From: kristoff@NET.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 22, no. 1, pt. 1, 8 January 1993
Date: 8 Jan 93 03:00:56 GMT
Distribution: bionet


$$XID NIHGUIDE 19930108 V22N01 P1O3 ************************************
X-comment: RFAS described: DK-93-14, CA-93-10, AI-93-05, EY-93-01, AR-93-004,
                            AR-93-005, AR-93-006, GM-93-003, DK-93-19, CA-93-
                         16, DK-93-15

NIH GUIDE - Vol. 22, No. 1 - January 8, 1993

$$INDEX BEGIN *******************************************************

                               NOTICES

$$INDEX N1 **********************************************************

ANIMAL WELFARE EDUCATION WORKSHOPS
National Institutes of Health
INDEX:  NATIONAL INSTITUTES OF HEALTH

$$INDEX N2 **********************************************************

NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS
National Institutes of Health
Food and Drug Administration
INDEX:  NATIONAL INSTITUTES OF HEALTH, FOOD AND DRUG ADMINISTRATION

$$INDEX N3 **********************************************************

COOPERATIVE AGREEMENTS FOR AIDS COMMUNITY-BASED OUTREACH/INTERVENTION
RESEARCH
National Institute of Drug Abuse
INDEX:  DRUG ABUSE, AIDS

$$INDEX N4 **********************************************************

REVISED PAGE LIMITATIONS FOR SMALL GRANTS
National Institute of Dental Research
INDEX:  DENTAL

$$INDEX N5 **********************************************************

CLARIFICATION:  RESEARCH INFRASTRUCTURE SUPPORT PROGRAM - PA-93-003
National Institute of Mental Health
INDEX:  MENTAL HEALTH

$$INDEX N6 **********************************************************

CHANGE IN FELLOWSHIP RECEIPT DATES
National Institutes of Health
Agency for Health Care Policy Research
INDEX:  FELLOWSHIPS, RESEARCH TRAINING

               NOTICES OF AVAILABILITY (RFPs AND RFAs)

$$INDEX R1 **********************************************************

CORONARY ARTERY DISEASE RISK DEVELOPMENT IN YOUNG ADULTS -
ECHOCARDIOGRAPHY READING CENTER (RFP NHLBI-HC-93-03)
National Heart, Lung, and Blood Institute
INDEX:  HEART, LUNG, BLOOD

$$INDEX R2 **********************************************************

IN VITRO ANTIVIRAL SCREEN FOR HERPES AND RESPIRATORY VIRUSES (RFP
NIH-NIAID-DMID-93-07)
National Institute of Allergy and Infectious Diseases
INDEX:  ALLERGY, INFECTIOUS DISEASES

$$INDEX R3 **********************************************************

DOMESTIC MASTER CONTRACT FOR HIV VACCINE EFFICACY TRIALS (RFP
NIH-NIAID-DAIDS-93-06)
National Institute of Allergy and Infectious Diseases
INDEX:  ALLERGY, INFECTIOUS DISEASES

$$INDEX R4 **********************************************************

INTERNATIONAL MASTER CONTRACT FOR HIV VACCINE EFFICACY TRIALS (RFP
NIH-NIAID-DAIDS-93-21)
National Institute of Allergy and Infectious Diseases
INDEX:  ALLERGY, INFECTIOUS DISEASES

$$INDEX R5 **********************************************************

INSULATING BIOMATERIALS (RFP NIH-NINDS-93-040)
National Institute of Neurological Diseases and Stroke
INDEX:  NEUROLOGY, STROKE

$$INDEX R6 **********************************************************

ELECTRODES FOR FUNCTIONAL NEUROMUSCULAR STIMULATION (RFP NIH-NINDS-
93-05)
National Institute of Neurological Diseases and Stroke
INDEX:  NEUROLOGY, STROKE

$$INDEX R7 **********************************************************

MASTER AGREEMENT FOR THE CLINICAL EVALUATION OF INVESTIGATIONAL
ANTIEPILEPTIC DRUGS (RFP NIH-NINDS-93-07)
National Institute of Neurological Disorders and Stroke
INDEX:  NEUROLOGY, STROKE

$$INDEX R8 **********************************************************

ESTABLISHMENT OF A PERINATAL RESEARCH FACILITY (RFP NICHD-IRP-92-24)
National Institute of Child Health and Human Development
INDEX:  CHILD HEALTH

$$INDEX R9 03/25/93 *************************************************

INNOVATIVE APPROACHES TO THE STUDY OF INTERSTITIAL CYSTITIS (RFA
DK-93-14)
National Institute of Diabetes and Digestive and Kidney Diseases
INDEX:  DIABETES, DIGESTIVE, KIDNEY

$$INDEX R10 04/23/93 ************************************************

SMALL GRANTS FOR CLINICAL TRIALS IN AIDS MALIGNANCIES (RFA CA-93-10)
National Cancer Institute
INDEX:  CANCER

$$INDEX R11 07/13/93 ************************************************

INTERNATIONAL COLLABORATIONS IN INFECTIOUS DISEASE RESEARCH (RFA
AI-93-05)
National Institute of Allergy and Infectious Diseases
INDEX:  ALLERGY, INFECTIOUS DISEASES

$$INDEX R12 03/12/93 ************************************************

CLINICAL CENTERS FOR OCULAR HYPERTENSION TREATMENT STUDY (RFA EY-93-
01)
National Eye Institute
INDEX:  NATIONAL EYE INSTITUTE

$$INDEX R13 04/08/93 ************************************************

MYCOPLASMA AND OTHER INFECTIOUS AGENTS AS A CAUSE FOR RHEUMATIC
DISEASES (RFA AR-92-004)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Allergy and Infectious Diseases
INDEX:  ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES, ALLERGY,
INFECTIOUS DISEASE

$$INDEX R14 04/08/93 ************************************************

RESEARCH ON CAUSAL MECHANISMS IN SYSTEMIC LUPUS ERYTHEMATOSUS (RFA
AR-93-005)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Allergy and Infectious Diseases
INDEX:  ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES, ALLERGY,
INFECTIOUS DISEASE

$$INDEX R15 04/08/93 ************************************************

SYSTEMIC LUPUS ERYTHEMATOSUS IN WOMEN AND MINORITIES (RFA-93-006)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
INDEX:  ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES

$$INDEX R16 04/27/93 ************************************************

PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS (RFA GM-93-003)
National Institute of General Medical Sciences
INDEX:  FELLOWSHIPS, RESEARCH TRAINING

$$INDEX R17 03/25/93 ************************************************

INTERSTITIAL CYSTITIS AND OTHER BLADDER DISORDERS OF WOMEN (RFA DK-
93-19)
National Institute of Diabetes and Digestive and Kidney Diseases
INDEX:  KIDNEY DISEASE

$$INDEX R18 04/23/93 ************************************************

SPORE IN GASTROINTESTINAL CANCER (RFA CA-93-16)
National Cancer Institute
INDEX:  CANCER

$$INDEX R19 04/21/93 ************************************************

PATHOGENESIS OF INFLAMMATORY BOWEL DISEASE AND CELIAC DISEASE (RFA
DK-93-15)
National Institute of Diabetes and Digestive and Kidney Diseases
INDEX:  DIGESTIVE DISEASE

