COMMUNITY CLINICAL ONCOLOGY PROGRAM

Release Date:  March 16, 1999

RFA:  CA-99-006

P.T.

National Cancer Institute

Letter of Intent Receipt Date:  July 22, 1999
Application Receipt Date:  August 27, 1999

PURPOSE

The Division of Cancer Prevention (DCP), National Cancer Institute (NCI),
invites applications from domestic institutions for cooperative agreements to
the Community Clinical Oncology Program (CCOP).  Applicants for new and
currently funded Community Clinical Oncology Programs (CCOP) and research
bases are invited to respond to this Request For Applications (RFA).

Using the national resource of highly trained oncologists in community
practice, the CCOP: 1) provides support for expanding the clinical research
effort in the community setting; 2) stimulates quality care in the community
through participation in protocol studies; 3) fosters the growth and
development of a scientifically viable community cancer network able to work
closely with NCI-supported clinical cooperative groups and cancer centers; 4)
supports development of and community participation in cancer prevention and
control intervention research, which includes chemoprevention, biomarkers and
early detection, symptom management, rehabilitation, and continuing care
research; 5) involves primary care providers and other specialists in cancer
prevention and control clinical trials; and 6) increases the involvement of
minority and underserved populations in clinical research.  Combining the
expertise of community physicians and other health care professionals with
NCI-approved cancer treatment and prevention and control clinical trials
provides the opportunity for the transfer of the latest research findings to
the community level.

This reissuance of the CCOP RFA seeks to build on the strength and
demonstrated success of the CCOP over the past sixteen years by:  1)
continuing the program as a vehicle for supporting community participation in
cancer treatment and prevention and control clinical trials through research
bases (clinical cooperative groups and cancer centers supported by NCI); 2)
expanding and strengthening the cancer prevention and control research effort;
3) utilizing the CCOP network for conducting NCI-assisted cancer prevention
and control research; and 4) evaluating on a continuing basis CCOP performance
and its impact in the community.

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),
Community Clinical Oncology Program, is related to the priority area of
cancer.  Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No. 017-001-
00473-1) through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-512-1800), or at
http://www.crisny.org/health/us/health7.html

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic institutions for cooperative
agreements to continue the Community Clinical Oncology Program (CCOP).  New
applicants and currently funded programs are eligible as described below. 
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.

A.  CCOP Applicants

1. An applicant may be a hospital, a clinic, a group of practicing physicians,
a health maintenance organization (HMO), or a consortium of hospitals and/or
clinics and/or physicians and/or HMOs that agree to work together with a
principal investigator and a single administrative focus.

2. A university, Veterans Administration hospital, or military treatment
facility (MTF) may be included in an application as a member of a consortium
led by a community institution, but may not be the applicant organization or
the major contributor to accrual.  An unfunded, non-university clinical trials
cooperative group member is eligible to apply.

3. Funded Cooperative Group Outreach Program (CGOP) participants are eligible
to apply, but should state in the application that CGOP support will be
relinquished if a CCOP award is received.

4. Institutions not eligible to apply as the CCOP applicant organization
include:

a. A comprehensive, consortial, or clinical cancer center holding an NCI
Cancer Center Support (CORE) grant;

b. A university hospital that is the major teaching institution for that
university; or

c. A university hospital clinical trials cooperative group member funded by
the Division of Cancer Treatment and Diagnosis (DCTD), NCI.

B.  Research Base Applicants

An applicant may be:

1. An NCI-funded clinical trials cooperative oncology group;

2. An NCI-funded clinical center, consortium, or comprehensive cancer center.

Cooperative groups must participate in both cancer treatment and prevention
and control clinical trials; cancer centers as CCOP research bases may
participate in both cancer treatment and prevention and control studies or
cancer prevention and control research only.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be
a cooperative agreement (U10), 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. 
Details of the responsibilities, relationships and governance of the study 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 an application submitted in response to this RFA
may not exceed 3 years for new applicants, and no more than 5 years for
applicants currently supported under this program.  Currently supported
applicants will be funded for 3, 4, or 5 years depending upon priority
score/percentile, review committee recommendations, and programmatic
considerations.  The anticipated award date is June 1, 2000.

Because the nature and scope of the research proposed in response to this RFA
may vary, it is anticipated that the size of awards will vary also.  Awards
and level of support depend on receipt of a sufficient number of applications
of high scientific merit.  Although this program is provided for in the
financial plans of the NCI, awards pursuant to this RFA are contingent upon
the availability of funds for this purpose.

NCI has determined that there is a continuing program need for community
participation in cancer clinical research trials, both cancer treatment and
prevention and control.  Although this RFA is a one-time issuance, it is
expected that a CCOP RFA will be published in the NIH Guide for Grants and
Contracts annually in the future provided that funds are available.

FUNDS AVAILABLE

It is anticipated that up to $8.0 million in total costs per year for 5 years
will be committed to specifically fund applications which are submitted in
response to this RFA.  Approximately four research base awards and fifteen
CCOP awards will be made.  This level of support 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 NCI, awards pursuant to
this RFA are contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

The CCOP was initiated in 1983 to bring the benefits of clinical research to
cancer patients in their own communities by providing support for physicians
to enter patients onto treatment research protocols.  In the first three years
of the CCOP, 62 community programs in 34 states were funded and accrued 14,000
patients to NCI approved treatment clinical trials.

The CCOPs were clearly effective in accruing patients to treatment clinical
trials.  The second CCOP RFA, issued in 1986, expanded the focus to include
cancer prevention and control research based on the rationale that the multi-
institutional clinical trials model essential for testing new treatment
regimens is also central for conducting large-scale cancer prevention and
control trials.  In 1998, there were 48 programs in 30 states plus the
District of Columbia involving over 330 hospitals and over 3,500 physicians. 
Approximately 5,150 patients were entered onto treatment trials and 3,250
participants on cancer prevention and control trials in 1998.

Cancer prevention and control research in the CCOPs is aimed at reducing
cancer incidence, morbidity, and mortality through the identification,
testing, and evaluation of interventions in controlled clinical trials.  The
development of cancer prevention and control research in the CCOP network has
been increasing steadily since funding started in 1987.  Protocols cover the
full spectrum of cancer prevention and control research, from chemoprevention
and the validation of biomarkers, screening and early detection, pain control
and symptom management, and other rehabilitation and continuing care
interventions.  Several large chemoprevention trials have been implemented
through the CCOP network, including the breast cancer prevention trial with
tamoxifen, two head and neck chemoprevention trials using 13-cis retinoic acid
(13-cRA), the prostate cancer prevention trial with finasteride, and other 13-
cRA secondary tumor prevention trials.

The CCOPs are a vital resource for conducting NCI cancer prevention and
control research because they provide access to: 1) a national network for
cancer prevention and control trials which require large sample sizes for
completion; 2) geographic areas which include cross sections of the
population, providing mixes of patients/participants not always available in
university or urban settings; 3) large populations of cancer patients free of
disease which provide a unique resource for chemoprevention clinical trials;
and 4) cancer patients' family members and others who may be at increased risk
of developing cancer and thus be candidates for prevention and detection
studies.  Participation in cancer prevention and control research by CCOPs
also further expands the network of community physicians, increasing the
potential for diffusion of state-of-the-art cancer prevention and control
practices.

Objectives and Scope

The CCOP initiative is designed to:

(1) Bring the advantages of state-of-the-art cancer treatment and prevention
and control research to individuals in their own communities by having
practicing physicians and their participants enter onto NCI-approved cancer
treatment and prevention and control clinical trials; (2) Provide a basis for
involving a wider segment of the community in cancer prevention and control
research and investigate the impact of cancer therapy and control advances in
community medical practices; (3) Increase the involvement of primary health
care providers and other specialists (e.g., surgeons, family practitioners,
urologists, gynecologists) with the CCOP investigators in cancer treatment and
prevention and control research, providing an opportunity for education and
exchange of information; (4) Facilitate wider community participation,
including minorities, women and, other underserved populations, in cancer
treatment and prevention and control research approved by NCI; and (5) Reduce
cancer incidence, morbidity, and mortality by accelerating the transfer of
newly developed cancer prevention, early detection, treatment, patient
management, rehabilitation, and continuing care technology to widespread
community application.

Participating community programs (CCOPs) will be required to enter patients
onto NCI-approved cancer treatment and prevention and control clinical trials
through the research base(s) with which each CCOP is affiliated.  CCOPs may
relate directly to NCI for assistance and participation in selected cancer
prevention and control protocols.  CCOP performance will be evaluated on a
continuing basis by the NCI program director.

