Full Text CA-93-028

CLINICAL CORRELATIVE STUDIES IN BREAST TUMORS

NIH GUIDE, Volume 22, Number 20, June 4, 1993

RFA:  CA-93-028

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Clinical Medicine, General 
  Clinical Trial 
  Bioassay 
  Growth Factors 


National Cancer Institute

Letter of Intent Receipt Date:  July 23, 1993
Application Receipt Date:  September 22, 1993

PURPOSE

The Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer
Treatment (DCT) and the Cancer Diagnosis Branch (CDB) of the Division
of Cancer Biology, Diagnosis and Centers (DCDBC) at the National Cancer
Institute (NCI) invite applications for cooperative agreements (U01)
from institutions or consortia, such as DCT Clinical Trials Cooperative
Groups and the NCI Cancer Centers, capable of and interested in
performing clinical correlative studies with new prognostic factors
ready for large scale evaluation.  These factors must be relevant to
the cancer treatment or clinical outcome of patients with breast
cancer.  It is essential for institutions to have access to sufficient
numbers of patients on phase III clinical protocols to be able to test
correlative hypotheses.

Awards will be made as cooperative agreements, which create an
assistance relationship with substantial NCI programmatic involvement
with the recipients during the performance of the project, as outlined
in this RFA.  The cooperative agreement 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.  Although this
project 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 in fiscal year 1994.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Clinical Correlative Studies in Breast Tumors, 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
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202/783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic non-profit and for-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  Applications may be
submitted from a single institution or may include arrangements with
one or more additional institutions, if appropriate.  Applications from
minority individuals and women are encouraged.

It is essential for teams to have access to sufficient numbers of
patients on phase III clinical protocols to be able to test correlative
hypotheses.  The study team must have access to a Central Operations
Office and a Statistical Center for coordination of research activities
and data analysis as defined below (see SPECIAL REQUIREMENTS,
Definitions).  The Central Operations Office and the Statistical Office
need not reside at the Principal Investigator's institution.

MECHANISM OF SUPPORT

Support of this program will be through the Cooperative Agreement
(U01), an assistance mechanism in which substantial NCI programmatic
involvement with the recipient during performance of the planned
activity is anticipated.  The nature of NCI staff involvement is
described in the section entitled SPECIAL REQUIREMENTS, Teams and
Conditions of Award, Nature of Participation by NCI Staff.  Applicants
will be responsible for the planning, direction, and execution of the
proposed project.  The total project period for applications submitted
in response to the present RFA may not exceed four years.  Except as
otherwise stated in this RFA, awards will be administered under PHS
grants policy as stated PHS Grants Policy Statement, DHHS Publication
No. (OASH) 90-50-000, revised October 1, 1990.

It is anticipated that the average amount of the total direct costs per
year for each award will range from $140,000 to $180,000.

This RFA is a one-time solicitation.  However, if it is determined that
there is a sufficient continuing program need, the NCI will invite
recipients of awards under this RFA to submit competitive continuation
cooperative agreement applications for review according to the
procedures described in Review Considerations.

FUNDS AVAILABLE

Approximately $1,000,000 in total costs per year for four years will be
committed to specifically fund applications submitted in response to
this RFA.  It is anticipated that four to five awards will be made.
This funding level is dependent on 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 also contingent upon the continuing
availability of funds for this purpose.

RESEARCH OBJECTIVES

A.  Background

Insights into the biologic function and clinical relevance of growth
factors, genes that promote and suppress neoplasia, mechanisms of
treatment sensitivity and resistance, and functions of the immune
system provide important new clinical research opportunities for
investigators studying patients with solid tumors.  While advances have
been made relating biological studies to clinical behavior of
hematologic malignancies, fewer clinical correlations have been
explored for solid tumors.  Historically, prognostic factors have
played a major role in assisting clinicians in the selection of
appropriate therapeutic interventions.  In the case of breast cancer,
estrogen receptor and progesterone receptor status are now commonly
used as prognostic and treatment indicators.  Currently, several well
defined laboratory tests are ready for inclusion in clinical
correlative studies to determine their clinical relevance and value.
For example, HER-2/neu, cathepsin D and stress response proteins are
currently being evaluated in adjuvant breast cancer studies.  New
technological advances in methodologies such as Polymerase Chain
Reaction (PCR), flow cytometry, immunohistochemistry, and in situ
hybridization allow laboratory investigators to do numerous analyses on
tumor specimens and study tumor heterogeneity in a variety of tumor
types.  Many opportunities exist for conducting correlative laboratory
studies that can be expected to be immediately relevant to cancer
treatment.

