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