Participating research bases will be required to continue providing clinical
treatment and/or cancer prevention and control research protocols, as
applicable, and as studies progress and findings indicate, to develop new
protocols.  Cancer prevention and control research should be intervention-
oriented and may include such areas as cancer prevention, early detection,
symptom management, rehabilitation, quality of life, and continuing care. 
Research bases will be expected to monitor the quality of protocol conduct,
follow CCOP accrual, and participate on a continuing basis in program
evaluation.

SPECIAL REQUIREMENTS

Terms and Conditions of Award

The administrative and funding instrument used for this program is a
cooperative agreement (U10), 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 Staff.

The following terms and conditions pertaining to the scope and nature of the
interaction between 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 terms and conditions described in this section are in addition
to, and not in lieu of, otherwise applicable OMB administrative guidelines;
HHS Grant Administration Regulations at 45 CFR part 74; other HHS, PHS, and
NIH Grant Administration policy statements; and other NCI administrative terms
of award.

A.  Terms and Conditions of Award for CCOP Awardees

1. CCOP Awardees Responsibilities

The awardee's programmatic responsibilities for the conduct of the research
supported by this cooperative agreement are described in the INVESTIGATOR'S
HANDBOOK, a Manual for Participants in Clinical Trials of Investigational
Agents Sponsored by the Division of Cancer Treatment and Diagnosis, (DCTD),
National Cancer Institute and the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING
OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES and any
subsequent modifications of these documents.  These documents are hereby
incorporated by reference as term of award and are available on request from
the Cancer Therapy Evaluation Program (CTEP) or the Community Oncology and
Rehabilitation Branch (CORB), Division of Cancer Prevention (DCP).

1.a. Protocols

All protocols used by the CCOPs must be reviewed and approved for CCOP use by
the Cancer Prevention and Control Protocol Review Committee (CPCPRC), Division
of Cancer Prevention (DCP), and/or the Protocol Review Committee (PRC),
Division of Cancer Treatment and Diagnosis (DCTD), NCI, prior to
implementation.

To be eligible to receive credit for accrual to a research base protocol, the
CCOP must have an affiliation agreement with the research base responsible to
NCI for that protocol.  The research base is responsible for the development
and implementation of high quality cancer treatment and prevention and control
clinical trials, and for evaluation of the results of such studies.

1.b. Research Base Affiliation(s)

Each CCOP must affiliate with a national multi-specialty cooperative group
having a spectrum of cancer treatment and prevention and control clinical
trials.  Each CCOP can affiliate with a maximum of four additional research
bases (exceptions may be granted in conjunction with participation in an NCI
sponsored project).

Note:  A list of currently eligible research bases may be obtained from the
program official listed in the Letter of Intent Section.

If participation in the protocols of one group competes with that of another
group with which the CCOP is affiliated, the CCOP must prioritize the
protocols in order to avoid bias in the allocation of patients to competing
protocols.

Initial affiliations should be maintained for the duration of the funding
cycle.  When circumstances require changes in research base affiliations,
prior written approval from the DCP Program Director is required.

1.c. Accrual

Each CCOP is required to accrue a minimum of 50 credits* per year to treatment
clinical trials that have been approved by the PRC, DCTD, NCI.  (The 50 credit
minimum requirement may be waived for those applicants whose specialty is
pediatrics and are able to place a majority of their eligible patients on
protocols.)  As one measure of performance, it is expected that at least 10
percent of patients for whom protocols are available will be placed on
clinical trials by CCOP physicians.

Each CCOP is required to accrue a minimum of 50 credits* per year to cancer
prevention and control clinical trials that have been approved by the CPCPRC,
DCP.

The CCOPs ability to meet projected accrual goals to both cancer treatment and
prevention and control clinical trials will be assessed.  For CCOPs that have
demonstrated an outstanding record of accrual to cancer prevention and control
clinical trials, the 50 credit minimum for treatment may be waived.

*  Each protocol approved for CCOP use will be assigned a credit value. 
Credits will be based on the complexity of the intervention, the amount of
data management required, and the duration of follow-up.  For example, each
patient accrued to an average Phase II or Phase III treatment protocol will
count 1 credit; an NCI-designated high-priority treatment protocol 1.5
credits; and a childhood acute lymphocytic leukemia protocol 2 credits. 
Cancer prevention and control protocols will be assessed for credit using a
similar approach.  For example, a randomized Phase III chemoprevention
protocol will be assigned a value of 1 credit per participant entered.  Cancer
control protocols involving limited interventions will receive credit that is
commensurate with the amount of data management effort required, usually an
assignment of 0.3 or 0.5 credit per participant entered.  Follow-up credit for
chemoprevention protocols may also be assigned.

1.d. Quality Control

The CCOP must establish and follow procedures for the assurance of data
quality and quality control in accordance with research base guidelines and
NCI policies.  The CCOP must follow NCI-approved procedures developed by the
research base for the prevention and/or identification of false or otherwise
unreliable data and for quality assurance of data collected by the research
base.

The CCOP must follow policies developed by the research base and approved by
the NCI for auditing the accuracy of scientific data submitted to them by the
research base participants.

1.e. Data Management

The CCOP must provide the DCP Program Director with access to all data
generated under this award for periodic review of data management procedures
of the CCOP.  Data must also be available for external monitoring if required
by NCI's agreement with other federal agencies, such as the FDA, and with
NCI's agreements with pharmaceutical companies for the co-development of
investigational agents.  The awardees will retain custody of and primary
rights to their data.

1.f. Investigational Drug Management

Investigators performing trials under cooperative agreements will be expected,
in cooperation with NCI, to comply with all FDA monitoring and reporting
requirements for investigational agents. Specifically, all CCOP investigators
must have an active NCI Investigator Number.

1.g. Organizational Changes

Certain CCOP organizational changes must have the prior written approval of
the DCP Program Director.  These include the addition/deletion of a
participating physician, a health professional other than a physician (who
actively enters patients to cancer prevention and control trials), an
affiliate, component, or research base.

1.h. Radiotherapy Equipment

Radiotherapy equipment must have its calibration verified according to
standards set by the Radiologic Physics Center (RPC) in order for institutions
to participate in protocols requiring radiation therapy, as required by the
affiliated research base(s).

1.i. Monitoring

Each CCOP must agree to periodic on-site audits by representatives of its
research base(s), NCI, or an NCI-designee.  Such on-site audits may include
review of the following:  use of investigational drugs; compliance with
regulations for Institutional Review Board (IRB) approval and informed consent
(compliance with 45 CFR 46); compliance with protocol specifications; quality
control and accuracy of data recording; and completeness of reporting adverse
drug reactions.  Reports of such on-site audits will be reviewed by the
Clinical Trials Monitoring Branch (CTMB), Cancer Therapy Evaluation Program
(CTEP), DCTD, and by the DCP Program Director.  In addition, NCI program and
grants management staff will review protocol accrual, fiscal and
administrative procedures.

CCOP members/affiliate performance sites and/or individual investigators
participating or collaborating on NCI-supported multi-institutional clinical
trials must be in compliance with the monitoring standards established by the
research base.  They should include the following standards: (1) Medical
records submitted in support of NCI multi-institutional trials must conform to
usual standards for the maintenance of clear, accurate, and unambiguous
medical records.  White-outs on medical records are unacceptable; (2) If it is
the usual and customary practice of a department, laboratory, clinic or office
to prepare or issue official reports, then only that department, laboratory,
clinic or office can change the report, and alterations of the medical record
must be initialed and dated by the person making such alterations.  For
clinical progress notes, the change must be dated and initialed by the person
making the change.  Only one line should be placed through the initial entry,
so that both the original entry and the change are legible; (3) The improper
modification of important patient records will result in additional
investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may
lead to suspension of accrual and funding.

1.j. Reporting Requirements

Annual progress reports must be submitted to DCP.  A suggested format
developed by the DCP Program Director for this purpose will be provided.  The
inability of a CCOP to meet the performance requirements set forth in the
Terms and Conditions of Award in the RFA, or significant changes in the level
of performance, may result in an adjustment of funding, withholding of
support, suspension or termination of the award.

1.k. Network Participation

CCOPs are part of a national network for conducting cancer treatment and
prevention and control clinical trials.  As such, each CCOP may be asked to
participate in strategy sessions or workshops and in the continuing evaluation
of the program and its impact in the community.

1.l. Patient/Participant Log

Each CCOP may be asked to periodically maintain a new patient/participant log
or minimal registry to include as applicable age, sex, race, insurance status,
risk factors, primary site of cancer, stage of disease, and disposition for
the potentially eligible patient/participant pool seen by the CCOP
investigators.

