Full Text CA-94-029

PLANNING GRANTS FOR PROSPECTIVE CANCER CENTERS

NIH GUIDE, Volume 23, Number 31, August 19, 1994

RFA:  CA-94-029

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Biomedical Research, Multidiscipl 


National Cancer Institute

Letter of Intent Receipt Date:  September 29, 1994
Application Receipt Date:  November 29, 1994

PURPOSE

The Cancer Centers Branch (CCB), Division of Cancer Biology, Diagnosis
and Centers (DCBDC), National Cancer Institute (NCI) announces the
availability of planning and development grants for cancer centers in
underrepresented areas of the nation.  This initiative provides
applicant institutions with the opportunity to either initiate or
continue their planning and development activities toward this goal.

The overall intent of these grants is to further assist eligible
institutions to develop the organizational capability that will lead to
the formation and/or development of cancer research centers.  The
ultimate goal of this Request for Applications (RFA) initiative is to
encourage the development of cancer research centers in geographic
areas that are currently not served by existing NCI-designated clinical
or comprehensive cancer centers.  In addition to basic cancer research,
these new centers should plan to emphasize clinical and
prevention/control research that will ultimately impact on the
populations in their regions, paying particular attention to minority,
rural, and other underserved populations.  It is anticipated that after
completion of these planning and development grants, recipient
institutions will be in a position to compete for Cancer Center Support
Grants (CCSG) from the NCI.

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,
Planning Grants for Prospective Cancer Centers, is related to the
priority area of cancer.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC  20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by the following institutions: 1)
Domestic medical research organizations, public and private such as
universities, that fulfill the following requirements and that do not
currently have a Cancer Center Support Grant (CCSG) (P30) Planning
Grant for Prospective Cancer Centers and (P20); 2) Institutions that
currently hold a P20 Planning Grant for Prospective Cancer Centers, but
have not yet developed their research base to be eligible to apply for
a CCSG.

Applicant institutions must intend to develop cancer research centers
that, define at a minimum, will have a strong basic research and
clinical research foundation, and will develop or include prevention
and control research in their long-term objectives.  Eligible
institutions must come from states that do not currently have an
NCI-designated Comprehensive, Clinical, or Consortium Cancer Center.
The NCI will also consider accepting applications from other
institutions if they are located outside of the regional service area
of an existing Comprehensive, or Clinical Cancer Center.  In addition,
eligible institutions must have three or more externally funded,
peer-reviewed, cancer research project grants or contracts (e.g., R01,
P01, N01, U01), or equivalent types of research projects.  The Cancer
Centers Branch in its 1992 "Guidelines for Cancer Center Support
Grant," established the bases for identifying funded peer-reviewed
cancer research projects.  This is the standard that will be followed
in determining eligibility of institutions to apply for a planning
grant.

Eligible institutions may request up to three years of support under a
planning and development grant to develop the institutional capability
to form a successful cancer research center of excellence.
Institutions that already have a fully established organizational
capability as a cancer center and a sufficient peer-reviewed cancer
research base of $1.5 million dollars or greater in cancer specific
research (See 1992 "Guidelines for Cancer Center Support Grants") are
not eligible under this program.

Potential applicants are strongly advised to contact NCI program staff
listed under INQUIRIES , to discuss eligibility requirements prior to
preparing an application.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of
Health (NIH) exploratory grant mechanism (P20).  Applicants will be
responsible for the planning, direction, and execution of the proposed
project.  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 90-50,000,
revised October 1, 1990)

This RFA is a one-time solicitation.  The earliest feasible start date
for the initial awards will be July 1, 1995. Although this program is
provided for in the financial plans of the NCI, the award of grants
pursuant to this RFA is also contingent upon the availability of funds
for this purpose.

FUNDS AVAILABLE

Approximately $750,000 in total costs per year will be committed
specifically to fund applications submitted in response to this RFA,
but no single institution may apply for more than $175,000 in direct
costs (See Review Criteria).  It is anticipated that three to five
awards will be made.  This funding level is dependent on the receipt of
a sufficient number of applications of high merit.  The total project
period for applications submitted in response to the present RFA may
not exceed three years.

