Full Text CA-94-027

SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN BREAST CANCER

NIH GUIDE, Volume 23, Number 24, June 24, 1994

RFA:  CA-94-027

P.T. 34

Keywords: 
  0715036 
  Biomedical Research, Multidiscipl 
  Diagnosis, Medical 
  Disease Prevention+ 
  Treatment, Medical+ 


National Cancer Institute

Letter of Intent Receipt Date:  July 29, 1994
Application Receipt Date:  October 25, 1994

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 for Specialized Programs of Research
Excellence (SPORE) in Breast Cancer.  The intent of this initiative is
to expand the Breast Cancer SPOREs from the current four SPOREs to a
minimum of five SPOREs through open recompetition by making awards to
those institutions that can conduct the highest quality balanced
translational research approaches on the prevention, etiology,
screening, diagnosis, and treatment of breast cancer.  SPOREs are at
institutions that have made or will make a strong institutional
commitment to the organization and conduct of these programs.  SPORE
applicants will be judged on their current and potential ability to
translate basic research findings into innovative research settings
involving patients and populations.  Each SPORE is encouraged to
conduct rehabilitation and quality-of-life research.  Each SPORE must
provide career development opportunities for new and established
investigators who wish to pursue active research careers in
translational breast cancer research; develop and maintain human breast
cancer tissue resources that will benefit translational research;
develop extended collaborations in critical areas of research need with
laboratory scientists and clinical scientists within the institution
and in other institutions; and participate with other SPORES on a
regular basis to share positive and negative information, assess
scientific progress in the field, identify new research opportunities,
and promote inter-SPORE collaborations to resolve areas of scientific
controversy.  Each SPORE and the "network" of SPOREs is expected to
conduct research that will have the most immediate impact possible on
reducing incidence and mortality to human breast cancer.  Each SPORE
should support a mix of basic and clinical researchers whose formal
interactive and collaborative research efforts will result in new
approaches for early detection, diagnosis, therapy, and prevention and
control.  The SPORE mechanism is not intended to support basic research
to the exclusion of clinical research or vice versa.

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), Specialized Program of Research Excellence
(SPORE) in Breast 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, DC 20402-9325
(telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.

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 breast cancer, and
who together represent experience in both laboratory and clinical
research, or in the alternate, a minimum of three independent
investigators, each having published articles that significantly
address breast cancer in peer-reviewed research journals, and who as a
group represent experience in both laboratory and clinical research;
(2) access to a patient care and service facility that serves breast
cancer patients and, if the facility is not part of the parent
institution, a statement that assures access to breast cancer patients
for clinical research; the statement must be signed by the responsible
officials of the applicant institution and the consortial care
facility; (3) although applications must be submitted from a single
institution, they may include subcontracted collaborative scientific
arrangements with scientists from other institutions as long as these
arrangements are clearly delineated, and formally and officially
confirmed by signed statements from the responsible officials of each
institution.  However, a full institutional commitment must come from
the parent institution receiving the award.

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

NCI staff (See INQUIRIES below) 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 specialized center grant
(P50) 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 career development, pilot research projects,
specialized resources and shared core facilities.  Applicants will be
responsible for the planning, direction, and execution of the proposed
SPORE program.  Except as otherwise noted in this RFA, awards will be
administered under PHS grants policy as stated in the Public Health
Service Grants Policy Statement.

FUNDS AVAILABLE

This RFA is a one-time solicitation.  The NCI anticipates making at
least five awards.  Applicants applying for competitive renewals may
request up to five years of support.  New applicants or applicants that
have received P20 SPORE feasibility awards in the past may request up
to three years of support.   The NCI anticipates setting aside $2.5
million per award or $12.5 million total for the initial year's
funding.  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 NCI,
the award of grants pursuant to this RFA is contingent upon the
anticipated availability of funds for this purpose.