1.m. Federally Mandated Regulatory Requirements

Each CCOP must establish mechanisms to meet DHHS/PHS regulations for the
protection of human subjects.  At a minimum, these include: (1) methods for
assuring that each facility at which CCOP investigators are conducting
clinical trials has a current, approved assurance on file with the Office for
Protection from Research Risks (OPRR); that each protocol is reviewed by the
responsible IRB prior to patient entry; and that each protocol is reviewed
annually by the IRB so long as the protocol is active; (2) methods for
assuring or documenting that each patient (or patient's parent/legal guardian)
gives fully informed written consent to participation in a research protocol
prior to the initiation of the experimental intervention; (3) a system for
assuring timely reporting of all serious and unexpected toxicities to the
Investigational Drug Branch, CTEP, DCTD, according to DCTD guidelines and/or
to DCP according to DCP guidelines; and (4) implementation of DCP/DCTD
requirements for storage and accounting for investigational agents provided
under DCP/DCTD sponsorship.

1.n. Publications

Timely publication of major findings is encouraged.  Publication or oral
presentation of work done under this agreement requires acknowledgment of NCI
support.

2.  NCI Staff Involvement

2.a. Protocol Review

All protocols used by the CCOPs must be reviewed and approved for CCOP use by
the Cancer Prevention and Control Protocol Review Committee (CPCPRC), DCP,
NCI, and/or the Protocol Review Committee (PRC), DCTD, NCI, prior to
implementation.

NCI will not provide investigational drugs, permit expenditure of NCI funds,
or allow accrual credit for a protocol that has not been approved, or that has
been closed (except for patients already on study).

2.b. Monitoring

There will be periodic on-site audits of each CCOP by representatives of its
research base(s), NCI, or an NCI-designee, such as DCTD's current Clinical
Trials Monitoring Service contractor.

The DCP and CTMB/CTEP will review and provide advice regarding mechanisms
established for study monitoring including the on-site auditing program.

DCP/CTEP and/or its contractor staff may attend the on-site audits conducted
by the Research Base or its NCI designee as observers.

2.c. Data Management

The DCP Program Director will have access to all data generated under this
award and will periodically review the data management procedures of the CCOP. 
Data must also be available for external monitoring if required by NCI's
agreement with other federal agencies, such as the Food and Drug
Administration (FDA).

2.d. Investigational Drug Management

The Regulatory Affairs Branch (RAB), Pharmaceutical Management Branch (PMB),
CTEP, DCTD and the Chemoprevention Branch (CB), Cancer Prevention Research
Program (CPRP), DCP will advise investigators of specific requirements and
changes in requirements about investigational drug management that the FDA and
NCI may mandate.

2.e. Organizational Changes

The DCP program director will review requests for certain organizational
changes and provide written approval.  These changes include the
addition/deletion of a participating physician or other health professional
entering patients/participants in cancer prevention and control research in
the CCOP, an affiliate, component, or research base.

2.f. Program Review

The DCP program director will review the annual progress report submitted by
each CCOP.  A suggested format will be developed by the DCP Program Director
for this purpose.  The DCP Program Director will review the progress of each
CCOP through consideration of the CCOP annual report, program site visits, and
reports from affiliated research bases.  This review may include, but not be
limited to, overall accrual credits, percent of available
patients/participants placed on study, eligibility and evaluability of
individuals entered on study, and timeliness and quality of data reporting. 
The inability of a CCOP to meet the performance requirements set forth in the
Terms and Conditions of Award in the RFA, or significant changes in the level
of performance, may result in an adjustment of funding, withholding of
support, suspension or termination of the award.

2.g. Strategy Sessions

The DCP Program Director or designee will sponsor strategy sessions when
indicated, attended by principal investigators from the CCOPs and appropriate
DCP/DCTD staff.  At these meetings, information relevant to the CCOPs will be
reviewed and discussed, including such issues as overall CCOP performance and
the science of current or proposed clinical trials.  Data will be analyzed and
the outstanding research questions established and prioritized into national
research goals by CCOP investigators and the DCP/DCTD attendees.  The
principal investigators will have the primary responsibility for analyzing and
prioritizing the research questions to be developed into clinical trials.  The
DCP Program Director will also assist the CCOP investigators in exploring
mutual interests in cancer prevention and control research.

2.h. Federally Mandated Regulatory Requirements

The DCP Program Director or designee and DCTD staff will review mechanisms
established by each CCOP to meet the Department of Health and Human Services
(DHHS)/Public Health Service (PHS) regulations for the protection of human
subjects and FDA requirements for the conduct of research using
investigational agents.

2.i. Arbitration Process

The Terms and Conditions of Award require that the DCP Program Director make
post-award administrative decisions related to program performance,
programmatic decisions on scientific-technical matters, and funding
adjustments.  NCI will establish an arbitration process when a mutually
acceptable agreement cannot be obtained between the awardee and the DCP
Program Director.  An arbitration panel (with appropriate expertise) composed
of one member of the recipient group, one NCI nominee, and a third member
chosen by the other two will be formed to review the NCI decision and
recommend a course of action to the Director, DCP.  These special arbitration
procedures in no way affect the awardee's right to appeal an adverse action in
accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS
regulations at 45 CFR Part 16.

B.  Terms and Conditions of Award for Research Base Awardees

1.  Research Base Awardees Responsibilities

It is the responsibility of the Research Base in accordance with its
constitution, bylaws, policies and procedures to develop the details of the
research design, including definition of objectives and approaches, planning,
implementation, analysis, and publication of results, interpretations and
conclusions of studies.  The research base shall designate research base
investigators to serve as Protocol Chairpersons for each proposed study. 
Protocols will be developed in accordance with the instructions in the
INVESTIGATOR'S HANDBOOK available on request from the CTEP or the CORB/DCP.

1.a. Protocol Development

The research base is responsible for the development and implementation of
high quality cancer treatment and prevention and control clinical trials, and
for evaluation of the results of such clinical trials.

The protocol should be a document mutually acceptable to the research base and
to DCP/DCTD.  Communication at the various stages of development is
encouraged.

1.b. Concept/Protocol Submission

All research base protocols utilized by the CCOPs must be reviewed and
approved for CCOP use by the Cancer Prevention and Control Protocol Review
Committee, (CPCPRC) DCP, and/or the Protocol Review Committee (PRC), DCTD,
NCI, prior to implementation.  Treatment and cancer prevention and control
protocols should be submitted to the Protocol Information Office (PIO), CTEP,
DCTD for review by the appropriate committee.

All cancer prevention and control protocols must be preceded by the submission
of a concept proposal for review by the DCP Cancer Prevention and Control
Concept Review Committee (CPCCRC).  The CPCCRC considers scientific merit and
the feasibility of implementing prospective cancer control protocols in the
CCOP research network.  Similarly, concept proposals for cancer treatment
protocols must precede protocol development.  Cancer treatment concepts are
reviewed by the CTEP Protocol Review Committee (PRC) in the DCTD.  All concept
and protocol documents should be submitted to the PIO, CTEP, DCTD.  DCTD may
also require a letter of intent for new cancer treatment trials.

1.c. Accrual

A research base for treatment research is required to accrue a minimum of 50
credits* per year from affiliated CCOPs to treatment clinical trials that have
been approved by the PRC, DCTD, NCI.  During the initial funding period, a
research base is required to develop sufficient affiliations to accrue 50
cancer treatment credits by the end of the third year.

A research base for cancer prevention and control research is required to
accrue a minimum of 50 credits* per year from CCOPs, members and other
affiliates to cancer prevention and control clinical trials that have been
approved by the CPCPRC, DCP.  During the initial funding period, a research
base is required to develop cancer prevention and control protocols to allow
accrual of 50 cancer control credits by the end of the third year.

*  Each protocol approved for CCOP use will be assigned a credit value. 
Credits will be based on the complexity of the intervention, the amount of
data management required, and the duration of follow-up.  For example, each
patient accrued to an average Phase II or Phase III treatment protocol will
count 1 credit; an NCI-designated high-priority treatment protocol 1.5
credits; and a childhood acute lymphocytic leukemia protocol 2 credits. 
Cancer prevention and control protocols will be assessed for credit using a
similar approach.  For example, a randomized Phase III chemoprevention
protocol will be assigned a value of 1 credit per participant entered.  An
additional 0.3 credits may be assigned for chemoprevention trials requiring
multiple years of follow-up.  Cancer control protocols involving limited
interventions will receive credit that is commensurate with the amount of data
management effort required.

1.d. Data Management and Analysis

The research base shall establish and implement mechanisms for data management
and analysis that ensure that data collection and management procedures are: 
(a) adequate for quality control and analysis; (b) as simple as is appropriate
in order to encourage maximum participation of physicians entering patients
and to avoid unnecessary expense; and (c) sufficiently uniform across research
bases.  CCOP members/affiliate performance sites are required to follow
procedures for data management and analysis.