RESEARCH OBJECTIVES

Background

The Cancer Centers Program was developed in the late 1960s and was
formally authorized by the National Cancer Act of 1971.  The language
of the Congress indicated that the NCI should develop an expanded
Cancer Centers Program of both comprehensive and specialized types that
would "be expected to perform fundamental research in clinical and
basic science disciplines; take the lead in planning and coordinating
organ site programs; develop the special competence of each individual
center; serve as focal points for testing and evaluating outputs of the
research and development efforts; and couple the output of the cancer
research efforts to medical practice."  In the last ten years,
legislative language has repeatedly stressed the need for cancer
centers to develop research compatibility in the area of prevention and
control.

The Cancer Centers Program of the NCI currently supports
multidisciplinary cancer research centers in a variety of institutions
through Cancer Center Support Grants using the P30 grant mechanism.
These NCI-designated cancer centers are responsible for implementing a
major portion of the National Cancer Program in all aspects of cancer
research, including basic, clinical, control, and prevention.  These
research activities favorably impact on the cancer treatment, control,
prevention, and other adjunct service functions that are associated
with clinical and comprehensive cancer centers.  NCI-designated Cancer
Centers provide the national standards of excellence in cancer
detection, diagnosis, treatment, rehabilitation, prevention, control,
and continuing care.  Additionally, they serve as major resources for
health professionals and the public in their regions.

Although the cancer research programs of NCI-designated Cancer Centers
are independently funded through a variety of peer-reviewed grants and
contracts from NIH and other funding sources, the Cancer Center Support
Grant (CCSG) undergirds these research activities by providing core
support through partial funding of shared research resources that
provide cost-effective access to sophisticated equipment,
state-of-the-art technologies, and essential services.  The CCSG also
supports central administrative expenses, partial salary support for
the center's senior leadership and other key research personnel, the
recruitment of key new members to the center, and the exploration of
new research opportunities. These functions, as well as detailed
application information, are described for the Cancer Center Support
Grant in "Guidelines: Cancer Center Support Grants (1992)."  This
document is available from Cancer Centers Branch DCBDC/NCI.  To be
eligible to apply for a CCSG, a prospective applicant must have a
minimum amount of peer reviewed cancer research. (currently, $1,500,000
in direct costs)

Since the passage of the National Cancer Act, Congress has emphasized
in legislative language the need for better geographic distribution of
NCI-designated cancer centers around the U.S.  A majority of funded NCI
designated Comprehensive, Clinical, and Consortium Cancer Centers are
located on the east and west coasts and around the Great Lakes, which
reflects both the U.S. population density and the locations of medical
research centers.  Nonetheless, there are medical institutions existing
in currently under-represented areas that have sufficient peer-reviewed
cancer research and could provide the base for developing cancer
research centers. However, the planning and development process
requires a significant investment of institutional resources; this may
have prevented some institutions from exploring the possibility of
forming a new cancer center. This RFA, like the previous RFA (RFA
CA-91-15) published in 1991, is designed to encourage qualified
institutions to make the investment necessary to establish a cancer
research center.

Detailed planning and development is crucial to the formation of a new
cancer research center with a broad range of research capabilities
(i.e., basic, clinical, and prevention and control research).  Since a
new cancer center must be an entity that has its own distinct
administrative identity and a measure of autonomy, it may need to be
'created' within the parent institution, which is often a complex
process. The goals of the new center must be clearly defined.  Space
and personnel must be dedicated to the cancer center.  The center must
have distinct multidisciplinary and interdisciplinary cancer research
programs.  These programs may need to be developed and members
recruited from within and outside the parent institution.  In addition,
specific central research resources must be identified for inclusion or
development as part of the cancer center.  Finally, the parent
institution must give tangible support to the new center.  These
planning elements are based on the recognized essential characteristics
of a cancer center as described in the CCSG guidelines mentioned above.
The essential characteristics of cancer centers include: (a) adequate
commitment of the parent institution that recognizes the center as a
major organizational element of the institution; (b) appropriate and
adequate organization; (c) availability and configuration of facilities
devoted to the cancer center to facilitate the research and other
activities of the center; (d) a qualified and effective director with
adequate authority over appointments, space, equipment, and
identifiable clinical research facilities to ensure smooth and
effective coordination; (e) clear cancer research focus and intent; and
(f) coordination of interdisciplinary and translational research
activities.

