Subject: NIH GUIDE - V20(33) 09/06/91 - P1/3
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 06 Sep 91 14:25 EST

Hi Paul,
  This is one of many coming over to you today.  Please post this to
the NIH Listserver as:
       NIHGUIDE.910906
 Thanks.   dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID NIHGUIDE 19910906 V20N33 P1O3 ************************************
X-comment: RFAS described: DK/HD-92-01, CA-91-21, CA-91-31, HD-92-03, CA-91-3
                           0, HL-91-08-P, DC-92-05, CA-91-28, AG/AM-91-11, AI
                         -91-14, HD-92-01
 
NIH GUIDE - Vol. 20, No. 33, September 6, 1991
 
$$INDEX BEGIN **********************************************************

                                       NOTICES
 
$$INDEX N1 *************************************************************
 
NATIONAL WORKSHOPS ON THE PROTECTION OF HUMAN SUBJECTS
National Institutes of Health
Food and Drug Administration
Index:  NATIONAL INSTITUTES OF HEALTH
        FOOD AND DRUG ADMINISTRATION
 
$$INDEX N2 *************************************************************
 
ESTIMATED TOTAL COSTS OF PROPOSED PROJECTS
National Institutes of Health
Index:  NATIONAL INSTITUTES OF HEALTH
 
$$INDEX N3 *************************************************************
 
NCI BRIEFING ON SPORE PROGRAM
National Cancer Institute
Index:  CANCER
 
$$INDEX N4 *************************************************************
 
NOTICE OF MEETING - KIDNEY AND UROLOGIC DISEASES RESEARCH CENTERS
National Institute of Diabetes and Digestive and Kidney Diseases
Index:  DIABETES AND DIGESTIVE AND KIDNEY DISEASES
 
$$INDEX N5 *************************************************************
 
AVAILABILITY OF BLOOD SAMPLES FROM PATIENTS ENROLLED IN THE EARLY
TREATMENT DIABETIC RETINOPATHY STUDY
National Eye Institute
Index:  EYE
 
$$INDEX N6 *************************************************************
 
DISCONTINUATION OF THE NIAID IMMUNOLOGIC AND INFECTIOUS DISEASES
ACADEMIC AWARD
National Institute of Allergy and Infectious Diseases
Index:  ALLERGY, INFECTIOUS DISEASES

                       NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$INDEX R1 *************************************************************
 
DEVELOPMENT OF DOSAGE FORMS AND DELIVERY SYSTEMS FOR NEW DRUGS (RFP)
National Cancer Institute
Index:  CANCER
 
$$INDEX R2 *************************************************************
 
PREPARATION OF ANTI-AIDS BULK DRUGS AND CHEMICALS FOR PRELINICAL
TOXICOLOGY, PHARMACOLOGY, AND CLINICAL USE (RFPs)
National Cancer Institute
Index:  CANCER
 
$$INDEX R3 *************************************************************
 
SUPPORT OF THE NATIONAL HORMONE AND PITUITARY PROGRAM (RFP)
National Institute of Diabetes and Digestive and Kidney Diseases
Index:  DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
 
$$INDEX R4 *************************************************************
 
NINDS LOGISTICAL RESEARCH SUPPORT (Sources Sought)
National Institute of Neurological Disorders and Stroke
Index:  NEUROLOGICAL DISORDERS, STROKE
 
$$INDEX R5 *************************************************************
 
EVALUATION OF THERAPIES FOR TREATMENT OF PNEUMOCYSTIS CARINII,
MYCOBACTERIUM AVIUM, TOXOPLASMA GONDII, AND PATHOGENIC
FUNGI INFECTIONS (RFP)
National Institute of Allergy and Infectious Diseases
Index:  ALLERGY, INFECTIOUS DISEASES
 
$$INDEX R6 *************************************************************
 
MODEL DEVELOPMENT AND EVALUATION OF THERAPIES FOR CRYPTOSPORIDIUM
INFECTION (RFP)
National Institute of Allergy and Infectious Diseases
Index:  ALLERGY, INFECTIOUS DISEASES
 
$$INDEX R7 *************************************************************
 
PLASMODIUM FALCIPARUM VACCINE DESIGN AND PRODUCTION (RFP)
National Institute of Allergy and Infectious Diseases
Index:  ALLERGY, INFECTIOUS DISEASES
 
$$INDEX R8 02/14/92 ****************************************************
 
ENDOCRINOLOGY OF BODY COMPOSITION (RFA DK/HD-92-01)
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development
Index:  DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES, CHILD
HEALTH, HUMAN DEVELOPMENT
 
$$INDEX R9 12/11/91 ****************************************************
 
EPIDEMIOLOGIC STUDY OF ADENOCARCINOMAS OF THE ESOPHAGUS AND
GASTRIC CARDIA (RFA CA-91-21)
National Cancer Institute
Index:  CANCER
 
$$INDEX R10 12/20/91 ***************************************************
 
MECHANISMS OF MULTISTAGE CARCINOGENESIS IN THE PROSTATE (RFA CA-91-31)
National Cancer Institute
Index:  CANCER
 
$$INDEX R11 12/20/91 ***************************************************
 
THE DECISION PROCESS SURROUNDING THE CHOICE OF NORPLANT AS A
CONTRACEPTIVE BY U.S. WOMEN (RFA HD-92-03)
National Institute of Child Health and Human Development
Index:  CHILD HEALTH, HUMAN DEVELOPMENT
 
$$INDEX R12 12/12/91 ***************************************************
 
UNDERSTANDING THE MECHANISMS OF HORMONAL CARCINOGENESIS (RFA
CA-91-30)
National Cancer Institute
Index:  CANCER
 
$$INDEX R13 11/19/91 ***************************************************
 
EVALUATION OF ADHERENCE INTERVENTIONS IN CLINICAL TRIALS (RFA
HL-91-08-P)
National Heart, Lung, and Blood Institute
Index:  HEART, LUNG, BLOOD
 
$$INDEX R14 ************************************************************
 
MAINTENANCE OF CHIMPANZEES FOR HEPATITIS OR AIDS RESEARCH (RFP)
National Heart, Lung, and Blood Institute
Index:  HEART, LUNG, BLOOD
 
$$INDEX R15 11/27/91 ***************************************************
 
TRANSPORT OF SUBSTANCES IN THE OLFACTORY SYSTEM (RFA DC-92-05)
National Institute on Deafness and Other Communication Disorders
Index:  DEAFNESS, COMMUNICATION DISORDERS
 
$$INDEX R16 12/11/91 ***************************************************
 
VACCINES FOR HUMAN CANCERS OF VIRAL ETIOLOGY (RFA CA-91-28)
National Cancer Institute
Index:  CANCER
 
$$INDEX R17 01/15/92 ***************************************************
 
USE OF TROPHIC FACTORS IN PREVENTING PHYSICAL FRAILTY (RFA AG/AM-91-11)
National Institute on Aging
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Index:  AGING, ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES
 
$$INDEX R18 02/11/92 ***************************************************
 
PROGRAM PROJECTS IN TRANSPLANTATION IMMUNOLOGY (RFA AI-91-14)
National Institute of Allergy and Infectious Diseases
Index:  ALLERGY, INFECTIOUS DISEASES
 
$$INDEX R19 05/15/92 ***************************************************
 
SPECIALIZED RESEARCH CENTER PROGRAMS AND CENTER CORE GRANTS TO SUPPORT
RESEARCH IN REPRODUCTION (RFA HD-92-01)
National Institute of Child Health and Human Development
Index:  CHILD HEALTH, HUMAN DEVELOPMENT