The NCI supports an extensive network of clinical and laboratory
research studies related to cancer therapy through contracts, grants
and cooperative agreements.  CTEP supports a program of integrated
national networks of clinical investigators and institutions (Clinical
Trials Cooperative Groups) for the conduct of large scale,
multi-institutional clinical trials.  The primary goal of these trials
is the definitive evaluation of clinical treatment programs.
Presently, the Clinical Trials Cooperative Groups (CTCG) conduct
approximately 500 clinical trials evaluating more than 23,000 patients
per year.  The CTCG have access to tumor specimens from large numbers
of patients with solid tumors.  They maintain statistical databases and
are capable of correlating laboratory data with the clinical outcome of
patients.  The NCI also supports Cancer Centers that conduct phase III
clinical trials and which have access to statistical operations,
headquarters, and consortia arrangements with other institutions and
hospitals.

This RFA is designed to promote collaborations and interactions between
basic researchers and clinical investigators to advance research on
clinical correlations that can improve therapeutic approaches.  NCI is
seeking to encourage correlative laboratory studies linked to large
scale clinical trials so that markers that correlate with prognosis and
response to treatment can be studied simultaneously.  In many instances
the laboratory investigators are already recipients of R01 or P01
support for their basic research and have developed preliminary data
supporting a large scale analysis of a new prognostic factor.
Likewise, many clinical investigators are supported through Cancer
Centers (P30) and the Clinical Trials Cooperative Group mechanism (U10)
for clinical research and have access to patient specimens with
clinical follow-up.  The Cancer Diagnosis Branch, DCBDC, is
establishing a Cooperative Breast Cancer Tissue Registry that will
enable participating organizations to inventory their tissue
collections and to establish a database for existing associated
clinical and outcome data.  This registry does not include funds for
conducting correlative studies but it can serve as a resource for
additional tissues.  This initiative proposes to link these activities
and provides a mechanism to obtain definitive data on the relationship
of biological features and the clinical behavior of the tumors.

B.  Research Goals and Scope

The objectives of this RFA are to foster collaborations and
interactions between basic researchers and clinical investigators to
advance therapeutic clinical research and conduct correlative studies
on new prognostic factors that are ready for large scale evaluation.
The CTEP and the CDB invite cooperative agreement applications (U01)
from institutions or consortia, such as the DCT Clinical Trials
Cooperative Groups and the NCI Cancer Centers, capable of and
interested in performing clinical correlative studies relevant to
cancer treatment or clinical outcome in breast cancer patients.
Applicants may propose to undertake several correlative studies during
the grant funding period (up to four years).  An individual scientist
or a consortia of institutions may be included on more than one
application.

The correlative studies should be based on strong and testable
hypotheses.  A clear rationale should be given for the experimental
design and technical methodologies selected.  The hypotheses tested
must relate to potential clinical applications such as development of
new treatment strategies or identification of patient subsets for
specific treatment approaches. Preliminary data from appropriate tumor
models or analysis of patient specimens should be provided to support
the feasibility of each study.  This RFA is for developing assays that
have already been demonstrated to be applicable to tissue samples
and/or body fluids.  The laboratory assays must utilize tumor specimens
from patients receiving defined treatments in large clinical trials
such as phase III clinical protocols.  Proposals must include a
statistical section describing plans for analysis of data designed to
test the hypotheses.  Applications will be considered responsive only
if investigators have access to sufficient numbers of patient
specimens.  All investigators are encouraged to work with multi-center
organizations or form a consortium of institutions in order to access
sufficient numbers of patients and clinical information to test the
proposed hypotheses.  To coordinate the above activities, each Team
must have a Central Operations Office and Statistical Center as defined
below (see SPECIAL REQUIREMENTS, Definitions).