The intent of this RFA is to provide support to new institutions that
need time and resources to develop their centers in order to meet the
essential characteristics of an NCI-designated cancer center and/or to
expand their research base.  A successful implementation of this RFA
will allow a larger proportion of the U.S. population to have direct
access to the most up-to-date cancer research, education, and care
through these regional research centers of excellence.

Goals and Scope

The primary goal of this RFA is to provide support to those
institutions that wish to develop the organizational capability that
will lead to the formation and/or development of new centers of cancer
research excellence in underrepresented geographic areas in the United
States.  Applicants must demonstrate their potential and/or actual
progress toward fulfilling the essential characteristics and obtaining
the required research base. Ultimately, the development of these
centers should provide wider access of regional populations to the
benefits of state-of-the art clinical and prevention and control
research.  It is anticipated that these new centers, after completion
of the planning and development effort, will be in a position to
compete for NCI cancer center designation through submission of a CCSG
application.

The Planning and Development Process

A.  Definition of the planning and development effort

The planning process involves identification of and the proposed
methods for achieving, goals and objectives that together will provide
the research capability, the organizational structure, financing, and
facilities needed for the cancer center.  These objectives should take
into account the following considerations:

1.  The identification of the special problems that need to be resolved
in order to develop a competitive cancer research center.  Plans and
contingencies should be noted.

2.  The overall objectives and purposes of the parent institution.  The
development of a cancer research center should be compatible with the
long-term goals and objectives of the parent institution and its
leadership.

3.  The identification of the specialized needs of the institution's
geographic area and its populations that can be addressed through
research.  The special needs of the center's region or service
population, especially as they relate to cancer incidence, mortality,
and survival must be strongly considered in the development of research
programs.  Research programs are included in a CCSG application.  These
same considerations influence the development of the education,
outreach, and service programs of the center.  Such programs are not
included for support in a CCSG application, but are clearly a
significant aspect of any cancer center desiring to have an impact on
its region.

4.  The effect that the establishment of a cancer-oriented center will
have on the internal structure or organization of an institution.
Cancer centers must actively promote multidisciplinary research and
service activities which transcend and work effectively across
traditional academic departments and disciplines.  Consideration of the
administration and organization of the center and its relationship to
other organizational elements within the parent institution is critical
to the planning process as are scientific, clinical, and technical
considerations.  For example, the center, to be effective, should have
its own administrative identity within the parent institution and
should have, at a minimum, equivalent status to academic departments.

5.  The level of commitment and resources the parent institution can
provide a new cancer center.  The development of a cancer center
requires substantial institutional investment in areas such as
facilities, staff, administrative reorganizations, and financial
resources.  A realistic view of the potential resources that could be
made available on a regular, stable basis to the new center is needed
if the goals and objectives of the institution are to be achieved.

6.  Definition of the interactive and translational research activities
to be included in the new center is at the heart of the cancer center
concept. Multidisciplinary research 'programs' must be defined in terms
of the current research activities and new research activities that
must be added to the center in order to give it greater balance and
effectiveness. However, the center must also consider how it will
capitalize on its unique capabilities and opportunities.  The usual
structural elements of the cancer research activities at a center
include multi-disciplinary research 'programs,' shared resources for
peer-reviewed research, and administrative support services.

7.  The relevance of the center to the mission of the National Cancer
Institute.  All of the above must be considered with respect to how the
planned activities of the cancer center are compatible with the mission
of the NCI.

B.  Elements of a planning and development effort

The following elements are essential in the planning and subsequent
development of a cancer center:

1.  Planning director.  A senior level person competent in scientific
administration must be assigned the responsibility for directing the
planning and development effort.  This person must devote a significant
proportion of his/her time to this endeavor.  The planning director
will be the Principal Investigator of the planning and development
grant.  It is both customary and desirable that the planning director
be the director of the new center.

2.  Planning and advisory committees.  An internal planning committee
must assist the planning director.  Committee members should be
selected from within the institution that is developing the center.
Additional members from the community can also be selected where
appropriate.  This committee is responsible for evaluating scientific,
medical, institutional, and regional considerations and should ensure
that all available resources and research opportunities are considered
in the planning process.  It may be advisable for all elements of the
institution affected by the center to be represented on this committee.
In addition, an external advisory group, consisting of senior
individuals who can contribute to or are familiar with the functions
and organization of NCI-designated cancer centers, should be convened
periodically to give the planning director insightful advice on the
development of a cancer research center as well as unbiased and
independent assessments of the new center's progress in achieving its
objectives and goals.

