From owner-sci-resources@net.bio.net Wed Jan 05 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 1, pt. 1, 7 January 1994 Date: 5 Jan 1994 19:13:46 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1500 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2gfvla$8bb@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940107 V23N01 P1O4 ************************************ X-comment: RFAS described: DE-94-001, DK-94-009, DK-94-010, DK-94-014, ES-94- 004, ES-94-005, GM-94-004, HD-94-013, LM-94-001, N R-94-003, RR-94-003 NIH GUIDE - Vol. 23, No. 1 - January 7, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** REVISED PAYBACK AGREEMENT FORMS National Institutes of Health Agency for Health Care Policy and Research Health Resources and Services Administration INDEX: NATIONAL INSTITUTES OF HEALTH; HEALTH CARE POLICY, RESEARCH; HEALTH RESOURCES, SERVICES ADMINISTRATION $$INDEX N2 ********************************************************** NIH GRANT SUPPORT MECHANISMS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD, DRUG ADMINISTRATION $$INDEX N4 ********************************************************** RESEARCH ON LYME DISEASE Center for Diseases Control and Prevention INDEX: DISEASES CONTROL, PREVENTION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** EARLY DETECTION RESEARCH NETWORK (MAA NCI-CN-45580-63) National Cancer Institute INDEX: CANCER $$INDEX R2 ********************************************************** HERMETIC PACKAGES AND FEEDTHROUGHS FOR NEURAL PROSTHESES (RFP NIH-NINDS-94-03) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R3 ********************************************************** RECOMPETITION OF THE OPERATIONS CENTER FOR THE TERRY BEIRN COMMUNITY PROGRAM FOR CLINICAL RESEARCH ON AIDS (RFP NIH-NIAID-DAIDS-95-02) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 ********************************************************** APPLICATION OF DATA ON THE HLA SYSTEM TO THE DEVELOPMENT AND IMPROVEMENT OF VACCINES AND INFLUENCE OF HLA AND OTHER GENES ON RESPONSE TO VACCINES (BAA NIH-NIAID-DAIT/DMID-94-30) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R5 ********************************************************** HIV VACCINE PREPAREDNESS AND PHASE III EFFICACY TRIAL SITES (SFP N01-AI-35176-JMEISTER1-94) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R6 03/18/94 ************************************************* IMMUNE RESPONSES TO LYME DISEASE INFECTION AND VACCINATION (RFA AI-94-008) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R7 09/21/94 ************************************************* REGIONAL RESEARCH CENTERS FOR MINORITY ORAL HEALTH: PHASE II (RFA DE-94-001) National Institute of Dental Research National Center for Research Resources INDEX: DENTAL RESEARCH; RESEARCH RESOURCES $$INDEX R8 04/20/94 ************************************************* RESEARCH ON HIV INFECTION IN THE GENITOURINARY TRACT (RFA DK-94-009) National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R9 04/20/94 ************************************************* EFFECTS OF HIV INFECTIONS ON THE KIDNEY (RFA DK-94-010) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R10 04/12/94 ************************************************ PROGRESSION OF RENAL DISEASE: IgA NEPHROPATHY IN CHILDREN AND YOUNG ADULTS (RFA DK-94-014) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R11 04/08/94 ************************************************ TIMING OF ENVIRONMENTAL EXPOSURES IN BREAST CANCER (RFA ES-94-004) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX R12 04/01/94 ************************************************ ENVIRONMENTAL EQUITY: PARTNERSHIPS FOR COMMUNICATION (RFA ES-94-005) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX R13 04/27/94 ************************************************ PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS (RFA GM-94-004) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX R14 05/24/94 ************************************************ PERINATAL EMPHASIS RESEARCH CENTERS (RFA HD-94-013) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R15 03/29/94 ************************************************ MOLECULAR BIOLOGY: RESOURCE DATABASE SUPPORT (RFA LM-94-001) National Library of Medicine INDEX: LIBRARY OF MEDICINE $$INDEX R16 04/21/94 ************************************************ SYMPTOM MANAGEMENT: ACUTE PAIN (RFA NR-94-003) National Institute of Nursing Research INDEX: NURSING RESEARCH $$INDEX R17 04/08/94 ************************************************ EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS (RFA RR-94-003) National Center for Research Resources INDEX: RESEARCH RESOURCES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD (PA-94-022) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P2 ********************************************************** HIV-RELATED THERAPEUTICS IN DRUG USERS (PA-94-023) National Institute on Drug Abuse National Institute of Allergy and Infectious Diseases INDEX: DRUG ABUSE; ALLERGY, INFECTIOUS DISEASES $$INDEX P3 ********************************************************** NIH LOAN REPAYMENT PROGRAM FOR AIDS RESEARCH (PA-94-024) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P4 ********************************************************** POSTDOCTORAL TRAINING IN ALTERNATIVE MEDICINE (PA-94-025) Office of Alternative Medicine National Institutes of Health INDEX: ALTERNATIVE MEDICINE $$INDEX P5 ********************************************************** BIOMEDICAL RESEARCH SUPPORT SHARED INSTRUMENTATION GRANT (PAR-94-026) National Center for Research Resources INDEX: RESEARCH RESOURCES ERRATUM $$INDEX E1 ********************************************************** MINORITY SCHOOL FACULTY DEVELOPMENT AWARD (PAR-94-017) National Cancer Institute INDEX: CANCER This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** REVISED PAYBACK AGREEMENT FORMS NIH GUIDE, Volume 23, Number 1, January 7, 1994 P.T. National Institutes of Health Agency for Health Care Policy and Research Health Resources and Services Administration Revised Payback Agreement Forms (PHS 6031, rev. 9/93) are available and must be completed by all trainees and fellows upon initiation of their first twelve months of postdoctoral National Research Service Award (NRSA) support. Previous versions of PHS 6031 will not be accepted for appointments to research training grants starting on or after February 1, 1994. Similarly, individuals receiving individual postdoctoral fellowship awards with issue dates on or after February 1, 1994 will receive and must complete the 9/93 version of PHS 6031. The 9/93 version of PHS 6031 will permit full implementation of Section 1602 of the NIH Revitalization Act as described in the NIH Guide for Grants and Contracts (Vol. 22, No. 27, July 30, 1993). By signing these forms, recipients of postdoctoral NRSA support agree to engage in a month of health-related research, health-related teaching, or health-related research training (including NRSA- supported training) for each month of postdoctoral NRSA research training support received during the first 12 months. Therefore the maximum obligation for any postdoctoral trainee or fellow beginning NRSA training on or after June 10, 1993 is 12 months. PHS awarding components will be mailing a supply of new agreements to training grant program directors in time for February start dates. Individual fellows will receive the new agreement with their award notice. Additional copies of the 9/93 revision of PHS 6031 are available from the Office of Administrative Services, Division of Research Grants, NIH, Westwood Building, Room 436, 5333 Westbard Avenue, Bethesda, MD 20816, telephone 301/594-7378. Questions about this policy should be directed to the cognizant program and grants management contacts within the various PHS awarding components. INQUIRIES REMINDER: Program directors and institutional business officials are reminded that timely submission of all appropriate forms, including the Statement of Appointment Form (PHS 2271), the Payback Agreement Form (PHS 6031) where appropriate, the Statement of Non-Delinquency on Federal Debt (PHS T-600), and the Termination Notice (PHS 416-7) is required and critically important, especially where a service payback obligation exists. The NIH further requests that all predoctoral and postdoctoral trainees that BEGAN APPOINTMENTS PRIOR TO JUNE 10, 1993 submit a signed Termination Notice at the end of their current appointment, even if they expect to be reappointed. This form will serve as the basis for determining the total payback obligation incurred before the implementation of the NIH Revitalization Act. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIH GRANT SUPPORT MECHANISMS NIH GUIDE, Volume 23, Number 1, January 7, 1994 P.T. 22, 34, 44; K.W. 1014006 National Institutes of Health The Institutes and Centers (ICs) at the National Institutes of Health (NIH) employ many award mechanisms to support the extramural research agenda. The mechanisms for which each IC currently accepts applications differ. Therefore, the NIH will periodically publish a list of the activity codes for mechanisms in use by all ICs (Section 1) and a list of activity codes that are selectively used by ICs (Sections 2 and 3). By consulting this list, a Principal Investigator may confirm, prior to preparation of an application, whether or not an IC supports a particular mechanism. Unique eligibility requirements may apply and special application procedures must be used for several of the types of grants. Also, some ICs accept applications for certain grant mechanisms only when solicited by a Request for Applications (RFA). Therefore, applicants are encouraged to contact IC program staff prior to the preparation of a grant application, particularly if the requested budget exceeds $500,000. All activity codes listed in Sections 1, 2, and 3 are also shown with the name of the mechanism in Section 4. Section 1. The following activity codes are supported by all institutes and centers (except the Fogarty International Center and the National Library of Medicine): F32, R01, R15, R29, R41, R42, R43, and R44 Section 2. Activity codes supported by the indicated institutes and centers: National Institute on Alcohol Abuse and Alcoholism (NIAAA) - F30, F31, K02, K05, K20, K21, P01, P50, R03, R13, R21, S15, T32, T35, U01, U10 National Institute on Aging (NIA) - F33, K01, K04, K07, K08, K11, K12, P01, P20, P30, P50, P60, R03, R13, R25, R35, S15, T32, T35, U01 National Institute of Allergy and Infectious Diseases (NIAID) - F31, F33, F35, K04, K06, K08, K11, P01, P20, P30, P50, R03, R13, R18, R21, R25, S15, T15, T32, T35, U01, U10, U19 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - F33, K04, K08, K11, P01, P20, P30, P50, P60, R13, R18, S15, T32, T35 National Cancer Institute (NCI) - C06, F31, F33, K04, K07, K08, K11, K12, K14, P01, P20, P30, P50, R03, R13, R18, R21, R25, R35, S15, T32, U01, U10, U13, U19, U43, U44 National Institute of Child Health and Human Development (NICHD) - F31, F33, F35, K04, K06, K08, K12, P01, P20, P30, P50, R03, R13, R24, R25, S15, T15, T32, T35, U01, U10, U18, U54 National Institute on Drug Abuse (NIDA) - F30, F31, F34, K02, K05, K20, K21, P01, P50, R03, R13, R21, R24, R25, S15, T32, U01, U18 National Institute on Deafness and Other Communication Disorders (NIDCD) - F31, F33, K04, K08, P01, P20, P50, P60, R03, R13, S15, T32, U01 National Institute of Dental Research (NIDR) - F33, F35, K04, K11, K15, K16, P01, P20, P30, P50, R03, R13, S15, T32, T35 National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) - F31, F33, K04, K08, K11, P01, P20, P30, P50, P60, R13, R21, S15, T32, T35, U01 National Institute of Environmental Health Sciences (NIEHS) - F31, K04, K07, K08, K11, P01, P30, P42, R13, R25, S15, T32, T35, U01, U45 National Eye Institute (NEI) - C06, F31, F33, K11, P30, R03, R13, R21, S15, T32, T35, U01, U10, U13 National Institute of General Medical Sciences (NIGMS) - F31, F33, F34, F36, K04, P01, P41, P50, R13, R25, S06, S14, S15, T32, T34, T35, T36, U13 National Heart, Lung, and Blood Institute (NHLBI) - C06, F31, F33, K04, K07, K08, K14, P01, P50, P60, R03, R10, R13, R18, R25, T15, T32, T35, U01 National Center for Human Genome Research (NCHGR) - F05, F31, F33, K01, K04, P01, P20, P30, P41, P50, R03 R13, R21, R25, T15, T32, U01, U13 National Institute of Mental Health (NIMH) - F30, F31, F34, F35, K02, K05, K07, K12, K20, K21, P01, P20, P30, P50, R03, R10, R13, R18, R24, R25, S15, T32, T34, T35, U01, U09, U10 National Institute for Nursing Research (NINR) - F31, F33, K07, K08, P01, P20, P30, P50, R03, R18, R21, S15, T32, U01, U10, U18 National Institute of Neurological Disorders and Stroke (NINDS) - F33, K04, K06, K08, K12, K17, P01, P20, P50, R13, S15, T32, U01, U10 National Center for Research Resources (NCRR) - C06, G12, G20, K01, M01, P01, P20, P40, P41, P51, R03, R13, R24, R25, S03, S10, T32, T35, U01, U24, U41, U42, Y01 National Library of Medicine (NLM) - F37, G07, G08, K10, P41, P50, R01, R15, R24, R29, R43, R44, T15, U09 Fogarty International Center (FIC) - D43, F05, F06, F07, F15, F20, R03, R13, T22, T37, U01 Section 3. The Agency for Health Care Policy and Research (AHCPR), a Public Health Service Agency independent of NIH, currently supports research grants designated by the following activity codes: F32, P01, R01, R03, R18, T32, U01 Section 4. The following is an alphabetical listing of activity codes with the name of the grant or cooperative agreement mechanism. C06 Research Facilities Construction Grants D42 Hazardous Waste Worker Health and Safety Training Cooperative Agreements D43 International Training Grants in Epidemiology F05 International Research Fellowship F06 Senior International Fellowship F07 NIH-French CNRS Program for Scientific Collaboration F15 Scholars-in-Residence Program F20 Foreign Funded Fellowships F30 Individual Predoctoral NRSA for M.D./Ph.D. Fellowships F31 Predoctoral Individual National Research Service Award