Full Text CA-94-008


NIH GUIDE, Volume 23, Number 21, June 3, 1994

RFA:  CA-94-008

P.T. 34

  Drug Design 
  Chemotherapeutic Agents 
  Clinical Trial 

National Cancer Institute

Letter of Intent Receipt Date:  July 15, 1994
Application Receipt Date:  September 20, 1994


The Developmental Therapeutics Program, Division of Cancer Treatment,
NCI invites applications for the continuance of the National
Cooperative Drug Discovery Group (NCDDG) Program.  An NCDDG is
defined as a unit with a minimum of at least three Laboratory
Programs that join together under one Principal Investigator (PI) and
function toward a common goal:  the conceptualization, invention, and
evaluation of new entities and strategies for the treatment and cure
of cancer.  After award, the Government serves as a partner in the
research.  Applications are sought from both recompeting and new
NCDDGs (also called Groups).

This Request for Applications (RFA) will support broad, innovative,
multidisciplinary approaches to the discovery of new, rationally
based anticancer treatments.  A multi-institutional approach
involving academic, nonprofit, and/or commercial/industrial
institutions is envisioned because the creative talents in the
required scientific disciplines will rarely be available in a single
institution.  The active participation of industry is encouraged
because it will allow this segment of the scientific community to
contribute its considerable intellectual and material resources.
Further, the interaction of academic and non-profit research
institutions with industry and Government will facilitate subsequent
development and marketing of new therapies, although these latter
activities are not within the scope of this RFA.

The present RFA is a reissuance of CA-91-19, which was released on
August 16, 1991 with the same goals.  The "Research Objectives" of
the RFA require that an NCDDG has the capacity within itself to
conceive, create, and evaluate new entities and strategies for the
treatment of cancer. The biological or molecular targets of attack
will be selected by the applying Group.  Either mechanism of action
or disease-oriented approaches are being solicited.  Although NCDDGs
do not support clinical trials, a timely evaluation of products
discovered by this mechanism is encouraged and is a measure of the
overall success of the program.

Subsequent studies required for development of new treatments and
progression to clinical trial (e.g., formulation development,
large-scale production for clinical trials, or toxicology in support
of Investigational New Drug Applications, etc.) are beyond the scope
of this RFA.  The development of analogs of established anticancer
agents is not responsive to this RFA.


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,
National Cooperative Drug Discovery Groups, 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).


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


The administrative and funding instrument to be used for the support
of an NCDDG will be a cooperative agreement (U19), an "assistance"
mechanism (rather than an "acquisition" mechanism) in which
substantial NIH scientific and/or programmatic involvement with the
awardee is anticipated during performance of the activity.  Under the
cooperative agreement, the NCI purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working
jointly with the award recipient in a partner role, but it is not to
assume direction, prime responsibility, or a dominant role in the
activity.  Details of the responsibilities, relationships and
governance of the study to be funded under cooperative agreement(s)
are discussed later in this document under the section "Terms and
Conditions of Award."

Assistance via cooperative agreement differs from the research grant
in that the Government component (NCI) awarding the cooperative
agreement anticipates substantial programmatic involvement during
performance of the award.  This partnership relationship will
facilitate technology transfer from Government-owned data bases and
the use of appropriate NCI-derived resources to enhance the
efficiency and effectiveness of a Group's efforts.  The nature of NCI
staff participation is described below under "Terms and Conditions of
Award".  There is no intent, real or implied, for NCI staff to direct
Group activities or to limit the freedom of investigators.

Each award will be made only to the Principal Investigator's
institution.  All Group activities will be coordinated through an
administrative core located at the Principal Investigator's

The total project period for an application submitted in response to
the present RFA may not exceed five years.  The earliest anticipated
award date is July 1, 1995.

Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the sizes of awards will
vary also.

Awards and level of support depend on receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the NCI, awards pursuant to
this RFA are contingent upon the availability of funds for this

At this time, the NCI anticipates that there will be a renewed
competition of this program.  If the NCI does not continue the
program, awardees may submit grant applications through the usual
investigator-initiated grants program.


The NCI has set aside approximately $4.0 million total costs for the
first year of funding.  This level of support is dependent on the
receipt of a sufficient number and diversity of applications of high
scientific merit.  Four to six awards, which will include both new
and competing continuation awards, are anticipated for project
periods up to five years.

Awards are subject to a first year limit of $900,000 in total costs
(direct plus indirect costs).  Budget requests should be carefully
justified and commensurate with the needs of the project.
Applications in excess of $900,000 total costs for the first year
will be returned without review.



