prime contractor, including any subcontractors, must have a minimum of 3,500 deliveries per year with a minimum of 20 percent high-risk pregnancies. Both the prime contractor and subcontractors must be located in the District of Columbia as mandated by Congress; (3) the prime contractor must have a residency program in Obstetrics and Gynecology and Pediatrics with Board approved fellowships in Maternal-Fetal Medicine and Neonatology; and (4) the prime contractor must have a tertiary care nursery and relevant pediatric subspecialties (Cardiology, Surgery, Clinical Genetics). All responsible sources may submit an offer that will be considered by the government. It is anticipated that one cost-reimbursement incrementally funded type contract will be awarded under the RFP for a period of five years. The anticipated starting date is July 1, 1993. This announcement is not a request from proposals (RFP). RFP NICHD-IRP-92-24 will be issued on or about January 15, 1993. Proposals will be due approximately 60 days thereafter. INQUIRIES Copies of the RFP may be obtained by sending a written or Fax request to. Please enclose a self-addressed label. Paul J. Duska, Contracting Officer Contracts Management Branch, OGC National Institute of Child Health and Human Development 6100 Building, Room 7A07 9000 Rockville Pike Bethesda, MD 20892 Telephone: 301-402-3676 $$R8 END ************************************************************ $$R9 BEGIN DK-93-14 FULL-TEXT *************************************** INNOVATIVE APPROACHES TO THE STUDY OF INTERSTITIAL CYSTITIS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: DK-93-14 P.T. 34; K.W. 0705075, 0755020, 0760003 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 25, 1993 Application Receipt Date: March 25, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRES, BELOW. PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is soliciting grant applications for support of studies focused on the study of interstitial cystitis, a disorder of the bladder also known as the painful bladder syndrome. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Innovative Approaches to the Study of Interstitial Cystitis, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01). 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. 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 five years. Applicants must limit their requests to not more than $100,000 direct costs for the initial budget period. The earliest possible award date will be September 30, 1993. Awards made from this RFA will be for the support of new projects. FUNDS AVAILABLE For FY 1993, $1,500,000 will be committed by the NIDDK to fund applications submitted in response to this RFA. It is anticipated that 10 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. 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 The purpose of this RFA is to solicit applications that propose unique, innovative approaches to the study of interstitial cystitis from investigators who are not currently being funded by the NIDDK for research on interstitial cystitis. It is not the intent to fund research in areas that are currently being supported by the NIDDK. Applications may be submitted for both non-human basic research and human clinical research studies. Since this request is for unique, innovative studies, it is understood that there may be limited preliminary data to support the application. In those cases, the applicant may wish to designate the proposal as a pilot project and reduce the number of requested project years, budget and scope of the project to that which is necessary for obtaining adequate data for a more extensive, full-scale project. SPECIAL REQUIREMENTS Applicants who receive an award through this announcement are encouraged to attend a yearly meeting (convened by the NIDDK) of investigators to discuss progress and exchange research information. Funds to support the travel to these meetings may be included in the proposed budget. In order to ensure that patient selection for clinical studies is uniform, the NIDDK has established Diagnostic Criteria for research studies on IC. All grant applications that use human subjects must state that the NIDDK IC diagnostic criteria will be applied to patients selected for inclusion in the research study. The NIDDK research criteria have been published in: the Journal of Urology 142(1): 139, 1989 and the American Journal of Kidney Diseases 8(4) 353, 1989. They may also be obtained from the program staff listed under INQUIRIES. STUDY POPULATIONS For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are requested, but not required, to submit a letter of intent to apply to the RFA. This letter should include the name, telephone number and mailing address of the Principal Investigator, the names of other key personnel, and 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 necessary requirement for application. Letters of intent are requested solely for planning purposes. The NIDDK staff will not provide responses to such letters. Letters of intent must be received no later than February 25, 1993 and must be addressed to: Dr. Robert Hammond Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 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 Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The RFA label available in the application form must be affixed to the bottom of the face page. 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: Robert Hammond, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by March 25, 1993. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the Division of Research Grants (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, the staff will contact the applicant to determine whether it should be returned to the applicant, or held until the next regular receipt date and reviewed in competition with all other applications. Those applications that are complete and responsive will be evaluated for scientific/technical merit by an appropriate peer review group convened by the NIDDK. Following this review, the applications will be given a secondary review by the National Diabetes and Digestive and Kidney Diseases Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for this RFA are generally the same as those for unsolicited research grant applications. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues and requests for the RFA to: Leroy M. Nyberg, Ph.D., M.D. Director, Urology Program Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05 Bethesda, MD 20892 Telephone: (301) 496-7133 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 496-7467 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 (NIDDK). 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. $$R9 END ************************************************************ $$R10 BEGIN CA-93-10 FULL-TEXT ************************************** SMALL GRANTS FOR CLINICAL TRIALS IN AIDS MALIGNANCIES NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: CA-93-10 P.T. 34; K.W. 0715008, 0715035, 0755015 National Cancer Institute Letter of Intent Receipt Date: February 1, 1993 Application Receipt Date: April 23, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRES, BELOW. PURPOSE The Cancer Therapy Evaluation Program of the Division of Cancer Treatment at the National Cancer Institute (NCI) invites small grant applications for innovative therapeutic studies in Acquired Immunodeficiency Syndrome (AIDS) malignancies. The studies should be restricted to pilot or phase I or II trials with approximately 5 to 30 patients/trial. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Small Grants for Clinical Trials in AIDS Malignancies, is related to the priority areas of cancer and AIDS. 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 Domestic for-profit and non-profit organizations, governments and their agencies are eligible to apply. Foreign institutions are not eligible to apply. Applications can be from single institutions or multiple institutions (collaborating institutions, consortia, cooperative groups). New and experienced investigators are encouraged to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) small grants mechanism (R03). The small grants research program provides limited funds (maximum of $48,000 direct costs per year) for short-term (up to two years) research projects. The R03 grants are non-renewable. Future competing renewals (type 2s) must be prepared and submitted as traditional research grant applications (R01s) to be considered along with other non-solicited investigator- initiated applications reviewed by the Division of Research Grant (DRG) study sections. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation for FY 93. Applications received after the deadline receipt date will be returned. FUNDS AVAILABLE Approximately $750,000 in total costs per year for two years will be committed to fund applications submitted in response to this RFA. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The direct cost for each R03 is limited to $48,000 per year. Thus it is anticipated that ten awards will be made in FY 93. The total project period for applications submitted in response to the RFA may not exceed two years. The earliest feasible start date for the initial awards will be September 30, 1993. Although this program is provided for in the financial plans of the NCI, the award of R03 grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Congenital and acquired states of immunodeficiency increase the incidence of high-grade B cell non-Hodgkin's lymphoma (NHL), Kaposi's sarcoma, and certain types of epithelial malignancies. Individuals infected with human immunodeficiency virus (HIV) have a marked increase in the appearance of intermediate and high-grade B cell NHL and Kaposi's sarcoma, and show trends for an increased incidence for Hodgkin's disease, anogenital dysplasia and cancer, and basal cell carcinoma, compared to age-matched controls. On October 22, 1992, the Center for Disease Control proposed the addition of invasive cervical cancer in HIV-infected individuals to the AIDS Surveillance case definition. The tumors in HIV-infected individuals are generally aggressive and insufficiently sensitive to conventional therapy. The median survival of HIV-associated NHL is less than one year and is only two months for primary central nervous system lymphoma. Clinical observations suggest that Hodgkin's disease, anogenital dysplasia and cancer, and basal cell carcinoma, have a different natural history and therapeutic outcome compared to the disease in the general population. The dramatic growth rate of the tumors, combined with the problems of myelosuppression and opportunistic infections, have made treatment extremely difficult. As children and adults with HIV-infection are surviving longer due to improved retroviral and opportunistic infection treatment, the incidence of the malignancies are expected to rise. Research into the pathogenesis of these tumors in the context of HIV has shed light on potential interactions of cytokines, HIV, other viral co-factors (i.e., human papilloma virus in squamous cell cancer of the anogenital region, and EBV in the high-grade primary central nervous system lymphomas), and oncogenes. Based on the current information on the potential interactions in the formation of these tumors, and the lack of effective, standard regimens, the NCI is encouraging investigators to apply novel therapies or innovative approaches in pilot or phase I or II clinical trials. Research Goals And Scope The aim of this RFA is to stimulate pilot, phase I, or phase II therapeutic clinical trials in AIDS malignancies so that new treatment strategies and new agents are moved more rapidly into the clinic. The ultimate goal of the NCI is to provide more effective management and treatment for HIV-associated malignancies in children, and adult men and women. The project will fund single or groups of institutions to perform innovative therapeutic studies in AIDS malignancies. The studies should be restricted to pilot, phase I, or II trials, with approximately 5 to 30 patients/trial. Examples of potential clinical studies to consider: (1) combinations of interferon-alpha and/or retinoic acid in anogenital dysplasia or cancer (recent report by Lippman and associates of a 68 percent response rate in patients with cutaneous squamous cell cancer, and a 50 percent major response rate in patients with locally advanced squamous cell cancer of the cervix); (2) angiogenesis inhibitors in Kaposi's sarcoma; (3) immune modulating therapy with IL-4 (and subsequent down-regulation of IL-6, which may have some role in the development of NHL or Kaposi's sarcoma), anti-B4 blocked ricin immunoconjugate in NHL, or anti-sense to potential viral cofactors such as HPV in Kaposi's sarcoma. The investigators are not limited to the above studies, and any innovative therapies with appropriate rationale are sought. Although the major purpose of these grants is to facilitate rapid testing of novel agents or innovative approaches, tumor tissue or other relevant biologic fluid collection is strongly encouraged for ongoing or future investigations of laboratory correlates. The interchange of ideas and tumor tissue between the recipients of the grants will be encouraged. The research plan should be focused on the clinical trial proposed. Laboratory studies addressing correlative issues to the clinical trials may be included but are not necessary. Clinical studies must involve human subjects and be designed to ultimately improve cancer treatment. The clinical studies must be based on a strong rationale and preclinical data should support the underlying hypothesis. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF FEMALES AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of females and minorities in study populations. If females or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by February 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigators, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to Dr. Roy S. Wu at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications must be received by April 23, 1993. If an application is received after that date, it will be returned. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441; and from the NCI Program Director named below. 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 NCI program staff function. Applications that are judged non-responsive will be returned by the NCI. Questions concerning the responsiveness of proposed research to the RFA are to be directed to program staff (see INQUIRIES). Institutional Review Board (IRB) approval must have been received and the date of approval provided to NCI prior to peer review. If this information is not provided prior to peer review, the application will be withdrawn from competition by the NCI and returned to the applicant without review. AWARD CRITERIA The anticipated date of award is September 30, 1993. In addition to the technical merit of the application, NCI will consider how well the applicant institution meets the goals and objectives of the program as described in the RFA, availability of resources, and study populations. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are encouraged and may be directed to NCI Program Directors at the addresses below. The NCI Program Directors welcome the opportunity to clarify any issues or questions from potential applicants. For technical information and to request the RFA: Dr. Roy S. Wu Cancer Therapy Evaluation Program Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 For business information: Ms. Joan Metcalfe Grants Management Specialist National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 28 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as From owner-sci-resources@net.bio.net Thu Jan 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 1, pt. 4, 8 January 1993 Message-ID: Date: 8 Jan 93 03:07:51 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 639 $$XID RFA CA9316 CA-93-16 P1O1 ***************************************** SPORE IN GASTROINTESTINAL CANCER NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: CA-93-16 P.T. 34; K.W. 0715035, 0705025, 0715085, 0785035, 0795003 National Cancer Institute Letter of Intent Receipt Date: February 26, 1993 Application Receipt Date: April 23, 1993 PURPOSE The Organ Systems Coordinating Branch of the Division of Cancer Biology, Diagnosis and Centers (DCBDC) at the National Cancer Institute (NCI) invites grant applications (P50) to establish Specialized Programs of Research Excellence that focus on human Gastrointestinal Cancers of highest incidence and mortality. These programs will be established at institutions that will make strong commitments to the organization and conduct of these programs. Each Specialized Program of Research Excellence (SPORE) must be dedicated to translational research which moves basic research findings into more applied research settings with patients and populations in order to have the most immediate impact possible on improving cancer prevention, diagnoses and treatment and on reducing cancer incidence, mortality and morbidity. This could include areas such as the development of new diagnostic and prognostic tests, the conduct of innovative therapeutic protocols, the development of new primary and secondary prevention measures, as well as cancer control studies and studies that encompass rehabilitation and quality-of-life research. Each SPORE must 1) both address colorectal cancer as well as mount a significant effort on pancreatic cancer; 2) represent a collaborative enterprise between basic and clinical scientists in the conceptualization and implementation of research projects; 3) develop and maintain human cancer tissue resources that will benefit translational research in these cancers; 4) develop extended collaborations in critical areas of research need with laboratory and clinical scientists in the parent institution and in other institutions; and 5) participate with other SPOREs and/or the NCI on a regular basis to share information, assess scientific progress in the field and identify new research opportunities for reducing colorectal and pancreatic cancer incidence and mortality, and for increasing and improving survival. Each SPORE must support a mix of basic and clinical research and focus on human disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, "Specialized Program of Research Excellence (SPORE) in Gastrointestinal Cancer" is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D. C. 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Domestic non-profit and for-profit organizations, institutions and government agencies are eligible to apply. To be eligible, applicant organizations must have (1) a minimum of three independent investigators who are successful in obtaining peer-reviewed research support directly related to gastrointestinal cancer, and who represent experience in both laboratory and clinical research; or a minimum of three independent investigators each having published articles that significantly address gastrointestinal cancers in peer- reviewed research journals and who combined represent experience in both laboratory and clinical research; (2) access to a patient care and service facility that serves gastrointestinal cancer patients and, if the facility is not part of the parent institution, a statement signed by the responsible officials of the applicant institution and the consortial care facility that assures access to gastrointestinal cancer patients for clinical research; (3) a statement signed by the SPORE Principal Investigator, the responsible institutional official and cancer center director that complies with the conditions noted below under SPECIAL REQUIREMENTS, if the institution is currently an NCI-designated clinical, comprehensive or consortium cancer center. While applications must be submitted from a single institution, they may include consortial arrangements with multiple institutions if these arrangements are clearly delineated and formally and officially confirmed by signed statements from the responsible officials of each institution. Support will not be provided for applications with research activities focused exclusively on basic research, clinical research or trials, or epidemiological research. Institute staff (see below, INQUIRIES) should be consulted if there are questions regarding any of the above eligibility requirements or exclusions. MECHANISM OF SUPPORT Support of this program will be through the P50 Specialized Center Grant mechanism. This mechanism supports any part of the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem. These grants differ from program project grants in that they are more complex and flexible in terms of the activities that can be supported. In addition to support for multidisciplinary research projects, support is also provided for pilot research projects, specialized resources and shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed SPORE program. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 revised October 1, 1990. FUNDS AVAILABLE This RFA is a one-time solicitation. NCI anticipates making one or two awards for initial project periods of three years and anticipates that a total of $1.5 million will be set aside for the initial year's funding. Applicants may apply for part or all of the $1.5 million. High quality applications that are not fundable in FY 1993 may be considered for funding in FY 1994. Funding in response to this RFA is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. The total project period for applications submitted in response to this RFA should not exceed three years. Application for renewal will be for five years subject to successful recompetition. Recognizing that the initial three year funding period may be too short for several substantive scientific accomplishments, the recompetition will be evaluated on scientific accomplishment and on interim progress in pursuit of SPORE organizational, collaborative and research objectives. This would include, for example, research accomplishments to date; the quality and substance of preliminary findings; the effective use of pilot project funds; progress in planning, developing and implementing new research programs that link laboratory and clinical scientists; progress in collecting and distributing tissue specimens for research; and progress toward developing substantive collaborative interactions, progress in testing innovative concepts through use of developmental funds. RESEARCH OBJECTIVES Background - Gastrointestinal cancers pose a major public health problem in this country. Colorectal cancers accounted for about 15 percent of all cancer diagnoses in 1991. There were 112,000 cases of colon cancer and 45,500 cases of rectal cancer with 53,000 and 7,500 deaths respectively. Although there have been recent advances in adjuvant therapy, there have been no major breakthroughs in the treatment of colorectal cancers. Animal studies have provided important insights into the etiology of colon cancer, but there have been no major advances in the prevention of this disease. The recent NCI sponsored "Workshop on Colorectal Cancer" indicated a number of areas where interdisciplinary applications could prove fruitful. Experts from many disciplines addressed prognostic markers, Intermediate endpoint markers, susceptibility to colon cancer, polyps, and diet in relation to colon cancer. Interdisciplinary groups considered the science presented at the workshop with specific focus on its relevance for incidence, diagnosis, treatment and prevention. The workshop report and the recommendations of the participants will be valuable information to all SPORE applicants. Copies of the report are available from the Organ Systems Coordinating Branch (see below, INQUIRIES). Pancreatic cancer remains a significant and intransigent problem. The incidence of this cancer (28,000 cases in 1991) approaches the mortality rate (25,200 deaths). Average survival time from time of diagnosis is less than a year. There have been no advances in understanding the causes of this disease, in detecting or diagnosing it early, and there is no effective treatment. Although there have been recent advances in the biology of this disease, pancreatic cancer remains an intransigent cancer. In recent years, the scientific information base for gastrointestinal cancers has expanded significantly; however, application of this scientific base to clinical and preventive activities has not been commensurate with this expansion. There is thus a need to encourage translational research that would require interdependence between basic and clinical investigators in both the planning and implementation of research and would emphasize clinical application of basic research findings with patients and populations. There exists significant scientific and clinical expertise in gastrointestinal cancer in NCI-designated cancer centers and other institutions throughout the country. A concerted effort to mobilize this expertise through SPOREs can accelerate advances in the management and ultimately prevention of these diseases. Goals and Scope - The goal of this RFA is to establish SPOREs, that will assemble critical masses of laboratory and clinical scientists working together to focus on human gastrointestinal cancers of highest incidence and the translation of basic findings into applied, innovative research with patients and populations. The SPORE must address both colorectal cancer and pancreatic cancer with a significant effort directed toward each of these cancers. Of interest are studies that address black/white differences in incidence and mortality. The ultimate objective is to reduce incidence and mortality, and to increase and improve survival to the disease. The essential characteristics of a SPORE include (1) a strong scientific program that will have a clear impact on the disease, (2) a strong innovative pilot research program that can respond quickly to new research opportunities, (3) a human colorectal and pancreatic cancer tissue procurement resource and other resources specifically dedicated to translational research objectives. The special features of SPORE grants provide opportunities for investigators with mutual or complementary interests to engage in multidisciplinary research that will impact on prevention, diagnosis or treatment of human gastrointestinal cancer, as well as rehabilitation or quality of life. Research conducted in SPOREs must be highly interactive both within and between projects. Individual research projects must be conceived, planned and implemented through the multidisciplinary interactions of independent laboratory and clinical scientists. Such interactions can be expected to accelerate the translation of research findings into practical benefits for patients and populations. A distinguishing feature of a SPORE P50 grant is the highly dependent nature of the research objectives upon intra- and inter- project interactions. Each project would not be expected to stand on its own in the absence of interactions with other research projects. Developmental research funds provide support for highly innovative pilot projects that take maximum advantage of new research opportunities. This provides a flexible means for responding quickly to new research opportunities. To facilitate achievement of SPORE program goals, each SPORE must develop resources specialized for gastrointestinal cancer research activities. This must include human colorectal and pancreatic cancer tissue collection for research activities of the SPORE and for use by scientists who are concentrating on translational research within and outside the parent institution. The development of additional resources specialized for research on these cancers is also encouraged. Interactions among SPOREs is an important objective of this initiative. This may be in the form of research collaborations, exchange of scientists on a visiting basis, exchange of resources and materials, and other innovative ways. All SPOREs are strongly encouraged to participate in regular meetings coordinated by the Organ Systems Coordinating Branch of the NCI. The purpose of the meeting is to share scientific information, assess scientific progress, identify new research opportunities, and establish priorities that will accelerate the translation of basic research findings to applied settings in patients and populations. SPECIAL REQUIREMENTS Each SPORE must include the following elements: A strong institutional commitment. An institution receiving this award must incorporate the SPORE high within its institutional priorities. The institution must demonstrate a strong commitment to the program's stability and success. The application must provide a plan that addresses how the institutional commitment will be established and sustained, and how it will maintain accountability for promoting scientific progress. This institutional commitment may be in the form of faculty appointments for SPORE investigators, assignment of research space, cost sharing of resources, or other ways to be proposed by the applicant. A qualified Principal Investigator. A leader must be selected as Principal Investigator who can oversee and conduct planning activities, provide direction to the SPORE and ensure a translational research emphasis. A substantive gastrointestinal cancer patient population. Each SPORE must be recognized as a leading program in the treatment of gastrointestinal cancers. The grant application must demonstrate and document access to a patient population that can participate in and can benefit from the innovative clinical and population research activities of the SPORE. Research Projects. Each SPORE must pursue at least three research projects. These should be new projects, not merely expansions or duplications of existing projects. Research projects must be conducted by multiple independent investigators, oriented toward translational research activities using human materials and human subjects that address innovative possibilities in gastrointestinal cancer research. Each project must involve multidisciplinary laboratory and clinical interaction in the conception, planning, design and implementation of research. Projects should be interactive with each other. Collaborative arrangements within the SPORE, within the parent institution and with other institutions are encouraged. Collaborations with scientists outside the immediate SPORE should be documented with appropriate letters of commitment as applicable. Collaborations with other institutions may involve consortial arrangements. Developmental Research Funds. Each SPORE must continually allocate a significant proportion of its budget and effort to pilot projects that explore innovative ideas. It is important that SPOREs use developmental funds as a flexible and significant source to stimulate projects that take maximum advantage of new research opportunities. Pilot projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE environment. The SPORE application should propose an institutional process that can continuously select pilot projects that represent the most innovative ideas and that will have the greatest impact on reducing gastrointestinal cancer incidence and mortality, and increasing and improving survival. Specialized Resources. The SPORE is encouraged to develop and maintain resources specialized for gastrointestinal cancer research. Each SPORE must have a dedicated activity for collecting and distributing human gastrointestinal cancer tissue. This should include the essential pathologic and clinical information needed for conducting research. This resource must benefit the specific research activities of the SPORE as well as the research activities of scientists within and outside of the parent institution who are concentrating on translational research issues. A plan must be proposed for prioritizing the distribution of tissues to SPORE scientists and scientists outside the SPORE. SPORE Meeting. Gastrointestinal Cancer SPOREs will be expected to participate in regular meetings coordinated by the Organ Systems Coordinating Branch of the NCI to share data, assess progress, identify new research opportunities, and establish priorities for effective approaches to reducing incidence and mortality, and improving survival. Travel funds for the Principal Investigator and Project Investigators should be budgeted for this purpose. This may include Project Investigators from other institutions who are actively collaborating with SPORE investigators. A SPORE application can originate from an institution with or without an existing NCI P30 core grant. However, if a P30 grant already exists: a) the Principal Investigator of the SPORE must be a senior or program leader in the cancer center; b) the P30 Center Director may be the Principal Investigator of the P50 SPORE, but this is not necessary; c) lines of authority should be indicated clearly such that the SPORE does not interfere with the P30 chain of authority; d) a letter of commitment that delineates organizational relationships and lines of authority is required; the letter must be signed by the proposed Principal Investigator of the SPORE, the Cancer Center Director and the appropriate institutional official; e) the SPORE must be a major programmatic element in the cancer center, but there must be a separate and distinctive institutional commitment to the SPORE; f) the development of resources in the SPORE should not duplicate resources already provided by the existing Cancer Center Support Grant (P30); however, SPORE resources can be used to augment existing center resources to orient these resources more effectively to SPORE research objectives if this is a more efficient and more cost effective alternative; g) the applicant should describe how the P50 SPORE will interact synergistically and effectively with the existing P30 programs in order to maximize SPORE research objectives and contribute to cancer center research objectives. STUDY POPULATIONS - SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology. prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit by February 26, 1993, a letter of intent that includes the name and address of the Principal Investigator and identifies the component research projects, core units and their Principal Investigators, any collaborating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding and does not enter into the review of subsequent applications, it provides an indication of the number and scope of the applications to be reviewed. The letter of intent should be sent to: BY U.S. POST: Andrew Chiarodo, Ph.D. Chief, Organ Systems Coordinating Branch Executive Plaza North, Suite 512 National Cancer Institute Bethesda, MD 20892 / Tel: (301) 496-8528 / FAX: (301) 402-0181 BY DIRECT DELIVERY: Andrew Chiarodo, Ph.D. Chief, Organ Systems Coordinating Branch Executive Plaza North, Suite 512 National Cancer Institute Bethesda, MD 20852 / Tel: (301) 496-8528 / FAX: (301) 402-0181 APPLICATION PROCEDURES Applications must be received by April 23, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants 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. Specific instructions for preparing a SPORE grant application are available from the Organ Systems Coordinating Branch (see below, INQUIRIES). The regular research grant application form PHS 398 (rev. 9/91) must be used in applying for these grants. These forms are available at most institutional offices of sponsored research or from the Office of Grants Inquiries, Division of Research Grants, Room 449, Westwood Building, National Institutes of Health, Bethesda, MD 20892-4500 / Tel: (301) 496-7441 / or from the NCI Program Director named below (see INQUIRIES). The RFA label available in the application form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of your application such that it may not reach the review committee in time for review. In addition, the RFA number and title "SPORE in Gastrointestinal Cancer" should be typed on line 2a of the face page of the application form. Submit a signed typewritten original of the application, including the checklist, and three signed, exact, clear, and single-sided photocopies, in one package, to: Division of Research Grants Room 240, Westwood Building National Institutes of Health Bethesda, MD 20892-4500 Applicants who wish to use express mail or carrier service should change the ZIP code to 20816. C.O.D. applications will not be accepted. At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer, NCI Executive Plaza North, Suite 650 6130 Executive Blvd Rockville, MD 20892-9903 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed initially by the Division of Research Grants for completeness. Incomplete or ineligible applications (see above, ELIGIBILITY REQUIREMENTS) will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function; this will be based primarily on the clear orientation of the application to (1) human gastrointestinal cancer with emphasis on both colorectal and pancreatic cancers, (2) translational research objectives, and (3) an absence of duplication between the proposed research and currently supported research. Applications judged to be non-responsive to this RFA will be returned without review. If the number of responsive applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review in order to eliminate those without significant and substantial merit; such applications are not recommended for further competition. The NCI will remove these applications from further competition and will provide an abbreviated summary statement to the Principal Investigator outlining the primary reasons and rationale for this peer review determination. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit and for special SPORE characteristics and requirements by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. Review Criteria - The major factors to be considered in the evaluation of applications will be: The Institutional Commitment - a) adequacy of institutional procedures and plans for monitoring, evaluating and assuming accountability for the general success of the SPORE; b) adequacy of facilities, equipment and space to promote translational research objectives; c) adequacy of recruitment objectives and plans to strengthen the scientific capabilities of the SPORE. Overall Program Organization and Capability - a) the scientific qualifications and demonstrated scientific and administrative leadership capabilities of the SPORE Principal Investigator; adequacy of the time commitment of the Principal Investigator; b) the depth and breadth of the proposed research activities and plans to effectively pursue translational research objectives; c) the adequacy of access to patients and to a population for conducting current and projected therapeutic, prevention and control research; d)the adequacy of the procedures, processes, and plans for promoting interactions. Individual Research Projects - a) qualifications and demonstrated competence of the investigators to conduct the proposed research; the adequacy of the time commitment of all key laboratory and clinical researchers associated with the project; b) clear evidence of significant multidisciplinary interactions in the conception, design and proposed implementation of the project; c) degree to which the project addresses an issue of substantive importance for reducing incidence and mortality or for increasing survival in human gastrointestinal cancer; d) the scientific merit and adequacy of experimental design of the project; e) the originality, novelty, and innovativeness of the experimental design and relevance to the overall goals and objectives of the SPORE; f) the degree to which the project is interactive with other projects in the SPORE conceptually, experimentally, and translationally; g) appropriateness of the budget to achieve research objectives. Developmental Funds - a) adequacy of the proposed process for continuously reviewing and funding pilot projects for their quality, innovativeness and potential impact on reducing incidence and mortality, and/or improving survival to gastrointestinal cancer; b) quality, innovativeness and potential impact of proposed pilot projects; c) degree to which developmental funds will be used to stimulate pilot projects with multidisciplinary interactions and/or collaborative interactions with other scientists within or outside of the parent institution; d) appropriateness of the proposed budget relative to the proposed pilot projects and potential of the program to generate innovative pilot projects on a consistent basis. Shared Resources - a) adequacy of the proposed plans to develop, maintain and distribute a fresh/frozen human gastrointestinal cancer tissue resource with pathological and clinical data; b) confirmation that the plan does not duplicate resources already available within the institution (e.g. as part of a Cancer Center Support Grant or P30) or through readily available national resources; c) adequacy of the justification for other specialized resources essential for the conduct of SPORE research; d) adequacy of qualifications of proposed managers of resources to conduct high quality, reliable resource operations; e) appropriateness of the requested budgets to conduct each resource operation. Interactions with other SPOREs - a) adequacy of plans to promote and maintain communication and integration with other gastrointestinal SPOREs; b) willingness to interact with other SPOREs and with the NCI in sharing data, in assessing scientific progress, in identifying new research opportunities and in establishing scientific priorities. Scoring the Applications - In addition to rating the merit of individual components, peer reviewers will be asked to judge the overall program in the following areas: 1) scientific merit and innovativeness; 2) evidence of interdependent, multidisciplinary design and conduct of the research; 3) potential for impacting on the disease; 4) institutional commitment. A verbal descriptor will be recorded for each of the above areas. A single numerical priority score will be assigned to the program as a whole. The score will weight each of the above four areas, 60 percent, 15 percent, 15 percent and 10 percent respectively. A recommendation for no further consideration for any required element of the program will result in an overall evaluation of "not recommended for further consideration." AWARD CRITERIA The anticipated date of award is September 30, 1993. In addition to the required elements as described above under Special Requirements, the NCI will consider how well the applicant institutions meet the goals and objectives of the program as described in the RFA, availability of resources, and study populations. INQUIRIES The program director welcomes the opportunity to clarify any issues or questions from potential applicants, including questions about the eleigibility requirements, funding issues, and peer review process. Initiating a dialogue with NCI staff at the earliest possible time usually benefits the applicant in the preparation of an application. Written or telephone inquiries concerning the objectives and scope of the RFA, or inquiries about whether or not specific proposed research would be responsive, are encouraged and should be directed to: Andrew Chiarodo, Ph.D. Chief, Organ Systems Coordinating Branch Executive Plaza North, Suite 512 National Cancer Institute Bethesda, MD 20892 Telephone: (301) 496-8528 FAX: (301) 402-0181 For fiscal or administrative matters, contact: Robert E. Hawkins Grants Management Specialist Executive Plaza North, Suite 216 National Cancer Institute Bethesda, MD 20892 / Tel: (301) 496-7800 ext. 13 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance no. 13.397. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended: 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Thu Jan 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 1, pt. 3, 8 January 1993 Message-ID: Date: 8 Jan 93 03:04:18 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1356 $$XID NIHGUIDE 19930108 V22N01 P3O3 ************************************ Letter of Intent Receipt Date: February 25, 1993 Application Receipt Date: March 25, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRES, BELOW. PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is soliciting R01 grant applications for support of basic and clinical studies focused on the normal and abnormal function of the urinary bladder, specifically as it relates to the urinary bladder disorders of women: interstitial cystitis, urinary tract infections, and urinary incontinence. 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, Interstitial Cystitis and Other Bladder Disorders of Women, is related to the priority area of ciabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, whether public or 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. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total requested project period for applications submitted in response to this RFA may not exceed five years. The average size of an award is anticipated to be about $200,000 per year total cost. The majority of applications funded from this RFA will be for the support of new projects. The earliest possible award date will be September 30, 1993. FUNDS AVAILABLE For FY 1993, $2,500,000 will be committed by the NIDDK to fund applications submitted in response to this RFA. It is anticipated that 10 to 15 awards will be made by the NIDDK. 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 plan of the NIDDK the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objective of this announcement is to solicit applications from basic science and clinical investigators who will develop new approaches to the study of the urinary bladder and its disorders in women. Included in the scope of this RFA are basic and clinical studies on bladder development, basic bladder physiology, studies of bladder immunology, bladder mucosa, comparative studies with other organ sytems such as the gut, etc. especially as related to intersitial cystitis, urinary tract infections and urinary incontinence. SPECIAL REQUIREMENTS Applicants who receive an award through this announcement are expected to attend a yearly meeting (convened by the NIDDK) of investigators to discuss progress and exchange research information. Funds to support the travel to these meetings may be included in the proposed budget and can be in addition to other proposed travel. In order to ensure that patient selection for clinical studies is uniform, the NIDDK has established Diagnostic Criteria for research studies on Interstitial Cystitis (IC). All Grant Applications For Research On IC that Use Human Subjects Must State That The NIDDK IC Dignostic criteria For Research Will Be Applied To Patients Selected For Inclusion In The Research Study. The NIDDK research criteria have been published in the Journal Of Urology 142(1): 139, 1989 and the American Journal Of Kidney Diseases 8(4) 353, 1989. The Diagnostic Criteria for other urological diseases that which are studied must also be defined in the research proposal. LETTER OF INTENT Prospective applicants are requested, but not required, to submit a letter of intent to apply to the RFA. This letter should include the name, telephone number and mailing address of the Principal Investigator, the names of other key personnel, and 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 necessary requirement for application. Letters of intent are requested solely for planning purposes. The NIDDK staff will not provide responses to such letters. Letters of intent must be received no later than February 25, 1993 and must be addressed to: Dr. Robert Hammond Chief, Review Branch The National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS-398 (revised 9/91) is to be used in applying for these grants. The form is available from most institutional offices of sponsered research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone (301) 496-7441. The RFA label available in the application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division Of Research Grants National Institutes of Health Westwood Building, Room 240 5333 Westbard Avenue Bethesda, MD 20892 At time of submission, two additional copies of the application must also be sent under separate cover to: Dr. Robert Hammond Chief, Review Branch The National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by March 25, 1993. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 and as a component project of a program project. 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. 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, the staff will contact the applicant to determine returned to the applicant, or whether it should be held until the next regular receipt date and reviewed in competition with all other applications. Those applications are complete and responsive will be evaluated for scientific/technical merit by an appropriate peer review group convened by the NIDDK. Following this review, the applications will be given a secondary review by the National Diabetes and Digestive and Kidney Diseases Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for this RFA are generally the same as those for unsolicited research grant applications. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues and requests for the RFA to: Ralph L. Bain, Ph.D. Deputy Director, Urology Program The National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05 Bethesda, MD 20892 Telephone: (301) 496-7574 FAX: (301) 402-0223 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain Grants Management Specialist Division of Extramural Activities The National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 496-7467 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 (NIDDK). 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. $$R17 END *********************************************************** $$R18 BEGIN CA-93-16 FULL-TEXT ************************************** SPORE IN GASTROINTESTINAL CANCER NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: CA-93-16 P.T. 34; K.W. 0715035, 0705025, 0715085, 0785035, 0795003 National Cancer Institute Letter of Intent Receipt Date: February 26, 1993 Application Receipt Date: April 23, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES BELOW. PURPOSE The Organ Systems Coordinating Branch of the Division of Cancer Biology, Diagnosis and Centers (DCBDC) at the National Cancer Institute (NCI) invites grant applications (P50) to establish Specialized Programs of Research Excellence that focus on human Gastrointestinal Cancers of highest incidence and mortality. These programs will be established at institutions that will make strong commitments to the organization and conduct of these programs. Each Specialized Program of Research Excellence (SPORE) must be dedicated to translational research which moves basic research findings into more applied research settings with patients and populations in order to have the most immediate impact possible on improving cancer prevention, diagnoses and treatment and on reducing cancer incidence, mortality and morbidity. This could include areas such as the development of new diagnostic and prognostic tests, the conduct of innovative therapeutic protocols, the development of new primary and secondary prevention measures, as well as cancer control studies and studies that encompass rehabilitation and quality-of-life research. Each SPORE must 1) both address colorectal cancer and mount a significant effort on pancreatic cancer; 2) represent a collaborative enterprise between basic and clinical scientists in the conceptualization and implementation of research projects; 3) develop and maintain human cancer tissue resources that will benefit translational research in these cancers; 4) develop extended collaborations in critical areas of research need with laboratory and clinical scientists in the parent institution and in other institutions; and 5) participate with other SPOREs and/or the NCI on a regular basis to share information, assess scientific progress in the field and identify new research opportunities for reducing colorectal and pancreatic cancer incidence and mortality, and for increasing and improving survival. Each SPORE must support a mix of basic and clinical research and focus on human disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, "Specialized Program of Research Excellence (SPORE) in Gastrointestinal Cancer" is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-1) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D. C. 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Domestic non-profit and for-profit organizations, institutions and government agencies are eligible to apply. To be eligible, applicant organizations must have (1) a minimum of three independent investigators who are successful in obtaining peer-reviewed research support directly related to gastrointestinal cancer, and who represent experience in both laboratory and clinical research. An alternative is a minimum of three independent investigators each having published articles that significantly address gastrointestinal cancers in peer-reviewed research journals and who combined represent experience in both laboratory and clinical research; (2) access to a patient care and service facility that serves gastrointestinal cancer patients and, if the facility is not part of the parent institution, a statement signed by the responsible officials of the applicant institution and the consortial care facility that assures access to gastrointestinal cancer patients for clinical research. While applications must be submitted from a single institution, they may include consortial arrangements with several institutions as long as these arrangements are clearly delineated, and formally and officially confirmed by signed statements from the responsible officials of each institution. MECHANISM OF SUPPORT Support of this program will be through the P50 Specialized Center Grant mechanism. This mechanism supports any part of the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem. These grants differ from program project grants in that they are more complex and flexible in terms of the activities that can be supported. In addition to support for multidisciplinary research projects, support is also provided for pilot research projects, specialized resources and shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed SPORE program. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 revised October 1, 1990. This RFA is a one-time solicitation. The total project period for applications submitted in response to the present RFA may not exceed three years. The anticipated award date will be September 30, 1993. FUNDS AVAILABLE This RFA is a one-time solicitation. NCI anticipates making one or two awards for initial project periods of three years and anticipates that a total of $1.5 million will be set aside for the initial year's funding. Applicants may apply for part or all of the $1.5 million. High quality applications that are not fundable in FY 1993 may be considered for funding in FY 1994. Funding in response to this RFA is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NCI, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. RESEARCH OBJECTIVES The goal of this RFA is to establish SPOREs, which will assemble critical masses of laboratory and clinical scientists working together to focus on human gastrointestinal cancers of highest incidence and the translation of basic findings into applied, innovative research with patients and populations. The SPORE must address both colorectal cancer and pancreatic cancer with a significant effort directed toward each of these cancers. Of interest are studies that address black/white differences in incidence and mortality. The ultimate objective is to reduce incidence and mortality, and to increase and improve survival to the disease. The essential characteristics of a SPORE include (1) a strong scientific program which will have a clear impact on the disease, (2) a strong innovative pilot research program which can respond quickly to new research opportunities, (3) a human colorectal and pancreatic cancer tissue procurement resource and other resources specifically dedicated to translational research objectives. STUDY POPULATIONS - SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit by February 26, 1993, a letter of intent that includes the name and address of the Principal Investigator and identifies the component research projects, core units and their Principal Investigators, any collaborating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding and does not enter into the review of subsequent applications, it provides an indication of the number and scope of the applications to be reviewed. The letter of intent is sent to Dr. Andrew Chiarodo, whose address is below. APPLICATION PROCEDURES Applications must be received by April 23, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The regular research grant application form PHS 398 (rev. 9/91) must be used in applying for these grants. These forms are available at most institutional offices of sponsored research or from: Office of Grants Inquiries, Division of Research Grants, Room 449, Westwood Building, National Institutes of Health, Bethesda, MD 20892-4500, Tel: (301) 496-7441. Specific instructions for preparing a SPORE grant application are available as a separate addendum available from the Organ Systems Coordinating Branch (see below, INQUIRIES). These instructions should be used in preparing the application. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed for completeness by the DRG and for responsiveness by the NCI. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. In addition to rating the merit of individual components, peer reviewers will be asked to judge the overall program in the following areas: scientific merit and innovativeness; evidence of interdependent, multidisciplinary design and conduct of the research; potential for impacting on the disease; institutional commitment. AWARD CRITERIA The anticipated date of award is September 30, 1993. In addition to the required elements as described above under Special Requirements, the NCI will consider how well the applicant institutions meet the goals and objectives of the program as described in the RFA, availability of resources, and study populations. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Andrew Chiarodo, Ph.D. Chief, Organ Systems Coordinating Branch Executive Plaza North, Suite 512 National Cancer Institute Bethesda, MD 20892 Telephone: (301) 496-8528 FAX: (301) 402-0181 Direct inquiries regarding fiscal matters to: Robert E. Hawkins Grants Management Specialist Executive Plaza South, Room 216 National Cancer Institute Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 13 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance no. 13.397. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended: 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R18 END *********************************************************** $$R19 BEGIN DK-93-15 FULL-TEXT ************************************** PATHOGENESIS OF INFLAMMATORY BOWEL DISEASE AND CELIAC DISEASE NIH GUIDE, Volume 22, Issue 1, January 8, 1993 RFA AVAILABLE: DK-93-15 P.T. 34; K.W. 0715085, 0710070, 1002019, 1002004, 1002008, 0785055 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 26, 1993 Application Receipt Date: April 21, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRES, BELOW. PURPOSE This Request for Applications (RFA) invites new as well as experienced investigators working in the areas of gastroenterology, epidemiology, immunology, physiology, molecular and cell biology and genetics to submit research project grant applications in the area of autoimmune gastrointestinal diseases including ulcerative colitis, Crohn's disease and celiac disease. Applications are encouraged from any interested, especially new investigators, regardless of their prior record of grant support. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Pathogenesis of Inflammatory Bowel Disease is related to the priority area of Diabetes and Chronic Disabling Conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit or nonprofit organizations, whether public or private, such as universities, colleges, hospitals, laboratories, units of State or 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 awards. MECHANISM OF SUPPORT The support mechanisms for this research will be the individual research grant (RO1) and the First Independent Research Support and Transition (FIRST) Award R29. This is a one-time solicitation. Subsequent unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to customary peer review procedures. This RFA will provide the opportunity for investigators to establish support for periods up to five years for meritorious research projects designed to investigate the cause, natural history and treatment of Inflammatory Bowel Disease (IBD) and celiac disease. This RFA is intended to support primarily new applications; however, applications for continuation of currently funded projects will be considered if they meet the objectives of this RFA. R01 awards are expected to average approximately $200,000 per year in total costs. FUNDS AVAILABLE For FY 1993, $ 2,000,000 (direct plus indirect costs) will be committed to fund applications submitted in response to this RFA. It is anticipated that 10 to 12 awards will be made depending 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 Research objectives of this RFA should focus on but are not limited to: o the role of the mucosal immune system and its immunoregulation in gastrointestinal inflammation characteristic of IBD and celiac disease. o the role and status of inflammatory mediators, the cytokine system and adhesion molecules in IBD and celiac disease. o the nature of the autoimmune reactions characteristic of IBD and celiac disease including definition of the autoantigens and the fine specificity of autoantibodies that are detected in patients with IBD and celiac disease. o genetic markers and specific gene products associated with IBD and celiac disease and in particular the molecular genetics of the major histocompatibility complex in these disorders. o epithelial cell biology and its disturbance in gastrointestinal inflammation characteristic of IBD and celiac disease. o the role of luminal bacterial flora viral infections in IBD and celiac disease. o the epidemiology of IBD and celiac disease with particular attention to special populations and risk factors for development of these diseases as well as their complications such as sclerosing cholangitis in ulcerative colitis and lymphoma in celiac disease. STUDY POPULATIONS It is NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them, and the study design must seek to identify any pertinent gender or minority population differences. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit 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 is being 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 by February 26, 1993 to: Robert Hammond, Ph.D., Chief, Review Branch, NIDDK Westwood Building, Room 605 National Institutes of Health Bethesda, MD 20892 / Tel: (301) 496-7083; FAX: (301) 402-1277 APPLICATION PROCEDURES The research grant application form PHS-398 (rev. 9/91) must be used in applying for these grants. The form is available from most institutional offices of sponsored research or from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892; (301) 496-7441. Information describing the FIRST Award grant may also be obtained from these sources. The RFA label available in the 9/91 revision of PHS 398 application form must be affixed to the bottom of the face page. Additional, detailed instructions on submission procedures are described the RFA. Applications must be received by April 21, 1993. Submit a signed, typewritten original of the application, including the Checklist, and three (3) signed, exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892 At the time of submission, two (2) additional copies of the application should also be sent under separate cover to: Robert Hammond, Ph.D. Westwood Building, Room 605 National Institutes of Health Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIDDK in accordance with the usual NIH peer review procedures. Following review, the applications will be given a secondary review by the National Diabetes and Digestive and Kidney Diseases Advisory Council unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant or held until the next regular receipt date and reviewed by the Division of Research Grants. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues and requests for copies of the full text RFA should be directed to: Frank A. Hamilton, M.D., MPH Westwood Building, Room 3A16 Bethesda, MD 20892 Telephone (301) 496-7821 Inquiries regarding fiscal matters should be directed to: Mrs. Thelma Jones Grants Management Specialist, NIDDK Westwood Bldg. Room 649C National Institutes of Health Bethesda, MD 20892 Telephone: (301) 496-7467 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R19 END *********************************************************** ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-034 ************************************************ MUCOSAL IMMUNITY IN THE UROGENITAL TRACT NIH GUIDE, Volume 22, Number 1, January 8, 1993 PA NUMBER: PA-93-034 P.T. 34; K.W. 0705075, 0710070 National Institute of Allergy and Infectious Diseases National Institute on Aging National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases The Division of Allergy, Immunology and Transplantation (DAIT) and the Division of Microbiology and Infectious Diseases (DMID) of the National Institutes of Allergy and Infectious Diseases (NIAID); the National Institute on Aging (NIA); the National Institute of Child Health and Human Development (NICHD); and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite research project grant applications for support of basic and preclinical studies aimed at elucidating the normal and pathologic cellular and humoral immune responses in the urogenital tract. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Mucosal Immunity in the Urogenital Tract, is related to the priority area of sexually transmitted diseases, maternal and infant health, immunization and infectious diseases, and 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 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible to apply for the First Investigator Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT The mechanism of support will be the individual research project grant (R01) and the FIRST (R29) award. Multidisciplinary approaches that involve collaborative efforts among investigators in the fields of basic immunology, endocrinology, urology and gynecology are strongly encouraged. Policies that govern research grant programs of the National Institutes of Health (NIH) will prevail. RESEARCH OBJECTIVES Background Although considerable progress has been made in understanding the immune responses in mucosal surfaces of the airways and the digestive tract, there is a serious lack of information regarding the immune responses in the mucosal lining of the urogenital system. Recent technologic advances should make it possible to isolate and characterize both the cells and the molecules that participate in the maintenance of immune homeostasis in the genitourinary tract. Millions of women and men of all ages suffer urinary and genital infections that not only cause pain, but could also have unwanted effects on fertility and urinary function. Despite control efforts to prevent the spread of STDs, including human immunodeficiency virus (HIV) infection, both bacterial and viral STDs remain epidemic in many areas of the United States. Although curative therapy is available for some of these acute infections, many individuals go on to develop serious complications and chronic disease. Furthermore, sexually transmitted infections have also been implicated in increased risk of HIV transmission. Unfortunately, except for Hepatitis B, there are no vaccines for STDs. STD vaccine development is extremely difficult and complex for reasons related primarily to (1) the nature of the host-pathogen relationship and (2) the consequences of co-infection with more than one sexually transmitted pathogen. As obligate pathogens of humans, the etiologic agents of these diseases have evolved to effectively avoid, subvert, or ignore the immunodominant host response. Furthermore, the presence of multiple infections in the reproductive tract is likely to complicate vaccine development as pre-existing STDs compromise epithelial barriers through tissue fragility, induction of inflammatory cytokines and the recruitment of target cells, such as lymphocytes (in the case of HIV), thereby lowering the infectious dose and compromising vaccine efficacy. Detailed knowledge of the basic mechanisms that normally participate in mucosal resistance against these conditions could create new opportunities for vaccine development and intervention. Research Objectives and Scope Areas of interest include: o Phenotypic and functional analysis of normal immune cell components in the urogenital mucosal linings, and changes during puberty, menopause and post-menopause. o Studies on the effects of steroid hormones on the composition and function of immune cells normally present in the mucosa of the urogenital tract. o Determination of the cellular and molecular factors that induce and regulate antibody production by mucosal-associated lymphocytes. o Effects of different forms of antigen presentation and adjuvants on the development of local immunity. o Mechanisms mediating the relationship between immune responses developing in the urogenital mucosa and systemic immunity. o Identification of critical factors that lead to development of full or partial protective immunity in the mucosal surfaces of the urogenital tract. o Identification of the kinetic parameters of protective immune responses and of new means to enhance and prolong protective immunity. o Determination of the molecular basis for the observed differences between the immune responses of the male and female reproductive tract and of the influence of reproductive hormones on infectivity and the host response to infection. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, check yes on item 2a of the face page and enter the title, PA-93-: Mucusal Immunity in the Genital Tract. Applications will be accepted in accordance with the standard submission dates for new applications: February 1, June 1, and October 1. All applications will be assigned by the Division of Research Grants (DRG) for review according to the NIH process for regular research grant applications. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the DRG, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council or board. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program balance among research areas of the announcement. INQUIRIES Requests for additional information and questions regarding this program may be directed to: Dr. Susana Serrate-Sztein Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 Bethesda, MD 20892 Telephone: (301) 496-7985 FAX: (301) 402-0175 Dr. Penny Hitchcock Sexually Transmitted Diseases Branch Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A21 Bethesda, MD 20892 Telephone: (301) 402-0443 FAX: (301) 402-1456 Dr. David H. Lavrin Biology of Aging Program National Institute on Aging Gateway Building, Room 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 Dr. Michael E. McClure Reproductive Science Branch, Center for Population Research National Institute of Child Health and Human Development Executive Plaza North, Room 603 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Dr. Leroy M. Nyberg Division of Kidney, Urologic and Hematologic Disorders National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05A Bethesda, MD 20892 Telephone: (301) 496-8248 Direct inquiries regarding fiscal matters to: Mr. Jeffrey Carow Chief, Immunology Grants Management Section Division of Extramural Affiars National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal DomesticAssistance, No. 93.855 - Immunology, Allergic and Immunologic Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review $$P1 END ************************************************************ $$P2 BEGIN PA-93-035 ************************************************ RESEARCH ON SALIVARY GLANDS AND SECRETIONS NIH GUIDE, Volume 22, Number 1, January 8, 1993 PA NUMBER: PA-93-035 P.T. 34; K.W. 0715148, 0785035 National Institute of Dental Research PURPOSE The National Institute of Dental Research (NIDR) supports studies to improve knowledge of the development, structure, function, and diseases of the salivary glands and to determine the influence of salivary constituents on oral health. Toward this end, the NIDR seeks to enhance its support of basic and clinical research in the broad area of the salivary system. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Research on Salivary Glands and Secretions, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Domestic applications may include international components. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. Applications from minority individuals and women are encouraged. Special eligibility requirements specified in the pertinent guidelines for the various mechanisms available for support of this program must be met. MECHANISMS OF SUPPORT The mechanisms available for support of this program include the traditional research project grant (R01), the program project grant (P01), the First Independent Research Support and Transition (FIRST) (R29) award, and the small grant (R03). Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Background Salivary gland research over the past two decades has been compartmentalized into two general areas: (1) salivary secretions (extracellular events) and (2) salivary glands (intracellular processes). Our knowledge of salivary secretions has proceeded at a faster pace than that of intracellular processes. Nevertheless, salivary research is at a crossroads due to the emergence of new biologies, most notably recombinant technologies, cell biology, and protein engineering. Indeed, the future of salivary research will require the integration of these new disciplines with the more traditional disciplines. Salivary researchers are at the critical threshold of having a large volume of scientific information that can be applied clinically towards enhancing natural defense mechanisms. For example, studies in the not-too-distant future could be directed toward topical vaccines against oral disease, the development of artificial salivas, or the diagnostic use of sialochemistry by dental practitioners. Before these clinical goals can be achieved, however, additional research is needed regarding the intracellular and extracellular events that modulate saliva secretion and function. Finally, clinical applications will demand consideration of normal vs. the compromised host, normal vs. high-risk populations, and local vs. systemic diseases in order to develop the appropriate diagnostic and treatment modalities. Research Goals and Scope The NIDR has been a mainstay of support for research and related training on salivary glands and their secretions and has thus contributed to advances in basic research and furthered progress in understanding diseases or syndromes in which salivary gland function is compromised. Based on recommendations by the Dental Research Programs Advisory Committee at its June 7-8, 1988 meeting, the NIDR "Broadening the Scope: Long-Range Research Plan for the Nineties," and the NIDR-sponsored international conference on "Contemporary Developments in Salivary Research" organized by Dr. Michael J. Levine and held on November 6-10, 1991 at Buffalo, New York, the NIDR desires to enhance its support of both basic and clinical research in the broad area of this announcement. Accordingly, applications are invited for research project grants (including minority research supplements), program project grants, FIRST awards, and small grants related, but not limited to, the following areas: o Description of the characteristics of the salivary-associated lymphoid tissue with emphasis on: (a) the mechanisms of homing of immune component cells to and within salivary glands, (b) the cellular elements and factors regulating differentiation and antibody production within specific gland types, including neuropeptide modulation of salivary immunity, (c) the intrinsic and extrinsic factors involved in the ontogeny of salivary immunity, and (d) specific enhancement of host defenses using local antigen delivery methods. o Definition of the molecular mechanisms involved in salivary secretion with emphasis on: (a) the diversity of signal transduction processes present in different salivary tissues and species, (b) the mechanisms of sorting and packaging of stored proteins into secretory granules in acinar cells, and (c) the mechanisms of secretory granule-plasma membrane fusion and its role on the process of exocytosis. o Further definition of the mechanisms of salivary-specific gene expression in developing and adult glands of various species with emphasis on: (a) the trans-acting factors that modulate gene transcription, and (b) the exogenous factors that modulate gene expression, thereby enabling genetic manipulation of salivary glands to address clinical problems. o Development of sophisticated model systems (transgenic animals and immortalized salivary gland epithelial cell lines with appropriate phenotypic expression) to investigate normal cellular processes and those evident in disease. o Extension of studies of the structure and function of salivary macromolecules to determine specific functional domains. o Confirmation of the biological role of individual salivary molecules in vivo. o Definition of salivary function in acquired immune deficiency syndrome (AIDS) and clarification of the role of salivary secretions in preventing oral transmission of human immunodeficiency virus (HIV). o Further research on the use of saliva to diagnose and monitor drug therapy and abuse, endocrine function, systemic disease, oral health, genetic defects, nutritional status, and age-specific changes. o Further investigations on the epidemiology, etiology, pathogenesis, diagnosis, and treatment of salivary gland disorders, such as Sjogren's syndrome. o Development of new sialogogues and improved, long-acting saliva substitutes. o Development of methods to expand and improve function of residual salivary gland tissue after destructive disease or therapy (e.g., radiation or chemotherapy to treat head and neck cancers). This research should include methods aimed at tissue repair and regeneration. o Development of organoids and techniques for the preservation and transplantation of salivary glands. It should be reemphasized that the above list of potential areas of investigation is not intended to be either comprehensive or exclusive, nor is it in order of priority. Rather, it is intended to exemplify the wide variety of new and/or continuing program emphases. 