Examples of therapeutic laboratory correlates of interest include but
are not limited to:  (1) phenotypic or genotypic alterations which
appear to correlate with the development of drug-, radiation-, or
hormone-resistance; (2) loss or inactivation of tumor suppressor genes
related to prognosis; (3) analysis of basal membrane factors related to
tumor invasion and metastases; (4) studies of chromosomal
rearrangements or deletions that may be used as prognostic indicators;
(5) correlation of tumor growth factors or oncogenies with response to
therapies; (6) characterization of tumor associated antigens that may
lead to new immunotherapies; and (7) evaluation of use of serum or
tumor markers that correlate with tumor progression.

The cooperative approach outlined in this RFA allows for interactions
among successful applicants and is designed to optimize use of patient
resources, tissues, reagents and methods.

Applicants must describe how they might interact with NCI and other
awardees in the sharing of data and improvements in laboratory
techniques and study design methodologies.

SPECIAL REQUIREMENTS

A.  Definitions

o  Cooperative Agreement - An assistance mechanism in which substantial
NCI programmatic involvement with the recipient is anticipated during
performance of the planned activity.

o  Study Team - A Study Team may be a single institution or a
consortium of institutions.  A Study Team functions as an integrated
unit with a common goal and is under the guidance and direction of a
single Principal Investigator.  Each Study Team is composed of
investigators with expertise in clinical investigations and laboratory
analyses.  Each Study Team must have access within its institution or
consortia to an Operations Office and Statistical Center.  In this RFA,
the terms Study Team and Team are used synonymously.

o  Principal Investigator (PI) - The person who submits the single
application in response to this RFA and who is responsible for
performance of the key personnel and the Study Team as a whole.  A
consortium of institutions must agree to work together with a single
Principal Investigator under a single cooperative agreement.  The
Principal Investigator is responsible for coordinating the Study Team's
activities scientifically and administratively.

o  Central Operations Office - An administrative unit that coordinates
all Team activities.  Responsibilities include coordinating protocol
development, study conduct, and quality control and study monitoring.
Each Study Team must have a Central Operations Office but it need not
be at the PI's institution.

o  Statistical Center - The Study Team must have a Statistical Center
for collection and analysis of patient and laboratory data.
Responsibilities will include participation in the planning and
coordination of study design methodologies, data management and
analysis, data monitoring, and reporting of data. Each Study Team must
have a Statistical Center but it need not be at the PI's institution.

o  NCI Program Directors - The Program Director, CTEP, Division of
Cancer Treatment and the Chief, CDB, Division of Cancer Biology
Diagnosis and Centers who will be coordinating their Division's
interactions and providing guidance for the overall program within the
NCI.

o  NCI Coordinator - The Breast Cancer Clinical Research Scientist,
Medicine Section, Clinical Investigations Branch, CTEP, DCT who
interacts scientifically with the Institutions.

B.  Terms and Conditions of Award

Under the cooperative agreement, a partnership will exist between the
recipient of the award and the NCI, with assistance from the NCI in
carrying out the planned activity.  The following terms and conditions
pertaining to the scope and nature of the interaction between the NCI
and the investigators will be incorporated in the Notice of Award.
These terms will be in addition to the customary programmatic and
financial negotiations which occur in the administration of grants.
The "Nature of Participation by NCI Staff" and "Responsibilities of
Awardees" described in this section are in addition to, and not in lieu
of, otherwise applicable OMB administrative guidelines; DHHS grant
administration regulations 45 CFR 74; DHHS grant administration
regulations 45 CFR 92; other DHHS, PHS, and NIH grant administration
policy statements; and other NCI administrative terms of award.

The cooperative agreements will require cooperation between an NCI
Coordinator and the Principal Investigators of the Teams.  The NCI
Coordinator will assist in coordinating the activities of the Teams as
defined below and in facilitating exchange of information.

1.  Nature of Participation by NCI Staff

The role of the Program Director CTEP and the Chief CDB staff as
described throughout these terms of cooperation is to assist and
facilitate but not to direct research activities.  The NCI Coordinator
will interact scientifically with all the Institutions.  Two levels of
coordination are anticipated.