                                       ERRATUM
 
$$INDEX E1 *************************************************************
 
NEW THERAPEUTIC APPROACHES TO THE TREATMENT OF PROSTATE CANCER
(RFA CA-91-16)
National Cancer Institute
Index:  CANCER

                            ONGOING PROGRAM ANNOUNCEMENTS
 
$$INDEX P1 *************************************************************
 
ACADEMIC AWARD IN SYSTEMIC AND PULMONARY VASCULAR DISEASES
(PA-91-86)
National Heart, Lung, and Blood Institute
Index:  HEART, LUNG, BLOOD
 
$$INDEX END ************************************************************

                                       NOTICES
 
$$N1 BEGIN *************************************************************
 
NATIONAL WORKSHOPS ON THE PROTECTION OF HUMAN SUBJECTS
 
P.T. 43; 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:
 
I.  NORTH MIDWESTERN WORKSHOP
 
DATES:  October 17 and 18, 1991
 
WORKSHOP SITE:
Westin Hotel
Renaissance Center
Detroit, MI
Telephone:  (313) 568-8000
 
SPONSORS:
Children's Hospital of Michigan
3901 Beaubien Blvd.
Detroit, MI  48201
 
Wayne State University
4237 Scott Hall
Detroit, MI  48201
 
REGISTRATION CONTACT:
Mr. Jerome Wilczynski
Vice President for Operations
Children's Hospital of Michigan
3901 Beaubien Blvd.
Detroit, MI  48201
Telephone:  (313) 745-5450
 
TOPIC:  Protection of Human Subjects in Research:  The Vulnerable
Patient
 
II.  WEST COAST WORKSHOP
 
DATES:  JANUARY 23 and 24, 1992  (REVISED DATES)
 
WORKSHOP SITE:  Los Angeles, CA
 
SPONSORS:
University of Southern California
Los Angeles, CA  90089-4014
 
California State University - Los Angeles
5151 State University Drive
Los Angeles, CA  90032-8202
 
REGISTRATION CONTACT:
Ms. Lily Patterson
Assistant to the Director
Research and Sponsored Programs
California State University - Los Angeles
5151 State University Drive
Los Angeles, CA  90032-8202
Telephone:  (213) 343-3820
 
TOPIC:  Protection of Human Subjects
 
III.  SOUTH MIDWESTERN WORKSHOP
 
DATES:  February 20 and 21, 1992
 
WORKSHOP SITE:  San Antonio, TX
 
SPONSORS:
University of Texas Health Science Center at San Antonio
7703 Floyd Curl Drive
San Antonio, TX  78284-7972
 
St. Mary's University
One Camino Santa Maria
San Antonio, TX  78228-8572
 
REGISTRATION CONTACT:
Ms. Angie Khan
Institutional Coordinator of Research Review
University of Texas Health Science Center at San Antonio
7703 Floyd Curl Drive (Room 402L)
San Antonio, TX  78284-7972
Telephone:  (512) 567-2351
 
TOPIC:  Protection of Human Subjects
 
IV.  NORTHEASTERN WORKSHOP
 
DATES:  April 27 and 28, 1992
 
WORKSHOP SITE:  Philadelphia, PA
 
SPONSORS:
University of Pennsylvania
133 South 36th Street
Suite 300
Philadelphia, PA  19104-3246
 
Lincoln University
Lincoln University, PA  19352
 
REGISTRATION CONTACT:
Ms. Lynn Bevan
Assistant Director
Office of Research Administration
University of Pennsylvania
133 South 36th Street, Suite 300
Philadelphia, PA  19104-3246
Telephone:  (215) 898-2614
 
TOPIC:  Protection of Human Subjects
 
For further information regarding these workshop or future NIH/FDA
National Protection of Human Subjects Workshops, contact:
 
Ms. Darlene Marie Ross
Executive Assistant for Education
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
9000 Rockville Pike
Building 31, Room 5B59
Bethesda, MD  20892
Telephone:  (301) 496-8101
 
$$N1 END ***************************************************************
 
$$N2 BEGIN *************************************************************
 
ESTIMATED TOTAL COSTS OF PROPOSED PROJECTS
 
P.T. 34; K.W. 1014006
 
National Institutes of Health
 
BACKGROUND
 
In response to the House of Representatives and Senate Appropriation
Reports (101-591 and 101-516, respectively), NIH has developed a
financial management plan to increase stability and predictability in
funding biomedical research.  One element of this plan is for National
Advisory Councils and Boards, in their review of applications, to
consider not only scientific merit and programmatic issues but also
total costs of proposed projects.  In order to consider this information
as part f their review, Councils/Boards must be provided with an
estimate of the total costs for each application reviewed.  To provide
Councils/Boards with this information, each summary statement will
include an estimate of the total costs of the proposed project.  This
will begin with summary statements for applications reviewed during the
October-November 1991 round of Initial Review Group (IRG) meetings.
Previously, only requested and recommended direct costs for each budget
period were included on summary statements.
 
CALCULATION METHOD
 
Estimated total costs will be based on information provided in the
applications as well as on the direct costs recommended by the IRG for
applications where negotiated indirect cost rates are applicable.  The
following calculation method will be used t estimate total costs:
 
	1) Total Costs Required for Entire Project will be divided by the Total
Direct Costs Requested for the Entire
      Project.
 
	2) This figure will then be multiplied by the Direct Costs Recommended
for Each Year.
 
Total costs requested and total direct costs requested are provided in
the application.
 
APPLICABILITY
 
Estimated total costs will be included on summary statements for the
first year, all future years, and for the total project period
(competitive segment).  These data will be helpful to Councils, Boards,
and institute staff primarily for applications at or near the margin of
fundability.  Where total costs could be a determining factor in the
funding decision, a more precise calculation will be made using actual
base and rate information.  This will be done before any final funding
decision is made.
 
$$N2 END ***************************************************************
 
$$N3 BEGIN *************************************************************
 
NCI BRIEFING ON SPORE PROGRAM
 
P.T. 42; K.W. 0715035
 
National Cancer Institute
 
The National Cancer Institute (NCI) plans to release Requests For
Applications (RFA) to invite P50 grant applications for Specialized
Programs of Research Excellence (SPORE) in Breast Cancer, Lung Cancer,
and Prostate Cancer.  The RFAs are expected to be released in
mid-September.
 