                    ONGOING PROGRAM ANNOUNCEMENTS

$$INDEX P1 **********************************************************

MUCOSAL IMMUNITY IN THE UROGENITAL TRACT (PA-93-034)
National Institute of Allergy and Infectious Diseases
National Institute on Aging
National Institute of Child Health and Human Development
National Institute of Diabetes and Digestive and Kidney Diseases
INDEX:  ALLERGY, INFECTIOUS DISEASES; AGING; CHILD HEALTH, HUMAN
DEVELOPMENT; DIABETES, DIGESTIVE, KIDNEY DISEASES

$$INDEX P2 **********************************************************

RESEARCH ON SALIVARY GLANDS AND SECRETIONS (PA-93-035)
National Institute of Dental Research
INDEX:  DENTAL

                               ERRATUM

$$INDEX E1 **********************************************************

SKIN DISEASES RESEARCH CORE CENTERS (RFA AR-93-03)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
INDEX:  SKIN DISEASE

This publication is also available electronically to institutions via
BITNET or INTERNET.  Alternative access is through the NIH Grant Line
using a personal computer.  Contact Dr. John James at 301/496-7554
for details, or send an E-mail message to ZNS@NIHCU.

$$INDEX END *********************************************************

                               NOTICES

$$N1 BEGIN **********************************************************

ANIMAL WELFARE EDUCATION WORKSHOPS

NIH GUIDE, Volume 22, Number 1, January 8, 1993

P.T. 42; K.W. 0201011, 1014003

National Institutes of Health

The National Institutes of Health (NIH), Office for Protection from
Research Risks (OPRR), is continuing to sponsor workshops on
implementing the Public Health Service Policy on Humane Care and Use
of Laboratory Animals.  Each of the workshops scheduled for FY 1993
will focus on a specific theme.

The workshops are open to institutional administrators, members of
Institutional Animal Care and Use Committees, laboratory animal
veterinarians, investigators and other institutional staff who have
responsibility for high-quality management of sound institutional
animal care and use programs.

Opportunities will be available through workshops, question periods,
and informal discussions for participants to exchange ideas and
interests with faculty and OPRR representatives.

DATE:  JANUARY 21-22, 1993

TOPIC:  Science and Animals:  Addressing Contemporary Issues

LOCATION:
Sheraton Grande Torrey Pines
10950 N. Torrey Pines Road
La Jolla, CA  92037
Telephone:  (619) 558-1500
FAX:  (619) 558-1131

SPONSORS:
Scripps Clinic and Research Foundation
Salk Institute

REGISTRATION:
Janie Partridge
Scripps Clinic and Research Foundation/MB
10666 North Torrey Pines Road
La Jolla, CA  92037-000
Telephone:  (619) 554-8048
FAX:  (619) 554-8841

INQUIRIES

For further information concerning these workshops and future NIH
National Animal Welfare Education programs contact:

Ms. Roberta Sonneborn
Office for Protection from Research Risks
National Institutes of Health
Building 31, Room 5B59
Bethesda, MD  20892
Telephone:  (301) 496-7163

$$N1 END ************************************************************

$$N2 BEGIN **********************************************************

NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS

NIH GUIDE, Volume 22, Number 1, January 8, 1993

P.T. 42; K.W. 0783005

National Institutes of Health
Food and Drug Administration

The National Institutes of Health (NIH) and the Food and Drug
Administration (FDA) are continuing to sponsor a series of workshops
on responsibilities of researchers, Institutional Review Boards
(IRBs), and institutional officials for the protection of human
subjects in research.  The workshops are open to everyone with an
interest in research involving human subjects.  The meetings should
be of special interest to those persons currently serving or about to
begin serving as a member of an IRB.  Issues discussed at these
workshops are relevant to all other Public Health Service agencies.
The current schedule includes the following:

SOUTHEASTERN WORKSHOP

DATES:  January 14 and 15, 1993

LOCATION:
Sheraton Sand Key Resort
1160 Gulf Boulevard
Clearwater Beach, FL  33515
Telephone:  (813) 595-1611

SPONSORS:
University of South Florida
Florida A & M University

REGISTRATION:
Ms. Eileen Highsmith
Executive Secretary
University of South Florida
4202 E. Fowler Avenue (MP.FAO-126)
Tampa, FL  33620-7900
Telephone:  (813) 974-2897

TITLE:  Barriers to Informed Consent:  Language, Age Factors, Trauma,
and Women/Minority Issues

DESCRIPTION:  Today's researchers face numerous barriers to obtaining
an informed consent.  Such issues as age, language, mental capacity,
and sobriety may affect the ability of subjects to give a truly
informed consent.  Many of these barriers oftentimes impact the pool
of subjects which an investigator is willing (or able) to use in a
research project.  In addition, recent legislation from the Congress
was designed to address the issue of inadequate numbers of women and
minorities in research projects.  This conference has been designed
to address three main areas in which barriers to informed consent may
exist:  mental competence, ethnic and gender issues, and research
with children and the elderly.

The conference program is designed to be of value to physicians,
nurses, pharmacists, scientific investigators, and other health care
professionals.  All IRB members, students in health care areas and
administrators will also benefit from the conference.  Attention will
be given to Federal regulations governing research on human subjects,
with special emphasis placed on the assessment of risks---medical,
legal, and psychosocial.  Ample opportunities will be provided to
exchange ideas and interests, through question and answer sessions
and informal discussions.