Important new discoveries in molecular biology, embryology and
related fields, together with major technological advances, permit
the design of highly selective and specific approaches to new cancer
therapies.  However, the scientists who are making these discoveries
often are not in a position to take advantage of their findings in
the design of new therapies for reasons that include lack of
familiarity with drug discovery, insufficient resources, lack of
expert collaborators in areas related to cancer treatment and lack of
capacity for synthesis and evaluation of lead compounds.

The NCDDG program was established in 1983 on advice of a special
subcommittee of the Division of Cancer Treatment's Board of
Scientific Counselors.  The concept, then as now, was to bring
together scientists doing exciting, cutting edge research from a
variety of disciplines and institutions into cohesive groups
dedicated to exploiting recent scientific advances for the discovery
of new therapies.  The participation of the NCI was considered
essential to assist and promote development of the new discoveries.
Groups are investigator-initiated and retain all of the associated
freedom for innovative discovery inherent in traditional grants,
while at the same time being highly targeted towards discovery and
development of new therapies.  Typically, an NCDDG is composed of
three to six laboratory and resource (core) programs from academic,
non-profit research, and industrial organizations.  Each laboratory
or resource program is directed by a Program Leader (or Core Leader
for resources) and the overall NCDDG is directed by a Principal
Investigator (PI) who may also be one of the Program Leaders.  Each
group meets regularly to review data, to make joint decisions on
directions and priorities, and to realign resources enabling the most
rapid advancement of the best leads.  The participation of an
industrial partner in each NCDDG is strongly encouraged to provide
expertise in, and focus on, drug discovery and development.  Since
the budgetary scope of the NCDDG awards does not cover costs of
advanced preclinical development, the participation of an industrial
partner willing to develop Group leads can provide a major additional

NCDDGs are peer-reviewed projects funded through cooperative
agreements.  The cooperative agreement is a mechanism in which the
NCI, through its extramural staff, is an active partner in the group.
NCI staff, represented by a Project Coordinator appointed after
award, provide advice and guidance in the area of drug discovery and
development and facilitate access to NCI resources including
repositories, chemical searches, and screens.  Resources for advanced
development including scale-up synthesis, pharmaceutics, toxicology,
Investigational New Drug Applications (INDAs) to the Food and Drug
Administration (FDA), and clinical trials support can be made
available through the NCI Decision Network process (M.R. Grever, S.A.
Schepartz, and B.A. Chabner, Seminars in Oncology, Vol. 19, No. 6
(December), 1992: pp 622-638) or through private venture capital.

The initial RFAs in the NCDDG program requested applications in
specific categories, focusing on target mechanisms, specific types of
cancer, anticancer model development and natural products-based
discovery.  The NCDDG program has facilitated development of new
agents to clinical trials, such as topotecan and DAB389-IL-2, a novel
diphtheria toxin-related interleukin-2 fusion protein, and is
currently supporting several leads in various stages of preclinical
development.  To the present, a total of 27 groups have received NCI
funding, of which 19 are currently active.  Fifteen of the 19 current
grants will expire in 1994 and 1995.  Eight will be eligible for
competing continuation awards under this RFA in direct competition
with new awards for mechanistic/disease-oriented approaches to the
discovery of new therapies.  The remaining seven incumbents will be
eligible to compete for a companion RFA (CA-94-007) for the
discovery, isolation and evaluation of anticancer agents from nature,
including plant, marine and microbial sources.

Objectives and Scope

The goals of this RFA are to encourage the development of novel
therapies and therapeutic strategies to improve the survival of
cancer patients and enhance their quality of life.  Approaches based
on recent advances in molecular genetics and cancer cell biology,
such as the role of oncogenes, tumor suppressor genes and cyclins in
malignant transformation are especially encouraged.  In addition to
classical approaches of lead optimization in medicinal chemistry,
drug design strategies based on receptor targets using computer
modelling and other new technologies, such as combinatorial
libraries, also are being solicited.  Examples appropriate for the
NCDDG program include but are not limited to gene therapies,
monoclonal antibodies, and vaccines; the design of agents to
interfere with transcription factors, signal transduction, cell
adhesion factors, angiogenesis, intracellular hormone or other
receptors; and other novel targets involved in the initiation and/or
maintenance of the transformed state and for which a strong rationale
can be provided.  Applications with relevance to high-priority
diseases, such as breast and prostate cancer, are encouraged, but
this RFA is not meant to exclude any approach or disease type.
Rather, the emphasis is on creative ideas.


o  The conceptualization, creation and preclinical evaluation of new
drugs and strategies designed to treat cancer effectively.

o  The recommendation of promising new treatment entities and/or
strategies for development to clinical trial.

o  The conduct of biological, biochemical, and pharmacological
studies that will permit enlightened clinical evaluation of agents or
strategies identified by the NCDDG, and which may provide information
leading to the discovery of even more effective treatments.

