kristoff@NET.BIO.NET (Dave Kristofferson) (10/28/89)
Vol. 18, No. 38, October 27, 1989
NOTICES
NEI INSTITUTIONAL TRAINING GRANTS .........................(84/104).......... 1
National Eye Institute
Index: EYE
DATED ANNOUNCEMENTS (RFPs AND RFAs)
LARGE BOWEL ADENOMATOUS POLYP DIETARY INTERVENTION STUDY--
CLINICAL CENTERS (RFP) ....................................(110/145)......... 1
National Cancer Institute
Index: CANCER
SUPPORT FOR "EMERGING TECHNOLOGY": STUDIES ON THE AUGMENTATION OF
CELLULAR AND HUMORAL IMMUNE FUNCTION TO INCREASE THE PROTECTIVE
IMMUNE RESPONSE TO HIV INFECTION (RFP) ....................(161/199)......... 2
National Cancer Institute
Index: CANCER
REAGENTS AND/OR SERVICES FOR AIDS VACCINE RESEARCH (RFP) ..(202/249)......... 2
National Cancer Institute
Index: CANCER
STUDIES USING PRIMATES AND OTHER ANIMALS FOR AIDS VACCINE RESEARCH (RFP) .... 3
National Cancer Institute (252/309)
Index: CANCER
NATIONAL CANCER INSTITUTE COOPERATIVE HUMAN TISSUE NETWORK (RFA) ............ 4
National Cancer Institute (321/404, 724/1219)
Index: CANCER
ONGOING PROGRAM ANNOUNCEMENTS
NUTRITION RESEARCH AND ORAL HEALTH .........................(410/552)........ 5
National Institute of Dental Research
Index: DENTAL RESEARCH
NEUROSCIENCE RESEARCH ON DRUG ABUSE ........................(561/709)........ 7
National Institute on Drug Abuse
Index: DRUG ABUSE
NOTICES
NEI INSTITUTIONAL TRAINING GRANTS
P.T. 44; K.W. 0720005, 1014002
National Eye Institute
The National Eye Institute has recently revised its supplemental instructions
for institutional National Research Service Award applications. NEI has only
one receipt date for these applications: January 10 of each year.
Investigators are strongly encouraged to obtain a copy of these revised
instructions before submitting applications for the January 10, 1990 receipt
date. Please contact:
Ralph J. Helmsen, Ph.D.
Research Training and Resources Officer
National Eye Institute
National Institutes of Health
Building 31, Room 6A46
Bethesda, Maryland 20892
Telephone: (301) 496-5884
DATED ANNOUNCEMENTS (RFPs AND RFAs)
LARGE BOWEL ADENOMATOUS POLYP DIETARY INTERVENTION STUDY--CLINICAL CENTERS
RFP AVAILABLE: NCI-CN-05220-20
P.T. 04; K.W. 0715035, 0705025, 0710095, 0755015
National Cancer Institute
The National Cancer Institute, Division of Cancer Prevention and Control, is
soliciting proposals for clinical centers to conduct a large bowel adenomatous
polyp dietary intervention study. This multi-center randomized controlled
intervention study will examine the effect of a low-fat, high-fiber, vegetable
and fruit-enriched diet on the recurrence of adenomatous polyps of the large
bowel. It is expected that an individual offeror will randomize participants
at a minimum rate of 7 per month, or 170 participants over the two-year
randomization period. General requirements include identification and accrual
of eligible participants, nutritional education and counselling, participant
follow-up and endpoint assessment. Intermediate endpoint specimens will be
collected. Data maintenance and reporting quality control systems will be
supported. A separate Request for Proposals (RFP) will be issued for a data
and nutrition coordinating center.
Date of issuance of the RFP will be approximately October 26, 1989, with a
closing date for receipt of proposals to be approximately January 4, 1990.
The Institute plans to award up to 12 contracts from this solicitation.
Copies of RFP No. NCI-CN-05220-20 may be obtained by sending a WRITTEN request
to:
Mr. Charles E. Lerner, Contract Specialist
National Institutes of Health
National Cancer Institute
Research Contracts Branch, PCCS
Executive Plaza South, Room 635
Bethesda, Maryland 20892
Telephone: (301) 496-8603
Vol. 18, No. 38, October 27, 1989 - Page 1
SUPPORT FOR "EMERGING TECHNOLOGY": STUDIES ON THE AUGMENTATION OF CELLULAR
AND HUMORAL IMMUNE FUNCTION TO INCREASE THE PROTECTIVE IMMUNE RESPONSE TO HIV
INFECTION
MASTER AGREEMENT ANNOUNCEMENT AVAILABLE: NCI-CP-95666-45
P.T. 34; K.W. 0745045, 0715008, 0760080, 0740023
National Cancer Institute
The National Cancer Institute, Division of Cancer Etiology is soliciting
proposals from offerors with the capability to conduct Studies on the
Augmentation of Cellular and Humoral Immune Function to Increase the
Protective Immune Response to HIV Infection. The successful offeror must be
able to develop procedures for immune therapy in HIV-infected human subjects
with purified HIV proteins and/or recombinant vector expressing HIV proteins.
The offeror must obtain consent and human subject protection certification;
furnish information on protocols used and results obtained; and provide
samples or serum and/or cells from the immunized subjects to NCI upon request.