SOUTHWESTERN WORKSHOP

DATES:  February 12 and 13, 1993

LOCATION:
Sheraton Tempe Mission Palms Hotel
60 East 5th Street
Tempe, AZ  85281
Telephone:  (602) 894-1400

SPONSORS:
Arizona State University
Northern Arizona University

REGISTRATION:
Ms. Carol Jablonski
IRB Coordinator
Office of the Assistant Vice President for Research
Arizona State University
Tempe, AZ  85287-3403
Telephone:  (602) 965-6788

TITLE:  Contemporary Issues in Human Subject Research:  Challenges
for Today's IRBs

DESCRIPTION:  This program is designed to be a practical working
session to explore contemporary issues in human subjects protection
including regulations and assurances, categorization of research
protocols, uses of special populations, experimental design and
scientific merit, fetal tissue research, ethical/legal issues in
human subjects research, and conflict of interest.  As appropriate,
topics will be discussed from the perspective of the clinical
researcher and the behavioral/social science researcher.  Issues will
be discussed in a panel format with ample time for audience
questions.  An outstanding faculty has been assembled.

This program should be of interest to researchers in clinical
medicine and the behavioral and social sciences. Institutional Review
Board members, university and hospital administrators, lawyers,
ethicists, health care practitioners, students, and other persons
with interests in human subject protection issues.

INQUIRIES

For further information regarding these workshops and future NIH/FDA
National Human Subject Protections Workshops, contact:

Ms. Darlene Marie Ross
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
Building 31, Room 5B59
Bethesda, MD  20892
Telephone:  (301) 496-8101

$$N2 END ************************************************************

$$N3 BEGIN **********************************************************

COOPERATIVE AGREEMENTS FOR AIDS COMMUNITY-BASED OUTREACH/INTERVENTION
RESEARCH

NIH GUIDE, Volume 22, Number 1, January 8, 1993

P.T. 34; K.W. 0715008, 0403004, 0404009, 0411005

National Institute on Drug Abuse

The National Institute on Drug Abuse, (NIDA), wishes to alert the
research community that the last date for acceptance of cooperative
agreements in response to DA-90-02, "A COOPERATIVE AGREEMENT FOR AIDS
COMMUNITY-BASED OUTREACH/INTERVENTION RESEARCH," will be January 3,
1993. After that date, and until further notice, no applications in
response to this program announcement will be accepted.  This program
announcement was originally published in the NIH Guide for Contracts
and Grants, Volume 19, No.2, January 12, 1990. Volume Current
cooperative agreement grantees should contact the Project Officer
regarding submission of competing supplements focusing on emerging
research related to evaluating the effectiveness of innovative
community-level behavior change strategies to prevent the spread of
HIV in a documented high risk, unreached or understudied "hidden"
populations of out-of-treatment injection drug abusers, non-injection
cocaine/crack users.  Newly proposed supplements are expected to be
consistent with the original purposes of the cooperative agreement.

INQUIRIES

Dr. Richard Needle
Community Research Branch Division of Clinical Research
National Institute on Drug Abuse
5600 Fishers Lane
Rockville, MD  20857
Telephone:  301) 443-6720

$$N3 END ************************************************************

$$N4 BEGIN **********************************************************

REVISED PAGE LIMITATIONS FOR SMALL GRANTS

NIH GUIDE, Vol. 22, No. 1, January 8, 1993

P.T. 34; K.W. 1014006

National Institute of Dental Research

The purpose of this notice is to modify the National Institute of
Dental Research, Small Grant Announcement (PA-91-36), that appeared
in the NIH Guide - Volume 20, Number 12, March 22, 1991.  Changes in
the reporting requirements for "Other Support" in form PHS 398
(Revised 9/91) have rendered impractical the 25 page limitation for
small grant applications.

Effective with the April 3, 1993 receipt date, the Research Plan
(Specific Aims, Background and Significance, Preliminary Studies, and
Research Design and Methods) may not exceed ten pages.  No appendix,
including reprints or manuscripts, may be submitted. Graphs,
diagrams, tables, charts and photographs must be included in the body
of the application.  Original glossy photographs should be included
in the original application sent to Division of Research Grants,
National Institutes of Health, and in the two copies sent to the
Scientific Review Office, National Institute of Dental Research.  The
introduction included in revised applications may not exceed one
page.  Applicants are reminded that the type size limitations
specified in the General Instructions, form PHS (Rev. 9/91) must be
observed.  All other instructions in Program Announcement-91-36
remain in effect.  Applications not conforming to the revised
instructions will be returned to the applicant without review.

INQUIRIES

Director, Extramural Program
Westwood Building - Room 503
National Institute of Dental Research
Bethesda, MD 20892-4500
Telephone (301)496-7723 (Effective 4/1/93 (301)594-7723)

$$N4 END ************************************************************

$$N5 BEGIN **********************************************************

CLARIFICATION:  RESEARCH INFRASTRUCTURE SUPPORT PROGRAM - PA-93-003

NIH GUIDE, Vol. 22, No. 1, January 8, 1993

National Institute of Mental Health

Program Announcement PA-93-003 (Research Infrastructure Support
Program) was published in the October 2 "NIH Guide to Grants and
Contracts."  The purpose of this program is "to stimulate the
development of new resources at institutions capable of developing
and maintaining programs of clinical and services research directed
at the major mental health disorders."  An eligibility requirement
was included that stated that "applications may be submitted by
public and private, non-profit and for-profit organizations such as
universities, colleges, hospitals, laboratories, units of State and
local governments, except for those institutions with NIMH research
support exceeding $3,000,000 (in total costs) in fiscal year 1991."
Potential applicants have asked NIMH staff about this restriction and
its interpretation.

Based upon the above, thirty one institutions are ineligible.
Eligible institutions must apply directly, however, and not in
conjunction with an ineligible one; e.g. subcontracting is NOT
acceptable.  Thus, eligible institutions affiliated with ineligible
institutions may apply, as long as the eligible institution is
awarded the entire grant.  Ineligible applications submitted to DRG
will be immediately administratively withdrawn.

$$N5 END ************************************************************

$$N6 BEGIN **********************************************************

CHANGE IN FELLOWSHIP RECEIPT DATES

NIH GUIDE, Vol. 22, No. 1, January 8, 1993

P.T. 22; K.W. 0720005, 1014006

National Institutes of Health
Agency for Health Care Policy Research

Effective April 1, 1993, there will be a change in receipt dates for
applications to the PHS for individual National Research Service
Awards (NRSAs -- fellowships, the F-series awards).  This change was
made subsequent to the merger of the former Alcohol, Drug Abuse, and
Mental Health Administration (ADAMHA) research Institutes with the
NIH. The three new Institutes,, the National Institute on Alcohol
Abuse and Alcoholism, the National Institute on Drug Abuse, and the
National Institute of Mental Health, will now expedite the review of
NRSA fellowship applications in accordance with this longstanding NIH
practice. The new receipt dates will apply to all individual
fellowship applications (F- series) to the NIH Institutes and Centers
as well as to the Agency for Health Care Policy and Research.

