Subject: RFA CA-91-15 4/26/9l NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 25 Apr 91 08:38 EST

HI Pual,
  Please post this to the NIH LIstserver as:
     RFACA-91-15.910426
 Thanks.
        Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA CA9115 CA-91-15 P1O1 *****************************************
 
REQUEST FOR APPLICATIONS
 
RFA:    CA-91-15
 
PLANNING GRANTS FOR PROSPECTIVE CANCER CENTERS
 
P.T. 04; K.W. 0715035, 0745027, 0795003, 0403004
 
National Cancer Institute
 
Letter of Intent Receipt Date:  July 15, 1991
Application Receipt Date:  August 28, 1991
 
I. INTRODUCTION
 
The Cancer Centers Branch (CCB) of the Division of Cancer Biology,
Diagnosis and Centers (DCBDC) of the National Cancer Institute (NCI)
announces the availability of planning and development grants for the
purpose of assisting eligible institutions to develop the organizational
capability that will lead to the formation and/or development of cancer
research centers of excellence.  The goal of this Request for
Applications (RFA) initiative is to encourage the development of
clinical and consortium 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.  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 from the NCI.
 
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 is
related to the priority area of cancer.  Potential applicants may obtain
a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238).
 
II. BACKGROUND INFORMATION
 
The Cancer Centers Program was developed in the late 1960's
and was formally authorized by the National Cancer Act of
1971.  The language of the legislation 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."
 
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; and 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, contracts, and other funding
sources, the Cancer Center Support Grant (CCSG) and the
related Consortium Cancer Center Support Grant (CCCSG)
undergirds these research activities by providing core
support through partial funding of shared research resources
that provide cost-effective access to essential services
(e.g., animal facilities) and to sophisticated equipment,
state-of-the-art technology, and expert services.  The CCSG
also supports central administrative expenses, partial
salary support for the center's senior leadership and
investigators, 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 (July,
1988)", and for the Consortium Cancer Center Support Grant
in "Guidelines:  Consortium Cancer Center Support Grants
(October, 1987)".  Both documents are available from the
Cancer Centers Branch, DCBDC, NCI.  A CCSG or
CCCSG applicant must have a minimum amount of peer-reviewed
cancer research support (currently $750,000 for a CCSG and
$300,000 for a CCCSG in annual direct costs) to be eligible
to apply for a center grant.
 
In the years 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 reflecting both the U.S. population density and the
locations of medical research centers.  Nonetheless, there
are medical institutions existing in currently
underrepresented 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 and that may have prevented some
institutions from exploring the possibility of forming a new
cancer center or consortium cancer center.  This RFA is
designed to encourage qualified institutions to make the
investment necessary to establish a cancer center.
 
Detailed planning and development is crucial to the
formation of a new clinical or consortium cancer center.
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(s)
through a process of sometimes complex negotiations.  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 the parent
institution(s).  In addition, specific central research
resources must be identified for inclusion or development as
part of the cancer center.  Finally, the parent
institution(s) 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) a clear cancer research focus
and intent, (b) coordination of interdisciplinary and
translational research activities, (c) appropriate and
adequate organization and facilities, (d) a qualified
director with adequate authority over appointments, space,
equipment, and identifiable clinical research facilities to
ensure smooth and effective coordination, and (e) an
adequate commitment of the parent institution(s) that
recognizes the center as a major organizational element of
the institution.
 
The response to this RFA will help the NCI expand the cancer
centers program to underrepresented geographic areas and
their populations that are not currently served by NCI-
designated cancer centers.  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 centers
of excellence.
 
III. GOALS AND SCOPE
 
The primary goal of this RFA is to help applicant
institutions develop the organizational capability that will lead
to the formation and/or development of new centers of cancer
research excellence that will benefit currently
underrepresented geographic areas in the United States.  To
allow wider availability of up-to-date cancer care research
and/or control research activities, this announcement is
directed to potential applicants for clinical or consortium
cancer centers rather than basic research centers.  It is
anticipated that applicant institutions will have a
sufficient base of peer-reviewed research and initial
organizational capability such that a three-year planning
and development grant is both justifiable and likely to lead
to the creation of a new cancer research center.  It is also
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 or CCCSG application.
 
