Full Text CA-94-009

COLLABORATIVE CANCER PREVENTION RESEARCH UNITS

NIH GUIDE, Volume 23, Number 22, June 10, 1994

RFA:  CA-94-009

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Disease Prevention+ 
  Health Promotion 


National Cancer Institute

Letter of Intent Receipt Date:  August 11, 1994
Application Receipt Date:  October 13, 1994

PURPOSE

The Cancer Control Science Program within the Division of Cancer
Prevention and Control (DCPC) of the National Cancer Institute (NCI),
seeks to stimulate the establishment of programs in primary and
secondary cancer prevention, health promotion and prevention services
research through the award of research grants involving
project-specific collaborations.  Certain questions in biomedical and
behavioral research require efforts that extend beyond the level
practical in a single project or require a variety of approaches
beyond the means of a single investigator.  There may be areas of
investigation that are underrepresented in individual research
project (R01) and First Independent Research Support and Transition
(FIRST) (R29) applications because of the lack of available
collaborative effort, or the perceived merit of individual projects
may be diminished by the lack of a comprehensive, interdisciplinary
approach, or by limitations in resident technical expertise.

This Request for Applications (RFA) invites the coordinated
submission of related research project grant (R01) and, to a limited
extent, FIRST award (R29) applications from investigators who wish to
collaborate on research, but do not require extensive shared physical
resources;  these applications must share a common theme and describe
the objectives and scientific importance of the interchange of, e.g.,
ideas, data and materials, among the collaborating investigators.  A
minimum of two independent investigators with related research
objectives are encouraged to submit concurrent, collaborative cross
referenced individual R01 or R29 applications.  Applicants may be
from the same or different institutions.  Applications will be
reviewed independently for scientific merit.  Applications judged to
have significant and substantial merit will be considered for funding
both as independent awards and in the context of the proposed
collaborations.

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,
Collaborative Cancer Prevention Research Units (CCPRU), 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
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 domestic, non-profit and for-profit
organizations, public and private entities such as universities,
colleges, hospitals, laboratories, units of state or local
governments, and eligible agencies of the federal government.
Applications from minority and women investigators are encouraged.
Foreign institutions are not eligible to apply for First Independent
Research Support and Transition (FIRST) (R29) awards.

Investigators may not concurrently submit additional R01 or R29
applications (either investigator-initiated or in response to a
Request for Applications) that represent significant duplication of
the efforts described in applications for this RFA.  Concurrent
submission of program project (P01) or cooperative agreement (U01)
applications that request support for essentially similar work is
also prohibited.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research
project grant (R01) and the FIRST (R29) award grant mechanisms.  The
CCPRU must consist of a minimum of two independent applications.  A
CCPRU package can consist of a combination of R01s and R29s, or R01s
only, but may not consist of solely R29 applications.  Applications
for both new and competing renewal awards may be submitted as
collaborative research projects within a CCPRU.  The total project
period for an R01 application submitted in response to the present
RFA may not exceed four years.  The anticipated award date is July 1,
1995.  This is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with the
investigator-initiated applications and will be reviewed according to
customary NIH peer review procedures.

FUNDS AVAILABLE

Approximately $3 million per year in total costs for four years will
be committed to specifically fund applications that are submitted in
response to this RFA.  It is anticipated that up to five (a
combination of approximately 10 individual R01 and R29 projects)
CCPRU awards will be made.  This funding level is dependent on the
receipt of a sufficient number of applications of high scientific
merit.  Although this program is provided for in the financial plans
of the NCI, the award of grants pursuant to this RFA is also
contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

DCPC supports research with an emphasis on studies to identify,
evaluate, and implement techniques and approaches for primary and
secondary prevention of cancer.  Those studies may include specific
cancers such as breast or prostate or more general areas of
prevention research such as cancer prevention and screening among
special populations, chemoprevention, tobacco prevention among
children and adolescents, diet and nutrition, and early detection.

The CCPRU should focus on problem- or program- oriented cancer
prevention research studies and involve multidisciplinary
participation.  Applicants for Phase IV and V studies must have
access to defined populations in order to measure the population
impact of any cancer control activities.  The CCPRU concept envisions
a multidisciplinary environment of scientists interacting closely
within the research program.  These can include new as well as
experienced investigators in relevant fields and disciplines, such as
disease prevention and control, medicine, public health, health
education, health promotion, epidemiology, nutrition sciences,
environmental and occupational health, health policy and economics,
health services research, behavioral and social sciences, community
organization, communications, and biostatistics.

