Full Text CA-97-022
 
INFORMATICS SUPPORT FOR BREAST AND COLON CANCER COOPERATIVE FAMILY
REGISTRIES
 
NIH GUIDE, Volume 26, Number 25, August 1, 1997
 
RFA:  CA-97-022
 
P.T. 34

Keywords: 
  0710078 
  Cancer/Carcinogenesis 
  0715036 
  Registries+ 

 
National Cancer Institute
 
Letter of Intent Receipt Date:  September 3, 1997
Application Receipt Date:  October 7, 1997
 
PURPOSE
 
The Extramural Epidemiology and Genetics Program (EEGP), Division of
Cancer Epidemiology and Genetics (DCEG), National Cancer Institute
(NCI) invites applications from organizations with demonstrated
excellence in information technology (informatics, software
development), and operations management (coordination of
participating centers, data management and quality assurance,
biostatistics and study methodology) for a cooperative agreement
(U01) for an Informatics Center (IC) for the NCI Cooperative Family
Registries for Breast and Colon Cancer (see RFAs CA-95-003 and
CA-96-011).  Applicants are referred to the earlier RFAs for a full
description of the purpose and organization of the Cooperative Family
Registries for Breast and Colon Cancer Studies (CFRBCCS).  Copies of
the earlier RFAs can be obtained by request from the contact names
listed in INQUIRIES, below. The purpose of the current solicitation
is to provide technical assistance and resource support services for
the Registries.
 
  The Registries represent an interdisciplinary consortium of
participating centers of excellence in clinical and human genetics
and epidemiology, funded as cooperative agreements.  The Registries
serve as a research infrastructure by linking the collective
scientific expertise of the collaborating centers with study
populations through a central registry of participating families, and
providing access to scientific expertise beyond the scope of a single
institution or organization. Technical skills and support services
are required to:
 
  (1) assist the CFRBCCS investigators to assure the establishment,
management and continuing quality of the CFRBCCS databases, including
epidemiologic, clinical and repository-related information;
 
  (2) provide the technical expertise for the development of key
information technologies, statistical methodology and study design
that will be integral to the development of the next generation of
cancer genetics studies; and
 
  (3) provide the technical expertise and training to the CFRBCCS
necessary to develop, implement and maintain a central informatics
system that facilitates the goals of the Registries and is secure and
confidential.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA) is related to the priority area of cancer.
Potential applicants may obtain a copy of  "Healthy People 2000"
(Full Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock
No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (Telephone
202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic non-profit and for-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal Government.
 
Applicant institutions need not have a formal affiliation with an
academic program in human genetics.  However, experience in research
related to genetic epidemiology and in the design and conduct of
multi-site projects with data collection, management and quality
assurance is highly desirable. Applications from centers of
interdisciplinary research excellence, such as cancer centers, are
encouraged.  Applications from racial/ethnic minority individuals,
women, and persons with disabilities as Principal Investigators are
also encouraged.
 
MECHANISM OF SUPPORT
 
Support for this program will be through the cooperative agreement
(U01). Substantial programmatic NCI involvement with the recipients
is anticipated during development, implementation, and performance.
Under the cooperative agreement, NCI will assist, support and/or
stimulate the recipient's activities, working jointly with the
participating centers and with the IC in a partnership role.
Participating organizations will be responsible for planning and
executing the proposed projects.  Details of the responsibilities,
relationship and governance of the project to be funded under
cooperative agreements are discussed later in this document under the
section "Terms and Conditions of Award."
 
The total project period for applications submitted in response to
the present RFA should not exceed five years. The anticipated award
date is April 1, 1998.  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. This RFA
is a one-time solicitation. At this time the NCI has not determined
whether or how this solicitation will be continued beyond the present
RFA.
 
Except as otherwise stated in the RFA, awards will be administered
under PHS grants policy as stated in the Public Health Service Grants
Policy Statement, DHHS Publication No. (OASH) 94-50,000 (Rev.) April
1, 1994.
 