Data generated are the property of the awardee; however, the research base
must provide DCP/DCTD with access to all data generated under this award.

Data must also be available for external monitoring if required by NCI's
agreement with other Federal agencies, such as the FDA and by NCI's agreements
with pharmaceutical companies for the co-development of investigational
agents.

1.e. Quality Control

A DCP/DCTD-funded research base must follow all the policies and procedures
for quality control established by NCI.  Similar policies and procedures for
quality control will be expected from cancer centers.

The research bases shall establish mechanisms for quality control of all
procedures and modalities employed in its trials.  CCOP member/affiliates are
required to follow research base procedures for quality control.

The research base shall establish mechanisms for study monitoring.  CCOP
Members/Affiliates are required to follow the awardee procedures for study
monitoring.

The research base is responsible for assuring accurate and timely knowledge of
the progress of each study through: (1) tracking and reporting of patient
accrual and adherence to defined accrual goals; (2) ongoing assessment of case
eligibility and evaluability; (3) timely medical review and assessment of
patient data; (4) Medical records used in support of NCI multi-institutional
trials must conform to usual standard for the maintenance of clear, accurate,
and unambiguous medical records.  White-outs on medical records are
unacceptable; (5) rapid reporting of treatment-related morbidity and measures
to ensure communication of this information to all parties; (6) interim
evaluation and consideration of measures of outcome as consistent with patient
safety and good clinical trials practice; (7) timely communication of results
of studies; and (8) an on-site monitoring program.

The research base is responsible for ensuring that all performance sites have
routine audits which are reported to the NCI in accordance with the NCI/CTMB
GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS
AND CCOP RESEARCH BASES.  Guidelines are available on request from the CTEP or
the CORB/DCP.  In the event that the NCI determines that the awardee failed to
comply with these guidelines, the accrual of new patients/participants to the
research base's protocols at the affected performance site shall be suspended
immediately upon notice of the NCI determination.  The suspension will remain
in effect until the awardee conducts the required audit and the audit report
is accepted by the NCI.

The research base will be responsible for notifying any affected performance
site of the suspension.  During the suspension period, no funds from this
award may be provided to the performance site for new accruals, and no changes
to the award for new accruals will be permitted.  The NCI will also notify an
institution that is the direct recipient of a cooperative agreement from the
NCI if it is necessary to suspend accrual at that institution.

1.f. Quality Assurance of Data

The research base must develop and follow procedures for the assurance of data
quality and quality control in accordance with research base guidelines and
NCI policies.  The research base must follow NCI-approved procedures for the
prevention and/or identification of false or otherwise unreliable data and for
quality assurance of data collected.

The research base must develop and implement NCI-approved policies for
auditing the accuracy of scientific data submitted to them.

In the event that there is a finding through the quality assurance and/or
quality control programs of any indication of a pattern of non-compliance with
protocol or regulatory requirements or a finding of possible alteration of
data, these findings must be reported in accordance with the NCI-CTMB
GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS
AND CCOP RESEARCH BASES.  Guidelines are available on request from the CTEP or
the CORB/DCP.

1.g. Data and Safety Monitoring Committees

The research base must establish and maintain Data and Safety Monitoring
Committees (DSMCs) for Phase III.  The policies and procedures of the DSMC
must be approved by the NCI.  The research base must comply with the approved
policies and procedures of the DSMC.

1.h. Protocol Closure

The research base shall establish a mechanism for interim monitoring of
results and monitoring protocol progress.  If the research base wishes to
close accrual to a study prior to meeting the initially established accrual
goal, the interim results and other documentation should be made available to
NCI staff for review and concurrence prior to closure.  It is recommended that
statistical guidelines for early closure be presented as explicitly as
possible in the protocol in order to facilitate these decisions.  In the event
that the DSMC has recommended early closure, DSMC procedures regarding
notification of DCP must be followed.

1.i. Protocol Reporting Requirements

Reporting requirements will be in agreement with FDA regulations and NCI
procedures.  Interim reports of each activated and ongoing study shall appear
in the minutes of each research base meeting and shall include specific data
on patient/participant accrual as well as, when appropriate, detailed reports
of treatment-associated morbidity.  Quarterly accrual reports must be provided
as appropriate to CTEP for all active studies.  A system for providing such
information in a timely manner should be in place.

1.j. Annual Progress Report

Annual progress reports, including an annual performance report on each
affiliated CCOP, must be submitted to DCP.  A suggested format developed by
the DCP Program Director for this purpose will be provided.  The DCP Program
Director will review the performance of each research base.

The annual report will include, at a minimum, information on:  overall case
accrual credits; cancer prevention and control research, existing or planned;
eligibility and evaluability of patients/participants entered on study;
timeliness and quality of data reporting; and results of quality control
review and audits if performed during that year.

Research base funding is contingent on accrual from affiliated CCOPs/Minority-
Based CCOPs and annual adjustments may be made.  The inability of a research
base to meet the performance requirements set forth in the Terms and
Conditions of Award in the RFA or significant changes in the level of
performance may result in an adjustment of funding, withholding of support,
suspension or termination of the award.

1.k. Adverse Event Procedures

In order to be in compliance with FDA regulations, all recipients of NCI
support for clinical trials, including research bases responsible for
coordinating and monitoring such trials, must promptly report adverse events
(including adverse drug reactions) to the NCI and any other trial sponsors
according to directions provided in the adverse event reporting section of the
NCI Investigator Handbook.

The awardee will notify all institutions/investigators participating in this
project, funded or unfunded, about the above requirement and about the
institutions'/investigators' responsibility to report adverse events as
specified in the protocol.  The awardee will also notify the Investigational
Drug Branch (IDB),CTEP, DCTD Drug Monitor for DCTD-sponsored investigational
agents and the Program Director for other agents, of serious or life-
threatening events, as specified in the protocol.

1.l. Performance Review

The research base shall establish policies and procedures for credentialing
participating CCOPS and conducting periodic review of the performance and
membership status of each performance site conducting prevention and control
clinical trials.  This review should examine scientific contributions, patient
accrual, data accuracy and timeliness, protocol compliance, and audit results.

1.m. Data Files Available to NCI Upon Request

Upon the request of the Grants Management Officer, NCI, copies of data files
and supporting documentation for all NCI-supported protocols that have a major
impact on patterns of care, as determined by the NCI, shall be made available
to the NCI in a timely manner.

1.n. Investigational Drug Management

Investigators performing trials under cooperative agreements will be expected,
in cooperation with DCP/DCTD to comply with all FDA distribution, monitoring,
and reporting requirements for investigational agents.

1.o. Network Participation

Research bases are part of a national network for conducting cancer treatment
and prevention and control clinical trials.  As such, each research base may
be asked to participate in strategy sessions or workshops and the continuing
evaluation of the program and its impact in the community.

1.p. Federally Mandated Regulatory Requirements

Each research base must establish mechanisms to meet FDA regulatory
requirements for clinical trials involving DCP/DCTD-sponsored investigational
agents and DHHS/PHS regulations for the protection of human subjects.  These
regulations include but are not limited to Title 21 CFR 50, 56 and 312 and
Title 45 CFR 46.  At a minimum the research base must be able to: (1)
demonstrate that each participant has a current approved assurance on file
with the NIH Office for Protection from Research Risks (OPRR); (2) demonstrate
that each protocol and informed consent is approved by the responsible
Institutional Review Board (IRB) prior to patient entry, that each
investigator has a current FDA Form 1572 and curriculum vitae on file with the
Pharmaceutical Management Branch, (PMB), CTEP; (3) demonstrate that each
patient (or legal representative) gives written informed consent prior to
entry on study; (4) implement the CTEP requirement for storage and accounting
for investigational agents provided under DCP/DCTD sponsorship; (5) establish
an on-site audit program for periodic data verification and review of
regulatory responsibilities at each CCOP, cooperative group member, and
Cooperative Group Outreach/cancer center affiliate institution; (6) provide a
method, upon DCP/DCTD request, of summarizing efficacy and toxicity data to be
included in DCP/DCTD's annual reports to the FDA for each investigational
agent; (7) establish a method for the timely reporting of all serious and
unexpected toxicities.

1.q. CCOPS/Minority-Based CCOPs

Research bases must agree to affiliate with CCOPs/Minority-Based CCOPs when
they are funded, according to guidelines established by each research base for
its affiliates, and as appropriate.

1.r. Publications

Timely publication of major findings is encouraged.  Publication or oral
presentation of work done under this agreement requires acknowledgment of NCI
support.