The NCI plans to conduct a briefing session on the SPORE program on
Tuesday, October 8, 1991, at the St. Louis Airport Marriott, I-70 at
Lambert Airport, St. Louis, Missouri.  The briefing will begin at 8:30
a.m. and will adjourn by noon.  There will be ample time for questions
and answers.  A summary of the proceedings of this meeting including
questions and answers will be available upon request.
 
Interested parties are invited to attend.  Rooms for the night of
October 7 are available at a special rate of $58 plus tax.  Reservations
must be made directly to the hotel at (314) 423-9700.  To receive the
special rate, make the reservation by September 27 and mention the
National Cancer Institute meeting.  Free shuttle service is available
from the airport to the hotel.  Passenger pick-up for the Marriott
shuttle is at exit 7 in the airport terminal.
 
For further information and to request a summary of the meeting, please
contact:
 
Dr. Andrew Chiarodo
Organ Systems Coordinating Branch
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Bethesda, MD  20892
Telephone:  (301) 496-8528
 
$$N3 END ***************************************************************
 
$$N4 BEGIN *************************************************************
 
NOTICE OF MEETING - KIDNEY AND UROLOGIC DISEASES RESEARCH CENTERS
 
P.T. 42; K.W. 0705075, 0785220, 1014006
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
A meeting of Center Directors for the George M. O'Brien Kidney and
Urologic Diseases Research Centers Program supported by the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is
scheduled for September 15, 1991, at the Crystal City Gateway Marriott
Hotel in Crystal City, VA.  The purpose of the meeting is to inform
investigators of current Institute policies and guidelines concerning
research centers.  The meeting is open on a space-available basis.  For
further information contact:
 
Dr. Ralph L. Bain
Program Director
Kidney and Urologic Diseases Research Centers Program
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 621
Bethesda, MD  20892
 
$$N4 END ***************************************************************
 
$$N5 BEGIN *************************************************************
 
AVAILABILITY OF BLOOD SAMPLES FROM PATIENTS ENROLLED IN THE EARLY
TREATMENT DIABETIC RETINOPATHY STUDY
 
P.T. 34; K.W. 0755015, 0715080, 0780005
 
National Eye Institute
 
The Early Treatment Diabetic Retinopathy Study (ETDRS), a multicenter
collaborative clinical trial supported by the National Eye Institute,
was designed to assess laser photocoagulation and aspirin treatment in
patients with mild-to-
 
severe nonproliferative and early proliferative diabetic retinopathy.
Follow-up of these patients extended for up to nine years.  The study
design and results of the clinical trial are published in Ophthalmology
1991;98:739-840.
 
Between April 1980 and September 1983, approximately 2,000 fasting
baseline blood specimens were drawn from ETDRS patients and analyzed
for:  hemoglobin A1C, cholesterol, triglyceride, high-density
lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol
(LDLC), creatinine, uric acid, glucose, C-peptide, albumin, fibrinogen,
alpha-2-macroglobulin, and thromboxane B2.  At that time a 3 cc aliquot
of each serum specimen was stored in a sealed glass Wheaton vial at -70
degrees Centigrade at the Centers for Disease Control in Atlanta, GA.
The ETDRS database includes extensive information on baseline
characteristics (systemic and ocular) as well as seven- to-nine-year
outcome information (morbidity, mortality, and ocular) for these 2000
Type I and Type II diabetics.  Investigators interested in using these
reserved frozen serum specimens for research projects are invited to
contact:
 
Frederick L. Ferris, III, M.D.
Chief, Clinical Trials Branch
National Eye Institute
National Institutes of Health
Building 31, Room 6A24
Bethesda, MD  20892
 
$$N5 END ***************************************************************
 
$$N6 BEGIN *************************************************************
 
DISCONTINUATION OF THE NIAID IMMUNOLOGIC AND INFECTIOUS DISEASES
ACADEMIC AWARD
 
P.T. 34; K.W. 0710070, 1014002
 
National Institute of Allergy and Infectious Diseases
 
Beginning with the October 1, 1991, application receipt date, the
National Institute of Allergy and Infectious Diseases (NIAID) will no
longer accept new or amended applications for the NIAID Immunologic and
Infectious Diseases Academic Award (K07).  However, NIAID will continue
to receive new and amended applications for the other career award
programs, namely the Clinical Investigator Award (K08), the Physician
Scientist Academic Award (K11), and the Modified Research Career
Development Award (K04).
 
This decision was reached because of the paucity of applications
received for the KO7 Award in recent years, and the desire of the NIAID
to focus its career award resources to the K04, K08, and K11 mechanisms,
particularly in keeping with its efforts to increase the recruitment and
retention of minority and women scientists in biomedical research.
 
$$N6 END ***************************************************************
 
                       NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$R1 BEGIN NCI-CM-27710-19 *********************************************
 
DEVELOPMENT OF DOSAGE FORMS AND DELIVERY SYSTEMS FOR NEW DRUGS
 
RFP AVAILABLE:  NCI-CM-27710-19
 
P.T. 34; K.W. 0740021, 1003008
 
National Cancer Institute
 
The Pharmaceutical Resources Branch of the Developmental Therapeutics
Programs, Division of Cancer Treatment, National Cancer Institute (NCI),
is seeking contractors to develop acceptable dosage forms for compounds
to be subsequently evaluated in cancer and HIV patients and to carry out
innovative studies leading to more effective approaches for the
intravenous delivery of compounds that possess limited solubility and/or
stability.  NCI will select and provide the compounds to be studied.  In
addition to solubility problems, the projects will require considerable
analytical work, particularly the development of a stability-indicating
assay to monitor the integrity of the parent compound during the
formulation studies.  These investigations will be directed toward a
pharmaceutical dosage form that will meet certain solubility and
stability targets predetermined by the Government.  The Principal
Investigator on this project must possess a Ph.D. in pharmaceutics or
medicinal chemistry and must also have at least three years experience
in the development of injectable formulations.  A portion of this
project is a recompetition of two NCI contracts.  The incumbent
contractors are the University of Kansas and the University of North
Carolina at Chapel Hill.
 
RFP No. NCI-CM-27720-19 will be issued upon request to Zetherine Gore,
Contract Specialist, on or about September 9, 1991.  Proposals will be
due approximately 45 days thereafter.  The contract period is to be for
five years beginning approximately June 1991.
 