Investigators may choose from the full range of scientific
approaches.  Many Phase II studies may contribute to the design,
implementation, or evaluation of future Phase III-V studies, e.g.,
validation of surveys or program materials for use in the proposed
population groups, testing of recruitment or compliance procedures
for participants, or testing of biochemical or dietary methods for
objectively monitoring participation in studies.  The proposed
research may occur in a variety of settings ranging from the
laboratory to communities, schools, health departments and worksites.

The Cancer Control Science Program supports the development and
testing of primary and secondary intervention strategies to modify
personal, social, and life-style factors known to contribute to the
development and/or increased risk of cancer.  This research includes
the health promotion sciences, special population studies, and
applications research, as well as implementation studies for proven
technologies such as breast and cervical cancer screening. Research
on cost-effective health services is encouraged, since it impacts on
obtaining optimal application of the interventions in community
settings.  Interventions aimed at reducing cancer incidence related
to smoking and tobacco use is also emphasized (e.g., Phase IV and V
research in achieving the goals of the Year 2000 for smoking).

Linkages between laboratory research and applied cancer prevention
and control research are encouraged, i.e., laboratory research in
support of these prevention studies.  Basic laboratory research
without this linkage will be deemed non-responsive to the RFA.

Investigators must address the specific aims and hypotheses, the
background and significance of the proposed work, results of any
preliminary studies, experimental design and methods, any theoretical
concepts which underlie the intervention research, human subjects
involvement and protection, and relevant
literature.

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

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

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

LETTER OF INTENT

Prospective applicants are asked to submit, by August 11, 1994, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other collaborating personnel and
participating institutions, and the number and title of this RFA in
response to which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains allows NCI staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Sherry Mills, M.D., M.P.H.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 320
Bethesda, MD  20892
Telephone:  (301) 496-8520
FAX:  (301) 402-0816

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 and from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/710-0267.

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.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

All requirements with regard to type, size, page limitations,
appendix material, etc., must be followed or applications will be
returned without review.  FIRST applications (new and revised) must
be accompanied by three letters of reference; FIRST applications
without these letters will be considered incomplete and returned
without review.

For each component CCPRU project, a signed, typewritten original
application, three exact single-sided copies, and three sets of
appendix material must be submitted.  Each application must be
complete in itself, with all necessary approvals, budgets, and
signatures from the appropriate officials of the application
institution.

Unlike submission of traditional R01 or R29 applications, all of the
R01 and R29 applications constituting the proposed CCPRU must be
submitted in a single package, whether or not the applications arise
from the same institution.  Each application within the package must
be clearly identified and a cover letter must list the total number
of applications submitted for the CCPRU, indicating the Principal
Investigator (PI) of each.  The various component applications should
not be collated together like a program project application.  For
each component application in the CCPRU the original, three copies,
and the appendix material must be bundled together and clearly
identified.  Failure to follow the instructions regarding packaging
may result in the return of the application without review.

Submit the complete CCPRU applications to:

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

At the same time a CCPRU package containing two copies of each
component application and the appendix material bundled together and
clearly identified with a copy of the cover letter must also be sent
to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Bethesda, MD  20892 (if using U.S. Postal Service)
Rockville, MD  20852 (If hand delivered or delivery service)

Applications must be received by October 13, 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 substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.  No additional
materials will be accepted after the receipt date unless explicitly
requested by the Scientific Review Administrator.

Special Instructions

The CCPRU package should include a cover letter that identifies the
Program Coordinator and lists the individual applications by title
and individual PIs.  The Program Coordinator is a single PI who will
be responsible for coordinating the collaborative efforts among the
research projects and communications among the PIs.

Particular attention must be paid to Section 7 of the application
(Consultants/Collaborators). In this section the collaborations that
are unique to the research proposed in this R01 or R29 should be
detailed in the usual way. In addition to a description of these
project-specific collaborations, each component application of the
CCPRU must also contain a special subsection (entitled "CCPRU
Collaborations") including information showing collaborative
utilization of any requested shared resources, the intended
interactions among the component projects of the CCPRU and the
perceived benefits of supporting all of the components of the CCPRU
as a combined effort.  Section 7 should be complete and sufficiently
detailed for NCI staff and reviewers to understand the full scope of
the collaborative interactions within the CCPRU.