The new receipt dates will be:  April 5 (instead of May 10)
                                August 5 (instead of September 10)
                                December 5 (instead of January 10)

NOTE:  Implementation of the new receipt date schedule will begin
with the April 5, 1993, receipt date;  the January 10, 1993, receipt
date remains the same.  Institutional Training Grant (T 32)
applications are not affected.  Their receipt dates remain January
10, May 10, and September 10.

$$N6 END ************************************************************

               NOTICES OF AVAILABILITY (RFPs AND RFAs)

$$R1 BEGIN NHLBI-HC-93-03 *******************************************

CORONARY ARTERY DISEASE RISK DEVELOPMENT IN YOUNG ADULTS -
ECHOCARDIOGRAPHY READING CENTER

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFP AVAILABLE:  NHLBI-HC-93-03

P.T.

National Heart, Lung, and Blood Institute

The National Heart, Lung, and Blood Institute (NHLBI) Epidemiology
and Biometry Research program, seeks an Echocardiography Reading
Center for the Coronary Artery Disease Risk Development in Young
Adults (CARDIA) project.  CARDIAs four field centers will continue to
examine and follow a total of 5000 men and women who were aged 18 to
30 years at the baseline examination in 1985 in a longitudinal study
of the evolution of coronary heart disease risk factors in young
adults.  The Echocardiography Reading Center will direct, with the
assistance of the study Steering Committee, the development of a
final protocol for repeating the echocardiographic examination in two
of the four field centers.  The protocol will perform M-mode,
2-dimensional and Doppler echocardiography.  The Echocardiography
Reading Center is the only competitive Request for Proposals (RFP)
anticipated for the CARDIA study.

This is an announcement for an RFP.  RFP NHLBI-HC-93-03 will be
available on or about December 22, 1992, with proposals due about
February 23, 1993.  One award is anticipated.  Written requests for
the RFP must include three self-addressed mailing labels and cite RFP
NHLBI-HC-93-03.

INQUIRIES

Requests for copies of the RFP are to be sent to:

Cheryl A. Jennings, Contracting Officer
Contracts Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Federal Building, Room 3C16
Bethesda, MD  20892

$$R1 END ************************************************************

$$R2 BEGIN NIH-NIAID-DMID-93-07 *************************************

IN VITRO ANTIVIRAL SCREEN FOR HERPES AND RESPIRATORY VIRUSES

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFP AVAILABLE:  NIH-NIAID-DMID-93-07

P.T. 34; K.W. 1002045, 0755060, 0740012, 0760035

National Institute of Allergy and Infectious Diseases

The Antiviral Research Branch of the Division of Microbiology and
Infectious Diseases, National Institute of Allergy and Infectious
Diseases (NIAID), has a requirement for investigators to perform in
vitro screening of compounds for their ability to inhibit the growth
and/or replication of herpes viruses (HSV, CMV, VZV, EBV) and
respiratory viruses (influenza, parainfluenza, respiratory syncytial
virus, measles).  The contractor(s) will provide the necessary
equipment, personnel, facilities, and materials to screen 200
compounds annually.  The contractor(s) will be responsible for
determining a compound's antiviral activity, cytotoxicity, and
selective index.  Research on the development of improved screening
methodology, studies on mechanism of action, and studies of efficacy
of drug combinations will be encouraged as an adjunct to the primary
antiviral evaluation.

It is anticipated that either one cost-reimbursement, completion,
contract covering all virus classes or two cost-reimbursement,
completion, contracts covering the virus classes individually will be
awarded for a period of five years.  This is an announcement for an
anticipated Request for Proposals (RFP).  RFP NIH-NIAID-DMID-93-07
will be issued on or about December 28, 1992, with a closing date
tentatively set for March 5, 1993.

INQUIRIES

Requests for the RFP are to be directed in writing to:

Sara Southard, Contract Specialist,
Contract Management Branch
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3C07
6003 Executive Boulevard
Bethesda, MD  20892

To receive a copy of the RFP, supply this office with two
self-addressed mailing labels.  All responsible sources may submit a
proposal that will be considered by the government.  This
advertisement does not commit the government to award a contract.

$$R2 END ************************************************************

$$R3 BEGIN NIH-NIADI-DIADS-93-06 ************************************

DOMESTIC MASTER CONTRACT FOR HIV VACCINE EFFICACY TRIALS

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFP AVAILABLE:  NIH-NIAID-DAIDS-93-06

P.T. 34; K.W. 0715008, 0755015, 0755018, 0740075, 0785055

National Institute of Allergy and Infectious Diseases

The Vaccine Trials and Epidemiology Branch (VTEB), Division of AIDS
(DAIDS), National Institute of Allergy and Infectious Diseases
(NIAID), is soliciting proposals from organizations with the capacity
to serve as the Domestic Master Contractor (DMC) for:  (1)
preparation of sites for efficacy trials and (2) phase III trials of
Human Immunodeficiency Disease (HIV) vaccines and other methods for
preventing HIV infection in high-risk populations in the United
States and its territories.  The proposed contract requires expertise
in the following areas:  coordination and management of multicenter,
longitudinal epidemiologic, vaccine, or clinical trials;
coordination, training and site monitoring of Phase III vaccine
trials; experience with populations at high risk of HIV infection;
and solicitation and management of subcontracts.  Specifically, the
selected contractor will be responsible for the operation and
maintenance of a master contract that will provide:  (1) subcontracts
to sites that are currently conducting baseline epidemiologic studies
to ascertain the feasibility of conducting future Phase III HIV
vaccine trials; (2) solicitation of proposals from, and monitoring
of, additional sites to conduct baseline/feasibility studies; (3)
solicitation of proposals from, and monitoring of, sites to conduct
Phase III HIV vaccine trials; (4) development of protocols to test
HIV vaccines and other biomedical interventions in high-risk
seronegative individuals; and (5) an orderly and efficient transition
of the proposed contract to a successor, if necessary, at the
expiration of the contract.

This is an announcement for an anticipated Request for Proposals
(RFP).  RFP NIH-NIAID-DAIDS-93-06 will be issued on or about January
20, 1993, with a closing date tentatively set for March 19, 1993.

