Full Text CA-93-16

SPORE IN GASTROINTESTINAL CANCER

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFA:  CA-93-16

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Digestive System 
  Digestive Diseases & Disorders 
  Clinical Medicine, General 
  Disease Control+ 


National Cancer Institute

Letter of Intent Receipt Date:  February 26, 1993
Application Receipt Date:       April 23, 1993

PURPOSE

The Organ Systems Coordinating Branch of the Division of Cancer
Biology, Diagnosis and Centers (DCBDC) at the National Cancer
Institute (NCI) invites grant applications (P50) to establish
Specialized Programs of Research Excellence that focus on human
Gastrointestinal Cancers of highest incidence and mortality.  These
programs will be established at institutions that will make strong
commitments to the organization and conduct of these programs.  Each
Specialized Program of Research Excellence (SPORE) must be dedicated
to translational research which moves basic research findings into
more applied research settings with patients and populations in order
to have the most immediate impact possible on improving cancer
prevention, diagnoses and treatment and on reducing cancer incidence,
mortality and morbidity.  This could include areas such as the
development of new diagnostic and prognostic tests, the conduct of
innovative therapeutic protocols, the development of new primary and
secondary prevention measures, as well as cancer control studies and
studies that encompass rehabilitation and quality-of-life research.
Each SPORE must 1) both address colorectal cancer as well as mount a
significant effort on pancreatic cancer; 2) represent a collaborative
enterprise between basic and clinical scientists in the
conceptualization and implementation of research projects; 3) develop
and maintain human cancer tissue resources that will benefit
translational research in these cancers; 4) develop extended
collaborations in critical areas of research need with laboratory and
clinical scientists in the parent institution and in other
institutions; and 5) participate with other SPOREs and/or the NCI on
a regular basis to share information, assess scientific progress in
the field and identify new research opportunities for reducing
colorectal and pancreatic cancer incidence and mortality, and for
increasing and improving survival.  Each SPORE must support a mix of
basic and clinical research and focus on human disease.

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,
"Specialized Program of Research Excellence (SPORE) in
Gastrointestinal Cancer" is related to the priority area of cancer.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, D. C. 20402-9325
(telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Domestic non-profit and for-profit organizations, institutions and
government agencies are eligible to apply.  To be eligible, applicant
organizations must have (1) a minimum of three independent
investigators who are successful in obtaining peer-reviewed research
support directly related to gastrointestinal cancer, and who
represent experience in both laboratory and clinical research; or a
minimum of three independent investigators each having published
articles that significantly address gastrointestinal cancers in peer-
reviewed research journals and who combined represent experience in
both laboratory and clinical research; (2) access to a patient care
and service facility that serves gastrointestinal cancer patients
and, if the facility is not part of the parent institution, a
statement signed by the responsible officials of the applicant
institution and the consortial care facility that assures access to
gastrointestinal cancer patients for clinical research; (3) a
statement signed by the SPORE Principal Investigator, the responsible
institutional official and cancer center director that complies with
the conditions noted below under SPECIAL REQUIREMENTS, if the
institution is currently an NCI-designated clinical, comprehensive or
consortium cancer center.  While applications must be submitted from
a single institution, they may include consortial arrangements with
multiple institutions if these arrangements are clearly delineated
and formally and officially confirmed by signed statements from the
responsible officials of each institution.

Support will not be provided for applications with research
activities focused exclusively on basic research, clinical research
or trials, or epidemiological research.

Institute staff (see below, INQUIRIES) should be consulted if there
are questions regarding any of the above eligibility requirements or
exclusions.

MECHANISM OF SUPPORT

Support of this program will be through the P50 Specialized Center
Grant mechanism.  This mechanism supports any part of the full range
of research and development from basic to clinical and intervention
studies.  The spectrum of activities comprises a multidisciplinary
attack on a specific disease entity or biomedical problem.  These
grants differ from program project grants in that they are more
complex and flexible in terms of the activities that can be
supported.  In addition to support for multidisciplinary research
projects, support is also provided for pilot research projects,
specialized resources and shared core facilities.  Applicants will be
responsible for the planning, direction, and execution of the
proposed SPORE program.  Awards will be administered under PHS grants
policy as stated in the Public Health Service Grants Policy
Statement, DHHS Publication No. (OASH) 90-50,000 revised October 1,
1990.