Mail requests for the RFP to:
 
Ms. Zetherine Gore
Contract Specialist
National Institutes of Health
National Cancer Institute
Treatment Contract Section
6120 Executive Blvd, Room 603
Rockville, MD  20852
 
$$R1 END ***************************************************************
 
$$R2 BEGIN NCI-CM-27722-72, NCI-CM-27723-71 ****************************
 
PREPARATION OF ANTI-AIDS BULK DRUGS AND CHEMICALS FOR PRECLINICAL
TOXICOLOGY, PHARMACOLOGY, AND CLINICAL USE
 
RFPs AVAILABLE:  NCI-CM-27722-71 (open competition)
		    NCI-CM-27723-71 (small business set-aside)
 
P.T. 34; K.W. 0710080, 1003012, 0740020
 
National Cancer Institute
 
The National Cancer Institute (NCI) is seeking contractors with the
capability to provide and operate material preparation laboratories for
(a) the development of existing or new processes, procedures, and
techniques for the preparation of compounds; and (b) the synthesis of
varying amounts of material not readily available from other sources in
the quantity and/or quality needed by the NCI.  Offerors will be
expected to provide an operating, large-scale facility with at least one
and preferably two large (200 gallons or larger) glass-lined reactors
and the necessary supporting equipment and facilities.  Quantities of
drugs may range from 50 grams to multi-kilograms.  Process development
for scale-up and access pilot plant equipment is essential.  Specific
assignment of the materials for preparation will be made by the NCI and
may include synthesis of all types of chemicals and drugs.  The
contractor will be responsible for preparing approximately 20-30 lots of
bulk drugs per year.  Quality specifications will be determined by the
NCI.  All materials must be evaluated by the synthesis laboratory for
identity and purity before submitted to the NCI.
 
The Principal Investigator must be trained in organic and medicinal
chemistry, preferably at the Ph.D. level, or possess equivalent
experience.  The Principal Investigator must have extensive experience
in chemical synthesis and synthetic process development.
 
At the time of submission of a best and final offer, the offerer must be
registered with the Food and Drug Administration (FDA) as a manufacturer
of bulk drugs and shall have submitted a facilities Drug Master File to
the FDA.  Facilities shall meet FDA standards in accordance with the
Current Good Manufacturing Practices.
 
RFP No. NCI-CM-27722-71, "Preparation of Anti-AIDS Bulk Drugs for
Preclinical Toxicology, Pharmacology, and Clinical Use" is an open
competition.  RFP No. NCI-CM-27723-71, "Preparation of Anti-AIDS Bulk
Drugs and Chemicals for Preclinical Toxicology, Pharmacology, and
Clinical Use" is a 100 percent Set-Aside for Small Business.  The
Standard Industrial Code (SIC) is 8731.
 
Offerors who qualify as a small business are encouraged to submit
proposals under both RFPs.
 
It is anticipated that four incrementally funded, cost-reimbursement
contracts will be awarded with the contract period beginning on or about
May 4, 1992.  The contract period will be five years.  RFP Nos:
NCI-CM-27722-71 and NCI-CM-27723-71 will be issued upon written request
to Joseph Bowe, Contract Specialist, on or about September 3, 1991.
Proposals will be due on or about October 17, 1991.  Requests for the
RFP must be addressed to:
 
Joseph Bowe
Contract Specialist
National Institutes of Health
National Cancer Institute
Treatment Contracts Section
Research Contracts Branch
Executive Plaza South, Room 603
9000 Rockville Pike
Bethesda, MD  20892
 
No calls will be accepted.
 
$$R2 END ***************************************************************
 
$$R3 BEGIN NIH-NIDDK-91-6 **********************************************
 
SUPPORT OF THE NATIONAL HORMONE AND PITUITARY PROGRAM
 
RFP AVAILABLE:  NIH-NIDDK-91-6
 
P.T. 34; K.W. 0760025, 0785050
 
National Institute of Diabetes and Digestive and Kidney Diseases

The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), Division of Diabetes, Endocrinology and Metabolic Diseases, is
conducting this project for the purpose of providing continuing support
to the National Hormone and Pituitary Program (NHPP), a component of the
Hormone Distribution Program of NIDDK.  The NHPP is responsible for
storage and distribution of materials procured by NIDDK for use by
researchers in endocrinology.  The contractor will receive, store, and
distribute purified human, rat, ovine, bovine, and porcine pituitary
hormones, selected other hormones, antisera to these hormones, and
frozen human pituitaries.  Currently, the NHPP distributes approximately
160 distinct research materials and approximately 2000 individual awards
of materials are made annually.  The contractor will also disseminate
information to the scientific community about the materials available.
 
This Request for Proposals (RFP) No. NIH-NIDDK-91-6 will be issued on or
about September 12, 1991 with responses due by December 11, 1991.  The
NIDDK expects to award one contract from this solicitation.
 
To receive a copy of this RFP, supply this office with two
self-addressed mailing labels and cite the RFP number referenced above.
Requests must be in writing and addressed to:
 
Ms. Linda Cameron
Contract Specialist
Contracts Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 602
Bethesda, MD  20892
Telephone requests will not be honored.
 
This advertisement does not commit the Government to make an award.
 
$$R3 END ***************************************************************
 
$$R4 BEGIN NIH-NINDS-91-002 ********************************************
 
NINDS LOGISTICAL RESEARCH SUPPORT
 
SOURCES SOUGHT:  NIH-NINDS-91-002
 
P.T. 34; K.W. 1002030, 1013004, 1002004, 1002008
 
National Institute of Neurological Disorders and Stroke
 
The Division of Intramural Research (DIR), National Institute of
Neurological Disorders and Stroke (NINDS), National Institutes of Health
(NIH), is seeking to identify sources capable of providing logistical
and research support.  The DIR, NINDS, has operated its Laboratories of
Biophysics, Neurobiology, Molecular and Cellular Neurobiology and
Neurochemistry at an outside marine laboratory on a part-time basis over
the last three years.  A five-year program beginning in May 1992 is
anticipated.  This program will support important research on neural
cells and neural cell membranes, neuronal signaling, and short- and
long- term memory mechanisms.  It is based on the need in the DIR,
NINDS, for live squid and other marine invertebrates to investigate the
cellular functions underlying central nervous system function.  Since
live squid cannot be transported, this work must be done at the
collecting site.
 
