COOPERATIVE PROSTATE CANCER TISSUE RESOURCE

Release Date:  April 29, 1999

RFA:  CA-99-012

P.T.

National Cancer Institute

Letter of Intent Receipt Date: July 29, 1999
Application Receipt Date: August 27, 1999

PURPOSE

The Resources Development Branch of the Cancer Diagnosis Program, Division of
Cancer Treatment and Diagnosis, National Cancer Institute (NCI) invites
applications for cooperative agreements from organizations (individual
institutions or consortia) capable and interested in working together to create
a virtual resource to be known as the NCI Cooperative Prostate Cancer Tissue
Resource (hereinafter called "Resource"). A virtual resource is comprised of the
specimen archives, which remain at the institution where they were collected, and
data associated with the specimens that is maintained in a central database.

The Resource will make tissue specimens, with associated demographic, clinical
and outcome data, available to support prostate cancer research.  Participants
will identify critical data elements, design the Resource database, and enter
data related to the selected cases.  The quality of the specimens and data will
be ascertained, a website designed, and a marketing plan developed. Prospective
collection of frozen tissue specimens will begin in the second year, both to meet
current needs and to create a bank to meet future needs.  Demographic, clinical
and pathology data related to banked frozen specimens will be collected and
entered into the database.  Follow-up and outcome data will be added to the
database as it becomes available.

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 Prostate Cancer Tissue Resource,  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 202-512-1800), or at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, Canadian or Mexican for-profit and
non-profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and Local governments, and eligible
agencies of the Federal Government.  Applications from minority and women
investigators are encouraged.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be a
cooperative agreement U01, an "assistance" mechanism, in which substantial NIH
scientific and/or programmatic involvement with the awardee is  anticipated
during performance of the activity.  Under the cooperative agreement, the NIH
role is to support and/or stimulate the recipient's activity by involvement in
the project and otherwise working jointly with the award recipient as a partner,
but not to assume direction, prime responsibility, or a dominant role in the
activity. Details of the responsibilities, relationships and governance of the
resource to be funded under cooperative agreement(s) are discussed later in this
document under the section "Terms and Conditions of Award."

The total project period for applications submitted in response to the present
RFA may not exceed 5 years.  The anticipated award date is April 1, 2000.

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 this RFA.

FUNDS AVAILABLE

The NCI intends to commit approximately $1,500,000 in FY 2000 to fund 3 to 5 new
awards in response to this RFA.  Since the collection and distribution of
fresh/frozen specimens will not be initiated until year two, the anticipated
budget will increase to $2,400,000/year for years 2-5.  An applicant may request
a project period of up to 5 years.  Because the nature and scope of the expected
resources may vary, it is anticipated that the size of each award will also vary. 
Although the financial plans of the NCI provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of applications of outstanding scientific and
technical merit.

RESEARCH OBJECTIVES

Background

Prostate cancer is the second leading cause of cancer death in men.  There were
about 185,000 new cases of prostate cancer in the United States in 1998 and about
39,000 men died of the disease.  The incidence of prostate cancer has risen
significantly in the past 25 years.

At present, there is an inadequate infrastructure for prostate cancer tissue
acquisition, storage, and research use. Existing tissue repositories are few in
number and not closely linked to appropriate clinical and pathological
information.  Further, most existing resources support local research efforts. 
A national prostate repository will greatly facilitate prostate cancer research
efforts nationwide by providing large numbers of specimens with associated
clinical data, with quality control of both specimens and data.  Initially an
archival resource containing paraffin embedded tissues and associated clinical
and outcome data will be created.  Archival prostate cancer tissues accrued to
a national repository could meet the needs of many researchers.  Tissue blocks
will remain in each of the participating  institutions.  Necessary patient
information should be collected and compiled in such a way as to ensure patient
confidentiality.

A prospective collection of fresh-frozen tissue will be required to meet
anticipated future needs such as  the development and application of new
technologies to measure RNA, DNA and protein.  Applicants will be asked to
include plans to bank frozen prostate tumors (malignant, pre-malignant and
benign), and normal tissue when available, and to collect associated clinical and
outcome data.  Procurement of fresh specimens and banking of fresh-frozen tissue
will begin in year 2.

The availability of institutions with access to large numbers of paraffin
embedded specimens and to the associated clinical data should permit the rapid
creation of a resource of archival formalin-fixed, paraffin-embedded specimens.
The high rate of accrual of new cases of prostate cancer in some institutions
should also allow procurement and banking for studies on fresh or frozen prostate
specimens.