The first level involves interactions between the NCI Coordinator and
the individual Team.  During the period of the award, the awardees
institutions(s) will have primary authority to determine research
priorities and statistical needs.  The NCI Coordinator may provide
appropriate assistance by participating in the design of research
activities, review of protocols, coordination of the tissue
utilization, establishment of priorities, and review of progress.  The
NCI Coordinator can assist in this process by providing information on
other ongoing studies and on NCI priorities.  Protocols will be
provided to the CTEP Protocol Review Committee and the Diagnosis
Decision and Implementation Committee for review to facilitate
coordination of research activities throughout NCI.  Although the
Team(s) are responsible for statistical analysis of data, computer
processing and statistical evaluations may be provided from NCI
resources if requested by the awardee.

The second level of coordination involves interactions between the NCI
Coordinator and the various Teams funded for research on breast cancer.
The NCI Coordinator will coordinate activities among the Teams such as
the sharing of patient specimens, new reagents, improved laboratory
techniques, data, and study design methodologies.  Although
investigators will have to demonstrate that they have access to the
necessary numbers of patients and/or specimens to answer specific
questions, other important correlations identified during the course of
the funded research may require patient resources from more than one
Team.  Priorities would need to be set for the most effective use of
available specimens since tumor specimens are often small in size.  The
NCI Coordinator can assist in this process by providing information on
other ongoing studies and on NCI priorities.

2.  Responsibilities of Awardees

The Study Team is responsible for the proposing research projects to
advance the goals of the RFA and to define its approaches to attain
these goals.  It is the primary responsibility of the PI to state
clearly the objectives of the Team, to direct the research stipulated
in the application, and to ensure that the results obtained are
published in a timely manner.  It is anticipated that decisions in all
activities will be reached by consensus of the collaborators of a Team
under the leadership of the PI and that the NCI Coordinator will have
the opportunity to offer input to this process.  Awardees are required
to have access to appropriate tumor tissue and clinical follow-up on
patients receiving defined treatments in phase III clinical trials.
Awardees must have the appropriate clinical and laboratory expertise to
accomplish their objectives within the Study Team.

The NCI Coordinator and all Awardees funded for breast cancer research
in this RFA will meet initially to discuss research activities and
establish priorities among the Awardees.  Subsequent periodic meetings
will be scheduled to review progress and coordinate new research
activities.  Sharing of data and reagents will be expected among
Awardees.  In addition, new studies that may require the sharing of
patient specimens and the prioritization of research studies among the
Awardees is envisioned.  Therefore, each Awardee should anticipate the
need to attend two meetings per year with the NCI Coordinator and other
Awardees to coordinate activities.

The Government, via the NCI Coordinator, will have access to data
generated under this cooperative agreement and may periodically review
the data.  However, the awardee will retain custody of primary rights
to their data developed under these awards, and timely publication of
major findings by the Team members is encouraged.  Publication or oral
presentation of work done under this agreement will require appropriate
acknowledgement of NCI support.

3.  Arbitration Committee

An arbitration panel of external consultants will be created as needed
to resolve any irreconcilable differences of opinion between the NCI
coordinator and the Team(s) related to scientific/programmatic matters
or implementation of a proposed operating policy.  The panel will
include one member selected by the Team(s), 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
post award administrative decisions in accordance with PHS regulations
at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and women
in study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis should be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to apply
to males and females of all ages.  If women or minorities are excluded
or inadequately represented in clinical research, particularly in
proposed population-based studies, a clear compelling rationale should
be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of the
study.  This information should be included in the form PHS 398 in
Sections 1-4 of the Research Plan AND summarized in Section 5, Human
Subjects.  Applicants are urged to assess carefully the feasibility of
including the broadest possible representation of minority groups.
However, NIH recognizes that it may not be feasible or appropriate in
all research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants
or cooperative agreements that do not comply with these policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by July 23, 1993, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal Investigator,
the identities of other key personnel and participating institutions,
and the number and title of the RFA in response to which the
application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
is helpful in planning for the review of applications.  It allows NCI
staff to estimate the potential review workload and to avoid conflict
of interest in the review.

The letter of intent is to be sent to Ms. Diane Bronzert at the address
listed under INQUIRES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for cooperative agreements.  These forms are available at
most institutional offices of sponsored research; from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
(301) 710-0267; and from the NCI program staff listed under INQUIRIES.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page.  Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee in time for review.  In addition,
the RFA number and title must be typed on line 2a of the face page of
the application form and the YES box must be marked.

