Full Text CA-93-19

COOPERATIVE BREAST CANCER TISSUE REGISTRY

NIH GUIDE, Volume 22, Number 7, February 19, 1993

RFA:  CA-93-19

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Registries+ 
  Tissue Culture 


National Cancer Institute

Letter of Intent Receipt Date:  March 15, 1993
Application Receipt Date:  April 29, 1993

PURPOSE

The Cancer Diagnosis Branch of the Division of Cancer Biology,
Diagnosis and Centers at the National Cancer Institute (NCI) invites
applications for cooperative Agreements from organizations
(individual institutions or consortia) capable of and interested in
participating in a network of organizations working together as the
Cooperative Breast Cancer Tissue Registry.  The purpose of the
proposed awards is to stimulate cooperative efforts to identify and
improve access to archival breast cancer tissue and other appropriate
breast specimens and associated clinical and outcome data for the
evaluation of predictive and diagnostic markers.  The Cooperative
Breast Cancer Tissue Registry will provide resources to enable
participating organizations to inventory their tissue collections and
to establish a database for existing associated clinical and outcome
data.  It will also provide resources to identify, obtain and provide
tissues and patient data to investigators for predictive marker
studies as approved by a Research Evaluation and Decision Panel, as
described below.  While initial focus of the Registry is on improving
access to formalin-fixed, paraffin-embedded archival breast cancer
tissue, applicants can also propose inclusion of archival frozen
breast tissue collections where appropriate.  The Registry is not
intended to directly support marker assay research, but only to
assist investigators funded through other sources with access to
tissue and related clinical and outcome data.

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), Cooperative Breast Cancer Tissue Registry, 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

Applicant organizations must be located in the United States, Canada
or Mexico.  Non-profit organizations and institutions, and government
agencies are eligible to apply.  For-profit organizations are also
eligible.

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 the performance of the planned
activity is anticipated.  The cooperative agreement funding mechanism
was selected because of substantial NCI programmatic involvement
required to coordinate activities among several organizations working
toward a common goal.  The nature of NCI staff involvement is
described under Terms of Cooperation, Nature of Participation by NCI
Staff.  Applicants will be responsible for the planning, direction,
and execution of the proposed project.  There is no intent, real or
implied, for NCI staff to direct awardee activities or limit the
freedom of applicants.

Under the cooperative agreement, a relationship exists between the
recipient of the award and the NCI.  Specifically, the Principal
Investigator defines the details of the project within the guidelines
of the RFA, retains primary responsibility for the performance of the
activity and agrees to accept close coordination, cooperation and
assistance of the NCI extramural staff (through the NCI Program
Administrator) in all aspects of the scientific and technical
management of the project in accordance with the terms of
cooperation.

Awards will be administered under PHS grants policy as stated in the
Public Health Service Grants Policy Statement, DHHS Publication No.
(OASH)) 90-50,000, revised October 1, 1990.

The anticipated average amount of direct cost awards will be
$100,000.

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

The NCI anticipates making six to ten awards for project periods of
up to four years and anticipates that a total of $1,500,000 will be
set aside for the initial year's funding.  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 September 30, 1993.  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 1993.

RESEARCH OBJECTIVES

A.  Background

Breast cancer is the second leading cause of cancer deaths in women
in the U.S., exceeded only by lung cancer.  The American Cancer
Society estimates 181,000 new cases of breast cancer and 46,300
deaths in 1992.  There is increasing emphasis on the need for better
markers to predict tumor aggressiveness, metastatic potential and
response to therapy.  Definitive evaluations of these markers have
been hindered by the lack of adequate numbers of patient specimens to
achieve statistically valid endpoints. Markers are particularly
important for the 30 percent of patients with no apparent involvement
of the axillary lymph nodes (node-negative breast cancer) whose
disease will progress.  Predictive markers can help determine which
patients will benefit from specific therapeutic interventions and
which patients can be spared chemotherapy.  Basic research has
provided much information about the molecular processes involved in
tumor progression and/or tumor spread and metastasis, but we do not
yet have the data to apply these observations to patient management.