Applications for funding as an NCDDG should stress creative
approaches to the discovery of effective anticancer therapies and
should emphasize the following:

o  Objectives of the proposed NCDDG.

o  Research approaches to the realization of objectives and the
provision of comprehensive information  (including citations) in
support of the rationale(s) for the proposed approaches.

o  Specific relevance to cancer treatment.

o  The scientific and technical areas of expertise (Program Leaders)
required to attain Group objectives.

Funds for projects or cores that depend on the successful completion
of other activities, such as the availability of certain reagents,
will be restricted and released only on specific approval of the NCI
Program Director or Coordinator when such products are available.


ADMINISTRATIVE CORE.  An administrative unit located at the Principal
Investigator's (PI's) institution that coordinates all Group
activities.  It is separately budgeted from the PI's Laboratory
Program (if any) and budgets for activities pertinent to the Group as
a whole.

CORE LEADER.  The director of a scientific core component, if any,
who is responsible for the conduct of that core.

DRUG.  In the context of this RFA, a term used broadly to encompass
synthetic agents and biological products, as well as novel
therapeutic strategies and inventions designed to treat and cure
cancer.  Strategies also encompass creative methods to maximize
antitumor selectivity.

GROUP.  See NCDDG, below.

LABORATORY PROGRAM.  A research component headed by a Program Leader
within an NCDDG with a separate, detailed research plan and budget.

of a Principal Investigator, Program Leaders, Core Leaders (if any),
their respective programs, and an NCI Coordinator (appointed after
award) which functions with a common goal:  the conceptualization,
invention, and evaluation of new entities and strategies for
treatment and cure of cancer.  In this RFA, the terms National
Cooperative Drug Discovery Group, NCDDG, and "Group" are used

NCI COORDINATOR.  A scientist from the NCI extramural program staff,
appointed after award by the NCI Program Director for the NCDDG
Program, who participates as a member of the Group, interacts
scientifically with the Group and facilitates the role of NCI as
partner in the NCDDG.  The Program Director also may serve as the NCI
Coordinator for a Group.

NCI PROGRAM DIRECTOR.  The senior staff member of the Grants and
Contracts Operations Branch, Developmental Therapeutics Program,
Division of Cancer Treatment who provides leadership and guidance for
the overall NCDDG Program within the NCI, maintains overall
scientific balance in the NCDDG Program, and ensures that the NCDDG
Program is consistent with the NCI mission for treatment research.

PROGRAM LEADER.  The director of one of the scientific Laboratory
Programs of the NCDDG, who is responsible for the scientific conduct
of that program and is responsible to the Principal Investigator.  A
PI also may be one of the Program Leaders.

SCIENTIFIC CORE.  A separately budgeted scientific service component
which provides essential facilities or services to two or more of the
proposed Laboratory Programs.  Core components typically use
established procedures or protocols rather than generating new


A.  The Group's objectives and goals should be relevant to and
compatible with the NCI's mission in cancer treatment as stated in
this RFA.  Applicants should describe their plans to accommodate the
stated NCDDG requirements, criteria, and NCI involvement.

B.  All applications must consist of at least three interrelated
projects, which are called Laboratory Programs in this RFA.  While no
maximum number of programs is stipulated, when an award exceeds five
programs the overall NCDDG becomes more difficult to manage.  Groups
may also have scientific cores which provide essential services to
two or more Laboratory Programs, but a core cannot serve as one of
the three Laboratory Programs.

C.  The Principal Investigator and each Program Leader should provide
a signed statement of acceptance of the participation of NCI staff
during performance of the award as outlined under "NCI Staff
Responsibilities" below.

D.  A plan should be provided for the development of an agent
identified by the NCDDG effort as worthy of clinical trial, even
though advanced development and clinical trials are not supported by
this mechanism.