IV.  THE PLANNING AND DEVELOPMENT PROCESS
 
A.  DEFINITION OF THE PLANNING AND DEVELOPMENT EFFORT
 
The first phase of the planning process involves the
definition of the goals and objectives for the new or
proposed cancer center that will provide the base on which
the organizational structure, financing, and facilities can
be developed.  The development of objectives should take
into account the following considerations:
 
The overall objectives or purposes of the parent
institution(s).  The development of a cancer research center of
excellence must agree with and support the long-term goals
and objectives of parent institution(s) and their
leadership.
 
The specialized needs of the institution's geographic area
and its populations.  The special needs of the center's
region or service population must be strongly considered
in the development of research activities as well as in the
education, outreach, and service programs of the center.
 
The effect that 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 across
traditional academic departments and disciplines.
Consideration of the administration and organization of the center
and its relationship with the parent institution(s) are as
necessary to the planning mission as are scientific,
clinical, and technical considerations.  For example, the
center, to be effective, should have its own administrative
identity within the parent institution.
 
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 to the new
center is needed to develop practical goals and objectives.
 
Definition of the research activities to be included in the
new center.  The nature of the research activities must be
defined in terms of the utilization and expansion of ongoing
research activities at the parent institution(s) and the
inauguration of new projects.  The usual structural elements
of the cancer research activities at a center include
multidisciplinary research programs, shared resources for
peer-reviewed research, and administrative support services.
 
The relevance of the center to the mission of the
NCI.  The relevance of the proposed cancer
research center to other programs of the
NCI must be evaluated and incorporated into the
objectives for the center.
 
The work being performed by others.  An institution planning
or developing a cancer center must evaluate existing local,
regional, and national programs relative to the unique and
important contributions of its own programs to the region.
 
B.  ELEMENTS OF A PLANNING AND DEVELOPMENT EFFORT
 
The following elements are essential in the planning and
subsequent development of a cancer center:
 
Planning director:  A senior level person competent in
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 current or proposed founding director of the new center.
 
Planning and advisory committees:  An internal planning
committee must assist the planning director.  Committee
members must be selected from within the institution(s)
that is(are) developing the center.  Additional members from the
community must also be selected where appropriate.  This
committee must evaluate scientific, medical, institutional,
and regional considerations and must make sure that
all available resources are considered in the planning
process.  It may be advisable for all elements of the
institution(s) affected by the center to be represented on
this committee.  In addition, an external advisory group,
consisting of senior individuals who are familiar with the
functions and organization of NCI-designated cancer centers,
must be convened periodically to give the planning
director knowledgeable advice on the development of a cancer
research center as well as unbiased and independent
assessments of the new center's progress to date and its
objectives and plans for the future.
 
Research program definition and implementation.  The cancer
research programs that will comprise the cancer center
must be defined in terms of relevance to the cancer
problem, productiveness, membership in the center (present
and future), peer-reviewed grant/contract research base,
space needs and utilization, and availability of patient
resources.  The research programs must be
multidisciplinary in nature and may focus on basic, clinical,
and prevention investigations.  They should build on the
current strengths of the institution.  This definition and
its subsequent implementation must also include
consideration of local, regional, and national needs.  Shared
resources that will support the peer-reviewed research
projects of the center programs will also need to be
defined.
 
Definition of the relationship of research activities to
patient care, educational, and other outreach
activities of the center:  The relationship between the
center's research activities and the patient care,
educational (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.
 
V. MECHANISM OF SUPPORT
 
Support of this program will be through the National
Institutes of Health (NIH) grant-in-aid.  The exploratory
grant mechanism, designated P20, will be used.  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.  However, if the
NCI determines that there is a sufficient continuing program
need, a request for competitive continuation applications
will be announced.  Only recipients of awards under this RFA
will be eligible to apply.
 
Approximately $750,000 in total costs per year will be
committed specifically to fund applications
submitted in response to this RFA.  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 should not exceed three
years.  The earliest feasible start date for the initial
awards will be August 1, 1992.  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.
 
