SMALL ANIMAL IMAGING RESOURCE PROGRAMS

Release Date:  August 20, 1998

RFA:  CA-98-023

P.T.

National Cancer Institute

Letter of Intent Receipt Date: October 23, 1998
Application Receipt Date: November 18, 1998

PURPOSE

The National Cancer Institute (NCI) invites applications for Small Animal Imaging
Resource Programs (SAIRPs).  These grants will support both (a) shared imaging
research resources to be used by cancer investigators and (b) research related to small
animal imaging technology.  SAIRPs will enhance capabilities for conducting basic,
clinical, and translational cancer research relevant to the mission of the NCI. Major goals
of this initiative are to increase efficiency, synergy, and innovation of such research and
to foster research interactions that cross disciplines, approaches and levels of analysis.
Building and strengthening such links holds great potential for better understanding
cancer, and ultimately, for better treatment and prevention.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion and
disease prevention objectives of "Healthy People 2000," a PHS-led national activity for
setting priority areas.  This Request for Application (RFA), Small Animal Imaging
Resource Programs, 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 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit organizations,
public and private, such as universities, colleges, hospitals, laboratories, units of State and
local governments, and eligible agencies of the Federal government.  Foreign institutions
are not eligible for resource-related research project (R24) grants.  Racial/ethnic
minority individuals, women, and persons with disabilities are encouraged to apply as
SAIRP Directors and heads of laboratories.  Applicants for SAIRPs may request support
for a period of up to 5 years.  Within 2 years of the date of the award, each application
for a SAIRP must serve a minimum of 6 cancer-related research projects (R01), FIRST
(R29), program projects (P01), relevant consortia (U01) and/or MERIT (R37) grants
(known as the base grants). Training grants (T32) and individual and institutional
fellowship grants are not eligible for inclusion as base grants.  R01-equivalent cancer-
related awards from other agencies may be included as base grants.  Only one SAIRP
will be awarded to any single applicant organization, but base grants may be housed in
multiple institutions.  In general, each cancer-related research project grant should only
serve as a base grant for one SAIRP.  If well justified, activities and research may be
located at sites and institutions other than that/those of the base grants and the SAIRP. 
For example, research related to a program might exist at a transgenic facility,
supercomputer center, imaging facility, etc., which is neither at nor part of the institution
applying for the SAIRP, nor at or part of any of the institutions housing the base grants.

One intention of this initiative is to promote regional distribution of small animal
imaging facilities.

MECHANISM OF SUPPORT

Small Animal Imaging Resource Programs will be supported by the resource-related
research projects (R24) mechanism.  This mechanism is used to support projects that
enhance capabilities of resources to contribute to extramural research of the Public
Health Service.

FUNDS AVAILABLE

Approximately $13 million total cost will be available for the 5-year period of the award
for all the SAIRPs.  Approximately $4.5 million total cost will be available for the first
year of this RFA, which should fund three to four resource related grants, including
funds for adding small animal imaging equipment as described below; subsequent year
funding would be less, because it would not fund equipment acquisition.  Approximately
$2.1 million total cost for all the SAIRPs will be available each year for years 2 through
5 of the award.  It is anticipated that three to four awards will be supported through this
RFA.

Purchase or assembling of imaging equipment will be allowed in the first year only.  The
funds requested should be based on the requirements of the project and the requested
costs must be fully justified. Each SAIRP will provide services, equipment and/or other
research resources to the base grants; imaging technology research related to the SAIRP,
in turn, will enhance the capabilities of the SAIRP.  The coordinated use of shared
resources increases the efficiency of cancer research, facilitates the use of new
technologies and the pursuit of new lines of research, and promotes interdisciplinary and
collaborative research. This RFA is a one-time solicitation.  Amended or competing
continuation applications will be accepted only through future RFAs, the publication of
which will be contingent upon program priorities and availability of funds.

RESEARCH OBJECTIVES

Background

Small animal models, particularly genetically engineered mice, are increasingly
recognized as powerful discovery tools in cancer research. The potential that could be
realized by the use of animal models has not yet fully been captured.  One of the
limitations is the need to sacrifice the animals to perform tissue or molecular analysis. 
This prevents researchers from observing in vivo the natural or perturbed evolution of
the processes under study.  Functional, quantitative imaging techniques are an important
tool for providing data about biochemical, genetic or pharmacological processes in vivo,
and repetitively in the same animal.

Neoplasms have an intrinsic spatially distributed nature.  That is, tumors develop in
different sites, metastasize to other sites and are internally heterogeneous.  To study
tumors one must make spatially distributed measurements. Imaging is a means of making
and displaying spatially coherent measurements and is therefore a key resource for
studying the development, growth and therapeutic response of neoplasms.  One of the
important research directions for imaging research is to provide quantitative information
in the setting of cancer diagnosis and therapy.  Quantitation of image data for small
animals will lead the way to application of quantitative methods in human beings.