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 for 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 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications will be accepted in accordance with the receipt, Initial Review Group, National Advisory Council, and earliest possible beginning dates specified in the pertinent application kits. The specific application forms and kits required in this connection are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The YES box must be checked and the title, Research on Salivary Glands and Secretions, and number of the announcement must be typed in Section 2a on the face page of the application form PHS 398 (rev. 9/91). FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with standard NIH peer review procedures and the review criteria customary for the support mechanism selected. Following scientific-technical review, the applications will receive a second-level review by one or more appropriate national advisory councils or boards. AWARD CRITERIA Applications recommended for further consideration will compete for available funds with all other applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program balance among research areas of the announcement. The NIDR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: G.G. Roussos, Ph.D. Director, Salivary Research and Oral Biology Centers Program Extramural Program National Institute of Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 496-7784 Direct inquiries regarding fiscal matters to: Ms. Theresa Ringler Chief, Grants Management Section Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 496-7437 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ ERRATA $$E1 BEGIN R9 19921211 APPEND RFA AR-93-03 FULL ************************ SKIN DISEASES RESEARCH CORE CENTERS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: AR-93-03 P.T. 04; K.W. 0715185, 0710070, 0710031 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: May 10, 1993 Application Receipt Date: June 18, 1993 In the full text of the RFA, under FUNDS AVAILABLE, the first sentence should read "The NIAMS intends to fund two SDRCs from this RFA..." As released, the RFA says three rather than two. The correct information was provided in the Notice of Availability of the RFA. INQUIRIES Dr. Michael Lochshin Director of Extramural Programs National Institute of Arthritis and Musculoskeletal and Skin Diseases Telephone: (301)-496-0802 $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Thu Jan 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 1, pt. 2, 8 January 1993 Message-ID: Date: 8 Jan 93 03:02:04 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1500 $$XID NIHGUIDE 19930108 V22N01 P2O3 ************************************ amended, Public Law 99-158, 42 USC 285a) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R10 END *********************************************************** $$R11 BEGIN AI-93-05 FULL-TEXT ************************************** INTERNATIONAL COLLABORATIONS IN INFECTIOUS DISEASE RESEARCH NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: AI-93-05 P.T. 34; K.W. 0715125, 0785215 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 12, 1993 Application Receipt Date: July 13, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) plans to continue its efforts in international health through a program of collaborative biomedical research on infectious diseases that are primarily endemic in or profoundly impact upon the health of people living in the tropics. The Parasitology and Tropical Diseases (PTD) Branch of the Division of Microbiology and Infectious Diseases (DMID), NIAID, therefore invites grant applications for International Collaboration in Infectious Diseases Research (ICIDR). The intent of this program is to bring together relevant biomedical knowledge and technology to develop new approaches for the detection, prevention and treatment of infectious diseases of recognized relevance to the health of people living in tropical countries; to increase relevant research experience for both U.S. and foreign investigators; and to enhance opportunities for scientific linkages and interaction between U.S. and foreign investigators through regularly scheduled meetings coordinated by the PTD Branch. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, International Collaborations in Infectious Disease Research, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of a "Healthy People 2000" (Full Report: Stock No. 017-001-00474-O) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, medical colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to participate. The U.S. grantee institution is responsible for developing an affiliation(s) with an established institution (e.g., university, research institute, federal or state health department, hospital) in a country where tropical diseases are endemic. Research activities on this project conducted at the foreign affiliate must be supported by the award made to the U.S.-based institution. For the grant award to be considered, the domestic applicant institution must include proof of having an off-site component as a foreign base of operations and one or more specified employees of the foreign institution(s) as co-investigators. The proposed research programs must be acceptable to the resident (foreign) scientists and to the advisory group(s) of their particular institution. The grant application will not be reviewed unless proof of an acceptable foreign affiliation is included. Proof of such an agreement must be submitted to Dr. Olivia Preble at the address listed under INQUIRIES, no later than two months after the application receipt date, in order to assure its availability prior to grant review. MECHANISM OF SUPPORT Successful applicants funded under this RFA will be supported through cooperative agreements (U01). This type of funding mechanism is utilized when it is desired to encourage investigator-initiated research projects in areas of special importance to the National Institutes of Health (NIH) and when substantial programmatic assistance by NIH staff is anticipated. The cooperative agreement funding instrument can support projects of either a multicomponent (program project-like) or single component nature, and both types of applications will be considered under this RFA. The awardee will be responsible for the planning, direction, and execution of the proposed project. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary review procedures. The total project period for applications submitted in response to the present RFA may not exceed five years. Reissuance of this RFA is uncertain. If, by the end of the third year of the award, NIAID has not announced its intent, due to budget uncertainties, to reissue the RFA, incumbents of multicomponent U01s should contact program staff before preparing a recompeting application to seek advice on the most appropriate method of application submission. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for all ICIDR awards are $3.5 million. It is anticipated that at least five awards will be made, which may represent new awards or competing continuation awards of currently funded projects. Applications for multicomponent grants should not exceed $500,000 in annual direct costs, while single component applications should not exceed $175,000 in direct costs annually. RESEARCH OBJECTIVES Tropical diseases constitute major public health problems disproportionately affecting populations residing in developing countries. The purpose of this RFA is to stimulate high quality collaborative research on those infectious diseases primarily endemic in or profoundly impacting upon people living in the tropics, including but not limited to protozoan and helminth infections, mycobacterial diseases, bacterial and viral enteric infections, and arboviral infections. Studies of human immunodeficiency virus (HIV) infection per se in developing countries will not be considered in response to this solicitation. Studies of the impact of HIV infection on the clinical course and outcome of these other tropical diseases will, however, be considered. The overall research goals of this RFA are: (1) to obtain increased information on the factors influencing distribution of infection and resulting clinical outcome and (2) to develop and test new intervention strategies that will contribute to the control of these diseases. It is the intent of the program to support the conduct of biomedical research that can only be performed outside the U.S., and thus, an emphasis on population-based studies would be appropriate. It is anticipated that these studies may involve such topics as diagnosis and natural history of infection (including the role of vectors and reservoir hosts), chemo- or immunotherapy, chemo- or immunoprophylaxis, pathogenesis and vector control. The majority of the research, in terms of personnel effort, must be conducted in the endemic area, and there must be active collaboration between domestic staff and scientists of the foreign affiliate(s). SPECIAL REQUIREMENTS Successful applicants will be designated as components of the NIAID International Centers for Tropical Disease Research (ICTDR), which constitutes a network of NIAID-supported activities in tropical diseases. Each ICIDR director will represent his/her program at annual centers meetings organized by the NIAID. These meetings will be held to share advances in tropical disease research among the ICIDR projects and other NIAID-tropical disease units, to discuss research needs and opportunities in this arena, and to facilitate the development of new collaborations. To encourage cross-fertilization of ideas and facilitate exchange of scientific personnel, a Visiting Scientist component must be included in these applications to provide for short-term travel of ICIDR personnel to other research institutions, or of other U.S. investigators to ICIDR facilities for the purpose of conducting specific research projects. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. 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. Applications without such documentation will not be accepted for review. The awardee should ensure that all requirements for the protection of human subjects, including the negotiation of human subject assurances for clinical studies performed at the foreign institution, are adhered to as described in 45 CFR Part 46. Studies involving human subjects which are conducted at the foreign site must adhere to current guidelines and policies in effect within the United States. Questions regarding these policies may be directed to the Office of Protection from Research Risk (OPRR). (See INQUIRIES below for address and phone numbers). LETTER OF INTENT Prospective applicants are asked to submit, by April 12, 1993, a letter of intent that includes a descriptive title of the proposed research, the names and affiliations of proposed key investigators. The letter of intent is requested in order to provide an indication of the number and scope of applications to be reviewed. This does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent is to be sent to Dr. Olivia Preble, at the address list under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), which is the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. In addition, applicants for multicomponent grants are strongly advised to read the information brochure "Program Project and Center Grants, NIAID", available from Dr. Michael Gottlieb at the address listed under INQUIRIES. Applications must be received by both the Division of Research Grants (original and 3 copies) and Dr. Olivia Preble (2 copies) by July 13, 1993. REVIEW CONSIDERATIONS Applications will be reviewed by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or nonresponsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group. Those applications judged to be competitive for award will be reviewed for scientific and technical merit by a Review Committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Michael Gottlieb Parasitology and Tropical Diseases Branch Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-37 Bethesda, MD 20892 Telephone: (301) 496-7115 FAX: (301) 402-0804 Send the Letter of Intent and direct any questions regarding review procedures to: Dr. Olivia Preble Chief, Microbiology and Immunology Review Section Scientific Review Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Chief, Microbiology Grants Management Section Grants Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-37 Bethesda, MD 20892 Telephone: (301) 496-7075 Questions concerning policies for studies involving human subjects may be directed to: Chief, Assurance Branch Division of Human Subjects Protection Office for Protection from Research Risks National Institutes of Health Bethesda, MD 20892 Telephone: (301) 496-7041 Fax: (301) 402-0527 Schedule Letter of Intent Receipt Date: April 12, 1993 Application Receipt Date: July 13, 1993 Scientific Review Date: November 1993 Council Meeting Date: February 1994 Earliest Award Date: May 1, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease 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. $$R11 END *********************************************************** $$R12 BEGIN EY-93-01 FULL-TEXT ************************************** CLINICAL CENTERS FOR OCULAR HYPERTENSION TREATMENT STUDY NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: EY-93-01 P.T. 34; K.W. 0715115, 1002046, 0755015 National Eye Institute Application Receipt Date: March 12, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MANY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Eye Institute (NEI) invites applications for cooperative agreements to support participating clinics in the Ocular Hypertension Treatment Study (OHTS). The OHTS is an investigator- initiated randomized, multicenter, clinical trial to determine whether medical reduction of intraocular pressure prevents or delays the onset of glaucomatous optic nerve and/or visual field damage in ocular hypertensive subjects. 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), Clinical Center for Ocular Hypertension Treatment Study, is related to the priority area of reducing significant visual impairment due to glaucoma. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public or private, such as universities, colleges, hospitals, private practice clinicians, health maintenance organizations or managed health care organizations, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority individuals and from women are encouraged. MECHANISM OF SUPPORT Awards will be made as cooperative agreements (U10). This assistance mechanism of support will be used because there will be substantial, ongoing involvement of NEI staff during performance of the clinical trial and interaction between the awardee and NEI staff during performance of the project. This RFA is a one-time solicitation. FUNDS AVAILABLE It is expected that approximately 30 to 40 awards will be made as a result of this RFA. The total funds available for the first year of support are expected to be approximately $1.9 million; however, this support level is conditional upon the receipt of applications of substantial and significant scientific merit. Awards are expected to be made in November 1993. Although the financial plans of the NEI provide for these projects, awards pursuant to this RFA are also contingent upon the availability of funds. RESEARCH OBJECTIVES The OHTS is a randomized, multicenter clinical trial to determine whether medical reduction of intraocular pressure (IOP) prevents or delays the onset of glaucomatous optic nerve and/or visual field damage in ocular hypertensive subjects. One thousand five hundred subjects with IOP greater than or equal to 26 mm Hg in at least one eye (IOP greater than or equal to 21 mm Hg in the fellow eye) and normal visual fields and optic discs in both eyes will be assigned randomly to receive stepped medical treatment to both eyes or no treatment to both eyes. These subjects are considered to be at moderate risk for the development of open-angle glaucoma. The subjects will be followed twice yearly with automated, threshold, central, static Humphrey 30-2 perimetry; yearly optic disc photographs will be taken. The study endpoints are progressive optic disc cupping and/or reproducible glaucomatous visual field loss in either eye of a patient. All visual fields and optic disc photographs will be read in masked fashion by central reading centers. It is projected that the time required to recruit the required patients will be two years and that each patient will be followed for a minimum of five years. Thus, the entire project period will be seven years. During the course of the study, data will be collected for an analysis of the cost effectiveness of preventative treatment in ocular hypertension. This will include ascertainment of both direct costs of treatment as well as indirect nonmonetary costs. In addition, data will be collected on the impact of medical treatment on the patients' quality of life. SPECIAL REQUIREMENTS An organization applying as a clinical center in the OHTS must document its capability to recruit 25 or more fully eligible patients per year for the OHTS. Potential applicants are requested to contact the person named in INQUIRIES to receive selected chapters from the Manual of Operations that describes the details of the study design, inclusion and exclusion criteria for patients, and the schedule of patient visits and clinical procedures. The Principal Investigator will be responsible for all aspects of the day-to-day operations of his/her clinical center and the local implementation of the study protocol. He/She will have the primary responsibility to identify and recruit eligible patients for the OHTS. He/She will be responsible for the follow up of each patient enrolled in the clinical trial and submitting the required data to the Coordinating Center. STUDY POPULATIONS For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES The Application for Public Health Service Grants Form PHS-398 (revised 9/91) must be used in applying for these cooperative agreements. These forms are available at institutional business offices or from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Bethesda, Maryland 20892. Information about application procedures may be obtained from: Janet M. Cuca, Ph.D. Review and Special Projects Officer National Eye Institute Building 31, Room 6A06 9000 Rockville Pike Bethesda, Maryland 20892 Applications must be received by March 12, 1993. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Applications will be evaluated in accordance with the criteria stated below by an initial review group that will be convened by the Review and Special Projects Office, NEI. Applications will then undergo second-level review by the National Advisory Eye Council. In the event of a large response to this RFA, applications may be subject to triage by a peer review group to determine their relative scientific merit. The NEI will remove from further consideration those applications judged by the triage process to be noncompetitive for award and notify the applicant and institutional official. Those applications judged to be competitive will undergo further review. The factors considered in evaluating responses to this RFA will be: 1. Experimental Design: adequacy of the participating clinic's procedures for patient recruitment and patient retention and followup, data collection and data management, quality control of clinical examinations, training and certification of personnel, testing and monitoring of study procedures; 2. Personnel: qualifications of all key personnel (whether compensated from the grant or not), including their experience and track record in clinical trials (NEI-supported and other); 3. Resources and Facilities: sources and numbers of fully-eligible patients, of patients with related disorders, and of eligible patients likely to have participated in the study who were seen over a recent one-year period; documentation of intended collaborations; the clinic's recruitment and retention track record in clinical trials; the physical facilities and equipment available for the study; and, 4. Budget: appropriateness and reasonableness of all items requested relative to the overall scope of the study, the potential for patient recruitment, and the budget justifications provided in the application. These competitive applications will undergo initial review by the Vision Research Review Committee on June 21-22, 1993, and receive second-level review by the National Advisory Eye Council at its September 9-10, 1993, meeting. AWARD CRITERIA The anticipated date of award is November 1993. Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs, and the availability of funds. The total cost of each application will also be taken into consideration. INQUIRIES Written and telephone inquires concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applications is welcome. Potential applicants are requested to write or telephone Dr. Richard L. Mowery to receive copies of selected chapters from the OHTS Manual of Procedures that will be helpful in preparing an application for submission. Direct requests for the RFA and inquiries regarding programmatic issues to: Dr. Richard L. Mowery Chief Collaborative Clinical Research Branch National Eye Institute Building 31, Room 6A49 9000 Rockville Pike Bethesda, Maryland 20892 Telephone: 301-496-5983 FAX: 301-402-0528 Direct inquiries regarding administrative matters to: Gaye Lynch Chief, Grants Management Section National Eye Institute Building 31, Room 6A48 9000 Rockville Pike Bethesda, Maryland 20892 Telephone: 301-496-5884 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.868. 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 Parts 74 and 92, as applicable. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R12 END *********************************************************** $$R13 BEGIN AR-93-004 FULL-TEXT ************************************* MYCOPLASMA AND OTHER INFECTIOUS AGENTS AS A CAUSE FOR RHEUMATIC DISEASES NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: AR-93-004 P.T. 34; K.W. 0715170, 0715103, 0715125, 0715015, 0715126 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRES, BELOW. PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute of Allergy and Infectious Diseases (NIAID) invite applications for research aimed at studying the possible causal relationship between mycoplasma and other infections and chronic systemic rheumatic diseases. The goal of the RFA is to investigate whether any of the chronic inflammatory rheumatic diseases might be caused by infection, and if so, which infection and by what mechanisms. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Mycoplasma and Other Infectious Agents as a Cause for Rheumatic Diseases, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "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 applications as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT The mechanism of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01) and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50-000, revised October 1, 1991. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. 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. FUNDS AVAILABLE Up to $925,000 for the first-year and additional approved expenses for up to five years has been committed to fund applications submitted in response to this RFA. The NIAMS and the NIAID plan to make approximately three to four and one to two awards, respectively, in FY 1993, contingent upon receipt of highly meritorious applications. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and the availability of funds. RESEARCH OBJECTIVES The chronic systemic rheumatic illnesses constitute an important burden for the United States. They disproportionately affect women and minority populations. These illnesses include rheumatoid arthritis, which is estimated to affect up to two percent of all Americans, systemic lupus erythematosus, juvenile arthritis, and ankylosing spondylitis and Reiter's syndrome. These illnesses share characteristic immunologic abnormalities; pathologically they demonstrate sterile inflammation, i.e., inflammation in which no infectious agent has been consistently identified. Nonetheless, based on both anatomic pathology and on clinical characteristics, suspicion remains that infectious agents including mycoplasma may play an important role in the development of these illnesses. In the recent past, several systemic rheumatic diseases have been demonstrated to be associated with infection, though the precise relationship between infection and the rheumatic illness is not yet known. The associations include that of hepatitis B infection with systemic necrotizing vasculitis (polyarteritis nodosa), hepatitis C infection with IgG-IgM cryoglobulinemia, and the documentation that an epidemic form of arthritis, primarily in children, is caused by infection with a previously unidentified spirochete Borrelia burgdorferi. Such findings have given impetus to the concept that infection can, in fact, trigger rheumatic illness. Mycoplasma has on occasion been suspected to be a trigger, but this hypothesis remains controversial. Autoantibodies frequently found in patients with rheumatic illness parallel antibodies that occur in a variety of infectious illnesses. The identification of potential microbial triggering agents for the reactive arthritis and for the spondyloarthropathies and a demonstration of the potential molecular relationships between the HLA B27 histocompatibility antigen and certain enteric pathogens gives further support to the hypothesis that infection triggers rheumatic diseases. The identification of pathogenic organisms, or description of the relationship between acute or persistent infections and chronic rheumatic illness, will lead to dramatic changes in current concepts of therapy and may lead as well to effective preventive measures. This RFA, therefore, seeks research projects that will advance knowledge in this field. STUDY POPULATIONS For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study popula-tions. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provid-ed. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by March 5, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIAMS staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to Dr. Tommy Broadwater at the address listed under INQUIRIES. APPLICATION PROCEDURE The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The completed and signed, typewritten original application and three signed, exact, clear, 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** At time of submission, two additional copies of the application must also be sent under separate cover to: Dr. Tommy Broadwater Chief, Review Branch, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 404 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by April 8, 1993. If an application is received after that date, it will be returned to the applicant without review. REVIEW PROCEDURES Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicants without further consideration. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by an appropriate peer review group convened by the NIAMS. Applications may be subject to triage by an NIAMS peer review group to determine scientific merit relative to other applications received in response to this RFA. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following initial review, applications will receive a second level review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council or the National Allergy and Infectious Diseases Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally similar as those for unsolicited investigator-initiated research grant applications. Schedule Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 Initial Review: June 1993 Second Level Review: September 9, 1993 Anticipated Date of Award: September 30, 1993 AWARD CRITERIA Applications will compete for available funds with all other applications responsive to this RFA. The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries regarding this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Susana A. Serrate-Sztein Director, Arthritis Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3340 Dr. Howard Dickler Chief, Clinical Immunology Branch Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A10 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Direct inquiries regarding fiscal matters to: Diane M. Watson Chief, Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732A Bethesda, MD 20892 Telephone: (301) 402-3352 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research and No. 93.855, Allergy, Immunology and Transplantation Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) 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. $$R13 END *********************************************************** $$R14 BEGIN AR-93-005 FULL-TEXT ************************************* RESEARCH ON CAUSAL MECHANISMS IN SYSTEMIC LUPUS ERYTHEMATOSUS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: AR-93-005 P.T. 34; K.W. 0715015, 0755030, 1002008, 1002019, 0710070 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute of Allergy and Infectious Diseases (NIAID) invite applications focused on the mechanisms and causes of tissue injury in systemic lupus erythematosus (SLE). The goals of the research are to identify and analyze the factors and mechanisms of tissue injury not only in the kidneys but in the brain and other organs, using advanced molecular, genetic, and immunological approaches; to develop new experimental systems to study and test the pathogenicity of human autoantibodies and autoreactive cells related to lupus; to elucidate the genetic factors important in the development of the illness; and to characterize the mechanisms involved in induction or exacerbation of disease by environmental factors. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Research on Causal Mechanisms in Systemic Lupus Erythematosus, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit applications as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT The mechanisms of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01) and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is September 30, 1993. Because the nature and scope of the proposed research may vary, it is anticipated that the size of an award will vary also. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50-000, revised October 1, 1991. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. 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 within the application. FUNDS AVAILABLE Up to $1,925,000 for the first-year and additional approved expenses for up to five years has been committed to fund applications submitted in response to this RFA. The NIAMS and the NIAID plan to make approximately seven to ten and one to two awards, respectively, in FY 1993, contingent upon receipt of highly meritorious applications. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and the availability of funds. RESEARCH OBJECTIVES Systemic lupus erythematosus (SLE) is an acute and chronic illness predominantly affecting young women, and affecting Afro-Americans disproportionately to Americans of European descent. This illness is characterized by a wide array of humoral and cellular immunological abnormalities involving both up-regulation and down-regulation of critical elements of the immune system. The order in which components of immunological dysregulation occur, i.e., which is a primary and which is secondary event, is not well understood. In some cases, the defective immune responses may be genetically determined. The occurrence of SLE is clearly related to the inheritance of a specific HLA types and C4 complement types, but not all persons with the characteristic genetic background are affected. To the contrary, identical twins discordant for disease are regularly seen, suggesting that environmental factors contribute to the disease. Whether these external factors induce the initial occurrence of the disease or are responsible for subsequent flares of the illness is unknown. An immunological model of the illness has dominated thinking for the past several decades. This model invokes the occurrence of autoantibodies (primarily to double-stranded DNA), the formation of immune complexes consisting of these antibodies and their antigens, the deposition of these complexes in vulnerable areas, such as the glomerular basement membrane, inducing complement-dependent tissue injury. This model has not satisfactorily explained many forms of injury seen in patients with lupus, including neurological and cardiac pathology and coagulation abnormalities. Other forms of tissue injury have occasionally been identified. These latter forms include the activities of cytotoxic antibodies, pathological regulation of a variety of cytokines, coagulation abnormalities leading to non- inflammatory vascular occlusion, and other phenomena. It is the purpose of this RFA to explore these additional causes. The RFA requests individual research projects (R01 and R29) that address questions relevant to defining the causes of the disease and mechanisms of tissue injury in SLE. STUDY POPULATIONS For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by March 5, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the statement, "submitted in response to AR-93-005, Research on Causal Mechanisms in Systemic Lupus Erythematosus." 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 NIAMS and NIAID staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to: Dr. Tommy Broadwater Chief, Review Branch, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 404 Bethesda, MD 20892 Telephone: (301) 496-0754 APPLICATION PROCEDURE The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. Applications must be received by April 8, 1993. REVIEW PROCEDURES Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by an appropriate peer review group convened by the NIAMS. Applications may be subject to triage by an NIAMS peer review group to determine scientific merit relative to other applications received in response to this RFA. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following initial review, applications will receive a second level review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council or the National Allergy and Infectious Diseases Advisory Council unless not recommended for further consideration by the initial review group. The National Institute of Environmental Health Sciences has primary interest in toxicological influences of the immune system. Applications of this description may be referred to that Institute. Review criteria for RFAs are generally similar as those for unsolicited investigator-initiated research grant applications. Schedule Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 Initial Review: June 1993 Second Level Review: September 9, 1993 Anticipated Date of Award: September 30, 1993 AWARD CRITERIA Applications will compete for available funds with all other applications responsive to this RFA. The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries regarding this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Susana A. Serrate-Sztein Director, Arthritis Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3340 Dr. Howard Dickler Chief, Clinical Immunology Branch Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A10 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Direct inquiries regarding fiscal matters to: Diane M. Watson Chief, Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732A Bethesda, MD 20892 Telephone: (301) 402-3352 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research and No. 93.855, Allergy, Immunology and Transplantation Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) 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. $$R14 END *********************************************************** $$R15 BEGIN AR-93-006 FULL-TEXT ************************************* SYSTEMIC LUPUS ERYTHEMATOSUS IN WOMEN AND MINORITIES NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: AR-93-006 P.T. 34, FF, II; K.W. 0715015, 1002004, 1002008, 0785055, 0760002 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRES, BELOW. PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for research projects aimed at identifying the biological and social factors that contribute to the disproportionate prevalence of systemic lupus erythematosus (SLE) in women and minority populations. The goal of this RFA is to promote research that will improve our knowledge of the genetic, cellular, molecular and environmental elements that predispose to and initiate immune responses that lead to tissue damage and clinical manifestation of SLE. These studies include the analysis of their possible interaction and synergy, and the identification and characterization of critical epidemiological, biological and genetic markers that may be used for diagnosis, prognosis or that may be subject to manipulation as a means of affecting disease outcome in women and minority 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 RFA, Systemic Lupus Erythematosus in Women and Minorities, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit applications as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT The mechanisms of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01) and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50-000, revised October 1, 1991. This RFA is a one- time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. 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 within the application. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support is $1.0 million. Approximately four to six awards are anticipated. Funding will depend on receiving applications judged highly meritorious by peer review. The total project period for these awards may not exceed five years. However, this level of support is dependent upon receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAMS, the award of a grant pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Systemic lupus erythematosus (SLE) is a serious acute and chronic illness. The disease disproportionately affects women primarily between the ages of 15 and 45. In the United States, women of African descent are affected approximately three times as frequently as are women of European descent. Worldwide, similar sex ratios are seen, and there have been unconfirmed suggestions that in the United States persons of Hispanic, East Asian, and Native American background are affected more frequently than persons of European ancestry. Although there are multiple genetic differences among different ethnic and racial groups, no single genetic difference related to susceptibility to systemic lupus erythematosus has been found. Susceptibility to age of onset and disease severity are probably linked to multiple genetic and environmental factors. These factors may vary among different populations defined by race and gender but the data are still preliminary and incomplete. Further, the effects of socioeconomic status on disease susceptibility, response to treatment and prognosis remain unknown. Numerous investigations focusing on the hormonal events of female puberty and child-bearing have provided clues but no definitive answers. These clues have led some clinicians strongly to advise against the use of exogenous hormones (oral contraceptives and estrogen replacement therapy) in persons with lupus, but there is no clear documentation that this advice is appropriate. The purpose of this RFA is to provide data that will answer some of these questions and to promote the design and use of new approaches to study this problem. STUDY POPULATIONS For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by March 5, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIAMS staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to: Dr. Tommy Broadwater Chief, Review Branch, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 404 Bethesda, MD 20892 Telephone: (301) 496-0754 APPLICATION PROCEDURE The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The completed and signed, typewritten original application and three signed, exact, clear, 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 PROCEDURES Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicants without further consideration. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by an appropriate peer review group convened by the NIAMS. Applications may be subject to triage by an NIAMS peer review group to determine scientific merit relative to other applications received in response to this RFA. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following initial review, applications will receive a second level review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally similar as those for unsolicited investigator-initiated research grant applications, Schedule Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 Initial Review: June 1993 Second Level Review: September 9, 1993 Anticipated Date of Award: September 30, 1993 AWARD CRITERIA Applications will compete for available funds with all other applications responsive to this RFA. INQUIRIES Written and telephone inquiries regarding this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Susana A. Serrate-Sztein Director, Arthritis Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3340 Direct inquiries regarding fiscal matters to: Diane M. Watson Chief, Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732A Bethesda, MD 20892 Telephone: (301) 402-3352 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) 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. $$R15 END *********************************************************** $$R16 BEGIN GM-93-003 FULL-TEXT ************************************* PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: GM-93-003 P.T. 22 National Institute of General Medical Sciences Application Receipt Date: April 27, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA AND GUIDELINES FROM THE CONTACT NAME IN INQUIRIES, BELOW. PURPOSE The National Institute of General Medical Sciences (NIGMS) is soliciting applications for individual National Research Service Award (NRSA) Predoctoral Fellowships for Minority Students. These fellowships will provide up to five years of support for research training leading to either the Ph.D. degree or the combined M.D./Ph.D. or other combined professional doctorate/research Ph.D. degrees in the biomedical sciences for highly qualified students from minority groups found to be underrepresented in the biomedical and behavioral sciences. Support is NOT available for individuals enrolled in medical or other professional schools UNLESS they are enrolled in a combined professional doctorate/Ph.D. degree program in biomedical research. The intent of this Minority Predoctoral Fellowship Program is to make graduate fellowships available to underrepresented minority graduates from all institutions, including the many minority undergraduate students who have participated in the various NIH-sponsored programs to prepare them for research careers. Graduates of the MARC Program are encouraged to apply to the MARC Predoctoral Fellowship Program. ELIGIBILITY REQUIREMENTS Eligibility for these awards is limited to students who are U.S. citizens, non-citizen nationals, or permanent U.S. residents. Applicants must currently be enrolled in a Ph.D. or combined M.D./Ph.D. (or other combined professional doctorate/research Ph.D. graduate) program in the biomedical sciences, or have been accepted by and agreed to enroll in such a graduate program in the 1993- 94 academic year. Applicants must be from ethnic/racial groups that have been determined by their sponsoring institution to be underrepresented in research in the biomedical sciences in the U.S. In making these awards, the NIH will give priority consideration to applications from Blacks, Hispanics, Native Americans, and Pacific Islanders and other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. MECHANISM OF SUPPORT The mechanism of support is the individual fellowship (F31) awarded under the auspices of the NRSA Act. Except as otherwise stated in the RFA, awards will be administered under the PHS Grants Policy Statement and the Guidelines for National Research Service Awards. Fellows receiving these awards are subject to the payback obligations of the National Research Service Award. The fellowship provides a stipend for the student's living expenses, applicable tuition and fees, and an annual institutional allowance that may be used for travel to scientific meetings and for laboratory and other training expenses. FUNDS AVAILABLE For FY 1993, between 30 and 45 new fellowship awards will be made, if sufficient numbers of high quality applications are received. In addition to the NIGMS, the following awarding components of the NIH are providing funds to support this program: the National Institute on Aging, the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Cancer Institute, the National Institute on Deafness and Other Communication Disorders, the National Institute of Environmental Health Sciences, the National Eye Institute, and the National Heart, Lung, and Blood Institute. REVIEW CONSIDERATIONS The review criteria include the academic record and research experience of the applicant; quality of the graduate program in which the applicant is already enrolled or plans to enroll; qualifications and research/research training experience of the applicant's sponsor or researcher advisor; the match between the research interests of the student and the research advisor/sponsor; for advanced graduate students, scientific significance, originality and feasibility of proposed research; and, for beginning students, quality and clarity of stated research interests. APPLICATION PROCEDURES The single receipt date for applications is April 27, 1993. The regular fellowship application form PHS 416-1 (rev.10/91) must be used in applying for these grants. These forms are available at most university business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, Telephone (301) 496-7441 and from the NIH program administrators named below. INQUIRIES Written and telephone inquiries and requests for the RFA are encouraged and may be directed to: Dr. Irene Eckstrand National Institute of General Medical Sciences Room 918 Westwood Building Bethesda, MD 20892 Telephone: (301) 496-7137 For fiscal and administrative matters contact: Ms. Ruth Monaghan Deputy Grants Management Officer National Institute of General Medical Sciences Westwood Building, Room 953 Bethesda, MD 20892 Telephone: (301) 496-7746 AUTHORITY AND REGULATIONS Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, 42 USC 288) and administered under PHS grant policies and Federal Regulations 42 CFR Part 66. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R16 END *********************************************************** $$R17 BEGIN DK-93-19 FULL-TEXT ************************************** INTERSTITIAL CYSTITIS AND OTHER BLADDER DISORDERS OF WOMEN NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA AVAILABLE: DK-93-19 P.T. 34, II; K.W. 0705075, 0715125 National Institute of Diabetes and Digestive and Kidney Diseases From owner-sci-resources@net.bio.net Thu Jan 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 1, pt. 5, 8 January 1993 Message-ID: Date: 8 Jan 93 03:08:59 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1251 $$XID RFA AR93006 AR-93-006 P1O1 *************************************** SYSTEMIC LUPUS ERYTHEMATOSUS IN WOMEN AND MINORITIES NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: AR-93-006 P.T. 34, FF, II; K.W. 0715015, 1002004, 1002008, 0785055, 0760002 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for research projects aimed at identifying the biological and social factors that contribute to the disproportionate prevalence of systemic lupus erythematosus (SLE) in women and minority populations. The goal of this Request for Applications (RFA) is to promote research that will improve our knowledge of the genetic, cellular, molecular, and environmental elements that predispose to and initiate immune responses that lead to tissue damage and clinical manifestation of SLE. These studies include the analysis of their possible interaction and synergy, and the identification and characterization of critical epidemiological, biological, and genetic markers that may be used for diagnosis, prognosis or that may be subject to manipulation as a means of affecting disease outcome in women and minority 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 RFA, Systemic Lupus Erythematosus in Women and Minorities, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit applications as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT The mechanisms of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01) and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is September 30, 1993. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50-000, revised October 1, 1991. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. 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 within the application. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support is $1.0 million. Approximately four to six awards are anticipated. Funding will depend on receiving applications judged highly meritorious by peer review. The total project period for these awards may not exceed five years. However, this level of support is dependent upon receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAMS, the award of a grant pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Systemic lupus erythematosus (SLE) is a serious acute and chronic illness. The disease disproportionately affects women primarily between the ages of 15 and 45. In the United States, women of African descent are affected approximately three times as frequently as are women of European descent. Worldwide, similar sex ratios are seen, and there have been unconfirmed suggestions that in the United States persons of Hispanic, East Asian and Native American background are affected more frequently than persons of European ancestry. Although there are multiple genetic differences among different ethnic and racial groups, no single genetic difference related to susceptibility to systemic lupus erythematosus has been found. Susceptibility to age of onset and disease severity are probably linked to multiple genetic and environmental factors. These factors may vary among different populations defined by race and gender but the data are still preliminary and incomplete. Further, the effects of socioeconomic status on disease susceptibility, response to treatment and prognosis remain unknown. Numerous investigations focusing on the hormonal events of female puberty and child-bearing have provided clues but no definitive answers. These clues have led some clinicians strongly to advise against the use of exogenous hormones (oral contraceptives and estrogen replacement therapy) in persons with lupus, but there is no clear documentation that this advice is appropriate. The purpose of this RFA is to provide data that will answer some of these questions and to promote the design and use of new approaches to study this problem. Appropriate research areas might include, but are not limited to: o Studies elucidating the cellular, molecular and behavioral basis for the observed differences in lupus prevalence between men and women. o Studies to identify and characterize the genetic factors associated with lupus in minority populations and the mechanisms by which they contribute to predisposition, onset and severity of disease. o Analysis of the molecular mechanisms involved in sex hormone regulation and immune self reactivity and their role in the induction and maintenance of disease. o Analysis of the contribution of non-hormonal gender factors to disease predisposition and resistance. o Studies on the effects of oral contraceptives and estrogen replacement therapies on immunological or clinical manifestations of the disease, including corticosteroid-induced osteoporosis. o Identification and characterizations of the factors that influence response to treatment by gender, ethnic group and socioeconomic status. 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 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' population, 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 5, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIAMS staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to: Dr. Tommy Broadwater Chief, Review Branch, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 404 Bethesda, MD 20892 Telephone: (301) 496-0754 APPLICATION PROCEDURE The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The RFA label available in the application kit must be affixed to the bottom of the face page. 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. In addition, "SYSTEMIC LUPUS ERYTHEMATOSUS IN WOMEN AND MINORITIES, AR-93-006" must be typed on line 2a of the face page of the application form and check the YES box. The completed and signed, typewritten original application and three signed, exact, clear, 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** At time of submission, two additional exact copies of the application must also be sent under separate cover to: Dr. Tommy Broadwater Chief, Review Branch, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 404 Bethesda, MD 20892 Applications must be received by April 8, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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 (P01). 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. REVIEW PROCEDURES Upon receipt, applications will be reviewed by the DRG for completeness. Incomplete applications will be returned to the applicants without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIAMS staff function. If the application is not responsive to the RFA, NIAMS 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 unsolicited applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by an appropriate peer review group convened by the NIAMS. Applications may be subject to triage by an NIAMS peer review group to determine scientific merit relative to other applications received in response to this RFA. If the number of applications submitted 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 if not competitive for the award. The NIAMS will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following initial review, applications will receive a second level review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally similar as those for unsolicited investigator-initiated research grant applications and include: o Scientific and technical merit criteria specific to the objectives of the RFA; o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to conduct 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 proposed 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. In addition, for foreign applications, the following criterion applies: o Uniqueness of research such that it can only be performed outside of the United States. Schedule Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 Initial Review: June 1993 Second Level Review: September 9, 1993 Anticipated Date of Award: September 30, 1993 AWARD CRITERIA Applications will compete for available funds with all other applications responsive to this RFA. The following items will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; and o Program balance among research areas represented in this RFA. The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries regarding this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Susana A. Serrate-Sztein Director, Arthritis Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3340 Direct inquiries regarding fiscal matters to: Diane M. Watson Chief, Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732A Bethesda, MD 20892 Telephone: (301) 402-3352 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) 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 AR93004 AR-93-004 P1O1 *************************************** MYCOPLASMA AND OTHER INFECTIOUS AGENTS AS A CAUSE FOR RHEUMATIC DISEASES NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: AR-93-004 P.T. 34; K.W. 0715170, 0715103, 0715125, 0715015, 0715126 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAID) and the National Institute of Allergy and Infectious Diseases (NIAID) invite applications for research aimed at studying the possible causal relationship between mycoplasma and other infections and the chronic systemic rheumatic diseases. The goal of the Request for Applications (RFA) is to investigate whether any of the chronic inflammatory rheumatic diseases might be caused by infection, and if so, which infection and by what mechanisms. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Mycoplasma and Other Infectious Agents as a Cause for Rheumatic Diseases, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "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 applications as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT The mechanism of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01) and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50-000, revised October 1, 1991. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. 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 within the application. FUNDS AVAILABLE Up to $925,000 for the first-year and additional approved expenses for up to five years has been committed to fund applications submitted in response to this RFA. The NIAMS and the NIAID plan to make approximately three to four and one to two awards, respectively, in FY 1993, contingent upon receipt of highly meritorious applications. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and the availability of funds. RESEARCH OBJECTIVES The chronic systemic rheumatic illnesses constitute an important burden for the United States. They disproportionately affect women and minority populations. These illnesses include rheumatoid arthritis, which is estimated to affect up to two percent of all Americans, systemic lupus erythematosus, juvenile arthritis, and ankylosing spondylitis and Reiter's syndrome. These illnesses share characteristic immunologic abnormalities; pathologically they demonstrate sterile inflammation, i.e., inflammation in which no infectious agent has been consistently identified. Nonetheless, based on both anatomic pathology and on clinical characteristics, suspicion remains that infectious agents including mycoplasma may play an important role in the development of these illnesses. In the recent past, several systemic rheumatic diseases have been demonstrated to be associated with infection, though the precise relationship between infection and the rheumatic illness is not yet known. The associations include that of hepatitis B infection with systemic necrotizing vasculitis (polyarteritis nodosa), hepatitis C infection with IgG-IgM cryoglobulinemia, and the documentation that an epidemic form of arthritis, primarily in children, is caused by infection with a previously unidentified spirochete Borrelia burgdorferi. Such findings have given impetus to the concept that infection can, in fact, trigger rheumatic illness. Mycoplasma has on occasion been suspected to be a trigger, but this hypothesis remains controversial. Autoantibodies frequently found in patients with rheumatic illness parallel antibodies that occur in a variety of infectious illnesses. The identification of potential microbial triggering agents for the reactive arthritis and for the spondyloarthropathies and a demonstration of the potential molecular relationships between the HLA B27 histocompatibility antigen and certain enteric pathogens gives further support to the hypothesis that infection triggers rheumatic diseases. The identification of pathogenic organisms, or description of the relationship between acute or persistent infections and chronic rheumatic illness, will lead to dramatic changes in current concepts of therapy and may lead as well to effective preventive measures. This RFA, therefore, seeks research projects that will advance knowledge in this field. Appropriate research areas may include, but are not limited to: o Identification of the role of and mechanisms used by pathogenic organisms such as mycoplasma in the induction and maintenance of self-reactivity and immune dysregulation in rheumatic diseases. o Studies on the effects of infection on self antigen processing and presentation, inflammatory cytokine and antibody production, and function of regulatory cells in human and experimental systems of rheumatic diseases, with emphasis on the mechanisms and molecular events mediating those effects. o Analysis of the relative contribution of the organism life cycle, products, components and the elicited host responses to the induction and maintenance of self-reactivity, immune dysregulation and tissue damage in rheumatic diseases. o Studies on the mechanisms involved in changes in the local environment induced by the pathogenic organisms and their products that lead to immune self-reactivity and tissue injury. o Development of new animal models of human chronic rheumatic diseases to establish the role of infectious agents in the etiology and pathogenesis of disease and to serve as models for therapeutic intervention. o Studies of the molecular basis for observed associations of HLA haplotypes and infection in rheumatic diseases and design of molecular approaches to manipulate this interaction to affect disease outcome. o Pilot studies of new forms of prevention and treatment of rheumatic diseases using anti-microbial agents to demonstrate feasibility for possible multicenter clinical trials. 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 (rev. 9/91) in SectionS 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' population, 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 5, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIAMS staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to: Dr. Tommy Broadwater Chief, Review Branch, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 404 Bethesda, MD 20892 Telephone: (301) 496-0754 APPLICATION PROCEDURE The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The RFA label available in the application kit must be affixed to the bottom of the face page. 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. 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. The completed and signed, typewritten original application and three signed, exact, clear, 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** At time of submission, two additional exact copies of the application must also be sent under separate cover to: Dr. Tommy Broadwater Chief, Review Branch, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 404 Bethesda, MD 20892 Applications must be received by April 8, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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 (P01). 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. REVIEW PROCEDURES Upon receipt, applications will be reviewed by the DRG for completeness. Incomplete applications will be returned to the applicants without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIAMS staff function. If the application is not responsive to the RFA, NIAMS 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 unsolicited applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by an appropriate peer review group convened by the NIAMS. Applications may be subject to triage by an NIAMS peer review group to determine scientific merit relative to other applications received in response to this RFA. If the number of applications submitted 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 if not competitive for the award. The NIAMS will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following initial review, applications will receive a second level review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council or the National Allergy and Infectious Diseases Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally similar as those for unsolicited investigator-initiated research grant applications and include: o Scientific and technical merit criteria specific to the objectives of the RFA; o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to conduct 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 proposed 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. In addition, for foreign applications, the following criterion applies: o Uniqueness of research such that it can only be performed outside of the United States. Schedule Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 Initial Review: June 1993 Second Level Review: September 9, 1993 Anticipated Date of Award: September 30, 1993 AWARD CRITERIA Applications will compete for available funds with all other applications responsive to this RFA. The following items will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; and o Program balance among research areas represented in this RFA. The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries regarding this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Susana A. Serrate-Sztein Director, Arthritis Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3340 Dr. Howard Dickler Chief, Clinical Immunology Branch Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A10 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Direct inquiries regarding fiscal matters to: Diane M. Watson Chief, Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732A Bethesda, MD 20892 Telephone: (301) 402-3352 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research and No. 93.855, Allergy, Immunology and Transplantation Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) 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 DK9314 DK-93-14 P1O1 ***************************************** INNOVATIVE APPROACHES TO THE STUDY OF INTERSTITIAL CYSTITIS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: DK-93-14 P.T. 34; K.W. 0705075, 0755020, 0760003 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 25, 1993 Application Receipt Date: March 25, 1993 PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is soliciting grant applications for support of studies focused on the study of interstitial cystitis, a disorder of the bladder also known as the painful bladder syndrome. The NIDDK is committed to increasing research into the urologic disorders that affect women's health. This request is part of the initiative to promote research in all areas of women's urologic health. 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), Innovative Approaches to the Study of Interstitial Cystitis, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as principal investigators. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01). 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. 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 five years. The earliest possible award date will be September 30, 1993. Applicants must limit their requests to not more than $100,000 direct costs for the initial budget period. FUNDS AVAILABLE For FY 1993, $1,500,000 will be committed by the NIDDK to fund applications submitted in response to this RFA. It is anticipated that 10 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. 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. Awards made from this RFA will be for the support of new projects. RESEARCH OBJECTIVES Interstitial Cystitis (IC) is a chronic, painful and variably incapacitating disorder that manifests a symptom complex consisting of pain in the region of the urinary bladder and associated pelvic musculature and variable motor and sensory dysfunctions of the urinary bladder. The purpose of this RFA is to solicit applications that propose unique, innovative approaches to the study of interstitial cystitis from investigators who are not currently being funded by the NIDDK for research on interstitial cystitis. It is not the intent to fund research in areas that are currently being supported by the NIDDK. Applications may be submitted for both non-human basic research and human clinical research studies. Examples of areas that could be studied include: o the role of the pelvic floor musculature and innervation in chronic bladder pain; o animal models of interstitial cystitis such as the feline urethral syndrome; o the relationship between bladder endothelins and the symptoms of interstitial cystitis; o release of urinary histamine as a marker for interstitial cystitis; o the relationship between reflex sympathetic dystrophy and the symptoms associated with interstitial cystitis; o the relationship between endometriosis and interstitial cystitis; and o similarities between chronic abacterial prostatitis and interstitial cystitis. This list is not all inclusive and is meant solely to stimulate interest for unique, innovative proposals for research in interstitial cystitis from diverse investigators. Program project grant applications (P01) are not suited to this announcement. Since this request is for unique, innovative studies, it is understood that there may be limited preliminary data to support the application. In those cases, the applicant may wish to designate the proposal as a pilot project and reduce the number of requested project years, budget and scope of the project to that which is necessary for obtaining adequate data for a more extensive, full-scale project. SPECIAL REQUIREMENTS Applicants who receive an award through this announcement are encouraged to attend a yearly meeting (convened by the NIDDK) of investigators to discuss progress and exchange research information. Funds to support the travel to these meetings may be included in the proposed budget. In order to ensure that patient selection for clinical studies is uniform, the NIDDK has established Diagnostic Criteria for research studies on IC. All grant applications that use human subjects must state that the NIDDK IC diagnostic criteria will be applied to patients selected for inclusion in the research study. The NIDDK research criteria have been published in: the Journal of Urology 142(1): 139, 1989 and the American Journal of Kidney Diseases 8(4) 353, 1989. They may also be obtained from the program staff listed under INQUIRIES. This requirement does not preclude using subjects who do not meet the criteria for comparison studies, but those who meet the criteria must be specifically identified and designated as a study group. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (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. 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 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 requested, but not required, to submit a letter of intent to apply to the RFA. This letter should include the name, telephone number, and mailing address of the Principal Investigator, the names of other key personnel, and 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 necessary requirement for application. Letters of intent are requested solely for planning purposes. The NIDDK staff will not provide responses to such letters. Letters of intent must be received no later than February 25, 1993 and must be addressed to: Dr. Robert Hammond Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 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 Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. For developing programs that deal with clinical populations, applicants may wish to consider utilization of General Clinical Research Center (GCRC) facilities. More information on the GCRC program is available from Dr. Judith Vaitukaitis at the National Center for Research Resources, telephone: (301) 496-6595. The RFA label available in the application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to: Robert Hammond, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by March 25, 1993. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 and as a component project of a program project. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be 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, the staff will contact the applicant to determine whether it should be returned to the applicant, or held until the next regular receipt date and reviewed in competition with all other applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. Applications may be subjected to triage by an NIDDK peer review group to determine their scientific merit relative to other applications received in response to this RFA. 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 staff will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following this review, the applications will be given a secondary review by the National Diabetes and Digestive and Kidney Diseases 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. AWARD CRITERIA Funding decisions will be made based on the initial review group and national advisory council recommendations, program relevance and availability of funds. The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues to: Leroy M. Nyberg, Ph.D., M.D. Director, Urology Program Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05 Bethesda, MD 20892 Telephone: (301) 496-7133 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 496-7467 Schedule Letter of Intent Receipt Date: February 25, 1993 Application Receipt Date: March 25, 1993 Initial Review: June 1993 Second Level Review: September, 13-14, 1993 Anticipated Date of Award: September 30, 1993 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 (NIDDK). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Thu Jan 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 1, pt. 6, 8 January 1993 Message-ID: Date: 8 Jan 93 03:10:08 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1141 $$XID RFA AI9305 AI-93-05 P1O1 ***************************************** INTERNATIONAL COLLABORATIONS IN INFECTIOUS DISEASE RESEARCH NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: AI-93-05 P.T. 34; K.W. 0715125, 0785215 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 12, 1993 Application Receipt Date: July 13, 1993 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) plans to continue its efforts in international health through a program of collaborative biomedical research on infectious diseases that are primarily endemic in or profoundly impact upon the health of people living in the tropics. The Parasitology and Tropical Diseases (PTD) Branch of the Division of Microbiology and Infectious Diseases (DMID), NIAID, therefore invites cooperative agreement applications for International Collaborations in Infectious Diseases Research (ICIDR). The intent of this program is to bring together relevant biomedical knowledge and technology to develop new approaches for the detection, prevention and treatment of infectious diseases of recognized relevance to the health of people living in tropical countries; to increase relevant research experience for both U.S. and foreign investigators; and to enhance opportunities for scientific linkages and interaction between U.S. and foreign investigators through regularly scheduled meetings coordinated by the PTD Branch. 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), International Collaborations in Infectious Disease Research, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of a "Healthy People 2000" (Full Report: Stock No. 017-001-00474-O) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, medical colleges, hospitals, laboratories. Minority individuals and women are encouraged to participate as Principal Investigators. The U.S. applicant institution is responsible for developing an affiliation(s) with an established institution (e.g., university, research institute, federal or state health department, hospital) in the host country. Research activities on this project conducted at the foreign affiliate must be supported by the award made to the U.S.-based institution. For the application to be considered, the domestic applicant institution must include proof of having an off-site component as a foreign base of operations and one or more specified employees of the foreign institution(s) as co-investigators. The proposed research programs must be acceptable to the resident (foreign) scientists and to the advisory group(s) of their particular institution. The application will not be reviewed unless proof of such a foreign affiliation is included. In addition, it will be necessary to establish a working agreement with the government of the host country to expedite deputation of personnel, equipment, and supplies from the U.S. to the off-site facility. The agreement may be developed directly between the domestic applicant institution and representatives of the foreign government, or it may be more convenient for the domestic component to arrange such an agreement through a regional organization such as the Pan American Health Organization or the relevant office of the World Health Organization. Proof of such an agreement must be submitted to Dr. Olivia Preble, at the address listed under INQUIRIES, no later than two months after the application receipt date in order to assure its availability prior to review. MECHANISM OF SUPPORT Successful applicants funded under this RFA will be supported through cooperative agreements (U01). This type of funding mechanism is utilized when it is desired to encourage investigator-initiated research projects in areas of special importance to NIAID and when substantial programmatic involvement by NIH staff is anticipated. This RFA represents a single competition with a specified deadline for receipt of applications. A. Support for this program will be through the cooperative agreement (U01) funding instrument. These are interactive assistance relationships in which an ongoing collaborative relationship exists between NIAID staff and the investigators. The nature of NIAID Program involvement is further described under "Terms of Award: Awardee Rights and Responsibilities; Nature of Participation of NIAID Staff". The awardee will be responsible for the planning, direction and execution of the proposed project and interrelated activities. Except as otherwise stated in this RFA, the award will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. The total project period for applications submitted in response to this RFA may not exceed five years. The earliest possible award date is May 1, 1994. Reissuance of this RFA is uncertain. If, by the end of the third year of the award, NIAID has not announced its intent, due to budget uncertainties, to reissue the RFA, incumbents of multicomponent U01s should contact program staff before preparing a recompeting application to seek advice on the most appropriate method of application submission. B. The cooperative agreement (U01) funding instrument can support projects of either a multicomponent (program project-like) or single component nature, and both types of applications will be considered by NIAID. Single component applications should focus on a discrete, circumscribed objective. Multicomponent programs consist of a minimum of three interrelated research projects. Multicomponent programs should be multidisciplinary and have a central research focus to which each component is related and makes a contribution. For the purpose of this RFA, ICIDR Directors are defined as Program Directors of the multicomponent programs and as Principal Investigators of the single project programs. Applications for multicomponent programs should describe in detail their organizational and administrative structure. Multicomponent programs may take advantage of the "core" mechanism to provide support for common resources (e.g., laboratory or clinical facilities). It is understood that support for such facilities will be included in the budget of a single component application as required. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the award will vary also. Applications for multicomponent programs should not exceed $500,000 in annual direct costs, while single component applications should not exceed $175,000 in direct costs annually. C. Research at the foreign affiliate institution will be supported by the U.S. applicant institution through a consortium arrangement, and the programmatic, fiscal and administrative agreements involved should be described within the application. The applicant organization's administrative support must provide the necessary management for the transfer of funds and material to the off-site component. Indirect costs will not be paid on any expense incurred by the foreign institution(s). Travel, salaries, and fringe benefits will be subject to the applicant institution's rules and regulations. Regarding travel, it is expected that scientists from the U.S. institution will travel to the foreign affiliate for long-term collaborations (involving periods of at least six months each) with the resident scientists in research on problems of local health importance. Senior scientists with major institutional responsibilities in the U.S. may spend shorter periods of time, e.g., one to two months several times a year, working at the foreign site with their associates. It is permissible to travel and support foreign professionals and selected technical staff for short visits to the U.S. institution to obtain relevant research experience and training. Provision should also be made for the ICIDR Director to travel to the annual meetings of the NIAID International Centers for Tropical Disease Research (ICTDR), to be held in the Washington, DC area. Such anticipated travel costs should be identified in advance and built into the budget of the ICIDR proposal. Applications must also include a Visiting Investigator constituent, under which a pool of funds will be set aside and restricted to cover costs for the exchange of scientific personnel to conduct short-term research projects or to learn new technology related to the objectives of the ICIDR project. Conditions qualifying for these funds would include: (1) unanticipated requirement for travel of ICIDR personnel between the domestic and foreign component institutions, (2) travel of ICIDR personnel to other laboratories, including but not restricted to other ICIDR projects or other members of the ICTDR network; and (3) travel of other U.S. investigators, including but not restricted to other members of the ICTDR network, to the foreign component of the ICIDR project. Visiting investigator funds should be used for projects of no longer than three months duration. In multicomponent program applications, the visiting investigator program should be treated as a "core" and should not exceed $30,000 per year to cover the costs of travel, housing and research supplies. In single component applications, the Visiting Investigator program should reside in the travel portion of the budget, and should not exceed $10,000 per year. This portion of the ICIDR application will be reviewed primarily on the basis of the methods proposed for soliciting and selecting nominees. The ultimate nomination process will involve submission to NIAID by the ICIDR Director of a one-page description of the project to be carried out. Each nomination will be reviewed by a committee composed of the NIAID Program Officer and Scientific Coordinators, who will advise the ICIDR director and his collaborators on final approval of selections. It is the NIAIDs intent under the Visiting Investigator program to provide a flexible means to enhance scientific exchange between the ICIDR projects and other investigators working in the area of tropical disease research and to increase opportunities to obtain research experience in endemic areas. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for all ICIDR awards are $3.5 million. It is anticipated that at least five awards will be made under this mechanism. Applications for multicomponent programs should not exceed $500,000 in annual direct costs, while single component applications should not exceed $175,000 in direct costs annually. RESEARCH OBJECTIVES Background Tropical diseases constitute major public health problems disproportionately affecting populations residing in developing countries. Diseases caused by protozoan and helminth parasites plague billions of people, killing millions annually and inflicting irreversible debilitating injuries such as blindness and disfiguration on additional millions. Their economic impact is enormous, and is often cited as a key impediment to further social and economic progress in these regions. According to a recent report of the World Health Organization, at least 500 million people, the equivalent of one person in ten worldwide, are estimated to be infected with one or more of the five major tropical parasitic diseases malaria, schistosomiasis, filariasis, trypanosomiasis, and leishmaniasis. Bacterial, viral and fungal infections are also of concern in tropical regions, resulting in such important health problems as measles, AIDS, diarrhea, tuberculosis and other respiratory diseases, leprosy and hemorrhagic fevers. Some of these bacterial and viral illnesses also occur commonly in developed countries, however, and in contrast to diseases caused by parasites, effective prevention methods already exist for some of them. The magnitude of many tropical disease problems in endemic areas is generally increasing, due to changing ecological patterns and development of resistance to previous methods of control. Tropical diseases are of increasing global concern as tourism, trade, business travel, immigration and military activities extend their impact into industrialized countries. The number of U.S. citizens traveling overseas is increasing annually. While most cases of tropical diseases currently reported in this country are imported, affecting people who have traveled in endemic regions, the potential for transmission of some of these infections continues to exist within the U.S. Fulfillment of its mission to control such diseases requires that NIAID have the capacity to carry out research on tropical infectious diseases in endemic areas. The improvement of scientific linkages between U.S. and foreign investigators also stimulates self-sufficiency of the collaborating foreign institution and strengthens the scientific infrastructure for further international collaborative arrangements. Scope of Research The purpose of this RFA is to stimulate high quality collaborative tropical disease research. Basic and clinical research appropriate to this RFA would apply the disciplines of biochemistry, immunology, genetics, pharmacology, molecular biology, microbiology, zoology and medical entomology, as well as infectious diseases, pathology, epidemiology or other clinical or public health specialties relevant to a specific tropical disease. The research to be supported by this RFA will focus on those infectious diseases primarily endemic in or profoundly impacting upon people living in the tropics, including but not limited to protozoan and helminth infections, mycobacterial diseases, bacterial and viral enteric infections, and arboviral infections. Studies of human immunodeficiency virus (HIV) infection in developing countries are supported by other NIAID activities, and will not be considered in response to this solicitation. Studies of the impact of HIV infection on the clinical course and outcome of these other tropical diseases will, however, be considered. The overall research goals of this RFA are: (1) to obtain increased information on the factors influencing distribution of infection and resulting clinical outcome and (2) to develop and test new intervention strategies that will contribute to the control of these diseases. It is the intent of the program to support the conduct of biomedical research that can only be performed outside the U.S., and thus, an emphasis on population-based studies would be appropriate. It is anticipated that these studies may involve such topics as diagnosis and natural history of infection (including the role of vectors and reservoir hosts), chemo-or immunotherapy, chemo- or immunoprophylaxis, pathogenesis and vector control. Investigators will choose the tropical disease agent(s) that they prefer to study, and U.S. applicant institutions will make their own arrangements for a mutually acceptable affiliation with one or more collaborating foreign institutions located in or near regions where tropical diseases are endemic. The majority of the research effort must take place in the endemic area. Investigators from the foreign institution(s) must be substantially involved, inasmuch as it is intended that there be active collaboration between domestic staff and scientists of the foreign affiliate(s). SPECIAL REQUIREMENTS Awardee Rights and Responsibilities; Nature of Participation of NIAID Staff Successful applicants (ICIDRs) will be designated as components of the NIAID International Centers for Tropical Disease Research (ICTDR), which constitutes a network of NIAID-supported activities in tropical diseases (ICIDRs, Tropical Disease Research Units, Tropical Medicine Research Centers and Intramural NIAID Center for Tropical Disease Research (see Appendix). Each ICIDR director will serve as a member of the ICTDR Coordinating Committee, which is composed of the directors of these tropical disease programs. ICIDR directors will represent their program at annual centers meetings organized by NIAID. These meetings will be held to share advances in tropical disease research among the ICIDR projects and other NIAID-tropical disease units, to discuss research needs and opportunities in this arena, and to facilitate the development of new collaborative protocols that may include multi-center studies. To encourage cross-fertilization of ideas and facilitate exchange of scientific personnel, a Visiting Scientist component will be included in these applications to provide for short-term travel of ICIDR personnel to other research institutions, or of other U.S. investigators to ICIDR facilities for the purpose of conducting specific research projects. The members of the ICTDR Coordinating Committee plan the agenda in consultation with NIAID staff, and following the meeting, make recommendations to the Institute concerning needs in the area of tropical disease research. Under the cooperative agreement, a partnership relationship exists between the recipient of the award and NIAID according to the guidelines and conditions set forth in the RFA. Investigators are expected to define research objectives and methods in accord with their own interests and perceptions of novel and exploitable approaches to research that ultimately is likely to contribute to the prevention and control of tropical diseases. Terms and Conditions It is the primary responsibility of each Principal Investigator to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. NIAID may periodically review and generate internal reports from data and progress reports developed under this cooperative agreement. The data obtained will, however, be the property of the awardee. It is the responsibility of the awardee to maintain a mutually acceptable arrangement with the foreign affiliate institution and host country. It is intended that publications resulting from collaborative research supported under this award will be co-authored by the involved foreign scientist(s) and that the data will be made readily available to the government of the host country. The awardee should ensure that all requirements for the protection of human subjects, including the negotiation of human subject assurances for clinical studies performed at the foreign institution, are adhered to as described in 45 CFR Part 46. Studies involving human subjects which are conducted at the foreign site must adhere to current guidelines and policies in effect within the United States. Questions regarding these policies may be directed to the Office of Protection from Research Risk (OPRR). (See INQUIRIES for address and phone numbers). Normal programmatic and stewardship responsibilities will be assumed by the NIAID International Tropical Disease Research Program Officer. In addition, NIAID anticipates substantial programmatic involvement during the performance of a Cooperative Agreement. NIAID staff will work closely with the ICIDR investigators. However, the role of NIAID will be to facilitate and not to direct the activities. For each ICIDR, NIAID will be represented by a Scientific Coordinator, who will be a Program Officer within DMID. During performance of this award, the NIAID Scientific Coordinator may work with the ICIDR to provide appropriate assistance, advice and guidance in: o the overall design and planning of ICIDR research activities, including suggestion of studies within the scope of the ICIDR's objectives and research activities; o selection of sources or resources, including provision of biological supplies, or reagent production and clinical testing facilities available through NIAID sources; o replacement of staff, including authorization of key personnel changes; o coordination, collection and/or evaluation of data; o technical and management performance of ICIDR activities; o preparation of publications; o selection of candidates for award of visiting investigator funds. NIAID will support and enhance coordination among the ICIDRs through: o facilitation of information exchange between ICIDRs, other members of the ICTDR network as well as other investigators and agencies engaged in tropical disease research; o provision of new research reagents and technologies or of other important resources and information that may not otherwise be available to the individual ICIDRs; o mechanisms to reduce of duplication of efforts both between ICIDRs and with other extramural projects. The NIAID will coordinate annual meetings of the ICIDR directors in the context of the yearly ICTDR meetings in the Washington, DC area. These meetings will provide a forum for the ICIDR directors to share research advances, discuss needs and opportunities in tropical disease research with NIAID staff and other investigators, and develop collaborations and multicenter studies. Applicants should include a statement indicating their willingness to participate in these activities, and include plans to attend these meetings in their budget requests. NIAID staff are responsible for preparing and disseminating information on the most recent advances in the field resulting from the meeting. At the annual meeting, NIAID Scientific Coordinators are able to meet with their specific ICIDR units and to provide assistance and advice. Additional ad hoc meetings or workshops for ICTDR network participants will also be organized by NIAID staff, as requested by the Coordinating Committee, in conjunction with other major national meetings. NIAID scientific coordinators serve a staff function for the ICTDR Coordinating Committee; they do not have a vote on matters pending before the Coordinating Committee. In the event that research supported by the Cooperative Agreement results in development of a therapeutic or other medical intervention, NIAID will retain the option to cross-file or independently file an application for investigational clinical trial, i.e., an Investigational New Drug Application (INDA) to the United States Food and Drug Administration. Reports of data generated by the ICIDR that are required for inclusion in the INDAs and for cross-filing purposes will be submitted in final draft form by the ICIDR director to the Scientific Coordinator upon request. Arbitration Panel It is anticipated that decisions in all activities outlined within this RFA will be reached by consensus of the investigators and that the NIAID staff will be given the opportunity to offer input to this process. The manner of reaching this consensus and the final decision-making authority will rest with the ICIDR director. Should any difference of opinion arise, an arbitration panel, composed of one NIAID designee, one ICIDR designee and a third member selected by these two, will be established to review any scientific or programmatic issue that is significantly restricting progress. This arbitration process in no way affects the right of an award recipient to appeal post award administrative decisions in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. 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 other HHS, PHS, and NIH grant administration policy statements. NIH reserves the right to withhold funds should any of the terms of the award not be implemented. Applicants should describe plans to accommodate these stated program requirements, criteria and staff involvement. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by April 12, 1993, a letter of intent that includes a descriptive title of the proposed research, the names and affiliations of proposed key investigators, and the number and title of the RFA in response to which the application may be submitted. The letter of intent is requested in order to provide an indication of the number and scope of applications to be reviewed. This does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. In addition, applicants for multicomponent programs are strongly advised to read the information brochure "Program Project and Center Grants, NIAID" which accompanies each RFA. The brochure describes the format for large multidisciplinary grants, outlines review criteria for such programs, and includes other important information that will aid in preparation of the application. For purposes of identification and processing, mark "yes" in item 2a on the face page of the application and type in the RFA number AI-93-05 and the title, INTERNATIONAL COLLABORATION IN INFECTIOUS DISEASES RESEARCH. The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. The signed, typewritten original of the application, including the Checklist, and three exact copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies must be sent to: Dr. Olivia Preble Chief, Microbiology and Immunology Review Section Program and Project Review Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 Bethesda, MD 20892 To ensure their review, applications must be received by both the Division of Research Grants (DRG) and Dr. Olivia Preble by July 13, 1993. Applications not received on the official date will be considered non-responsive and will be returned to the applicant. The DRG will not accept any application in response to this announcement that is essentially the same as one currently pending initial review by any other NIH awarding unit, unless the applicant withdraws the pending application. REVIEW CONSIDERATIONS Review Procedures Applications will be reviewed by DRG staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to the RFA. Those judged to be incomplete or nonresponsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group to determine their scientific merit relative to the other applications submitted in response to this RFA. This triage may be conducted before or during the initial review committee meeting. The NIH will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applications judged to be competitive for award will be reviewed for scientific and technical merit by a Review Committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The factors to be considered in scientific review of the application are: 1. Scientific merit of research approach, design, and methodology as well as the potential scientific, technical or medical significance of the proposed research. 2. Scientific appropriateness and administrative adequacy of the proposed affiliation with the foreign institution(s) and host country. 3. Research experience and competence of the Principal Investigator(s) and other staff to conduct the proposed studies. 4. Adequacy of the time (effort) which the Principal Investigator(s) and staff would devote to the proposed studies. 5. Adequacy of facilities, both at the domestic and foreign institutions, including, if relevant to the proposed research, adequacy of the clinical facilities and patient availability for clinical studies. 6. Adequacy of mechanisms proposed for visiting investigator component. AWARD CRITERIA It is the desire of the NIAID to fund a group of applications that together will provide research opportunities on the broadest possible spectrum of tropical diseases. While scientific merit is a prime consideration in the selection of applications for awards, program balance will also be considered. Insofar as possible, every effort will be made to achieve a geographic distribution of ICIDR cooperative agreements that adequately reflects the occurrence of tropical diseases. 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. Michael Gottlieb Parasitology and Tropical Diseases Branch Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-37 Bethesda, MD 20892 Telephone: (301) 496-7115 FAX: (301) 402-0804 Send the letter of intent and direct any questions regarding review procedures to: Dr. Olivia Preble Chief, Microbiology and Immunology Review Section Scientific Review Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Chief, Microbiology Grants Management Section National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-37 Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Questions concerning policies for studies involving human subjects may be directed to: Chief, Assurance Branch Office for Protection from Research Risks National Institutes of Health Bethesda, MD 20892 Telephone: (301) 496-7041 FAX: (301) 402-0527 Schedule Letter of Intent Receipt Date: April 12, 1993 Application Receipt Date: July 13, 1993 Scientific Review Date: November 1993 Council Meeting Date: February 1994 Earliest Award Date: May 1, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease 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. $$XID RFA GM93003 GM-93-003 P1O1 *************************************** PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: GM-93-003 P.T. National Institute of General Medical Sciences Application Receipt Date: April 27, 1993 PURPOSE The National Institute of General Medical Sciences (NIGMS) is accepting applications for individual National Research Service Award (NRSA) Predoctoral Fellowships for Minority Students. These fellowships will provide up to five years of support for research training leading to either the Ph.D. degree or the combined M.D./Ph.D. or other combined professional doctorate/research Ph.D. degrees in the biomedical sciences for highly qualified students from minority groups found to be underrepresented in the biomedical and behavioral sciences. Support is NOT available for individuals enrolled in medical or other professional schools UNLESS they are enrolled in a combined professional doctorate/Ph.D. degree program in biomedical research. The intent of this Minority Predoctoral Fellowship Program is to make graduate fellowships available to under represented minority graduates from all institutions, including the many minority undergraduate students who have participated in the various NIH- sponsored programs to prepare them for research careers. This program is designed to encourage greater numbers of under represented minorities to pursue graduate degrees, thus fulfilling the goal of increasing the number of minorities trained for careers in biomedical research. ELIGIBILITY REQUIREMENTS Eligibility for these awards is limited to students who are U.S. citizens, non-citizen nationals, or permanent U.S. residents. Applicants must be from ethnic/racial groups that are under represented in research in the biomedical sciences in the U.S. For purposes of this announcement, under represented minority students are defined as individuals belonging to a particular ethnic or racial group that has been determined by the applicant's graduate institution to be underrepresented in biomedical or behavioral research. In making these awards, the NIH will give priority consideration to applications from Blacks, Hispanics, Native Americans, and Pacific Islanders and other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. In addition, an applicant must currently be enrolled in a Ph.D. or combined M.D./Ph.D. (or other combined professional doctorate/research Ph.D. graduate) program in the biomedical sciences, or have been accepted by and agreed to enroll in such a graduate program in the 1993-94 academic year. The Minority Access to Research Careers (MARC) program of the NIGMS has a similar fellowship program of support for graduates of its various MARC Honors Undergraduate Research Training programs to attend graduate school in biomedical sciences. Graduates of the MARC Program are encouraged to apply to the MARC Predoctoral Fellowship Program. MECHANISM OF SUPPORT This Request for Applications (RFA) for individual fellowships (F31) is under the auspices of the NRSA Act. Applicants must work with their research advisor or graduate program director in preparing the application. Except as otherwise stated in this RFA, awards will be administered under the PHS Grants Policy Statement and the Guidelines for National Research Service Awards. The period of fellowship support requested in response tothis RFA may not exceed five years. (Note: the total period of predoctoral training grant support under the NRSAauthorization may not exceed five years.) Continuation ofthe fellowship award for each subsequent year beyond thefirst is based on evidence of satisfactory progress in a graduate program. There is a single receipt date for applications: April 27,1993. The NIGMS may announce subsequent RFA receipt dates at a later time. Stipends and Other Expenses The fellowship award provides an annual stipend of $8800 to help meet the fellow's living expenses; a tuition and fee allowance in accordance with NIH policy; and an annual institutional allowance of $2000 that may be used for travel to scientific meetings and for laboratory and other training expenses. FUNDS AVAILABLE For FY 1993, it is anticipated that between 30 and 45 new fellowship awards will be made, if sufficient numbers of high quality applications are received. The NIGMS will be joined by the following awarding components of the NIH in providing funds to support this program: the National Institute on Aging, the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Cancer Institute, the National Institute on Deafness and Other Communicative Disorders, the National Institute on Environmental Health Sciences, the National Eye Institute, and the National Heart, Lung and Blood Institute. Although this program is included in the financial plans of the participating institutes, the award of fellowships in response to this RFA is also contingent upon the availability of funds for this purpose. SPECIAL PAYBACK REQUIREMENTS All individuals receiving NRSA support must agree to fulfill the payback requirements legislatively mandated under the NRSA Act. Recipients must agree to engage in health-related biomedical or health-related behavioral research and/or teaching for a period equal to the period of NRSA support in excess of 12 months. Details are found in Part VII of the application instructions (PHS 416-1, rev. 10/91). REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness to this announcement. Incomplete or non-responsive applications will be returned to the applicant without review. All items listed under APPLICATION PROCEDURES must be included for the application to be considered complete. Applications may be subjected to preliminary review to determine their merit relative to other applications received in response to this RFA. The NIH will administratively withdraw from competition those applications judged to be noncompetitive and notify the applicant of such with drawal. Complete and responsive applications which are judged to be competitive will be evaluated for scientific merit and training potential by an appropriately constituted initial review group within the NIGMS using the criteria stated below. The second level ofreview will be provided by the NIGMS Fellowship Overview Group. The review criteria include: o academic record and research experience of the applicant; o quality of the graduate program in which the applicant is already enrolled or plans to enroll; o qualifications and research/research training experience of the applicant's sponsor or researcher advisor; the match between the research interests of the student and there search advisor/sponsor; o for advanced graduate students, scientific significance,originality and feasibility of proposed research; for beginning students, quality and clarity of stated research interests. APPLICATION PROCEDURES The regular fellowship application form PHS 416-1 (rev. 10/91) must be used in applying for these grants. These forms are available at most university business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone 301/496-7441; and from the NIH program administrators named below. The applicant must follow all instructions in the application kit and those described in these supplemental instructions. Incomplete applications will not be reviewed. The following must be included with the application at thetime of submission: o a copy of the results of either the Graduate Record Examination or the Medical College Admission Test (for M.D./Ph.D. applicants); o a clear and legible copy of the applicant's transcript(s) from all undergraduate and graduate institutions in which the applicant is/has been enrolled; o a description of the graduate or combined degree program in which the applicant is either enrolled or has been admitted and agreed to enroll (Item 33); o at least three reference letters sealed in envelopes; and o certification of eligibility completed by the institution. Supplemental Instructions for Completing the Application A. To be completed by the Student-Applicant Item 1. (Title of Research Training Proposal), type: MINORITY PREDOCTORAL FELLOWSHIP PROGRAM - NIGMS. Item 2. (Level of Fellowship) type: Predoctoral. Item 3. (Program Announcement Area), type: RFA GM-93-003. Items 4 - 8. Self explanatory. ITEM 4i (Citizenship), see explanation on page 7 of PHS 416-1. Non- citizen nationals are citizens of areas that are not States but are under the jurisdiction of the United States, e.g., American Samoa. Applications from permanent residents MUST be accompanied by a notarized statement indicating that the Immigration and Naturalization Service has lawfully admitted the applicant for permanent residence. (Items 9 - 14. Completed by sponsor). Item 15. You must sign the application. Items 16-19. Self explanatory; if any do not apply to you, type N/A. (Item 20. Completed by sponsor) Item 21. (Abstract of Proposed Research) If you have selected a thesis topic, you should briefly describe, in abstract form, the question you are studying, how you are approaching it, and the health relatedness of your project. If you have not yet selected a thesis project, say "no thesis selected" and instead give a brief description of the research area that interests you most and why, even if your research interests are still very broad. Item 22. (Scholastic Performance) You must complete this section, listing all undergraduate and graduate course you have taken and the grades you received. In addition, you must submit a LEGIBLE copy of a transcript from all undergraduate and graduate institutions you have attended. Item 23. (Employment) Your employment history during college should be included if a significant time commitment was involved. Items 24-26. Self-explanatory Item 27. Research Experience a. (Summary) Provide a thorough description of your relevant work and research experiences, including time, place, research director, and your role in the research. b. (Doctoral Dissertation) should not be completed. c. (Publications) Include a list of publications, abstracts, and poster presentations. Three collatedsets of copies of publications may be provided as part of Section 3 (Appendix). Item 28. (Revised Application) To be completed only if this application is a revision of an application submitted earlier. Item 29. (Research Training Plan) a. (Activities Under Award) - Include a statement concerning your research training and long-range career goals, with an explanation of how the proposed course of study to be supported by this fellowship will help you attain these goals. If appropriate, explain how prior work and research experiences affected the choice of career goals. b and c. (Research Proposal and Respective Contributions)If you have selected a research thesis topic, complete this section according to the instructions. If you have not yet selected a thesis, give a description of the research area that interests you most. d. (Selection of a Sponsor and Institution) Explain why you chose to enroll in this university/institution and in this graduate program. If you have selected a research advisor, give the rationale for your choice. If you have not selected an advisor, you should identify up to five individuals with whom you would like to work, giving arationale for your choices. B. To be completed by the Research Advisor or Sponsor If the applicant HAS SELECTED A RESEARCH ADVISOR, the ADVISOR must complete the items in this section. If the applicant HAS NOT YET SELECTED A RESEARCH ADVISOR, the director of the graduate program should designate a sponsor to complete these items. The director may choose to serve as the sponsor. Items 9 - 14, 20, and 30-37 ITEM 33, in addition to the information requested in the application kit, (1) for ALL students, provide a full description of the graduate or combined degree program in which the applicant is (or is to be) enrolled. This description should also outline the normal course of study (both didactic and laboratory) for students enrolled in the program; (2) for students already enrolled in the graduate program, describe the applicant's course of study up to the time of submission of the application and plans for further study; and (3) for ALL students, provide the applicable tuition and fees for each year of support requested. C. To be supplied by the University or Institution 1. A statement from the institution certifying that (a) the applicant is enrolled as a predoctoral student OR has been accepted by and agreed to enroll in the graduate training program; (b) the applicant is an eligible minority individual, determined by the institution to be underrepresented in biomedical or behavioral research; this certification MAY include an OPTIONAL identification of theapplicant's ethnic/racial group; and (c) the applicant is acitizen, non-citizen national or permanent resident of the U.S. (see page 7 of PHS 416-1, rev. 10/91). This statement must be signed by the director of the graduate program in which the student is (or is to be) enrolled and by the official authorized to sign for the institution. Failure To Include This Certification Will Preclude Review Of The Application.The institution may wish to use the format given at the end of this announcement. 2. Certification of the accuracy of the tuition and fees requested for each year of support (Item 33). SUBMISSION Submit a signed, typewritten original of the application (including the Checklist, Personal Data form, at least three sealed reference letters, and all other required materials) and two exact, clear, single-sided photocopies of the signed application, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Applications must be received by April 27, 1993. Any application received after that date will be returned to the applicant. Applications submitted without three reference letters will be returned without review. Simultaneous submission of identical applications will not be allowed nor will essentially identical applications be reviewed by different review committees. Thus, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. If a candidate submits an application in response to this RFA that is substantially similar to one s/he has already submitted to the NIH for review but which has not yet been reviewed, the applicant will be asked to withdraw one of them. INQUIRIES Written and telephone inquiries concerning this RFA should be directed to: Dr. Irene Eckstrand National Institute of General Medical Sciences Westwood Building, Room 918 Telephone: (301) 496-7137 or Dr. John Norvell National Instititute of General Medical Sciences Westwood Building, Room 907 Bethesda, MD 20892 Telephone: (301) 496-7309 For fiscal and administrative matters, contact: Ms. Ruth Monaghan Deputy Grants Management Officer National Institute of General Medical Sciences Westwood Building, Room 953 Bethesda, MD 20892 Telephone: (301) 496-7746 AUTHORITY AND REGULATIONS Something Missing Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, 42 USC 288) and administered under PHS grant policies and Federal Regulations 42 CFR Part 66. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. SUGGESTED FORMAT FOR INSTITUTIONAL CERTIFICATION: PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS INSTITUTIONAL CERTIFICATION This is to certify that____________________________, who submitted an application for an NIH Predoctoral (Applicant Name) Fellowship Award for Minority Students is: _____(1) currently enrolled in a Ph.D. or combined M.D./Ph.D. (or other combined professional doctorate/research Ph.D.) degree program in the biomedical sciences at this institution, or has been accepted by and agreed to enroll in such a program during the 1993-94 academic year; ______(2) an underrepresented minority student, i.e., belonging to a particular ethnic or racial group that has een determined by our institution to be underrepresented in biomedical or behavioral research in the U.S.; OPTIONAL. This individual is a member of the __________________________ racial/ethnic group. ______(3) a U.S. citizen, non-citizen national, or permanent resident. _________________________ _________________________ Signature Signature _________________________ _________________________ Name: Graduate Program Name: Authorized Director University Official _________________________ _________________________ Title Title From owner-sci-resources@net.bio.net Thu Jan 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 1, pt. 7, 8 January 1993 Message-ID: Date: 8 Jan 93 03:11:39 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1156 $$XID RFA EY9301 EY-93-01 P1O1 ***************************************** CLINICAL CENTERS FOR OCULAR HYPERTENSION TREATMENT STUDY NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: EY-93-01 P.T. 34; K.W. 0715115, 1002046, 0755015 National Eye Institute Application Receipt Date: March 12, 1993 PURPOSE The National Eye Institute (NEI) invites applications for cooperative agreements to support participating clinics in the Ocular Hypertension Treatment Study (OHTS). The OHTS is an investigator- initiated, randomized, multicenter, clinical trial to determine whether medical reduction of intraocular pressure prevents or delays the onset of glaucomatous optic nerve and/or visual field damage in ocular hypertensive subjects. 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), Clinical Center for OHTS, is related to the priority area of reducing significant visual impairment due to glaucoma. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, private practice clinicians, health maintenance organizations or managed health care organizations, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority individuals and from women are encouraged. MECHANISM OF SUPPORT Awards will be made as cooperative agreements (U10). This is an assistance mechanism of support in which there will be substantial, ongoing involvement by NEI staff during the performance of the clinical trial and interaction between the awardee and NEI staff during performance of the project. This RFA is a one-time solicitation. FUNDS AVAILABLE It is expected that approximately 30 to 40 awards will be made as a result of this RFA. The total funds available for the first year of support are expected to be approximately $1.9 million; however, this support level is conditional upon the receipt of applications of substantial and significant scientific merit. Awards are expected to be made in November 1993. Although the financial plans of the NEI provide for these projects, awards pursuant to this RFA are also contingent upon the availability of funds. RESEARCH OBJECTIVES Background Glaucoma is one of the leading causes of blindness in the United States and other industrialized countries, and is the number one cause of blindness in African Americans. Moreover, glaucoma is one of the most common causes of blindness in individuals above age 60, one of the fastest growing groups in the U.S. Elevated intraocular pressure (IOP) is a key risk factor for the development of open- angle glaucoma. However, there is no consensus on whether early treatment of elevated IOP prevents or delays the onset of open-angle glaucoma. The OHTS is an investigator-initiated activity funded by cooperative agreements from the NEI. Applications were received in October 1991 from Dr. Michael Kass, professor of ophthalmology at Washington University, as the Study Chairman and Dr. Mae Gordon, assistant professor of ophthalmology at Washington University, for the Coordinating Center. Initial review for scientific merit was held in March 1992; secondary review by the National Advisory Eye Council (NAEC) was in May 1992. Cooperative agreements were made in September 1992 to support these central OHTS activities. Although the OHTS is designed to study the efficacy and safety of early medical treatment in ocular hypertension, there will be other benefits as well. This study will allow one to refine and validate estimates of risk for individual patients with ocular hypertension in a large national sample. African Americans have a much higher prevalence of open- angle glaucoma than do whites. However, there are no prospectively obtained data on the conversion rate of African Americans with ocular hypertension to open-angle glaucoma. This study will include a minimum of 400 African American ocular hypertensives, and will provide data to determine the conversion rate of African American ocular hypertensive subjects to open-angle glaucoma. At the conclusion of this study, practitioners should be able to provide reasonable estimates of risk for individual ocular hypertensive patients and know which ocular hypertensive individuals are most likely to benefit from early prophylactic medical treatment. Other The OHTS is a randomized, multicenter clinical trial to determine whether medical reduction of intraocular pressure (IOP) prevents or delays the onset of glaucomatous optic nerve and/or visual field damage in ocular hypertensive subjects. One thousand five hundred subjects with IOP greater than or equal to 26 mm Hg in at least one eye (IOP greater than or equal to 21 mm Hg in the fellow eye) and normal visual fields and optic discs in both eyes will be assigned randomly to receive stepped medical treatment to both eyes or no treatment to both eyes. These subjects are considered to be at moderate risk for the development of open-angle glaucoma. The subjects will be followed twice yearly with automated, threshold, central, static Humphrey 30-2 perimetry, and yearly optic disc photographs will be taken. The study endpoints are progressive optic disc cupping and/or reproducible glaucomatous visual field loss in either eye of a patient. All visual fields and optic disc photographs will be read in masked fashion by central reading centers. It is projected that the time required to recruit the required patients will be two years, and each patient will be followed for a minimum of five years. During the course of the study, data will also be collected for an analysis of the cost effectiveness of preventative treatment in ocular hypertension. This will include ascertainment of both direct costs of treatment as well as indirect nonmonetary costs. In addition, data will be collected on the impact of medical treatment on the patients' quality of life. An organization applying as a clinical center in the OHTS must document its capability to recruit 25 or more fully eligible patients per year (for two years) for the clinical trial. SPECIAL REQUIREMENTS The Principal Investigator and Clinical Coordinator will be asked to attend a two-day training meeting to be held in St. Louis during the first project year. Applicants are advised to include plans for this training meeting in their budget requests. The Principal Investigator and Clinic Coordinator of each participating clinic will be requested to attend an annual one-day meeting of study investigators to be held in conjunction with the annual meeting of the American Academy of Ophthalmology. Applicants are advised to include plans for meeting travel expenses in their budget requests using the following as guidance: The NEI will provide support for the cost of one night's lodging and one day of per diem for the Principal Investigator; roundtrip air fare, one night's lodging, and one day of per diem will be provided for the Coordinator to attend this annual meeting. Applicants are advised to describe plans to accommodate the stated program requirements, criteria, and NEI staff involvement (explained below). Terms and Conditions. The Principal Investigator will be responsible for all aspects of the day-to-day operations of his/her clinical center and the local implementation of the study protocol. He/She will have the primary responsibility to identify and recruit eligible patients. He/She will be responsible for the follow up of each patient enrolled in the clinical trial and submitting the required data to the Coordinating Center. The Principal Investigator will retain custody of and have primary rights to the data developed under the cooperative agreement, subject to Government rights of access, consistent with current DHHS, PHS, and NIH policies. The Chief of the NEIs Collaborative Clinical Research Branch (CCRB) will participate with and assist, but not direct: 1. The Study Chairperson and Coordinating Center Director in the nomination and selection of the independent Data and Safety Monitoring Committee. 2. The Study Chairperson and, when appropriate, the Executive Committee, in ensuring that standardized patient information handbooks, recruitment information, press releases, and publicity exhibits are properly prepared and implemented. 3. The Study Chairperson in the identification of additional clinics, if necessary, in order to enhance patient recruitment. 4. The Executive Committee in routine performance monitoring of the entire study including matters of quality control among various components and in the determination of inadequate patient recruitment or failure to comply with the protocol on the part of individual clinics. Clinic support can be withheld or terminated based on these determinations. 5. 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, and to announce study findings and the timing of release of any interim or final reports. 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 conduct of the study. This arbitration process in no way affects the rights of a recipient to appeal selected grants administration decisions in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. These special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Parts 74 and 92, as applicable, and other DHHS, PHS, and NIH grant administration policies. 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 all applications for NIH research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications involving human subjects 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 The application form PHS 398 (rev.10/91) is to be used in applying for these cooperative agreements. These forms are available at institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449 Bethesda, MD 20892, telephone 301/496-7441. The RFA label available in the PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title of the application and the RFA number must be typed on line 2a of the face page of the application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application and all appendix material must be sent to: Janet M. Cuca, Ph.D. Review and Special Projects Officer National Eye Institute Building 31, Room 6A06 Bethesda, MD 20892 Applications must be received by March 12, 1993. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications will be evaluated in accordance with the criteria stated below by an initial review group that will be convened by the Review and Special Projects Office, NEI. Applications will then undergo second-level review by the National Advisory Eye Council. In the event of a large response to this RFA, applications may be subject to triage by a peer review group to determine their scientific merit relative to other applications. The NEI will remove from further consideration those applications judged by the triage process to be noncompetitive for award and notify the applicant and institutional official. Those applications judged to be competitive will undergo further review. The factors considered in evaluating responses to this RFA will be: 1. Experimental Design: adequacy of the participating clinic's procedures for patient recruitment and patient retention and followup, data collection and data management, quality control of clinical examinations, training and certification of personnel, and testing and monitoring of study procedures; 2. Personnel: qualifications of all key personnel (whether compensated from the grant or not), including their experience and track record in clinical trials (NEI-supported and other); 3. Resources and Facilities: sources and numbers of fully-eligible patients, of patients with related disorders, and of eligible patients likely to have participated in the study who were seen over a recent one-year period; documentation of intended collaborations; the clinic's recruitment and retention track record in clinical trials; and, the physical facilities and equipment available for the study; and, 4. Budget: appropriateness and reasonableness of all items requested relative to the overall scope of the study, the potential for patient recruitment, and the budget justifications provided in the application. These competitive applications will undergo initial review by the Vision Research Review Committee on June 21-22, 1993, and receive second-level review by the National Advisory Eye Council at its September 9-10, 1993, meeting. AWARD CRITERIA The anticipated date of award is November 1993. Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs, and the availability of funds. The total cost of each application will also be taken into consideration. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Potential applicants are requested to write or telephone Dr. Richard L. Mowery to receive copies of selected chapters from the OHTS Manual of Procedures that will be helpful in preparing an application for submission. Direct inquiries regarding programmatic issues to: Dr. Richard L. Mowery Chief, Collaborative Clinical Research Branch National Eye Institute Building 31, Room 6A49 Bethesda, MD 20892 Telephone: (301) 496-5983 FAX: (301) 402-0528 Direct inquiries regarding administrative matters to: Gaye Lynch Chief, Grants Management Section National Eye Institute Building 31, Room 6A48 Bethesda, MD 20892 Telephone: (301) 496-5884 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.868. 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 Parts 74 and 92, as applicable. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA CA9310 CA-93-10 P1O1 ***************************************** SMALL GRANTS FOR CLINICAL TRIALS IN AIDS MALIGNANCIES NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: CA-93-10 P.T. 34; K.W. 0715008, 0715035, 0755015 National Cancer Institute Letter of Intent Receipt Date: February 1, 1993 Application Receipt Date: April 23, 1993 PURPOSE The Cancer Therapy Evaluation Program of the Division of Cancer Treatment at the National Cancer Institute (NCI) invites small grant applications for innovative therapeutic studies in Acquired Immunodeficiency Syndrome (AIDS) malignancies. The studies should be restricted to pilot or phase I or II trials with approximately 5 to 30 patients/trial. 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), Small Grants for Clinical Trials in AIDS Malignancies, is related to the priority area of cancer and AIDS. 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 Domestic for-profit and non-profit organizations, governments and their agencies are eligible to apply. Foreign institutions are not eligible to apply. Applications can be from single institutions or multiple institutions (collaborating institutions, consortia, cooperative groups). New and experienced investigators are encouraged to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) small grants mechanism (R03). The small grants research program provides limited funds (maximum of $48,000 direct costs per year) for short-term (up to two years) research projects. The R03 grants are non-renewable. Future competing renewals (type 2s) must be prepared and submitted as traditional research grant applications (R01s) to be considered along with other non-solicited investigator initiated applications reviewed by the Division of Research Grant (DRG) study sections. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation for FY 93. Applications received after the deadline receipt date will be returned. FUNDS AVAILABLE Approximately $750,000 in total costs per year for two years will be committed to fund applications submitted in response to this RFA. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The direct cost for each R03 is limited to $48,000 per year. Thus it is anticipated that ten awards will be made in FY 93. The total project period for applications submitted in response to the RFA may not exceed two years. The earliest feasible start date for the initial awards will be September 30, 1993. Although this program is provided for in the financial plans of the NCI, the award of R03 grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Congenital and acquired states of immunodeficiency increase the incidence of high-grade B cell non-Hodgkin's lymphoma (NHL), Kaposi's sarcoma, and certain types of epithelial malignancies. Individuals infected with human immunodeficiency virus (HIV) have a marked increase in the appearance of intermediate and high-grade B cell NHL and Kaposi's sarcoma, and show trends for an increased incidence for Hodgkin's disease, anogenital dysplasia and cancer, and basal cell carcinoma, compared to age-matched controls. On October 22, 1992, the Center for Disease Control proposed the addition of invasive cervical cancer in HIV-infected individuals to the AIDS Surveillance case definition. The tumors in HIV-infected individuals are generally aggressive and insufficiently sensitive to conventional therapy. The median survival of HIV-associated NHL is less than one year and is only two months for primary central nervous system lymphoma. Clinical observations suggest that Hodgkin's disease, anogenital dysplasia and cancer, and basal cell carcinoma, have a different natural history and therapeutic outcome compared to the disease in the general population. The dramatic growth rate of the tumors, combined with the problems of myelosuppression and opportunistic infections, have made treatment extremely difficult. As children and adults with HIV-infection are surviving longer due to improved retroviral and opportunistic infection treatment, the incidence of the malignancies are expected to rise. Research into the pathogenesis of these tumors in the context of HIV has shed light on potential interactions of cytokines, HIV, other viral co-factors (i.e., human papilloma virus in squamous cell cancer of the anogenital region, and EBV in the high-grade primary central nervous system lymphomas), and oncogenes. Based on the current information on the potential interactions in the formation of these tumors, and the lack of effective, standard regimens, the NCI is encouraging investigators to apply novel therapies or innovative approaches in pilot or phase I or II clinical trials. Research Goals And Scope The aim of this RFA is to stimulate pilot, phase I, or phase II therapeutic clinical trials in AIDS malignancies so that new treatment strategies and new agents are moved more rapidly into the clinic. The ultimate goal of the NCI is to provide more effective management and treatment for HIV-associated malignancies in children and adult men and women. The project will fund single or groups of institutions to perform innovative therapeutic studies in AIDS malignancies. The studies should be restricted to pilot, phase I, or II trials, with approximately 5 to 30 patients/trial. Examples of potential clinical studies to consider: (1) combinations of interferon-alpha and/or retinoic acid in anogenital dysplasia or cancer (recent report by Lippman and associates of a 68 percent response rate in patients with cutaneous squamous cell cancer, and a 50 percent major response rate in patients with locally advanced squamous cell cancer of the cervix); (2) angiogenesis inhibitors in Kaposi's sarcoma; (3) immune modulating therapy with IL-4 (and subsequent down-regulation of IL-6, which may have some role in the development of NHL or Kaposi's sarcoma), anti-B4 blocked ricin immunoconjugate in NHL, or anti-sense to potential viral cofactors such as HPV in Kaposi's sarcoma. The investigators are not limited to the above studies, and any innovative therapies with appropriate rationale are sought. Although the major purpose of these grants is to facilitate rapid testing of novel agents or innovative approaches, tumor tissue or other relevant biologic fluid collection is strongly encouraged for ongoing or future investigations of laboratory correlates. The interchange of ideas and tumor tissue between the recipients of the grants will be encouraged. The research plan should be focused on the clinical trial proposed. Laboratory studies addressing correlative issues to the clinical trials may be included but are not necessary. Clinical studies must involve human subjects and be designed to ultimately improve cancer treatment. The clinical studies must be based on a strong rationale and preclinical data should support the underlying hypothesis. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF FEMALES AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and females in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and females 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 females or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. As Kaposi's sarcoma occurs predominantly in men, the lack of female participation should be rationally explained. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in the Research Plan, 1-4, AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from females and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of females or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by February 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the names and addresses of the Principal Investigators, the names of other investigators and key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to Dr. Roy S. Wu at the address listed under INQUIRIES. APPLICATION PROCEDURES The PHS 398 (rev 9/91) research grant application form is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441; and from the NCI Program Director named below. The RFA label available in the PHS 398 research grant 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 number and title must be typed on line 2a of the face page of the application form. 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 must be included with the application. Submit the signed, typewritten original application, including the Checklist, and three signed, exact photocopies of each R03. The photocopies must be clear and single sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, send two additional copies of each application to: Referral Officer Division of Extramural Activities National Cancer Institute Westwood Building, Room 838 Bethesda, MD 20892 Applications must be received by April 23, 1993. If an application is received after that date, it will be returned. 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. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedure Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. Applications that are judged to be non-responsive will be returned to the applicant by the NCI. Applications judged to be non-responsive to this RFA may be submitted as an investigator initiated regular research grant (R01) or as a project within a program project grant (P01) at the next receipt date. The application would require modification in accordance with R01 or P01 guidelines. The revised application would not be considered an application for a small grant nor would it be considered a response to another RFA. Questions concerning the responsiveness of proposed research to the RFA may be directed to program staff (see INQUIRIES). Applications may be triaged by an NCI peer review group on the basis of relative competitiveness. The NCI will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical review by an appropriate peer review group convened by the Division of Extramural Activities, NCI. Institutional Review Board (IRB) approval must have been received and the date of approval provided to NCI prior to peer review. If this information is not provided prior to peer review, the application will be withdrawn from competition by the NCI and returned to the applicant without review. The second level of review will be provided by the National Cancer Advisory Board. Review Criteria The factors considered in evaluating the scientific merit of each application will be: o Extent to which the proposed research addresses the goals 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 Research or clinical experience, training, time availability, and qualifications of the investigators involved; o Adequacy of plans for effective collaboration among laboratory, clinical, and statistical investigators; o Adequacy of the available resources and environment (e.g., facilities, equipment, statistical resources; patient population); o Adequacy of the mechanisms for quality control, study monitoring, data management and reporting, and data analysis; o Adequacy of provisions for the protection of human subjects; o Adequacy of the plans for inclusion of females and minorities. The reviewers will also judge the appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The anticipated date of award is September 30, 1993. In addition to the technical merit of the application, the NCI will consider how well the applicant institution meets the goals and objectives of the program as described in the RFA, availability of resources, and study populations. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are encouraged and may be directed to NCI Program Directors at the addresses below. The NCI Program Directors welcome the opportunity to clarify any issues or questions from potential applicants. For technical information: Dr. Roy S. Wu Cancer Therapy Evaluation Program Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 For business information: Ms. Joan Metcalfe Grants Management Specialist National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 28 FAX: (301) 496-8601 Applicants who use express mail or a courier service are advised to follow the carrier's requirements for showing a street address. The addresses for the Executive Plaza North and the Executive Plaza South are: Executive Plaza North Executive Plaza South 6130 Executive Boulevard 6120 Executive Boulevard Rockville, MD 20852 Rockville, MD 20852 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC 285a) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA DK9319 DK-93-19 P1O1 ***************************************** INTERSTITIAL CYSTITIS AND OTHER BLADDER DISORDERS OF WOMEN NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: DK-93-19 P.T. 34, II; K.W. 0705075, 0715125 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 25, 1993 Application Receipt Date: March 25, 1993 PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) solicits R01 grant applications for support of basic and clinical studies focused on the normal and abnormal function of the urinary bladder, specifically as it relates to the urinary bladder disorders of women: interstitial cystitis, urinary tract infections, and urinary incontinence. The NIDDK is committed to increasing research into the urological disorders which affect women's health. This request is part of the initiative to promote research in all areas of women's urological health. 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 Request For Applications, Interstitial Cystitis and other Bladder Disorders of Women, is related to the priority area of Diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under (PHS) grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total requested project period for applications submitted in response to this RFA may not exceed five years. The average size of an award is anticipated to be about $200,000 per year total cost. The majority of applications funded from this RFA will be for the support of new projects. The earliest possible award date will be September 30, 1993. FUNDS AVAILABLE For FY 1993, $2,500,000 will be committed by the NIDDK to fund applications submitted in response to this RFA. It is anticipated that 10 to 15 awards will be made by the NIDDK. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. In order to help meet NIDDK goals for managing the costs of biomedical research, 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 plan 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 Women of all ages suffer from a disproportionately high rate of disorders of the urinary bladder. These disorders have many features in common: they are usually chronic, they go through periods of remission and exacerbation, and they have no universally effective cure, treatment, or prevention strategy. Although there have been many speculative theories for the discrepancy between incidence of bladder disorders in females and males, there have been no well- documented research studies that focus on the basic science of the urinary bladder in females, the differences between the development of the bladder in the two sexes, extrinsic factors in early development which can affect adult urinary bladder dysfunction, the interrelationship between the most common urinary bladder disorders of women, (i.e., interstitial cystitis, urinary tract infections, and urinary incontinence) and how the treatment of one disorder can affect the development of another disorder. This announcement solicits applications from basic science investigators in such diverse fields as biochemistry, molecular genetics, developmental biology, molecular and cellular biology neurophysiology, immunology, nutrition, endocrinology, epidemiology, and pharmacology and from clinical investigators in adult and pediatric urology, gynecology, infectious diseases, endocrinology, psychology and psychiatry. Examples of Research Areas The following are examples of research areas which are applicable to this RFA. It is emphasized that this is a list of suggested research areas; it includes just a few of the topics that could be considered for investigation. It is anticipated that many of the successful applications will propose areas that are not included in this list. o The relationship between interstitial cystitis and urinary tract infections; epidemiological studies, effects of infection on the bladder mucosa and subsequent mucosal immunological abnormalities. o Intra- and intercellular communication in bladder tissues. o The molecular biology of bladder mucosa in the normal bladder, in the developing bladder and in response to extrinsic factors. o The urethra and the development of bladder disorders of women. o Comparative studies of the molecular biology of bladder development, especially relating early extrinsic influences to later bladder abnormalities. o The role of the pelvic musculature in normal and abnormal bladder function; its relationship to the frequency, urgency and pain symptoms of interstitial cystitis. o The pelvic musculature and recurrent urinary tract infections. o The molecular biology and genetics of normal bladder urothelial turnover, factors which affect turnover, and urothelial turnover in interstitial cystitis and urinary tract infections. o Factors that affect the development of urinary incontinence. o Studies of the psychological effects of chronic bladder disorders, comparative studies of the various disorders. o The molecular biology of collagen synthesis in the normal and dysfunctional bladder. o The effects of pregnancy on the urinary bladder. o Ethnic and racial differences in bladder disorders of women. o Factors in the urine that affect normal bladder function. o Studies comparing the bladder with other organs such as the gut to elucidate bladder pathophysiology. Although this RFA is focused on bladder dysfunction in females, it does not preclude the study of male bladder function when it is used to enhance the understanding of female bladder function by comparative studies. For example included in the scope of this RFA are: o studies that compare interstitial cystitis with chronic abacterial prostatitis, as a means of elucidating the pathogenesis of interstitial cystitis; o studies of differential hormone effects on the developing bladder of both sexes in relation to an adult female bladder disorder such as interstitial cystitis, urinary tract infections or urinary incontinence. Program project grant applications (PO1) are not suited to this announcement. SPECIAL REQUIREMENTS 1. Annual meeting of NIDDK Women's Urological Health Investigators Applicants who receive an award through this announcement are expected to attend a yearly meeting (convened by the NIDDK) of investigators to discuss progress and exchange research information. Funds to support the travel to these meetings may be included in the proposed budget and can be in addition to other proposed travel. 2. Diagnostic Criteria for Research Studies on Interstitial Cystitis and Other Clinical Disorders In order to ensure that patient selection for clinical studies is uniform, the NIDDK has established Diagnostic Criteria for research studies on Interstitial Cystitis (IC). All Grant Applications For Research On IC that Use Human Subjects Must State That The NIDDK IC Diagnostic Criteria For Research Will Be Applied To Patients Selected For Inclusion In The Research Study. The NIDDK research criteria have been published in the Journal Of Urology 142(1): 139, 1989 and the American Journal Of Kidney Diseases 8(4) 353, 1989. The criteria may also be obtained from the Deputy Director, Urology Program, DKUHD, listed in this request. This requirement does not preclude using subjects who do not meet the criteria for comparison studies, but those who do not meet the criteria must be specifically identified and designated as a study group. The Diagnostic Criteria for other urological diseases which are studied must also be defined in the research proposal. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (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. 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 requested, but not required, to submit a letter of intent to apply to the RFA. This letter should include the name, telephone number and mailing address of the Principal Investigator, the names of other key personnel, and 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 necessary requirement for application. Letters of intent are requested solely for planning purposes. The NIDDK staff will not provide responses to such letters. Letters of intent must be received no later than February 25, 1993 and must be addressed to: Dr. Robert Hammond Chief, Review Branch NIDDK, Westwood Building, Room 605 Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS-398 (revised 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 Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892; Telephone: (301) 496-7277. For developing programs that deal with clinical populations, applicants may wish to consider utilization of General Clinical Research Center (GCRC) facilities. More information on the GCRC program is available from Dr. Judith Vaitukaitis at the National Center for Research Resources, telephone: (301) 496-6595. The RFA label available in the application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division Of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 At time of submission, two additional copies of the application should also be sent under separate cover to: Dr. Robert Hammond Chief, Review Branch NIDDK Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by March 25, 1993. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 and as a component project of a program project. 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. 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, the staff will contact the applicant to determine whether it should be returned to the applicant, or be held until the next regular receipt date and reviewed in competition with all other applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. Applications may be subjected to triage by an NIDDK peer review group to determine their scientific merit relative to other applications received in response to this RFA. 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 staff will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following this review, the applications will be given a secondary review by the National Diabetes and Digestive and Kidney Diseases 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. AWARD CRITERIA Funding decisions will be made based on the initial review group and national advisory council recommendations, program relevance, and availability of funds. The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues to: Ralph L. Bain, Ph.D. Deputy Director, Urology Program The National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 496-7574 FAX: (301) 402-0223 Inquiries regarding fiscal matters should be directed to: Ms. Trude McCain Grants Management Specialist Division of Extramural Activities The National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 496-7467 SCHEDULE: Application Receipt: March 25, 1993 Initial Review: June 1993 Second Level Review: September, 13-14, 1993 Anticipated Award: September 30, 1993 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 (NIDDK). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Thu Jan 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 1, pt. 8, 8 January 1993 Message-ID: Date: 8 Jan 93 03:14:35 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 879 $$XID RFA AR93005 AR-93-005 P1O1 *************************************** RESEARCH ON CAUSAL MECHANISMS IN SYSTEMIC LUPUS ERYTHEMATOSUS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: AR-93-005 P.T. 34; K.W. 0715015, 0755030, 1002008, 1002019, 0710070 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute of Allergy and Infectious Diseases (NIAID) invite applications focused on the mechanisms and causes of tissue injury in systemic lupus erythematosus (SLE). The goals of the research are to identify and analyze the factors and mechanisms of tissue injury not only in the kidneys but in the brain and other organs, using advanced molecular, genetic, and immunological approaches; to develop new experimental systems to study and test the pathogenicity of human autoantibodies and autoreactive cells related to lupus; to elucidate the genetic factors important in the development of the illness; and to characterize the mechanisms involved in induction or exacerbation of disease by environmental factors. 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), Research on Causal Mechanisms in Systemic Lupus Erythematosus, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No . 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit applications as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT The mechanisms of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01) and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is September 30, 1993. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50-000, revised October 1, 1991. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. 