VI. ELIGIBILITY REQUIREMENTS
 
Applicant institutions must intend to develop clinical or consortium
cancer centers.  Eligible institutions must come from states that do not
currently have an NCI-designated Comprehensive, Clinical, or Consortium
Cancer Center, and are located outside of a reasonable distance from an
existing Comprehensive, Clinical, or Consortium 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.
At this time, the Cancer Centers Branch defines peer-reviewed cancer
research projects as NCI research grants and contracts, American Cancer
Society research project grants, and other NIH and the National Science
Foundation (NSF) research grants that meet the NCI referral guidelines
as cancer-related research.  Questions concerning the NCI referral
guidelines should be addressed to the individual noted in Section X of
this announcement.
 
Eligible institutions should require approximately three
years of support under a planning and development grant to
develop the institutional capability to form and or develop
a cancer research center of excellence.  Institutions that
already have an established organizational capability as a
cancer center and a sufficient peer-reviewed cancer research
base are not eligible under this program.

Potential applicants are strongly advised to contact NCI
program staff of the Cancer Centers Branch to discuss
eligibility prior to preparing an application (See section
XI below).
 
VII. METHOD OF APPLYING
 
A. APPLICATION PREPARATION
 
The most recent revision of the research grant
application form PHS 398 (revised 10/88) must be used in
applying for these grants.  These forms are available at
most institutional business offices; from the Office of
Grants Inquiries, Division of Research Grants, National
Institutes of Health, Room 449, Westwood Building, 5333
Westbard Avenue, Bethesda, MD 20892; and from the NCI Program
Director named below.
 
Complete information about the proposed planning and
development effort must be submitted with the application.
Follow the instructions for 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 section VIII.B below.  The narrative portions of the
application, sections I, II, III described below, must be
limited to fifty pages of text.  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 contain the following elements:
 
BASIC INFORMATION:
 
FACE PAGE:  Identify the application as being in response to
this RFA by checking YES on item 2 of page 1 of the form PHS 398
and entering the title and number of this RFA.  The RFA label available
in the PHS 398 kit 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.  List the planning
director as the Principal Investigator of the application.
The planning director should be the primary author of the
application.  The face page is page 1 of the application;
all succeeding pages should be numbered consecutively.
 
ABSTRACT AND LIST OF KEY PERSONNEL IN THE PLANNING EFFORT:
Page 2 of form PHS 398 should contain an brief abstract of the
proposed planning and development effort including the name
of the parent institution(s), goals of the proposed center,
the elements of the proposed planning effort, and the impact
the center's development will have on its geographic area.
List key personnel including the planning director and other
senior level faculty and administrators who will be involved
in the planning process in a major way.
 
TABLE OF CONTENTS:  Page 3 of form PHS 398 must
be used to present a table of contents for the application.
 
ITEMIZED FIRST YEAR BUDGET AND COMPOSITE 3 YEAR BUDGET WITH
JUSTIFICATIONS:   Present a detailed, composite budget for
all requested support for the first year on page 4 of the
form PHS 398.  Estimate the required budget for future years on
page 5.  Future year increases should
be limited to 4 percent.  If collaborative efforts
involving other institutions or organizations are planned
and will use funds awarded under this grant, itemize all
costs associated with such other institution participation,
including any applicable indirect costs on a separate budget
page and enter the total under the "Consortium Contracted
Costs" budget category of the budget on page 4.  (See
"Policy for Establishing Consortium Grants," NIH Guide for
Grants and Contracts Vol. 14, No. 7, June 21, 1985.)  If
developmental funds are requested ($35,000/yr maximum), it
must be entered in the composite budget on page 4 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.  Detailed
justifications for each budget item must be provided on
page 5 and on continuation pages as needed.  See VII.B,
"Allowable Budget Items" below.
It is estimated that the average first-year
budget for planning and development grants should not exceed
$175,000, direct costs.
 
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.
Describe the new or developing 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(s) 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 (see Section III below).  The
potential relevance of the new center to other programs funded by
the NCI or that could be
implemented in its region must also 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 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.
 