INQUIRIES

Requests for the RFP are to be directed in writing to:

Jacqueline C. Holden
Contract Management Branch
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3C-07
6003 Executive Boulevard
Bethesda, MD  20892
FAX:  (301) 402-0972

Requests sent via overnight mail service should use Rockville, MD
20852 instead of the Bethesda zip code

To receive a copy of the RFP, supply this office with three
self-addressed mailing labels.  Telephone inquiries will not be
honored, and all inquiries must be in writing.  A short-form version
of the RFP will be provided first.  It includes only the Statement of
Work and Evaluation Criteria to be used for selection of the awardee.
After examining this, a full text version of the RFP must be
requested, in writing, for those offerors interested in responding.
FAX requests are acceptable for the full-text version only.  All
proposals from responsible sources will be considered by the NIAID.
This advertisement does not commit the government to award a
contract.

$$R3 END ************************************************************

$$R4 BEGIN NIH-NIAID-DAIDS-93-21 ************************************

INTERNATIONAL MASTER CONTRACT FOR HIV VACCINE EFFICACY TRIALS

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFP AVAILABLE:  NIH-NIAID-DAIDS-93-21

P.T. 34; K.W. 0715008, 0755015, 0755018, 0740075, 0785055

National Institute of Allergy and Infectious Diseases

The Vaccine Trials and Epidemiology Branch (VTEB), Division of AIDS
(DAIDS), National Institute of Allergy and Infectious Diseases
(NIAID), is soliciting proposals from organizations with the capacity
to serve as the International Master Contractor (IMC) for:  (1)
preparation of sites for efficacy trials, (2) Phase I/II trials, and
(3) Phase III trials of HIV vaccines and other methods for preventing
HIV infection in high-risk populations in countries outside of the
United States and its territories.  The proposed contract requires
expertise in the following areas:  coordination and management of
multicenter, longitudinal epidemiologic studies, coordination of
Phase I/II and Phase III trials; coordination, training and site
monitoring of Phase III vaccine trials; experience with populations
at high risk of HIV infection; and solicitation and management of
subcontracts.  Specifically, the selected contractor will be
responsible for the operation and maintenance of a master contract
that will provide:  (1) subcontracts to sites that are currently
conducting baseline epidemiologic studies to ascertain the
feasibility of conducting future Phase III HIV vaccine trials; (2)
solicitation of proposals from, and monitoring of, additional sites
to conduct baseline/feasibility studies; (3) solicitation of
proposals from, and monitoring of, sites to conduct Phase I/II and
Phase III HIV vaccine trials; (4) development of protocols to test
HIV vaccines and other biomedical interventions in high risk
seronegative individuals; and (5) an orderly and efficient transition
of the proposed contract to a successor, if necessary at the
expiration of the contract.

This is an announcement for an anticipated Request for Proposals
(RFP).  RFP NIH-NIAID-DAIDS-93-21 will be issued on or about January
20, 1993, with a closing date tentatively set for March 19, 1993.

INQUIRIES

Requests for the RFP are to be directed in writing to:

Cyndie Cotter
Contract Management Branch
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3C-07
6003 Executive Boulevard
Bethesda, MD  20892
FAX:  (301) 402-0972

Requests sent via overnight mail service should use Rockville, MD
20852 instead of the Bethesda zip code

To receive a copy of the RFP, supply this office with three
self-addressed mailing labels.  Telephone inquiries will not be
honored and all inquiries must be in writing.  A short-form version
of the RFP will be provided first.  It includes only the Statement of
Work and Evaluation Criteria to be used for selection of the awardee.
After examining this, a full text version of the RFP must be
requested, in writing for those offerors interested in responding.
Fax requests are acceptable for the full-text version only.  All
proposals from responsible sources will be considered by the NIAID.
This advertisement does not commit the government to award a
contract.

$$R4 END ************************************************************

$$R5 BEGIN NIH-NINDS-93-04 ******************************************

INSULATING BIOMATERIALS

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFP AVAILABLE:  NIH-NINDS-93-04

P.T. 34; K.W. 0740050, 0750005

National Institute of Neurological Disorders and Stroke

The Neural Prosthesis Program of the National Institute of
Neurological Disorders and Stroke (NINDS), National Institutes of
Health, is seeking a contract for the development of biomaterials for
the long-term insulation of implantable stimulating and recording
microelectrodes and interconnect cables.  In-vitro and in-vivo
studies will be conducted.  Insulating biomaterials, intended to
protect implanted probes and cables over the lifetime of an implant
recipient, will be developed and tested.  The focus of the work shall
be on finding and characterizing insulating biomaterials.  A research
team with expertise in materials science, biomaterials,
microelectronic packaging, and animal testing will be required to
successfully conduct this research.  It is anticipated that one (1)
award will be made for a period of three (3) years in September 1993.

INQUIRIES

This notice is not the Request for Proposals (RFP).  To receive a
copy of the RFP, please submit a written request to the following
address, and supply this office with two (2) self-addressed mailing
labels.  All responsible sources shall be considered by the agency.
A RFP will be issued on or about January 29, 1993, with proposals due
on March 31, 1993.

Contracting Officer
Federal Building, Room 901
National Institute of Neurological Disorders and Stroke
Bethesda, MD  20892
Attention:  RFP No. NIH-NINDS-93-04

$$R5 END ************************************************************

$$R6 BEGIN NIH-NINDS-93-05 ******************************************

ELECTRODES FOR FUNCTIONAL NEUROMUSCULAR STIMULATION

NIH GUIDE, Vol. 22, No. 1, January 8, 1993

RFP AVAILABLE:  NIH-NINDS-93-05

P.T. 34; K.W. 0745047, 0750005

National Institute of Neurological Disorders and Stroke

The Neural Prosthesis Program of the National Institute of
Neurological Disorders and Stroke (NINDS), National Institutes of
Health, is seeking a contract to develop stimulating electrodes that
permit safe, reliable, and graded activation of selected muscles for
use in functional neuromuscular stimulation (FNS).  The studies will
concentrate on developing electrodes that are capable of selectively
activating specific functional muscle groups required by a
collaborating clinical group.  In order to encourage the broadest
competition, the particular muscles to be stimulated are not
specified.  The offeror will define this focus in association with a
collaborating clinical research group.  Personnel with established
expertise in physiology, biomedical engineering, electrode
development, and animal testing are needed.  It is anticipated that
one award will be made for a period of three years in September 1993.

This notice is not the Request for Proposals (RFP).  To receive a
copy of the RFP, please submit a written request to the address
indicated above, and supply this office with two self addressed
mailing labels.  A RFP will be issued on or about January 11, 1993
with proposals due on March 10, 1993.  All responsible sources shall
be considered by the agency.