Objectives and Scope

This RFA requests applications for the development of a prostate cancer tissue
resource that will accrue large numbers (thousands) of prostate cancer cases with
archival tissue blocks representative of the patient diagnosis, as well as nodal
metastatic tissue blocks, and normal tissue when available (such as prostate
tissue adjacent to tumors, or blood cells), as well as the clinical information
related to those cases. A network of  cooperating institutions will be assembled
by the NCI and will work together to meet the goals of the RFA.  The PI's and
perhaps other participants from the cooperating institutions, and an NCI
representative, will constitute a Coordinating Committee to govern the Resource. 
The Resource will make tissues and associated clinical information available to
researchers.  An outside scientific review group, the Research Evaluation Panel
(REP) will be assembled by NCI in consultation with the Coordinating Committee
to review requests for use of the Resource (see "Coordinating Committee" and
"Research Evaluation Panel" under TERMS OF COOPERATION).

Applicants must propose the establishment of a paraffin tissue archive. Because
the number of specimens, the availability of specimens for distribution, the
types of specimens, and the quality of accompanying data (demographics, clinical
history, treatment, outcome) are important to the utility of the Resource,
applicants should estimate their potential to contribute to each of these
Resource elements.  The first year will focus on creating the bank
infrastructure; including forming a coordinating committee to oversee the
operation of the bank, developing operating policies and procedures, and
identifying cases with appropriate formalin-fixed, paraffin-embedded tissue
blocks for entry into the bank.

SPECIAL REQUIREMENTS

Terms and Conditions of Award

1.  These special Terms of Award are in addition to and not in lieu of otherwise
applicable OMB administrative guidelines, HHS Grant Administration Regulations
at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration
policy statements.  [Part 92 applies when state and local governments are
eligible to apply as a "domestic organization."]

2.  The administrative and funding instrument used for this program is a
cooperative agreement (U01), an "assistance" mechanism (rather than an
"acquisition" mechanism) in which substantial NIH scientific and/or programmatic
involvement with the awardee is anticipated during performance of the activity. 
Under the cooperative agreement, the NIH purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working jointly with the
award recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Consistent with this
concept, the dominant role and prime responsibility for the activity resides with
the awardee(s) for the project as a whole, although specific tasks and activities
in carrying out the studies will be shared among the awardees and the NCI Program
Coordinator.

3.  Terms of Cooperation

The cooperative agreements (U01) will require cooperation between an NCI
representative (the Program Coordinator) and the principal investigators (PI) of
the individual projects participating in a Coordinating Committee in order to
administer the Resource and ensure smooth interactions among the cooperating
organizations.  The Program Coordinator participates as a member of the
Coordinating Committee and assists in coordinating the activities of the awardees
and facilitating communications.  The principal investigators, and in some cases
other representatives of the cooperating institutions, participate as members of
the Coordinating Committee.  The Chair of the Coordinating Committee is
responsible for maintaining oversight and cooperation among participants and
chairing Coordinating Committee meetings.  These responsibilities are described
more fully below.

a.  Nature of Participation by NCI Staff

The Program Coordinator will be designated by the Associate Director of the
Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis.  The
Program Coordinator's role, as detailed throughout these terms of cooperation is
to coordinate, assist and facilitate, but not to direct the activities of the
Resource.  The Program Coordinator attends and participates as a voting member
in all meetings of the Coordinating Committee and will facilitate access to an
NCI contractor to assist in implementing the central database for the
resource.Data will be supplied to the contractor in a format agreed upon by the
Coordinating Committee.  The format could include such approaches as a "flat
file" or a particular commercial database structure.  Ownership of the data is
retained by the awardee institutions.  The contractor will provide a central
point of contact for the resource and to provide support for the implementation
and operation of the database.  The Program Coordinator also acts as a resource
for information about NCI activities.  As a member of the Coordinating Committee,
the Program Coordinator attends and participates in all Coordinating Committee
meetings and assists in developing operating policies and procedures and assures
that those policies are acceptable to the NCI. The NCI Program Coordinator may
review the activities of awardees for compliance with operating policies
developed by the Coordinating Committee and may recommend withholding support,
suspension or termination of an award for failure to comply with such policies. 
An arbitration system, detailed below, is available to resolve disagreements
between awardees and NCI staff.