(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.  These advisory groups
will have central, although very different, roles in the
development of the center.  Thus, it is important 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(s) and other
affiliations (e.g., Veterans Administration hospital staff).
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(s) 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 four 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.
 
(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) a cancer research focus, (b) interdisciplinary
coordination, (c) appropriate organizational capability and
facilities, (d) center director with adequate authority, and (e)
institutional commitment;
 
3.  identify multidisciplinary basic and clinical research
programs for inclusion in the center;
 
4.  identify appropriate staff from the parent institution(s)
for center membership and areas where additional recruitment
is necessary;
 
5.  identify shared research resources for inclusion or
development by the center;
 
6.  develop appropriate long-term relationships with parent
institution(s) and with departments and/or centers
within the institution(s);
 
7.  develop affiliations with other institutions.  If a
consortium center is planned, describe plans for sharing the
responsibilities and benefits of the new center.
 
SECTION II.  THE PARENT INSTITUTION'S RESEARCH BASE,
ENVIRONMENT, AND RECOURCES:
 
(A)  Current cancer research activities and publications.
Discuss whether all peer-reviewed cancer
research projects located at the parent institution(s)
(listed in Section IV.B below) will be associated with the
cancer center.  If not, please explain.  Describe plans to
expand the peer-reviewed grant/contract base.
 
(B)  Description of the parent institution(s).  Discuss the
environment of the parent institution(s) and its suitability
for attracting appropriate staff.  Describe the institutional
officials who will be associated with and support the
proposed center and the planning effort, the experience of
the institution(s) with developing similar centers or
programs, and the effect that the new cancer center will have on
other programs and centers at the institution(s).  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(s) to the new center and 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.  If a consortium center is
planned, describe how the responsibility for developing and
sustaining the new center will be divided among the
consortium partners.
 
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.
 
(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.  Provide a
list of currently active, peer-reviewed, cancer research
grants and contracts at the parent institution(s).  At this
time, the Cancer Centers Branch defines peer-reviewed cancer
research projects as NCI research grants and contracts,
American Cancer Society research project grants, and other
NIH and NSF research grants that meet the NCI referral
guidelines as cancer-related research.  Leukemia Society of
America faculty salary support grants may also be listed.
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.
 
(C)  Bibliography.  Provide a bibliography of cancer
research publications from the parent institution(s) during
the previous three years.
 
(D)  Letters or statements from senior officials of the
parent institution(s) documenting their support for the
proposed planning and development process.  These
document(s) must include a description of substantive actions
by the parent institution(s) to promote the development of a
center, e.g., the commitment of space and funds to the
project as well as providing substantive authority to the
planning director.
 
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).  The purchase of equipment is
discouraged.
 
In addition, developmental funds may be requested up to a
maximum level of $35,000/year.  These developmental funds may
be used by the planning director to help recruit new
scientific staff to the center or to help develop peer-
review quality, new cancer research projects or new shared
resources for the peer-reviewed research projects of 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.
 
C. APPLICATION SUBMISSION
 
Before submitting the application, affix the RFA label in
the 10/88 revision of application form PHS 398 to the bottom of
the face page.  Failure to use this label could result in
delayed processing of your application such that it may not
reach the review committee in time for review.  In addition,
the RFA number and title must by typed on line 2 of the
face page of the application form.
 
Submit a signed, typewritten original of the application
(without appendices), including Checklist, and four (4)
signed, exact photocopies, in one package to the address
below.  The photocopies must be clear and single sided.
 
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
At the time of submission, send two (2) additional copies of
the application to:
 
REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Room 838, Westwood Building
5333 Westbard Avenue
Bethesda, MD  20892
 
Appendix materials should be retained by the applicant until
specifically requested by NCI staff.  Six copies of the
appendices will be requested.
 
Applications must be received by August 28, 1991.  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 a research grant application already
submitted to the NIH for review, but has not yet been reviewed,
the applicant will be asked to withdraw either the pending
application or the new one.  Simultaneous submission of identical
applications will not be allowed, nor will essentially identical
applications be reviewed by different review committees.
Therefore, an application cannot be submitted in response to this
RFA that is essentially identical to one that has already been
reviewed.  This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.
 