FUNDS AVAILABLE

This RFA is a one-time solicitation.  NCI anticipates making one or
two awards for initial project periods of three years and anticipates
that a total of $1.5 million will be set aside for the initial year's
funding.  Applicants may apply for part or all of the $1.5 million.
High quality applications that are not fundable in FY 1993 may be
considered for funding in FY 1994.  Funding in response to this RFA
is dependent upon the receipt of a sufficient number of applications
of high scientific merit.  Although this program is provided for in
the financial plans of the NCI, the award of grants pursuant to this
RFA is contingent upon the anticipated availability of funds for this
purpose.  The total project period for applications submitted in
response to this RFA should not exceed three years.  Application for
renewal will be for five years subject to successful recompetition.
Recognizing that the initial three year funding period may be too
short for several substantive scientific accomplishments, the
recompetition will be evaluated on scientific accomplishment and on
interim progress in pursuit of SPORE organizational, collaborative
and research objectives.  This would include, for example, research
accomplishments to date; the quality and substance of preliminary
findings; the effective use of pilot project funds; progress in
planning, developing and implementing new research programs that link
laboratory and clinical scientists; progress in collecting and
distributing tissue specimens for research; and progress toward
developing substantive collaborative interactions, progress in
testing innovative concepts through use of developmental funds.

RESEARCH OBJECTIVES

Background - Gastrointestinal cancers pose a major public health
problem in this country.  Colorectal cancers accounted for about 15
percent of all cancer diagnoses in 1991.  There were 112,000 cases of
colon cancer and 45,500 cases of rectal cancer with 53,000 and 7,500
deaths respectively.  Although there have been recent advances in
adjuvant therapy, there have been no major breakthroughs in the
treatment of colorectal cancers. Animal studies have provided
important insights into the etiology of colon cancer, but there have
been no major advances in the prevention of this disease.  The recent
NCI sponsored "Workshop on Colorectal Cancer" indicated a number of
areas where interdisciplinary applications could prove fruitful.
Experts from many disciplines addressed prognostic markers,
Intermediate endpoint markers, susceptibility to colon cancer,
polyps, and diet in relation to colon cancer.  Interdisciplinary
groups considered the science presented at the workshop with specific
focus on its relevance for incidence, diagnosis, treatment and
prevention.  The workshop report and the recommendations of the
participants will be valuable information to all SPORE applicants.
Copies of the report are available from the Organ Systems
Coordinating Branch (see below, INQUIRIES).

Pancreatic cancer remains a significant and intransigent problem.
The incidence of this cancer (28,000 cases in 1991) approaches the
mortality rate (25,200 deaths). Average survival time from time of
diagnosis is less than a year.  There have been no advances in
understanding the causes of this disease, in detecting or diagnosing
it early, and there is no effective treatment.  Although there have
been recent advances in the biology of this disease, pancreatic
cancer remains an intransigent cancer.

In recent years, the scientific information base for gastrointestinal
cancers has expanded significantly; however, application of this
scientific base to clinical and preventive activities has not been
commensurate with this expansion.  There is thus a need to encourage
translational research that would require interdependence between
basic and clinical investigators in both the planning and
implementation of research and would emphasize clinical application
of basic research findings with patients and populations.  There
exists significant scientific and clinical expertise in
gastrointestinal cancer in NCI-designated cancer centers and other
institutions throughout the country.  A concerted effort to mobilize
this expertise through SPOREs can accelerate advances in the
management and ultimately prevention of these diseases.