Since the discovery of new and improved anticancer treatments is the
objective of this effort and active involvement by industrial
laboratories is facilitated by the existence of adequate patent
coverage, it is essential that applicants provide plans to assure
such coverage.  The situation could be complicated since multiple
institutions are likely to be involved.  Each applicant Group must
therefore provide a detailed description of the approach to be used
for obtaining patent coverage and for licensing where appropriate, in
particular where the invention may involve investigators from more
than one institution.  Procedures must be described for resolution of
legal problems should they arise.  Your attention is drawn to P.L.
96-517 as amended by P.L. 98-620 and 37 CFR Part 401. Instructions
were also published in the NIH GUIDE FOR GRANTS AND CONTRACTS, Vol.
19, No. 23, June 22, 1990.

NOTE:  A formal statement of Patent Agreement among all Group members
and their institutions as well as a detailed description of
procedures to be followed for resolution of legal problems which may
develop, signed and dated by the organizational official authorized
to enter into patent arrangements for each Group member and member
institution is preferred with the application.  If this signed
agreement is not included in the application, it must be submitted to
the Scientific Review Administrator, Division of Extramural
Activities, NCI prior to peer review.

F.  The following terms and conditions will be incorporated into the
award statement and provided to the Principal Investigator as well as
the institutional official at the time of award.

Terms and Conditions of Award

NOTE:  Failure to abide by any of the Terms of Award pertaining to
awardee responsibilities stipulated in this Section may result in a
reduction of funding, withholding of support, suspension or
termination of the award.

These special Terms of Award are in addition, to and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR parts 74 and 92, and other HHS,
PHS, and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is a
cooperative agreement (U19), an "assistance" mechanism (rather than
an "acquisition" mechanism) in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated
during performance of the activity.  Under the cooperative agreement,
the NIH purpose is to support and/or stimulate the recipient's
activity by involvement in and otherwise working jointly with the
award recipient in a partner role, but it is not to assume direction,
prime responsibility, or a dominant role in the activity.  Consistent
with this concept, the dominant role and prime responsibility for the
activity resides with the awardee for the project as a whole,
although specific tasks and activities in carrying out the studies
will be shared between the awardee and the NCI Coordinator.

1.  Awardee Rights and Responsibilities

a.  The Principal Investigator, Program Leaders, and NCI Coordinator
will meet periodically to review progress, plan and design research
activities, and establish priorities.  The frequency of meetings, not
fewer than two per year, will be determined by the Principal
Investigator who will be responsible for scheduling the time and
place (generally at one of the performance sites) and for preparing
concise proceedings or minutes (two or three pages) which will be
delivered to the members of the Group within 60 days of the meeting.
NCI staff may not chair Group meetings.

b.  The Government, via the NCI Coordinator, will have access to data
generated under this cooperative agreement and may periodically
review the data.  However, the awardee will retain rights to the
data, and timely publication of major findings by the Group members
is encouraged.  Publication or oral presentation of work done under
this agreement will require appropriate acknowledgement of NCI
support, including the cooperative agreement number.  Dissemination
of information on synthetic or natural substances supplied to the
Group by NCI (e.g., for comparative testing purposes, as reference
material, etc.) will require clearance by NCI to assure conformity to
existing confidentiality agreements with suppliers.

2.  NCI Staff Responsibilities

NCI shall participate as a member of the Group and will be
represented by a Coordinator.  The NCI Coordinator will be selected
after award by the NCI Program Director for the NCDDG Program from
the extramural but not the intramural senior staff.  During
performance of the award, NCI may provide appropriate assistance by
participating in the design of activities; advising in the selection
of sources for resources, staff, etc.; advising in management and
technical performance; and participating in the preparation of
publications.  In all cases, the role of NCI will be to assist and
facilitate and not to direct activities.

The NCI Coordinator, as well as any other Group member, may assist in
research planning; may suggest studies within the scope of the
Group's objectives and research activities; may present to the Group
experimental findings from published sources or from contract
projects in support of these suggestions; may participate in the
design of experiments agreed to by the Group; and may participate in
the analysis of results.  However, the NCI Coordinator will not
conduct laboratory studies.