F32 Postdoctoral Individual National Research Service Award F33 National Research Service Awards for Senior Fellows F34 MARC NRSA Faculty Fellowships F35 Intramural NRSA Individual Postdoctoral Program Appointee F36 MARC Visiting Scientist Fellowships G07 Resources Improvement Grant G08 Resources Project Grant K01 Research Scientist Development Award Research and Training K02 Research Scientist Development Award Research K04 Modified Research Career Development Awards K05 Research Scientist Award K06 Research Career Award K07 Academic/Teacher Award K08 Clinical Investigator Award K10 Special Scientific Project (NLM) K11 Physician Scientist Award (Individual) K12 Physician Scientist Award (Program) K14 Minority School Faculty Development Awards K15 Dentist Scientist Award (Individual) K16 Dentist Scientist Award (Program) K17 Career Award for Re-entry into the Neurological Sciences K20 Scientist Development Award for Clinicians K21 Scientist Development Award M01 General Clinical Research Centers Program P01 Research Programs Projects P20 Exploratory Grants P30 Center Core Grants P40 Animal (Mammalian and Non-mammalian Model), and Animal and Biological Material Resources Grants P41 Biotechnology Resource Grants P42 Hazardous Substances Basic Research Grants Program P50 Specialized Center P51 Primate Research Center Grants P60 Comprehensive Center R01 Research Project (Traditional) R03 Small Research Grants R10 Cooperative Clinical Research R13 Conference (Traditional) R15 Academic Research Enhancement Awards (AREA) R18 Research Demonstration and Dissemination Projects R21 Exploratory/Developmental Grants R24 Resource-Related Research Projects R25 Education Projects R29 First Independent Research Support and Transition (FIRST) R41 Small Business Technology Transfer Research (STTR) Phase I R42 Small Business Technology Transfer Research (STTR) Phase II R43 Small Business Innovation Research Grants (SBIR) Phase I R44 Small Business Innovation Research Grants (SBIR) Phase II R35 Outstanding Investigator Grants S03 Minority High School Student Research Apprentice Program S07 Biomedical Research Support Grant S10 Biomedical Research Support Shared Instrumentation Grants S14 Minority Biomedical Research Support Grant Program for Undergraduate Colleges S15 Small Instrumentation Grants Program T15 Continuing Education Training Grants T22 Institutional Research Fellowships T32 Institutional National Research Service Award T34 MARC Undergraduate NRSA Institutional Grants T35 NRSA Short-Term Research Training T36 MARC Ancillary Training Activities T37 Minority International Research Training Grants U01 Research Project (Cooperative Agreements) U10 Cooperative Clinical Research (Cooperative Agreements) U13 Conference (Cooperative Agreement) U18 Research Demonstration (Cooperative Agreements) U19 Research Programs (Cooperative Agreements) U24 Resource-Related Research Project (Cooperative Agreements) U42 Animal (Mammalian and Non-mammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements U45 Hazardous Waste Worker Health and Safety Training Cooperative Agreements U54 Specialized Center (Cooperative Agreements) INQUIRIES Further information on may be obtained from the appropriate Institute, Center, or Division contact listed below. Dr. Kenneth Warren National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Telephone: (301) 443-4375 Dr. Miriam Kelty National Institute on Aging Gateway Building, Room 218 Bethesda, MD 20892 Telephone: (301) 496-9322 Dr. Allan Czarra National Institute of Allergy and Infectious Diseases Solar Building, Room 3C28 Bethesda, MD 20892 Telephone: (301) 496-7291 Dr. Michael Lockshin National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 31, Room 4C32 Bethesda, MD 20892 Telephone: (301) 496-0802 Dr. Vincent Oliverio National Cancer Institute Building 31, Room 10A05 Bethesda, MD 20892 Telephone: (301) 496-9138 Ms. Hildegard Topper National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892 Telephone: (301) 496-0104 Dr. Khursheed Asghar National Institute on Drug Abuse Parklawn Building, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2620 Dr. Earleen Elkins National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C Bethesda, MD 20892 Telephone: (301) 496-8683 Dr. John Townsley National Institute of Dental Research Westwood Building, Room 506 Bethesda, MD 20892 Telephone: (301) 594-7642 Dr. Walter Stolz National Institute of Diabetes and Digestive and Kidney Disease Westwood Building, Room 657 Bethesda, MD 20892 Telephone: (301) 594-7527 Dr. Thorsten Fjellstedt National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-01 Research Triangle Park, NC 27709 Telephone: (919) 541-0131 Dr. Ralph Helmsen National Eye Institute 6120 Executive Boulevard, Room 350 Bethesda, MD 20892 Telephone: (301) 496-5301 Dr. Michael Martin National Institute of General Medical Sciences Westwood Building, Room 936 Bethesda, MD 20892 Telephone: (301) 594-7753 Dr. Ronald Geller National Heart, Lung, and Blood Institute Westwood Building, Room 7A17 Bethesda, MD 20892 Telephone: (301) 594-7454 National Center for Human Genome Research Dr. Anthony Pollitt National Institute of Mental Health Parklawn Building, Room 9105 Rockville, MD 20857 Telephone: (301) 443-4673 Dr. Teresa Radebaugh National Institute for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 594-7590 Mr. Edward Donohue National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 Bethesda, MD 20892 Telephone: (301) 496-4188 Dr. Louise Ramm National Center for Research Resources Westwood Building, Room 854 Bethesda, MD 20892 Telephone: (301) 594-7906 Dr. Milton Corn National Library of Medicine Building 38A, Room 5N505 Bethesda, MD 20892 Telephone: (301) 496-4621 Dr. David Wolff Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS NIH GUIDE, Volume 23, Number 1, January 7, 1994 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 persons and those 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: WEST COAST WORKSHOP DATES: January 23-24, 1994 LOCATION Doubletree Hotel, Pasadena, CA SPONSORS City of Hope National Medical Center, Duarte, CA Charles R. Drew University of Medicine and Science, Los Angeles, CA REGISTRATION Ms. Donna Pearce Administrative Secretary, IRB City of Hope National Medical Center Beckman Research Institute Duarte, CA 91010 Telephone: (818) 359-8111, ext. 2700 TITLE: Ethical Issues in Human Subject Research: Catastrophic Diseases and Minorities DESCRIPTION: This workshop is intended for physicians, nurses, pharmacists, and other health care professionals as well as administrators, members of Institutional Review Boards, students, ethicists and legal experts, and lay persons with interest and concern for human subject research. The program will address the following issues: (1) new governmental policies on human subject research; (2) resolving ethical principles in clinical research on AIDS, gene transfer, and cancer prevention trials involving catastrophic illnesses; (3) drug trials and parallel track protocols; (4) minorities as research subjects; and (5) the uncertain fate of clinical research in the current era of health care reform. SOUTH COAST CENTRAL WORKSHOP DATES: February 17-18, 1994 LOCATION Fairmont Hotel, New Orleans, LA SPONSORS University of New Orleans - Lakefront, New Orleans, LA Xavier University of Louisiana, New Orleans, LA REGISTRATION Ms. Anne O'Hearn Jakob Office of Conference Services University of New Orleans - Lakefront New Orleans, LA 70148 Telephone: (504) 286-6680 TITLE: Recent Trends in Human Subjects Research DESCRIPTION: The purpose of this conference is to explore recent issues and trends related to the protection of human subjects in research. It will provide discussions and opportunities among participants to share views on NIH's new guidelines on fetal research, the inclusion of women and minorities in research, and FDA's recent policy on enrolling women of childbearing age in drug trials. Workshops and meetings will be conducted by faculty of more than 25 national experts whose research interests include alzheimer's disease, environmental research, women's health, human genome research, biomedical research, and others. DATES: April 27-28, 1994 LOCATION Magovern Conference Center, Allegheny General Hospital, Pittsburgh, PA SPONSORS Allegheny-Singer Research Institute, Pittsburgh, PA Delaware State College, Dover, DE REGISTRATION Ms. Kathleen Hardlicka Continuing Medical Education Allegheny General Hospital 320 E. North Avenue Pittsburgh, PA 15212 Telephone: (412) 359-4952 TITLE: Contemporary Issues in Human Subject Protection DESCRIPTION: The protection of human subjects is the fundamental responsibility of institutional review boards. Today there are many challenges facing IRBs and research investigators in accomplishing this objective. This workshop will focus on current legal, ethical, and media issues related to human subjects participating in research. Emphasis will be directed at risk assessment (including mechanisms to minimize risk), research fundamentals, regulatory updates, and a special session will address the impact of the media on biomedical research. The format for the workshop will include large and small group didactic presentations and panel discussions providing a forum for audience participation. INQUIRIES For further information regarding these workshop and future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B63 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** RESEARCH ON LYME DISEASE NIH GUIDE, Volume 23, Number 1, January 7, 1994 P.T. 34; K.W. 0715125, 0715151 Center for Diseases Control and Prevention The Division of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, Centers for Diseases Control and Prevention, is pleased to announce the availability of $2,700,000 to be used in funding the first year of a new 3-year cycle of competitive Cooperative Agreements to conduct research on Lyme disease. Public and private non-profit organizations, universities, state and local health departments and research institutes are eligible to apply. It is anticipated that Program Announcement #400 will be published in the Federal Register by early to mid-December 1993. Applications will be due in the Procurement and Grants Office at the Centers for Disease Control and Prevention in Atlanta, GA on or about January 31,1994. Specific instructions for application format, structure, contents, mailing instructions, etc., will be detailed in the announcement. INQUIRIES Individual application packets may obtained by writing to: Mr. Locke Thompson Centers for Diseases Control and Prevention Procurement & Grants Office Mailstop E18 Atlanta, GA 30333 Telephone: (303) 221-8416 $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NCI-CN-45580-63 ****************************************** EARLY DETECTION RESEARCH NETWORK NIH GUIDE, Volume 23, Number 1, January 7, 1994 MAA AVAILABLE: NCI-CN-45580-63 P.T. 34; K.W. 0780020, 0760002, 0715035, 1002004 National Cancer Institute The Division of Cancer Prevention and Control, National Cancer Institute (NCI), in its annual requirement to seek new sources, is soliciting proposals for the Early Detection Research Network (EDRN) to increase the number of Master Agreement (MA) Holders originally awarded under MAA No. NCI-CN-15340-04. Current MA Holders for this program are not required to submit a proposal. The Master Agreement Announcement (MAA) is issued to solicit MA holders who have knowledge in establishing a biorepository of normal premalignant and malignant tissues by collecting and storing tissues and associated fluids to identify potential cellular and molecular markers for early detection. The project will focus on tissues of the colon and rectum, lung, prostate, and urinary bladder. There will be an associated database with demographic information, exposure to potential carcinogens, and risk factors on the subjects from whom specimens have been obtained; and expertise in conducting cellular and molecular studies on these tissues with the goal of developing new procedures assessing the sequence of genetic alterations in protooncogenes, analyzing allelic deletions of suppressor genes, identifying activated oncogenies, identifying oncogene products suitable for evaluating neoplastic progression, and developing cellular and molecular markers that will identify individuals who are at high risk of cancer. INQUIRIES Requests for this solicitation must be in writing and reference MAA No. NCI-CN-45580-63. The Master Agreement Announcement (MAA) is now available and responses will be due approximately COB January 28, 1994. Requests are to be addressed to: Ms. Tina Huyck Research Contracts Branch, PCCS National Cancer Institute Executive Plaza South, Room 635 Bethesda, MD 20892 Telephone: (301) 496-8603 $$R1 END ************************************************************ $$R2 BEGIN NIH-NINDS-94-03 ****************************************** HERMETIC PACKAGES AND FEEDTHROUGHS FOR NEURAL PROSTHESES NIH GUIDE, Volume 23, Number 1, January 7, 1994 RFP AVAILABLE: NIH-NINDS-94-03 P.T. 34; K.W. 0740027, 0740050, 0706000 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS) is seeking a contract to develop and demonstrate the reliability of implantable, microsized, hermetic packages and feedthroughs. The micropackage is required to permit neural prostheses that utilize integrated circuits and discrete components such as microcoils and capacitors to be chronically implanted. Electrical feedthroughs from inside the package to the biological side of the package are required. These must be compatible with high density connections to both conventional microelectrodes and thin-film microelectrodes or potentially to electrodes that are integrated as part of the micropackage. The package must be biocompatible and must protect the implanted electronics from the biological environment for periods of up to 40 years. The package should be transparent to light and