It is anticipated that a Master Agreement Award will be made FOR A PERIOD OF
FORTY-EIGHT (48) MONTHS. MASTER AGREEMENTS CONSIST OF A POOL OF PREQUALIFIED
OFFERORS. After award, groups of Master Agreement holders will be invited to
propose competitively on Master Agreement Orders that will be designed to
accomplish a specific task to be designated by the Government.
Master Agreement announcement No. NCI-CP-95666-45 for the task described above
will be available to interested offerors on approximately October 21, 1989.
Responses will be due approximately 30 days after the publication date of this
announcement. Copies of this RFP may be obtained by sending a written request
to:
Opal J. Bailey
Contract Specialist
Cancer Etiology Contract Section, Research Contracts Branch
National Cancer Institute
Executive Plaza South, Room 620
Bethesda, Maryland 20892
REAGENTS AND/OR SERVICES FOR AIDS VACCINE RESEARCH
MASTER AGREEMENT ANNOUNCEMENT AVAILABLE: NCI-CP-95664-45
P.T. 34; K.W. 0715008, 0740075, 0780005, 0755041, 0755045, 0760060
National Cancer Institute
The National Cancer Institute, Division of Cancer Etiology, is soliciting
proposals from offerors with the capability to conduct Studies on Tasks A
through H listed below or on any combination thereof. Separate, complete
proposals are required for each task.
Task A: Protein Purification; Immunological Services, and
Virus Detection and Isolation.
Task B: Virus Production.
Task C: DNA Sequencing.
Task D: Molecular Cloning; Production of Recombinant HIV,
SIV, and/or EIAV proteins; Production of recombinant
vaccinia virus.
Task E: Peptide Synthesis.
Task F: Immunological Assays and Virus Characterization.
Task G: PCR Analysis.
Task H: Pathology.
It is anticipated that a Master Agreement Award will be made for a period of
forty-eight (48) months. Master Agreements consist of a pool of prequalified
offerors. After award, groups of Master Agreement holders will be invited to
propose competitively on Master Agreement Orders that will be designed to
accomplish a specific task designated by the Government.
Master Agreement announcement No. NCI-CP-95664-45 for the tasks described
above will be available to interested offerors approximately October 21, 1989.
Responses will be due approximately 30 days after the publication date of this
announcement.
Vol. 18, No. 38, October 27, 1989 - Page 2
Copies of the RFP may be obtained by sending a written request to:
Opal J. Bailey
Contract Specialist
Cancer Etiology Section
Research Contracts Branch
National Cancer Institute
Executive Plaza South, Room 620
Bethesda, Maryland 20892
STUDIES USING PRIMATES AND OTHER ANIMALS FOR AIDS VACCINE RESEARCH
MASTER AGREEMENT ANNOUNCEMENT AVAILABLE: NCI-CP-95665-45
P.T. 34; K.W. 0715008, 0740075, 1002002
National Cancer Institute
The National Cancer Institute, Division of Cancer Etiology, is soliciting
proposals from offerors with the capability to conduct Task A, B, C-1, C-2 or
any combination listed below. Separate proposals are required for each task
or subtask.
Task A: Provide non-human primates and, housing, care and health surveillance
for these primates; immunize primates with SIV, HV-1 or HV-2 vaccines (to be
provided by NCI); infect primates with HIV or SIV vaccines and assess the
status of these immunized and infected primates; and conduct other
experiments.
Task B: Provide, house, and care for severe combined immunodeficient (SCID)
mice; reconstitute these animals with human tissue to obtain lymhpoid and/or
cells which can be infected with HIV in the mice; develop methods to
reconstitute the mice with human immune cells; evaluate various antibodies;
and, if suitable systems are developed, conduct immunization in the human-SCID
mice and assess the response.
Task C-1: Provide other animals and house and care for them; infect animals
with virus; determine the immune response; and re-isolate virus from tissues
of infected animals.
Task C-2: Provide animals for immunogenicity studies; house and care for
these animals; immunize these animals, immunize these animals with candidate
vaccines; and provide NCI with sera and cells from immunized animals.
The offeror's facilities must conform to the standards for animal care
outlined in the Guide for care and Use of Laboratory Animals as published in
the DHHS publication Number (NIH 85-23) or superseding editions.
It is anticipated that a Master Agreement Award will be made for a period of
forty-eight (48) months. Master Agreements consist of a pool of prequalified
offerors. After award, groups of Master Agreement holders will be invited to
propose competitively on Master Agreement Orders that will be designed to
accomplish a specific task to be designated by the Government.
Master Agreement Announcement No. NCI-95665 for the tasks described above will
be available to interested offerors on approximately October 21, 1989.
Responses will be due approximately 30 days after the publication date of this
announcement.
Copies of the RFP may be obtained by sending a written request to:
Opal J. Bailey
Contract Specialist
Cancer Etiology Section
Research Contracts Branch
National Cancer Institute
Executive Plaza South, Room 620
Bethesda, Maryland 20850
Vol. 18, No. 38, October 27, 1989 - Page 3
NATIONAL CANCER INSTITUTE COOPERATIVE HUMAN TISSUE NETWORK
RFA AVAILABLE: 90-CA-01
P.T. 34, FF, II; K.W. 0780000, 0780020, 0715035
National Cancer Institute
Letter of Intent Receipt Date: January 12, 1990
Application Receipt Date: April 25, 1990
The Diagnosis Research Program of the Division of Cancer Biology and Diagnosis
at the National Cancer Institute (NCI) invites applications for Cooperative
Agreements from institutions capable of and interested in participating in The
Cooperative Human Tissue Network. The purpose of this established network is
to collect and distribute human tumor tissue and normal tissue to stimulate
research. The Network was developed in response to a growing need by
researchers for improved access to human tumor tissue. Basic and
developmental studies in many areas of cancer research, including molecular
biology, immunology and genetics, have been encouraged by improved access to
tissue. Hundreds of investigators have taken advantage of the existence of
the Network and thousands of tissues have been distributed since the inception
of the Network in January 1987. The NCI plans expand the Network from three
institutions to four or five institutions.