Contracting Officer
Federal Building, Room 901
National Institute of Neurological Disorders and Stroke
Bethesda, MD  20892
Attention:  RFP No. NIH-NINDS-93-05

$$R6 END ************************************************************

$$R7 BEGIN NIH-NINDS-93-07 ******************************************

MASTER AGREEMENT FOR THE CLINICAL EVALUATION OF INVESTIGATIONAL
ANTIEPILEPTIC DRUGS

NIH GUIDE, Vol. 22, No. 1, January 8, 1993

RFP AVAILABLE:  Master Agreement Announcement/RFP NIH-NINDS-93-07

P.T. 34; K.W. 0740010

National Institute of Neurological Disorders and Stroke (NINDS)

The NINDS intends to reissue its Master Agreement
Announcement/Request for Proposals (MAA/RFP) entitled: "Master
Agreement for the Clinical Evaluation of Investigational
Antiepileptic Drugs," with the intent of seeking new sources to add
to the current pool of qualified Master Agreement (MA) holders.  In
May 1991 the NINDS issued MAA/RFP No. NIH-NINDS-91-10 to renew its
Master Agreement Program for performance of future clinical
evaluation studies of investigational antiepileptic drugs through
January 1997.  In an effort to continually enlarge the pool of
qualified holders under this program, the NINDS, each year, reissues
the MAA/RFP.  Current Master Agreement (MA) holders are not required
to compete at this time.  MA's will be awarded to those sources
determined to be technically capable of performing clinical
evaluations of investigational antiepileptic drugs in tolerability
and preliminary efficacy studies, controlled efficacy and safety
trials, or both, in patients with epilepsy.  Only MA holders will be
eligible to compete for future Master Agreements Orders (MAOs) that
fund for the actual clinical evaluation of specific drugs as they
become available for testing.

INQUIRIES

This notice is not the Master Agreement Announcement/Request for
Proposals (MAA/RFP).  MAA/RFP No. NIH-NINDS-93-07 will be issued on
or about January 15, 1993 with a tentative closing date set for
receipt of proposals on March 31, 1993.  The award of any MA under
this RFP will be valid through January 31, 1997.  It is anticipated
that as a result of this MAA/RFP, a number of new sources will be
added to the current pool of MA holders.  All responsible sources may
submit a proposal that shall be considered by the Government.  To
receive a copy of MAA/RFP No. NIH-NINDS-93-07, please submit a
written request to the following address, and supply two (2) self-
addressed mailing labels:

Contracting Officer
Federal Building, Room 901
National Institute of Neurological Disorders and Stroke
Bethesda, MD  20892
Attention:  MAA/RFP No. NIH-NINDS-93-07

$$R7 END ************************************************************

$$R8 BEGIN NICHD-IRP-92-24 ******************************************

ESTABLISHMENT OF A PERINATAL RESEARCH FACILITY

NIH GUIDE, Vol. 22, No. 1, January 8, 1993

RFP AVAILABLE:  NICHD-IRP-92-24

P.T. 34; K.W. 0785135, 0785170, 0775025

National Institute of Child Health and Human Development

The National Institute of Child Health and Human Development (NICHD)
seeks a contractor to provide the space, patient population,
personnel, and support services required by the Intramural
Perinatology Research Branch to perform the research associated with
this project.  The following mandatory qualification criteria are
conditions that must be met at the time of proposal submission: (1)
the prime contractor must be a University-based medical center with
an appropriate environment to support clini- cal and laboratory
research.  Subcontractor institu- tion(s) are not required to be
University-based medical institutions; (2) the prime contractor,
including any subcontractors, must have a minimum of 3,500 deliveries
per year with a minimum of 20 percent high-risk pregnancies.  Both
the prime contractor and subcontractors must be located in the
District of Columbia as mandated by Congress; (3) the prime
contractor must have a residency program in Obstetrics and Gynecology
and Pediatrics with Board approved fellowships in Maternal-Fetal
Medicine and Neonatology; and (4) the prime contractor must have a
tertiary care nursery and relevant pediatric subspecialties
(Cardiology, Surgery, Clinical Genetics).  All responsible sources
may submit an offer that will be considered by the government.  It is
anticipated that one cost-reimbursement incrementally funded type
contract will be awarded under the RFP for a period of five years.
The anticipated starting date is July 1, 1993.  This announcement is
not a request from proposals (RFP).  RFP NICHD-IRP-92-24 will be
issued on or about January 15, 1993.  Proposals will be due
approximately 60 days thereafter.

INQUIRIES

Copies of the RFP may be obtained by sending a written or Fax request
to.  Please enclose a self-addressed label.

Paul J. Duska, Contracting Officer
Contracts Management Branch, OGC
National Institute of Child Health and Human Development
6100 Building, Room 7A07
9000 Rockville Pike
Bethesda, MD  20892
Telephone: 301-402-3676

$$R8 END ************************************************************

$$R9 BEGIN DK-93-14 FULL-TEXT ***************************************

INNOVATIVE APPROACHES TO THE STUDY OF INTERSTITIAL CYSTITIS

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFA AVAILABLE:  DK-93-14

P.T. 34; K.W. 0705075, 0755020, 0760003

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  February 25, 1993
Application Receipt Date:  March 25, 1993

THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS
ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.
POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN
INQUIRES, BELOW.

PURPOSE

The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) is soliciting grant applications for support of studies
focused on the study of interstitial cystitis, a disorder of the
bladder also known as the painful bladder syndrome.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Innovative Approaches to the Study of Interstitial Cystitis, is
related to the priority area of diabetes and chronic disabling
conditions.  Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report:  Stock No. 017-001-00474-0) or "Healthy
People 2000" (Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Minority individuals and women are encouraged to submit as Principal
Investigators.

MECHANISM OF SUPPORT

Support of this program will be through the NIH research project
grant (R01).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  Awards will be administered under PHS grants policy as
stated in the PHS Grants Policy Statement.

This RFA is a one-time solicitation.  Generally, future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.  The total requested project period
for applications submitted in response to this RFA may not exceed
five years.  Applicants must limit their requests to not more than
$100,000 direct costs for the initial budget period.  The earliest
possible award date will be September 30, 1993.  Awards made from
this RFA will be for the support of new projects.

FUNDS AVAILABLE

For FY 1993, $1,500,000 will be committed by the NIDDK to fund
applications submitted in response to this RFA.  It is anticipated
that 10 to 12 awards will be made.  However, this funding level is
dependent upon the receipt of a sufficient number of applications of
high scientific merit.  Although this program is provided for in the
financial plans of the NIDDK, the award of grants pursuant to this
RFA is also contingent upon the availability of funds for this
purpose.