radio frequency electromagnetic waves to permit power and telemetry signals to be received within the package. Personnel with established expertise in microfabrication, hermetic packaging, and biomedical engineering are needed. It is anticipated that one award will be made for a period of three years in September 1994. This is not a Request for Proposals (RFP). The RFP was issued on December 30, 1993 and proposals are due on February 28, 1994. All responsible sources shall be considered by the agency. INQUIRIES To receive a copy of the RFP, submit a written request and supply two self-addressed mailing labels, to: Contracting Officer Contracts Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 ATTN: RFP NIH-NINDS-94-03 $$R2 END ************************************************************ $$R3 BEGIN NIH-NIAID-DAIDS-94-02 ************************************ RECOMPETITION OF THE OPERATIONS CENTER FOR THE TERRY BEIRN COMMUNITY PROGRAM FOR CLINICAL RESEARCH ON AIDS NIH GUIDE, Volume 23, Number 1, January 7, 1994 RFP AVAILABLE: NIH-NIAID-DAIDS-95-02 P.T. 04; K.W. 0715008, 0403004 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases has a requirement for the continuation of the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) Operations Center to work in partnership with a series of CPCRA research units awarded to community-based health organizations. The purpose of the five-year CPCRA Operations Center contract is to: I. Provide scientific collaboration and technical services necessary to establish clinical expertise in the development and maintenance of community-based clinical research; II. Coordinate educational and training activities for CPCRA participants in the areas of protocols. Coordinate the planning, design, implementation and evaluation of educational and training activities and materials designed for CPCRA patients and clinicians in addition to the CPCRA Statistical Center and Clinical Site Monitoring Group staff; III. Develop and maintain a computerized database management information system (MIS) for tracking the receipt, review, development, and status of CPCRA research studies, from concept stage through site registration, protocol implementation, and subsequent amendment if needed; IV. Develop and implement systems to facilitate communications between CPCRA participants. Maintain the existing nationwide electronic mail system using a commercial electronic mail system that is user friendly and cost-effective, provides for the reliable, confidential, and efficient transfer of data and word processing files, and allows users on a NIAID network and users on a FAX network to send mail messages and files to each other; and, V. Provide administrative support for the CPCRA. The CPCRA is a clinical research program involving community physicians and their patients in studies of treatments for HIV. A unique feature of this program is its community-based focus for evaluating the effectiveness of a broad spectrum of therapies and treatment regimens. The CPCRA is comprised of 17 research units, consisting of consortiums of primary care physicians, located in 13 cities across the United States, the CPCRA Operations Center, the CPCRA Statistical Center, and the Clinical Site Monitoring Group. The 17 research units represent significant geographic, racial, and risk group diversity. Through this diversity, the CPCRA extends greater opportunity for participation in clinical research to those persons underrepresented in traditional, university-based HIV-related studies, i.e. women, minorities, and injection drug users. In addition to the above described tasks, crisis situations will frequently demand that meetings with the Contractor be rapidly convened to discuss appropriate plans of action for specific situations. Because of this factor, it is essential that the location of the Contractor's office allows for this needed interaction. This is an announcement for an anticipated Request for Proposals (RFP). The issuance of RFP-NIH-NIAID-DAIDS-95-02 will be available on or about January 5, 1994, and proposals will be due by 4:30 p.m., local time, on March 8, 1994. It is anticipated that one (1) contract will be warded as a result of this solicitation. It is expected that the contract will have a five year period of performance, and a completion cost-reimbursement type contract is anticipated. INQUIRIES Requests for the RFP shall be directed in writing to: Ms. Brenda Velez Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 Bethesda, MD 20892 Please provide this office with five 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. This includes only the Statement of Work, Reporting Requirements, and the Evaluation Criteria to be used for selection of the award. 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 full text versions of the RFP only (FAX No. 301- 402-0972). 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-DAID/DMID-94-30 ******************************** APPLICATION OF DATA ON THE HLA SYSTEM TO THE DEVELOPMENT AND IMPROVEMENT OF VACCINES AND INFLUENCE OF HLA AND OTHER GENES ON RESPONSE TO VACCINES NIH GUIDE, Volume 23, Number 1, January 7, 1994 RFP AVAILABLE: BAA NIH-NIAID-DAIT/DMID-94-30 P.T. 34; K.W. 0740075 National Institute of Allergy and Infectious Diseases The Genetics and Transplantation Branch of the Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, promotes and supports research leading to a better understanding of the HLA system, the human major histocompatibility system, including the identification, mapping, and regulation of the HLA genes, the structure and function of the products of the HLA genes, and the role of the HLA system in regulating immune responses in health and disease. The focus of Part I of this Broad Agency Announcement is on basic research that will serve to acquire the data necessary for developing new safe and effective vaccines and for improving existing vaccines, for developing improved methods for isolating, characterizing, and assessing the immunogenic potential of HLA-bound peptides of infectious agents, for developing improved methods for modifying peptides and screening their potential for use in vaccines, for defining the mechanisms underlying regulation of the response to infection and vaccination by the HLA system, and to acquire knowledge about the factors governing the interactions between peptide and HLA molecules and between T cell antigen receptors and HLA-peptide complexes. Part II of this Broad Agency Announcement invites offerors to submit proposals for conducting population research on the role of products of HLA, T cell receptor, immunoglobulin, cytokine, complement, and other genes, in responses to immunization. BAA NIH-NIAID-DAIT/DMID-94-30 will be available on or about January 03, 1993, and proposals will be due approximately March 8, 1994. It is anticipated that more than one cost-reimbursement contract covering one or more categories listed under the Research and Technical Objectives will be awarded for a period up to five years. This advertisement does not commit the government to award a contract. INQUIRIES To receive a copy of this RFP, please supply two self-addressed mailing labels. All inquiries must be in writing and addressed to the office below: Rosemary McCabe Hamill Contracting Officer National Institute of Allergy and Infectious Diseases Contracts Management Branch Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 $$R4 END ************************************************************ $$R5 BEGIN N01-AI-35176-JMEISTER1-94 ******************************** HIV VACCINE PREPAREDNESS AND PHASE III EFFICACY TRIAL SITES NIH GUIDE, Volume 23, Number 1, January 7, 1994 SFP AVAILABLE: N01-AI-35176-JMEISTER1-94 P.T. 34; K.W. 0755015, 0715008, 0740075 National Institute of Allergy and Infectious Diseases Abt Associates Inc., under Contract No. N01-AI-35176 with the Vaccine Trials and Epidemiology Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), requires clinical trial sites to conduct seroepidemiologic and other studies in preparation for HIV vaccine efficacy trials and collaborate in potential, future multi-center phase III trials of HIV vaccines. Offerors must be capable of enrolling and following HIV-seronegative volunteers at increased risk of exposure to HIV in preparatory studies and subsequent efficacy trials. Contractors will recruit a cohort of at least 500 volunteers in preparatory studies, and must demonstrate a capacity to recruit 1,000 volunteers in efficacy trials, which may be undertaken in the future. Offerors must provide evidence of appropriate experience and feasible strategies for: retaining at least 90 percent of enrolled study participants during a two-year prospective study; reliably interviewing study participants regarding HIV-related risk behavior; collecting, processing, storing, and shipping of laboratory specimens; handling vaccine product that requires refrigerated storage; providing HIV pre-test and post-test counseling and referrals to relevant community services; assessing participants' attitudes about enrollment in preventive vaccine efficacy trials before and after delivery of relevant information about clinical trials and HIV vaccines; assuring compliance with regulations governing the protection of human research subjects including protection of participant confidentiality; and performing clinical assessments and documenting medical findings as required by vaccine trial protocols. Organizations submitting proposals must respond to Solicitation for Proposal (SFP) requirements for both vaccine preparedness studies (Part A) and plans for potential future phase III efficacy trials (Part B). Proposals that address only the requirements of Part A will not be considered. Plans and budgets for Part A are to be developed for a period of performance of two years. Plans and budgets for Part B are to be developed for a period of performance of five years. Abt Associates contemplates award of cost plus fixed fee subcontracts to successful offerors. Initial awards will support Part A studies only. Award of funds for Part B trials will be contingent upon the availability of promising vaccine candidates. Subcontract modifications to support Part B trials and associated budgets will be negotiated only after authorization by NIH to proceed with the implementation of vaccine efficacy trials. Technical evaluation of proposals will consider offerors' experience and approach to both components of the SFP (Part A and Part B). It is anticipated that offerors will be invited to include, as an optional component of their submission, proposals for the conduct of non-vaccine HIV prevention interventions (Part C). Results of the technical review of proposals for non-vaccine prevention interventions (Part C) will not be considered in the determination of the number and size of awards for preparedness studies and efficacy trials (Parts A and B). This is an announcement for an anticipated SFP. This notice does not commit the Government or Abt Associates Inc. to award a contract. SFP N01-AI-35176-JMEISTER1-94 will be issued on or about January 10, 1994, with a closing date for receipt of proposals tentatively set for March 10, 1994. To receive a copy of the SFP, supply Abt Associates Inc. with three self-addressed mailing labels. All inquiries must be in writing and addressed to: A. Walker Re: SFP-JMEISTER1-94 HPRA, Abt Associates Inc. 4800 Montgomery Lane, Suite 600 Bethesda, MD 20814 $$R5 END ************************************************************ $$R6 BEGIN AI-94-008 ************************************************ IMMUNE RESPONSES TO LYME DISEASE INFECTION AND VACCINATION NIH GUIDE, Volume 22, Number 44, December 10, 1993 RFA AVAILABLE: AI-94-008 P.T. 34; K.W. 0715125, 0710070, 0740075, 0710075 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: February 7, 1994 Application Receipt Date: March 18, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES", BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research on host immune responses to infection by the etiologic agent of Lyme disease, Borrelia burgdorferi, and research on candidate vaccines for Lyme disease. Research focusing on the characterization of host immunoprotective and immunopathologic responses to infection, host-bacterium-vector interactions, and new vaccine approaches and candidates are appropriate subjects for an application. 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, Immune Responses to Lyme Disease Infection and Vaccination, is related to the priority areas of immunity and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Domestic and foreign non-profit and for-profit organizations and institutions, State and local governments and their agencies, are eligible to apply. Minorities and women are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) award. Applications from or involving minority institutions or women's institutions are encouraged. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01), and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years. The earliest anticipated award date is September 1994. This RFA is a one-time solicitation. Future unsolicited competing- continuation applications will compete with investigator-initiated applications and be reviewed according to customary review procedures. FUNDS AVAILABLE The estimated minimum total funds (direct and indirect costs) available for the first year of this program will be $1,500,000. In fiscal year 1994, the NIAID plans to fund at least six R01s and/or R29s. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES The goal of this RFA is to stimulate new and innovative programs of basic and preclinical research focused on host immune responses to Lyme disease that will lead to the development of candidate vaccines. Applications submitted in response to this RFA should focus on characterizing protective and pathologic immune responses that will guide the logical development of vaccine candidates for human use. Applications with a primary focus on the development of new animal models are not appropriate for this RFA. A separate solicitation for the development of animal models for vaccine testing is planned. Examples of research goals that are appropriate for pursuing through this RFA, include, but are not limited to: o The characterization of protective immune responses, including the contribution of antibodies, cytokines and cell-mediated responses. o The identification of B- and T-cell epitopes that play a major role in the development of protective immunity and could be considered as likely vaccine candidates. o The identification and characterization of cross-reacting antigens that may elicit adverse host reactions to immunization. o The establishment of objective criteria for distinguishing chronic Lyme disease from other disease states. o Delineation of the role(s) of borrelia antigen variability, molecular mimicry and persistence of bacteria or antigens in chronic Lyme disease. o The evaluation of candidate immunogens for the duration of active immunity, and the extent of cross-protection among borrelia strains. o Studies of host-bacterium or host-vector-bacterium interactions important in the establishment or prevention of infection. These studies are all necessary prerequisites to the development of an effective vaccine that will protect human hosts from infection without risk of harmful side effects resulting from immunization. SPECIAL REQUIREMENTS NIAID program staff will organize annual meetings which Principal Investigators, and other key members (as designated by the Principal Investigators in consultation with the program staff) of the projects, will be asked to attend to discuss progress. This will facilitate overall program planning and development, evaluation of the feasibility of planned approaches, and will promote productive interactions among the awardees. Funds for travel to these meetings must be included in the budget. NIAID program staff will also ensure and arrange for the participation in these meetings of investigators from other relevant NIAID-supported Lyme disease research projects, if appropriate, in order to further promote relevant interactions. 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 7, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number and FAX number of the Principal Investigator, the identities of other key personnel and the participating institution(s), and the number and title of the RFA in response to which the application may be submitted. A letter of intent is not required, is not binding, and does not enter into the review of subsequent applications. It will be used to assist NIAID staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The deadline for receipt of applications is March 18, 1994. Applicants for FIRST (R29) awards must attach three reference letters (in sealed envelopes) to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center of Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director should be included in the application material. The RFA label available in the PHS 398 (rev. 9/91) 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 (Immune Responses to Lyme Disease Infection and Vaccination) and number (AI-94-008) must be typed on line 2a of the face page of the application. The typed original, signed application package and three exact single-sided photocopies must be sent or delivered in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional exact copies must be sent to Dr. Olivia Preble at the address listed under INQUIRIES. Applications received after the receipt date will be returned without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not exclude the submission of substantial revisions of application already reviewed. These applications must, however, include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications and supporting material will be reviewed by the DRG for completeness and by the NIAID staff for responsiveness to the RFA. Incomplete and non-response applications will be returned to the applicant without further consideration or review. The NIAID will remove from further competition those applications judged to be non-competitive for award and will notify the applicant and the institutional business official. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by an appropriate review committee. A second level of review will be provided by the NIAID Council. Review criteria for applications received in response to an RFA are generally the same as those for unsolicited applications: o Scientific, technical, or medical significance and originality of the proposed research. o Appropriateness and adequacy of the experimental approach and methodology proposed to accomplish the research. o Qualification and research experience of the Principal Investigator and staff, particularly, but nor exclusively, in the area of the proposed research. o Availability of resources to carry out the proposed research. o Appropriateness of the proposed budget and duration of the project in relation to the proposed research. AWARD CRITERIA The anticipated date of award is September 1994. The NIAID will consider for funding all R01s and R29s rated by peer review as having significant and substantial scientific merit. Awards are subject to the availability of funds. Applications will also be rated for their responsiveness to the aims of the RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Dr. Edward McSweegan Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A32 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7728 FAX: (301) 402-2508 E-mail: EM8P@NIH.GOV Direct inquiries regarding the review of applications to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 6003 Executive Boulevard Bethesda, MD 20892*** Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: February 4, 1994 Application Receipt Date: March 18, 1994 Scientific Review Date: June 15, 1994 Advisory Council Date: September 1994 Earliest Award Date: September 1994 AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is Sec. 93.856, Microbiology and Infectious Diseases Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. $$R6 END ************************************************************ $$R7 BEGIN DE-94-001 FULL-TEXT ************************************** REGIONAL RESEARCH CENTERS FOR MINORITY ORAL HEALTH: PHASE II NIH GUIDE, Volume 23, Number 1, January 7, 1994 RFA AVAILABLE: DE-94-001 P.T. 04, FF; K.W. 0715148, 0785040 National Institute of Dental Research National Center for Research Resources Letter of Intent Receipt Date: March 15, 1994 Application Receipt Date: September 21, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Dental Research (NIDR) and the Research Centers in Minority Institutions (RCMI) Program of the National Center for Research Resources (NCRR) invite applications for grants for Phase II of the Regional Research Centers for Minority Oral Health (RRCMOH) initiative. Receipt of a Phase I grant is not a prerequisite for submission of an application for a PhaseII grant. The objective of the RRCMOH initiative is to improve the oral health of U.S. racial and ethnic minorities, to expand the research opportunities for minority scientists by encouraging their participation in oral health research, and to develop and strengthen the biomedical and behavioral oral health research capacity of minority dental schools and RCMI eligible institutions. 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 research priority areas. This RFA, Regional Research Centers for Minority Oral Health: Phase II, is related to the priority area of reducing health disparities among Americans by improving oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Only minority dental schools and dental schools serving large minority populations are eligible to submit applications in response to this request. Applications from foreign institutions or those involving foreign collaborations are not eligible. To be responsive to this RFA, an applicant institution must propose collaborative affiliations with other institutions that conform to the following organizational structures. o A minority dental school must propose an affiliation with one or more research intensive dental schools. In addition, this arrangement may include affiliations with one or more minority institutions. Applications proposing affiliations between minority institutions without substantive involvement of research intensive institutions are not acceptable. From owner-sci-resources@net.bio.net Wed Jan 05 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA GM-94-004 - V23(01) 01/07/94 Date: 5 Jan 1994 19:31:07 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 401 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2gg0lr$959@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA GM94004 GM-94-004 P1O1 *************************************** PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS NIH GUIDE, Volume 23, Number 1, January 7, 1994 RFA: GM-94-004 P.T. 22, FF; K.W. 0720005 National Institute of General Medical Sciences Application Receipt Date: April 27, 1994 PURPOSE The National Institute of General Medical Sciences (NIGMS) is accepting applications for individual National Research Service Award (NRSA) Predoctoral Fellowships for Minority Students. These fellowships will provide up to five years of support for research training leading to either the Ph.D. degree or the combined M.D./Ph.D. or other combined professional doctorate/research Ph.D. degrees in the biomedical sciences for highly qualified students from minority groups found to be underrepresented in the biomedical and behavioral sciences. Support is not available for individuals enrolled in medical or other professional schools unless they are enrolled in a combined professional doctorate/Ph.D. degree program in biomedical research. The intent of this Minority Predoctoral Fellowship Program is to make graduate fellowships available to underrepresented minority graduates from all institutions, including the many minority undergraduate students who have participated in the various NIH-sponsored programs to prepare them for research careers. This program is designed to encourage greater numbers of underrepresented minorities to pursue graduate degrees, thus fulfilling the goal of increasing the number of minorities trained for careers in biomedical research. ELIGIBILITY REQUIREMENTS Eligibility for these awards is limited to students who are U.S. citizens, non-citizen nationals (citizens of areas outside the U.S., but under U.S. jurisdiction), or permanent U.S. residents. Applicants must be from ethnic/racial groups that are underrepresented in research in the biomedical sciences in the U.S. For purposes of this announcement, underrepresented minority students are defined as individuals belonging to a particular ethnic or racial group that has been determined by the applicant's graduate institution to be underrepresented in biomedical or behavioral research. In making these awards, the NIH will give priority consideration to applications from Blacks, Hispanics, Native Americans, and Pacific Islanders and other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. In addition, an applicant must currently be enrolled in a Ph.D. or combined M.D./Ph.D. (or other combined professional doctorate/research Ph.D. graduate) program in the biomedical sciences, or have been accepted by and agreed to enroll in such a graduate program in the 1994-95 academic year. The Minority Access to Research Careers (MARC) Program of NIGMS has a similar fellowship program of support for graduates of its various MARC Honors Undergraduate Research Training programs to attend graduate school in biomedical sciences. Graduates of the MARC Program are encouraged to apply to the MARC Predoctoral Fellowship Program. MECHANISM OF SUPPORT This RFA for individual fellowships (F31) is under the auspices of the NRSA Act. An applicant must work with her/his research advisor or graduate program director in preparing the application. Awards will be administered under the PHS Grants Policy Statement and the Guidelines for National Research Service Awards and as stated in this RFA. The period of fellowship support requested in response to this RFA may not exceed five years (Note: the total period of predoctoral training grant support under the NRSA authorization may not exceed five years). Continuation of the fellowship award for each subsequent year beyond the first is based on evidence of satisfactory progress in a graduate program. There is a single receipt date for applications: April 27, 1994. The NIGMS may announce subsequent RFA receipt dates at a later time. Stipends and Other Expenses The fellowship award provides an annual stipend to help meet the fellow's living expenses; a tuition and fee allowance in accordance with NIH policy; and an annual institutional allowance of $2000, which may be used for travel to scientific meetings and for laboratory and other training expenses. FUNDS AVAILABLE For FY 1994, it is anticipated that at least 50 new fellowship awards will be made, if sufficient numbers of high quality applications are received. The NIGMS will be joined by the following awarding components of the NIH in providing funds to support this program: National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Cancer Institute, National Institute of Child Health and Human Development, National Institute on Deafness and Other Communicative Disorders, National Institute of Dental Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Drug Abuse, National Institute on Environmental Health Sciences, National Eye Institute, National Heart, Lung and Blood Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Library of Medicine, National Center for Human Genome Research, and National Center for Research Resources. Although this