Upon recommendation of the NCI Coordinator, NCI may utilize its drug
development resources in support of Group research activities when
such resources may be required on an occasional basis.  The following
is a list of some resources that might be supplied if they become
desirable during performance, are not anticipated as a continuing
need, and are readily available:

a.  Reference compounds for standardization of test systems, as
analytical standards, and for related purposes.

b.  Needed resources such as test materials and information that may
not otherwise be available to the Group.

c.  Data from testing conducted in resource contract laboratories.

d.  Laboratory testing capacity, whenever appropriate and possible,
in the current contract based preclinical therapy-related laboratory
testing program.  The Group is expected to provide sufficient test
material for such testing.

e.  Searches of computer files of materials, chemical structures and
biological activity, if requests for such searches are sufficiently
focused to avoid excessive costs.  Information given to an NCDDG will
be restricted by any standard confidentiality agreements between the
Government and suppliers of test materials to the Government.

f.  Experimental animals and cultured cells, if available, to Groups
whose main research activities do not require these materials on a
regular basis.  Groups whose experimental approach involves studies
that require animals on a regular basis must budget for these costs
in their application.

g.  Computer processing and statistical evaluations if costs are not

These "Terms and Conditions of Award" require that the NCI Program
Director approve the following:  changes in the Principal
Investigator or Program Leaders; reports intended for inclusion in
INDAs and Clinical Brochures;  redistribution, outside the NCDDG, of
biological and chemical materials received from the Government; and
dissemination of research findings resulting from the use of such

3.  Collaborative Responsibilities

a.  The principal end product of NCDDG activities will be the
discovery of new entities and strategies for development to clinical
trial.  Subsequent developmental work through private resources is
encouraged.  Alternatively, the Group may recommend that development
be sponsored by NCI.  In the latter case, it will be necessary for
the Principal Investigator and NCI Coordinator to cooperate in the
analysis, summarization, preparation, and presentation of data to the
appropriate NCI staff, such as the NCI Decision Network Committee.

NOTE:  It is understood that the Government supports studies in the
interest of promoting the transition of effective, innovative
therapies to the clinic, and that identified therapies that have been
derived via Government support mechanisms will be offered to the
public at reasonable costs.

b.  NCI will retain the option to cross-file or independently file an
application for investigational clinical trial (e.g., an
Investigational New Drug Application [INDA] to the United States Food
and Drug Administration) of any invention resulting from these NCI
supported Cooperative Agreements.  Reports of data generated by the
Group or any of its members required for inclusion in INDAs and
Clinical Brochures and for cross-filing purposes will be submitted
promptly by the Principal Investigator to the NCI Coordinator upon
request.  Such reports will include background information, methods,
results, and conclusions.  They will be subject to approval and
revision by NCI and may be augmented with test results from other
Government sponsored projects prior to submission to the appropriate
regulatory agency.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award), between the awardee and the NCI may
be brought to arbitration.  An arbitration panel will be composed of
three members:  one Group designee, one NCI designee, and a third
designee with expertise in the relevant area chosen by the other two.
This special arbitration procedure in no way affects the awardee's
right to appeal an adverse action that is otherwise appealable in
accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS
regulations at 45 CFR Part 16.



It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subject or the purpose of the research.  This new policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which was reprinted in the Federal
Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting
errors in the earlier publication, and reprinted in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

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


Prospective applicants are asked to submit, by July 15, 1994, a
letter of intent that includes a descriptive title of the overall
proposed research; the name, address, telephone number, and
institution of the Principal Investigator; names of prospective
Program Leaders, other key investigators, and their respective
institutions; title and Program Leader for each Group Program; and
the number and title of the RFA in response to which the application
may be submitted.

Although the letter of intent is not required, is not binding, and is
not a factor in the peer review of the application, the information
it contains is helpful in planning for the review of applications.
It allows NCI staff to estimate the potential review workload and to
avoid conflict of interest in the review process. It also allows
staff to provide special instructions on the completion of the PHS
398 application form for this RFA.

The letter of intent is to be sent to:

Mary K. Wolpert, Ph.D.
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Suite 832
6130 Executive Boulevard
Bethesda, MD  20892    (U.S. Mail Service)
Rockville, MD  20852   (express mail or courier service)
Telephone:  (301) 496-8783
FAX:  (301) 496-8333 or (301) 402-0831


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these awards.  These forms are available at most
institutional offices of sponsored research or from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone (301) 584-7248.

This RFA requires the submission of a single application for the
proposed NCDDG.  Because of the multidisciplinary and likely
multi-institutional nature of an NCDDG and the special requirements
in this RFA, additional written instructions regarding format will be
provided by Dr. Mary K. Wolpert (see INQUIRIES below).  Potential
applicants are urged to obtain the "Special Instructions to
Applicants" to avoid omitting essential information and to expedite
review.  If required information is not contained within the
application, the application will be returned without review.