FUNDS AVAILABLE
 
Approximately $850,000 in total costs per year for five years will be
committed to fund applications that are submitted in response to this
RFA; the NCI anticipates making one award as a result of this RFA.
Funding beyond the first and subsequent years of the cooperative
agreement will be contingent upon satisfactory progress during the
preceding years and availability of funds.
 
RESEARCH OBJECTIVES
 
Background
 
The rapid identification of cancer susceptibility genes and the
commercial availability of predictive genetic testing have created an
urgent need for research to define the clinical implications of
inherited mutations, including factors that modulate gene expression
and potential preventive interventions, and to communicate up-to-date
information about cancer genetics, genetic testing and cancer risk to
health care providers and other interested individuals.
 
To obtain answers to the next generation of questions in human cancer
genetics, studies of unprecedented size and complexity will be
required.  By providing an infrastructure for interdisciplinary
genetic epidemiology research, the CFRBCCS, in concert with other
initiatives, will further our understanding of the genetics of cancer
susceptibility, facilitate the translation of research findings into
medical practice and address pressing public health issues.
 
The strength of both the Breast and Colon Cancer Registries is based
on the multicenter, multidisciplinary talents brought by the various
teams and investigators, and on the collection of epidemiologic,
clinical and family history data as well as biological specimens from
participating families. The IC will provide the means to achieve
cross-site analyses.
 
The Cooperative Family Registry for Breast Cancer Studies is a
network of investigators at seven sites who have had cooperative
agreements since 1995 to collect pedigree information, epidemiologic
and clinical data, and biological specimens from individuals and
patients with a family history of breast cancer to provide a resource
for basic, clinical, epidemiologic, and behavioral breast cancer
genetics research, and to identify a population at high risk for
breast cancer that could benefit from new preventive and therapeutic
strategies. In the past two years, the Breast Cancer Registry has
developed core protocols and questionnaires, as well as site-specific
protocols reflecting the specific expertise and capability of each
center.
 
Participating Breast Cancer Registry institutions include:
 
Northern California Cancer Center,
Ontario Cancer Treatment and Research Foundation,
Memorial Sloan-Kettering Cancer Center,
University of Melbourne,
Fox Chase Cancer Center,
Huntsman Cancer Institute,
University of California at Irvine.
 
Recruitment of Breast Cancer Registry subjects is now actively
underway; an estimated total of 8,000 families are projected to be
enrolled during the coming two and one-half years.
 
Similar to the Breast Cancer Registry, the Cooperative Family
Registry for Epidemiologic Studies of Colon Cancer is envisioned to
be a multi-center Registry which serves as a research resource to the
scientific community.  Plans for data collection are similar to the
Breast Cancer Registry; in addition, genetic characterization is to
be performed and population-based controls are to be accrued. The IC
shall provide support to the Colon Cancer Registry as well as the
Breast Cancer Registry. Six Colon Cancer Registry awards are pending.
 
A total of 11,000 families are projected to be enrolled in the Colon
Cancer Registry within five years.
 
Illustrative of CFRBCCS projects that are envisioned but which
require analysis of multi-site data to achieve adequate power
include:
 
Descriptive studies of the prevalence of carriers of specific
mutations by ethnicity, religious affiliation, prior primary breast
and colon cancer history, etc; assessment of the risk of breast and
other cancers by mutation status and other demographic variables; and
age-adjusted stage-specific survival from breast and colon cancer
among mutation carriers;
 
Pathology studies of the distribution of histologic types among
breast and colon cancer cases with specific mutations;
 
Etiologic studies of gene-gene and gene-environmental interactions
including variables such as reproductive factors, alcohol
consumption, body size, diet, physical activity, and radiation
exposure;
 
Psychosocial studies of the impact of registry participation on
anxiety, family dynamics; the impact of genetic testing on
psychological well-being; and the effectiveness of various
interventions to increase understanding of genetic testing and to
reduce anxiety;
 
Pathology-based studies which compare histopathologic and molecular
characteristics in carriers vs. non-carriers according to various
demographic and epidemiologic characteristics.
 