In June 1990 the Consensus Development Conference on Treatment of
Early Stage Breast Cancer indicated that refinement of existing
prognostic factors would depend on development and utilization of new
and existing tissue and clinical data banks.  The Cancer Diagnosis
Branch has been exploring ways to assure that existing collections
are effectively used.  It has become apparent that the most efficient
method would be to take advantage of the careful follow-up and
monitoring of patients in the context of clinical trials and in the
major institutions involved in comprehensive breast cancer treatment
programs.  In essentially all the clinical trials, paraffin blocks
are prepared for pathologic review and confirmation of the diagnosis,
but these blocks have not been readily available for retrospective
studies.  Pathologists generally have not had the time or the
personnel resources to locate and retrieve large numbers of archived
samples or to cut additional sections for research purposes.  Blocks
are generally retained at individual collaborating institutions
rather than centralized in a coordinating center.  Research
institutions may have local priorities that restrict outside use of
tumor specimens.  These and other factors limit the creation of large
specialized repositories of tumor samples with associated clinical
data.

Investigators have attempted to carry out studies using tissues
collected in therapeutic trials, but they have often been hindered by
the problems noted above.  Similar problems are associated with
collections of frozen tissue.  The size of biopsy specimens is
decreasing as a result of earlier detection through mammography and
other screening efforts and much of the resulting sample is required
for patient diagnosis.  This creates a situation whereby tissue
collections may lack significant numbers of the smallest and earliest
stage tumors.  Some studies may also require access to normal or
pre-cancerous breast tissue specimens.

A number of groups have potential access to large numbers of archival
breast cancer and other breast tissue specimens from patients treated
on standard therapeutic regimens or clinical trials, and for whom
significant clinical and outcome data are available.  These include
the DCT clinical cooperative groups, consortia of community clinical
oncology groups, NCI cancer centers, and other major organizations
involved in comprehensive breast cancer treatment programs.  While
these groups accrue large numbers of patients and archive large
amounts of surgical tissue, they often lack the resources to utilize
those specimens in a comprehensive way to evaluate promising
predictive tissue markers.  There is no complete inventory of the
samples that might be made available for research and no mechanism to
coordinate the efforts of these disparate groups.

B.  Research Goals and Scope

The objective of this RFA is to invite applications for cooperative
agreements to support a network of organizations working
cooperatively to form the Cooperative Breast Cancer Tissue Registry.
The Registry will provide breast cancer tissue, as well as normal and
pre-cancerous breast tissue as appropriate, for large scale
validation studies of breast cancer predictive markers.  The
development of breast cancer tissue resources could have considerable
impact on the development of cancer diagnostic and prognostic assays.
This initiative for the Cooperative Breast Cancer Tissue Registry is
designed to provide such a resource.  Archival paraffin-embedded
tissues will be the initial focus because large numbers of
paraffin-embedded formalin-fixed tissues from earlier clinical trials
already exist, because such tissues are easier to obtain and
transport, and because these archival tissues are routinely prepared
in the standard practice of pathology.  However, it would also be
appropriate to include substantial collections of archival frozen
tissue, as many assay reagents do not work on formalin-fixed
paraffin-embedded material.  Tissues to be included in the Registry
should be from existing collections involving large groups of
patients treated uniformly on standard therapeutic regimens or
clinical trials where clinical and outcome data are available.
Additional specimens could be added to the Registry as outcome data
become available.

Awardees must agree to provide tissue for high priority research
studies as identified by a committee selected by Registry members,
the Research Evaluation and Decision Panel (REDP) and agree to
participate as part of a Coordinating Committee.  An assumption of
the registry concept is that the establishment of a large cooperative
breast cancer tissue resource will make available the specimens
necessary for large scale validation studies.  It is anticipated that
decisions about which research studies will be provided with tissue
will be made by a REDP selected by Registry participants according to
criteria established by the Registry Coordinating Committee.  The
Registry REDP, may also act as a "catalyst" bringing together groups
with tissues and groups with promising reagents that are ready for
validation testing.  The NCI will help coordinate this process
through the program administrator's membership in the REDP.  Research
studies will not be supported by registry funding.

