Full Text CA-97-015
 
COMMUNITY CLINICAL ONCOLOGY PROGRAM
 
NIH GUIDE, Volume 26, Number 18, May 30, 1997
 
RFA:  CA-97-015
 
P.T.  34

Keywords: 
  Cancer/Carcinogenesis 
  Clinical Trial 
  Diagnosis, Medical 
  Disease Prevention+ 

 
National Cancer Institute
 
Letter of Intent Receipt Date:  July 10, 1997
Application Receipt Date:  August 26, 1997
 
PURPOSE
 
The Division of Cancer Prevention and Control (DCPC), 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, patient 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 issuance of the CCOP RFA seeks to build on the strength and
demonstrated success of the CCOP over the past fourteen 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 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 "Healthy People
2000" (Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
D.C.  20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted from 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, Diagnosis, and
Centers,(DCTDC), 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,m 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 applications 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, 1998.
 
Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the sizes 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.  While 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 $4.2 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 twelve 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
 
A.  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
1996, there were 51 programs in 30 states plus the District of
Columbia involving over 300 hospitals and over 3,300 physicians.
Approximately 3,700 patients were entered onto treatment trials and
2,200 subjects on cancer prevention and control trials in 1996.
 
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-cis retinoic
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/subjects 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.
 
B.  Goals and Scope
 
The CCOP initiative is designed to:
 
o 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
patients/subjects participate in NCI-approved cancer treatment and
prevention and control clinical trials;
 
o 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;
 
o 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;
 
o Facilitate wider community participation, including minorities,
women, and other underserved populations, in cancer treatment and
prevention and control research approved by NCI; and
 
o 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, patient management,
rehabilitation, 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
 
A.  Terms and Conditions of Award for CCOP Awardees
 
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 of Award:
Nature of NCI Staff Involvement" and "Terms and Conditions:
Responsibilities of Awardees" described in this section are in
addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines; DHHS grant administration regulations 45
CFR 74; other DHHS, PHS, and NIH grant administration policy
statements; and other NCI administrative terms of award.
 
1. Responsibilities of CCOP Awardees
 
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, Diagnosis, and Centers (DCTDC), 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
CORB/DCPC.
 
1.a. Protocols
 
All protocols used by the CCOPs must be reviewed and approved for
CCOP use by the Cancer Control Protocol Review Committee (CCPRC),
Division of Cancer Prevention and Control (DCPC), and/or the Protocol
Review Committee (PRC), Division of Cancer Treatment, Diagnosis, and
Centers (DCTDC), 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.
 
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 DCPC 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, DCTDC,
NCI.  (For applicants whose specialty is pediatrics, the 50 credit
minimum requirement may be waived for those applicants who 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 CCPRC, DCPC.
 
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
subject 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 subject 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 DCPC 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.
 
1.g. Organizational Changes
 
Certain CCOP organizational changes must have the prior written
approval of the DCPC 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), DCTDC, and by the DCPC 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:
 
o Medical records submitted 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.
 
o 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 initialled 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.
 
o 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 DCPC.  A suggested
format developed by the DCPC 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/Subject Log
 
Each CCOP may be asked to periodically maintain a new patient/subject
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/subject
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:
 
o 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;
 
o 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;
 
o a system for assuring timely reporting of all serious and
unexpected toxicities to the Investigational Drug Branch, CTEP,
DCTDC, according to DCTDC guidelines and/or to DCPC according to DCPC
guidelines; and
 
o implementation of DCPC/DCTDC requirements for storage and
accounting for investigational agents provided under DCPC/DCTDC
sponsorship.
 
1.n. Publications
 
Timely publication of major findings is encouraged.  Publication or
oral presentation of work done under this agreement requires
acknowledgement of NCI support.
 
2.  Nature of NCI Staff Involvement
 
2.a. Protocol Review
 
All protocols used by the CCOPs must be reviewed and approved for
CCOP use by the Cancer Control Protocol Review Committee (CCPRC),
DCPC, NCI, and/or the Protocol Review Committee (PRC), DCTDC, 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 DCTDC's
current Clinical Trials Monitoring Service contractor.
 
The DCPC and CTMB/CTEP will review and provide advice regarding
mechanisms established for study monitoring including the on-site
auditing program.
 
DCPC/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 DCPC 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, DCTDC, and Chemoprevention Branch (CB), Chemoprevention
Research Program (CPRP), and DCPC staff 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 DCPC 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/subjects in cancer prevention
and control research in the CCOP, an affiliate, component, or
research base.
 
2.f. Program Review
 
The DCPC program director will review the annual progress report
submitted by each CCOP.  A suggested format will be developed by the
DCPC Program Director for this purpose.  The DCPC 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/subjects
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 DCPC Program Director or designee will sponsor strategy sessions
when indicated, attended by principal investigators from the CCOPs
and appropriate DCPC/DCTDC 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 DCPC/DCTDC attendees. The
principal investigators will have the primary responsibility for
analyzing and prioritizing the research questions to be developed
into clinical trials. The DCPC 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 DCPC Program Director or designee and DCTDC 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 DCPC 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 DCPC 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, DCPC.  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.
 