There is a need to provide for coordination of the central database
that will permit ready access to cross-site core data from the
Registries, conduct range and quality control checks, and ensure the
confidentiality of the highly sensitive data.  The central database
will also include data collected in pilot studies approved by the
Advisory and Steering Committees of the Registries (see Collaborative
Responsibilities) and data generated from studies conducted by
outside investigators who use Registry data for their investigations.
 
  Research Goals and Scope
 
  This RFA seeks to stimulate a cooperative effort to develop key
information technologies and operational systems.  Substantial effort
should be directed towards design, implementation, maintenance, and
technologic advancement of basic Registry activities.  To facilitate
these functions, this RFA will provide a broad base of support for
technical services and developmental research, such as research on
key information technologies, statistical methodology and study
design integral to cancer genetics studies.  Funds may be requested
for personnel, for equipment, and for specific research projects
relevant to development, implementation and support of the
Registries.
 
  This RFA will support one group to develop the informatics
infrastructure to support the CFRBCCS.  Specifically, in
collaboration with investigators from the Registry centers, the IC
shall, at a minimum:
 
Coordinate the activities of the operations units at the Registry
centers, which are providing statistical and logistical support to
the local centers as well as preparing data for the central
databases;
 
Provide information and software to support local entry of data that
will go into the central databases;
 
Provide training materials and conduct on-site training when needed
to ensure consistency and quality control of data collection;
 
Perform quality control checks of data collected and entered at local
sites but submitted to the central databases, and provide timely
feedback to sites to enhance quality control of data collection and
entry;
 
Provide service statistics to NCI program officials and to the
Advisory and Steering Committees of the Registries concerning
recruitment, retention, and protocol compliance;
 
Conduct analyses of cross-site data at the request of Registry
investigators or NCI program officials, as approved by the Steering
Committees of the Registries;
 
Develop and maintain anonymous databases for use as a research
resource as approved by the Advisory Committees of the CFRBCCS;
 
Promote information dissemination through newsletters and a WWW site.
 
SPECIAL REQUIREMENTS
 
Applicants must have existing programs of scientific excellence and
technical expertise in areas relevant to the type of application
submitted.  All applications must address the following questions in
a clear and organized manner:
 
(1) How will existing (and proposed) resources and expertise support
specific tasks in Registry development and implementation; contribute
to support and maintenance of Registry functions; and present unique
opportunities for Registry activities?
 
(2) How does past technical experience and performance support the
applicant's ability to provide the required technical services;
demonstrate the scientific expertise and the ability to apply
scientific considerations to technical functions; and show the
applicant's ability and willingness to collaborate effectively as a
member of a consortium?
 
Study Organization and Function
 
The NCI Cooperative Cancer Family Registries represent a consortium
of participating centers of excellence in interdisciplinary genetic
epidemiology research that will be linked in a dynamic and
interactive fashion through the central informatics and operations
functions of the IC into a research resource.
 
To ensure close integration between the IC and the Registry
participating centers, the Principal Investigator (PI) of the IC will
serve as a full voting member of the Steering Committees of the
Registries.
 
The external Advisory Committees (ACs) of the Registries consist of
senior scientists with multidisciplinary expertise in cancer genetics
research and are responsible for reviewing, evaluating and
prioritizing all research proposals involving the Registries. This
will include proposals made by the IC.  AC members are nominated by
the members of the Steering Committees (SCs) and will be appointed by
the NCI for a two-year tenure.
 
  Terms and Conditions of Award
 
  The Terms and Conditions of Award, below, will be included in any
award issued as a result of this RFA. It is critical that each
applicant include specific plans for responding to these terms.
These special Terms of Award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines, HHS grant
administration regulations in 45 CFR Part 74 and 92, and other HHS,
PHS and NIH grant administration policy statements.
 