program is included in the financial plans of the participating institutes and centers, the award of fellowships in response to this RFA is also contingent upon the availability of funds for this purpose. Payback Requirements The NIH Revitalization Act of 1993, signed into law on June 10, 1993, includes provisions in Section 1602, which eliminate the payback obligation requirements for predoctoral support. Accordingly, Section VII (pages 29 and 30) of the fellowship application, PHS 416-1, Revised 10/91, are no longer applicable to this program. For more details concerning this change, see the NIH Guide for Grants and Contracts, Volume 22, Number 27, July 30, 1993. APPLICATION PROCEDURES The fellowship application form PHS 416-1 (rev. 10/91) is to be used in applying for these grants. These forms are available at most university offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NIH program administrators listed under INQUIRIES. The applicant must follow ALL instructions in the application kit AND those described in these supplemental instructions. Incomplete applications will not be reviewed. The following must be included with the application at the time of submission. Failure to include any of these items will preclude review of the application. o a copy of the results of either the Graduate Record Examination or the Medical College Admission Test (for M.D./Ph.D. applicants); o a clear and legible copy of the applicant's transcript(s) from all undergraduate and graduate institutions in which the applicant is/has been enrolled; o a description of the graduate or combined degree program in which the applicant is either enrolled or has been admitted and agreed to enroll (Item 33); o at least three reference letters sealed in envelopes; and o certification of eligibility completed by the institution. Supplemental Instructions for Completing the Application A. To be completed by the Student-Applicant Item 1. ("Title of Research Training Proposal"), type: MINORITY PREDOCTORAL FELLOWSHIP PROGRAM - NIGMS. Item 2. ("Level of Fellowship") type: Predoctoral. Item 3. ("Program Announcement Area"), type: RFA GM-94- 004. Items 4 - 8. Self explanatory. ITEM 4i ("Citizenship"), see explanation on page 7 of PHS 416-1. Non-citizen nationals are citizens of areas that are not States but are under the jurisdiction of the United States, e.g., American Samoa. Applications from permanent residents MUST be accompanied by a notarized statement. (Items 9 - 14. Completed by sponsor). Item 15. YOU MUST SIGN THE APPLICATION. Items 16-18. Self explanatory; if any do not apply to you, type N/A. (Items 19 and 20. Completed by sponsor) Item 21. (Abstract of Proposed Research) If you have selected a thesis topic, you should briefly describe, in abstract form, the question you are studying, how you are approaching it, and the health relatedness of your project. If you have not yet selected a thesis project, say "no thesis selected" and instead give a brief description of the research area that interests you most and why, even if your research interests are still very broad. Item 22. (Scholastic Performance) You must complete this section, listing all undergraduate and graduate course you have taken and the grades you received. In addition, you MUST submit a LEGIBLE copy of a transcript from all undergraduate and graduate institutions you have attended. Item 23. (Employment) In addition to prior or current NRSA support, include your employment history during and after college if a significant time commitment was involved. All time between graduation from college and entrance into this graduate program should be accounted for. Items 24-26. Self-explanatory Item 27. Research Experience a. (Summary) Provide a thorough description of your relevant work and research experiences, including time, place, research director, and your role in the research. b. (Doctoral Dissertation) should not be completed. c. (Publications) Include a list of publications, abstracts, and poster presentations. Three (3) collated sets of copies of publications may be provided as part of Section 3 (Appendix). Item 28. (Revised Application) To be completed ONLY if this application is a revision of an application submitted earlier. Item 29. (Research Training Plan) a. (Activities Under Award) - Include a statement concerning your research training and long-range career goals, with an explanation of how the proposed course of study to be supported by this fellowship will help you attain these goals. If appropriate, explain how prior work and research experiences affected the choice of career goals. b and c. (Research Proposal and Respective Contributions) If you have selected a research thesis topic, complete this section according to the instructions. If you have not yet selected a thesis, give a description of the research area that interests you most. d. (Selection of a Sponsor and Institution) Explain why you chose to enroll in this university/institution and in this graduate program. If you have selected a research advisor, give the rationale for your choice. If you have not selected an advisor, you should identify up to five individuals with whom you would like to work, giving a rationale for your choices. B. To be completed by the Research Advisor or Sponsor If the applicant has selected a research advisor, the advisor must complete the items in this section. If the applicant HAS NOT YET SELECTED A RESEARCH ADVISOR, the director of the graduate program should designate a sponsor to complete these items. The director may choose to serve as the sponsor. Items 9 - 14, 20, and 30-37 Item 33, in addition to the information requested in the application kit, (1) for ALL students, provide a full description of the graduate or combined degree program in which the applicant is (or is to be) enrolled. This description should also outline the normal course of study (both didactic and laboratory) for students enrolled in the program; (2) for students ALREADY ENROLLED in the graduate program, describe the applicant's course of study up to the time of submission of the application and plans for further study; and (3) for ALL students, provide the applicable tuition and fees for each year of support requested. C. To be supplied by the University or Institution 1. A statement from the institution certifying that (a) the applicant is enrolled as a predoctoral student OR has been accepted by and agreed to enroll in the graduate training program; (b) the applicant is an eligible minority individual, determined by the institution to be underrepresented in biomedical or behavioral research; this certification MAY include an OPTIONAL identification of the applicant's ethnic/racial group; and (c) the applicant is a citizen, non-citizen national or permanent resident of the U.S. (see page 7 of PHS 416-1, Rev. 10/91). This statement must be signed by the director of the graduate program in which the student is (or is to be) enrolled and by the official authorized to sign for the institution. FAILURE TO INCLUDE THIS CERTIFICATION WILL PRECLUDE REVIEW OF THE APPLICATION. The institution may wish to use the format given at the end of this announcement. 2. By signing item 37, the institution is certifying the accuracy of the tuition and fees requested for each year of support listed in Item 33. Submission Submit a signed, typewritten original of the application (including the Checklist, Personal Data form, at least three sealed reference letters, and all other required materials) and two exact, clear, single-sided photocopies of the signed application, in one package to: Division of Research Grants National Institute of Health Westwood Building, Room 240 Bethesda, MD 20892** Applications must be received by April 27, 1994. Any application received after that date will be returned to the applicant. Applications submitted without three reference letters will be returned without review. Simultaneous submission of identical applications will not be allowed nor will essentially identical applications be reviewed by different review committees. Thus, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. If a candidate submits an application in response to this RFA that is substantially similar to one s/he has already submitted to the NIH for review but which has not yet been reviewed, the applicant will be asked to withdraw one of them. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness to this announcement. Incomplete or non-responsive applications will be returned to the applicant without review. All items listed above (see APPLICATION PROCEDURES) MUST be included for the application to be considered complete. Applications may be subjected to preliminary review to determine their merit relative to other applications received in response to this RFA. The NIH will administratively withdraw from competition those applications judged to be noncompetitive and notify the applicant of such withdrawal. Complete and responsive applications that are judged to be competitive will be evaluated for scientific merit and training potential by an appropriately constituted initial review group within the NIGMS using the criteria stated below. The second level of review will be provided by the NIGMS Fellowship Overview Group. The review criteria include: o academic record and research experience of the applicant; o quality of the graduate program in which the applicant is already enrolled or plans to enroll; o qualifications and research/research training experience of the applicant's sponsor or researcher advisor; the match between the research interests of the student and the research advisor/sponsor; o for advanced graduate students, scientific significance, originality and feasibility of proposed research; for beginning students, quality and clarity of stated research interests. AWARD CRITERIA The anticipated date of award is September 30, 1994. Award decisions will be based on the technical merit of the applications based on the review criteria, programmatic priorities, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA may be directed to: Dr. Irene Eckstrand National Institute of General Medical Sciences Westwood Building, Room 918 Bethesda, MD 20892 Telephone: (301) 594-7762 Dr. John Norvell National Institute of General Medical Sciences Westwood Building, Room 907 Bethesda, MD 20892 Telephone: (301) 594-7784 Inquiries regarding fiscal and administrative matters may be directed to: Ms. Toni Holland National Institute of General Medical Sciences Westwood Building, Room 935 Bethesda, MD 20892 Telephone: (301) 594-7820 AUTHORITY AND REGULATIONS Awards are authorized by sections 301 and 405 of the Public Health Service Act, as amended and administered under PHS grants policies and Federal Regulations 45 CFR Part 74 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. This program is described in the Catalog of Federal Domestic Assistance No. 93.960, Special Minority Initiatives Program. From owner-sci-resources@net.bio.net Wed Jan 05 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-94-013 - V23(01) 01/07/94 Date: 5 Jan 1994 19:29:51 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 470 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2gg0jf$93s@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD94013 HD-94-013 P1O1 *************************************** PERINATAL EMPHASIS RESEARCH CENTERS NIH GUIDE, Volume 23, Number 1, January 7, 1994 RFA: HD-94-013 P.T. 04; K.W. 0755013, 0710030, 0403020, 0775020 National Institute of Child Health and Human Development Letter of Intent Receipt Date: February 7, 1994 Application Receipt Date: May 24, 1994 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from current members of the Perinatal Emphasis Research Centers (PERC) program (competitive continuation applications) and from prospective members (new applications) with the objective of encouraging investigators to develop multidisciplinary research efforts that will advance knowledge about diseases and disorders of pregnancy and infancy and special issues relevant to rural populations. These grants are for the support of hypothesis-testing research efforts; they are not intended to support service or demonstration projects. PERCs are organized around problem/need themes and are established where research can be coordinated with existing programs of health care to ensure the rapid assimilation of new scientific knowledge into health care delivery. Active PERCs are addressing issues in high-risk pregnancies (diabetes, hypertension), prevention of prematurity, fetal hypoxia, intrauterine growth retardation, and infant sleep physiology. PERC centers work closely with the NICHD in participating in the center network and in carrying out its objectives in a manner consistent with NICHD goals and missions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Perinatal Emphasis Research Centers, is related to the priority area of maternal and infant health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS The need for continuous and active communication among centers mandates that only institutions in the United States will be eligible for participation. Domestic, non-profit organizations and institutions are eligible to apply. Applications from minority individuals and women are encouraged. As stated in the NICHD Center Guidelines, the NICHD will not support more than one NICHD center grant (P50) in a given department or specialty unit. MECHANISM OF SUPPORT Grants will be awarded using the NIH specialized research center grant (P50) mechanism. Review of applications and management of grants will be subject to applicable policies for NIH research center P50 grants. The P50 is an institutional award, made in the name of a Principal Investigator, and awarded competitively. It provides support for both research projects and the core services used by those projects. It is expected that up to two awards will be made as the