1.s. Procedures in the Event of Scientific Misconduct

If a duly authorized governmental or institutional body issues a final
determination that scientific misconduct has occurred or if the awardee
determines that other events have occurred which have significantly affected
the quality or integrity of the Group data or patient safety, the awardee is
responsible for notifying the Group Data and Safety Monitoring Committee
(DSMC), the CTMB, the collaborating investigators, the appropriate
Institutional Review Boards (IRBs), and other sponsors of the affected work.

The awardee is also responsible, if the events described above have occurred,
for ensuring that submitted but unpublished abstracts and manuscripts are
corrected, if possible.  If publication deadlines have passed or if abstracts
and/or manuscripts containing the affected data have already been published,
the awardee is responsible, within 90 days after learning of the event(s)
significantly affecting the quality of the Group data or patient safety, for
submitting to NCI a re-analysis of the results deleting the false or otherwise
unreliable data, and disclosing within the text the reason(s) for the
reanalysis.  The awardee must submit the reanalysis for publication.  The NCI
may disseminate information about the reanalysis as broadly as it deems
necessary.

The awardee must use its best efforts to notify all scientists, research
laboratories, and other organizations to which the awardee has sent research
materials affected by false or otherwise unreliable data.

True copies of data files and other supporting documentation from studies
affected by scientific misconduct or other findings affecting the quality or
integrity of data or patient safety shall be made available to the NCI in a
timely manner upon the request of the Grants Management Officer, NCI.  The NCI
reserves the right to reanalyze, to publish, or to distribute its analyses of
these data when it is in the interest of public health.  Prior to release,
publication or distribution of such analyses, the NCI will provide such
analyses to the awardee.

1.t. Notification of Patients by the Awardee During Patient's Lifetime

In order for there to be an appropriate response in the event the NCI
determines, either while a protocol is active or (if relevant) during the
lifetime of the participants following protocol closure, that a medically
important toxicity or side effect is associated with protocol-directed
treatment or that the medical care of one or more participants may have been
compromised by scientific misconduct or other finding affecting the integrity
of the data or patient safety at the awardee institution or at a third-party
institution, funded or unfunded, the awardee shall assure that the
institution(s) responsible for these participant(s') accrual, whether funded
or unfunded, will have procedures in place to: (a) contact each participant
individually at his or her last known address on file with the institution and
give each participant contacted appropriate information and the right to
communicate with an appropriate institutional representative and, in the event
of misconduct, to meet with a physician not connected with the clinical trial
or study in which the participant has participated; and (b) encourage
participants to notify the institution of any changes of address.  The
procedure must provide for informing the participants fully of the
consequences of the toxicity or misconduct for their care and well-being, if
any, and the availability of follow-up; and their opportunity to examine any
portion of their medical records relevant to the potential effect of the
toxicity or side effect upon them or that may be affected by scientific
misconduct or other findings affecting the quality or integrity of the data or
patient safety.

It is understood that under regulations at 45 CFR Section 74.53, NCI has a
right of access to research records pertinent to the NCI funding.  In
exceptional circumstances, such as a public health emergency, the institutions
will be required to provide participant names and treatments to the NCI in a
format which allows direct notification of the patient by the NCI.

2. NCI Staff Involvement

2.a. Scientific Resource

The Division of Cancer Prevention (DCP) and Division of Cancer Treatment and
Diagnosis (DCTD) staff will serve as a resource for specific scientific
information on cancer prevention and control clinical trials, treatment
regimens, and clinical trial design.  The DCP Program Director will assist the
research base as appropriate in developing information concerning the
scientific basis for specific trials and will also be responsible for advising
the research base of the nature and results of relevant trials being carried
out nationally or internationally.  The DCP Program Director will sponsor
strategy sessions when indicated, attended by leading investigators from the
research bases, other extramural scientists, and appropriate experts to
discuss specific research initiatives.  The Investigational Drug Branch (IDB),
Cancer Therapy Evaluation Program (CTEP), DCTD, and the Chemoprevention Branch
(CB), Cancer Prevention Research Program (CPRP), DCP, through the DCP Program
Director, will provide updated information on the efficacy, toxicity and
availability of all Investigational New Drugs (INDs) supplied by NCI to the
research base.

2.b. Protocol Development

The protocol is a document mutually acceptable to the research base and to
DCP/DCTD.  Communication at the various stages of development is encouraged. 
DCP/DCTD staff will assist the research base in protocol design as appropriate
by providing information regarding:  a) the existence and nature of concurrent
clinical trials in the area of research, with an emphasis on preventing
duplication of effort; b) relevant pharmacokinetic and pharmacodynamic data on
investigational agents; c) availability of investigational agents, including
biologic response modifiers; d) feasibility and appropriateness of the
research for use by the CCOPs and/or in a community setting; and e) basic
research in cancer centers and other NCI-funded programs which may be ready
for clinical trials.  DCP/DCTD will also comment on the scientific rationale,
programmatic relevance, priority, design, statistical requirements, and
implementation of the proposed study.

2.c. Concept/Protocol Review

All research base protocols utilized by the CCOPs must be reviewed and
approved for CCOP use by the Cancer Prevention and Control Protocol Review
Committee, (CPCPRC) DCP, NCI and/or the Protocol Review Committee (PRC), DCTD,
NCI, prior to implementation.

The major considerations in protocol review by DCP or DCTD include;  a)
strength of the scientific rationale supporting the study; b) importance of
the question being proposed; c) avoidance of undesirable duplication with
ongoing clinical trials; d) appropriateness and feasibility of study design;
e) satisfactory projected accrual rate and follow-up period; f)
patient/participant safety; g) compliance with NIH and the federal regulatory
requirements; h) adequacy of data management; and i) appropriateness of
patient/participant selection, evaluation, assessment of toxicity, response to
intervention, and follow-up.

The DCP/DCTD review committee chairperson will provide the research base with
a consensus review that describes recommended modifications and other
suggestions as appropriate.  If a protocol is disapproved, reasons will be
communicated to the research base principal investigator as a consensus review
within a reasonable time.

The DCP Program Director will work with the research base, where appropriate,
to develop a mutually acceptable protocol compatible with the research
interests, abilities, and needs of the base, its affiliates, and NCI.  Credit
will be assigned following final approval of the protocol.

NCI will not provide investigational drugs, permit expenditure of NCI funds,
or allow accrual credit for a protocol that has not been approved.

2.d. Data Management and Analysis

The awardees will retain custody of and primary rights to their data; however,
DCP/DCTD will have access to all data generated under this award.  The DCP
Program Director or a DCTD representative may review data management and
analysis procedures of the research base, under mutually agreeable
circumstances, for consistency with policies and procedures established by
DCP/DCTD for awardees conducting cancer treatment and prevention and control
clinical trials.

Data must also be available for external monitoring if required by NCI's
agreement with other federal agencies, such as the Food and Drug
Administration (FDA) and by NCI's agreements with pharmaceutical companies for
the co-development of investigational agents.

2.e. Quality Control and Monitoring

The Clinical Trials Monitoring Branch (CTMB), CTEP, DCTD/DCP Program Director
may review quality control and monitoring procedures of the research base
including the on-site auditing program for consistency with policies and
procedures established by DCTD/DCP for awardees conducting cancer treatment
and prevention and control clinical trials.

2.f. Review of Quality Control and Study Monitoring

The DCP and CTMB, CTEP will review and provide advice regarding mechanisms
established for study monitoring including the on-site auditing program.

DCP/CTEP and/or its contractor staff may attend as observers, the on-site
audits conducted by the Research Base or its NCI designee.  The frequency of
participation by an NCI representative as observer will be determined by the
NCI.

2.g. Data and Safety Monitoring Committees

The NCI Staff will assess the research base compliance with NCI established
policies on Data and Safety Monitoring Committees for Phase III trials.  One
or more DCP/CTEP staff will serve as non-voting members on the DSMC.

2.h. Investigational Drug Management

The Regulatory Affairs Branch, CTEP, DCTD, and the Chemoprevention Branch,
CPRP, DCP, staff will advise investigators of specific requirements and
changes in requirements concerning investigational drug management that the
FDA may mandate.

2.i. Program Review

Annual progress reports, including an annual performance report on each
affiliated CCOP, must be submitted to DCP.  DCP staff will provide a suggested
format for this purpose.  The DCP Program Director will review the progress of
each research base through consideration of the research base quarterly
accrual reports, annual report and program site visits.

The DCP program director will make funding recommendations based on accrual
from affiliated CCOPs/Minority-Based CCOPs and annual adjustments in funding
may be made.  The inability of a research base to meet the performance
requirements set forth in the Terms and Conditions of Award in the RFA, or
significant changes in the level of performance, may result in an adjustment
of funding, withholding of support, suspension or termination of the award.