  The administrative and funding instrument used for this program is
a cooperative agreement (U01). This is an assistance mechanism for
support of a research resource 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 assist, supports and/or stimulates the recipient's
activities, by facilitating performance of the program effort in a
partner role. Consistent with this concept, the prime responsibility
for the activity resides with the awardee for the project as a whole.
 
I.  Awardee Rights and Responsibilities
 
The Informatics Center (IC) awardee will have primary rights and
responsibilities to define projects and approaches and to plan and
conduct the work of the IC. The IC will have engage in methodological
and developmental investigations, and develop novel methodological
approaches, using data from the CFRBCCS. The development of
standardized instruments for data collection and management for this
large multi-site project will provide an opportunity for
methodological research that can be exported to other centers engaged
in the informatics support of genetic studies.
 
Responsibilities of the IC will include:
 
A.  Statistical and Research Design. The IC will provide intellectual
input about statistical issues, study design and methodology for the
Registries. The IC's responsibilities will include:
 
1.  Providing expert statistical assistance to CFRBCCS investigators
in developing design and analytic approaches, estimating sample size
requirements for specific research questions, planning and performing
interim and final analyses, and preparing reports that summarize the
results of such analyses.  Expertise in modeling, repeated methods,
exploratory data analysis and robust methods will be important for
the investigations supported by the CFRBCCS; and
 
2.  Developing approaches to statistical modeling, analysis, and
study design to maximize the efficiency of genetic epidemiology
studies performed using Registry resources, especially the
investigation of gene-gene and gene-environment interactions.
 
B.  Data Management and Quality Assurance.
 
1.  The IC will establish an optimal computing environment for
processing, storage and retrieval of data through a central data
management facility or a distributed data system, including multiple
sets of longitudinal data and creation of data files for specific
analyses. The IC will maintain and update an information management
system for tracking data from the study sites as well as maintain and
update codebooks, active files and inventory files. Combined
codebooks  may need to be created to interface with other genetics
and epidemiology databases, such as the Cancer Genetics Network.
Archiving of data should be provided. Record-keeping and encrypting
procedures should ensure confidentiality of data with personal
identifiers.
 
2.  A study-wide quality assurance system should be developed and
implemented by the IC to allow for regular evaluation of reliability,
validity and completeness of CFRBCCS databases. The IC should provide
documentation of any changes in the quality assurance and data entry
instruction manuals.  The IC should site visit CFRBCCS centers during
the first two years of funding, the schedule to be developed in
consultation with the ACs and the NCI. The IC should bring any data
suggesting quality assurance problems at study sites to the attention
of the NCI and the SCs.  The IC will play a central role in
discussing such problems and suggesting solutions at the periodic AC
meetings.
 
3.  The data processing, storage and retrieval procedures and quality
assurance systems of the IC will need to be approved by the SCs
before implementation.
 
4.  The IC will monitor adherence to the clinical and laboratory
protocols, and will coordinate implementation of new or modified
protocols approved by the SCs.  IC activities related to new or
modified protocols include new data collection form development, data
management system modifications, operations and training manual
updates, and study site staff training.
 
C.  Specimen Tracking System for the Storage and Retrieval of
Biological Specimens.  The IC should provide central coordination of
stored specimens in collaboration with Registry site investigators.
This includes updating and improving as needed a system for specimen
tracking at each stage (collection, processing, transfer, storage and
retrieval).  The IC should also plan to maintain an electronic
inventory updated biannually and integrated into the Registry
databases.  This inventory should list all specimens from each
clinical site, describing the type and quantity of all specimens.  To
facilitate the evaluation of new studies by the AC, a repository
status summary should be prepared and distributed to the AC members
before their scheduled meetings.  The IC should record requests for
biological specimens and work with the repository and the SCs to
account for the current amount and type of specimens available.
 