NCI policy for SPORE grants establishes the following limits to the
requested budgets:  All new and competing renewal P50 SPORE
applications may request a maximum annual direct cost of $1.5 million
and maximum annual total cost of $2.5 million per individual SPORE.  In
complying with the direct cost cap of $1.5 million, the indirect costs
related to subcontracts to other institutions or organizations will not
apply toward the direct cost cap, but the total dollar request may not
exceed $2.5 million.  Future year increases are limited to four
percent, but may not exceed this cap.  Funding for successful P50
renewal applications will be for up to five years.  Initial funding for
new P50 SPOREs will be for no more than three years.  Recognizing that
the initial three year funding period for new SPOREs may be too short
for multiple substantive scientific accomplishments, any future
recompetition for this group will be evaluated on scientific
accomplishment and on interim progress in pursuit of SPORE
organizational, collaborative and research objectives.  This would
include, for example, progress toward planning, developing and
implementing new innovative translational research programs, progress
toward developing the careers of new scientists, progress toward
procuring and distributing tissue specimens, progress toward developing
substantive collaborative interactions.

RESEARCH OBJECTIVES

Background

Breast cancer is the most common cancer among U.S. females, is the
highest incidence cancer in the U.S., and is the second leading cause
of cancer death among women.  Since 1980, breast cancer incidence has
increased dramatically in both pre- and post menopausal women at a rate
of approximately two percent per year.  During this time, the
scientific information base for breast cancer 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.  Translational research also applies clinical
findings to advance basic research that ultimately may lead to
hypothesis-driven clinical trials or prevention and control
interventions.  It should be noted that clinical research that is not
based on nor derived from basic research is not considered
translational for purposes of this RFA.

Other

The goal of this RFA is to expand the current Breast Cancer SPORE
program with the addition of at least one new SPORE.  Each SPORE
assembles critical masses of laboratory and clinical scientists to work
together on human breast cancer and to focus on innovative translation
of basic findings into research settings involving patients and
populations.  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 human disease, (2) a
strong innovative developmental or pilot research program that can
respond quickly to new research opportunities, (3) a strong career
development program to develop and expand the scientific cadre of
investigators dedicated to translational research on human breast
cancer, (4) a human breast cancer tissue procurement resource and other
resources specifically dedicated to translational research objectives,
and (5) a willingness and commitment to work with other SPOREs and
scientists in order to maximize research progress.

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 breast cancer, as well as rehabilitation or
quality of life.  Individual research projects must be highly
interactive, and must be conceived, planned and implemented through the
multidisciplinary interactions of independent laboratory and clinical
scientists.  Such interactions should demonstrate the potential for
accelerating 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.  Thus, each
project may, but ordinarily 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.  Career development of new and
established investigators will generate a cadre of scientists who could
leave the SPORE with research experience to develop independent breast
cancer research programs which emphasize translational research
objectives.

In order to facilitate achievement of SPORE program goals, each SPORE
must develop resources specialized for breast cancer research
activities.  This must include human breast 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
breast cancer research 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.  A requirement for all SPOREs is an annual
meeting 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:

1.  A strong institutional commitment.  An institution receiving this
award must incorporate the SPORE high within its institutional
priorities.  The institution should demonstrate a strong commitment to
the program's stability and success.  The application  must provide a
plan which addresses how the institutional commitment will be
established and sustained, how it will maintain accountability for
promoting scientific progress, and how the SPORE research effort will
be given a high priority within the institution relative to other
research efforts.  This institutional commitment may be in the form of
commitments to recruit scientific talent, provision of discretionary
resources to the SPORE director, faculty appointments for SPORE
investigators, assignment of research space, cost sharing of resources,
or other ways to be proposed by the applicant.

2.  A qualified principal investigator.  A leader should be selected as
principal investigator who can oversee and conduct planning activities,
provide direction to the SPORE and ensure a translational research
emphasis.

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

4.  Research projects.  Each SPORE application must include at least
three approved research projects that together represent reasonably
diverse experimental approaches.  Each research project must be headed
by basic and clinical co-investigators.  It is not necessary that both
co-investigators commit equal effort to the project, but it should be
evident from this collaboration that translational research objectives
will be accelerated.  The research must be oriented toward
translational activities using human materials and human subjects that
address new, innovative possibilities in breast cancer research.  As
indicated above, 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 whenever possible.  This program will not support basic research
that is without translational potential or significance nor will it
support clinical studies that are not "translated" from basic research.