2.j. Protocol Closure

DCP/DCTD will review research base mechanisms for interim monitoring of
results and will monitor protocol progress.  DCP/DCTD may request that a
protocol study be closed for reasons including:  a) insufficient accrual rate;
b) accrual goal met; c) poor protocol performance; d) patient/participant
safety; e) already conclusive study results; and f) emergence of new
information which diminishes the scientific importance of the study question.

NCI will not provide investigational drugs, permit expenditure of NCI funds,
or allow accrual credit for a study after requesting closure (except for
patients already on study).

2.k. Federally Mandated Regulatory Requirements

The DCP Program Director and a DCTD representative will review mechanisms
established by each research base to meet Department of Health and Human
Services (DHHS)/Public Health Service (PHS) regulations for the protection of
human subjects and FDA requirements for the conduct of research using
investigational agents.

2.l. CCOPs/Minority-Based CCOPs

The DCP Program Director will notify research bases when CCOPs/Minority-Based
CCOPs are funded.

2.m. Arbitration Process

The Terms and Conditions of Award require that the DCP Program Director make
post-award decisions related to protocol review, program performance and
adjustments in funding.  NCI will establish an arbitration process when a
mutually acceptable agreement cannot be obtained between the awardee and NCI
staff.  An arbitration panel (with appropriate expertise) composed of one
member of the recipient group, one NCI nominee, and a third member chosen by
the other two will be formed to review the NCI decision and recommend an
appropriate course of action to the Director, DCP.  These special arbitration
procedures in no way affect the awardee's right to appeal an adverse action in
accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS
regulations 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.  Program staff may also provide additional relevant
information concerning the policy.

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) application
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.

Note:  Applicants need to address the Inclusion of Children in their
application.  This CCOP RFA does not include children because the number of
children with cancer is limited and because the majority are already accessed
by a nationwide pediatric cancer research network.  This exemption is based on
Exclusion 4b of the NIH Policy and Guidelines on the Inclusion of Children as
Participants in Research Involving Human Subjects.

LETTER OF INTENT

Prospective applicants are asked to submit, by July 22, 1999, 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 is being submitted.  Although
a letter of intent is not required, is not binding, and does not enter into
the review of subsequent applications, the information allows NCI staff to
estimate the potential review workload and to avoid possible conflict of
interest in the review.

The letter of intent should be sent to the program staff listed under
INQUIRIES.

APPLICATION PROCEDURES

Preparation of Application

The research grant application form PHS-398 (rev. 4/98) is to be used in
applying for cooperative agreements.  Application 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
number (301) 435-0714, Email: grantsinfo@nih.gov.  Application kits are also
available on the internet at: http://grants.nih.gov/grants/forms.htm

A suggested format will be sent to all applicants requesting an RFA or
submitting a letter of intent.  All applicants are encouraged to obtain and
use the suggested format instructions for organizing the specific information
concerning the RFA programmatic requirements in the PHS 398.  If tables from
the "Suggestions for Organizing Information for a CCOP Application" are
included, those tables should be part of the body of the application, and not
included in the appendix.  Also, responses to the instructions concerning
"Human Subjects" verification must be provided when the application is
initially submitted.

1. CCOP Applicants

Because the Terms and Conditions of Award (discussed in the SPECIAL
REQUIREMENTS Section above) 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 NCI staff involvement as well as how all the responsibilities of awardees
will be fulfilled.

An application from a currently funded program will be a competing
continuation and must include a progress report, which at a minimum consists
of: (1) a summary of prior CCOP activities/accomplishments, including a clear
presentation of annual accrual over the funding period.  Accrual tables from
previous annual progress reports should be included.  A summary of accrual to
all cancer treatment and a summary of accrual to all cancer prevention and
control protocols by gender and ethnicity must be provided; progress in
meeting DCP's established accrual goals must be presented;  (2) a plan for
continuing to meet prevention and control accrual requirements including plans
for follow-up of participants from the large prevention trials as well as
plans for implementation of additional cancer control protocols; (3) tables of
the current budget and FTEs with a justification for any request for
additional resources; (4) an evaluation of CCOP performance by affiliated
research base(s); and (5) a complete description of how the applicant has met
the special cooperative agreement terms and conditions of the award.

For ALL Applicants:

1.a. Each applicant must delineate its catchment area.  A map of the service
area, designating counties or zip codes from which approximately 80 percent of
the patients will be drawn, should be provided.  A description of other cancer
care resources in the catchment area (i.e., hospitals, clinics, physicians,
cancer centers) which are not part of the application should be included.  In
describing the study population, a breakdown by percentage of the gender and
minority composition of the study population should be provided.  This
information may be based on the institutional records and/or prior experience.

1.b. Each applicant must demonstrate the potential and stated commitment to
accrue a minimum of 50 credits per year to treatment clinical trials (except
if waived for applicants whose specialty is pediatrics or those with an
outstanding record in cancer prevention and control accrual).  Documentation
must include any prior participation in treatment research clinical trials
with a clear presentation of the total number of patients and credits accrued
to NCI-approved treatment clinical trials.

A list of the NCI approved treatment protocols in which the applicant expects
to participate and the projected accrual to each must be provided.  Plans for
recruiting women and minority participants must be included.

1.c. Each applicant must demonstrate the potential and plans for accrual of a
minimum of 50 credits per year to cancer prevention and control protocols. 
Documentation must include any prior participation in cancer prevention and
control research clinical trials with a clear presentation of the total number
of patients and credits accrued to NCI approved cancer prevention and control
clinical trials.  A list of the NCI approved prevention and control protocols
in which the applicant expects to participate and the projected accrual must
be provided.  Plans for recruiting women and minority participants must be
included.

For NEW Applicants:

New applicants must provide implementation plans for at least two examples of
NCI-approved cancer prevention and control protocols that utilize an
intervention.  The applicant should describe their plan for implementation,
including specifics on patient/participant recruitment, compliance and follow-
up.  These studies must come from research bases with which they propose to
affiliate.

The CCOP applicant must document the ability to access the appropriate
physicians and patient/participant populations, and adequate facilities to
participate in the proposed clinical trials.
1.d. A designated Principal Investigator is required.  An associate principal
investigator should also be named to assure continuity in the event of
resignation of the principal investigator.  The qualifications and experience
of both, in terms of ability to organize and manage a community oncology
program that includes cancer treatment and prevention and control research and
related activities, as well as experience in accruing patients/participants to
treatment and cancer prevention and control clinical trials must be described.

1.e. Each applicant is expected to have a committed multidisciplinary
professional group appropriate for its expected protocol participation.  This
team may include medical oncologists, surgeons, radiation oncologists,
pathologists, oncology nurses, data managers, health educators, and other
disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family
practice) as appropriate.  The training and experience of participating
physicians must be provided, along with a description of working
relationships. Any experience working together as a group, particularly in
implementing clinical cancer treatment and prevention and control research and
related activities, should be included.  An organizational chart showing how
the group will function must also be included.

1.f. Each applicant must provide the qualifications and experience of all
proposed support personnel as well as a description of the proposed duties for
each position.

1.g. Through formal affiliations with a maximum of five research bases, one of
which must be a national multi-specialty cooperative group, each applicant
must demonstrate access to both cancer treatment and prevention and control
research protocols. Evidence must be provided that an affiliation has been
established with at least one NCI-approved research base which has the
capacity to provide both clinical cancer treatment and prevention and control
protocols.  In addition, affiliations with research bases offering only cancer
prevention and control protocols are appropriate.  The conditions of
affiliation must be provided in the CCOP-research base affiliation
agreement(s).  Initial affiliations should be maintained during the funding
cycle.

Multiple research base affiliations are permitted provided they are not
conflicting.  The affiliation agreements must state specifically how the
problem of competing protocols will be resolved.

Note:  A list of currently eligible research bases may be obtained from the
program official listed in the Letter of Intent Section.

1.h. Quality control procedures must be described in detail.  Assurance of
quality is the joint responsibility of the CCOP and its research base(s). 
Quality control procedures of the research base will be applied to the CCOPs
and should be specified in the CCOP-research base affiliation agreement.

Procedures for investigational drug monitoring and data management must also
be described.

1.i. The availability of facilities, including laboratories, inpatient and
outpatient resources, cancer registries, etc., must be described.  A statement
of commitment from each participating institution or organization and/or
documentation of consortium arrangements must be provided.  Evidence of
involvement with community-based voluntary organizations may be submitted.  In
addition, each applicant must have a defined space for administrative
activities and administrative personnel which will serve as a focus for data
management, quality control, and communication.