TERMS OF COOPERATION

The cooperative agreements (U01) will require cooperation between an
NCI representative (the Program Administrator) and the Principal
Investigators (PI) of the individual projects in order to assure
smooth interactions among the cooperating organizations.  The Program
Administrator will assist in coordinating the activities of the
awardees and in facilitating exchange of information.

Nature of Participation by NCI Staff

A representative of the NCI (Program Administrator) will be
designated by the Chief of the Cancer Diagnosis Branch, Division of
Cancer Biology, Diagnosis and Centers.  The role of the Program
Administrator, as detailed throughout these terms of cooperation is
to assist and facilitate, but not to direct activities of the
Cooperative Breast Cancer Tissue Registry.  The Program Administrator
acts as liaison to the NCI and as an information resource about
research activities in cancer diagnosis and prediction of outcome and
response to therapy.  The Program Administrator coordinates and
facilitates the activities supported by these cooperative agreements.

As a member of the Coordinating Committee, the Program Administrator
attends and participates in all meetings and assists in developing
operating policies, quality control procedures and consistent
policies for dealing with recurring situations that require
coordinated action.  As a member of the REDP, the Program
Administrator participates in decisions about which assays should be
tested and which groups obtain access to tissue and provides liaison
between the Coordinating Committee and the REDP.  To ensure
consistency and quality, the Program Administrator must concur in
operating policies prior to their implementation.  In addition to
normal program duties, the NCI Program Administrator may review the
activities of awardees for compliance with operating policies
developed by the Coordinating Committee and can recommend withholding
of support, suspension or termination of an award for failure to
comply with such policies.

Responsibilities of Awardees

The PI in cooperation with the other Coordinating Committee members,
is responsible for developing the details of Registry operating
policies, including definition of objectives and approaches,
planning, implementation and interaction with other Registry
awardees.  The application should include specific proposals for each
of the areas noted in the section APPLICATION PROCEDURES,
Requirements for Application.  The PI must also assure that
designated Registry tissues remain available and that the relevant
clinical data as designated by the Coordinating Committee is
obtainable.

Awardees are also responsible for formulating operating policies,
quality control procedures and consistent policies for dealing with
recurring situations that require coordinated action through
participation by the Principal Investigator and any other designated
representatives at Coordinating Committee meetings. The PI is
required to submit a progress report at each meeting of the
Coordinating Committee.  At the discretion of program staff, awardees
may also be asked to attend the annual SPORE meeting. Awardees will
retain custody and primary rights to data developed under these
awards, subject to government, e.g., NCI, NIH, or PHS, rights of
access, consistent with current DHHS, PHS, and NIH policies.

Coordinating Committee

The NCI and awardees are responsible for forming a Coordinating
Committee as defined below.  The Coordinating Committee is
responsible for reviewing the plans for development of the Registry
proposed in the individual applications of awardees.  They will
develop uniform procedures for tissue registration, processing, and
distribution; will develop uniform methods of quality control; and
will consider rules for access to clinical and outcome data
associated with the registered tissues.  They will also review and
approve the operating procedures proposed by individual awardee
organizations in order to insure that they are compatible with the
overall goals of the RFA.  The Coordinating Committee is also
responsible for selecting members and coordinating the activities of
the REDP as described below.

The Coordinating Committee will initially consist of the Principal
Investigator of each cooperating institution and the Program
Administrator.  Additional members can be added by action of the
Coordinating Committee.  The structure of the Coordinating Committee
should be established at the first meeting as noted below.

The Chair of the Coordinating Committee is responsible for
coordinating the Committee activities, for preparing meeting agendas,
and for scheduling and chairing meetings.   The Program Administrator
attends and participates in all meetings of the Coordinating
Committee and should be informed of any major interactions.  The
Coordinating Committee must prepare an annual progress report which
will include individual reports from each awardee.  Each awardee is
responsible for timely preparation of this report.