The clinical research components must include provisions for rigorous
data management, quality assurance, and auditing procedures.  For any
treatment protocols supported directly or indirectly by the SPORE,
copies of Informed Consent forms, Early Stopping rules and procedures
to detect and monitor Adverse Drug Reactions (ADR) must be provided in
the application, or in the case of future protocols, to the NCI program
director.

At least one research project must be on breast cancer prevention or
early detection and screening.  The NCI is particularly interested in
early detection and screening efforts that will either refine
mammography methodology or provide alternative approaches that will be
improvements over mammography.  There is also a strong interest in
developing genetic methods for determining high risk to breast cancer
either through inheritance or through environmental exposures.
However, the NCI is open to all novel innovative approaches to
prevention.

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 subcontracting arrangements but an award
will be made to one institution only; that institution is expected to
demonstrate the full institutional commitment noted in 1. above.

It is expected that all SPOREs will have a balanced approach to breast
cancer that encompasses the areas of prevention, etiology, screening,
diagnosis and treatment.  This balanced approach may be either through
research being conducted in their institution, or through collaborative
associations they have developed or plan to develop with other SPOREs
or with other investigators in the biomedical research community.

5.  Developmental Research Funds.  Each SPORE should 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 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 review process that selects pilot projects for
funding which represent the most innovative ideas and are likely to
have the greatest impact on reducing breast cancer incidence and
mortality, and increasing and improving survival and quality-of-life of
breast cancer patients.  These funds are intended to remain flexible
and to support feasibility and pilot studies of a limited duration,
e.g., two years or less, rather than the duration of the entire grant
period.  The expectation is that successful feasibility studies will
become fully developed projects within the SPORE, or funded through
other forms of research support, e.g., R29, R01.

6.  Specialized Resources.  The SPORE is encouraged to develop and
maintain resources of special significance to translational breast
cancer research.  While all types of resources may be proposed, each
SPORE must have a dedicated activity for collecting and distributing
human breast cancer tissue.  This should include the essential
pathologic and clinical information needed for conducting research.
This resource should benefit the specific research activities of the
SPORE as well as the research activities of other scientists within and
outside of the parent institution who are concentrating on
translational research issues.  The SPORE must be willing to
participate in any national prioritization for distribution of tissues
through NCI supported tissue networks.  A plan must be proposed for
prioritizing distribution of tissues to SPORE scientists and others
based on the most innovative ideas in translational breast cancer
research.  This plan should be flexible enough to accommodate and
complement broader national priorities as they are developed.

7.  Career Development.  The SPORE should demonstrate a consistent
commitment to career development.  A sufficient portion of the budget
should be dedicated to the salaries and research activities of
investigators who wish to pursue careers in translational research on
breast cancer and who would acquire the necessary research experience
to develop independent breast cancer translational research programs
within or outside of the parent institution.  These may be new
investigators or established investigators who wish to change research
directions.  Candidates should be scientists who have demonstrated
outstanding research potential but who need additional time in a
productive scientific environment to establish an independent breast
cancer research program. Candidates are expected to devote full time to
research. Any deviation will require prior NCI approval.  Recruitment
should encourage the participation of qualified women and minorities
where possible.  To this end, each applicant should include a clear
policy and plans for recruiting minorities and women.  The SPORE
application should propose the number of slots available, the criteria
for eligibility and for selection of candidates, and describe the
selection process.  Also, the application should indicate prospective
mentors who are already in place at the proposed SPORE,briefly describe
their research programs, and describe complementary activities that
contribute to the environment for career development (e.g., existing
training grants, other career development mechanisms and relevant
programs).