The existing Network has already demonstrated the feasibility of the network
approach and the continuing need of researchers for access to human materials.
Systems have been developed that allow efficient communication among
laboratories regarding tissue requests and availability. The Network is not a
tissue bank, but rather responds to investigator requests to meet existing
tissue requirements on a current basis. Applicants may plan for limited
storage of rare tumors that would otherwise not be available. Special
consideration will be given to ensuring access to and nationwide distribution
of rare pediatric tumor specimens.
Awards will be made as cooperative agreements which create an assistance
relationship with substantial involvement of NCI staff during the performance
of the project, as outlined in this request for applications (RFA). This
mechanism is used when the NCI wishes to stimulate investigator interest and
proposes to advise or assist in an important and opportune area of research.
The NCI anticipates making four or five awards for project periods of five
years. Although this project is provided for in the financial plans of the
NCI, the award of cooperative agreements pursuant to the RFA is contingent on
the availability of funds appropriated in fiscal year 1991.
Inclusion of women and minorities are encouraged. If they are excluded,
reasons for this exclusion must be included in the application.
This RFA is a one-time solicitation with a specified deadline of April 25,
1990, for receipt of applications.
The RFA label available in the 10/88 revision of Application Form 398 must be
affixed to the bottom of the face page. Failure to use this label could
result in delayed processing of your application such that it may not reach
the review committee in time for review. In addition, the RFA number and
title should be typed on line 2 of the face page of the application form.
A copy of the complete RFA describing eligibility criteria, the research goals
and scope, the cooperative agreement mechanism, the review criteria and the
method of applying should be obtained before beginning the application
process. Copies of the complete RFA can be obtained from:
Roger L. Aamodt Ph.D.
Program Director for Pathology and Cytology
Diagnosis Program
Division of Cancer Biology and Diagnosis
National Cancer Institute
Executive Plaza South, Room 638
6120 Executive Boulevard
Rockville, Maryland 20892
Telephone: (301) 496-7147
Inquiries concerning this RFA are encouraged and should be directed to Dr.
Aamodt at the address or telephone number listed above.
This program is described in the catalog of Federal Domestic Assistance no
13.394, Cancer Detection and Diagnosis Research. Awards are under
authorization of the Public Health Service Act, Title IV, Part A (Public Law
Vol. 18, No. 38, October 27, 1989 - Page 4
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.
ONGOING PROGRAM ANNOUNCEMENTS
NUTRITION RESEARCH AND ORAL HEALTH
P.T. 34; K.W. 0710095, 0715148, 0755020, 0785055, 0710030
National Institute of Dental Research
The National Institute of Dental Research (NIDR) encourages submission of high
quality applications for the support of research and research training on the
influence of diet and nutrition on oral health and disease, salivary gland
function, craniofacial development, osteoporosis as related to craniofacial
structures, and wound healing in order to expand its activities in these and
other related areas. Appropriate studies might encompass basic research,
development of animal models, epidemiological studies, and clinical studies of
special population groups, including the aged and minorities and those in
foreign countries which present special research opportunities.
BACKGROUND
The oral cavity and associated structures are the sites of disease (e.g.,
dental caries, periodontal disease, herpes, salivary gland disorders, oral
cancer) and congenital anomalies (such as cleft lip and palate) that may
relate to nutritional status. It is also evident that nutrients interact with
physiologic systems in the oral cavity such as host and microbial cell
replication mechanisms, host cell repair mechanisms and immune response
mechanisms in such a manner as to increase or decrease the risk of disease and
influence tissue development. Thus, the oral tissues and associated
structures constitute a major site of interactions between nutritional factors
and physiological systems, a relationship that makes oral health no less
vulnerable to the effects of nutrition than general health.
Expansion of the NIDR Nutrition Research Program was recommended by expert
panels on Long-Range Research Plans for the 1990's, at a recent Workshop on
International Collaboration for Oral Research, and by the Dental Research
Programs Advisory Committee (PAC) at its November 1988 meeting. The PAC
recommended the issuance of a Program Announcement to encourage the needed
research and training in this area.
RESEARCH GOALS
The objective of this announcement is to solicit applications for research
grants and individual research training to elucidate the role of diet and
nutrition in the development and maintenance of oral and craniofacial tissues
and in the prevention of oral diseases. Projects concerning nutrition and
oral health and disease as related to minorities, women, and the elderly and
to populations in developing countries which present special research
opportunities (via international collaboration) are
encouraged. Examples of research projects are:
o Influence of nutrient-drug interactions on specific salivary gland
structure and functions in the elderly.
o Relationship between nutrient intake during critical periods of
gestation and susceptibility to craniofacial anomalies.
o Effect of malnutrition on abnormal tooth development or on
osteoporosis of the jaw bone.
o Effect of sugar substitutes and food additives on the physiology of
cariogenic bacteria and on dental caries.
o Bioavailability and mineralized tissue effects of fluoride in
nutritionally compromised individuals.
o Preventive role of antioxidant nutrients in diseases of the
periodontium or of the oral mucosa.