Goals and Scope - The goal of this RFA is to establish SPOREs, that
will assemble critical masses of laboratory and clinical scientists
working together to focus on human gastrointestinal cancers of
highest incidence and the translation of basic findings into applied,
innovative research with patients and populations.  The SPORE must
address both colorectal cancer and pancreatic cancer with a
significant effort directed toward each of these cancers. Of interest
are studies that address black/white differences in incidence and
mortality.  The ultimate objective is to reduce incidence and
mortality, and to increase and improve survival to the disease.  The
essential characteristics of a SPORE include (1) a strong scientific
program that will have a clear impact on the disease, (2) a strong
innovative pilot research program that can respond quickly to new
research opportunities, (3) a human colorectal and pancreatic cancer
tissue procurement resource and other resources specifically
dedicated to translational research objectives.

The special features of SPORE grants provide opportunities for
investigators with mutual or complementary interests to engage in
multidisciplinary research that will impact on prevention, diagnosis
or treatment of human gastrointestinal cancer, as well as
rehabilitation or quality of life. Research conducted in SPOREs must
be highly interactive both within and between projects.  Individual
research projects must be conceived, planned and implemented through
the multidisciplinary interactions of independent laboratory and
clinical scientists.  Such interactions can be expected to accelerate
the translation of research findings into practical benefits for
patients and populations.  A distinguishing feature of a SPORE P50
grant is the highly dependent nature of the research objectives upon
intra- and inter- project interactions.  Each project would not be
expected to stand on its own in the absence of interactions with
other research projects.  Developmental research funds provide
support for highly innovative pilot projects that take maximum
advantage of new research opportunities.  This provides a flexible
means for responding quickly to new research opportunities.

To facilitate achievement of SPORE program goals, each SPORE must
develop resources specialized for gastrointestinal cancer research
activities.  This must include human colorectal and pancreatic cancer
tissue collection for research activities of the SPORE and for use by
scientists who are concentrating on translational research within and
outside the parent institution.  The development of additional
resources specialized for research on these cancers is also
encouraged.

Interactions among SPOREs is an important objective of this
initiative.  This may be in the form of research collaborations,
exchange of scientists on a visiting basis, exchange of resources and
materials, and other innovative ways.  All SPOREs are strongly
encouraged to participate in regular meetings coordinated by the
Organ Systems Coordinating Branch of the NCI.  The purpose of the
meeting is to share scientific information, assess scientific
progress, identify new research opportunities, and establish
priorities that will accelerate the translation of basic research
findings to applied settings in patients and populations.

SPECIAL REQUIREMENTS

Each SPORE must include the following elements:  A strong
institutional commitment.  An institution receiving this award must
incorporate the SPORE high within its institutional priorities.  The
institution must demonstrate a strong commitment to the program's
stability and success. The application must provide a plan that
addresses how the institutional commitment will be established and
sustained, and how it will maintain accountability for promoting
scientific progress.  This institutional commitment may be in the
form of faculty appointments for SPORE investigators, assignment of
research space, cost sharing of resources, or other ways to be
proposed by the applicant.

A qualified Principal Investigator.  A leader must be selected as
Principal Investigator who can oversee and conduct planning
activities, provide direction to the SPORE and ensure a translational
research emphasis.

A substantive gastrointestinal cancer patient population.  Each SPORE
must be recognized as a leading program in the treatment of
gastrointestinal cancers.  The grant application must demonstrate and
document access to a patient population that can participate in and
can benefit from the innovative clinical and population research
activities of the SPORE.

Research Projects.  Each SPORE must pursue at least three research
projects.  These should be new projects, not merely expansions or
duplications of existing projects.  Research projects must be
conducted by multiple independent investigators, oriented toward
translational research activities using human materials and human
subjects that address innovative possibilities in gastrointestinal
cancer research.  Each project must involve multidisciplinary
laboratory and clinical interaction in the conception, planning,
design and implementation of research.  Projects should be
interactive with each other.  Collaborative arrangements within the
SPORE, within the parent institution and with other institutions are
encouraged.  Collaborations with scientists outside the immediate
SPORE should be documented with appropriate letters of commitment as
applicable.  Collaborations with other institutions may involve
consortial arrangements.