The contractor shall provide the personnel, equipment, and facilities
necessary to support this research.  Approximately 11 DIR, NINDS
scientists per year will require support.  The following is a general
description of the support required.  The contractor shall collect
Loligo Pealeii (4-24" body length) from May to November each year of the
contract period and store them in appropriate live holding tanks.  The
contractor shall supply the NINDS investigators with specific
mariculture services supportive of their research program on marine
nudibranches.  A qualified aquavet shall be in residence at the
contractor's facility to take care of any health problems of the marine
animals.  An animal holding facility with appropriate veterinary support
shall be on site to hold small numbers of mice and rabbits (for antibody
production).  A full-service biomedical library with a wide range of
current periodicals must be on site.  The contractor shall also provide
machine and instrument shop services, photo and graphic services,
computer programming and applied mathematics, telephone, facsimile,
mail, and shipping services.  The NINDS investigators will also require
the use of special equipment (e.g., ultracentrifuges, liquid
scintillation counters, atomic absorption spectrometers, osometers,
scanning electron microscope, transmission electron microscope,
ultramicrotome, and equipment for preparing tissues for ultramicrotomy
and darkroom for processing electron micrographs).  A specialized light
microscopy facility capable of performing fluorescence and video
microscopy is also required.  The research space needs from May to
November each year are 2,700 square feet.  Separate office space is not
necessary.  Fluorescent lighting of the space is required.  Four units
of laboratory space that includes fume hoods and a laboratory sink for
each unit shall be provided.  Low benches, chairs, air filters, and a
refrigerator shall be provided for each unit.  Seawater holding tanks
shall also be provided to each of the four units.
 
This is not a Request For Proposals (RFP).  It is a request for
capability/ qualification statements.  The Government does not intend to
award a contract on the basis of responses to this announcement nor to
make payment for preparation of any information that may be submitted.
Potential sources that respond to this notice shall be added to the
appropriate solicitation mailing list for subsequent solicitation if an
RFP is issued.
 
Acknowledgement will not be made by the Government of receipt of
responses nor will respondents be notified of the Government's
evaluation of information submitted.  Five copies of a capability
statement that addresses the aforementioned requirements must be
received at the following address no later than 3:30 p.m., local time,
on September 23, 1991.  The capability statement should reference
NIH-NINDS-91-002.
 
Eileen D. Webster
Contracting Officer
Contracts Management Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 901
7550 Wisconsin Avenue
Bethesda, MD  20892
Attention:  NIH-NINDS-91-002
 
$$R4 END ***************************************************************
 
$$R5 BEGIN NIH-NIAID-DAIDS-92-07 ***************************************
 
EVALUATION OF THERAPIES FOR TREATMENT OF PNEUMOCYSTIS CARINII,
MYCOBACTERIUM AVIUM, TOXOPLASMA GONDII, AND PATHOGENIC FUNGI INFECTIONS
 
RFP AVAILABLE:  NIH-NIAID-DAIDS-92-07
 
P.T. 34; K.W.0715125, 0715103, 0715165, 0745070
 
National Institute of Allergy and Infectious Diseases
 
The Developmental Therapeutics Branch, Basic Research and Development
Program, Division of AIDS, National Institute of Allergy and Infectious
Diseases (NIAID) has a requirement for the evaluation of promising
therapies for the following opportunistic infections (OIs) associated
with AIDS:  Pneumocystis carinii, Mycobacterium avium, Toxoplasma
gondii, and
 
Pathogenic Fungi.  The offeror must at the time of proposal, have
available an animal system, including relevant strains of organisms (as
applicable), suitable for evaluation of therapies with potential for
treatment of the organisms specified.  The proposed test system must
approximate the clinical manifestations of the infection as it occurs in
AIDS or should have documented utility as a model of drug efficacy in
human disease.  Basic model development is not part of this effort.
Additional studies will be required such as in vitro tests,
determination of plasma drug concentrations, and prophylaxis evaluation.
At the present time, NIAID has seven contracts that are scheduled to end
in 1992 to evaluate new drugs for the following organisms:  P. carinii,
M. avium, and C. albicans.
 
This Request for Proposals (RFP) will be divided into four parts (by
organism) consisting of:  (1) Pneumocystis carinii, (2) Mycobacterium
avium, (3) Toxoplasma gondii, and (4) Pathogenic Fungi (which includes
Cryptococcus, Histoplasma, and Candida).  There will be a separate work
statement and competitive range established for each part.  Offerors may
respond to one or more parts.  It is anticipated that one or more
contracts will be awarded per part.  This NIAID-sponsored project will
take approximately five years to complete.  A cost
reimbursement/completion contract is anticipated.
 
This is an announcement for an anticipated RFP.  RFP
NIH-NIAID-DAIDS-92-07 shall be issued on or about September 20, 1991,
and proposals will be due on or about December 20, 1991.  Requests for
the RFP shall be directed in writing to:
 
Cyndie Cotter
Contract Specialist
Contract Management Branch
National Institute for Allergy and Infectious Disease
Control Data Building, Room 326P
6003 Executive Blvd.
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.  This advertisement does not commit the government to
make awards.
 
$$R5 END ***************************************************************
 
$$R6 BEGIN NIH-NIAID-DAIDS-92-08 ***************************************
 
MODEL DEVELOPMENT AND EVALUATION OF THERAPIES FOR CRYPTOSPORIDIUM
INFECTION
 
RFP AVAILABLE:  NIH-NIAID-DAIDS-92-08
 
P.T. 34; K.W. 0755020, 0715103
 
National Institute of Allergy and Infectious Diseases
 
The Developmental Therapeutics Branch, Basic Research and Developmental
Program, Division of AIDS, National Institute of Allergy and Infectious
Diseases (NIAID), has a requirement for the Model Development and
Evaluation of Therapies for Cryptosporidium Infection.  This initiative
will consist of two phases.  In Phase I, contractors will develop, over
a period of two years, a standardized and reproducible small animal
model for cryposoridiosis that is suitable for evaluation of therapies
with potential for treatment of cryptosporidium parvum infection in
humans.  Offerors will be evaluated on the applicability and suitability
of the proposed animal model for development of a therapy evaluation
system for the Cryptosporidium infection.  The Government will have the
option to extend the performance period for one or more contractors who
have satisfactorily completed the requirements of Phase I, for an
additional three years (Phase II).  In Phase II, contractors will
evaluate new drugs using the animal models developed.
 
The Request for Proposals (RFP) will contain qualification criteria
requiring offerors to provide documentation of an adequate source and
delivery schedule of viable Cryptosporidium parvum oocysts.  This
announcement is a new solicitation.  Multiple awards are anticipated for
this procurement.
 
The issuance of this RFP (NIH-NIAID-DAIDS-92-08) will be on or about
October 7, 1991, and proposals will be due by close of business on or
about January 7, 1992.  This NIAID-sponsored Phase I project will take
approximately two years to complete.  A cost-reimbursement contract is
anticipated.  Requests for the RFP shall be directed to:
 
Mr. Ross Kelly
Contract Specialist
Contract Management Branch
National Institute for Allergy and Infectious Disease
Control Data Building, Room 326P
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.  This advertisement does not commit the Government to
make awards.
 
$$R6 END ***************************************************************
 
$$R7 BEGIN NIH-NIAID-DMID-92-06 ****************************************
 
PLASMODIUM FALCIPARUM VACCINE DESIGN AND PRODUCTION
 
RFP AVAILABLE:  NIH-NIAID-DMID-92-06
 
P.T. 34; K.W. 0715125, 0740075, 0755041
 
National Institute of Allergy and Infectious Diseases
 
The National Institute of Allergy and Infectious Diseases has a
requirement for a facility and team of scientists to construct
recombinant malaria antigens, test these antigens for safety and
immunogenicity in small animal models, and formulate experimental
vaccines for clinical testing using Good Manufacturing Practices.  This
requirement is part of a cooperative initiative with the Agency for
International Development.  Respondents must have facilities and
equipment to allow the construction of recombinant antigen genes from
known sequences and cloned DNA specimens, the efficient expression of
recombinant proteins, protein purification, and vaccine formulation.
Quality control, including toxicological evaluation of vaccines, and
other Good Manufacturing Practices elements must also be a part of the
capability.  The Government will work closely with the contractor in the
design of vaccines.  Aspects of the preclinical evaluation and clinical
trials will be conducted at other facilities.
 