A major limitation to studying tumors in model systems with current imaging techniques
is the limited availability of small animal imaging systems. Most biomedical imaging
devices have been optimized for human studies and have suboptimal spatial resolution
for small animals and their tumors.  However, imaging techniques can be scaled down to
yield very high resolution and signal sensitivity for in vivo images of mouse-sized organs.
Furthermore, there are some applications of imaging techniques which could provide
valuable knowledge from small animal models, but are not feasible for human subjects. 
Therefore, in order to take full advantage of the small animal tumor models being
developed, it has been recommended that dedicated small animal imaging laboratories
be developed.

The NCI recognizes the importance, synergy and innovation that often accrues from
research crossing disciplines, approaches, and levels of analysis. The SAIRP award is
envisioned as enhancing such activities by supporting coordinated shared research
resources for NIH-funded investigators performing cancer research.  The use of such
shared resources can increase efficiency in an area of research by eliminating
unnecessary duplication of effort and/or the support of research resources (e.g., costly
equipment) that might be needed in, but not fully utilized by, the activities of any one
research grant. Shared-resource laboratories can stimulate new research directions by
providing access to equipment, services, and other resources that might not otherwise be
available.  Finally, shared research resources which are properly coordinated will
promote research interactions and collaborations that cross disciplines, technical and
theoretical approaches, and levels of analysis, including interactions across basic and
clinical cancer research.  Such interactions often have results that exceed the sum of the
contributing activities.  For this reason, participation of scientifically diverse base grants
are strongly encouraged and, all else being equal, applications for SAIRPs with such
scientific diversity will be given higher priority for funding consideration.

Objectives and Scope

SAIRPs will offer a unique opportunity for multidisciplinary teams within the cancer
research community to address critical cancer research questions.

Small Animal Imaging Resource Programs (SAIRP) will provide:

Multiple imaging technologies for small animals, emphasizing, but not limited to, those
technologies which can provide biochemical, genetic or pharmacological information in
vivo.

Technology research and development on innovative new imaging technologies
appropriate for small animals, as well as refinement and development of technologies
already established.

Capabilities and personnel to assist in the development and/or production of necessary
probes for the imaging technologies provided.

Capabilities and personnel to aid in small animal anesthesia, management, and care, as
well as to consult on the optimal use of animals in connection with the imaging
experiments.

Structure

The structure of the SAIRP must reflect the need to ensure that the small animal
imaging technologies available for access or under development through this mechanism
are pushing the state of the art.  In addition, the SAIRP should explore the broadest
range of cancer research related applications appropriate.

The primary purpose of each SAIRP is to support coordinated shared research resources
and related research to enhance the capabilities of NIH-supported investigators to
pursue cancer research relevant to the mission of the NCI.  A SAIRP is characterized as
follows:

SAIRPs and SAIRP-related research represent shared research resources and  activities
that can include services (e.g., software development, histological processing,
biostatistical support), equipment (e.g., image analysis systems, multi-channel recording
equipment), and other resources (e.g., use of animal handling  facilities, access to
supercomputing centers, time on scanners, other clinical research resources).

SAIRPs must benefit the base grants that they serve and are expected to increase
efficiency, promote new research directions and foster interactions and synergy among
investigators.

SAIRPs may also be used by those not in base grants, particularly to the extent that they
provide opportunities for young investigators, women and minorities.  If this is planned,
rationale for such usage and for selection of such investigators should be provided.

Resource

The SAIRP should use approximately one half to two thirds of its resources and time to
provide imaging services and collaboration to cancer-related research projects.  As part
of the initial application, there must be commitments from at least three cancer-related
research projects [R01, FIRST (R29), program project (P01), relevant consortia (U01)
and/or MERIT (R37) grants],or R01-equivalent cancer-related awards from other
agencies, that will use the small animal imaging resource at the beginning of year 2.
After implementation, the applicants would be expected to form similar collaborations
with at least three additional cancer-related research projects by the beginning of the
third year of the SAIRP award.  At the time of application, applicants must give
evidence of potential to form these additional collaborations.  Collaboration with at least
six other research projects using small animals within 2 years after the award is a
MINIMUM requirement.  Collaboration with more than six research projects is strongly
encouraged.

Applicants must demonstrate that at the time of application they have available at least
one state-of-the-art imaging technology optimized for small animals.  In addition, they
must show evidence of experience with in vivo imaging of small animals using the
available technology.

Applicants must provide plans for providing at least one additional imaging technology
for small animals within the first year of the award.  This could be acquired
commercially or developed in-house.  Funds to acquire or develop this additional
imaging technology may be included in the budget of year 1 of the application.