Developmental Research Funds.  Each SPORE must continually allocate a
significant proportion of its budget and effort to pilot projects
that explore innovative ideas.  It is important that SPOREs use
developmental funds as a flexible and significant source to stimulate
projects that take maximum advantage of new research opportunities.
Pilot projects may be collaborative among scientists within one or
more SPOREs, or with scientists outside the SPORE environment.  The
SPORE application should propose an institutional process that can
continuously select pilot projects that represent the most innovative
ideas and that will have the greatest impact on reducing
gastrointestinal cancer incidence and mortality, and increasing and
improving survival.

Specialized Resources.  The SPORE is encouraged to develop and
maintain resources specialized for gastrointestinal cancer research.
Each SPORE must have a dedicated activity for collecting and
distributing human gastrointestinal cancer tissue.  This should
include the essential pathologic and clinical information needed for
conducting research. This resource must benefit the specific research
activities of the SPORE as well as the research activities of
scientists within and outside of the parent institution who are
concentrating on translational research issues.  A plan must be
proposed for prioritizing the distribution of tissues to SPORE
scientists and scientists outside the SPORE.

SPORE Meeting.  Gastrointestinal Cancer SPOREs will be expected to
participate in regular meetings coordinated by the Organ Systems
Coordinating Branch of the NCI to share data, assess progress,
identify new research opportunities, and establish priorities for
effective approaches to reducing incidence and mortality, and
improving survival. Travel funds for the Principal Investigator and
Project Investigators should be budgeted for this purpose.  This may
include Project Investigators from other institutions who are
actively collaborating with SPORE investigators.

A SPORE application can originate from an institution with or without
an existing NCI P30 core grant.  However, if a P30 grant already
exists:  a) the Principal Investigator of the SPORE must be a senior
or program leader in the cancer center; b) the P30 Center Director
may be the Principal Investigator of the P50 SPORE, but this is not
necessary; c) lines of authority should be indicated clearly such
that the SPORE does not interfere with the P30 chain of authority; d)
a letter of commitment that delineates organizational relationships
and lines of authority is required; the letter must be signed by the
proposed Principal Investigator of the SPORE, the Cancer Center
Director and the appropriate institutional official; e) the SPORE
must be a major programmatic element in the cancer center, but there
must be a separate and distinctive institutional commitment to the
SPORE; f) the development of resources in the SPORE should not
duplicate resources already provided by the existing Cancer Center
Support Grant (P30); however, SPORE resources can be used to augment
existing center resources to orient these resources more effectively
to SPORE research objectives if this is a more efficient and more
cost effective alternative; g) the applicant should describe how the
P50 SPORE will interact synergistically and effectively with the
existing P30 programs in order to maximize SPORE research objectives
and contribute to cancer center research objectives.

STUDY POPULATIONS - SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING
IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND
MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions that disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group together with a rationale for
its choice.  In addition, gender and racial/ethnic issues should be
addressed in developing a research design and sample size appropriate
for the scientific objectives of the study.  This information should
be included in the form PHS 398 in Sections 1-4 of the Research Plan
AND summarized in Section 5, Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).  The rationale for
studies on single minority population groups should be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology.
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

If the required information is not contained within the application,
the application will be returned.
Peer reviewers will address specifically whether the research plan in
the application conforms to these policies. If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research to NIH are required to address
these policies.  NIH funding components will not award grants or
cooperative agreements that do not comply with these policies.

LETTER OF INTENT

Prospective applicants are asked to submit by February 26, 1993, a
letter of intent that includes the name and address of the Principal
Investigator and identifies the component research projects, core
units and their Principal Investigators, any collaborating
institutions, and the number and title of the RFA in response to
which the application is being submitted.  Although a letter of
intent is not required, is not binding and does not enter into the
review of subsequent applications, it provides an indication of the
number and scope of the applications to be reviewed.  The letter of
intent should be sent to:

BY U.S. POST:

Andrew Chiarodo, Ph.D.
Chief, Organ Systems Coordinating Branch
Executive Plaza North, Suite 512
National Cancer Institute
Bethesda, MD 20892             / Tel:  (301) 496-8528  / FAX:  (301)
402-0181