Any contract awarded will be subject to DHHS regulations regarding the
animal subjects in research.
 
One contract may be awarded as a result of this solicitation.  It is
expected that the contract will have a three-year period of performance
with options for two additional years.
 
The issuance of the Request for Proposals (RFP) will be on or about
September 6, 1991, and proposals will be due by the close of business on
December 2, 1991.  Any responsible offeror may submit a proposal that
will be considered by the Government.
 
To receive a copy of this RFP, supply this office with a request in
writing and two self-addressed mailing labels addressed to:
 
Mr. Carl R. Henn
Contract Specialist
Contract Management Branch
National Institute of Allergy and Infectious Diseases
Control Data Building, Room 326P
Bethesda, MD  20892
 
This advertisement does not commit the Government to make an award.
 
$$R7 END ***************************************************************
 
$$R8 BEGIN DK/HD-92-01 FULL-TEXT ***************************************
 
ENDOCRINOLOGY OF BODY COMPOSITION
 
RFA AVAILABLE:  DK/HD-92-01
 
P.T. 34; K.W. 0785050, 0760025, 0760020, 0715006
 
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development
 
Letter of Intent Receipt Date:  January 15, 1992
Application Receipt Date:  February 14, 1992
 
PURPOSE
 
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) and the National Institute of Child Health and Human Development
(NICHD) encourage investigator-initiated research grant (R01)
applications for support of basic and clinical studies on the role of
both endogenous and administered hormones in the determination of body
composition.
 
BACKGROUND
 
There is a clear link between a number of hormones and body composition,
yet the roles of these hormones in the regulation of body composition
remain to be elucidated.  A precise understanding of the endocrine
regulation of body composition in humans, and of other health outcomes
relating to intervention in this system, is critical to a wide range of
clinically and ethically significant issues.  A recent report that
growth hormone administration to a selected small group of elderly men
increased bone density and lean body mass, and reduced adiposity, led
some to suggest that growth hormone treatment may have potential
beneficial effects in the elderly.  However, significant questions about
risks and benefits of growth hormone treatment in elderly men remain to
be answered, as do questions about a possible role of growth hormone
administration in older women, growth hormone deficient adults, burn
victims, and other conditions associated with increased catabolism.
 
The recent rise in abuse of so called performance enhancing drugs by
athletes and more recently by teenagers wishing to improve their
appearance has focussed attention on the physiologic role of these
hormones in determining body composition, on metabolism, and on athletic
performance.  Variable results have been reported on the effects of
treatment with high dose anabolic steroids and/or growth hormone on
muscle mass and athletic performance.  A precise understanding of the
effects of these hormones on peri-and post-pubertal growth, body
composition and performance is a requisite part of any attempt to stem
the abuse of these drugs.
 
The balance between nutrient intake and energy expenditure in normal
individuals is influenced by a number of determinants such as age,
exercise, gender, and nutrient type.  Against this background, the role
and mechanisms of hormones such as growth hormone, thyroid hormone,
anabolic and other steroids, and locally or systemically acting growth
factors in determining body composition require elucidation and are the
subjects of this announcement.
 
SCOPE
 
Some examples of research topics that would be considered responsive to
this announcement include the following:
 
o effects of recombinant human growth hormone (rhGH), thyroid hormone,
insulin-like growth factors, anabolic and other steroids or other
hormones on carbohydrate, fat, protein, and mineral metabolism;
 
o relationship between growth hormone levels and loss of lean body mass
with age;
 
o effects of rhGH therapy in specific populations including the elderly,
growth hormone deficient adults, burn victims, and other conditions
associated with increased catabolism;
 
o the effects of drugs used for performance or image enhancement, such
as anabolic steroids or growth hormone, on body
 
mass and composition, metabolic function, athletic performance, strength
and/or growth and development;
 
o identification of other short- or long-term effects of anabolic
steroids or growth hormone on the endocrine reproductive or immune
systems, neoplasia, behavior, or other parameters;
 
o the effects of exercise on growth hormone, androgenic steroid, or
other hormone levels;
 
o the role of hormones in the etiology of obesity or in determining the
obese phenotype (upper or lower body obesity);
 
o identification of sites or mechanisms of neuroendocrine control of
lean body mass at the molecular or cellular level.
 
These areas of interest are not listed in any particular order nor do
they represent a comprehensive inventory of research topics that would
be fostered under this RFA.  While work proposed may utilize human or
animal models, or cell lines, the goal of the research should be an
understanding of the endocrine processes involved in the regulation of
body composition in humans.
 
MECHANISM OF SUPPORT
 
The mechanism of support for this program will be the traditional, grant
(R01).  The NIDDK plans to support approximately five applications and
the NICHD plans to support two to three applications submitted in
response to this solicitation; however, the specific number to be funded
will depend upon the overall merit, the scope of the applications
received, and availability of funds.  Up to $1.4 million for first-year
expenses, and additional expenses for up to five years, will be
committed to fund applications submitted in response to the RFA.
Although this solicitation is included in the sponsoring Institutes
funding plans for Fiscal Year 1992 support for this solicitation is
contingent upon receipt of appropriated funds for this purpose.  Since a
variety of approaches would represent valid responses to this
solicitation, it is anticipated that there will be a range of costs
among individual grants awarded.  With respect to post-award
administration, the current policies and requirements that govern the
regular research grant programs of the PHS, as described in the PHS
Grants Policy Statement, will prevail.
 
REVIEW PROCEDURES AND CRITERIA
 
Upon receipt, applications will initially be reviewed by the Division of
Research Grants (DRG) for completeness.  Incomplete applications will be
returned to the applicant without further consideration.  Applications
also will be reviewed by staff for their responsiveness to the
objectives of this RFA.  Applications will first be reviewed for
scientific and technical merit by an Initial Review Group, that will be
convened by the Review Branch, Division of Extramural Activities, NIDDK.
The applications will then be reviewed by the National Diabetes and
Digestive and Kidney Disease Advisory Council and the National Advisory
Child Health and Human Development Council.  Review criteria include the
extent of relevance and/or contribution of the proposed research to the
overall goals and objectives of the RFA; the novelty, originality, and
feasibility of the approach; the adequacy of the experience, and
research competence of the investigator(s); the adequacy of the
experimental design; the suitability of the facilities; and the
appropriateness of the requested budget to the work proposed.
 