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 within the application. FUNDS AVAILABLE Up to $1,925,000 for the first-year and additional approved expenses for up to five years has been committed to fund applications submitted in response to this RFA. The NIAMS and the NIAID plan to make approximately seven to ten and one to two awards, respectively, in FY 1993, contingent upon receipt of highly meritorious applications. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and the availability of funds. RESEARCH OBJECTIVES Systemic lupus erythematosus (SLE) is an acute and chronic illness predominantly affecting young women, and affecting Afro-Americans disproportionately to Americans of European descent. This illness is characterized by a wide array of humoral and cellular immunological abnormalities involving both up-regulation and down-regulation of critical elements of the immune system. The order in which components of immunological dysregulation occur, i.e., which is a primary and which is secondary event, is not well understood. In some cases, the defective immune responses may be genetically determined. The occurrence of SLE is clearly related to the inheritance of a specific HLA types and C4 complement types, but not all persons with the characteristic genetic background are affected. To the contrary, identical twins discordant for disease are regularly seen, suggesting that environmental factors contribute to the disease. Whether these external factors induce the initial occurrence of the disease or are responsible for subsequent flares of the illness is unknown. An immunological model of the illness has dominated thinking for the past several decades. This model invokes the occurrence of autoantibodies (primarily to double-stranded DNA), the formation of immune complexes consisting of these antibodies and their antigens, the deposition of these complexes in vulnerable areas, such as the glomerular basement membrane, inducing complement-dependent tissue injury. This model has not satisfactorily explained many forms of injury seen in patients with lupus, including neurological and cardiac pathology and coagulation abnormalities. Other forms of tissue injury have occasionally been identified. These latter forms include the activities of cytotoxic antibodies, pathological regulation of a variety of cytokines, coagulation abnormalities leading to non-inflammatory vascular occlusion, and other phenomena. It is the purpose of this RFA to explore these additional causes. The RFA requests individual research projects (R01 and R29) that focus on questions relevant to defining the causes of the disease and mechanisms of tissue injury in SLE. Appropriate research areas include, but are not limited to: o Design and use of new experimental systems to dissect the events leading to immune dysregulation in human lupus and analysis of their relative contribution to predisposition, onset and severity of disease. o Development of new experimental systems of human lupus to study pathogenicity of autoantibodies, autoreactive, accessory and regulatory cells and factors. o Analysis of the fine molecular characteristics and mechanisms involved in tissue damage by immune complexes, including new systems to test for pathogenicity of human autoantibodies and immune complexes. o Studies of immune and non-immune mechanisms involved in cardiac and neurological pathology including development and use of new experimental models of these manifestations in human lupus. o Studies of the molecular basis for specificity and pathogenicity of cytotoxic antibodies with emphasis on the identification of critical sites and/or activities involved in tissue injury. o Characterization of the genetic and molecular mechanisms involved in cytokine dysregulation in lupus and elucidation of the mechanisms by which cytokine dysregulation leads to tissue injury and clinical disease. o Identification and characterization of the molecular components and mechanisms that initiate vascular injury in lupus. o New approaches to study coagulation abnormalities including antiphospholipid antibody and the mechanisms leading to noninflammatory vascular occlusion and other phenomena of the antiphospholipid antibody syndrome. o Studies on the molecular mechanisms involved in induction and exacerbation of disease caused by environmental factors. o Studies on the environmental factors that may induce the illness or its exacerbation. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to asses s carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific 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 March 5, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the statement, "submitted in response to AR-93-005, RESEARCH ON CAUSAL MECHANISMS IN SYSTEMIC LUPUS ERYTHEMATOSUS". 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 NIAMS and NIAID staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to: Dr. Tommy Broadwater Chief, Review Branch, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 404 Bethesda, MD 20892 Telephone: (301) 496-0754 APPLICATION PROCEDURE The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/ 496-7441. The RFA label available in the application kit must be affixed to the bottom of the face page. 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. In addition, RESEARCH ON CAUSAL MECHANISMS IN SYSTEMIC LUPUS ERYTHEMATOSUS AR-93-005, must be typed on line 2a of the face page of the application form and the YES box should be checked. The completed and signed, typewritten original application and three signed, exact, clear, 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** At time of submission, two additional exact copies of the application must also be sent under separate cover to: Dr. Tommy Broadwater Chief, Review Branch, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 404 Bethesda, MD 20892 Applications must be received by April 8, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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 (P01). 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. REVIEW PROCEDURES Upon receipt, applications will be reviewed by the DRG for completeness. Incomplete applications will be returned to the applicants without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIAMS staff function. If the application is not responsive to the RFA, NIAMS 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 unsolicited applications. The National Institute of Environmental Health Sciences has primary interest in toxicological influences of the immune system. Applications of this description may be referred to that Institute. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by an appropriate peer review group convened by the NIAMS. Applications may be subject to triage by an NIAMS peer review group to determine scientific merit relative to other applications received in response to this RFA. If the number of applications submitted 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 if not competitive for the award. The NIAMS will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following initial review, applications will receive a second level review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council or the National Allergy and Infectious Diseases Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally similar as those for unsolicited investigator-initiated research grant applications and include: o Scientific and technical merit criteria specific to the objectives of the RFA; o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to conduct 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 proposed 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. In addition, for foreign applications, the following criterion applies: o Uniqueness of research such that it can only be performed outside of the United States. Schedule Letter of Intent Receipt Date: March 5, 1993 Application Receipt Date: April 8, 1993 Initial Review: June 1993 Second Level Review: September 9, 1993 Anticipated Date of Award: September 30, 1993 AWARD CRITERIA Applications will compete for available funds with all other applications responsive to this RFA. The following items will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; and o Program balance among research areas represented in this RFA. The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries regarding this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Susana A. Serrate-Sztein Director, Arthritis Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3340 Dr. Howard Dickler Chief, Clinical Immunology Branch Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A10 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Direct inquiries regarding fiscal matters to: Diane M. Watson Chief, Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732A Bethesda, MD 20892 Telephone: (301) 402-3352 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research and No. 93.855, Allergy, Immunology and Transplantation Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) 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 DK9315 DK-93-15 P1O1 ***************************************** PATHOGENESIS OF INFLAMMATORY BOWEL DISEASE AND CELIAC DISEASE NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFA: DK-93-15 P.T. 34; K.W. 0715085, 0710070, 1002019, 1002004, 1002008, 0785055 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: March 24, 1993 Application Receipt Date: April 21, 1993 PURPOSE This Request for Applications (RFA) invites new as well as experienced investigators working in the areas of gastroenterology, epidemiology, immunology, physiology, molecular and cell biology and genetics to submit research project grant applications in the area of autoimmune gastrointestinal diseases including ulcerative colitis, Crohn's disease and celiac disease. Applications are encouraged from any interested investigators regardless of their prior record of grant support. HEALTHY PEOPLE 2000 The NIH 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, Pathogenesis of Inflammatory Bowel Disease and Celiac Disease, is related to the priority area of Diabetes and Chronic Disabling Conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, non-profit and for-profit organizations, whether public or private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Among a team of applicants, one institution must be proposed as the lead organization to serve as the Grantee Institution and assume responsibility for the fiscal and programmatic conduct of this project. Other members of the team should be proposed based on individual consortium agreements (subcontracts). The grantee organization and any proposed consortium must have the staff and facilities required for the proposed program. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The support mechanisms for this research will be the individual research grant (R01) and the First Independent Research Support and Transition (First) Award (R29). This is a one-time solicitation. Subsequent unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to customary peer review procedures. This RFA will provide the opportunity for investigators to establish support for periods up to five years for meritorious research projects designed to investigate the cause, natural history and treatment of Inflammatory Bowel Disease and celiac disease. This RFA is intended to support primarily new applications; however, applications for continuation of currently funded projects will be considered if they meet the objectives of this RFA. R01 awards are expected to average approximately $200,000 per year in total costs. Note: Foreign institutions are not eligible for FIRST awards. FUNDS AVAILABLE The NIDDK plans to support approximately 10 to 12 applications submitted in response to this solicitation. Total costs of $2 million (direct and indirect costs) for this program have been included in the financial plans for fiscal year 1993. The number of awards to be made is dependent upon receipt of a sufficient number of applications of high scientific merit and upon availability of funds. Applicants for an R01 award must limit their request to not more than $160,000 direct costs for the initial budget period, and normal biomedical inflation increments in future years will be allowed. Applicants for FIRST awards must limit their requests to $350,000 total direct costs across 5 years. Although this program is provided for 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 Inflammatory Bowel Disease (IBD) is a general term given to two diseases, ulcerative colitis and Crohn's disease, that together are major causes of morbidity and mortality from gastrointestinal disorders. It is estimated that 2 million Americans are affected by IBD, many of them in the younger age groups. Ulcerative colitis and Crohn's disease have many similar clinical and pathological features and are considered to be autoimmune in etiology. However, the pathogenesis of IBD is complex and not well understood. Ulcerative colitis and Crohn's disease appear to be the result of a combination of factors including genetic predisposition, alterations in the mucosal immune system and exposure to unknown, triggering exogenous factors, such as intestinal microbes, toxins, food substances or drugs. As for most autoimmune diseases, the specific etiology and pathogenesis of both ulcerative colitis and Crohn's disease remain unclear. Current therapies for IBD are helpful in ameliorating the symptoms and complications of these diseases but are, in general, unsatisfactory and do not provide a specific cure or prevent or alter the eventual natural history of disease in the majority of patients. Celiac disease, also known as non-tropical sprue and gluten-sensitive enteropathy, is another mucosal disease of the gastrointestinal tract that is believed to be autoimmune in etiology. Celiac disease affects approximately a quarter million Americans and usually presents with clinical symptoms during infancy or childhood. Celiac disease is triggered by ingestion of gluten products from wheat, rye, barley and possibly oats, but it also has a major genetic component. Nevertheless, the primary pathogenesis of celiac disease remains obscure. It is not clear how gluten interacts with the intestinal mucosa and induces injury, what components of gluten are responsible for the injury, what genetic defect(s) or abnormal gene(s) predispose to the disorder, or what other exogenous exposures induce this condition. Celiac disease represents a paradigm for autoimmunity and autoimmune diseases in requiring a genetic background, immunologic disturbance and exogenous exposure (gluten) for its expression. At present, the clinical features of celiac disease can be resolved by avoidance of gluten in the diet. However, the dietary restrictions for treatment of celiac disease are challenging and require life-long adherence. Furthermore, there remains an increased incidence of gastrointestinal lymphoma among patients with celiac disease. The NIDDK believes that an intensified research effort into defining the pathogenesis of IBD and celiac disease will help in the prevention and therapy of these important gastrointestinal diseases. The NIDDK encourages collaborative research among the multiple disciplines of gastroenterology, immunology, epidemiology, physiology, molecular, structural and cell biology and genetics to help elucidate the etiology and pathogenesis of IBD and celiac disease. The NIDDK especially encourages new investigators from different fields of research to apply cutting edge research technology and innovative approaches to the understanding of these autoimmune gastrointestinal diseases. Institutions that have demonstrated experience in both clinical and basic science research will be considered most favorably for support. Applications should be directed at the information needed to fill gaps in our knowledge concerning the etiology of ulcerative colitis, Crohn's disease and celiac disease. Examples of possible topics relevant to this RFA include: o the role of the mucosal immune system and its immunoregulation in gastrointestinal inflammation characteristic of IBD and celiac disease; o the role and status of inflammatory mediators, the cytokine system and adhesion molecules in IBD and celiac disease; o the nature of the autoimmune reactions characteristic of IBD and celiac disease including definition of the autoantigens and the fine specificity of autoantibodies that are detected in patients with IBD and celiac disease; o genetic markers and specific gene products associated with IBD and celiac disease and in particular the molecular genetics of the major histocompatibility complex in these disorders; o epithelial cell biology and its disturbance in gastrointestinal inflammation characteristic of IBD and celiac disease; o the role of luminal bacterial flora and viral infections in IBD and celiac disease; and o the epidemiology of IBD and celiac disease with particular attention to special populations and risk factors for development of these diseases as well as their complications such as sclerosing cholangitis in ulcerative colitis and lymphoma in celiac disease. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. 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 disproportionally affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (Rev. 9/91) in Item 4 (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). 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 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 is being 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 by February 26, 1993 to: Robert Hammond, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 496-7083 FAX: (301) 402-1277 APPLICATION PROCEDURES The research grant application form PHS-398 (revised 9/91) must be used in applying for these grants. The form is available from most institutional business offices or from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892; (301) 496-7441. Information describing the FIRST Award grant may also be obtained from these sources. The RFA label available in the 9/91 revision of 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 your 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 Westwood Building, Room 240 National Institutes of Health Bethesda, MD 20892 At the time of submission, two additional copies of the application should also be sent under separate cover to Dr. Robert Hammond, at the address shown above. Applications must be received by April 21, 1993. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 (or R29) and as a component project of a program project. 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. For investigators applying for support through the FIRST award mechanisms (R29), three letters of references must be submitted with the application. An applicant submitting a revised application in response to this RFA must again submit reference letters. Note: Foreign institutions are inelgible for the R29 award. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the Division of Research Grants (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 whether it should be held until the next regular receipt date and reviewed in competition with all other research project applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. In cases where the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further competition when they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following this review, the applications will be given a secondary review by the National Diabetes and Digestive and Kidney Diseases 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 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. AWARD CRITERIA The anticipated date of award is September 30, 1993. Applications will compete for available funds with all other recommended applications submitted in response to this RFA. The following will be considered in making funding decisions: Quality of the proposed projects as determined by peer review, availability of funds, and program balance and scientific interrelationships among the proposed projects. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues should be directed to: Frank A. Hamilton, M.D., MPH Mucosal and Immunology Program Director, NIDDK Westwood Bldg, Room 3A16 National Institutes of Health Bethesda, MD 20892 / Tel. 301 496-7821 Inquiries regarding fiscal matters should be directed to: Mrs. Thelma Jones Grants Management Specialist, NIDDK Westwood Building, Room 649C National Institutes of Health Bethesda, MD 20892 / Telephone: (301) 496-7467 SCHEDULE: Letter of Intent: February 26, 1993 Application Receipt: April 21, 1993 Initial Review: June/July 1993 Second Level Review: September 1993 Anticipated Award: September 30, 1993 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Mon Jan 11 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 10 January 1992 Message-ID: Date: 12 Jan 93 22:33:08 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 63 ** NEW DOCUMENTS ON STIS ** Document Type: SRS Federal Support Survey FY90 Title: Table of Contents File size (bytes): 4083 STIS Filename: fs90atoc ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 89760 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 91034 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Wed Jan 13 22:00:00 1993 Path: biosci!uwm.edu!linac!att!bu.edu!stanford.edu!rock!concert!samba!northcot From: northcot@med.unc.edu (Robert W. Northcott) Newsgroups: bionet.sci-resources Subject: test Message-ID: <1993Jan14.205751.23991@samba.oit.unc.edu> Date: 14 Jan 93 20:57:51 GMT Sender: usenet@samba.oit.unc.edu Organization: UNC-CH School of Medicine Lines: 1 Originator: northcot@nakina Nntp-Posting-Host: nakina.med.unc.edu Testing From owner-sci-resources@net.bio.net Thu Jan 14 22:00:00 1993 Path: biosci!news.cs.indiana.edu!att!linac!uwm.edu!zaphod.mps.ohio-state.edu!news.acns.nwu.edu!casbah.acns.nwu.edu!athieme From: athieme@casbah.acns.nwu.edu (Aaron Thieme) Newsgroups: bionet.general,bionet.sci-resources,bionet.molbio.methds-reagnts,misc.forsale,sci.engr.biomed,sci.materials,sci.chem.organomet Subject: *** Iron 57 (enriched) for sale *** Message-ID: <1993Jan15.073348.22906@news.acns.nwu.edu> Date: 15 Jan 93 07:33:48 GMT Sender: usenet@news.acns.nwu.edu (Usenet on news.acns) Organization: Northwestern University, Evanston Illinois. Lines: 18 Xref: biosci bionet.general:3844 bionet.sci-resources:584 bionet.molbio.methds-reagnts:3948 misc.forsale:9028 sci.engr.biomed:178 sci.materials:469 sci.chem.organomet:29 Nntp-Posting-Host: unseen1.acns.nwu.edu For Sale: Iron 57 Enriched: 95-98% 3.56 grams available. Entire amount must be purchased. For more information, please contact: Andrew Sernovitz Osage 215-567-4442 in the USA Please mention this announcement. No responses via email or usenet, please. Please post no followups! If you know someone who might be interested, please forward this announcement! From owner-sci-resources@net.bio.net Thu Jan 14 22:00:00 1993 Path: biosci!news.cs.indiana.edu!att!linac!uwm.edu!zaphod.mps.ohio-state.edu!news.acns.nwu.edu!casbah.acns.nwu.edu!athieme From: athieme@casbah.acns.nwu.edu (Aaron Thieme) Newsgroups: bionet.general,bionet.sci-resources,bionet.molbio.methds-reagnts,misc.forsale,sci.engr.biomed,sci.materials,sci.chem.organomet Subject: *** Osmium 187 for sale *** Message-ID: <1993Jan15.073141.22813@news.acns.nwu.edu> Date: 15 Jan 93 07:31:41 GMT Sender: usenet@news.acns.nwu.edu (Usenet on news.acns) Organization: Northwestern University, Evanston Illinois. Lines: 19 Xref: biosci bionet.general:3843 bionet.sci-resources:583 bionet.molbio.methds-reagnts:3947 misc.forsale:9027 sci.engr.biomed:177 sci.materials:468 sci.chem.organomet:28 Nntp-Posting-Host: unseen1.acns.nwu.edu For Sale: Osmium 187 GUARANTEED high quality. Various quantities available. This is legitimate, hiqh grade osmium. For more information, please contact: Andrew Sernovitz Osage 215-567-4442 in the USA Please mention this announcement. No responses via email or usenet, please. Please post no followups! If you know someone who might be interested, please forward this announcement! From owner-sci-resources@net.bio.net Thu Jan 14 22:00:00 1993 Path: biosci!news.cs.indiana.edu!att!linac!uwm.edu!zaphod.mps.ohio-state.edu!news.acns.nwu.edu!casbah.acns.nwu.edu!athieme From: athieme@casbah.acns.nwu.edu (Aaron Thieme) Newsgroups: bionet.general,bionet.sci-resources,bionet.molbio.methds-reagnts,misc.forsale,sci.engr.biomed,sci.materials,sci.chem.organomet Subject: *** Zinc Selenide for sale *** Message-ID: <1993Jan15.072052.22336@news.acns.nwu.edu> Date: 15 Jan 93 07:20:52 GMT Sender: usenet@news.acns.nwu.edu (Usenet on news.acns) Organization: Northwestern University, Evanston Illinois. Lines: 18 Xref: biosci bionet.general:3842 bionet.sci-resources:582 bionet.molbio.methds-reagnts:3946 misc.forsale:9026 sci.engr.biomed:176 sci.materials:467 sci.chem.organomet:27 Nntp-Posting-Host: unseen1.acns.nwu.edu For Sale: Zinc Selenide Approx. 506 lbs avaiable in 5 lb bottles. For more information, please contact: Andrew Sernovitz Osage 215-567-4442 in the USA Please mention this announcement. No responses via email or usenet, please. Please post no followups! If you know someone who might be interested, please forward this announcement! From owner-sci-resources@net.bio.net Fri Jan 15 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 2, pt. 1, 15 January 1993 Message-ID: Date: 16 Jan 93 01:56:45 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1500 $$XID NIHGUIDE 19930115 V22N02 P1O2 ************************************ X-comment: RFAs described: DK-93-13 NIH GUIDE - Vol. 22, No. 2 - January 15, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIDCD REVISED GUIDELINES REGARDING REQUESTED BUDGETS AND SUPPLEMENTS FOR PROGRAM PROJECT AND CLINICAL RESEARCH CENTER APPLICATIONS National Institute on Deafness and Other Communications Disorders INDEX: DEAFNESS, COMMUNICATION DISORDERS NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 07/13/93 ************************************************* DIGESTIVE DISEASES CORE CENTERS (RFA DK-93-13) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD (PA-93-36) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P2 ********************************************************** ASTHMA AS A T-CELL-MEDIATED DISEASE (PA-93-37) National Institute of Allergy and Infectious Diseases National Heart, Lung, and Blood Institute INDEX: ALLERGY, INFECTIOUS DISEASES; HEART, LUNG, BLOOD $$INDEX P3 ********************************************************** MULTIPLE SCLEROSIS (PA-93-38) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX P4 ********************************************************** BREAST CANCER IN THE NORTHEASTERN AND MIDDLE ATLANTIC UNITED STATES (PA-93-39) National Cancer Institute INDEX: CANCER ERRATA $$INDEX E1 PA-93-17 ************************************************* OXIDATIVE DAMAGE, ANTIOXIDANT DEFENSE, AND AGING (PA-93-017) National Institute on Aging INDEX: AGING $$INDEX E2 HL-93-09 AND HL-93-10 ************************************ TUBERCULOSIS ACADEMIC AWARD and ASTHMA ACADEMIC AWARD (RFAs HL-93-09L and HL-93-10L) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer. Contact Dr. John James at 301/496-7554 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIDCD REVISED GUIDELINES REGARDING REQUESTED BUDGETS AND SUPPLEMENTS FOR PROGRAM PROJECT AND CLINICAL RESEARCH CENTER APPLICATIONS NIH GUIDE, Volume 22, Number 2, January 15, 1993 P.T. 04, 34; K.W. 1014006 National Institute on Deafness and Other Communication Disorders Since June 1991 the National Institute on Deafness and Other Communication Disorders (NIDCD) has imposed a budgetary cap on new applications for program projects and clinical research centers (See NIH Guide to Grants and Contracts, Vol. 19, No. 46, December 28, 1990). This current announcement supersedes the December 1990 announcement. Effective with the submission deadline of October 1, 1993, this budget cap is extended to all competing applications. New and competing continuation (renewal) applications for program projects and clinical research centers may not exceed $750, 000 (direct costs) in the first year of requested support. Applications exceeding this limit will be returned to the applicant without further review. Future year requested levels of support must be calculated for inflationary increases only, using standard NIH guidelines. In addition, effective with the October 1, 1993 deadline, supplemental applications to program projects and clinical research centers will only be accepted if they are continuations of previously-funded sub-projects. The budget for a supplement must be at the current level of support for the subproject, with inflationary increases, using standard NIH guidelines. INQUIRIES Budgetary constraints have dictated the issuance of this new policy. For additional information and for NIDCD Guidelines for the preparation of program project and clinical research grant applications, please contact: Ralph Naunton, M.D. Director, Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders 6120 Executive Plaza South, Room 400B Bethesda, MD 20892 Telephone: (301) 496-1804 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN DK-93-13 FULL-TEXT *************************************** DIGESTIVE DISEASES CORE CENTERS NIH GUIDE, Volume 22, Number 2, January 15, 1993 RFA AVAILABLE: DK-93-13 P.T. 04; K.W. 0715085, 0785035, 0785055, 0755030 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 15, 1993 Application Receipt Date: July 13, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES BELOW. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Digestive Diseases Core Center grants. The NIDDK anticipates the award of three competitive Digestive Diseases Core Center Grants (P30s) in Fiscal Year 1994. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Digestive Diseases Core Center, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (not 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. Applicant institutions must have an adequate base of established programs of high quality in laboratory and/or clinical digestive diseases related research. MECHANISM OF SUPPORT Support of this program will be through the NIH core center (P30) award. Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. This RFA is a one-time solicitation. The receipt of three competing continuation applications is anticipated. These applications will compete for the awards along with other applications received in response to this RFA. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest possible award dates will be June 1994 for one center grant and September 1994 for the other two grants. 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 a Principal Investigator must be included with the application. FUNDS AVAILABLE For FY 1994, up to $2,307,000 in total costs will be committed to fund applications submitted in response to this RFA. It is anticipated that three awards will be made with an average size of approximately $750,000 per year, total costs; 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 $700,000 direct costs for the initial budget period. Included in this $700,000 are funds with a limit of $100,000 for the pilot and feasibility program. Future budget period escalations should not exceed a four percent increase over the previous 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 The objective of the Digestive Diseases Core Centers is to bring together clinical and basic science investigators from relevant disciplines to enhance and extend the effectiveness of research related to digestive diseases and their complications. There must be an existing peer reviewed and funded program of excellence in this area. At least one half of the research must have a central theme or focus. Examples of a central theme or focus include, but are not restricted to, inflammatory bowel disease, peptic ulcer disease, liver disease, pancreatic disease, pediatric gastrointestinal disease, GI hormones, GI motility, or gene therapy. Core facilities which enhance productivity or in other ways benefit a group of investigators working in digestive diseases centers to accomplish the stated goals of the center will be supported. Two other activities may also be supported with center funding: (1) a pilot and feasibility grant program which may include temporary salary support for one Named New Investigator and (2) an enrichment program including for example, seminars, visiting scientists, consultants, and workshops. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. SPECIAL REQUIREMENTS At least 50 percent of the already funded research base in a new application must be supported by the NIDDK. In competing continuation applications the percent may be less than 50 percent due to, for example, a growing research base of investigators entering digestive diseases from other fields. The significance of the research base will be determined by the initial review group. STUDY POPULATIONS It is NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them, and the study design must seek to identify any pertinent gender or minority population differences. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Submission date: June 15, 1993 Contents should include only 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. A letter of intent is not required, is not binding, and does not enter into the review of subsequent applications. A letter of intent is to be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 496-7083 FAX: (301) 402-1277 APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91), available in the business or grants offices of most academic or research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Detailed instructions on submission procedures are described in the RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIDDK in accordance with the usual NIH peer review procedures. Following review, the applications will be given a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant. Review criteria are given in the RFA. INQUIRIES Written and telephone inquiries are encouraged. It is imperative that the RFA and the pamphlet "Administrative Guidelines for Digestive Diseases Core Centers" be obtained before an application is prepared. These documents and information about programmatic issues may be obtained from: Ms. Tommie Sue Tralka Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 496-9717 Inquiries regarding fiscal matters may be directed to: Ms. Nancy Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637A Bethesda, MD 20892 Telephone: (301) 496-7467 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R2 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-36 ************************************************* ACADEMIC RESEARCH ENHANCEMENT AWARD NIH GUIDE, Volume 22, Number 2, January 15, 1993 PA NUMBER: PA-93-36 P.T. 34; K.W. 0710030, 0404000, 1014006 National Institutes of Health Application Receipt Date: June 18, 1993 PURPOSE The National Institutes of Health (NIH) is making a special effort to stimulate research in educational institutions that provide baccalaureate training for a significant number of the Nation's research scientists, but that historically have not been major recipients of NIH support. Since FY 1985, Congressional appropriations for the NIH have included funds for this initiative, the Academic Research Enhancement Award (AREA) Program. The AREA funds are intended to support new research projects or expand ongoing research activities proposed by faculty members of eligible institutions in areas related to the health sciences. Applications received in June 1992 for AREA grants to be awarded this year (FY 1993) have been reviewed for scientific merit and program relevance. Approximately $13 million will be available for the NIH AREA program in FY 1993. As a result, about 130 AREA grants will be made from the applications received June 1992. Since it is anticipated that additional funds will be available next year, the NIH is inviting grant applications at this time for AREA grants to be awarded competitively in FY 1994. ELIGIBILITY REQUIREMENTS Applicant Institutions o All domestic health professional schools and other academic institutions offering baccalaureate or advanced degrees in the sciences related to health are eligible, EXCEPT those that have received research grants and/or cooperative agreements from the NIH (including the National Institute on Alcohol Abuse and Alcoholism [NIAAA], the National Institute on Drug Abuse [NIDA], and the National Institute of Mental Health [NIMH]) totaling more than $2 million per year (direct and indirect costs) in four or more years during the period from FY 1986 through FY 1992. o For purposes of eligibility for the AREA program, "research grants and cooperative agreements" include the following activity codes ONLY: K01, K02, K04, K05, K06, K08, K11, K12, K14, K15, K16, K20, K21, P01, P40, P41, P42, P50, P60, R01, R03, R10, R21, R22, R23, R24, R29, R35, R37, R55, U01, U10, U24, U41, U42, and U54. o "Health professional schools" (schools of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, and podiatry) means an accredited public or non-profit private school in a State that provides training leading to a degree granted by that school, for example, a doctor of medicine, a doctor of dentistry, or equivalent degree. The term "accredited" means a school or program that is accredited by a recognized body or bodies approved for such purpose by the Secretary of Education. o "Other academic institutions" means, as a SINGLE eligible component, all other schools, departments, colleges and free-standing institutes of the institution except the health professional schools. o Several applications proposing different research projects may be submitted by an applicant institution. Proposed Principal Investigators: o Must not have active research grant support (including an AREA) from the NIH (including the NIAAA, the NIDA, and the NIMH) at the time of award of an AREA grant. o May not submit a regular NIH research grant application for essentially the same project as a pending AREA application. o Are expected to conduct the majority of their research at their own institution, although limited access to special facilities or equipment at another institution is permitted. o May not be awarded more than one AREA grant at a time nor be awarded a second AREA grant to continue the research initiated under the first AREA grant. APPLICATION PROCEDURES Applications for the AREA program will be accepted under the application submission procedures of the Division of Research Grants (DRG), NIH. The research grant application form PHS 398, (rev. 9/91), is to be used in applying for an AREA grant. Applicants must obtain the AREA Program Guidelines containing supplemental instructions for AREA applications from the Office of Grants Inquiries, DRG, NIH (see address below). These instructions must be followed in preparing an application. AREA grants are awarded on a competitive basis. Applicants may request support for up to $75,000 for direct costs (plus applicable indirect costs) for a period not to exceed 36 months. No more than $35,000 may be requested for direct costs for any one year. Although this award is non-renewable, it will enable qualified individual scientists within the eligible institutions to receive support for feasibility studies, pilot studies, and other small-scale research projects preparatory to seeking more substantial funding from the NIH research grant programs. REVIEW CONSIDERATIONS Applications for the AREA program will be subjected to the standard peer review process involving two sequential levels of review. The first level of review is performed by initial review groups composed primarily of non-Federal scientists selected for their competence in particular scientific fields. The second level of review is made by the National Advisory Council or Board of the NIH awarding component to which the grant application has been assigned by the DRG. These groups are composed of both scientific and lay representatives who are chosen for their expertise, interest, or activity in matters related to the mission of the individual awarding component. Council or Board recommendations are based on both scientific merit and relevance to awarding component program goals. In general, the NIH may award a grant only if the corresponding application has been recommended for funding by both levels of review. AWARD CRITERIA Funding decisions will be based on the proposed research project's scientific merit and relevance to NIH programs and the institution's contribution to the undergraduate preparation of doctoral-level health professionals. Among projects of essentially equivalent scientific merit and program relevance, preference will be given to those submitted by institutions that have granted baccalaureate degrees to 25 or more individuals who have obtained academic or professional doctoral degrees in the health related sciences during the period 1983-1992. Scientists working in eligible minority and women's educational institutions are encouraged to participate in this program. Since a primary purpose of the AREA program is to furnish support to those undergraduate institutions that provide student training in the sciences, principal investigators are encouraged to include the participation of students in the proposed Research Plan to the extent practicable. INQUIRIES Supplemental instructions/application forms Those individuals and institutions meeting the eligibility requirements may contact the office named below to receive the AREA Program Guidelines and/or form PHS 398 application packages. Academic Research Enhancement Award Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building, Room 449 Bethesda, MD 20892 Telephone: (301) 496-7441 Questions regarding eligibility, policies, procedures, and other administrative aspects of the NIH AREA program should be referred FIRST to the office of sponsored programs at the institution. Issues that remain AFTER consultation with the institutional office of sponsored programs and that are NOT ADDRESSED in the AREA Program Guidelines may be addressed to: Research Training and Special Programs Office Office of Extramural Research National Institutes of Health Building 31, Room 5B44 Bethesda, MD 20892 Telephone: (301) 496-1968 FAX: (301) 496-0166 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.390. Grants will be awarded under authority of the Public Health Service Act, Title III, Section 301 (Public Law 78- 410, as amended; 42 USC 241) and administered in accordance with the PHS Grants Policy Statement and Federal Regulations at 42 CFR Parts 52 and 74. $$P1 END ************************************************************ $$P2 BEGIN PA-93-37 ************************************************* ASTHMA AS A T-CELL-MEDIATED DISEASE NIH GUIDE, Volume 22, Number 2, January 15, 1993 PA NUMBER: PA-93-37 P.T. 34; K.W. 0715013, 0710070, 1002008, 0710030 National Institute of Allergy and Infectious Diseases National Heart, Lung and Blood Institute PURPOSE The Division of Allergy, Immunology, and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) and the Division of Lung Diseases (DLD) of the National Heart, Lung, and Blood Institute (NHLBI) invite applications for support of basic and preclinical studies designed to define the role of T cell subsets and the cytokines that they secrete in the inflammation that is characteristic of both clinical asthma and the late phase reactions following bronchial challenge with antigen. 