B.  Terms and Conditions of Award for Research Base Awardees
 
1.  Responsibilities of Awardees
 
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.
 
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 DCPC/DCTDC.  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 Control Protocol Review
Committee (CCPRC), DCPC, and/or the Protocol Review Committee (PRC),
DCTDC, NCI, prior to implementation.  Treatment and cancer prevention
and control protocols should be submitted to the Protocol Information
Office (PIO), CTEP, DCTDC 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 DCPC Cancer
Control Concept Review Committee (CCCRC).  The CCCRC 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 DCTDC.  All concept and
protocol documents should be submitted to the PIO, CTEP, DCTDC.
DCTDC 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, DCTDC, 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 CCPRC, DCPC.  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
subject entered.  An additional 0.3 credits may be assigned for
chemoprevention trials requiring multiply 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 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 is the property of the awardee; however, the research
base must provide DCPC/DCTDC 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 DCPC/DCTDC-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:
 
o tracking and reporting of patient accrual and adherence to defined
accrual goals;
 
o ongoing assessment of case eligibility and evaluability;
 
o timely medical review and assessment of patient data;
 
o 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;
 
o rapid reporting of treatment-related morbidity and measures to
ensure communication of this information to all parties;
 
o interim evaluation and consideration of measures of outcome as
consistent with patient safety and good clinical trials practice;
 
o timely communication of results of studies; and
 
o 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.  In the event
that the NCI determines that the awardee failed to comply with these
guidelines, the accrual of new patients/subjects 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.
 
1.g. Data and Safety Monitoring Committees
 
The research base must establish and maintain Data and Safety
Monitoring Committees (DSMCs) for Phase III prevention and control
clinical trials.  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 DCPC 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/subject 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 DCPC.  A suggested format
developed by the DCPC Program Director for this purpose will be
provided.  The DCPC 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/subjects 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 protocol.
 
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, DCTDC Drug Monitor
for DCTDC-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, true 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 DCPC/DCTDC 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 DCPC/DCTDC-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:
 
o demonstrate that each participant has a current approved assurance
on file with the NIH Office for Protection from Research Risks
(OPRR).
 
o 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.
 
o demonstrate that each patient (or legal representative) gives
written informed consent prior to entry on study.
 
o implement the CTEP requirement for storage and accounting for
investigational agents provided under DCPC/DCTDC sponsorship.
 
o 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.
 
o provide a method, upon DCPC/DCTDC request, of summarizing efficacy
and toxicity data to be included in DCPC/DCTDC's annual reports to
the FDA for each investigational agent.
 
o 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
acknowledgement 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 subjects 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
subjects 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 subject(s') accrual, whether funded or
unfunded, will have procedures in place to; (a) contact each subject
individually at his or her last known address on file with the
institution and which give each subject 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 subject has participated; and (b) encourage subjects to
notify the institution of any changes of address.  The procedure must
provide for informing the subjects 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 subject names
and treatments to the NCI in a format which allows direct
notification of the patient by the NCI.
 
2.  Nature of NCI Staff Involvement
 
2.a. Scientific Resource
 
The Division of Cancer Prevention and Control (DCPC) and Division of
Cancer Treatment, Diagnosis, and Centers (DCTDC) staff will serve as
a resource for specific scientific information on cancer prevention
and control clinical trials, treatment regimens, and clinical trial
design.  The DCPC 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 DCPC 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), DCTDC,  Chemoprevention Branch (CB), DCPC, through
the DCPC 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 should be a document mutually acceptable to the research
base and to DCPC/DCTDC.  Communication at the various stages of
development is encouraged.  DCPC/DCTDC 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.  DCPC/DCTDC 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 (CCPRC), DCPC, NCI and/or the (PRC),
DCTDC, NCI, prior to implementation.
 
The major considerations in protocol review by DCPC or DCTDC 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/subject
safety; g) compliance with NIH and the federal regulatory
requirements; h) adequacy of data management; and i) appropriateness
of patient/subject selection, evaluation, assessment of toxicity,
response to intervention, and follow-up.
 
The DCPC/DCTDC 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 DCPC 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, DCPC/DCTDC will have access to all data generated under this
award.  The DCPC Program Director or a DCTDC representative may
review data management and analysis procedures of the research base,
under mutually agreeable circumstances, for consistency with policies
and procedures established by DCPC/DCTDC 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, DCTDC/DCPC
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 DCTDC/DCPC
for awardees conducting cancer treatment and prevention and control
clinical trials.
 