On line 2a of the face page of the application form, the YES box must
be marked, the RFA number must be listed as RFA CA-94-008 and the
title must be given as "National Cooperative Drug Discovery Groups;"
personalized titles more fitting for your application may be listed
on line 1.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
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.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, 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, two additional copies of the application
must also be sent to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute          National Cancer Institute
Executive Plaza North, Room 636    Executive Plaza North, Room 636
6130 Executive Boulevard
Bethesda, MD  20892   (U.S. Mail service)
Rockville, MD  20852  (express mail or courier service)
Telephone:  (301) 496-3428

Applications must be received by September 20, 1994.  If an
application is received after that date, it will be returned to the
applicant without review.  The Division of Research Grants (DRG) will
not accept any application in response to this RFA that is
essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The DRG will not
accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of a substantial
revision of an application already reviewed, but such an application
must include an introduction addressing the previous critique.


General Considerations

All applications will be judged on the basis of the scientific merit
of the proposed project and documented ability of the investigators
to meet the RESEARCH OBJECTIVES of the RFA.  Although the technical
merit of the proposed studies is important, it will not be the sole
criterion for selection of a study.  Other considerations, such as
the likelihood of identifying a clinical trial candidate, will be
part of the evaluation criteria. Applications should provide a plan
for development even though some of the activities will be beyond the
scope of the RFA.

Review Method

Upon receipt, applications will be reviewed for completeness by the
DRG and responsiveness by the NCI.  Incomplete applications will be
returned to the applicant without further consideration.  If NCI
staff find that the application is not responsive to the RFA, it will
be returned 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-competitve will be withdrawn from
further consideration and the Principal Investigator/Program Director
and the official signing for the applicant organization will be
promptly notified.

Each Laboratory Program will be evaluated on its relevance to the
Group's objectives as well as its individual scientific merit.

Review Criteria

o  Extent to which the application addresses the goals and objectives
of the RFA (see RESEARCH OBJECTIVES section) and the probability of
discovery of a novel therapy or strategy for the treatment of cancer.

o  Scientific merit and originality of proposed research.

o  Extent of progress on prior award (RECOMPETING GROUPS) or
preliminary results (NEW APPLICANTS).

o  Extent and effectiveness of cooperation with the NCI (RECOMPETING
GROUPS) and adequacy of plans for cooperation with the NCI in the
event of an award (ALL APPLICANTS).

o  Technical merit of proposed methods for producing or obtaining
test materials and for their evaluation.

o  Adequacy of the developmental plan for recommending a new cancer
therapy or strategy for clinical trial.

o  Adequacy of the scientific disciplines and specific competencies
represented by the Principal Investigator and Program Leaders;
research experience, competence, commitment, and time availability of
Principal Investigator, Program Leaders, and other key personnel.

o  Leadership, scientific ability, and administrative experience and
competence of Principal Investigator in the development,
implementation, and management of comprehensive research programs.

o  Adequacy of plans for effective intra-Group communication and for
assuring Group cohesiveness.

o  Evidence of approval and commitment of institutions represented by
Group members to Group goals.

o  Evidence of availability and competence of the applying
institution to serve as the Administrative Core for the Group.

o  Adequacy of existing physical facilities and resources of the
Principal Investigator and Program Leaders.

o  Justification and usefulness of cores to the overall NCDDG.

The review group will critically examine the budget requested and
will recommend an appropriate budget and period of support for each
approved application.


Applications recommended by the National Cancer Advisory Board (NCAB)
will be considered for award based on scientific merit as reflected
in the priority score; on programmatic priorities and relevance; on
program balance; and on funds available.

Letter of Intent Receipt Date:  July 15, 1994
Application Receipt Date:       September 20, 1994
Scientific Review Date:         January/February 1995
NCAB Meeting Date:              May 15, 1995
Earliest Award Date:            July 1, 1995


Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues, requests for the
"Special Instructions to Applicants" on application format, and
address the letter of intent to:

Mary K. Wolpert, Ph.D.
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Suite 832
Bethesda, MD  20892
Telephone:  (301) 496-8783
FAX:  (301) 496-8333 or (301) 402-0831

Direct inquiries regarding fiscal or administrative matters to:

Ms. Joan Metcalfe
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, Ext. 228


This program is described in the catalog of Federal Domestic
Assistance No. 93.395, Cancer Treatment Research.  Awards are made
under authorization of the Public Health Service Act, Title IV, Part
A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal
Regulations 42 CFR Parts 52 and 45 CFR Parts 74 and 92.  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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