The above list is not intended to describe the full range of possible
activities to be supported nor to direct applicants to these areas. Applicant
institutions are encouraged to focus on their areas of greatest strength.
Vol. 18, No. 38, October 27, 1989 - Page 5
The announcement is also intended to: encourage increased collaboration among
the various disciplines of dental research involving nutrition and among basic
and clinical scientists; encourage training of basic and clinical research
scientists in oral nutrition; and expedite the translation of advances in
nutrition/oral biology research into new and improved methods for patient
care.
MECHANISMS OF SUPPORT
Support for this program will be through regular research project grants
(R01), program project grants (P01), small grants (R03), FIRST awards (R29),
AREA awards (R15), career development awards (K04, K11, K15), and postdoctoral
fellowships (F32, F33). Receipt dates and policies that govern research grant
programs of the National Institutes of Health will prevail.
APPLICATION AND REVIEW PROCEDURES
Applications in response to this announcement will be reviewed on a nationwide
basis in competition with other applications and in accordance with NIH peer
review procedures. Review criteria include: the significance and originality
of the research goals and approaches; feasibility of the research and adequacy
of the experimental design; training, experience, research competence, and
dedication of the investigator(s); adequacy of available facilities and
availability of appropriate study populations; provisions for the protection
of human subjects and humane care of animals; and appropriateness of the
requested budget relative to the work proposed. Applicants are encouraged to
include women and minorities in clinical and epidemiological studies. For
studies which exclude women or minorities, a clear rationale for exclusion
should be provided.
Funding decisions will be based on the Study Section's and the National
Advisory Council's recommendations regarding scientific merit and program
relevance, and on the availability of appropriated funds.
Inquiries concerning this announcement should be addressed to Dr. Joseph E.
Ciardi at the address given below. The specific application forms and kits
required to respond to this announcement are available from the institution's
Office of Research and Sponsored Programs or from the Division of Research
Grants, NIH. Applications will be accepted on an indefinite basis in
accordance with the receipt dates specified in the pertinent application kits.
The phrase "NIDR PA: NUTRITION RESEARCH AND ORAL HEALTH" should be typed on
line 2 of the face page of the application form PHS 398 (rev. 10/88) or on
line 3 of the fellowship application form PHS 416 (rev. 7/88). The original
and six copies should be sent or delivered to:
Grants Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, Maryland 20892-4500**
For further information concerning this announcement and the mechanisms of
support for research and training available in this connection, applicants are
encouraged to contact:
Joseph E. Ciardi, Ph.D.
Program Administrator
Caries, Restorative Materials
and Salivary Research Branch
Extramural Program
National Institute of Dental Research
Westwood Building, Room 505
Bethesda, Maryland 20892-4500
Telephone: (301) 496-7884
This program is described in the Catalog of Federal Domestic Assistance No.
13.121, Diseases of the Teeth and Supporting Tissues. Awards will be made
under authorization of the Public Health Service Act, Title III, Section 301
(Public Law 78-410, as amended; 42 USC 241); and administered under PHS grants
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This
program is not subject to the intergovernmental review.
Vol. 18, No. 38, October 27, 1989 - Page 6
NEUROSCIENCE RESEARCH ON DRUG ABUSE
P.T. 34; K.W. 1002030, 0404009, 0705055, 0760075, 0414005, 0404000, 0785115
National Institute on Drug Abuse
This Program Announcement was published in the NIH Guide for Grants
and Contracts on October 20, 1989, Vol. 18, No. 37, however, it was
inadvertently omitted in the Table of Contents. The Announcement is
being repeated in its entirety.
PURPOSE
The purpose of this announcement is to encourage and stimulate investigator
interest in broad areas of neuroscience research relevant to the problem of
drug abuse. Many research tools are now available to allow for major advances
in understanding the neurobiology of drug abuse to determine the effects of
drugs on the structure and function of the nervous system. These include new
histochemical and autoradiographic procedures, light and electron microscopic
analysis, imaging and analytic techniques applicable to living tissue (e.g.,
PET, MRI), and various neurophysiological and neuropharmacological techniques,
especially those monitoring neural processes during ongoing behavior (e.g.,
single-cell electrophysiology, in vivo microdialysis and voltammetry, evoked
potentials, EEG). As a final part of this initiative, The National Institute
on Drug Abuse (NIDA) expects that an increased understanding of the
relationship between brain anatomy, physiology, and pharmacology and drug
abuse behaviors will increase the capacity to design appropriate therapeutic
pharmaceuticals void of abuse liability and its consequences, and develop drug
therapies for correcting neurochemical imbalances created by the abuse of
drugs. Additionally, investigations into the neural basis of drug seeking
should identify those neurobiological factors that make an individual
vulnerable to the abuse of drugs.