3.  Research program definition and implementation.  The cancer
research programs that will comprise the cancer center should be
defined in terms of their leadership, relevance to the cancer problem,
productivity, individual membership (present and future), peer-reviewed
grant/contract research base, space needs and utilization, and
availability of patient resources for clinical research (if
applicable).  The research programs must be multidisciplinary in nature
and may focus on basic, clinical, and prevention and control
investigations.  They should build on the current strengths of the
institution.  Their definition and its subsequent implementation must
also include consideration of local, regional, and national needs.

4.  Shared resources.  It is important to identify and establish shared
resources that will best support the peer-reviewed research projects of
the center programs.

5.  Definition of the relationship of research activities to patient
care, education, and other outreach activities of the center.  The
relationship between the center's research activities and the patient
care, education (both professional and lay), community outreach, and
other activities of the center must be defined.  Mechanisms must be
developed so that the results of cancer research performed at the
center and elsewhere can impact quickly and positively on the
populations served by the center in its geographic area.  Such
translational activities are a fundamental aspect of a cancer center.

6.  Description of the use of developmental funds.  Developmental funds
can serve to stimulate the planning and implementation of the center
through careful allocation of "seed monies" or recruitment monies in
areas of particular need or importance to the center.

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 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 Guide for Inclusion of Women and Minorities in Clinical
Research", which have been published 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 on March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from the 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 requested to submit, by September 29, 1994,
a letter of intent that includes a descriptive title of the proposed
cancer center, the name, address, and telephone/fax number of the
planning director, the names of other key personnel, the participating
institutions, and the number and title of this RFA.  Although a letter
of intent is not required, is not binding, and does not enter into the
review of a subsequent application, it is requested in order to provide
an indication of the number and scope of applications to be reviewed.
This advance information provides you with an opportunity to work with
NCI program staff with regard to the policies and guidelines of the
Cancer Centers Program before you submit your application and ensures
that the NCI review staff will have the lead time to assemble highly
qualified group of peer-reviewers.

Prospective applicants are strongly encouraged to contact the NCI staff
listed below before the submission of a letter of intent and/or an
application.  Such contact is advantageous to the prospective applicant
because it will start a dialogue with the NCI staff where issues such
as eligibility requirements and application procedures may be
discussed.

The letter of intent is to be sent to J. Blanche O'Neill at the address
listed under INQUIRIES.

APPLICATION PROCEDURES

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, 5333 Westbard Avenue, Bethesda, MD
20892, telephone 301/435-0714; and from the NCI Program Director listed
under INQUIRIES.

Before submitting the application, affix the RFA label in the
application form PHS 398 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 must by typed on line 2a of the face
page of the application form.

Submit a signed, typewritten original of the application (without
appendices), including Checklist, and three signed, exact, clear, and
single-sided photocopies, in one package to:

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

At the time of submission, send two additional copies of the
application 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  20892-7148 (If using U.S. Postal Service)

It is important to send these copies at the same time 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.

Appendix materials should be retained by the applicant until
specifically requested by NCI staff.  Five copies of the appendices
will be requested.

Applications must be received by November 29, 1994.  If an application
is received after that date, it will be returned.  If the application
submitted in response to this RFA is substantially similar to another
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.

Complete information about the proposed planning and development effort
must be submitted with the application.  Follow the instructions in
form PHS 398 where appropriate.  However, the form PHS 398 was
developed for research grant applications.  To provide the required
information, the following supplemental instructions must be used to
prepare the application.  It is also advisable for the prospective
applicant to examine the review criteria for these applications,
described in the section "Review Criteria," below.  The narrative
portions of the application, sections I, II, III described below, must
be limited to fifty pages of text or it will be returned without any
further action.  The application must be a complete document that
includes all essential information necessary for its evaluation.
Additional explanatory material may be submitted as appendices.  There
is no page limitation on appendices.  However, appendices should not be
used to bypass page limitations in the application because only
selected reviewers will receive copies of the appendices.  The
application should be prepared using the standard PHS 398.  List the
planning director as the Principal Investigator of the application. The
planning director should be the primary author of the application.  The
application should contain the following elements:

Narrative Descriptions and Supporting Documents

Include the following sections on the form PHS 398 continuation pages:

Section I.  THE NEW CENTER AND THE PROPOSED PLANNING AND DEVELOPMENT
EFFORT:

(A) Description of the current or planned cancer center.  Discuss the
institution's concept of a cancer center.  List and discuss proposed
short-term and long-term goals and objectives of the center.  These
goals must include cancer research objectives (such as basic, clinical,
and/or prevention research) appropriate for the institution as well as
goals designed to translate the results of the research into improved
patient care, prevention, control, education/ information, and other
activities of the center.  This discussion must include references to
the proposed relationship between the center's research activities and
its goals for its community and geographic region, making special
reference to opportunities related to minority and other special
populations (see Section III below).  The special significance of the
new cancer center to the institution and its relationship to other
existing centers or comparable entities should be addressed.  Also, the
relationship of the center to other existing programs funded by the NCI
in its region should be discussed (see Section III for examples).

(B) Description and discussion of progress to date toward attaining the
goals and objectives of the center.  Discuss the history of the new
center and its current strengths.  Describe the evolution of the
relationship between the parent institution and the center.  Describe
the benefits the local community and region have received or will
receive from the center.  Discuss the level of progress that has been
made toward achieving the short- and long-term goals of the center.
Discuss whether the center is at a preliminary or advanced stage of
development in terms of its eligibility to apply for a CCSG grant. (See
1992 "Guidelines for Cancer Center Support Grants").

(C) Description of the Planning Director and his/her responsibilities
and authority to carry out the proposed planning and development
process. Discuss the selection of this individual as planning director
and his/her future role in the center.  If the planning director is not
the current center director or the director designate of a new center,
discuss the status of the institution's search for a permanent
director.  The planning director is considered to be the pivotal person
responsible for implementing the planning and development effort.  It
is essential that this section adequately present his/her scientific
qualifications and administrative experience as well as the formal
authorities of the planning director that will enable him/her to guide
the formation and development of a new center during its formative
stage.

(D) Description of planning and advisory committees.  List the
membership of the internal planning committee and the center director's
external advisory committee.  Discuss the selections for the
committees. Each of these advisory groups will have different, but
important, roles in the development of the center.  Thus, it is
critical that their duties and responsibilities be clearly described in
the application.

(E) Description of other key personnel and their duties.  Discuss the
selection and duties of the key personnel for the planning effort.
Describe the key personnel's current positions in the parent
institution.  Describe their role in the planning and development
process and their current/future responsibilities in the cancer center.

(F) Description of issues at the parent institution that will need to
be resolved through the planning and development process.  Discuss the
major issues and obstacles that must be considered in the planning and
development process.  Examples of such issues are an adequate cancer
research base and implementation of the six essential characteristics
of a cancer center (see (H) below and/or the CCSG guidelines).

(G) Describe how award of this planning and development grant to your
institution will help resolve the issues listed in (F) above and aid in
the development of the center.  Describe how other institutional
resources will be combined with the planning grant to achieve overall
objectives.

(H) Detailed description of the planning and development proposed.
Include, where appropriate, discussions of plans to:
1.  attain the necessary peer-reviewed cancer research base relative to
the current research base;
2.  implement the essential characteristics of cancer centers:
a.  institutional commitment,
b.  appropriate organizational capability
c.  appropriate facilities,
d.  center director with adequate authority,
e.  a cancer research focus and
f.  interdisciplinary coordination and collaboration;

3.  identify multidisciplinary basic, clinical, and prevention and
control research programs that are or would be included in the center;

4.  identify appropriate staff from the parent institution for center
membership and areas where additional recruitment is necessary;

5.  identify shared research resources for inclusion or development by
the center and the research capability of the center;

6.  address the efforts needed to develop appropriate long-term,
productive relationships with the parent institution and with
departments and/or other centers within the institution.

Section II.  THE PARENT INSTITUTION'S RESEARCH BASE, ENVIRONMENT, AND
RESOURCES:

(A) Current cancer research activities and publications.  Discuss
whether all peer-reviewed cancer research projects located at the
parent institution (listed in Section IV (B) below) will be associated
with the cancer center.  If not, explain.  Describe plans to expand the
peer-reviewed grant/contract base.