b.  Responsibilities of Awardees

The PI in cooperation with the other Coordinating Committee members is
responsible for developing the details of Resource operating policies, including
defining objectives and approaches, planning, implementation and interaction with
other Resource awardees, marketing the Resource, managing fiscal arrangements
regarding charges for the distribution of Resource specimens, and establishing
quality assurance measures for all aspects of the operation of the Resource.  The
PI must also assure that designated Resource tissues remain available and that
the relevant clinical data, as designated by the Coordinating Committee, is
obtainable.  The PI can be required, at the discretion of the Chair, to submit
a progress report at any meeting of the Coordinating Committee.  Awardees 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.

c.  Coordinating Committee

The NCI and awardees are responsible for forming a Coordinating Committee to
oversee the operation of the Resource.  The Coordinating Committee will act as
the governing body of the Resource and all participants are bound by its actions. 
The structure of the Coordinating Committee will be defined at the first meeting. 
Initially the Coordinating Committee will consist of the principal investigator
for each cooperating institution and the Program Coordinator.  Additional members
may be added at the first or subsequent meetings by action of the Coordinating
Committee.  The Coordinating Committee will meet three times in the first year
and at least twice a year with additional meetings and conference calls as
necessary.  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.  At its initial meeting, the Coordinating
Committee will elect a chairperson (who cannot be the Program Coordinator).  The
Chair is responsible for coordinating the Committee activities, for preparing
meeting agendas, and for scheduling and chairing meetings.

The Coordinating Committee is initially responsible for reviewing and
implementing, as appropriate, the plans for the Resource proposed in the
individual applications.  It is responsible for developing uniform procedures to
accession, process, and distribute tissue, uniform quality control methods and
rules for access to the clinical and outcome data associated with the accrued
cases.  It will also review and approve the local operating procedures proposed
by each awardee to insure that they are compatible with the overall goals of the
RFA.

d.  Research Evaluation Panel (REP)

The Research Evaluation Panel (REP) is an independent group of experts that will
be constituted by the NCI in consultation with the Coordinating Committee.  The
REP is responsible for reviewing requests from investigators for tissues. The REP
then provides scientific advice about the scientific quality and priority of the
request to the NCI and the Coordinating Committee.  An NCI representative to the
REP, the Program Liaison, will be designated by the Associate Director of the
Cancer Diagnosis Program.  The Program Liaison, who cannot be the NCI Program
Coordinator nor chair the REP, is a member of the REP and participates in
developing recommendations to the Coordinating Committee about the scientific
importance of proposed assays and the design of proposed studies.  The REP works
independently but collaboratively with the Coordinating Committee.

The composition and expertise of the REP will be determined initially by the
Coordinating Committee.  REP members must have appropriate expertise in prostate
cancer and might include clinicians, laboratory researchers, statisticians or
members with other expertise that the Coordinating Committee determines to be
needed.  Two members of the Coordinating Committee serve as ad hoc non-voting
members of the REP.  Once the REP is established, the REP will select
replacements for members who have completed their terms.  Operating policies for
the REP will be determined by the REP, consistent with operating policies
developed by the Coordinating Committee.  The REP members will attend at least
one Coordinating Committee meeting each year to help coordinate REP activities
with those of the Coordinating Committee.  This meeting may be associated with
a REP meeting as required.

4.  ARBITRATION

Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipients and the NCI may be brought to
arbitration.  An arbitration panel will be composed of three members: one
selected by the Coordinating Committee (with the NCI member not voting) or by the
individual awardee in the event of an individual disagreement, a second member
selected by NCI, and the third member selected by the two prior selected members.
This special arbitration procedure in no way affects the awardee's right to
appeal an adverse action that is otherwise appealable in accordance with the PHS
regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  This
policy results from the NIH Revitalization Act of 1993.

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.  Investigators may also obtain copies of the policy
from the program staff listed under INQUIRIES.

Applications received in response to this RFA are expected to focus on scientific
issues related to prostate cancer.  In describing the plan to recruit human
subjects, investigators may cite a focus on prostate cancer as the justification
for why women will be excluded.  In this regard applicants may use Justification
1 from the policy announcement: the research topic to be studied is irrelevant
to women.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling scientific and ethical reasons not to
include them.  This policy applies to all initial (Type 1) applications submitted
for receipt dates after October 1, 1998.  All investigators proposing research
involving human subjects should read the "NIH Policy and Guidelines on the
Inclusion of Children as Participants in Research Involving Human Subjects" that
was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is
available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

As part of the scientific and technical merit evaluation of the research plan,
reviewers will be instructed to address the adequacy of plans for including
children as appropriate for the scientific goals of the research, or
justification for exclusion.