RESEARCH OBJECTIVES
The neuroscience program of the NIDA's Division of Preclinical Research
encourages investigations into the basic mechanisms underlying the action of
abused drugs and substances on the central nervous system as well as research
leading to the development of drugs that potentially may be used on the
relationship between drug-receptor interactions or neurochemical alterations
and consequences of drug usage in terms of behavioral processes is
specifically encouraged. Areas of particular interest include the following:
(1) Brain Reward Mechanisms in Drug Abuse
(2) Neuropsychopharmacology of Abused Drugs
(3) Anabolic Steroid Abuse
(4) Drug-Induced Neurotoxicity
(6) Developmental Neurobiology
(7) Drug Effects on Cognitive Processes
(8) Drug Effects on Sensory Processes
(9) Blood-Brain Barrier Studies
(l0) Clinical Neuroscience
Support can be obtained in the form of R01 (Research Project Grants), R03
(Small Grants), R13 (Research Conference Grants), and R29 (First Independent
Research Support and Transition Awards).
NIMH and various NIH Institutes have specific programs in the neurosciences.
Grant applications will be assigned to the appropriate Institute based upon
existing programmatic guidelines.
ELIGIBILITY
Applications may be submitted by public or private nonprofit or for-profit
organizations such as universities, colleges, hospitals, laboratories, units
of State or local governments, and eligible agencies of the Federal
government. Women and minority investigators are encouraged to apply.
APPLICATION PROCEDURES AND RECEIPT SCHEDULE
State and local government agencies may use form PHS 5161-1 (rev. 11/88).
All other applicants should use the research grant application from PHS 398
(rev. 10/88). The title of this announcement "NEUROSCIENCE RESEARCH ON DRUG
ABUSE" should be typed in item number 2 on the face page of the PHS 398
application form or in item 9 on the PHS 5161-1.
Application kits containing the necessary forms and instructions may be
obtained from business offices or offices of sponsored research at most
Vol. 18, No. 38, October 27, 1989 - Page 7
universities, colleges, medical schools, and other major research facilities.
If such a source is not available, the following office may be contacted for
the necessary application material: Grants Management Branch, NIDA, Parklawn
Building, Room 10-25, 5600 Fishers Lane, Rockville, Maryland 20857.
Applications received under this announcement will be assigned to an initial
review group (IRG) in accordance with established PHS Referral Guidelines.
The IRGs, consisting primarily of non-Federal scientific and technical
experts, will review the applications for scientific and technical merit.
Notification of the review recommendations will be sent to the applicant after
the initial review.
Applications will receive a second-level review by an appropriate National
Advisory Council whose review may be based on policy as well as scientific
merit considerations. Only applications recommended for approval by the
advisory council may be considered for funding.
The signed original and six (6) permanent, legible copies of the completed
application (original and two copies, if using PHS 5161-1) should be sent to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, Maryland 20892**
Receipt of Initial Advisory Council Earliest
Applications Review Review Start Date
February 1 June/July Sept/Oct December 1
June 1 Oct/Nov Jan/Feb April 1
October 1 Feb/March May/June July 1
Applications submitted in response to this Announcement are not subject to the
intergovernment review requirements of Executive Order 12372, as implemented
through Department of Health and Human Services regulations at 45 CFR Part 100
and are not subject to Health Systems Agency review.
REVIEW CRITERIA
Criteria for scientific/technical merit review of regular research grant
applications will include the following: significance and originality from a
scientific and technical standpoint of the goals of the proposed research;
adequacy of the methodology proposed to carry out the research; qualifications
of the Principal Investigator and other key research personnel; availability
of adequate facilities, other resources, and collaborative arrangements
necessary for the research, appropriateness of budget estimates for the
proposed research activities, and adequacy of provisions for the protection of
human subjects and welfare of animals subjects as applicable.
FURTHER INFORMATION
Further information and consultation on program requirements relevant to
neuroscience research inquiries can be obtained from:
Dr. Roger Brown
Neuroscience Research Branch
National Institute on Drug Abuse
Parklawn Building, Room 10A-31
5600 Fishers Lane
Rockville, Maryland 20857
Telephone: (301) 443-6975
FOOTNOTE: This program is described in the catalog of Federal Domestic
Assistance No. 13.279. Grants will be awarded under the authority of Section
301 of the Public Health Service Act, as amended (42 USC 241) and administered
in accordance with the PHS Grants Policy Statement and Federal regulations at
42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE
CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO
USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S
REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD
BUILDING IS: 5333 Westbard Avenue
Bethesda, Maryland 20816kristoff@NET.BIO.NET (Dave Kristofferson) (10/28/89)
Vol. 18, No. 38, October 27, 1989 - Page 8
FULL TEXT OF RFAs FOR ONLINE ACCESS
REQUEST FOR APPLICATIONS FOR COOPERATIVE AGREEMENT: RFA
90-CA-01
NATIONAL CANCER INSTITUTE COOPERATIVE HUMAN TISSUE NETWORK
P.T. 34, FF, II; K.W. 0780000, 0780020, 0715035
National Cancer Institute
Application Receipt Date: April 25, 1990
Letter of Intent Receipt date: January 12, 1990
INTRODUCTION:
The Diagnosis Research Program of the Division of Cancer
Biology and Diagnosis at the National Cancer Institute (NCI)
invites applications for Cooperative Agreements from
institutions capable of and interested in participating in
The Cooperative Human Tissue Network. The purpose of this
established network is to collect and distribute human tumor
tissue and normal tissue to stimulate research. The Network
was developed in response to a growing need by researchers
for improved access to human tumor tissue. Basic and
developmental studies in many areas of cancer research,
including molecular biology, immunology and genetics, have
been encouraged by improved access to tissue. Hundreds of
investigators have taken advantage of the existence of the
Network and thousands of tissue specimens have been distributed since
the inception of the Network in January 1987.