(B) Description of the parent institution.  Discuss the environment of
the parent institution and its suitability for attracting appropriate
research expertise.  Describe the institutional officials who will be
associated with and support the proposed center and the planning
effort, the experience of the institution with developing similar
centers or programs, and the effect that the new cancer center will
have on other programs and centers at the institution.  Include
discussions of the history of cancer research activities, access to
appropriate patient and client populations, special programs to include
women and minorities in clinical trials, local referral patterns,
community interactions, financial resources, appropriate current or
proposed facilities, and organizational capabilities.

(C) Description of the resources that will be allocated by the
institution to the new center during and after the proposed planning
and development effort.  Discuss the space, personnel, administrative,
financial, and other resources that have been allocated and are planned
to be allocated to the new or developing center.  For example, the
applicant may describe institutional payment of part of the salaries of
staff involved in the planning effort, seed money to help start new
cancer research projects or new shared resources, and funds for the
recruitment of new scientific and support staff for the center.

Section III.  THE IMPACT OF THE NEW CENTER ON ITS GEOGRAPHIC AREA AND
ITS POPULATIONS:

(A) Description of the parent institution's current relationship to and
recognition within its geographic area. Discuss the resources related
to cancer that the institution currently provides to its region.

(B) Discussion of the need in the institution's geographic area for an
NCI-designated cancer center.  Discuss how the region is underserved
from the perspective of the linkage of high quality cancer research
with patient care, prevention, control, and other activities.  Describe
the potential impact of the new center on its region.  Discuss how new
research programs initiated through the center would ultimately benefit
the populations in its area.  Discuss special problems of the region as
they relate to higher incidence and mortality rates of certain cancers
and to special populations and minorities.   Describe how the potential
cancer center can address these problems through its research programs.

(C) Description of the potential relevance of the new center to other
programs of the NCI that already exist or could be implemented in its
region.  Examples of such programs are national cooperative groups,
cancer information service (CIS), drug discovery groups, and the
community clinical oncology program (CCOP).

Section IV.  ESSENTIAL SUPPORTING DOCUMENTS:

(A) Biographical sketches of the planning director and other key
personnel.  Use forms provided in the form PHS 398.  These sketches are
limited to two pages.

(B) Peer-Reviewed Research Grants and Contracts.  This is a list of the
research base of the center and additional to page GG of the PHS 398
form.  List the currently active, peer-reviewed, research grants and
contracts that will be included as the existing research base of the
center at the parent institution.  The Cancer Centers Branch has
defined peer-reviewed cancer research projects in the 1992 "Guidelines
for Cancer Center Support Grants."  Each entry for a peer-reviewed
research project on the list should include the Principal Investigator,
his/her percent effort on the project, funding agency, I.D. number,
title, total grant period, and current year's direct cost award.  Other
sources of support that contribute to the overall research capability
of the center (e.g., cancer development awards, training grants) may be
listed.  This must be a separate listing.

(C) Bibliography.  Provide a bibliography of cancer research
publications from the parent institution during the previous three
years.

(D) Letters or statements from senior officials of the parent
institution documenting their support for the proposed planning and
development process.  These documents must include a description of
substantive actions by the parent institution to promote the
development of a center, e.g., the commitment of space and funds,
recruitment packages, funds to the programs, as well as  substantive
authority to the planning director, who will provide scientific and
administrative leadership during the planning period.

B.  Allowable Budget Items

Allowable budget items for these planning and development grants are
limited to a portion of the salaries of the planning director
(Principal Investigator), key scientific personnel, administrative and
clerical support personnel, travel and per diem expenses for outside
advisors (the use of commercial consultants is discouraged), supplies,
travel expenses for the planning director or other key personnel, and
other justifiable operating expenses of the planning effort.  The level
of effort of personnel on this grant should reflect the commitment of
the individual to the planning and development process although the
salaries may be paid in part from other sources (these other sources
must be described).

In addition, developmental funds may be requested up to a maximum level
of $35,000/year.  If developmental funds are requested, it must be
entered in the composite budget on page 4 of the PHS 398 form as a line
item under other expenses.  A detailed budget for the potential uses of
developmental funds must be provided on a separate budget page and
fully justified.  These developmental funds may be used by the planning
director to help recruit new scientific staff to the center, to support
pilot studies that will help expand the peer-reviewed research base of
the center, and to initiate new shared resources that will be needed by
the center.  Developmental funds may not be used for major equipment
purchases.