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

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

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

Ms. Toby Friedberg, Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 650
6130 Executive Boulevard
Bethesda, MD  20892

Applications must be received by September 22, 1993.  If an application
is received after that date, it will be returned.  The Division of
Research Grants (DRG) will not accept any application in response to
this announcement that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
The DRG will not accept any application that is essentially the same as
one already reviewed.  This does not preclude the submission of
substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous
critique.

Special Instructions for Preparation of Cooperative Agreement
Applications

The grant application form PHS 398 (rev. 9/91) must be used for the
cooperative agreement application.  The general instructions, e.g., for
format and budget issues, included in the application packet must be
followed.

Because the Terms and Conditions of Award discussed in the SPECIAL
REQUIREMENTS section will be included in all awards issued as a result
of this RFA, it is critical that each applicant include specific plans
for responding to these terms.  Plans must describe how the applicant
will comply with staff involvement.

Teams should anticipate the need to attend two meetings per year to
share data and to coordinate activities.  Travel funds for two
representatives from a Team (one basic researcher and one clinician,
one of whom must be the PI) should be included in the budget.  This
budget item will be negotiable.

REVIEW CONSIDERATIONS

A.  Review Procedures

Upon receipt, applications will be reviewed by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Applications that are judged
non-responsive will be returned by the NCI.  An application judged to
be non-responsive to this RFA may be submitted as an investigator-
initiated regular research grant (R01) or program project grant (P01)
at the next receipt date.  The application would require modification
in accordance with either the R01 or P01 guidelines.  The new
application would not be considered an application for a Cooperative
Agreement, nor would it be considered a response to an RFA.  Questions
concerning the relevance of proposed research to the RFA may be
directed to program staff listed under INQUIRIES.

Applications may receive a preliminary scientific peer review (triage)
by an NCI scientific peer review group on the basis of relative
competitiveness.  The NCI will withdraw from further competition those
applications judged to be noncompetitive for award and notify the
applicant and institutional business official.  Those applications
judged to be both competitive and responsive will be further evaluated,
using 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 will be
provided by the National Cancer Advisory Board.

B.  Review Criteria

o  Scientific merit and feasibility of the proposed research.

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research.

o  Adequacy of plans for effective collaboration between laboratory,
clinical, and statistical investigators.

o  Qualifications, demonstrated expertise in both the appropriate basic
and clinical sciences, and proposed responsibilities of the Principal
Investigator and key personnel.

o  Demonstration of availability of and access to appropriate patients
receiving defined treatments on phase III clinical trials and/or to
human tissue with the associated pathological data and clinical
follow-up.

o  Scientific plans and timetable for implementing the proposed
research program.

o  Adequacy of the available facilities and data management resources.
Evidence of the competence of the Central Operations Office and
statistical center with regard to the mechanisms for quality control,
study monitoring, data management and reporting, and data analysis.

o  Plans for effective interaction and coordination among cooperating
institutions within the Study Team, with other Teams working on the
same solid tumor, and with the NCI.

o  Adequacy of provisions for the protection of human subjects.

o  Adequacy of the plans for inclusion of females and minorities.

o  Adequacy of the proposed budget and duration in relation to the
proposed research.

AWARD CRITERIA

The anticipated date of award is July 1, 1994.  In addition to the
technical merit of the application, NCI will consider how well the
applicant institution meets the goals and objectives of the program as
described in the RFA, availability of resources, and study populations.

INQUIRIES

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

Direct inquiries regarding programmatic issues and address the letter
of intent to:

Ms. Diane Bronzert
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
FAX:  (301) 480-4663

Dr. Sheila E. Taube
Division of Cancer Biology, Diagnosis, and Treatment
National Cancer Institute
Executive Plaza North, Room 513
Bethesda, MD  20892
Telephone:  (301) 496-1591
FAX:  (301) 402-1037

Direct inquiries regarding fiscal matters to:

Ms. Barbara A. Fisher
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 29
FAX:  (301) 496-8601

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No 93.395, Cancer Treatment Research.  Awards are made under the
authorization of the Public Health Service Act, Title IV Sections 301,
410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public
Law 99-158, 42 USC 285a) and administered under PHS grants policies 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.

.

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