1.j. Allocation of funds to support community costs for receipt, handling, and
quality control of patient data must be specified.  Allowable items in the
budget are requests for full or part-time administrative personnel, clinical
research associates, data managers, and study assistants; supplies and
services directly related to study activities (e.g., processing and sending
material for pathology review, processing and sending port films for radiation
therapy quality control); and appropriate travel to meetings directly related
to study activities (e.g., research base meetings, NCI-sponsored strategy
sessions/workshops, local travel).  Funding is not allowed for clinical care
provided to patients (e.g., reimbursement of patient care expenses;
transportation costs).  Funding is not allowed for clinical support personnel
(e.g. pharmacist, physicist, clinical psychologist, dosimetrist).  Physician
compensation is only an allowable cost for the Principal Investigator (PI) and
Co-PI, specifically for time spent on CCOP organizational/administrative
tasks.  Justification must be provided for personnel time, effort and funds
requested.
2. RESEARCH BASE Applicants

Because the Terms and Conditions of Award (discussed in the Special
Requirements Section above) 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 NCI staff involvement as well as how all the responsibilities of awardees
will be fulfilled.

An application from a currently funded research base will be a competing
continuation and must include a progress report, which at a minimum consists
of: 1) a summary of prior research base activities/accomplishments, including
a clear presentation of annual accrual to cancer treatment and annual accrual
to cancer prevention and control protocols (gender and racial/ethnic minority
composition) from affiliated CCOPs over the funding period; 2) progress in
developing and implementing a cancer prevention and control research program. 
Include the process and organizational structure for protocol development and
implementation, selection and evaluation (auditing) of performance sites, data
management, quality control, statistical analysis, and study safety
monitoring; 3) a clear presentation of annual accrual to each NCI-approved
prevention and control clinical trial for CCOPs, and research base members and
affiliates; (4) status of concepts and protocols under development; (5) a
description of how the applicant has met the special cooperative agreement
terms and conditions of the award.

Cooperative groups must participate in both cancer treatment and prevention
and control clinical trials; cancer centers may participate in cancer
treatment and prevention and control clinical trials or cancer prevention and
control research only.

In describing the study population, it is required that a description of the
gender and minority population and subpopulation served be provided, as well
as an outreach plan.  This information may be based on the institutional
records and/or prior experience.

2.a. Each applicant must demonstrate the ability to design and implement
multi-institutional treatment clinical trials (if applicable).

A list of treatment protocols available for CCOP participation must be
provided.

2.b. Each applicant must demonstrate the ability to design and implement
multi-institutional cancer prevention and control clinical trials.

A list of cancer prevention and control protocols available for CCOP
participation must be provided.

New research base applicants must also provide at least two examples of active
or proposed cancer prevention and control intervention clinical trials and
describe plans for study design, intervention(s), and statistical
considerations; access to potential patients/participants to be studied; and
procedures for data management, quality control, and follow-up.  The
availability of appropriate expertise to design, implement, and analyze the
results of the proposed clinical trials must be documented.

2.c. Each applicant must have an organizational structure for involving
appropriate personnel in the design and implementation of treatment and/or
cancer prevention and control research.  An organizational chart and a
description of the research base operations showing the relationship(s)
between the scientific and administrative functional units of the research
base, vis-a-vis the conduct of treatment and/or cancer prevention and control
clinical trials, must be provided.

The organizational focus within the research base for cancer prevention and
control research must be described, including the composition and activities
of the research base cancer prevention and control committee, or equivalent,
and its relationship to other clinical trial committees and activities.

2.d. Collaboration with affiliated CCOPs/Minority-Based CCOPs in treatment
and/or cancer prevention and control research, as applicable, is required.
CCOP-research base affiliation agreements must be included in the application.
For treatment research, each applicant must demonstrate the ability to accrue
a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to
treatment clinical trials. During the initial funding period a research base
must demonstrate that they have developed sufficient CCOP affiliations to
accrue a minimum of 50 cancer treatment credits by the end of the third year.

For cancer prevention and control research, each applicant must demonstrate
the ability to accrue a minimum of 50 credits per year from affiliated
CCOPs/Minority-Based CCOPs, members and other affiliates to cancer prevention
and control clinical trials.  During the initial funding period a research
base must develop cancer prevention and control protocols to allow accrual of
a minimum of 50 cancer prevention and control credits by the end of the third
year.

It is expected that selected cooperative group members and/or Cooperative
Group Outreach/cancer center affiliates other than the CCOPs will participate
in cancer prevention and control research.  Research Base applications can
include requests for non-CCOP member institutions to become "prevention
members." The Research Base applicants must describe the experience and
contribution of the non-CCOP member institution to the science and accrual to
cancer chemoprevention clinical trials.  The applicant must indicate the
participants and their expected level of participation, and describe their
ability to participate.

2.e. A designated Principal Investigator is required and his/her
qualifications and experience must be described.  An individual must be
designated to coordinate cancer prevention and control research.  His or her
qualifications and experience within the research base structure should also
be described.  Each applicant must also demonstrate the ability to access
professionals with the appropriate expertise to design and implement the
proposed treatment and/or cancer prevention and control clinical trials. 
Basic scientists, medical, surgical, radiation and other oncology specialists,
nurse oncologists, epidemiologists, health educators and/or other public
health professionals may be included.

2.f. Each applicant's ability to manage the data from multi-institutional
treatment and/or cancer prevention and control clinical trials must be
described.  Data management includes development of data collection forms,
procedures for data transmittal, procedures for data entry, data editing,
compilation, and analysis, as well as procedures for quality control and
verification of submitted data.  Standards should exist for determining
eligibility and evaluability of patients/participants entered on protocols. 
Statistical capability must exist to develop protocol statistical parameters,
analyze the data, and report results.

2.g. Each applicant must demonstrate the ability to initiate procedures for
training and maintaining the proficiency of personnel from affiliated
CCOPs/Minority-Based CCOPs on techniques for successful management of
treatment and/or cancer prevention and control clinical trials research. 
Depending on the clinical trials initiated and the interventions involved,
this will include training for data managers/nurses and any other individuals
responsible for data collection, monitoring, or carrying out the
intervention(s).

2.h. Each applicant's ability to provide mechanisms for periodic review of the
performance of affiliated CCOPs/Minority-Based CCOPs, including on-site
monitoring (auditing) and written procedures and criteria for continued
affiliations, must be described.  Similar measures must be described for other
member/affiliates participating in cancer prevention and control research.

2.i. Each applicant must describe its plan for independent data and safety
monitoring for all phase III prevention and control clinical trials.

2.j. Requests for funds must reflect operations/statistical costs for quality
control and data management costs for CCOP participation in protocols.  This
estimate is based on the expected accrual credits of affiliated
CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer
prevention and control.  CCOP-research base affiliation agreements must be
included.  Each applicant should include a budget for monitoring and auditing
activities.  Funding can be requested for scientific development and pilot
testing of new cancer prevention and control research initiatives (including
support of a cancer prevention and control committee for the research base),
and funds can also be requested for appropriate travel to meetings directly
related to study activities (such as NCI-sponsored strategy
sessions/workshops).  In addition, the Research Bases may request funding for
specific non-CCOP member institutions that apply to become "prevention
members."  Specific justification must be provided.

Method of Applying

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)

Photocopies must be clear and single-sided.  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  20852 (for express/courier service)

It is important to send these copies at the same time that the original and
three copies are sent to CSR; otherwise, the NCI cannot guarantee that the
applications will be reviewed in competition with other applications received
on or before the designated receipt date.

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 substantial
revisions of applications 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

A. REVIEW PROCEDURES

Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the NCI staff.  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.

B. REVIEW CRITERIA

1.  CCOP Applicants

All applicants will be evaluated on the following criteria:

1.a. Adequacy of plans to include both genders and minorities and their
subgroups.  Plans for the recruitment and retention of participants will also
be evaluated.  In describing the study population, it is required that a
description of the gender and minority population and subpopulation served be
provided, as well as an outreach plan.  This information may be based on the
institutional records and/or prior experience.

1.b. Ability to accrue a minimum of 50 credits per year to treatment clinical
trials and a minimum of 50 credits per year to cancer prevention and control
clinical trials.  Established CCOPs will be funded at a yearly accrual goal
that may be higher than 50 credits for treatment clinical trials and 50
credits for cancer prevention and control clinical trials.  These established
CCOPs will be evaluated for their past performance in meeting these accrual
goals.  The minimum treatment accrual requirement may be waived for applicants
whose specialty is pediatrics, or for applicants with an outstanding record in
prevention and control.  Each applicant's ability to access the appropriate
populations, professional disciplines, and facilities to participate with
affiliated research bases in NCI-approved cancer prevention and control
intervention protocols will be appraised.  Any prior participation in cancer
treatment and prevention and control research will be considered.  For new
CCOP applicants, the plans for implementing at least two NCI-approved
protocols will be assessed for feasibility and practicality.