All budget items must be justified in terms of their support of the
planning and development process.  Budget requests for applications
submitted under this RFA must not exceed $175,000 direct costs per
year.  In addition, unless otherwise noted, allowable costs and
policies governing the research grant program of the NIH will prevail.
Overlapping support between the planning and development grant and
other NIH grants and contracts to the applicant institution will be
administratively reviewed and, if appropriate, adjustments will be made
to avoid duplication of funding.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
staff and responsiveness by NCI staff.  Incomplete and non-responsive
applications will be returned to the applicant without further
consideration.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate
peer-review group convened by the NCI in accordance with the review
criteria stated below.  As part of the initial merit review, a process
(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 competitive will be discussed and
be assigned a priority score.  Applications determined 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.  Questions
concerning the relevance of proposed work to the RFA may be directed to
program staff listed under INQUIRIES.

The second level of review will be performed by the National Cancer
Advisory Board.  This Board considers the special needs of the NCI and
the priorities of the National Cancer Program.

Review Criteria

Applications will be assessed in three general areas:  (1) the
technical merit of the proposed planning and development process; (2)
the institutional commitment and environment; and (3) the potential of
the proposed center to enhance its impact on the quality of patient
care, prevention, control, and related activities in its geographic
area.  Peer- reviewers will be asked to specifically comment on these
three areas.  An unacceptable evaluation in any one of these review
categories can be grounds for Not Recommended For Further Consideration
of the application.  The final priority scores will reflect the
peer-reviewers' overall assessment based on their judgements of the
three review areas.  Below are the specific criteria that will be used
by the peer-review group in the evaluation of these three major areas.

1.  The technical merit of the proposed planning and development
process.  If the application is a renewal, the application should
stress the progress that has been made during the past grant period,
making specific reference to the previous summary statement as needed.
If the application is new, emphasis should be placed on the potential
for these investigators and the proposed activities to form a viable
center.

a.  Clarity and appropriateness of the goals and objectives of the new
or proposed cancer center; the extent to which the proposed concept of
a cancer center is consistent with the concept of cancer centers as
illustrated by the 1992 "Guidelines for Cancer Center Support Grants";

b.  Extent to which the application appropriately defines the problems
that need to be resolved to achieve the formation or development of a
center of cancer research excellence;

c.  Extent to which the proposed detailed planning and development
effort has clear and appropriate plans and is of adequate scope with
regard to important issues including:

(1) Adequacy of the peer-reviewed cancer research base; identification
with the parent institution of independent investigators in basic,
clinical, prevention, and control research who will be important in
providing the leadership necessary to develop multidisciplinary cancer
research programs; identification of shared resources that will be
important for multidisciplinary research programs for inclusion or
development in the center;

(2) Progress toward implementing or the potential to implement the six
essential characteristics of a cancer center:  institutional
commitment, organizational capabilities, adequate facilities, center
director with adequate authority, progress toward and potential for
developing an appropriate cancer research focus, and interdisciplinary
coordination;

(3) Progress and/or plans to develop the appropriate leadership, stable
research infrastructure, and administrative capacity within the parent
institution, paying special attention to the status of the cancer
center relative to other organizational components (e.g., departments,
other centers);

d.  Qualifications of the proposed planning director to lead the
planning and development effort, his/her leadership experience and
scientific background, and the adequacy of the director's authority
from the institution with respect to recruitment, staff appointments
and promotions, space allocation, fiscal and administrative
responsibilities, and review and direction of the planning effort;

e.  Potential effectiveness of the planning director's external
advisory committee in assisting the director in planning the center;
the appropriateness of the proposed membership and stated functions of
this advisory group;

f.  Appropriateness of the membership and stated functions of the
proposed internal planning committee to assist the director in the
planning and development effort;

g.  Qualifications and appropriateness of the key personnel designated
to assist the planning director; the potential of listed key personnel
to become senior leaders or major program leaders in the new center;

h.  Adequacy of the applicant's consideration and assessment of such
factors as the utilization and need for space, staff recruitment,
availability of patients for research, patient referral patterns in the
community, and financial planning;

i.  Current level of progress of the new or proposed center toward
realization of its objectives; if the applicant is at an advanced stage
of development, consideration should be given to whether a planning and
development grant is appropriate or whether the applicant should
directly apply for a CCSG.