At its initial meeting, the Committee will elect a chairperson (who
may not be the Program Administrator).  The Coordinating Committee
will determine whether additional Coordinating Committee
representation is required.  Depending on availability of appropriate
expertise, the REDP described below could be constituted as a
sub-committee of the Coordinating Committee.

The Coordinating Committee will meet three times in the first year to
map strategies, to develop operating procedures and to evaluate
progress.  The initial meeting will be as soon as possible after
funding.  Two additional meetings will be held during the first year
of operation and there will be at least two meetings a year
thereafter.  Meetings may be held at any of the participating
organizations or at another convenient location. These meetings are
aimed at coordinating the activities of the participating
laboratories, establishing new policies and priorities, and reviewing
progress.  The Program Administrator will participate in the
discussions at these meetings.

The NCI Program Administer, as a member of the Coordinating
Committee, will assure that operating policies are acceptable to the
NCI.  An arbitration system, as detailed below, will be available to
resolve disagreements between awardees and NCI staff.

Research Evaluation and Decision Panel

The Research Evaluation and Decision Panel (REDP) is responsible for
reviewing and approving requests from investigators for tissues
needed to carry out large scale validation studies of breast cancer
predictive markers.  The composition and expertise of REDP will be
determined by the Coordinating Committee. Members must have
appropriate expertise in breast cancer, which might include
clinicians, laboratory researchers, statisticians or other expertise
that the Coordinating Committee determines is needed.  The Program
Administrator is a member (but not the chair) of the REDP.  The
applicant should propose how the REDP activities will be carried out
and budget accordingly.  This could include joint meetings, mail,
and/or telephone conference.  The REDP will meet with the
Coordinating Committee at least once yearly and each group should
include travel funds for one REDP member in the budget.  Members of
the Coordinating Committee may also serve on the REDP.

Arbitration Procedures

An arbitration panel of external consultants will be created as
needed to resolve any irreconcilable differences of opinion related
to scientific/programmatic matters between the Program Administrator
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.  These special arbitration procedures in no way
affect the awardee's right to appeal an adverse determination 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 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
or 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, together with a rationale
for its choice.  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,
the NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of the
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 prevention strategies), diagnosis or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning 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
populations 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 March 15, 1993, a
letter of intent that includes a descriptive title of the proposed
project, the name, address and telephone number of the Principal
Investigator, the names 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 workload and to avoid conflicts of
interest in the review.

The letter of intent is to be sent to Roger L. Aamodt, Ph.D. at the
address listed under INQUIRIES below.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for the cooperative agreement. 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 20892-4500,
telephone 301 496-7441; and from Roger L. Aamodt, Ph.D. at the
address listed under INQUIRIES below.

The general instructions for format, budget issues, etc., in the
application packet should be followed.

Applicants must address the issues listed below and in the Review
Criteria section.

Requirements for Applications

1.  Plans should describe resources, including information on the
potential number of archived specimens that can be made available.
Tumor specimens should be from patients receiving defined treatments
in clinical studies (e.g., Phase III clinical trials) or from those
on standard treatments at major treatment centers, for whom clinical
and outcome data are available.

2.  Information about the number of years of follow-up and the nature
of the data collected.

3.  Examples of pathology and clinical data forms used at the
institution or consortium, or examples of forms that might be
appropriate for use by the Registry.

4.  Applicants should propose detailed plans for how to organize the
Breast Cancer Tissue Registry.

a.  Plans should describe which categories of archival breast cancer
and other appropriate breast tissues should be included in the
Registry and criteria for inclusion of individual specimen blocks.

b.  Methods should be proposed for establishing an inventory of
tissue specimens, as well as procedures for retrieving tissue, such
as handling archived blocks, providing sections and storing slides.

c.  Appropriate quality control procedures and methods for
retrieving, validating and maintaining the clinical and outcome data
associated with each registered sample should be detailed.

d.  Rules for access to the Registry should be proposed and the
relationship between Registry members and investigators proposing
studies defined.

e.  Describe how the availability of the Registry will be made known
to the scientific community (notices of availability in scientific
journals, displays at national meetings, etc.) and include costs as
budget items.