D.  Summary Data and Support and Coordination for Data Presentation.
 
1.  The IC will be responsible for preparing and updating operations
manuals and data collection forms and providing regular statistical
summary reports to the CFRBCCS sites and the NCI, including summary
data on descriptive statistics and response rates of the study
participants.
 
2.  The IC should coordinate with Registry investigators the process
of generating scientific material for presentations at conferences
and meetings.  The IC should provide datasets for analysis by
Registry investigators and outside collaborators, as requested by the
SC.  The IC will maintain and regularly distribute a list of all
publications, manuscripts and presentations that use data from the
CFRBCCS.
 
E.  Study-wide Communication, Coordination and Administrative Duties.
The IC will have overall responsibility for the following activities:
 
1.  Establishing electronic mail linkages among CFRBCCS sites and the
NCI;
 
2.  Developing milestones/time lines to identify major steps and
anticipated accomplishments. Particular attention is suggested in
setting milestones in the following areas: methods of data input;
distribution of instruments/operation manuals; ongoing training of
Registry site staff; and implementation of quality assurance
protocols;
 
3.  Providing regular data "freezes," based on a schedule established
by the SCs;
 
4.  Providing meeting-related support for SCs and ACs and working
group meetings by distributing agendas and other materials and
preparing highlights of meetings and conference calls; and
 
5.  Developing and updating a CFRBCCS WWW site, and, in cooperation
with the participating sites, developing a regular newsletter for
distribution by the sites to participants.
 
F.  Communications with Registry Sites and NCI. Regular reporting of
activities will help the Registry sites and the NCI to monitor
progress and identify areas of potential interest for further
investigation.
 
G.  Informatics and Information Technology Development. The IC will
develop computer-based tools which will facilitate the data
collection and distribution goals of the Registries.  This
responsibility will include development, implementation and
maintenance of an information management system for core data. This
management system will incorporate safeguards such as encryption
technologies to ensure confidentiality and strictly limit access to
databases. The information management system will be flexible enough
to accommodate follow-up data collections and to integrate data
generated through additional studies which use these resources.
 
H.  Software for Genetic Epidemiology Research. The IC will survey
research needs for software and Internet-based applications to
facilitate the collection, integration and analysis of genetic and
pedigree data, evaluate existing software and develop new materials
as needed, which will be made available to the genetic epidemiology
community.
 
I.  Developmental Studies. The IC will provide technical expertise
for the development of key information technologies, statistical
methodology and study designs that will be integral to the
development of the next generation of cancer genetics studies.
 
II.  The NCI Program Coordinator will:
 
A.  Serve as liaison from the NCI, specifically to coordinate
activities among the IC, the Registry awardees, and the NCI program
coordinator for the Registries (see INQUIRIES);
 
B.  Serve as scientific liaison between the awardees and other
program staff at NCI with experience in informatics and multicenter
studies;
 
C.  Serve as a full participant and voting member of the Registry
SCs, and, as appropriate, their subcommittees; and attend AC meetings
in a non-voting liaison member role;
 
D.  Assist the IC in the standardization of data collection methods
across Registry participating centers for data that will go into the
central databases; assist in developing operating guidelines, quality
control procedures, and consistent policies for dealing with
recurrent situations in data collection that require coordinated
action; and assist in developing plans for information dissemination
through newsletter and a WWW site.
 
The NCI reserves the right to reduce the budget, to withhold support,
and to suspend, terminate or curtail a study or an award in the event
of delinquent data reporting, inadequate quality control of data
collection, refusal to carry out the recommendations of the SCs or
ACs, or substantial failure to comply with the terms of the award.
Periodic external progress reviews of the program will be carried out
as NCI deems appropriate.
 