2.  Institutional commitment and environment.

If the application is a renewal, the applicants should stress the
progress that has been made during the past grant period; making
specific reference to the previous Summary Statement as needed.  If the
application is new, emphasis should be placed on the potential for
these investigators and the proposed activities to form a viable
center.

a.  Adequacy of the institution's commitment to cancer research;
include an evaluation of the plans to expand the peer-reviewed cancer
research grant/contract funding base through appropriate recruitment,
encouragement of existing faculty, and other appropriate measures;

b.  Evidence for a substantial institutional commitment to the cancer
center planning and development effort in terms of space, personnel,
organizational, and financial resources that have been allocated to the
effort;

c.  Adequacy of the administrative, organizational, and management
capabilities and the facilities of the applicant institution; and

d.  Adequacy of the environment of the applicant institution with
regard to its ability to recruit qualified scientists that will enhance
the center's multidisciplinary research capability, the track record of
the institution in developing similar programs in other fields, if any,
the potential for adequate continuity of institutional commitment for
the center, and the potential effect of the new cancer center on other
programs within the institution.

3.  The potential of the proposed center to enhance the level of cancer
research in its region and, ultimately, to enhance the impact of that
research on the quality of patient care, prevention and control, and
related activities in its geographic area.

If the application is a renewal, the applicants should stress the
progress that has been made during the past grant period; making
specific reference to the previous Summary Statement as needed.  If the
application is new, emphasis should be placed on the potential for
these investigators and the proposed activities to form a viable
center.

a.  Extent to which the institution's geographic area is underserved by
high quality cancer research that is effectively linked to patient
care, prevention, control, and other activities; the role in cancer
already played by the institution within its community and region;

b.  Proposed role and potential impact of the new cancer center in its
geographic area; a demonstrated understanding of the cancer incidence
and mortality rates in the region, especially with regard to minorities
and special populations; the adequacy of proposed mechanisms to move
the results of research into improvements of cancer treatment,
prevention, control, education, and other activities that will benefit
the center's local community and region.

c.  Potential relevance of the new center to other NCI programs (e.g.,
national cooperative groups, cancer information service, and the
community cancer oncology program) that already exist or could be
implemented in its geographic area;

d.  Extent to which award of a planning and evaluation grant will
enhance the ability of the institution to form and/or develop a cancer
center that will benefit its region;

In the overall evaluation, the appropriateness of the proposed
multi-year planning and development effort to allow the new cancer
center to reach a level of excellence that would be comparable to
current NCI-designated cancer centers will be considered.

The review group will recommend an appropriate budget for each rated
application.  Requests for equipment and commercial consultants are
discouraged and, if present in an application, such requests will be
highly scrutinized.

AWARD CRITERIA

The anticipated date of award is August 1, 1995.  Grant applications
recommended for approval by the National Cancer Advisory Board and
selected for funding will be negotiated by the NCI staff with the
applicant institution.  A Notice of Grant Award will summarize the
results of the negotiations.  Award of funds for the approved future
years of the grant will require the submission of a noncompeting
continuation application, form PHS 2590 (rev. 10/88) at least two
months prior to the anniversary date of the award.

As with research grants, interim and terminal progress reports must be
submitted to the NCI in accordance with the current PHS Grants Policy
Statement.  The interim progress reports will be a part of the non-
competing continuation application and should include the following
information:  (a) a brief statement and critique of progress toward
achieving originally stated objectives; (b) a description or listing of
related issues, positive or negative, considered to be significant by
the planning director; and (c) plans for the next funding period.
Terminal progress reports must be submitted within 90 days after the
end of the project and should include items (a) and (b) above.

INQUIRIES

Written and telephone inquiries concerning the objectives, scope,
application procedures, and allowable budget items for this RFA and
inquiries about whether specific applications would be responsive are
encouraged and must be directed to the Cancer Centers Branch, NCI,
program officer listed below.  The Branch staff welcomes the
opportunity to clarify any issues or questions from potential
applicants.  In addition, questions of a more administrative nature not
directly related to the programmatic aspects of this RFA may be
directed to the Grants Administration Branch official, also listed
below.

J. Blanche O'Neill
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Executive Plaza North, Room 502
Bethesda, MD  20892
Telephone:  (301) 496-8531

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 282

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
Number 93.397.  Awards are made under authorization of the Public
Health Service Act, Title IV, Part A (Public Law 78-410, as amended by
Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.

The Public Health Service 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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