Awards will be made as cooperative agreements which create
an assistance relationship with substantial involvement of
NCI staff during the performance of the project, as outlined
in this request for applications (RFA). This mechanism is
used when the NCI wishes to stimulate investigator interest
and proposes to advise or assist in an important and
opportune area of research. The NCI anticipates making four
or five awards for project periods of five years.
Although this project is
provided for in the financial plans of the NCI, the award of
cooperative agreements pursuant to the RFA is contingent on
the availability of funds appropriated in fiscal year 1991.
CONTENTS
A. Background Information
B. Research Goals and Scope
C. Mechanism of Support - Cooperative Agreement
D. Terms of Award
1. Program Staff Involvement
2. Responsibilities of Awardees
a. Organization and Role of the Coordinating Committee
3. Eligibility Requirements
4. Arbitration procedures
E. Eligibility Requirements
F. Special Instructions for Preparation of Cooperative
Agreement Applications
G. Review Procedures and Criteria
H. Application
I. Letter of Intent
J. Inquiries
A. BACKGROUND:
Advances in molecular biology and genetics have opened new
possibilities for understanding basic mechanisms in cancer
development, invasion and metastasis. This understanding
has led to new and more effective approaches to improve
diagnostic accuracy, to make prognostic and therapeutic
decisions, to more effectively monitor response to therapy,
to detect cancer at earlier stages and to identify high-risk
populations. Since animal models are not always appropriate
for this type of research, demand for human tissue has
increased greatly. The Cancer Diagnosis Branch of the
Division of Cancer Biology and Diagnosis of the NCI became
aware of the need for tissue by the scientific community.
Recommendations of an ad hoc working group provided the
basis for development of the Cooperative Human Tissue
Network (CHTN).
Careful attention to its
handling and to the quality of tissue diagnosis is required
for human tissue to have value for research. The CHTN
was established January 1987 in response to an NCI request
for applications (RFA). The original concept for the CHTN
called for the development of a cooperative network of
tissue procurement laboratories working closely with the NCI
to provide tumor and normal tissue to investigators in the
major biomedical research centers throughout the United
States. Since its creation, the CHTN has become a vital
part of the resources used by the cancer research community.
The CHTN has experienced rapid growth and has provided
thousands of specimens to hundreds of researchers.
B. RESEARCH GOALS AND SCOPE
The objective of this RFA is to continue support for a
network of laboratories capable of providing improved access
to adequately prepared and well documented human tumor and
normal tissue. An important aspect of this project is the
continuation and expansion of a model distribution network
to stimulate efforts in this area. The existing Network has
already demonstrated the feasibility of the network approach
and the continuing need of researchers for access to human
materials. Systems have been developed that allow efficient
communication among laboratories regarding tissue requests
and availability. The Network is not a tissue bank, but
rather responds to investigator requests to meet existing
tissue requirements on a current basis. Applicants may plan
for limited storage of rare tumors that would otherwise not
be available. Special consideration will be given to
ensuring access to and distribution of pediatric tumor
specimens throughout the United States. The investigators
in the Network will be responsible for future planning and
direction of the program, building on previous efforts. NCI
staff will assist in setting priorities and in evaluating
progress to ensure that the Network conforms to the
objectives and conditions of the award. It is anticipated
that each of the laboratories funded under this program will
propose specific procedures for collecting and processing
tissue and will have established the organizational
structure required for its operation.
The Coordinating Committee oversees the operation of the
Network and resolves problems affecting the Network, while
the NCI representative provides advice and functions as
liaison between the participating laboratories during the
intervals between meetings of the Coordinating Committee.
C. MECHANISM OF SUPPORT - COOPERATIVE AGREEMENT
Support of this program will be through the Cooperative
Agreement, an assistance mechanism in which substantial NCI
programmatic involvement with the recipients is anticipated
during performance of the planned activity, as outlined in
this RFA. Applicants will be responsible for the planning,
direction and execution of the proposed project. Except as
otherwise stated in the RFA, awards will be administered
under PHS grants policy as stated in the Public Health
Service Grants Policy Statement, DHHS Publication No.
(OASH)) 82-50,000, revised January 1987.
This RFA is a one-time solicitation. Generally future
unsolicited competing continuation applications will compete
as research project applications with all other investigator
initiated applications and be reviewed by the Division of
Research Grants (DRG). However, should the NCI determine
that there is a sufficient continuing program need, the NCI
will invite recipients of awards under this RFA to submit
competing continuation cooperative agreement applications
for review according to the procedures described in Section
G.
NCI anticipates making 4 to 5 awards for project periods of
up to 5 years.
Funding in response to this RFA
is dependent on the receipt of a sufficient number of
applications of high scientific merit. The earliest
feasible start date for the initial awards will be 12/1/90.
Although this program is provided for in the financial plans
of the NCI, the award of cooperative agreements pursuant to
this RFA is contingent on the availability of funds
appropriated for fiscal year 1991.
The purpose of the proposed awards is to enhance and expand
the availability to the research community of human tissue.
The cooperative agreement funding mechanism was selected
because substantial NCI programmatic involvement is required
to assist in facilitating the activities of several
laboratories working toward a common goal.