III.  Collaborative Responsibilities
 
The IC awardee will, in a dynamic and interactive fashion, link the
NCI Cooperative Cancer Family Registries into a research resource.
The PI of the IC will serve as a full voting member of the Steering
Committees (SCs) of the Registries.  The SCs for the Registries are
responsible for development and implementation of CFRBCCS policies
and procedures, integrating and coordinating activities of the
participating centers and the IC. The SCs have responsibility for
approving the procedures for data processing, storage, retrieval and
quality assurance that are study-wide.
 
The external Advisory Committees (ACs) of the Registries will
evaluate all research proposals (those from Registry investigators as
well as from the external research community) on a regular basis.
This will include research proposals made by the IC. All reviews will
be held according to rules pertaining to the conduct of reviews for
NIH grants, contracts, and cooperative agreements, with special
attention to issues of conflict of interest (whether real or
apparent). The ACs will provide recommendations to the SCs as to the
priority of the proposed research projects. The ACs will also provide
advice to the SCs on scientific matters, as appropriate and as
needed. The IC will provide data to the AC regarding recruitment and
repository contents, and provide data for support of research
approved by the SCs and ACs.
 
IV.  Arbitration Procedures
 
Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between award recipients and the NCI
may be brought to arbitration. An arbitration panel will be composed
of three members -- one selected by the awardee, a second member
selected by NCI, and the third member selected by the two previously
selected members. These special arbitration procedures in no way
affect the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulations at 42 CFR
Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their 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 new 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 have been 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 September 3, 1997, a
letter of intent that includes a descriptive title of the proposed
project, the name, address and a telephone number of the Principal
Investigator, the names of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted. Although a letter of intent
is not required, is not binding, and does not enter into the review
of subsequent applications, the information is helpful in planning
for the review of applications. It allows NCI staff to estimate the
potential workload and to avoid conflicts of interest in the review.
The letter of intent is to be sent to Amy Sheon, Ph.D., at the
address listed under INQUIRIES below.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants. These forms are available at most
institutional offices of sponsored research and may be obtained from
the Office of Extramural Outreach and Information Resources, Division
of Research Grants, National Institutes of Health, 6701 Rockledge
Drive, Suite 6095, MSC 7910, Bethesda, MD 20892-7910, telephone
301-710-0267, e-mail asknih@odrockm1.od.nih.gov.
 
The RFA label available in the application form PHS 398 (rev. 5/95)
must be affixed to the bottom of the face page. Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee in time for review. In
addition, the number and title of the RFA must be typed on line 2 of
the face page of the application and YES must be checked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact photocopies in one package to
the Division of Research Grants at the address below. The photocopies
must be clear and single sided.
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 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 by sent to:
 
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Blvd.
Rockville, MD 20850 (if hand delivered or delivery service)
Bethesda MD 20892-7399 (if using U.S. Postal 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 application will be reviewed in competition with
other applications received on or before the designated receipt date.
 
Applications must be received by October 7, 1997. If an application
is received after that date, it will be returned to the applicant
without review. If the application submitted in response to this RFA
is substantially similar to a research grant application already
submitted to the NIH for review, but has not yet been reviewed, the
applicant will be asked to withdraw either the pending application or
the new one. Simultaneous submission of identical applications will
not be allowed, nor will essentially identical applications be
reviewed by different review committees. Therefore, an application
cannot be submitted in response to this RFA that is essentially
identical to one that has already been 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
 
All applications will be judged on the basis of the scientific merit
of the proposed project and the documented ability of the
investigators to meet the OBJECTIVES of the RFA. Although the
technical merit of the proposed protocol is important, it will not be
the sole criterion of evaluation of a study.
 
Review Method
 
Upon receipt, applications will be reviewed for completeness by the
DRG and for responsiveness to the RFA by the NCI. Incomplete
applications will be returned to the applicant without further
consideration. If NCI staff find that the application is not
responsive to the RFA, it will be returned and receive no further
consideration.
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NCI in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will receive a written critique and undergo a process by
which only those applications deemed to have the highest scientific
merit, generally the top half of applications under review, will be
discussed, assigned a priority score, and receive a second level
review by the National Cancer Advisory Board.
 