Imaging Technology Research

The SAIRP should use approximately one third to one half of its resources and time for
research and development of small animal imaging technology.  This could be further
development and optimization of existing technologies or exploration of novel
technologies.  Methods to produce valid quantitative results would be particularly
encouraged. Funds for small animal imaging technology research may be included the
application budget for all years of the award.

Governance

The Director of the SAIRP must have a demonstrated capability to organize, administer
and direct the shared resource. Applicants must describe their plan for governance, and
methods to be used to evaluate and select protocols to support with the SAIRP.  It is
suggested that a scientific advisory board of collaborators and other cancer investigators
would be established for this purpose. The competences of the scientific advisors and the
structure of the board should be discussed, but the advisors do not need to named in the
application.

Two years after the award there will be a review by NCI program staff to confirm that:
two
or more small animal imaging technologies have been implemented and are operational;
collaboration with a minimum of six cancer-related research projects requiring imaging
data from small animals is in progress; developmental research on small animal imaging
systems is in progress.

If these components do not exist or are insufficient, the award will be phased out.

Research Support

The following are examples of ancillary research capabilities for which funding could be
requested in SAIRP application.  This list of examples is not meant to be comprehensive
or exclusive of other possibilities.

Contrast agent support: synthesize agents that can be used by investigators to
differentially label normal or abnormal structures, or make evident specific processes in
tumor imaging studies.

Supercomputer support: fund access to high performance platforms and technical
assistance in parallelizing algorithms used in analyzing very large data sets resulting from
high resolution imaging, 3D and 4D imaging, etc.

Informatics support: funds to support the purchase as well as research and development
of tools and approaches for data storage, retrieval, analysis, visualization and
manipulation.

Imaging instrument support:  purchase equipment, supplies, and service contracts needed
for small animal imaging.

Research animal support: support of laboratory facilities to provide the animal imaging
operations.

Biostatistics support: support for statistical consultation in experimental design and data
analysis for small animal imaging.

Activities Supported

An overall budget for the SAIRP should be provided, as well as budgets for each of the
proposed imaging instruments, including instrument-related research. Direct costs may be
requested that are essential for the support of the SAIRPs and must be fully documented
and justified; salary support for administrative costs should be kept at a minimum.  A
budget item to support travel of two persons to an annual meeting of individuals from all
the funded SAIRPs should be included.

LETTER OF INTENT

Prospective applicants are asked to submit, by October 23, 1998, 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 key personnel and
participating institutions, and the number and title of the RFA in response to which the
application may be submitted.  Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information that it
contains allows NCI staff to estimate the potential review workload and avoid conflict of
interest in the review.

The letter of intent is to be sent to Dr. Barbara Croft, at the address listed under
INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.5/95) and
will be accepted on or before November 18, 1998.  Application kits are available at most
institutional offices of sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714; fax:
(301)480-0525 Email: grantsinfo@nih.gov. PHS 398 forms and instructions may be found
at:  http://grants.nih.gov/grants/funding/phs398/phs398.html.

The SAIRPs are intended to enhance the capabilities of scientists to pursue cancer
research relevant to the mission of this Institute.  The manner in which the proposed
SAIRP will do this must be made clear in the application.  The following sections should
replace the Specific Aims, Background and Significance, Preliminary Studies/Progress
Report, and the Research Design and Methods sections of the traditional Research Plan
in form PHS 398 (Rev. 5/95) (adhering to the 25-page limit):

General Description of the SAIRP:

Describe the SAIRP, existing small animal imaging instrument(s), proposed small animal
imaging instrument(s), and ancillary capabilities existing and proposed.  Describe the
provision of imaging services and the small animal imaging research and development
proposed.

General Description of the Base Grants of the SAIRP (Not to exceed 1 page for each
base grant participating in the SAIRP):

Provide an overview of the research goals and approaches used in each of the base
grants and the manner in which the SAIRP award will benefit the research activities of
the base grants.  In addition, describe the specific ways in which the SAIRP will increase
efficiency, promote new research directions and foster research interactions and synergy
of cancer-related research.  Finally, for each of the base grants, the following must be
provided: the grant number, title, name of the PI, grantee organization, the project
period end date, and the direct cost budget for the year on which the budget of the
SAIRP application is based.

Operational Plan:

Describe arrangements required to implement the SAIRP, including the manner in which
priority for imaging facility access and use is decided, the operational and administrative
role of the director of the imaging facility, etc.  This section is especially important for
those applications proposing an offsite facility.

Imaging Equipment Descriptions:

Describe the purpose of each component, describe imaging technology-related research
including the manner in which it is expected to enhance the capabilities of the imaging
instruments, and clearly indicate the space, facilities, resources, services, technical and
professional expertise and support that the applicant institution will provide.