D. TERMS OF AWARD
The Cooperative Agreements will require cooperation between
an NCI representative and the principal investigators of the
individual projects in order to assure smooth interactions
among the cooperating institutions. The NCI representative
will assist by coordinating the activities of the research
groups, and by facilitating exchange of information.
1. Organization and Role of the Coordinating Committee
The NCI and the participating research groups will be
responsible for forming a Coordinating Committee as defined
below. Operating policies will be developed by the
Coordinating Committee and submitted to the NCI
representative for concurrence prior to implementation. NCI
will facilitate the review of operating policies. Results
of the NCI review will be discussed with the Coordinating
Committee and an arbitration system, as detailed below, will
be available to resolve disagreements between investigators
and NCI staff.
Under the cooperative agreement mechanism, awardees are
responsible for planning and carrying out all aspects of the
project and for publishing results as appropriate. The
Coordinating Committee will review the operating procedures
proposed by the individual research groups to insure that
they are compatible with the overall goals of the RFA; will
establish publication guidelines; will develop uniform
procedures for tissue acquisition, processing, distribution
and storage; will develop uniform methods of
histopathological diagnosis, and will assure appropriate
control of tissue quality.
The Coordinating Committee will consist of 2 members from
each cooperating institution, one of whom is the principal
investigator. The NCI representative will be appointed by
the Chief of the Cancer Diagnosis Branch, Division of Cancer
Biology and Diagnosis. The Coordinating Committee will be
responsible for electing a chairperson (who may not be the
NCI representative). This can be a rotating position. The
Chairperson of the Coordinating Committee will be
responsible for coordinating the Committee activities, for
preparing meeting agendas, and for scheduling and chairing
meetings. The NCI representative will attend and
participate in all meetings of the Coordinating Committee
and should be informed of major inter-group interactions.
The Coordinating Committee will prepare an annual progress
report which will include individual reports from each
participating research group; each group is responsible for
timely preparation of its report.
The Coordinating Committee will meet initially to plan for
integration of new cooperating institutions and phaseout, if
necessary, of previous institutions and will review basic
operating procedures and policies. The Coordinating
Committee will meet at least twice a year thereafter. These
meetings are aimed at coordinating the activities of the
participating laboratories, establishing new policies and
priorities, and reviewing progress. The NCI representative
shall participate in the discussions at these meetings.
Travel funds for Coordinating Committee meetings are to be
set aside as a budget line item in each project budget.
2. ROLE OF NCI REPRESENTATIVE
The NCI representative will coordinate and facilitate the
programs supported by these Cooperative Agreements, will
attend and participate in all meetings of the Coordinating
Committee, and will provide liaison between the Coordinating
Committee and participating research groups. The NCI
representative will assist the Coordinating Committee in
developing operating policies, quality control procedures
and consistent policies for dealing with recurring
situations that require coordinated action. To assure
consistency and quality, NCI must concur in operating
policies and procedures prior to their implementation. The
NCI Representative may review the operations of individual
laboratories for compliance with quality control standards
and with operating policies developed by the Coordinating
Committee. The NCI representative may recommend withholding
of support, suspension or termination of an award for lack
of progress or failure to adhere to policies established by
the Coordinating Committee.
3. RESPONSIBILITIES OF AWARDEES
The principal investigator (PI) of a Cooperative Human
Tissue Network laboratory should be an experienced surgical
pathologist with demonstrated research experience in an area
related to cancer. The PI should also be actively
involved in the operation of a pathology laboratory with
demonstrated access to a wide range of human cancer tissues.
Two members of each research group are required to attend
meetings of the Committee (as detailed above), to help
formulate the Committee's policies (which will be submitted
to the NCI for approval), and to implement those policies.
Awardees are required to have access to appropriate tumor
tissue and normal tissue. They are required to submit
progress reports at each meeting of the Coordinating
Committee.
Inclusion of women and minorities are encouraged. If they are
excluded, reasons for this exclusion must be included in the
application.
4. ARBITRATION PROCEDURES
An arbitration panel of external consultants will be created
as needed to resolve any irreconcilable differences of
opinion between the NCI and the Coordinating Committee with
respect to implementation of a proposed operating policy.
The panel will include one member selected by the
Coordinating Committee, one member selected by the NCI, and
a third member chosen by the other two members of the
arbitration panel. The NCI arbitration process for the
Cooperative Agreement in no way affects the rights of
awardees to appeal selected postaward administrative
decisions in accordance with PHS regulations at 42 CFR part
50, subpart D and HHS regulations at 45 CFR part 16.
E. ELIGIBILITY REQUIREMENTS
Eligibility requirements include those listed under
"Responsibilities of Awardees" in Section D.3. In addition,
applicant organizations should be located in the United
States. Non-profit organizations and institutions,
for-profit organizations and
government agencies are eligible to apply.
F. SPECIAL INSTRUCTIONS FOR PREPARATION OF COOPERATIVE
AGREEMENT APPLICATIONS
General instructions for the preparation of the Cooperative
Agreement application are contained in the Grant Application
Form PHS 398 (revised 10/88).