RESEARCH OBJECTIVES

The purpose of this RFA is to solicit applications that propose
unique, innovative approaches to the study of interstitial cystitis
from investigators who are not currently being funded by the NIDDK
for research on interstitial cystitis.  It is not the intent to fund
research in areas that are currently being supported by the NIDDK.
Applications may be submitted for both non-human basic research and
human clinical research studies.

Since this request is for unique, innovative studies, it is
understood that there may be limited preliminary data to support the
application.  In those cases, the applicant may wish to designate the
proposal as a pilot project and reduce the number of requested
project years, budget and scope of the project to that which is
necessary for obtaining adequate data for a more extensive,
full-scale project.

SPECIAL REQUIREMENTS

Applicants who receive an award through this announcement are
encouraged to attend a yearly meeting (convened by the NIDDK) of
investigators to discuss progress and exchange research information.
Funds to support the travel to these meetings may be included in the
proposed budget.

In order to ensure that patient selection for clinical studies is
uniform, the NIDDK has established Diagnostic Criteria for research
studies on IC.  All grant applications that use human subjects must
state that the NIDDK IC diagnostic criteria will be applied to
patients selected for inclusion in the research study.  The NIDDK
research criteria have been published in:  the Journal of Urology
142(1): 139, 1989 and the American Journal of Kidney Diseases 8(4)
353, 1989.  They may also be obtained from the program staff listed
under INQUIRIES.

STUDY POPULATIONS

For projects involving clinical research, NIH requires applicants to
give special attention to the inclusion of women and minorities in
study populations.  If women or minorities are not included a
specific justification for this exclusion must be provided.
Applications without such documentation will not be accepted for
review.

LETTER OF INTENT

Prospective applicants are requested, but not required, to submit a
letter of intent to apply to the RFA.  This letter should include the
name, telephone number and mailing address of the Principal
Investigator, the names of other key personnel, and the name of the
applicant institution, and the number and title of this RFA.  Such a
letter of intent is not binding and it will not enter into the review
of any application subsequently submitted, nor is it a necessary
requirement for application.  Letters of intent are requested solely
for planning purposes.  The NIDDK staff will not provide responses to
such letters.  Letters of intent must be received no later than
February 25, 1993 and must be addressed to:

Dr. Robert Hammond
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  The form is available from most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
(301) 496-7441.

The RFA label available in the application form must be affixed to
the bottom of the face page.  Failure to use this label could result
in delayed processing of the application such that it may not reach
the review committee in time for review.  In addition, the RFA title
and number must be typed on line 2a of the face page of the
application form and check the YES box.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact photocopies, in one package
to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application must
also be sent under separate cover to:

Robert Hammond, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

Applications must be received by March 25, 1993.  If an application
is received after that date, it will be returned to the applicant.

REVIEW CONSIDERATIONS

Upon receipt, applications will be initially reviewed by the Division
of Research Grants (DRG) for completeness. Incomplete applications
will be returned to the applicant without further consideration.
Evaluation for responsiveness to the program requirements and
criteria stated in the RFA is an NIDDK staff function.  If the
application is not responsive to the RFA, the staff will contact the
applicant to determine whether it should be returned to the
applicant, or held until the next regular receipt date and reviewed
in competition with all other applications.

Those applications that are complete and responsive will be evaluated
for scientific/technical merit by an appropriate peer review group
convened by the NIDDK. Following this review, the applications will
be given a secondary review by the National Diabetes and Digestive
and Kidney Diseases Advisory Council unless not recommended for
further consideration by the initial review group.

Review criteria for this RFA are generally the same as those for
unsolicited research grant applications.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues and requests for the
RFA to:

Leroy M. Nyberg, Ph.D., M.D.
Director, Urology Program
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-05
Bethesda, MD  20892
Telephone:  (301) 496-7133

Inquiries regarding fiscal matters may be directed to:

Ms. Trude McCain
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 496-7467

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.849 (NIDDK).  Awards are made under authorization
of the Public Health Service Act, Title IV, Part A (Public Law
78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and
administered under PHS grants policies and Federal Regulations 42 CFR
52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

$$R9 END ************************************************************

$$R10 BEGIN CA-93-10 FULL-TEXT **************************************

SMALL GRANTS FOR CLINICAL TRIALS IN AIDS MALIGNANCIES

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFA AVAILABLE:  CA-93-10

P.T. 34; K.W. 0715008, 0715035, 0755015

National Cancer Institute

Letter of Intent Receipt Date:  February 1, 1993
Application Receipt Date:  April 23, 1993

THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS
ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.
POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN
INQUIRES, BELOW.

PURPOSE

The Cancer Therapy Evaluation Program of the Division of Cancer
Treatment at the National Cancer Institute (NCI) invites small grant
applications for innovative therapeutic studies in Acquired
Immunodeficiency Syndrome (AIDS) malignancies.  The studies should be
restricted to pilot or phase I or II trials with approximately 5 to
30 patients/trial.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Small Grants for Clinical Trials in AIDS Malignancies, is related to
the priority areas of cancer and AIDS.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238).

ELIGIBILITY REQUIREMENTS

Domestic for-profit and non-profit organizations, governments and
their agencies are eligible to apply.  Foreign institutions are not
eligible to apply.  Applications can be from single institutions or
multiple institutions (collaborating institutions, consortia,
cooperative groups).  New and experienced investigators are
encouraged to apply.  Applications from minority individuals and
women are encouraged.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of
Health (NIH) small grants mechanism (R03).  The small grants research
program provides limited funds (maximum of $48,000 direct costs per
year) for short-term (up to two years) research projects.  The R03
grants are non-renewable.  Future competing renewals (type 2s) must
be prepared and submitted as traditional research grant applications
(R01s) to be considered along with other non-solicited investigator-
initiated applications reviewed by the Division of Research Grant
(DRG) study sections.  Responsibility for the planning, direction,
and execution of the proposed research will be solely that of the
applicant.  Awards will be administered under PHS grants policy as
stated in the Public Health Service Grants Policy Statement, DHHS
Publication No. (OASH) 90-50,000, revised October 1, 1990.

This RFA is a one-time solicitation for FY 93.  Applications received
after the deadline receipt date will be returned.

FUNDS AVAILABLE

Approximately $750,000 in total costs per year for two years will be
committed to fund applications submitted in response to this RFA.
This funding level is dependent on the receipt of a sufficient number
of applications of high scientific merit.  The direct cost for each
R03 is limited to $48,000 per year.  Thus it is anticipated that ten
awards will be made in FY 93.  The total project period for
applications submitted in response to the RFA may not exceed two
years.  The earliest feasible start date for the initial awards will
be September 30, 1993.  Although this program is provided for in the
financial plans of the NCI, the award of R03 grants pursuant to this
RFA is also contingent upon the availability of funds for this
purpose.