VIII. REVIEW PROCEDURES AND CRITERIA
 
A. REVIEW PROCEDURES
 
Upon receipt, applications will be reviewed initially for
completeness.  Incomplete
applications will be returned to the applicant without
further consideration.  Evaluation for responsiveness to the
program requirements and eligibility criteria stated in the
RFA is an NCI program staff function.  Applications will be
judged to determine how well they meet the goals and
objectives of the program as described in the RFA.
Applications that are judged non-responsive will be
returned to the applicant.  Questions concerning the relevance of
proposed work to the RFA should be directed to program staff
as described in the INQUIRIES Section XI below.
 
If the number of applications received is large compared
to the number of awards to be made, the NCI may conduct a
preliminary scientific peer review to eliminate those
applications that are clearly not competitive.  The NCI will
withdraw from further competition those applications judged
as noncompetitive and will notify the applicant and
institutional business official.
 
Those applications judged to be responsive and competitive
will be further evaluated according to the review criteria
stated below by an appropriate peer review group convened by
the Division of Extramural Activities, NCI.  The second
level of review will be performed by the National Cancer
Advisory Board.  This Board considers the special needs of
the Institute and the priorities of the National Cancer
Program.
 
B. 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; 3)
the potential of the proposed center to enhance the level of
cancer research in its region and, ultimately, to enhance
the impact of research on the quality of patient care,
prevention, control, and related activities in its geographic
area.  Peer reviewers will be asked to specifically
comment in these three areas.  An unacceptable evaluation in
any one of these review categories can be grounds for
disapproval 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.
 
THE TECHNICAL MERIT OF THE PROPOSED PLANNING AND DEVELOPMENT
PROCESS.
 
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 existing
NCI-designated clinical/consortium centers;
 
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, but
not limited to:
 
1.  Adequacy of the peer-reviewed cancer research base;
 
2.  Progress toward implementing the essential characteristics
of a cancer center:  interdisciplinary coordination,
appropriate organizational capabilities and facilities,
center director with adequate authority, and institutional
commitment; progress toward and potential for developing an
appropriate cancer research focus;
 
3.  Identification at the parent institution of senior
investigators in basic, clinical, prevention, and control
research who will be important for developing
multidisciplinary cancer research programs; identification
of shared resources that will be important for
multidisciplinary research programs for inclusion or
development in the center;
 
4.  Plans to develop appropriate long-term relationships
with senior leadership/administration of the parent
institution(s) and with other departments and centers within
the institution(s);
 
5.  For consortium centers, the plans to develop appropriate
formal relationships with clear commitments and division of
responsibilities among consortium partners and the center;
 
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 or CCCSG award.
 
INSTITUTIONAL COMMITMENT AND ENVIRONMENT:
 
a. Adequacy of the institutions' 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;
 
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; assess the track record of the institution in
developing similar programs in other fields, if any; discuss
the potential for adequate continuity of institutional
commitment for the center; and assess the potential effect
of the new cancer center on other programs within the
institution;
 
e.  If a consortium center is planned, the effectiveness of
the relationships among the current member institutions
and with regard to the proposed functions within the
consortium; the adequacy of the demonstrated commitment of
the component institutions to the planning effort.
 
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.
 
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 for its community and region;
 
b.  Proposed role and potential impact of the new cancer
center in its geographic area; 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; 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 and, thus, competitive for a CCSG
award.
 
The review group will recommend an appropriate budget for
each approved application.  Requests for equipment and
commercial consultants are discouraged and, if present in an
application, such requests will be highly scrutinized.
 
IX. NEGOTIATION, AWARD, AND REPORTING REQUIREMENTS
 
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, PHS
form 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
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.
 
X. LETTER OF INTENT
 
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.
Prospective applicants are
requested to submit, by July 15, 1991, 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.
 
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:
 
Dr. Alan A. Schreier
Program Director
Cancer Centers Branch
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Executive Plaza North, Room 308
Bethesda, MD  20892
Telephone:  (301) 496-8531
 
XI. 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 above.
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 listed
below.
 
Ms. Francis Cohen
Grants Specialist
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 42
 
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 100-607) 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.