Because the Terms of Award in Section D above will be
included in all awards issued as a result of the RFA, it is
critical that each applicant include specific plans for
responding to these terms. Plans should document that the
PI is a surgical pathologist and describe the applicant's
approaches to tissue collection, preparation and
distribution; histopathologic diagnosis; and coordination of
data collection and analysis. They should describe how they
will comply with NCI Program Staff involvement and how they
will fulfill their responsibilities in the Cooperative
Agreement. Detailed individual plans should be proposed in
order to provide the Coordinating Committee with a basis for
selecting the final operating procedures. For competing
continuation applications, a complete description of past
cooperative efforts is also required as part of the progress
report.
G. REVIEW PROCEDURES AND CRITERIA
REVIEW PROCEDURES
Upon receipt, applications will be reviewed initially by the
Division of Research Grants 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 will be
performed by NCI program. Applications judged to be
nonresponsive to this RFA will be returned but may be
submitted as regular investigator-initiated research grant
applications at the next grant application receipt date.
If the number of applications is large compared
to the number of awards to be made, the NCI may conduct a
preliminary scientific peer review to eliminate those which
clearly are not competitive for award. The NCI will remove
from competition those applications judged to be
noncompetitive and notify the applicant and institutional
business official. Those applications judged to be both
competitive and responsive will be further evaluated
according to the review criteria stated below for scientific
and technical merit by an appropriate peer review group
convened by the Division of Extramural Activities, NCI. The
second level of review by the National Cancer Advisory Board
considers the special needs of the Institute and the
priorities of the National Cancer Program.
REVIEW CRITERIA
Factors considered to be important for review include
demonstrated expertise in pathology and tissue preparation
techniques; availability of a variety of cancer and normal
tissues; good interaction among collaborating institutions
and clinicians; adequate facilities; and willingness to
interact within the terms of a Cooperative Agreement as
outlined in this document.
Reviewers will be asked to review the grant applications by
considering the following criteria:
1) Appropriateness and relevance of the proposed project to
the overall goals and objectives of the RFA.
2) Qualifications, experience and proposed responsibilities
of the principal investigators and key support
personnel.
3) Scientific merit and organizational plans for
implementing the proposed program.
4) Demonstration of availability of and access to
appropriate tissue from a wide variety of cancer sites
and related control tissue and to appropriate clinical
data.
5) Proposed collaborations with surgeons and other key
personnel within the applicant and collaborating
institutions.
6) Facilities and resources, and their availability for
this project.
7) Plans for effective interaction and coordination among
cooperating projects and with the NCI.
8) Plans to protect the rights of human subjects.
The review group will recommend an appropriate budget and
period of support for each application.
H. APPLICATION
Complete applications are due no later than April 25, 1990,
and must address all requirements in the RFA. Applications
received after this date will not be accepted. Also, the
Division of Research Grants will not accept any application
in response to this announcement that is the same as one
currently being considered by any other review group or NIH
awarding unit. Applications should be as concise as
possible.
The regular research grant application form PHS 398
(Revised 10/88) must be used in applying for these grants.
These forms are available at most institutional business
offices or from:
Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
Room 449, Westwood Building
5333 Westbard Avenue
Bethesda, MD 20892
or from the NCI Program Director named below.
The RFA label available in the 10/88 revision of Application
Form 398 must be affixed to the bottom of the face page.
Failure to use this label could result in delayed processing
of your application such that it may not reach the review
committee in time for review. In addition, the RFA number
and title, "NCI COOPERATIVE HUMAN TISSUE NETWORK, 90-CA-01,"
should be typed on line 2 of the face page of the
application form.
You should submit a signed typewritten original of the
application, including the checklist, and four signed exact
photocopies, in one package to:
Division of Research Grants
National Institutes of Health
Room 240, Westwood Building
Bethesda, Maryland 20892-4500**
The photocopies must be clear and single sided.
In addition, two copies should also be sent to:
Referral Officer
Division of Extramural Activities, DEA, NCI
Room 848 Westwood Building
5333 Westbard Avenue
Bethesda, MD 20892
I. LETTER OF INTENT
Prospective applicants are asked to submit, by January 12,
1990, a letter of intent that includes a descriptive title of
the proposed project, the name and address of the principal
investigator, the names of other key personnel, the
collaborating institutions, and the number and title of the
RFA in response to which the application is being submitted.
Although a letter of intent is not required, is not binding
and does not enter into the review of subsequent
applications, the NCI would like to emphasize the benefits
to the applicant of having the principal investigator submit
a letter of intent. The letter of intent allows NCI staff
to estimate the potential review workload and to avoid
possible conflict of interest in the review.
J. INQUIRIES
Written or telephone inquiries concerning the objectives and
scope of the RFA, or inquiries about whether or not specific
proposed research would be responsive, are encouraged and
should be directed to Dr. Roger L. Aamodt at the address
shown below. The program director welcomes the opportunity
to clarify any issues or questions from potential
applicants.
The letter of intent and inquiries should be addressed to:
Roger L. Aamodt Ph.D.
Program Director for Pathology and Cytology
Diagnosis Program
Division of Cancer Biology and Diagnosis
National Cancer Institute
Room 638, Executive Plaza South
6120 Executive Boulevard
Rockville, MD 20892
Tel. No. (301)-496-7147
This program is described in the
catalog of Federal Domestic Assistance no 13.394, Cancer
Detection and Diagnosis Research. Awards are under
authorization of the Public Health Service Act, Title IV,
Part A (Public Law 78-410 as amended: 42 USC 241) and
administered under PHS grant policies and Federal
Regulations 42 CFR Part 52 and 45 CFR Part 74. This program
is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.