8.  Annual Meeting of SPORE.  Breast Cancer SPOREs will be expected to
participate in an annual meeting with the Organ Systems Coordinating
Branch of the NCI to share positive and negative results with other
SPOREs, share materials, assess progress, identify new research
opportunities, and establish interactions and research priorities and
collaborations that will maximize the impact of the research on
reducing incidence and mortality, and improving survival.  Travel funds
for the Principal Investigator and selected Project Investigators may
be budgeted for this purpose.  This may include Project Investigators
from other institutions who are actively collaborating with SPORE
investigators.  In addition, travel funds should be budgeted for the
SPORE Director to attend an annual SPORE Directors' administrative and
planning meeting at the NCI.  This Directors' meeting is in addition to
the annual SPORE Investigators' meeting.

A SPORE application can originate from an institution with or without
an existing NCI Cancer Center Support Grant or P30 core grant.
However, if a P30 grant already exists:

a) the Principal Investigator of the SPORE should be a senior 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
is an integral part of the Cancer Center and does not interfere with
the P30 chain of authority;

d) a letter of commitment which 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 an integrated major programmatic element in the
cancer center; however, there must also be a separate and distinctive
institutional commitment to the SPORE as opposed to the NCI-designated
Cancer Center;

f) the development of resources in the SPORE should not duplicate
resources already provided by the existing P30 grant; 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

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)
and supersedes and strengthens the previous policies (Concerning the
Inclusion of Women in Study Populations, and Concerning the Inclusion
of Minorities in Study Populations) which have been in effect since
1990.  The new policy contains some new provisions that are
substantially different from the 1990 policies.

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 reprinted in the Federal
Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting
errors in the earlier publication, and reprinted in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the program
staff or contact person listed below.  Program staff may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by July 29, 1994, 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
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 allows NCI staff to estimate the
potential review workload and to avoid conflict of interest in the
review.  Furthermore, NCI staff can discuss the most recent policies of
the NCI relative to funding issues, potential problems in meeting
eligibility requirements or clarification of the peer review process
before the final application is submitted.

The letter of intent is to be sent to:

Andrew Chiarodo, Ph.D.
Division of Cancer Biology, Diagnosis, and Centers
National Cancer Institute
Executive Plaza North, Suite 512
Bethesda, MD  20892 (by U.S. Postal Service)
Rockville, MD  20852 (by Delivery Service)
Telephone:  (301) 496-8528
FAX:  (301) 402-0181

APPLICATION PROCEDURES

Complete applications are due no later than October 25, 1994.
Applications must meet all eligibility requirements as described above
and must address all programmatic requirements (see SPECIAL
REQUIREMENTS above) in the RFA.  Applications received after this date
will not be accepted.  Also, the Division of Research Grants will not
accept any application in response to this RFA, any part of which is
the same as one currently being considered by any other review group or
NIH awarding unit.

Specific instructions for preparing a SPORE grant application are
available as a separate addendum to this RFA.  These instructions are
to be used in preparing the application.  They are available from Dr.
Andrew Chiarodo at the address listed under INQUIRIES.

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of Grants
Information, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, MD 20892-4500, telephone
(301) 435-0714; and from the NCI Program Director listed under
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 the application such that it may
not reach the review committee in time for review.  In addition, the
RFA number and title "SPORE in Breast Cancer" must be typed on line 2a
of the face page of the application form.

A signed typewritten original of the application, including the
checklist, and three signed exact photocopies, in one package, must be
submitted to:

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

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

Ms. Toby Friedberg
Division of Extramural Activities,
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Rockville, MD  20852 (if hand-delivered or delivery service)
Bethesda, MD  20892 (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 applications will be reviewed in competition with other
applications received by the designated receipt date.