Review Criteria
 
Applications for IC awards will be judged on the basis of the
scientific merit of the proposed project and the documented ability
of the investigators to meet the OBJECTIVES of the RFA. Although the
technical merit of the proposed protocol is important, it will not be
the sole criterion of evaluation of an application. Applicants are
expected to address all issues identified under SPECIAL REQUIREMENTS
of the RFA. In addition, applicants will be evaluated based on the
additional criteria listed below.
 
Applications for the IC will be reviewed on the basis of the
following criteria:
 
1.  Scientific excellence of the application and the extent to which
it addresses the special scientific and technical program
requirements presented in the RFA;
 
2.  The adequacy of the applicant's plan for safeguarding
confidentiality of the central Registry database and providing
technical advice to Registry participating centers in developing
protocols to ensure local data security;
 
3.  Demonstrated ability and willingness to provide technical
assistance for the development of informatics structures for
collaborative multi-center research;
 
4.  Qualifications and research experience of the Principal
Investigator and staff with regard to development and implementation
of complex informatics structures; previous experience with design
and administration and analysis of data from multi-institutional
clinical trials and relevant epidemiologic or laboratory studies;
competence with regard to the mechanisms for administration,
experimental design, quality control, study monitoring, data
management and reporting, statistical analysis, and compliance with
regulatory requirements;
 
5.  The adequacy of existing physical facilities and resources of the
applicants' institution(s); how effectively any proposed resource
expansion will enhance the applicant's participation in Registry
functions; and the unique resources and capabilities the applicant
will bring to the Registries;
 
6.  Adequacy of plans for effective communication and coordination
between the participating centers, IC, and NCI;
 
7.  Appropriateness and adequacy of proposed developmental and
methodological studies; and
 
8.  Scientific and technical merit of the proposed project as
determined by peer review.
 
The review group will also examine the proposed budget and will
recommend an appropriate budget and period of support for each
application that is recommended for further consideration.
 
The second level of review by the National Cancer Advisory Board
considers the special needs of the Institute and the priorities of
the National Cancer Program.
 
AWARD CRITERIA
 
Applications recommended by the National Cancer Advisory Board will
be considered for award based upon technical merit of the application
as reflected in the priority score, availability of resources, and
availability of funds. Furthermore, the applicant organization must
indicate a commitment to accept provisions outlined under the SPECIAL
REQUIREMENTS section, Terms and Conditions of Award. The earliest
anticipated date of award is April 1, 1998.
 
INQUIRIES
 
Written and telephone inquiries concerning the RFA and the
opportunity to clarify any issues or questions from potential
applications are welcome.
 
Direct inquiries regarding RFA-related programmatic and scientific
issues to:
 
Amy Sheon, Ph.D.
Division of Cancer Epidemiology and Genetics
National Cancer Institute
6130 Executive Boulevard, Suite 535 - MSC 7395
Bethesda, MD 20892-7395
Telephone: (301) 496-9600
Email:  as31r@nih.gov
 
Direct inquiries regarding the CFRBCCS to:
 
Daniela Seminara, Ph.D., M.P.H.
Division of Cancer Epidemiology and Genetics
National Cancer Institute
6130 Executive Boulevard, Suite 535 - MSC 7395
Bethesda, MD 20892-7395
Telephone: (301) 496-9600
 
Direct inquiries regarding fiscal matters to:
 
Ms. Crystal Wolfrey
Grants Management Specialist
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892
Telephone: (301) 496-7800, ext. 282
Email:  wolfreyc@gab.nci.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No.93.393, Cancer Cause and Prevention Research. Awards
are made under authorization of the Public Health Service Act, Title
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42
USC 241 and 285) and administered under PHS grants policies and
Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 and 92. This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review. Unless
otherwise noted all PHS grants policies apply.
 
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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