RESEARCH OBJECTIVES

Background

Congenital and acquired states of immunodeficiency increase the
incidence of high-grade B cell non-Hodgkin's lymphoma (NHL), Kaposi's
sarcoma, and certain types of epithelial malignancies. Individuals
infected with human immunodeficiency virus (HIV) have a marked
increase in the appearance of intermediate and high-grade B cell NHL
and Kaposi's sarcoma, and show trends for an increased incidence for
Hodgkin's disease, anogenital dysplasia and cancer, and basal cell
carcinoma, compared to age-matched controls.  On October 22, 1992,
the Center for Disease Control proposed the addition of invasive
cervical cancer in HIV-infected individuals to the AIDS Surveillance
case definition.

The tumors in HIV-infected individuals are generally aggressive and
insufficiently sensitive to conventional therapy.  The median
survival of HIV-associated NHL is less than one year and is only two
months for primary central nervous system lymphoma.  Clinical
observations suggest that Hodgkin's disease, anogenital dysplasia and
cancer, and basal cell carcinoma, have a different natural history
and therapeutic outcome compared to the disease in the general
population.  The dramatic growth rate of the tumors, combined with
the problems of myelosuppression and opportunistic infections, have
made treatment extremely difficult.  As children and adults with
HIV-infection are surviving longer due to improved retroviral and
opportunistic infection treatment, the incidence of the malignancies
are expected to rise.

Research into the pathogenesis of these tumors in the context of HIV
has shed light on potential interactions of cytokines, HIV, other
viral co-factors (i.e., human papilloma virus in squamous cell cancer
of the anogenital region, and EBV in the high-grade primary central
nervous system lymphomas), and oncogenes.  Based on the current
information on the potential interactions in the formation of these
tumors, and the lack of effective, standard regimens, the NCI is
encouraging investigators to apply novel therapies or innovative
approaches in pilot or phase I or II clinical trials.

Research Goals And Scope

The aim of this RFA is to stimulate pilot, phase I, or phase II
therapeutic clinical trials in AIDS malignancies so that new
treatment strategies and new agents are moved more rapidly into the
clinic.  The ultimate goal of the NCI is to provide more effective
management and treatment for HIV-associated malignancies in children,
and adult men and women.

The project will fund single or groups of institutions to perform
innovative therapeutic studies in AIDS malignancies.  The studies
should be restricted to pilot, phase I, or II trials, with
approximately 5 to 30 patients/trial.  Examples of potential clinical
studies to consider:  (1) combinations of interferon-alpha and/or
retinoic acid in anogenital dysplasia or cancer (recent report by
Lippman and associates of a 68 percent response rate in patients with
cutaneous squamous cell cancer, and a 50 percent major response rate
in patients with locally advanced squamous cell cancer of the
cervix); (2) angiogenesis inhibitors in Kaposi's sarcoma; (3) immune
modulating therapy with IL-4 (and subsequent down-regulation of IL-6,
which may have some role in the development of NHL or Kaposi's
sarcoma), anti-B4 blocked ricin immunoconjugate in NHL, or anti-sense
to potential viral cofactors such as HPV in Kaposi's sarcoma.  The
investigators are not limited to the above studies, and any
innovative therapies with appropriate rationale are sought.

Although the major purpose of these grants is to facilitate rapid
testing of novel agents or innovative approaches, tumor tissue or
other relevant biologic fluid collection is strongly encouraged for
ongoing or future investigations of laboratory correlates.  The
interchange of ideas and tumor tissue between the recipients of the
grants will be encouraged.  The research plan should be focused on
the clinical trial proposed.  Laboratory studies addressing
correlative issues to the clinical trials may be included but are not
necessary.  Clinical studies must involve human subjects and be
designed to ultimately improve cancer treatment.  The clinical
studies must be based on a strong rationale and preclinical data
should support the underlying hypothesis.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS FOR INCLUSION OF FEMALES AND MINORITIES IN
CLINICAL RESEARCH STUDIES

For projects involving clinical research, NIH requires applicants to
give special attention to the inclusion of females and minorities in
study populations.  If females or minorities are not included in the
study populations for clinical studies, a specific justification for
this exclusion must be provided.  Applications without such
documentation will not be accepted for review.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 1, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigators, the
names of other key personnel, the participating institutions, and the
number and title of the RFA in response to which the application may
be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, it is requested
in order to provide an indication of the number and scope of
applications to be reviewed.

The letter of intent is to be sent to Dr. Roy S. Wu at the address
listed under INQUIRIES.

APPLICATION PROCEDURES

Applications must be received by April 23, 1993.  If an application
is received after that date, it will be returned.  The research grant
application form PHS 398 (rev. 9/91) is to be used in applying for
this RFA.  These forms are available at most institutional offices of
sponsored research; from the Office of Grants Inquiries, Division of
Research Grants, National Institutes of Health, Westwood Building,
Room 449, Bethesda, MD 20892, telephone (301) 496-7441; and from the
NCI Program Director named below.

REVIEW CONSIDERATIONS

Upon receipt, applications will be initially reviewed by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NCI program staff function.  Applications that are judged
non-responsive will be returned by the NCI.  Questions concerning the
responsiveness of proposed research to the RFA are to be directed to
program staff (see INQUIRIES).  Institutional Review Board (IRB)
approval must have been received and the date of approval provided to
NCI prior to peer review.  If this information is not provided prior
to peer review, the application will be withdrawn from competition by
the NCI and returned to the applicant without review.

AWARD CRITERIA

The anticipated date of award is September 30, 1993.  In addition to
the technical merit of the application, NCI will consider how well
the applicant institution meets the goals and objectives of the
program as described in the RFA, availability of resources, and study
populations.

INQUIRIES

Written and telephone inquiries concerning the objectives and scope
of this RFA and inquiries about whether or not specific proposed
research would be responsive are encouraged and may be directed to
NCI Program Directors at the addresses below.  The NCI Program
Directors welcome the opportunity to clarify any issues or questions
from potential applicants.

For technical information and to request the RFA:

Dr. Roy S. Wu
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
FAX:  (301) 480-4663

For business information:

Ms. Joan Metcalfe
Grants Management Specialist
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 28
FAX:  (301) 496-8601

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No 93.395, Cancer Treatment Research.  Awards are made
under the authorization of the Public Health Service Act, Title IV
Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as