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, Asthma as a T-cell-mediated Disease, is related to the priority area 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 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible to apply for the First Independent Research Support and Transition (FIRST) Award (R29). MECHANISMS OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and the FIRST award (R29). Multidisciplinary approaches that involve collaborative efforts among investigators in the fields of basic and clinical immunology, allergy, pulmonology, biochemistry and molecular biology are strongly encouraged. Policies that govern research grant programs of the National Institutes of Health will prevail. RESEARCH OBJECTIVES Background The etiology of asthma remains poorly understood. A series of studies have recently emphasized that asthma is an inflammatory disease of the airways, and that reducing inflammation is critical for successful management of severe asthma. The inflammatory cells include increased numbers of eosinophils, basophils and T lymphocytes. Of particular interest from the standpoint of new approaches to the pathogenesis of asthma is the involvement of T lymphocytes. In allergic asthma, the inflammatory T cells express TH2-like lymphokines [i.e., IL-4 and IL-5 but not interferon-~ (IFN)]. Both IL-4 and IL-5 appear to be critically important to allergic inflammation. The universality of these findings in all asthmatics is controversial. Some data suggest that so-called "intrinsic" asthmatics (who have low total IgE levels and no IgE antibodies to known allergens) express the cytokines IL-5 and IFN, that are not characteristic of known T-cell subsets. In contrast, other data indicate that all asthmatics, including non-atopic asthmatics, have higher total levels of IgE than non-asthmatics; high levels of IgE presumably are associated with increased production of IL-4. The elevated levels of IgE may represent IgE antibody to allergen(s). Indeed, production of IgE antibodies to specific allergens, notably indoor allergens derived from dust mite, cat and cockroach, is characteristic of a substantial proportion of asthmatics and measures which reduce exposure to these allergens result in asthma improvement. Research Objectives and Scope - To elucidate the importance of T cells in the etiology of asthma, the NIAID and the NHLBI are soliciting individual research project grants that are designed to define the role of T cell subsets and their secreted products in the inflammatory processes associated with asthma. Such studies may include but are not limited to: o Biochemical and molecular characterization of bulk and antigen- specific T lymphocyte populations in lung and blood, including evaluation of such parameters as T-cell receptors, adhesion molecules, and patterns of cytokine expression o Correlation between T-cell populations and clinical and immunological patient parameters such as asthma severity, and levels of antigen-specific and total serum IgE, basophil and eosinophil accumulation and activation, and airways reactivity. o Determination of the effects on T-cell populations of agents useful in treatment of allergic diseases and asthma, such as allergen immunotherapy and glucocorticosteroids. The use of modern, state-of-the-art technology in biochemistry and molecular biology in these projects would be of great value. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in items 1-4 of the Research Plan AND summarized in item 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, check yes on item 2a of the face page and enter the PA number and title: "PA-93-37: Asthma as a T-cell-mediated Disease". Applications will be accepted in accordance with the standard submission dates for new applications: February 1, June 1, and October 1. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The completed signed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** For FIRST award (R29) applications, three reference letters (in sealed envelopes) must be attached to the face page of the original application and submitted with the application. Failure to provide the three reference letters will result in return of the application to the investigator. REVIEW PROCEDURES Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants (DRG), NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council or board. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Marshall Plaut, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A23 Bethesda, MD 20892 Telephone: (301) 496-8973 FAX: (301) 402-2571 Susan P. Banks-Schlegel, Ph.D. Division of Lung Diseases National Heart, Lung and Blood Institute Westwood Building, Room 6A15 Bethesda, MD 20892 Telephone: (301) 496-7332 FAX: (301) 496-9886 Direct inquiries regarding fiscal matters to: Mr. Jeffrey Carow Immunology Grants Management Section National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 Tanya McCoy Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 4A17A Bethesda, MD 20892 Telephone: (301) 496-4970 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 and No. 93.838. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and 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, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$P3 BEGIN PA-93-38 ************************************************* MULTIPLE SCLEROSIS NIH GUIDE, Volume 22, Number 2, January 15, 1993 PA NUMBER: PA-93-38 P.T. 34; K.W. 0715140, 0755030, 0765033 National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health, invites research grant applications seeking support of a wide spectrum of research on multiple sclerosis. Multiple sclerosis (MS) is one of the most common neurological disorders of young adults. It has been estimated that there are about 250,000 to 300,000 MS patients in the U.S., and some 200 new cases are diagnosed each week. Median duration of the disease is over 30 years. MS is a chronic demyelinating disease of the central nervous system, thought to be of autoimmune pathogenesis, whose etiology may involve genetic, viral, and immunological factors. Affected patients may exhibit neurological abnormalities such as visual and other sensory disturbances, and partial or complete paralyses. The course of the disease may vary from relapsing- remitting to a chronic-progressive course. Because this disabling disease, without effective treatment, afflicts young adults with near normal life expectancy, the cost of medical care, including patient rehabilitation and loss of productivity, represent an economic burden estimated to be in excess of $2.5 billion annually. Progress and achievements in brain and nervous system research culminated in the Congressional House resolution and Presidential Proclamation declaring the Decade of the Brain (1990s). NINDS's Implementation Plan pointed out unsolved problems, and offered recommendations for significant and profitable research areas to pursue. In support of these recommendations, NINDS is issuing this program announcement soliciting grants from individuals in all disciplines for support of research into the etiology and pathogenesis of MS, and in research areas that are directly and indirectly relevant to MS. HEATHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Multiple Sclerosis, is related to the priority area of 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 Applications may be submitted by foreign and domestic institutions, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority institutions, minority individuals, and women are particularly encouraged. Foreign institutions are not eligible for R29, P01, K04, K08, F32, and T32. MECHANISM OF SUPPORT Research support may be requested through application for an individual investigator originated research project grant (R01). Applications from new investigators who have not received previous PHS research grant support may apply for a First Independent Research Support and Transition (FIRST) award (R29). To apply for the support of a more broadly based multidisciplinary research program, the research program project (P01) mechanism is suggested. NINDS also provides support for the career development of clinical investigators through Clinical Investigator Development Award (K08), and development of young scientists through Research Career Development Awards (K04), Individual National Research Service Awards (fellowships) (F32), and Institutional National Research Service Awards (T32). RESEARCH OBJECTIVES There are a number of research directions whose exploration may shed new light on understanding the causation, pathogenesis, diagnosis, and potential treatment of this important chronic disease. This program announcement seeks to stimulate and encourage ideas that can compete successfully for support through grants-in-aid from NINDS. Examples of research goals, many of which may lend themselves to study in man as well as in animal models and in in vitro systems, that may be considered for research grant applications in response to this program announcement would include, but are not limited to, the following: o Further genetic studies of the human disease and its animal models are needed. There is some limited evidence in humans that there is a predilection to the development of MS in individuals with a particular genetic makeup. A familial tendency is noted with moderate risk increases in twins and first degree relatives of index cases. There are significant variations in MS prevalence in various ethnic groups and geographic variation in the disease. In animal model disorders such as Experimental Autoimmune Encephalomyelitis, there is very pronounced evidence of genetic factors of susceptibility and resistance. o Genetic, hormonal, and other innovative studies are needed to elucidate the reason(s) for the pronounced susceptibility of women to this disorder and/or the relative sparing of men. o Cell biological studies of normal and pathological functions and interactions of oligodendroglia, myelin, and neurons are needed to shed light on mechanisms of demyelination and remyelination in MS. o There is a need for further studies of protein and lipid synthetic mechanisms in myelin assembly. Knowledge of mechanisms controlling transcription and translation of proteins, limiting enzymes, lipid pathways, and myelin maintenance could give new information into the control and pathways of demyelinating disorders. o Studies are encouraged on cytokine expression during phases of MS, including studies of cytokine activity in plaque material and in cerebrospinal fluid during active and quiescent phases of the disease. o The bases of central nervous system inflammation as precursor or companion of demyelination deserve further study. Examples of active research include studies of lymphocyte trafficking in relation to blood-brain-barrier, studies of cell adhesion and other recognition molecules, and studies of heat shock protein (HSP) expression by glial cells. Additional studies are warranted on the role of cellular surface and adhesion molecules in normal development and in demyelinating disease. o Proposals are solicited for innovative neuroimaging methods for in vivo studies of demyelinating disorders, including new approaches to MS lesion quantification. There is a special need for development of new techniques for improved classification of MS lesions. These technologies could be usefully applied both in patients and in animal model systems. o Further studies of viruses are needed, especially those that initiate demyelinating diseases, utilizing primary inflammatory and indirect immunological mechanisms, despite many years of failure to identify a specific viral cause or single inducing antigen in humans. o Expansion of epidemiological and demographical studies of MS are encouraged. o There is a need for rigorously designed and well controlled clinical trials of promising new therapeutic modalities. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan and summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaska Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. 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 Use form PHS 398 (rev. 9/91) to apply for R01, R29, P01, K04, K08, and T32. Additional instructions and substitute pages are included with the PHS 398 kit for K04, K08, and T32. Application receipt dates for R, K, and P grants are: February 1, June 1, October 1; for T grants: January 10, May 10, September 10; and for F grants: April 5, August 5, December 5. "NINDS Application Guidelines for Program Project (P01) and Center (P50) Grants" (rev. 4/92), as are guidelines for Clinical Investigator Development Award (K08), are available upon request from the Program Administrator identified below. Application kits are available at most business and grants and contracts offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, Maryland 20892, telephone (301) 496-7441. On the first (face) page, item 2a, of the application, the word "yes" must be checked and the title and number of the announcement typed in the space provided: "Multiple Sclerosis" PA-93-38. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The original and five copies of the application must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** The Division of Research Grants, NIH, serves as central point for receipt of applications. 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 collaboration from the GCRC Program Director or Principal Investigator should be included with the application. REVIEW CONSIDERATIONS Applications received under this PA will be assigned to an Initial Review Group (IRG) in accordance with established PHS referral guidelines. The IRGs, that are composed primarily of non-federal scientific and technical experts, will review applications for scientific and technical merit. Following IRG review, the applications will receive a second-level review by one or more appropriate Advisory Councils. AWARD CRITERIA The standard review criteria will be used to assess the scientific merit of applications. Applications will compete for available funds with all other applications. The following will be considered when making funding decisions: o Quality of the proposed projects as determined by peer review; o Availability of funds; o Program balance among research areas. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. A. P. Kerza-Kwiatecki Division of Demyelinating, Atrophic, and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 804 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 402-2060 Direct inquiries regarding fiscal matters to: Ms. Laura Williams Grants Management Branch, Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.853 and 93.854. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END ************************************************************ $$P4 BEGIN PA-93-39 ************************************************* BREAST CANCER IN THE NORTHEASTERN AND MIDDLE ATLANTIC UNITED STATES NIH GUIDE, Volume 22, Number 2, January 15, 1993 PA NUMBER: PA-93-39 P.T. 34; K.W. 0715035, 0710030, 1002019, 1002008, 0710070, 0710095 National Cancer Institute PURPOSE Despite significant strides in prevention, diagnosis, and treatment, breast cancer continues to be a leading cause of death in the United States. It has been estimated that approximately 46,000 women will die of breast cancer in the United States in 1993 and that about 18 percent of all female cancer deaths in the U.S. will be due to malignancies of the breast. The average annual U.S. mortality rate for breast cancer is 27.5 per hundred thousand. Of particular concern are recent data that point to an unexplained increase in breast cancer incidence, and to breast cancer mortality rates that exceed the national average, among women residing in certain of the northeastern and mid-Atlantic states. In the Report of the Senate Committee on Appropriations, regarding the bill (H.R. 5677) making Fiscal Year 1993 appropriations for the Departments of Labor, Health and Human Services, Education and Related Agencies, there was included the following language: "The Committee is concerned by the high breast cancer mortality rates in the northeastern and mid-Atlantic regions of the country and directs the National Cancer Institute to conduct a study with update for four succeeding years for the purpose of determining the factors contributing to the high breast cancer mortality rates in Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont and the District of Columbia." The National Cancer Institute (NCI) has devoted, and will continue to devote, significant resources to studies of breast cancers. However, not only does a great deal remain to be accomplished so that more effective preventive, diagnostic, and therapeutic modalities can be established, but more emphasis on pertinent basic research is also necessary. This Program Announcement (PA) is one of several initiatives that serve to notify and reaffirm to the scientific community the continuing commitment of the NCI to expanding research support in basic and applied studies of the etiology, biology and immunology, genetic regulation, diagnosis, treatment, assessment of demographics, patterns of care, and strategies for control and prevention of breast cancer, but specifically to identify, as a matter of the highest Institute priority, the support of such studies as they may apply to populations within the localities identified in the Congressional language cited above. Research under this program announcement also may include data collection, statistical analysis and mathematical modeling, health services research, and information database linkage studies to monitor progress toward cancer control. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Breast Cancer in the Northeastern and Middle Atlantic U.S., is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications are encouraged from, but not limited to, sites with direct access to the affected populations in the Northeastern United States. Further, the NCI is especially interested in receiving applications from women and from minority investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISMS OF SUPPORT Support of this program will be through the research project grant (R01) or the First Independent Research Support and Transition (FIRST) award (R29) as well as through competing supplemental awards to currently active research project grants (R01) or Method to Extend Research in Time (MERIT) awards (R37). While there is no limit or cap on the amount of total cost of an individual award under this program, it is anticipated that the average annualized direct cost of awards made under this PA will be approximately $35,000 for competing supplements, $75,000 for FIRST awards and $150,000 for new research project grants. Investigators holding active R01 or R37 grants to study breast cancer or related subjects, with at least one year of support remaining at the time of the anticipated award, or individuals desiring to apply for support under the R01 or R29 mechanisms, are specifically encouraged to apply for grants citing this program announcement. RESEARCH OBJECTIVES The purpose of this program is to provide support for investigators to pursue promising avenues of research addressed to breast cancer incidence and mortality occurring in the aforementioned geographical areas. Studies may directly involve populations within this geographical area, e.g., in clinical investigations, or may be concerned with the full range of biological, genetic, environmental, occupational, behavioral or clinical factors that may be relevant to the disease in these populations. Topics of interest include: o studies of whether or not excess mortality can be identified as a direct consequence of excess incidence in these jurisdictions or is due entirely or in part to other factors, such as late stage at diagnosis or problems with access or availability of good quality care; o delineation of demographic characteristics, including prevalence of personal, family, or socioenvironmental risk factors that could be expected to result in higher than average incidence rates, such as age at menarche, age at first birth, use of exogenous hormones, and/or dietary patterns; o assessment, through environmental measurements and biochemical analyses, of differences in exposure among appropriate samples of women in areas of low and high breast cancer incidence (e.g., to dietary and nutritional factors, to electromagnetic fields, to toxic substances, especially pesticides, herbicides or contaminants from sewage in drinking water and food); and o approaches to elucidate racial/ethnic/socioeconomic differences with respect to breast cancer incidence and mortality and the potential role(s) of suspected risk factors, for regions in these jurisdictions having heterogeneous populations. Interdisciplinary collaborations between geneticists, molecular biologists, epidemiologists, environmental health scientists, public health officials and others are encouraged. While applications will be accepted within any of NCI's relevant extramural program areas as outlined below, the Institute would strongly urge the submission of competing supplemental applications proposing novel projects that represent laboratory-to-clinic transitions in breast cancer or that offer the opportunity for participation of women or underrepresented minority individuals. The NCI is composed of four program Divisions that support extramural research relevant to this program announcement. The spectrum of research supported by these Divisions is as follows: The NCIs Division of Cancer Etiology plans and directs a national program of basic research including laboratory, field, and epidemiologic and biometric research on the cause and natural history of cancer and means for preventing cancer, and evaluates mechanisms of cancer induction and promotion by chemicals, viruses, and environmental agents. Representative types of research activities appropriate to this program announcement include, but are not limited to, assessment of the relative contributions and interactions of lifestyle, environment, occupation, genetic factors, viruses, and/or metabolism on the risk of cancers of the breast. In addition, integrated multidisciplinary studies in chemical carcinogenesis are encouraged to identify epithelial cell markers for various stages of transformation, to identify inhibitors of carcinogenesis including natural inhibitors in the human environment, and to determine the specific molecular changes that occur as epithelial cells are transformed. The Division of Cancer Biology, Diagnosis, and Centers supports research on the cellular and molecular biology of malignant cells, the role of the immune system in tumor growth (including vaccine research) and progression and on the transfer of basic research findings to clinical application for the improved diagnosis/prognosis of cancer. In the area of cancer biology, areas of emphasis include, but are not limited to: soluble factors (e.g., hormones, growth factors), and matrix and membrane macromolecules that modulate the growth of tumor cells; the regulation of the expression of these effectors and the mechanism of action; and the genetic events responsible for progression of tumors to a highly malignant and metastatic state. In the area of cancer immunology, specific interests include, but are not limited to: cellular and humoral immune recognition of tumor antigens, methods of improving immune killing of tumor cells, immune control of tumor metastasis, other regulatory effects of the immune system on tumor growth, and tumor modulation of host immune function. Studies are specifically solicited for further research in these areas of immunology aimed at the eventual development of vaccines for the primary or secondary prevention of these cancers. In the area of cancer diagnosis, areas of emphasis include, but are not limited to: more precise staging of tumors for prognostic and therapeutic decision making, more effective monitoring of response to therapy, earlier detection of both initial and recurrent tumors, and identification of populations at risk for developing particular cancers. The Division of Cancer Prevention and Control plans, develops, directs, and coordinates research on prevention, control, and community oncology. Representative studies involve the identification and evaluation of agents that may inhibit carcinogenesis (initiation, promotion, transformation, and/or progression). These studies could include identification of appropriate agents through literature searches or laboratory methods, efficacy and toxicology studies in animals to aid in selection of materials for human studies, and phase I and II clinical trials of potential preventive agents. Other research could focus on reduction of cancer morbidity and mortality through early detection including identification of biological markers of risk, exposure, and pre-malignant events of progression. Research on the roles of nutrients, food groups, and other dietary components in cancer incidence is appropriate including the influence of dietary factors on the modulation of cancer risk markers or intermediate endpoints. Cancer control includes research on the development and testing of intervention strategies to modify personal, social, and lifestyle factors known to contribute to the development and/or increased risk of cancer, and multidisciplinary intervention research aimed at addressing minority, underserved, and other special populations. The Division of Cancer Treatment plans, directs, and coordinates an integrated program of preclinical and clinical cancer treatment research with the objective of curing or controlling cancer in humans by utilizing single or combination treatment modalities. The tumor site addressed by this program announcement currently requires multimodality treatment for optimal management of all stages and presentations of disease, but these treatment methods cause serious morbidity and fail to cure most patients with advanced disease. In preclinical cancer treatment research, there is an urgent need to translate recent developments in the molecular biology of cancer into the discovery of new anticancer treatments whose actions will be highly specific for particular genes or gene products. Exciting areas that may be exploited include oncogenes such as the HER-2/neu oncogene in breast cancer, suppressor genes, signal transduction, cell cycle regulation, growth factors/receptors, metastasis, and angiogenesis. Several approaches will be necessary to take advantage of these new opportunities. Additional topics include, but are not limited to, drug discovery of new anticancer agents, biochemical and molecular mechanisms of antitumor drug action, and pharmacology and toxicology of antitumor agents. Studies to circumvent individual and multiple drug resistance and prevent metastasis of these cancers to other organs are included. Clinical research opportunities exist in the areas of high-dose chemotherapy followed by autologous bone marrow rescue, multidrug resistance, radiosensitizers, adjuvant chemotherapy, innovative surgical or multimodality approaches, particle beam irradiation, novel immune therapies and genetic manipulations of host or malignant tissues, therapy with biological products, such as interleukins, monoclonal antibodies, and/or retinoic acid. Applications that address these opportunities and these particular tumors are specifically solicited. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purposes of this PA, it is expected that women residing in the states or jurisdictions cited in the Senate Report (H.R. 5677) will be the focus of the proposed research project. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The title and number of the announcement must be typed in line 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants (DRG), NIH, in accordance with the standard NIH peer review procedures. Applications for supplements to ongoing From owner-sci-resources@net.bio.net Fri Jan 15 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 2, pt. 2, 15 January 1993 Message-ID: Date: 16 Jan 93 01:58:15 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 684 $$XID NIHGUIDE 19930115 V22N02 P2O2 ************************************ awards will be assigned to DRG study sections on the basis of current NIH referral guidelines, and reviewed according to criteria applicable to the mechanism of the ongoing award. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council or board. AWARD CRITERIA Applications will compete for available funds with all other approved applications. Applicants are encouraged to seek matching funds from state or municipal sources wherever these might be appropriate to augment the institutional or investigational resources available in support of the proposed project. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES The opportunity to clarify any issues or questions from potential applicants is welcome. Written and telephone inquiries concerning the objectives and scope of this program announcement are encouraged and may be directed to: NCI Referral Office National Cancer Institute Westwood Building, Room 850 Bethesda, MD 20892 Telephone: (301) 496-7173 FAX: (301) 402-0275 Inquiries will be referred to the appropriate NCI Program Director in one of the program Divisions noted above in the RESEARCH OBJECTIVES section of this announcement. Direct inquiries regarding fiscal matters to: Ms. Jean Cahill Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800, extension 47 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance under one or more of the applicable sections: No. 93.393, No. 93.394, No. 93.395, No. 93.396, and No. 93.399. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P4 END ************************************************************ ERRATA $$E1 BEGIN P3 19921113 APPEND PA-93-17 BOTH **************************** OXIDATIVE DAMAGE, ANTIOXIDANT DEFENSE, AND AGING NIH GUIDE, Volume 22, Number 2, January 15, 1993 PA NUMBER: PA-93-017 P.T. 34; K.W. 0710010, 0765035, 0760070, 0765025 National Institute on Aging The following language was inadvertently omitted from Program Announcement PA-93-017 (reference NIH Guide, Vol. 21, No. 41, November 13, 1992): RESEARCH OBJECTIVES .... and the National Institute of General Medical Sciences (NIGMS) supports basic research on mitochondrial function as well as the role of oxidative damage in cell injury and tissue repair. $$E1 END ************************************************************ $$E2 BEGIN R5 AND R6 19921113 APPEND RFA HL-93-09/10 BOTH ************** TUBERCULOSIS ACADEMIC AWARD and ASTHMA ACADEMIC AWARD NIH GUIDE, Volume 22, Number 2, January 15, 1993 RFA AVAILABLE: HL-93-09-L and HL-93-10-L P.T. 34; K.W. 0715165, 0502024, 0785035, 0715013 National Heart, Lung, and Blood Institute The following language was inadvertently omitted from RFA HL-93-09L, Tuberculosis Academic Award, and RFA HL-93-10L, Asthma Academic Award, (reference NIH Guide, Vol. 21, No. 41, November 13, 1992): Applications may be triaged by a National Heart, Lung, and Blood Institute peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated in the RFA for scientific/technical merit by an appropriate peer review group convened by NHLBI. The second level of review will be provided by the National Heart, Lung, and Blood Advisory Council. $$E2 END ************************************************************ $$XID RFA DK9313 DK-93-13 P1O1 ***************************************** DIGESTIVE DISEASES CORE CENTERS NIH GUIDE, Volume 22, Number 2, January 15, 1993 RFA: DK-93-13 P.T. 04; K.W. 0715085, 0785035, 0785055, 0755030 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 15, 1993 Application Receipt Date: July 13, 1993 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Digestive Diseases Core Center grants. The NIDDK anticipates the award of three competitive Digestive Diseases Core Center Grants (P30s) in Fiscal Year 1994. The Digestive Diseases Core Centers are part of an integrated program of digestive diseases-related research support provided by the NIDDK. The Centers currently funded in this program have provided a focus for increasing collaboration and improving the cost-effectiveness of supported research among groups of successful investigators at institutions with an established comprehensive digestive diseases research base. 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), Digestive Diseases Core Centers, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (not 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. Applicant institutions must have an adequate base of established programs of high quality in laboratory and/or clinical digestive diseases related research. The quality of the programs must be evident from the fact that they have been awarded support through peer reviewed competition, such as NIDDK research project grants (R01), program project grants (P01), FIRST (R29) awards, cooperative agreements, and contracts or peer reviewed and funded through other Federal Agencies or non-federal groups. MECHANISM OF SUPPORT Support of this program will be through the NIH core center (P30) award. Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. This RFA is a one-time solicitation. The receipt of three competing continuation applications is anticipated. These applications will compete for the awards along with other applications received in response to this RFA. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest possible award dates will be June 1994 for one center grant and September 1994 for the other two grants. Applicants must limit their requests to not more than $700,000 direct costs for the initial budget period. Included in this $700,000 are funds with a limit of $100,000 for the pilot and feasibility program. Future budget period escalations should not exceed a four percent increase over the previous budget period. 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 a Principal Investigator must be included with the application. FUNDS AVAILABLE For FY 1994, up to $2,307,000 in total costs will be committed to fund applications submitted in response to this RFA. It is anticipated that three awards will be made with an average size of approximately $750,000 per year, total costs; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. 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 The objective of the Core Centers is to bring together investigators from relevant disciplines to enhance and extend the effectiveness of research related to digestive diseases and their complications. A Core Center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the Core Center is to bring together clinical and basic science investigators in a manner that will enrich the effectiveness of digestive diseases research. An existing program of excellence in biomedical research in the area of digestive diseases disorders is required. This research must be in the form of NIH funded research projects, program projects, or other peer reviewed research that is already funded at the time of submission of a Center grant application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. The Core Centers must ha