result of this announcement (one award in the area of perinatology and one in the area of rural maternal-infant health). The number of grants to be awarded is contingent upon receipt of a sufficient number of meritorious applications. Awards will be made initially for a five-year period with an option for renewal following competitive review. FUNDS AVAILABLE Although the program is included and provided for in the financial plans for FY 1994, award of PERC grants is contingent upon ultimate allocation of appropriated funds for this purpose. Awards will not exceed $500,000 for direct costs for the first year for new applications, plus up to four percent of current award for competitive renewal applications. The initial award will be made for a period of five years. Budgets of applications for new and renewal support will be stringently reviewed within these guidelines. RESEARCH OBJECTIVES Background A major goal of the Pregnancy and Perinatology (PP) Branch of the Center for Research for Mothers and Children (CRMC) of the NICHD is the prevention of diseases and disorders during pregnancy and infancy. Too many infants are born too soon, too small for their gestational age, or with an abnormality in development initiated prior to birth or shortly thereafter that causes immediate or delayed abnormality in structure or function. If all newborns were free of defects and were mature enough to cope during the first month of life, much of this nation's infant mortality and morbidity could be eliminated. The PP Branch invites applications for research centers to develop new knowledge about diseases and disorders of pregnancy and infancy with the aim of reducing infant morbidity and mortality. By issuing this RFA, the CRMC is indicating its wish to encourage investigator interest in developing multidisciplinary research efforts that will advance knowledge in areas important to its mission. A PERC grant is used to promote and support multidisciplinary research efforts in areas where (a) knowledge gaps are not being sufficiently addressed by ongoing research, or (b) there are needs to stimulate and intensify efforts in promising research areas. Research areas for PERC grants have been and will continue to be identified by CRMC and PP in consultation with outside advisors. Through the PERC programs for mothers and infants, NICHD has undertaken concerted biomedical and behavioral research efforts directed toward improving pregnancy outcome and ensuring infant survival and well-being. PERCs are located throughout the United States and presently are addressing the issues listed in the PURPOSE paragraph above. Research Goals and Scope In addition to the areas addressed in the current PERCs, which continue to be of interest, it is recognized that other medical problems need to be approached in the same multidisciplinary fashion. Clinical studies may include etiologic mechanisms, improvement of diagnostic techniques, and various aspects of prevention and management. All investigative approaches can be used from molecular biology to cellular, organ or whole organism physiology, epidemiology as well as clinical evaluations. The PERC in rural health may address, among other problems, distance to available medical facilities and the effect on rates of preventable illnesses and disease. Supported research may be carried out in experimental animals. The development of animal models may be necessary in selected areas. A minimum of one subproject must address issues in patients. Research concerns include, but are not necessarily limited to, the following: 1. High-Risk Pregnancies (e.g., diabetes, hypertension, drug abuse) - Effects upon pregnancy, fetal development, and neonatal adaptation. 2. Intrauterine Growth - All aspects that may contribute to the regulation of fetal growth such as role of growth factors, hypoxia, nutrients, hormones, infections; placental function; regulation of maternal blood volume and uterine and umbilical blood flow; methodology to assess fetal health and development. 3. Perinatal Toxicology and Pharmacology - Effects of drug administration to the mother or fetus on gestation and pregnancy outcome; neonatal toxicology and pharmacology; drug distribution in tissues; role of nutrition, stage of pregnancy, placental function, and maternal or fetal disease; interplay of genetic composition and environment; drug action during perinatal period on both mother and/or fetus and newborn infant. 4. Initiation of Labor - Normal and abnormal mechanisms and outcomes in term, preterm, and/or postterm births. 5. Neonatal Disorders - Adaptation, response to external stimuli, unique nutritional requirements, response to acute and chronic injury (including asphyxia, ROP, BPD, NEC), remodeling and repair, immune function, and development. 6. Perinatal epidemiology and clinical research addressing the special needs of rural populations. Overall goals are similar to the ones stated above; developing and testing interventions to reduce infant mortality, low birth weight, intrauterine growth retardation, and preterm delivery as they apply to stable and statewide rural populations. One center will be awarded to applications addressing issues mentioned in the first five bullets and the other center to an application focused on rural health. 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 which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. 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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by February 7, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NICHD staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Charlotte Catz at the address listed under INQUIRIES. APPLICATION PROCEDURES Detailed guidelines are found in "NICHD Research Center Programs" - P50 specialized research center guidelines (hereafter called NICHD Center Guidelines). The guidelines include the following restrictions: (1) a five-year total program funding period, (2) at least three projects at all times, and (3) each core serving as a resource for at least three projects at all times. The NICHD Center Guidelines may be obtained from Dr. Charlotte Catz at the address listed under INQUIRIES. Applicants for P50 grants must propose a program of not fewer than three and not more than six related and integrated research projects of high quality that provides a multidisciplinary, yet unified approach to the problem to be investigated. Each project must be fully developed within the prescribed 20-page limit. The applicant cannot rely upon a site visit to explain the proposed research. The center program must have at least three projects at all times. The principal investigator for the PERC must be a scientist who can provide strong, effective administrative and scientific leadership. He/she will be responsible for the organization and operation of the PERC and for communication with the NICHD on scientific and operational matters. Scientific personnel and institutional resources capable of providing a strong research base in the field specified must be available. In addition, the institution and pertinent departments have to show a strong commitment to the center's support. Both administrative and research core facilities must be adequately described and documented (see NICHD Center Guidelines) to show how they will support the proposed research. Cores must support a minimum of three research projects at any one time during the entire five-year period of support. A description of the population available to carry out the clinical studies is needed, indicating what studies are planned. Interdisciplinary collaboration among center scientists is considered a necessity for an effective PERC program. As part of the application, a plan must be submitted indicating how continuing interaction among participating scientists will achieve an interdisciplinary approach to the problem to be studied. It is a goal of the NICHD to promote active collaboration among PERCs. To accomplish this goal, successful applicant(s) will be encouraged to participate in the collaborative efforts of established PERC programs. A complete application must be prepared using research grant application form PHS 398 (rev. 9/91) following both the PHS 398 instructions and the NICHD P50 Center Guidelines. Appropriate human subject and animal welfare documentation must be submitted before the review. Applications must be identified by checking the "YES" box in Item 2a and typing in the words "RFA HD-94-013" in Item 2a on the front page of the grant application form. This RFA indicates plans by NICHD to make two awards in fiscal year 1994-95 (one in perinatal medicine, and one in perinatal rural health). Application must be received by April 10, 1994. Late or incomplete applications will not be accepted. Instructions in the PHS 398 (rev. 9/91) grant application kit must be followed, and the RFA label (supplied in the application kit) must be attached to the bottom of the face page of the original grant application and placed on top of the entire package. The original and three copies of the application should be mailed or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two copies of the application must also be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 6100E, Room 5E03F Bethesda, MD 20892 Telephone: (301) 496-1485 REVIEW CONSIDERATIONS Applications will be received by the NIH Division of Research Grants and reviewed for completeness. Incomplete applications will be returned to the applicant. NICHD staff will review the applications for responsiveness to the RFA. Applications judged to be nonresponsive will be returned. Responsive applications may be subjected to a triage by a peer-review group to determine the scientific merit relative to the other applications received in response to this RFA. NICHD will withdraw from competition those applications judged to be non-competitive and will notify the applicant and institutional official. Those applications judged to be competitive will be further evaluated for scientific and technical merit by a review group convened solely for this purpose by the Division of Scientific Review, NICHD. Following review by the Initial Review Group, applications will be evaluated by the National Advisory Child Health and Human Development Council at its September 1994 session. The earliest possible funding date is September 29, 1994. Review procedures and criteria are detailed in the P50 Specialized Research Center Grant Guidelines. Applications will be reviewed under the criteria indicated below: 1. Significance of the proposed research program to the CRMC perinatal research mission. 2. Scope and breadth of the center's program, the component research projects, and core units. 3. Suitability of the program's central theme for a cooperative research effort. 4. Multidisciplinary scope of the program and provisions for coordinating the research projects and core units. 5. Leadership and scientific stature of the program director and his/her ability to meet the program's demands of time and effort. 6. Adherence to NIH policy regarding inclusion of women and minorities. The review of the projects and core units will consider: 1. Scientific merit of each project and the relation of the project to the central theme of the overall program (a simple compilation of several R01-type projects loosely related will not be acceptable). 2. Technical merit, cost effectiveness, and quality control of each core unit (each core should be used by at least three research projects). 3. The appropriateness of the research projects' use of core services. 4. Qualifications, experience, and commitment of the investigators responsible for the research projects or core units and their ability to devote the required time and effort to the program. 5. Appropriateness of budgetary requests. 6. The adequacy of the means proposed for protecting against risks to human subjects, animals, and/or environment. 7. Participation of a suitable number of responsible, experienced investigators. 8. Academic and physical environment as it bears on patients, space, and equipment, and on the potential for interaction with scientists from other departments and institutions. 9. Arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, and internal communication and cooperation among the investigators in the program. 10. Presence of an administrative and organizational structure conducive to attaining the objectives of the proposed program. The existence of an external advisory board and a description of its function are necessary. 11. Institutional commitment to the requirements of the program. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The staff welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues and address the letter of intent to: Dr. Charlotte Catz Center for Research for Mothers and Children National Institute of Child Health and Human Development Building 6100E, Room 4B03E Bethesda, MD 20892 Telephone: (301) 496-5575 FAX: (301) 402-2085 Inquiries regarding budgetary issues may be directed to: Mr. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100E, Room 8A17F Bethesda, MD 20892 Telephone: 301) 496-1303 Schedule Letter of Intent Receipt Date: February 7, 1994 Application Receipt Date: May 24, 1994 Initial Review: July 1994 Review by National Advisory Council: September 1994 Anticipated Award Date: September 29, 1994 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance No. 13.965, Research for Mothers and Children. Awards will be made under the authority of the Public Health Service Act, Sections 1004, 301 and 444, and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to A-95 Clearinghouse or Health Systems Agency Review. From owner-sci-resources@net.bio.net Wed Jan 05 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA RR-94-003 - V23(01) 01/07/94 Date: 5 Jan 1994 19:29:05 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 437 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2gg0i1$938@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA RR94003 RR-94-003 P1O1 *************************************** EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS NIH GUIDE, Volume 23, Number 1, January 7, 1994 RFA: RR-94-003 P.T. 02; K.W. 0710030 National Center for Research Resources Letter of Intent Receipt Date: February 18, 1994 Application Receipt Date: April 8, 1994 PURPOSE The National Center for Research Resources is authorized under Sections 481A and 481B of the Public Health Service Act, as amended by the National Institutes of Health Revitalization Act, Public Law (PL) 103-43, to "make grants to public and nonprofit private entities to expand, remodel, renovate or alter existing research facilities or construct new research facilities" for biomedical and behavioral research and research training. The Appropriations Act for the Department of Health and Human Services for Fiscal Year 1994 (PL 103-112) provides $7,000,000 in the budget of the National Center for Research Resources (NCRR) of the National Institutes of Health (NIH) for extramural facilities construction grants, to be awarded competitively. The NCRR is issuing a Request for Applications (RFA) RR-94-003 for support of construction and renovation of facilities for biomedical and behavioral research and research training. ELIGIBILITY REQUIREMENTS Under Section 481A of the Public Health Service (PHS) Act, domestic, non-Federal, public and private non-profit institutions, organizations, and associations that conduct or support biomedical/behavioral research are eligible to apply. An institution of emerging excellence must have been so designated under Section 739 of the PHS Act as revised in PL 102-408, and received a PHS Centers of Excellence grant award in Fiscal Year 1993 to be eligible to apply. Under Section 481B of the PHS Act, Regional Primate Research Centers are also eligible to apply. In addition to any applications submitted from Regional Primate Research Centers or recipients of 1993 PHS Centers of Excellence awards an institution may submit only one application in response to this specific announcement. For example, a medical school and a dental school of the same institution, even if separated geographically, may not submit separate applications. MECHANISM OF SUPPORT The award mechanism will be the construction grant award (C06). Awards will be administered under Federal Regulation 45 CFR Part 74 - Administration of Grants. Matching funds from non-Federal sources will be required. FUNDS AVAILABLE This one-time solicitation is based on the Fiscal Year 1994 appropriation that provides $7,000,000 for this initiative, with up to 25 percent of these funds targeted for institutions of emerging excellence. Up to 50 percent of the necessary and allowable costs of a project may be awarded, or 40 percent of costs proportionate to use in a multipurpose facility, not to exceed $2,000,000. Because the nature and scope of the activities proposed in response to this RFA may vary, it is anticipated that four to ten awards at different levels will be made. Prior to grant award, the applicant must provide an assurance of required matching funds and that additional funds will be secured to meet any projected costs in excess of the award amount. Requests of less than $500,000 will not be accepted. No indirect costs or continuation costs will be awarded. RESEARCH OBJECTIVES The main objective of this program is to facilitate the conduct of PHS-supported biomedical and behavioral research by providing funds for construction of basic and clinical research facilities and for the purchase of associated fixed research equipment essential for the operation of these facilities. Support also may be requested for the costs of designing and constructing non- Federal facilities to meet the biomedical/behavioral research, research training, and research service needs of an institution or a research group at that institution. Support for instrumentation or equipment that usually would be requested as part of a research project grant will not be provided. In addition, neither land acquisition nor off site improvements will be supported. Applications proposing to broaden the scope of research and research training programs of the institution by promoting interdisciplinary research, research on emerging technologies, or other novel research programs are particularly encouraged, as are applications from institutions of emerging excellence as defined in the PHS Act, Section 739 as amended by PL 102-408. Facility construction that may be supported under this program includes: o Construction of new facilities o Additions to existing buildings o Completion of uninhabitable "shell" space in new or existing buildings o Major alterations and renovations LETTER OF INTENT Prospective applicants are asked to submit by February 18, 1994, a letter of intent to the individual noted below. The letter, requested for planning purposes only, should identify the RFA number noted above, the Principal Investigator, and include a brief title of the type(s) of research or research support to be conducted in the new facility. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIH staff to estimate the potential workload and to avoid conflict of interest in the review. The letter of intent is to be addressed to: Dr. Charles L. Coulter Research Facilities Improvement Program National Center for Research Resources Westwood Building, Room 8A15 Bethesda, MD 20892 Telephone: (301) 594-7952 APPLICATION PROCEDURES o Intergovernmental-Review -- Executive Order 12372 Applicants are required to comply with Executive Order 12372 as supplemented by DHHS 45 CFR Part 100, Intergovernmental Review of Department of Health and Human Services Programs and Activities. Standard Form 424 meets the reporting requirements of Executive Order 12372. The purposes of this review are to: 1. Identify the relationship of any proposed project to State or area-wide comprehensive plans and evaluate the significance of these projects for the plans or programs of particular State agencies or local governments; and 2. Ensure that public agencies responsible for environmental standards and civil rights have an opportunity to review and comment upon proposed projects. Each applicant is encouraged to discuss projects with the Single Point of Contact (SPOC) at the earliest time possible and to provide the SPOC with required information in a timely manner. (The State Single Point of Contact List is included as an attachment in the special instructions accompanying the application Standard Form 424 package.) The SPOC must be given 60 days to review a construction grant application. Applications submitted to NIH in response to this solicitation must contain either SPOC comments or documentation indicating the date on which the application was submitted to the SPOC for review. The SPOC comment period ends 60 days after the application receipt date. Applicants are to provide the SPOC with a copy of the application NOT LATER THAN the time the application is submitted to the Division of Research Grants, NIH. Applicants required to submit applications for review to a Health Systems Agency (HSA), or Statewide Health Planning and Development Agency (SHPDA), must contact the SPOC/HSA/SHPDA to determine what coordination has been agreed to by those agencies. NIH is required to notify the SPOC when an application is received without an indication that the application has been provided to the SPOC for review. All SPOC comments must be forwarded to both the applicant and to the NCRR fiscal contact given below. If comments are provided by the SPOC, the applicant may wish to submit to the NIH a statement of its reaction to the comments and any appropriate changes to its application. If no response is received from the SPOC by the end of the 60 days allotted for review of the application, the applicant must notify the NIH that no response was received. o Public Disclosure Applicants must also make a public disclosure of the project by publication and describe its environmental impact at the time the SPOC is notified. It is suggested that the notice be published in a large-circulation newspaper in the area. This public disclosure is required by Section 102 of the National Environmental Policy Act (NEPA) of 1969 and by Federal Executive Order 11514. One example of a suitable disclosure statement follows: "PUBLIC NOTICE" "Notice is hereby given that the Uptown Medical School proposes to construct additional space, partially utilizing Federal funds. The proposed construction project is the addition of 2,700 square feet connected to the existing Allen Building, which is located at 5333 Main Street, Downtown, Ohio." "The Medical School has evaluated the environmental and community impact of the proposed construction. There will be construction noise and increased construction traffic during the construction period. No significant permanent environmental impacts are foreseen. All building permits and zoning approvals have been obtained." "In accordance with Federal Executive Order 11514, which implements the NEPA of 1969, any individual or group may comment on, or request information concerning, the environmental implications of the proposed project. Communications should be addressed to the Office of Planning, Uptown Medical School, and be received by (date). The Federal grant application may be reviewed at the Office of the Dean, School of Medicine, 5333 Main Street, during working hours." o Design Standards Design requirements are imposed to protect the health and safety of persons using the proposed facility, control the project's impact on the natural environment, conserve energy resources, achieve economy in construction costs, and protect against natural disasters such as earthquake and flood. Therefore, the documents listed under REFERENCES at the end of the RFA must be consulted, and the design requirements incorporated in the development, review, and evaluation of all drawings and specifications. Application Applicants must use Standard Form 424, "Application for Federal Assistance." Application forms and special instructions for completing the forms relevant to this RFA must be requested from the contact official noted below. Those responsible for preparing the application are advised to consult with appropriate institutional officials before completing the application forms. In addition to any applications from Regional Primate Research Centers or recipients of 1993 PHS Centers of Excellence awards an institution may submit only one application in response to this specific announcement. An original and two copies of the application including appendices must be submitted to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 Applications must be received at NIH by April 8, 1994. To insure against carrier delays, retain a legible proof-of-mailing receipt from the carrier, dated no later than one week prior to the receipt date. Applications received after the receipt date will not be accepted for review in this competition and will be returned to the applicant. REVIEW CONSIDERATIONS Applications will be reviewed by DRG staff for completeness and by NCRR staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or nonresponsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review to determine their scientific merit relative to the other applications submitted in response to this RFA. This triage review will be done by the Biomedical and Behavioral Research Review Committee or a subgroup thereof, established for the purpose of initial peer review by the NCRR. The NIH will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applications judged to be competitive for award will be reviewed for scientific and technical merit by the Biomedical and Behavioral Research Review Committee to be convened by the Office of Review, NCRR. The second level of review will be provided by the National Advisory Research Resources Council in September 1994. Applications will be evaluated on the basis of criteria intended to assess the following overall questions: 1) How will the proposed change in the research environment facilitate the applicant's ability to conduct or expand, improve, or maintain biomedical/behavioral research? 