BY DIRECT DELIVERY:

Andrew Chiarodo, Ph.D.
Chief, Organ Systems Coordinating Branch
Executive Plaza North, Suite 512
National Cancer Institute
Bethesda, MD 20852   / Tel:  (301) 496-8528  / FAX:  (301) 402-0181

APPLICATION PROCEDURES

Applications must be received by April 23, 1993.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants will not accept any
application in response to this announcement that is essentially the
same as one currently pending initial review, unless the applicant
withdraws the pending application.  Specific instructions for
preparing a SPORE grant application are available from the Organ
Systems Coordinating Branch (see below, INQUIRIES).

The regular research grant application form PHS 398 (rev. 9/91) must
be used in applying for these grants.  These forms are available at
most institutional offices of sponsored research or from the Office
of Grants Inquiries, Division of Research Grants, Room 449, Westwood
Building, National Institutes of Health, Bethesda, MD 20892-4500   /
Tel:  (301) 496-7441 / or from the NCI Program Director named below
(see INQUIRIES).
The RFA label available in the application form PHS 398 (rev. 9/91)
must be affixed to the bottom of the face page. Failure to use this
label could result in delayed processing of your application such
that it may not reach the review committee in time for review.  In
addition, the RFA number and title "SPORE in Gastrointestinal Cancer"
should be typed on line 2a of the face page of the application form.

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

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

Applicants who wish to use express mail or carrier service should
change the ZIP code to 20816.  C.O.D. applications will not be
accepted.

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

Ms. Toby Friedberg
Referral Officer, NCI
Executive Plaza North, Suite 650
6130 Executive Blvd
Rockville, MD 20892-9903

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed initially by the Division
of Research Grants for completeness.  Incomplete or ineligible
applications (see above, ELIGIBILITY REQUIREMENTS) will be returned
to the applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NCI program staff function; this will be based primarily on
the clear orientation of the application to (1) human
gastrointestinal cancer with emphasis on both colorectal and
pancreatic cancers, (2) translational research objectives, and (3) an
absence of duplication between the proposed research and currently
supported research.  Applications judged to be non-responsive to this
RFA will be returned without review.

If the number of responsive applications is large compared to the
number of awards to be made, the NCI may conduct a preliminary
scientific peer review in order to eliminate those without
significant and substantial merit; such applications are not
recommended for further competition. The NCI will remove these
applications from further competition and will provide an abbreviated
summary statement to the Principal Investigator outlining the primary
reasons and rationale for this peer review determination.  Those
applications judged to be both competitive and responsive will be
further evaluated according to the review criteria stated below for
scientific and technical merit and for special SPORE characteristics
and requirements by an appropriate peer review group convened by the
Division of Extramural Activities, NCI.  The second level of review
by the National Cancer Advisory Board considers the special needs of
the Institute and the priorities of the National Cancer Program.

Review Criteria - The major factors to be considered in the
evaluation of applications will be:

The Institutional Commitment - a) adequacy of institutional
procedures and plans for monitoring, evaluating and assuming
accountability for the general success of the SPORE; b) adequacy of
facilities, equipment and space to promote translational research
objectives; c) adequacy of recruitment objectives and plans to
strengthen the scientific capabilities of the SPORE.

Overall Program Organization and Capability - a) the scientific
qualifications and demonstrated scientific and administrative
leadership capabilities of the SPORE Principal Investigator; adequacy
of the time commitment of the Principal Investigator; b) the depth
and breadth of the proposed research activities and plans to
effectively pursue translational research objectives; c) the adequacy
of access to patients and to a population for conducting current and
projected therapeutic, prevention and control research; d)the
adequacy of the procedures, processes, and plans for promoting
interactions.