1.c. Qualifications and experience of the principal investigator/associate
principal investigator, in terms of ability to organize and manage a community
oncology program that includes both cancer treatment and prevention and
control research as well as accrual to such protocols, and related activities.

1.d. Training, experience, and commitment of participating physicians for
accruing individuals to protocols in which the applicant has agreed to
participate.  The experience of proposed investigators in the entry and
treatment of cancer patients on research trials (gained from residency,
fellowships, postdoctoral training and/or subsequent practice) will be
appraised.  For multidisciplinary studies, evidence of the availability of
appropriate professional resources (e.g., radiotherapy, pediatrics, surgery,
gynecology, urology, pathology, internal medicine, family practice, nursing,
and nutrition) will be required.  Experience or special skills in cancer
prevention and control research and related activities will be considered,
together with availability of other community resources and personnel for such
clinical trials.

1.e. Stability of the functional unit or group applying to become a CCOP. 
Preexisting organizational affiliations of at least a core of the group
applying, and evidence of stable working relationships, will be appraised. 
Examples of established consortium arrangements, and committee structure which
demonstrates the participation of appropriate physicians and administrators,
may be submitted.  Evidence of previous success as a group in implementing
clinical cancer treatment and prevention and control research and related
activities will be considered.

1.f. Qualifications and experience of all proposed support personnel relative
to their position descriptions.  The relevant credentials and expected
contributions to the program of personnel resources not fiscally supported by
the award will be considered.

1.g. Adequacy of quality assurance mechanisms for both cancer treatment and
prevention and control interventions, and adequacy of procedures for
investigational drug monitoring and data management and identification of
false or otherwise unreliable data.

1.h. Adequacy of available facilities, including laboratories, in-patient and
outpatient resources, cancer registries, etc., and adequacy of space for
administrative activities and personnel.

1.i. Appropriateness of research base affiliations and of the cancer treatment
and prevention and control research protocols chosen.  Affiliation agreements
must be provided in the application.

The review group will critically examine the submitted budget and will
recommend an appropriate budget and period of support for each favorably
recommended application.

Allowable items in the budget are requests for full or part-time
administrative personnel, clinical research associates, data managers, and
study assistants; supplies and services directly related to study activities
(e.g., processing and sending material for pathology review, processing and
sending port films for radiation therapy quality control); and appropriate
travel to meetings directly related to study activities (e.g., research base
meetings, NCI-sponsored strategy sessions/workshops, local travel).  Funding
is not allowed for clinical care provided to patients (e.g., patient care
reimbursement, transportation costs).  Funding is not allowed for clinical
support personnel (e.g. pharmacist, physicist, clinical psychologist,
dosimetrist).  Physician compensation is only an allowable cost for the
Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP
organizational/administrative tasks.  Justification must be provided for
personnel time and effort and funds requested.

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups and plans for the recruitment and retention of
subjects; the provisions for the protection of human and animal subjects; and
the safety of the research environment.

For competing continuations, the review group will critically examine the
adequacy of progress during the funding period, including ability to meet the
accrual goals in cancer treatment and prevention and control, progress made as
a CCOP, and evaluation of CCOP performance by affiliated research bases(s). 
Consideration will be given to previous accrual and the ability to meet the
previous accrual projections for which the CCOP was funded.  The research base
evaluation report(s) must be provided in the application.  Plans for continued
accrual and follow-up of participants on protocols will be evaluated.

2.  Research Base Applicants

All research base applicants will be evaluated on the following criteria:

2.a. Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of participants will also be evaluated.  In
describing the study population, it is required that a description of the
gender and minority population and subpopulation served be provided, as well
as an outreach plan.  This information may be based on the institutional
records and/or prior experience.

2.b. Experience in conducting multi-institutional clinical trials;
demonstrated ability to develop such studies and act as a coordinating and
statistical center; adequate facilities to conduct the clinical trials;
adequate procedures to collect, monitor, and analyze the data and assure the
safety of patients/participants.

2.c. Quality and availability of cancer treatment and/or prevention and
control protocols, as applicable, which are appropriate for CCOP
participation, or the potential for developing such clinical trials.  For new
applications, a detailed description of at least two examples of actual or
planned cancer prevention and control protocols, with professional expertise
to assure the quality of the proposed intervention clinical trial will be
evaluated.

2.d. The ability to accrue a minimum of 50 credits per year from affiliated
CCOPs/Minority-Based CCOPs to treatment clinical trials.

The ability to accrue a minimum of 50 credits per year from affiliated
CCOPs/Minority-Based CCOPs to cancer prevention and control clinical trials. 
Experience as well as the potential for developing future clinical trials will
be considered.

Documentation must include CCOP-research base affiliation agreements.

2.e. Organizational structure for involving appropriate personnel in the
design and implementation of treatment and/or cancer prevention and control
research.  The organizational focus within the research base for cancer
prevention and control research, including the composition and activities of
the cancer prevention and control committee, and the designation of protocol
chairpersons and its relationship to other clinical trial committees and
activities will be assessed.

2.f. Qualifications and experience of the principal investigator and/or the
individual responsible for directly relating to the CCOPs.  The availability
and experience of multidisciplinary health professionals and allied
professionals with skills needed to develop, utilize, and analyze treatment
and/or cancer prevention and control clinical trials will also be evaluated. 
The qualifications and contribution to the science and accrual of cancer
chemoprevention clinical trials will be assessed in the evaluation of the
Research Base's request for the non-CCOP member institutions that apply for
the designation of "prevention member".

2.g. Experience in working with community oncologists, orienting community
data management personnel to protocol requirements, organizing scientific and
educational meetings for those participating in the clinical trials, and
participating in intergroup clinical trials.

2.h. Ability to establish quality control, quality assurance, and data
management procedures.  Experience in data management and analysis of multi-
institutional clinical trials and adequacy of data management staff will be
appraised.  The use of mechanisms for periodic review of quality control,
quality assurance, and data management procedures, safety monitoring,
including procedures for data safety and monitoring committee and on-site
auditing program will be assessed.

2.i. For competitive continuations, adequacy of progress in implementing a
prevention and control clinical trials program including cancer prevention and
control protocol development and implementation, accrual, data management,
evaluation of performance sites; current status of each protocol and progress
towards meeting planned accrual goals from CCOPs and members/affiliates;
summary of prior activities with a clear presentation of annual accrual;
completion of clinical trials, interim analyses, publication of findings, or
other dissemination of trial findings throughout the research base; and other
progress in meeting the requirements for a CCOP research base.  During the
initial funding period, a research base must demonstrate the adequacy of
progress in implementing a cancer prevention and control clinical trials
program that will result in attainment of accrual goals by the end of the
third year.

The review group will critically examine the submitted budget and will
recommend an appropriate budget and period of support for each favorably
recommended application.

Requests for funds must reflect operations/statistical costs for quality
control and data management costs for CCOP participation in protocols.  This
estimate is based on the expected accrual credits of affiliated
CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer
prevention and control.  Research bases should include a budget for monitoring
and auditing costs.  Funding may be requested for scientific development and
pilot testing of new cancer prevention and control research initiatives, other
costs related to implementation of specific cancer prevention and control
protocols (including support of a cancer prevention and control committee for
the research base), or for appropriate travel to meetings directly related to
study activities (such as NCI-sponsored strategy sessions/workshops).
Additionally, funding may be requested to provide infrastructure support for
non-CCOP member institutions of the Research Bases that can show significant
contribution to the science and/or accrual for chemoprevention trials.
Specific justification must be provided.

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects; the
provisions for the protection of human and animal subjects; and the safety of
the research environment.

AWARD CRITERIA

The anticipated date of award is June 1, 2000.  Applications recommended by
the National Cancer Advisory Board will be considered by NCI staff for award
based upon (a) scientific and technical merit; (b) demographic and geographic
distribution of applicants to assure inclusion of minority and underserved
population; (c) availability of funds.  Multiple CCOP applicants for funding
who are competing for the same patient population will be considered, but all
may not be awarded unless warranted by the population density.

SCHEDULE

Letter of Intent Receipt Date:  July 22, 1999
Application Receipt Date:       August 27, 1999
Review by NCAB Advisory Board:  February 2000
Anticipated Award Date:         June 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:

Lori Minasian, MD, FACP
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Room 300-D, MSC-7340
Bethesda, MD  20892-7340
Telephone:  (301) 496-8541
FAX:  (301) 496-8667
Email:  lm145a@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  20852 (for express/courier service)
Telephone:  (301) 496-3428
FAX:  (301) 496-0275
Email:  tf12w@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, Ext. 282
FAX:  (301) 496-8601
Email:  WolfreyC@gab.nci.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.399, Cancer Control.  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 grant policies and
Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.

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.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.