Describe the specific manner in which each component will relate to the base grants. 
For each component, describe the level of use by the base grants; starting in year 3 of
the award, each imaging technology must be used by at least three of the base grants.

Ancillary Capabilities

Describe the specific ancillary capabilities requested and how they will enhance the
SAIRP.

Table of Contents

The table of contents should reflect the actual contents of the application and should not
copy the categories of PHS 398 Form Page 3.

Budget and Financial Information

Break out the budget contribution for each proposed small animal imaging instruments. 
The budget and the proposed research and resource provision should be aligned.

Appendix:   All instructions in the Form 398 application kit apply.

The RFA label available in the PHS 398 (rev. 5/95) 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 2 of the face page of the application form and the YES box must be marked.

The completed original application and three legible copies must be sent or delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, send two additional copies of the application to:

Ms. Toby Friedberg
Referral Officer
National Cancer Institute
6130 Executive Boulevard, Room 636a, MSC 7405
Bethesda, MD  20892-7405
Rockville, MD  20852 (for courier/courier service)
Telephone:  (301) 496-3428
FAX:  (301) 402-0275

Applications must be received by November 18, 1998.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the Center for Scientific
Review (CSR) and responsiveness by the NCI.  Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.  Applications
that are complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the NCI in accordance
with the review criteria stated below and receive a second level of review.  As part of the
initial merit review, all applications will receive a written critique and undergo a process
in which only those applications deemed to have the highest scientific merit, generally
the top half of the applications under review, will be discussed, assigned a priority score,
and receive a second level review by the National Cancer Advisory Board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of biological
systems, improve the control of disease, and enhance health.  The reviewers will
comment on the following aspects of the application in their written critiques in order to
judge the likelihood that the proposed research will have a substantial impact on the
pursuit of these goals.  Each of these criteria will be addressed and considered by the
reviewers in assigning the overall score weighting them as appropriate for each
application.  Note that the application does not need to be strong in all categories to be
judged likely to have a major scientific impact and thus deserve a high priority score. 
For example, an investigator may propose to carry out important work that by its nature
is not innovative but is essential to move a field forward.

1.  Significance.  Does the application address an important problem?  If the aims of the
application are achieved, how will scientific knowledge be advanced?  What will be the
effect of this resource program on the concepts or methods that drive this field?  What is
the likelihood that the proposed SAIRP will increase efficiency, promote new research
directions, facilitate interactions across disciplines and levels of analysis, and/or across
theoretical and technological approaches?

2.  Approach.  Are the conceptual framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the SAIRP?  Does the
applicant acknowledge potential problem areas and consider alternative tactics?  How
will the effectiveness of the SAIRP in achieving its goals be judged?

3.  Innovation.  Does the imaging research project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the imaging research project
challenge existing paradigms or develop new methodologies or technologies?

4.  Investigator.  Is the investigator appropriately trained and well suited to manage the
SAIRP and carry out the research?  Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?  Has the principal
investigator assembled the appropriate team to manage the SAIRP and conduct the
proposed research?

5.  Environment.  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take advantage of
unique features of the scientific environment or employ useful collaborative
arrangements? Is there evidence of institutional support?

6.  Relationship to base grants: Will the SAIRP significantly enhance the capabilities of
the base grants to pursue cancer research relevant to the NCI?

The initial review group will also examine: the appropriateness of proposed project
budget and duration; the provisions for the protection of animal subjects; and the safety
of the research environment.

AWARD CRITERIA

Applications will compete with other applications received in response to this RFA.  The
following will be considered in making funding decisions: Quality of the proposed project
as determined by peer review, availability of funds, and program balance.

SCHEDULE

Letter of Intent Receipt Date:      October 23, 1998
Application Receipt Date:           November 18, 1998
Review by National Cancer Advisory Board: May 1999
Award Date:                         July 1, 1999

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues and letters of intent to:

Barbara Y. Croft, Ph.D.
Diagnostic Imaging Program
National Cancer Institute
6130 Executive Boulevard, Room 800
Rockville, MD  20892-7440
Telephone:  (301) 496-9531
FAX:  (301) 480-5785
Email:  bc129b@nih.gov

Direct inquiries regarding fiscal matters to:

Kathleen J. Shino, M.B.A.
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243, MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800 ext. 248
FAX:  (301) 496-8601
Email: shinok@gab.nci.nih.gov

Direct inquiries regarding review matters to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636
Bethesda, MD  20892-7150
Telephone:  (301) 496-3428
FAX:  (301) 402-0275
Email: tf12w@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 93.394. 
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 part 92.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products.  In addition, Public Law
103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some
cases, any portion of a facility) in which regular or routine education, library, day care,
health care or early childhood development services are provided to children.  This is
consistent with the PHS mission to protect and advance the physical and mental health
of the American people.


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