Individual Research Projects - a) qualifications and demonstrated
competence of the investigators to conduct the proposed research; the
adequacy of the time commitment of all key laboratory and clinical
researchers associated with the project; b) clear evidence of
significant multidisciplinary interactions in the conception, design
and proposed implementation of the project; c) degree to which the
project addresses an issue of substantive importance for reducing
incidence and mortality or for increasing survival in human
gastrointestinal cancer; d) the scientific merit and adequacy of
experimental design of the project; e) the originality, novelty, and
innovativeness of the experimental design and relevance to the
overall goals and objectives of the SPORE; f) the degree to which the
project is interactive with other projects in the SPORE conceptually,
experimentally, and translationally; g) appropriateness of the budget
to achieve research objectives.

Developmental Funds - a) adequacy of the proposed process for
continuously reviewing and funding pilot projects for their quality,
innovativeness and potential impact on reducing incidence and
mortality, and/or improving survival to gastrointestinal cancer; b)
quality, innovativeness and potential impact of proposed pilot
projects; c) degree to which developmental funds will be used to
stimulate pilot projects with multidisciplinary interactions and/or
collaborative interactions with other scientists within or outside of
the parent institution; d) appropriateness of the proposed budget
relative to the proposed pilot    projects and potential of the
program to generate innovative pilot projects on a consistent basis.

Shared Resources - a) adequacy of the proposed plans to develop,
maintain and distribute a fresh/frozen human gastrointestinal cancer
tissue resource with pathological and clinical data; b) confirmation
that the plan does not duplicate resources already available within
the institution (e.g. as part of a Cancer Center Support Grant or
P30) or through readily available national resources; c) adequacy of
the justification for other specialized resources essential for the
conduct of SPORE research; d) adequacy of qualifications of proposed
managers of resources to conduct high quality, reliable resource
operations; e) appropriateness of the requested budgets to conduct
each resource operation.

Interactions with other SPOREs - a) adequacy of plans to promote and
maintain communication and integration with other gastrointestinal
SPOREs; b) willingness to interact with other SPOREs and with the NCI
in sharing data, in assessing scientific progress, in identifying new
research opportunities and in establishing scientific priorities.

Scoring the Applications - In addition to rating the merit of
individual components, peer reviewers will be asked to judge the
overall program in the following areas:  1) scientific merit and
innovativeness; 2) evidence of interdependent, multidisciplinary
design and conduct of the research; 3) potential for impacting on the
disease; 4) institutional commitment.

A verbal descriptor will be recorded for each of the above areas.  A
single numerical priority score will be assigned to the program as a
whole.  The score will weight each of the above four areas, 60
percent, 15 percent, 15 percent and 10 percent respectively.  A
recommendation for no further consideration for any required element
of the program will result in an overall evaluation of "not
recommended for further consideration."

AWARD CRITERIA

The anticipated date of award is September 30, 1993.  In addition to
the required elements as described above under Special Requirements,
the NCI will consider how well the applicant institutions meet the
goals and objectives of the program as described in the RFA,
availability of resources, and study populations.

INQUIRIES

The program director welcomes the opportunity to clarify any issues
or questions from potential applicants, including questions about the
eleigibility requirements, funding issues, and peer review process.
Initiating a dialogue with NCI staff at the earliest possible time
usually benefits the applicant in the preparation of an application.
Written or telephone inquiries concerning the objectives and scope of
the RFA, or inquiries about whether or not specific proposed research
would be responsive, are encouraged and should be directed to:

Andrew Chiarodo, Ph.D.
Chief, Organ Systems Coordinating Branch
Executive Plaza North, Suite 512
National Cancer Institute
Bethesda, MD 20892
Telephone:  (301) 496-8528
FAX: (301) 402-0181

For fiscal or administrative matters, contact:

Robert E. Hawkins
Grants Management Specialist
Executive Plaza North, Suite 216
National Cancer Institute
Bethesda, MD 20892   / Tel:  (301) 496-7800 ext.  13

AUTHORITY AND REGULATIONS

This program is described in the catalog of Federal Domestic
Assistance no. 13.397. Awards are under authorization of the Public
Health Service Act, Title IV, Part A (Public Law 78-410 as amended:
42 USC 241) 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.

.

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