Applications received in response to this RFA are expected to focus on scientific
issues related to prostate cancer.  In describing the plan to recruit human
subjects, investigators may cite a focus on prostate cancer as the justification
for why children will be excluded.  In this regard applicants may use
Justification 1 from the policy announcement: the research topic to be studied
is irrelevant to children.

LETTER OF INTENT

Prospective applicants are asked to submit, by July 29, 1999, a letter of intent
that includes a descriptive title of the proposed research, name, address, and
telephone number of the Principal Investigator, identities of other key
personnel, other participating institutions if any, and number and title of the
RFA.  Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, the information 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 the program staff listed under INQUIRIES.

APPLICATION PROCEDURES

Awards will be made to multiple institutions or consortia to create a multi-
institutional virtual resource with a central database. The special requirements
listed below address the ability of applicants to contribute tissues and data to
the Resource and the ability and to cooperate with Principle Investigators from
several other institutions, whose identity not be known until after the award.

1.  Applicants should describe the available institutional resources.

a.  Estimate the anticipated number of cases that have available archival blocks
and complete clinical and outcome data.  Applicants should describe the racial,
ethnic and age distribution of their cases.  In addition, describe the types of
specimens (biopsy or prostatectomy, benign tissue, normal tissue, etc.) that are
available.  Applicants should also estimate their access to cases with fresh
prostate specimens suitable for freezing and the numbers and types of specimens
that will be available.

b.  Describe how Gleason grading is performed.  Is a Gleason score rendered on
each prostate cancer specimen at diagnosis?  If so, describe the Gleason
components recorded.  Are prostate cases coded or indexed by a standard
nomenclature (e.g. SNOMED)?

2.  Applicants should propose detailed plans for organizing the Prostate Cancer
Tissue Resource

a.  Applicants should propose plans to develop an archival prostate cancer tissue
resource.  Describe methods to accrue cases, as well as procedures for
identifying and retrieving tissue blocks.  Include operating procedures for
handling specimens, including quality control, inventory management, specimen
preparation, shipping, etc.  Propose appropriate procedures and methods for
obtaining and validating the demographic, clinical and outcome data, including
quality control  associated with cases, information and ideas for implementing
the database including common data elements and formats for data transmission to
the central database.

b.  Propose plans to develop a prostate tissue procurement service and a
prospective frozen tissue bank designed to include the same data as the archival
bank and describe the logistical measures required to procure and distribute
specimens.  The budget for year two should include any additional staff needed
for tissue procurement.  The budget should also list and justify any additional
equipment (liquid Nitrogen freezers, etc) needed to bank tissue.  Applicants
should clearly detail their ability to contribute to the procurement and banking
efforts, including agreements with relevant practitioners.

c.  Propose methods for marketing the Resource to the scientific community and
include the costs of these efforts as budget items.

3.  Applicants are encouraged, but not required, to include plans for developing
and contributing to an electronic image library of prostate tissues.  A large
archive of imaged biopsies linked to clinical data could permit rapid access to
morphologic information for case selection and rapid verification of diagnosis,
thus reducing the time for histology review.

4.  Since the Terms of Cooperation will be included as terms of award in all
awards issued as a result of this RFA, applicants should specify their
willingness to participate in all activities described in "Terms and Conditions
of Award," and applicants should specify their willingness to interact with the
Coordinating Committee and be bound by the actions of the Coordinating Committee. 
They should also propose what expertise is needed in order to create an effective
REP.

5.  Applicants must obtain full board IRB approval for the Resource.  Applicants
must complete the "Human Subjects" section of the PHS 398 grant application,
including plans to protect patient confidentiality and procedures to obtain
informed consent for prospective procurement of tissues and patient data.

6.  The travel budget should include funds for travel by two people to three
meetings of the Coordinating Committee in the first year of the grant and two
meetings of the Coordinating Committee in subsequent years. Travel to national
meetings to take part in exhibits to market the Resource should also be included
as a budget item.

7.  Since the REP will meet with the Coordinating Committee once a year, funds
to support travel by one member of the REP to attend one Coordinating Committee
meeting each year should also be included in each budget.