REVIEW CONSIDERATIONS

A.  Review Procedures

Upon receipt, applications will be reviewed initially by the Division
of Research Grants for completeness.  Applications that have not
addressed all of the required elements noted above under SPECIAL
REQUIREMENTS or that do not meet the eligibility requirements as noted
above, will be returned to the applicant without further consideration.
Evaluation for responsiveness to the program requirements stated in the
RFA is an NCI program staff function; this will be done stringently and
will be based primarily on the clear orientation of the application to
human breast cancer, to translational research objectives, and to 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.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit and for special SPORE
characteristics and requirements by an appropriate peer review group
convened by the NCI in accordance with the review criteria stated
below.  As part of the initial merit review, a process (triage) may be
used by the initial review group in which applications will be
determined to be competitive or non-competitive based on their
scientific merit relative to other applications received in response to
the RFA.  Applications judged to be non-competitive will be withdrawn
from further consideration and the principal investigator/program
director and the official signing for the applicant organization will
be promptly notified.  Applications judged to be competitive will be
discussed and be assigned a priority score.  The second level of review
will be provided by the National Cancer Advisory Board.

B.  Review Criteria

The major factors to be considered in the evaluation of all
applications are given below.  Additional factors are noted in a
separate section below for applications from existing P20 SPORE
feasibility grantees and for applications from P50 SPOREs applying for
competitive renewal.

1.  The Institutional Commitment

a) adequacy of facilities, equipment and space to promote translational
research objectives;
b) adequacy of institutional procedures and plans for monitoring,
evaluating and assuming accountability for the general success of the
SPORE;  adequacy of the institutional infrastructure for assessing
progress and needs;
c) adequacy of recruitment objectives and plans to strengthen the
scientific capabilities of the SPORE;
d) presence of other tangible commitments, i.e., discretionary
resources, to the SPORE, e.g., dollars and space.

2.  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;
e) if applicable, the adequacy of plans for synergistic and effective
interactions with existing P30 programs.

3.  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 basic and clinical
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 breast cancer;
d) the scientific merit and adequacy of experimental design of the
project;
e) in clinical research components, clear evidence of full protection
of human subjects, and appropriate mechanisms for the rigorous
management and verification of research data.
f) the originality, novelty, and innovativeness of the experimental
design and relevance to the overall goals and objectives of the SPORE;
g) the degree to which the project is interactive with other projects
in the SPORE conceptually, experimentally, and translationally;
h) appropriateness of the budget to achieve research objectives.

4.  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 breast 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.

5.  Career Development
a) the adequacy of the process for selecting candidates for career
development who demonstrate potential for independent research careers
or who are established investigators and are changing the direction of
their research careers;
b) adequacy of the policies to seek out and include qualified
minorities and women in the career development program;
c) adequacy of the individuals available in the program to serve as
possible mentors of career development candidates; the current
availability and adequacy of projects for career development
candidates;
d) complementary activities that contribute to the environment for
career development;
e) capacity of the overall program to absorb career development
candidates and prepare them for independent breast cancer research
careers;
f) appropriateness of the budget relative to the proposed plans for
sustaining a strong activity in career development.

6.  Shared Resources

a) adequacy of the proposed plans to develop, maintain and distribute
a fresh/frozen human breast cancer tissue resource with pathological
and clinical data;
b) willingness to participate in any national prioritization for
distribution of tissues through NCI-supported tissue networks;
c) 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;
d) adequacy of the justification for other specialized resources
essential for the conduct of SPORE research;
e) adequacy of qualifications of proposed managers of resources to
conduct high quality, reliable resource operations;
f) appropriateness of the requested budgets to conduct each resource
operation.

7.  Interactions with other SPOREs

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

The above criteria apply to all new and competing applications.
Additional factors to be considered in the evaluation of competing
applications from P20 Feasibility SPORE grantees, will be:

a) nature and quality of planning in the context of focusing on
translational activities;
b) extent to which applied researchers (e.g., clinical researchers,
prevention and control researchers) are interacting with basic
investigators in planning translational approaches to the problem of
breast cancer;
c) how funds have been used to foster planning for a SPORE in breast
cancer;
d) positive and/or negative results of pilot projects, if applicable.
e) extent to which pilot projects, where applicable, have led to
proposal of new full research projects in the current grant
application.