2.f. Review of Quality Control and Study Monitoring
 
The DCPC and CTMB/CTEP will review and provide advice regarding
mechanisms established for study monitoring including the on-site
auditing program.
 
DCPC/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 DCPC/CTEP staff will serve as non-
voting members on the DSMC.
 
2.h. Investigational Drug Management
 
The Regulatory Affairs Branch, CTEP, DCTDC, and CISB, CPRP, DCPC,
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 DCPC.  DCPC staff will
provide a suggested format for this purpose.  The DCPC 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 DCPC 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
 
DCPC/DCTDC will review research base mechanisms for interim
monitoring of results and will monitor protocol progress.  DCPC/DCTDC
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/subject 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 DCPC Program Director and a DCTDC 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 DCPC 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 DCPC 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, DCPC.  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 subpopulations 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 (Section 492B of Public Law
103-43).
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which was published in the Federal
Register of March 28, 1994 (59 FR 14508-14513) and in the NIH GUIDE
FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by July 10, 1997, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the principal
investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.
 
Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NCI staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Jeffrey A. Perlman, M.D., M.Sc.
Division of Cancer Prevention and Control
National Cancer Institute
6130 Executive Boulevard, Room 300-D - MSC-7340
Bethesda, MD  20892-7340
Telephone:  (301) 496-8541
Email:  PerlmanJ@dcpcepn.nci.nih.gov
 
APPLICATION PROCEDURES
 
A. PREPARATION OF APPLICATION
 
General instructions for the preparation of the cooperative agreement
application are contained in the Grant Application Form PHS-398 (rev.
5/95). 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 competitive
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 DCPC'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 subjects 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
subjects must be included.
 
For NEW Applicants:
 
New applicants must provide at least two examples of NCI-approved
intervention cancer prevention and control protocols appropriate for
CCOP's participation. The applicant should describe their
implementation, including specifics on patient/subject recruitment,
compliance and follow-up.  These studies must come from research
base's with which they propose to affiliate.
 
The CCOP applicant must document the ability to access the
appropriate physicians and patient/subject 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/subjects 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, only one of which may 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
competitive 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 a 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/subjects
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.
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/subjects 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 their plans 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).  Specific justification must be provided.
 
METHOD OF APPLYING
 
The research grant application form PHS-398 must be used in applying
for cooperative agreements.  These forms are available at most
institutional business offices; from the Office of Extramural
Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD, 20892-7910, Phone number (301) 435-0714, E-mail:
asknih@odrockm1.od.nih.gov; and from the NCI program official named
in the LETTER OF INTENT Section.
 
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.
 
The RFA label available in the PHS-398 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, exact photocopies, in one package to
DRG at the address below.  The photocopies must be clear and single
sided.
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
must also be sent to:
 
Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard - Room 636
Bethesda, MD  20892
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 DRG; 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 26, 1997.  If an application
is received after that date, it will be returned to the applicant
without review. The Division of Research Grants (DRG) 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 DRG will not accept any
application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
A. REVIEW PROCEDURES
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NCI staff.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NCI staff will return it.
 
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, all
applicants will receive a written critique and may undergo a process
in which only those applications deemed to have the highest
scientific merit will be discussed, assigned a priority score, and
received a second level review by the appropriate 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 as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects 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 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.
 
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.
 
1.j. For competitive continuations, 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 subjects
on protocols will be evaluated.
 
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 provisions for the
protection of human subjects, recruitment plans for the inclusion of
women, minorities and sub-populations to clinical trials, and the
safety of the research environment.
 
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 subjects 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/subjects.
 
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.
 
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). Specific justification must be
provided.
 
The initial review group will also examine the provisions for the
protection of human subjects, the plans for the accrual of women,
minorities and sub-populations to clinical trials, and the safety of
the research environment.
 
AWARD CRITERIA
 
The anticipated date of award is June 1, 1998.  NCI program staff
will take into account demographic and geographic distribution of
applicants in the final funding selection process to assure inclusion
of minority and underserved populations.  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.
 
INQUIRIES
 
Written and telephone inquiries concerning the objectives and scope
of this RFA or inquiries about whether or not specific proposed
research would be responsive are encouraged.  The program official
welcomes the opportunity to clarify any issues or questions from
potential applicants.
 
Jeffrey A. Perlman, M.D., M.Sc.
Division of Cancer Prevention and Control
National Cancer Institute
6130 Executive Boulevard, Room 300-D - MSC-7340
Bethesda, MD  20892-7340
Telephone:  (301) 496-8541
Email:  PerlmanJ@dcpcepn.nci.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Ms. Crystal Wolfrey
Grants Administration Branch
Office of the Director, NCI
Executive Plaza South - Room 243
6120 Executive Boulevard
Bethesda, Maryland  20892
Telephone:  (301) 496-7800, Ext. 282
E-mail: WolfreyC@gab.nci.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 13.399, Cancer Control.  Awards are 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 Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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