Submission Instructions

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  Applications kits are available at most institutional offices
of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, E-mail:
grantsinfo@nih.gov.  For those applicants with Internet access, the 398 kit may
be found at http://grants.nih.gov/grants/funding/phs398/forms_toc.html

The RFA label available in the PHS 398 (rev.4/98) application form must be
affixed to the bottom of the face page of the application.  Failure to use this
label could result in delayed processing of the application such that it may not
reach the review committee in time for review.  In addition, the RFA title and
number must be typed on line 2 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 photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Bethesda, MD  20892-7399
Rockville, MD  20850 (for express/courier service)

Applications must be received by August 27, 1999.  If an application is received
after that date, it will be returned to the applicant without review.  The Center
for Scientific Review (CSR) will not accept any application in response to this
RFA that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The CSR will not accept any
application that is essentially the same as one already reviewed.  This does not
preclude the submission of a substantial revision of an application already
reviewed, but such an application must follow the guidance in the PHS form 398 
application instructions for the preparation of revised applications, including
an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and for
responsiveness by the NCI.  Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NCI in accordance with the review criteria stated below.  As part of the
initial merit review, a process will be used by the initial review group in which
applications receive a written critique and undergo a process in which only those
applications deemed to have the highest scientific merit, generally the top half
of the applications under review, will be discussed, assigned a priority score,
and receive a second level review by the National Cancer Advisory Board.

Review Criteria

The goal of NIH-supported human specimen resources is to facilitate research that
advances the understanding of biological systems, improves the control of
disease, and enhances health. In the written comments reviewers will be asked to
discuss the following aspects of the application in order to judge the likelihood
that the proposed resource would have a substantial impact on the pursuit of
these goals. Each of the criteria will be addressed and considered in assigning
the overall score, weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

(1) Significance: Does the resource design fulfill the needs of the cancer
research community? Will the resource facilitate progress in the field of
prostate cancer research?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ creative approaches and methods for the
development and implementation of the resource?
(4) Investigator: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level of
the principal investigator and other participants?
(5) Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Does the proposed resource take
advantage of unique features of the institutional environment or employ useful
collaborative arrangements? Is there evidence of institutional and departmental
support for the effort?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research.  In
addition does the population represent an appropriate age distribution?
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals or the environment,
to the extent they may be adversely affected by the project proposed in the
application.

Additional scientific/technical merit criteria:
Quality and quantity of the pre-existing surgical pathology and prostate tissue
archives serving the applicant institutions

Quality of the pre-existing hospital or laboratory information services of the
applicant institutions.  This would include the completeness, quality,
extensiveness, quantity and accessibility of clinical and pathological
information pertaining to patients who have had prostate biopsies in the
applicant institutions.  It is desirable that the data be stored in electronic
form.

AWARD CRITERIA

Applications recommended by the National Cancer Advisory Board will be considered
for award based upon (a) scientific and technical merit; (b) program balance,
including in this instance, sufficient compatibility of features to make a
successful collaborative program a reasonable likelihood; and (c)  availability
of funds.

SCHEDULE

Letter of Intent Receipt:         July 29, 1999
Application Receipt Date:         August 27, 1999
Review by NCAB Advisory Board:    February 15, 2000
Earliest Anticipated Start Date:  April 1, 2000

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.  The
opportunity to clarify  any issues or questions from potential applicants is
welcome. Direct inquiries regarding programmatic issues to:

Jules J. Berman, Ph.D., M.D.
Resources Development Branch, Cancer Diagnosis Program
National Cancer Institute
6130 Executive Boulevard, Room 700, MSC-7420
Bethesda MD 20892-7240
Rockville, MD 20850 (for express/courier service)
Telephone: (301) 496-7147
FAX: (301) 402-7819
Email: bermanj@mail.nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Bethesda MD 20892-7399
Rockville, MD 20850 (for express/courier service)
Telephone (301) 496-3428
FAX:  (301) 402-0275
Email:  tf12w@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Sara Stone
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243, MSC 7150
Bethesda, MD  20892-7150
Rockville, MD 20850 (for express/courier service)
Telephone:  (301) 496-7800 ext. 266
FAX:  (301) 496-8601
Email: stones@gab.nci.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 93.3
94 Cancer Detection and Diagnosis. Awards are made under authorization of the
sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and
284) and administered under PHS grants policies and Federal Regulations 42 CFR
Parts 52 and 45 CFR Part 74 [and Part 92 when applicable for State and Local
governments]. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities ( or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.


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