EXPLORATORY/DEVELOPMENTAL GRANTS FOR DIAGNOSTIC CANCER IMAGING

NIH GUIDE, Volume 26, Number 37, November 7, 1997

PA NUMBER:  PA-98-008

P.T.

National Cancer Institute

PURPOSE

The Diagnostic Imaging Program (DIP), of the Division of Cancer
Treatment and Diagnosis (DCTD) solicits exploratory/developmental
(R21) grants that articulate highly innovative research concepts in
diagnostic cancer imaging.  Within each area of importance in
imaging, there exists a need for innovative and creative approaches
leading to new avenues of research.  One way to encourage research
into high risk/high impact areas is to provide investigators with
the initial resources required to accomplish feasibility and pilot
testing of innovative ideas.

Investigators with innovative ideas for research in diagnostic
cancer imaging have previously had difficulty identifying potential
funding sources.  The R21 mechanism will provide investigators at
all career levels with a defined level of funding adequate for the
initial feasibility testing of high risk/high impact concepts and,
if the concepts are viable, for the generation of experimental
preliminary data.  This would render the investigators competitive
for funding through the research project grant (R01) and/or First
Independent Research Support and Transition (FIRST) (R29) award
mechanisms, thus potentially leading to the establishment of new
research programs in areas that might have previously remained
unexplored.

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 PA, Exploratory/Developmental Grants for Diagnostic
Cancer Imaging, 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 foreign and 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. 
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

The National Institutes of Health (NIH) exploratory/developmental
grants mechanism (R21) will be used. Applicants may request up to
two years of support and up to $100,000 per annum in direct costs. 
The award is non- renewable.  If desired, the specific aims of the
R21 project may be incorporated into a research project grant
application (R01 or R29) submitted prior to the termination of the
R21 award.  Awards will be administered under PHS grants policy as
stated in the Public Health Service Grants Policy Statement, DHHS
Publications No. (OASH) 90-50-000, revised April 1, 1994.

RESEARCH OBJECTIVES

Research topics to be supported by the R21 mechanism will be those
falling within broad areas of clear importance to the future of
diagnostic imaging.

1.  Development of new and innovative imaging modalities and their
optimization, characterization and preclinical evaluation, with
emphasis on their potential for cancer screening, diagnosis or
treatment.

2.  Development of new and innovative contrast or
molecular/radiotracer agents for tumor visualization and
interpretation for cancer diagnosis, staging or treatment or
understanding the physiological states of organ systems and tumor
systems.

3.  Development of new and innovative methods for image
acquisition, display, transmission, computer assisted analysis,
teleradiology and telemedicine applications that impact cancer
screening, diagnosis or treatment or improve cost effectiveness in
the oncology setting.

4.  Development of innovative methods for interventional radiology
and techniques for improved image guided diagnosis or treatment.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority
groups and their subpopulations must be included in all NIH
supported biomedical and behavioral research 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 policy results from the NIH Revitalization Act of
1993 (Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects
should read the "NIH Guidelines For Inclusion of Women and
Minorities as Subjects in Clinical Research," which have been
published in the Federal Register of March 20, 1994 (FR 59
14508-14513) and in the NIH Guide for Grants and Contracts, Volume
23, Number 11, March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  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
301/710-0267, E-mail: [email protected]. The title and number of
the program announcement must be typed in Section 2 on the face
page of the application.

Specific Instructions

It is strongly suggested that items a-d of the Research Plan not
exceed a total of ten pages. Tables and figures are included in the
ten page limitation.  Applications that exceed the page limitation
or NIH requirements for type size and margins (refer to PHS 398
application for details) will be returned to the applicant without
further consideration.

The suggested ten page limitation does not include items (e)-(i)
(Human Subjects, Vertebrate Animals, Literature Cited, Consortia,
Consultants/Collaborators).

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

CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants)
National Institutes of Health
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public
Health Service referral guidelines. Applications will be reviewed
for scientific and technical merit by study sections of the
Division of Research Grants, NIH (or by the review group of the
relevant Institute, Center, or Division), in accordance with the
standard NIH peer review procedures.  Following scientific-
technical review, the applications will receive a second-level
review by the appropriate national advisory council. As part of the
initial merit review, a process 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 PA. 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 and the
official signing for the applicant organization will be notified.

Review Criteria

The goals of NIH-supported research are to advance our
understanding of biological systems, improve the control of
disease, and enhance health.  In the written review, comments on
the following aspects of the application will be made 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 in the assignment of the
overall score.

1.  Significance.  Does this study address an important problem
with the potential of leading to new areas of research?  If the
aims of the application are achieved, how will scientific knowledge
be advanced?  What will be the effect of these studies on the
concepts or methods that drive this field?

2.  Approach.  Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate for
the testing of feasibility of the approach within the time and
budget limits of the R21 mechanism?  Does the applicant acknowledge
potential problem areas and consider alternative tactics?

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

4)  Investigator:  Are the qualifications and research experience
of the Principal Investigator and staff appropriate for 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?

The initial review group also will examine the provisions for the
protection of human and animal subjects, the safety of the research
environment, and conformance with the NIH Guidelines for the
Inclusion of Women and Minorities as Subjects in Clinical Research.

AWARD CRITERIA

Applications will compete for available funds with all other
approved applications assigned to that IC.  The following will be
considered in making funding decisions:  Quality of the proposed
project as determined by peer review, availability of funds, and
program priority.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Anne E. Menkens, Ph.D.
Division of Cancer Therapy and Diagnosis
National Cancer Institute
Executive Plaza North, Suite 800
Bethesda, MD  20892
Telephone:  (301) 496-9531
FAX:  (301) 480-5785
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Ms Cynthia W. Mead
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800 - ext. 254
FAX:  (301) 496-8601
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.395.  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.  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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