METHOD OF APPLYING
 
Applications must be submitted on form PHS 398 (rev. 10/88), that is
available from an applicant institution's Office of Sponsored Research
and from Office of Grants Inquiries, Division of Research Grants,
National Institutes of Health, Westwood Building, Room 449, 5333
Westbard Avenue, Bethesda, MD 20892 telephone (301) 496-7441.  Use the
conventional format for research project grant applications and ensure
that the points identified in the RFA in the section on "Review
Procedures and Criteria" are fulfilled.  To identify the application as
a response to this RFA check "yes" on item two of page one of the
application and enter the title "Endocrinology of Body Composition" and
the RFA number DK/HD-92-01.  Applications must be received by February
14, 1992, to be considered.
 
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
 
NIH policy requires that applicants for clinical research grants and
cooperative agreements include minorities and women in study populations
so that research findings can benefit all persons with the disease,
disorder or condition under study.  Specific information concerning the
NIH policy on inclusion of women and minorities can be found in the NIH
Guide for Grants and Contracts, Vol. 19, No. 31, August 24, 1990, pages
18-19, and Vol. 19, No. 35, September 28, 1990, respectively.
 
INQUIRIES
 
For copies of the RFA or for further information, investigators are
encouraged to contact the following individuals:
 
Philip F. Smith, Ph.D.
Director, Endocrinology Research Program
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Bldg, Room 603
Bethesda, MD  20892
Telephone:  (301) 496-7341
 
Gilman D. Grave, M.D.
Chief, Endocrinology, Nutrition and Growth Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
National Institutes of Health
Executive Plaza North, Room 637
Bethesda, MD  20892
Telephone:  (301) 496-5593
 
Bruce  R. Butrum
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Bldg, Room 649
Bethesda, MD  20892
Telephone:  (301) 496-7467
 
E. Douglas Shawver
Grants Management Branch
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
Bethesda, MD  20892
Telephone:  (301) 496-1303
 
This program is described in the Catalog of Federal Domestic Assistance
93.846; No. 93.847, Diabetes, Endocrinology, and Metabolism; and No.
93.855, Research for Mothers and Children.  Awards will be made under
the authority of the Public Health Service Act, Title III, Section 301
(Public Law 78-410, as amended; 42 USC 241) and administered under PHS
grant policies and Federal Regulations 42 CFR part 52 and 45 CFR Part
74.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
 
$$R8 END ***************************************************************
 
$$R9 BEGIN CA-91-21 FULL-TEXT ******************************************
 
EPIDEMIOLOGIC STUDY OF ADENOCARCINOMAS OF THE ESOPHAGUS AND GASTRIC
CARDIA
 
RFA AVAILABLE:  CA-91-21
 
P.T. 34; K.W. 0715035, 0785055, 0715085
 
National Cancer Institute
 
Letter of Intent Receipt Date:  November 15, 1991
Application Receipt Date:  December 11, 1991
 
PURPOSE
 
The Epidemiology and Biostatistics Program (EBP) of the Division of
Cancer Etiology (DCE) invites cooperative agreement applications from
investigators to participate, with the assistance of the National Cancer
Institute (NCI), in an epidemiologic study to identify risk factors for
adenocarcinomas of the esophagus and gastric cardia and contrast them
with risk factors for other cancers of the esophagus and stomach.
Subjects for study will be patients newly diagnosed with these cancers
and appropriate controls.  The assistance mechanism used to support
these studies will be the cooperative agreement, which is similar to a
traditional research grant, but in which NCI scientific staff
participate with study investigators as partners in the research effort.
 
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) entitled, Epidemiologic Study of Adenocarcinomas of
the Esophagus and Gastric Cardia, is related to the priority area of
prevention of cancer.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325,
telephone (202) 783-3238.
 
BACKGROUND
 
Recent analyses of incidence data from the Surveillance, Epidemiology
and End Results (SEER) program of cancer registration covering
approximately 10 percent of the U.S. population have revealed sharply
rising rates during 1976-87 for adenocarcinomas of the esophagus and
gastric cardia.  The increases among males in this period ranged from 4
to 10 percent per year, outpacing rises in skin melanoma, non-Hodgkin's
lymphomas, and other cancers.  In contrast, there were relatively stable
trends for squamous cell carcinoma of the esophagus and slight declines
for adenocarcinoma of more distal portion of the stomach.  The
adenocarcinomas of the esophagus and gastric cardia disproportionately
affected white males and rarely occurred among women.  The male:female
ratios for these cancers exceeded five, the greatest relative excess for
any cancer except lip cancer.  By the mid-1980s, among white males,
adenocarcinomas accounted for about one-third of all esophageal cancers,
while cardia cancers accounted for about one-half of all stomach cancers
with subsite specified.  The annual age-adjusted incidence rate for
white males for adenocarcinomas of the esophagus and gastric cardia
combined was 5.1 per 100,000.
 
The unexplained increase in incidence rates, which has also been
observed in western Europe, points to the need for investigation into
the causes of these poorly understood cancers.  Reasons for the striking
racial differences between these cancers and squamous cell carcinomas of
the esophagus or adenocarcinomas occurring elsewhere in the stomach also
remain to be determined.  Because of their rarity in the past, however,
few epidemiologic studies have evaluated risk factors for esophageal
adenocarcinoma and/or gastric cardia cancer.
 
RESEARCH GOALS AND SCOPE
 
This initiative proposes new research into the etiology of these
emergent cancers.  It will be the first systematic analytic
epidemiologic study of adenocarcinomas of the esophagus and gastric
cardia and enable exploration of associations with a variety of possible
environmental and host determinants.  Its objectives are to identify
risk factors for adenocarcinomas of the esophagus and gastric cardia and
contrast them with risk factors for other cancers of the esophagus and
stomach.  Cooperative agreements will be sought to enable the conduct of
a multi-center, case-control study.  Cases will be patients newly
diagnosed during a recent period with adenocarcinoma of the esophagus or
gastric cardia.  To compare characteristics of these patients with those
of persons with other esophageal and stomach cancers, it is anticipated
that approximately equal numbers of squamous cell carcinomas of the
esophagus and adenocarcinomas elsewhere in the stomach of similar age,
sex, and race will also be included.  Controls from the populations from
which the cases arose would be selected for comparison with the cancer
patients.  To ensure sufficient numbers of cases for pooled statistical
analyses of a variety of environmental and host factors it is
anticipated that, across all centers, at least 250 patients recently or
newly diagnosed with esophageal adenocarcinoma and at least 250 with
gastric cardia cancer will need to be enrolled.
 