Each request for limited shared resources, if any, must be included
in one of the component applications.  No shared resource request may
be submitted separately.  The budget for each shared resource should
be requested only once in each CCPRU; in the individual application
with the proposed project personnel most closely suited to oversee
that resource activity.

As needed, a new section (entitled "Shared Resources") should be
inserted between Section 8 (Consortium/Contractual Arrangements) and
Section 9 (Literature Cited) for each Shared Resource to be supported
within the component application.  The first page of this section
should clearly indicate the descriptive title of the individual who
will manage the Shared Resource and the specific location
(department, institution, city) of the Shared Resource.

Then, as concisely as possible, provide an explicit description and
justification for the Shared Resource requested.  This section should
present a clear picture of the approaches, methods, techniques,
special populations, etc. that will be used to support each of the
projects that will utilize the resource.  The role of the individual
who will manage the Shared Resource (if someone other than the PI)
and of each of the key participants should be described.
Specifically address how the available resources and environment will
be sufficient to address the needs of all of the projects in the
CCPRU which will make use of the Shared Resource.  If appropriate,
address the involvement and protection of human subjects and/or
vertebrate animals that have not already been addressed in Sections 5
and 6 of the Research Plan of the project.

A sample format for providing budget information to justify
utilization of shared activities and/or resources and distribution of
effort for all personnel (professional, technical and clerical) of
the cohort of applications for each CCPRU may be obtained from the
NCI Program Director listed under INQUIRIES.  The utilization of
these resources by each component of the CCPRU will be independently
evaluated by the initial review group and any appropriate
modifications recommended.

The budget of each component application responding to this RFA
should include one round trip, two-day meeting for the Principal
Investigator and one key staff member to Bethesda, MD, for each year
of funding proposed.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by 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 noncompetitive
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.   The second level of review will be by the
National Cancer Advisory Board.

The initial review for scientific and technical merit will focus on
each application independently.  Reviewers will read Section 7 and
will assess the intended collaborations just as they do the proposed
collaborative arrangements in any other application.  As appropriate,
the effectiveness and merit of the collaborations may contribute to
the overall assessment of each application.

Review criteria are the following:

1.  Scientific and technical significance and originality of proposed
research;

2.  Appropriateness and adequacy of the experimental design and
methodology proposed to carry out the research;

3.  Qualifications and research experience of the Principal
Investigators, Program Coordinator, and collaborating scientists,
particularly in the area of the proposed research;

4.  Demonstrated previous collaborative research experience of the
proposed research team;

5.  Availability of the resources necessary to perform the research;

6.  Extent to which the research addresses the special requirements
of the RFA;

7.  Plans for inclusion of women and minorities in clinical studies.

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

In an Administrative Note, the reviewers will indicate the
effectiveness and feasibility of the proposed CCPRU interactions and
whether they enhance the prospects for reaching the stated objectives
of the CCPRU, and the extent of synergy between the various projects
derived from the interactions.  The initial review group will
evaluate the requested Shared Resource component(s) in the
application (qualification of key personnel; adequacy of approaches,
methods, and facilities; appropriateness for the CCPRU; and
utilization by the component applicants of the CCPRU) independently
from the research project.  The review group may also make
recommendations about the Shared Resource(s) or the reasonableness of
the budget.

AWARD CRITERIA

The anticipated award date is July 1, 1995.

Applications found to have significant and substantial merit will be
considered for funding by the following:

1.  Quality of the proposed project as determined by peer review
2.  The collaborative nature of the program and of the component
CCPRU projects
3.  Availability of funds
4.  Program balance among research areas

The National Cancer Institute will have the opportunity to fund some
or all of the component CCPRUs.  If some component CCPRUs are
considered not supportable, the collaborative plans may need to be
changed.

INQUIRIES

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 to:

Sherry Mills, M.D., M.P.H.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 320
Bethesda, MD  20892
Telephone:  (301) 496-8520

Direct inquiries regarding fiscal matters to:

Marian F. Focke
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 246

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No 93.399, Cancer Control.  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 52 and 45 CFR Part 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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