Additional factors to be considered in the evaluation of competing
renewal applications from current P50 SPORE grantees, will be:

1.Research Projects

a) progress in establishing a high quality research effort and
scientific productivity in translational research over the previous
funding period;
b) degree to which applied researchers (e.g., clinical researchers,
prevention and control researchers) are interacting with basic
investigators in the planning, design, and implementation of research
projects;
c) collaborative efforts that have been established within and outside
the SPORE institution;
d) results (positive or negative) from each research project;
e) degree to which each project is interacting with other projects;
f) translational potential or significance of each individual research
project;

2.Developmental Projects

a) progress in the effective use of developmental funds to explore new
research opportunities and/or stimulate the field;
b) quality, innovativeness, and potential or actual impact of funded
pilot projects;
c) positive and/or negative results for each developmental project;
d) how the SPORE has set priorities in the use of developmental funds;
e) impact of developmental projects in stimulating new full
translational research projects within the SPORE, or through other
support mechanisms;
f) impact of developmental projects in stimulating new
multidisciplinary or collaborative interactions within or outside the
SPORE.

3.Career Development

a) progress toward recruiting candidates including women and
minorities, for career development;
b) progress in developing the careers of new or established
investigators in translational breast cancer research;
c) quality and adequacy of the research activities of these
individuals;
d) current status and research activities of individuals who have
completed career development, if applicable.

4.Shared Resources

a) effectiveness and efficiency of previously funded resources in
meeting the specific translational research needs of the scientific
projects in the SPORE;
b) extent to which shared resources are being used by research and
pilot projects, both within and outside the SPORE;
c) quality, utility, and efficiency of the shared resources;
d) progress toward establishing the breast cancer tissue resource to
include pathological and clinical data;  nature, quality, and
distribution of tissues being procured;  plans for prioritizing
distribution of tissues within and outside the SPORE.

5.Other Considerations

a) special efforts to recognize unique research opportunities based on
incidence and mortality rates in the community or region of the SPORE;
b) special efforts to enhance the research capability of the SPORE
through interactions with individuals, organizations, and institutions
within the community;
c) special efforts to promote and maintain communication and
integration with other breast SPOREs;
d) progress toward meeting previously stated (above) institutional
commitments;
e) demonstrated effectiveness of the SPORE Director in terms of
scientific and administrative leadership;
f) progress in refining and improving upon the translational research
infrastructure of the SPORE during the previous funding period as it
relates to a) through e) above.

Each component of the application will receive a recommendation of
approval, or not recommended for further consideration.  Approved
components will receive an appropriate verbal descriptor of merit.  The
review group will critically examine the proposed budget for each
component of the application.

C.  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;  progress, if applicable;
2) evidence of interdependent, multidisciplinary design and conduct of
the research;
3) impact, or 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.  Although primary emphasis will be placed on scientific merit,
innovativeness, and progress, if applicable, significant consideration
will be given to multidisciplinary interactions, potential for
impacting on the disease, and institutional commitment.

A recommendation for no further consideration for any required element
of the program (see SPECIAL REQUIREMENTS above) will result in an
overall evaluation of "not recommended for further consideration."

AWARD CRITERIA

The earliest anticipated date of award is September 1, 1995.
Applications considered by the National Cancer Advisory Board will be
considered for award based upon (a) priority score, (b) availability of
funds, and (c) programmatic priorities.  The NCI anticipates making at
least five awards for project periods of five years for successful P50
competitive renewals, and for project periods of three years for
applications from new applicants or current P20 SPORE feasibility
grantees applying for P50 funding.

INQUIRIES

Written and telephone inquiries concerning the objectives and scope of
the RFA, and inquiries about whether or not specific proposed research
would be responsive, are encouraged.  The program director welcomes the
opportunity to clarify any issues or questions from potential
applicants.

Direct inquiries regarding programmatic issues and address the letter
of intent contact:

Andrew Chiarodo, Ph.D.
Division of Cancer Biology, Diagnosis, and Centers
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Suite 512
Bethesda, MD  20852
Telephone:  (301) 496-8528

For fiscal or administrative matters, contact:

Joan Metcalfe
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800  ext. 228

AUTHORITY AND REGULATIONS

This program is described in the catalog of Federal Domestic Assistance
No. 13.397.  Awards are made 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 grants 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 (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use of
all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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