MECHANISM OF SUPPORT
 
Support of this program will be through the cooperative agreement, an
assistance mechanism in which substantial NIH programmatic involvement
with the recipient during performance of the planned activity is
anticipated.  Applicants will be responsible for the planning,
direction, and execution of the proposed project.
 
Approximately $750,000 in total costs per year for three years will be
committed to specifically fund applications which are submitted in
response to this RFA.  It is anticipated that three to four awards will
be made.  This funding level is dependent on the receipt of a sufficient
number of applications of high scientific merit.  The total project
period for applications submitted in response to the present RFA should
not exceed three years.  The earliest feasible start date for the
initial awards will be June 1, 1992.  Although this program is provided
for in the financial plans of the NCI, the award of grants pursuant to
the RFA is also contingent upon the availability of funds for this
purpose.
 
ELIGIBILITY REQUIREMENTS
 
Non-profit and for-profit organizations and institutions, governments
and their agencies are eligible to apply.  Foreign institutions are also
eligible.
 
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.
 
INQUIRIES
 
Written and telephone inquiries concerning the objectives and scope of
the RFA and inquiries about whether or not specific proposed research
would be responsive are encouraged and are to be directed to the
following:
 
Administrative Coordinator
G. Iris Obrams, M.D., Ph.D.
National Cancer Institute
EPN, Room 535
Bethesda, MD  20892
Telephone:  (301) 496-9600
Fax:  (301) 496-9146
 
Grants Management Contact
Sara Stone
National Cancer Institute
EPN, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800
Fax:  (301) 496-8601
 
Scientific Coordinator
William J. Blot, Ph.D.
National Cancer Institute
EPN, Room 431
Bethesda, MD  20892
Telephone:  (301) 496-4153
Fax:  (301) 402-0081
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.393, Cancer Cause and Prevention Research.  Awards are under
authorization of the Public Health Service Act, Section 301(c) and
Section 402 (Public Law 78-410, as amended; 42 USC 241; 42 USC 282) and
administered under PHS grant policies and Federal regulation 42 CFR Part
52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
 
$$R9 END ***************************************************************
 
$$R10 BEGIN CA-91-31 FULL-TEXT *****************************************
 
MECHANISMS OF MULTISTAGE CARCINOGENESIS IN THE PROSTATE
 
RFA AVAILABLE:  CA-91-31
 
P.T. 34; K.W. 0715035, 0715085, 0785140, 0755020
 
National Cancer Institute
 
Letter of Intent Receipt Date:  October 1, 1991
Application Receipt Date:  December 20, 1991
 
PURPOSE
 
The Chemical and Physical Carcinogenesis Branch, Division of Cancer
Etiology (DCE), National Cancer Institute (NCI), invites
investigator-initiated research grant applications (R01s) to elucidate
the basic, complex mechanisms of multistage carcinogenesis in the
prostate.  New advances in prostate tissue and cell culture and
descriptions of potentially useful animal models, coupled with rapid
advancements in molecular biology and improvement in the general
understanding of human carcinogenesis processes, may provide the
foundation for major new insights, including identification of the
cellular and molecular mechanisms and environmental causes of
transformation to invasive cancer forms in normal and latent prostatic
epithelial cells.  New and experienced investigators in relevant fields
and disciplines may apply for funds to pursue investigations in animal
and human prostatic epithelial cells.
 
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), Mechanisms of Multistage Carcinogenesis in the
Prostate, is related to the priority area of cancer.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017- 001-00474-0 or 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, public and private organizations, such as universities,
colleges, hospitals, laboratories, units of state and local governments,
and eligible agencies of the Federal Government.  Applications from
minority individuals and women are encouraged.
 
MECHANISM OF SUPPORT
 
Support of this program will be through the National Institutes of
Health (NIH) grant-in-aid (R01).  Applicants will be responsible for the
planning, direction, and execution of the proposed project.  The total
project period for applications submitted in response to this RFA may
not exceed five years.  The earliest feasible start date for the initial
awards will be July 1, 1992.
 
FUNDS AVAILABLE
 
$1,000,000 per year for five years will be committed to specifically
fund applications submitted in response to this RFA.  It is anticipated
that five to seven awards will be made.  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 NCI, the award of grants pursuant to this RFA is
contingent upon the availability of funds for this purpose.
 
RESEARCH GOALS AND SCOPE
 
The goal of this initiative is to accelerate further understanding of
carcinogenesis in the prostate gland in animals and man.  Integrated
studies are encouraged in one or more of the following categories:  (a)
cell biology and carcinogenesis, including identification of prostatic
epithelial cells undergoing change; (b) carcinogen metabolism, including
comparative metabolism, repair, and adduct formation between animals and
man and from inter/intra individual donors; (c) molecular mechanisms,
including molecular markers of change throughout transformation of an
epithelial cell; (d) cellular mechanisms, including cell-cell
interactions and responses to endogenous and exogenous factors; and (e)
appropriate models, including suitable in vitro or animal models for
prostate epithelial cell carcinogenesis.
 
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.  Due to the specific subject of this
RFA, i.e., prostate cancer, the inclusion of women is not applicable.
However, the inclusion of minorities remains relevant.
 
APPLICATION PROCEDURES
 
Applications must be received by close of business December 20, 1991.
The research grant application form PHS 398 (revised 10/88) must be used
in applying for awards under this RFA.  The application package is
available at most institutional business offices; from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD
20892, telephone (301) 496-7441; and from the NCI Program Director named
below.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by October 1, 1991, a letter
of intent that includes a descriptive title of the proposed research,
the name and address of the Principal Investigator, the names of other
key personnel, the participating institutions, and the number and title
of the RFA in response to which the application is being submitted.
Such letters are requested for the purpose of obtaining an indication of
the number and scope of applications to be received.  A letter of intent
is not binding, is not a requirement of submission, and does not enter
into the review of the application.  The letter of intent is to be sent
to:
 
Dr. David G. Longfellow
Chief, Chemical and Physical Carcinogenesis Branch
Division of Cancer Etiology
National Cancer Institute
Executive Plaza North, Suite 700
Bethesda, MD  20892
Telephone:  (301) 496-5471
FAX:  (301) 496-1040
 
INQUIRIES
 
This Notice of Availability is an abbreviated version of the RFA.
Copies of the complete RFA and written and telephone inquiries
concerning the objectives and scope of the RFA, and inquiries about
whether or not specific proposed research would be responsive, are
encouraged and are to be directed to Dr. Longfellow at the above
address.  The Program Director welcomes the opportunity to clarify any
issues or questions from potential applicants.
 
Written and telephone inquiries of a budgetary, administrative, and/or
policy nature are to be directed to:
 
Ms. Sara Stone
Grants Management Team Leader
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, Ext. 66
FAX:  (301) 496-8601
 
AUTHORITY AND REGULATIONS