2) How will the proposed project meet national unmet health needs for biomedical/behavioral research, research training and/or research support facilities? Thus reviewers will consider the following factors: o The overall scope of the ongoing PHS-supported biomedical and behavioral research and/or research support activities that will be impacted by the proposed construction, as well as the expanded or proposed future biomedical/behavioral research and/or research support activities. o Appropriateness and suitability of the proposed facilities for the research to be conducted and/or research support to be provided. o The applicant's consideration of safety and biohazard issues in planning the construction and administering the facilities. o Specific deficiencies in the existing research facilities that would be remedied. o Impact of proposed project on current and future research activities, particularly for institutions of emerging excellence. o The appropriateness of the proposed physical location and layout of the new facility. o Reasonableness of the proposed time-course, cost and sequence for the construction. o Adequacy of the proposed administrative arrangements with respect to: --Institutional commitment to use the space for biomedical/behavioral research and/or research support. --Institutional safety and biohazard issues. --Capabilities of the Principal Investigator and staff for scientific and fiscal administration of the facility. AWARD CRITERIA Factors considered in making awards include the merit of the proposal, the needs of the institution, with special consideration for institutions designated as institutions of emerging excellence, the commitment of the institution, the availability of funds and the overall program priorities. Awards will be made on or before September 30, 1994. Award Conditions Advertisement for construction bids and construction can be initiated only after receipt of the construction grant award and subsequent approval of the working drawings and specifications by NIH staff. Therefore, no requests to initiate construction, consistent with Public Health Service policy, will be entertained prior to receipt of a construction grant award from NIH and subsequent approval of working drawings and specifications by NIH staff. The Principal Investigator should be a highly placed institutional official, at the level of Dean or equivalent, who has the responsibility for allocation of space for the program(s) of biomedical/behavioral research and research training addressed in the submitted application. The facility must be utilized for the specific biomedical/behavioral research purposes for which it was constructed for at least twenty (20) years beginning ninety (90) days following completion of the construction project. The NIH staff will evaluate use of the facility periodically to assure its continued use for the approved purposes. Failure to comply with the twenty (20) year utilization requirement will result in recovery of the Federal share of the value of the facility in accordance with Federal regulation 45 CFR Part 74, Subpart O. INQUIRIES Inquiries for further information or clarification regarding this RFA are encouraged. For information concerning programmatic issues, please contact: Dr. Charles L. Coulter Research Facilities Improvement Program National Center for Research Resources Westwood Building, Room 8A15 Bethesda, MD 20892 Telephone: (301) 594-7952 For application Standard Form 424, special application instructions, and information on fiscal matters contact: Ms. Katherine A. Springmann Office of Grants and Contract Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 REFERENCES A. PHS Policy. The project shall meet the PHS policies as described in the "Public Health Service Grants Policy Statement, "DHHS Publication No. (OASH) 90-50,000 (rev.) October 1, 1990 as updated. B. The design of facilities to be constructed or altered with PHS grant funds will be evaluated for compliance with design requirements contained in the most recent edition of Technical Handbook 2.1, "Information for Project Applicants and State Agencies on Design and Construction Related Activities." The Handbook is part of the Department's Facilities Engineering and Construction Manual and is available from the Office of Engineering Services. Applicants from Regions I, II, III, and V should write to: Director of the Regional Office of Engineering Services Office of the Regional Health Administrator, PHS Jacob K. Javits Federal Building 26 Federal Plaza New York, New York 10278 Applicants from Regions IV, VI, and IX should write to: Director of the Regional Office of Engineering Services Office of the Regional Health Administrator, PHS 1200 Main Tower Dallas, Texas 75202 Applicants from Regions VII, VIII, and X should write to: Director of the Regional Office of Engineering Services Office of the Regional Health Administrator, PHS Blanchard Plaza Building 2201 6th Avenue Seattle, Washington 98121 Where State and local codes or requirements exceed the design requirements set forth in Technical Handbook 2.1 or standards incorporated in it, the more stringent requirement will be applied. State or local codes may be used as a basis for facility design in lieu of the design requirements in Technical Handbook 2.1, but a prior determination must be made by HHS that the specific State or local code is equivalent to, or exceeds, HHS requirements. AUTHORITY AND REGULATIONS All awards will be made under the authority of the Public Health Service Act and administered under the PHS grant policies as outlined in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 (Rev.) Department of Health and Human Services, OASH, October 1, 1990, and Federal Regulation 45 CFR Part 74. Applicants are required to comply with Executive Order 12372 as supplemented by DHHS 45 CFR Part 100, Intergovernmental Review of Health and Human Services Programs and Activities. This program will be described in the Catalog of Federal Domestic Assistance, number pending. From owner-sci-resources@net.bio.net Wed Jan 05 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA ES-94-005 - V23(01) 01/07/94 Date: 5 Jan 1994 19:36:43 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 587 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2gg10b$9dc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA ES94005 ES-94-005 P1O1 *************************************** ENVIRONMENTAL EQUITY: PARTNERSHIPS FOR COMMUNICATION NIH GUIDE, Volume 23, Number 1, January 7, 1994 RFA: ES-94-005 P.T. 34; K.W. 0725000, 1004017 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: March 01, 1994 Application Receipt Date: April 01, 1994 PURPOSE The purpose of this program is to strengthen the NIEHS effort that supports research aimed at achieving environmental equity for socioeconomically disadvantaged and medically underserved populations in the United States. One goal of the NIEHS is to stimulate investigative efforts that attempt to address questions related to the influence of economic and social factors on the health status of individuals exposed to environmental toxicants. This component of the NIEHS environmental equity research program is designed to stimulate community outreach, training, and education efforts that will become the catalyst for reducing exposure to environmental pollutants in underserved populations. The main objective of this RFA is to establish a new paradigm for linking members of a community who are directly affected by adverse environmental conditions with researchers and health care providers. This will ensure that: o the community is aware of basic environmental health concepts, issues, and resources; o the community has a role in identifying and defining problems and risks related to environmental exposures; o the community is included in the dialogue shaping potential future research approaches to the problem; and o the community actively participates with researchers and health care providers in developing responses and setting priorities for intervention strategies. The aim of this program is to facilitate the process of developing the trust needed for establishment of effective partnerships among individuals who are adversely impacted by an environmental hazard in a socioeconomically disadvantaged community, researchers in environmental health, and health care providers. 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, "Environmental Equity: Partnerships for Communication," is related to the priority area of Environmental Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001- 00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit organizations, both public and private including predominantly minority institutions, individually or as joint efforts of minority institutions and majority institutions. Usually, only one award under this RFA will be funded at an institution. While a single institution must be the applicant, a multi-institutional arrangement (consortium) is possible. Such consortia, entailing active participation by more than one organization, are encouraged if there is clear evidence of close interaction among the participants. It is important to note that, because of the wide range of environmental health problems to be addressed and the diversity of affected communities, applications should include at least one of each of the following: o A research scientist in environmental health sciences (such as those at NIEHS Environmental Health Sciences Centers). o A primary health care provider directly involved in a community affected by an environmental pollutant. This individual could, but need not necessarily, be affiliated with a county or state public health department. o A member of an organization representing an underserved community affected by an environmental pollutant. The NIEHS has a significant commitment to the support of programs designed to increase the number of underrepresented minority and female scientists participating in biomedical and behavioral research. Therefore, applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Education Grant (R25). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years, and projects are not renewable. This RFA is a onetime solicitation for applications for new awards. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The estimated total funds available for the first year of support for the entire program are anticipated to be $500,000. The maximum award will be $150,000 in direct costs per year. It is anticipated that one to three grants will be awarded depending upon the availability of funds for this purpose and the quality of the applications received. RESEARCH OBJECTIVES The Extent of the Problem Americans want to live long and healthy lives, and the majority of them achieve that goal. In general, however, people who are economically disadvantaged and/or who live or work in areas and occupations where conditions impart greater exposure to hazardous substances are less likely to do so. At every stage of life, these persons suffer disproportionate levels of morbidity and mortality. Evidence suggests that certain groups, especially minorities and low-income communities, bear an uneven share of hazardous environmental exposures. Socioeconomically disadvantaged people suffer the lowest life expectancy and highest adverse health consequences of inadequate access to high-quality health care. Additionally, they most often experience the highest degree of exposure to environmental agents and frequently have the least information available about the health consequences of exposure to these agents. Environmental equity refers to the perceived unequal burden of residential exposure to greater than acceptable levels of environmental pollution, occupational exposure to hazardous substances, and fewer civic benefits such as sewage and water treatment borne by socioeconomically disadvantaged persons. Geographic location plays an important role in environmental exposure of socioeconomically disadvantaged persons. Inner city poor often live in homes with high lead levels. They may also be exposed to higher levels of air pollution. Toxic wastes sites are more frequent in rural, low socioeconomic counties in the US. Nuclear facilities and chemical plants are often located in rural areas. Exposure to pesticides is another example where rural, socioeconomically disadvantaged populations are at a greater than average risk. Disadvantaged neighborhoods may rely on well water, which may be polluted with toxic chemicals. In addition, medical care is often inadequate or unavailable to a significant proportion of the socioeconomically disadvantaged and minority people in America today. Lead poisoning and the cognitive and developmental damage associated with exposure to lead occur disproportionately among minorities. High blood pressure and prostate cancer are very common among African-Americans. Low birth weight babies and other problems during pregnancy are common among groups of women who do not have access to good prenatal care. Some of these conditions or other diseases may have an environmental component in their etiology. The lack of resources for early identification of the effects of toxic agents may lead to an increased disease burden in people who are economically least able to cope with it. Recent progress and opportunities Some work has been done to investigate the effects of pesticides in agricultural workers, of polychlorinated biphenyls in children in rural areas, and of lead exposure in socioeconomically disadvantaged urban children. The effect of low versus high air pollutant exposure on pulmonary function has been extensively studied. Evidence from the NHANES study has shown that, for comparable levels of exposure, different racial groups have different levels of blood lead. Some evidence is also available that suggests the toxic effects of some agents such as lead can be mitigated by good nutrition. Many of these studies have used underserved populations, but none have focused on such problems from the perspective of identifying issues of highest impact on these populations. Thus, progress has been minimal in most areas due to the lack of well-developed studies targeting socioeconomically disadvantaged populations. More effort must be put into defining disadvantaged populations having high levels of exposure to various types of environmental hazards in residential or occupational settings. Comprehensive outcomes to these exposures must be defined and measured. Prevention and treatment of these effects must also be generated. Prominent among the goals of the NIEHS is support of research aimed at achieving environmental equity for all populations. It is equally important to bring minority populations into the mainstream of biomedical research as scientists, health care providers, and allied health service professionals. Both of these goals have a clear benefit to the health of the nation and provide a means of addressing a potential labor shortage in the twenty-first century. As one new aspect of this effort, the NIEHS is requesting submission of applications that focus on establishing new avenues of communication among those living or working in a community impacted by an environmentally-related health problem and the researchers and health care providers attempting to ameliorate such problems. Objectives and Scope The main objective of this program is to establish a new paradigm linking members of the community, who are directly affected by adverse environmental cond