5.  Because the Terms of Cooperation discussed 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.

a.  Plans should describe clearly how applicants plan to interact
with the other awardees involved in the Registry and describe how
they will comply with the involvement of the NCI representative
(Program Administrator).

b.  The expertise required for an effective REDP should be proposed
as well as how the REDP would function to identify appropriate
quantifiable markers of breast cancer which are ready for evaluation
and to approve appropriate investigator proposed studies for access
to tissues and clinical and outcome data.

c.  Plans should describe the role of the Coordinating Committee in
coordinating activities of the Registry, establishing policies and
priorities, and reviewing progress.

6.  The Principal Investigators of each funded application will be
members of a Coordinating Committee that will meet three times in the
first year and twice in each subsequent year.  Travel funds for
Coordinating Committee meetings should be set aside as a budget line
item.  For planning purposes, either three trips to Washington DC or
one East Coast, one West Coast and one Central U.S. trip in the first
year may be proposed.

7.  The REDP will meet with the Coordinating Committee once a year.
Funds should be included to support travel by one member of the REDP
to one Coordinating Committee meeting each year plus any additional
travel anticipated for REDP members.

The RFA label available in the application form PHS 398 (rev. 9/91)
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.

Submit a signed typewritten original of the application, including
the checklist, and three signed exact, clear, single-sided
photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892-4500**

At the time of submission send two additional copies of the
application to:

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

Applications must be received by April 29, 1993.  Applications
received after this date will be returned.  The Division of Research
Grants (DRG) will not accept any application in response to this
announcement that is 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.

REVIEW CONSIDERATIONS

Review Procedures

Upon receipt, applications will be reviewed (initially) by the DRG
for completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NCI program staff function.  An applications that is judged
to be non-responsive will be returned by the NCI, but may be
submitted as an investigator-initiated regular research grant (R01)
or program project (P01) application 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 activities to the RFA may be directed to Roger L. Aamodt,
Ph.D. at the address listed under INQUIRIES.

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 are clearly not competitive for
award.  The NCI will remove from further competition those
applications that are judged to be noncompetitive and notify the
applicant Principal Investigator and institutional official.

Those applications judged to be both competitive and responsive will
be further evaluated according to the review criteria stated below
for 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

Reviewers will be asked to review the grant applications by
considering the following criteria:

1.  Merit of the proposed activities and organizational plans for
implementing the proposed registry and the extent to which they
address the overall goals and objectives of the RFA and sections 4
and 5 of APPLICATION PROCEDURES, Requirements for Applications.

2.  Availability of and access to appropriate archival breast tissue
specimens as detailed in section 1 of APPLICATION PROCEDURES,
Requirements for Applications, (including representative numbers of
minorities or sufficient justification for their exclusion) and
access to clinical data.

3.  Qualifications, experience and proposed responsibilities of the
Principal Investigators and key support personnel.

4.  Availability and quality of facilities and resources required for
this project.

5.  Plans for effective cooperation and coordination among
participating awardees and the NCI.

6.  Plans to protect the rights of human subjects.

Reviewers will also judge the appropriateness of the proposed budget
and duration for each meritorious application.

AWARD CRITERIA

The anticipated date of award is September 30, 1993.  Awards will be
based on the peer review priority score and programmatic priorities.

INQUIRIES

Written and telephone inquiries concerning the objectives and scope
of this RFA and inquiries about whether or not specific activities
would be responsive are encouraged and may be directed to:

Roger L. Aamodt, Ph.D.
Division of Cancer Biology, Diagnosis, and Centers
National Cancer Institute
Executive Plaza North, Room 513
6130 Executive Boulevard
Rockville, MD  20892-9904
Telephone:  (301) 496-7147
FAX:  (301) 496-8656

The Program Director welcomes the opportunity to clarify any issues
or questions from potential applicants.

AUTHORITY AND REGULATIONS

This program is described in the catalog of Federal Domestic
Assistance no 93.394, Cancer Detection and Diagnosis Research. Awards
are made under authorization of the Public Health Service Act, Title
IV, Part A (Public Law 78-410 as amended by public law 99-158, 42 USC
241 and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 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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