Full Text PAR-97-021
NIH GUIDE, Volume 25, Number 44, December 20, 1996
PA NUMBER:  PAR-97-021
P.T. 34

  Diagnosis, Medical 

National Cancer Institute
The Technology Development Branch of the Cancer Diagnosis Program,
Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National
Cancer Institute (NCI) invites Program Project grant applications
(P01s) proposing the development of high-throughput technologies for
the evaluation of the spectrum of molecular alterations in primary
tumor tissue. To take full advantage of the advances made in
sequencing of the human genome and in our understanding of the
alterations underlying cancer, it will be necessary to develop new
and improved technologies to scan the entire genome of a cancer cell
or of tumor tissue for constellations of gene mutations and to
identify changes in gene expression at the level of both RNA and
protein.  Assessing the potential utility of these new techniques for
doing genome-wide genetic analyses or for analyzing patterns of
protein expression will require the coordination of technology
development efforts with the application of the technologies to
appropriate clinical specimens.  The P01 funding mechanism is being
used to facilitate collaborations between researchers developing
novel technologies and clinical investigators with the appropriate
expertise and resources to assess the application of the technologies
to tumor specimens.  The Advanced Technology Program (ATP) of the
National Institute of Standards and Technology (NIST) is supporting
commercial organizations to develop DNA-based technologies for a wide
variety of diagnostic applications.  The current Program Announcement
will complement this important effort by supporting application of
these and other technologies to the analysis of tumor tissue and by
supporting the modification of technologies to optimize their utility
in the clinical setting.
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 Program
Announcement (PA), High-Throughput Technologies to Detect Alterations
in Tumor Specimens, 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).
Applications may be submitted by domestic, for-profit, and nonprofit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal Government.  Applications may be
from single institutions but collaborative studies between companies
developing technologies and institutions with clinical resources and
expertise are also encouraged.  Racial/ethnic minority individuals,
women and persons with disabilities are encouraged to apply as
principal investigators.
Support for this program will be through the National Institutes of
Health (NIH) program project grant (P01) mechanism.  The applications
should be constructed using the P01 application guidelines of the
NCI.  The P01 mechanism is designed to support multiple, interacting
projects focused on a central theme.  P01s may support projects that
are performed at multiple sites but coordinated by a single principal
investigator at the grantee institution.  PIs will be responsible for
the planning, direction and execution of the proposed project.
Applicants may request up to $750,000 per year direct cost, however,
each budget item must be carefully justified (See Letter of Intent).
The period of support for applications submitted in response to this
PA may be for up to five years.  This PA will be in effect for two
years, up to and including the October 1, 1998 P01 receipt.
The impressive advances in our understanding of the molecular
alterations underlying tumor initiation and progression coupled with
the sequencing of the entire human genome will provide the
intellectual basis for dramatic changes in the way cancer patients
are managed.  Previous studies to correlate alterations in tumors to
clinical parameters have suggested the potential importance of
measuring these changes as a part of clinical decision-making.  The
sequencing of the human genome and ongoing development of
technologies to analyze genetic alterations on a genome-wide scale
may soon make it feasible to simultaneously look at all or a subset
of the alterations in tumor tissue.  Similar technologies to detect
patterns of protein expression or to detect changes in proteins
functioning in pathways of cellular regulation are also needed.  The
development of these new technologies will facilitate the discovery
of new alterations in tumor cells and, ultimately, the rapid
collection of diagnostic and prognostic information that may be
useful in cancer patient management.
Research Goals and Scope
This initiative invites grant applications to support development of
high-throughput technologies for analysis of the spectrum of
molecular alterations in primary tumor tissues.  The applications
should propose development of appropriate technologies and studies to
assess their use in analysis of primary tumor specimens.
Modification of these technologies to optimize their utility in the
clinical setting may also be proposed.  Technologies may be designed
to analyze a variety of  alterations including genome-wide
cytogenetic changes; mutations in constellations of genes known to be
important in tumor initiation and progression, including genes that
are members of pathways of cellular regulation; analysis of all
possible mutations in a single gene; changes in patterns of gene
expression at the level of both RNA and protein; or changes in
protein function.  The applications must document access to
appropriate tumor tissue resources to facilitate evaluation of the
technologies in clinical specimens.  Development of informatics
systems to support collection and evaluation of research data may
also be proposed.
This program encourages interactions among academic scientists and
clinicians, basic scientists involved in the development of new
technologies and informatics specialists. The initiative envisions
collaborations among commercial or academic organizations with
appropriate programs in technology development and academic
institutions with expertise and ongoing programs in cancer biology
and genetics with the necessary clinical resources.  These
collaborations will ensure that the technologies developed are
appropriate steps toward meeting the clinical needs of the cancer
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 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
provisions that are substantially different from the 1990 policies.
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 reprinted
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.
Prospective applicants are asked to submit a letter of intent that
includes a descriptive title of the proposed research and a list of
titles for the anticipated components of the P01, 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 PA 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.  Applicants requesting budgets greater than $500,000
are required to contact NCI program staff prior to submitting their
applications (NIH GUIDE, Vol. 25, No. 14, May 3, 1996).  Applications
with budgets of more than $500,000 received without prior
communication with the NCI program staff listed under INQUIRIES will
not be accepted for review.
The letter of intent is to be sent to the Referral Officer, National
Cancer Institute at the address listed under APPLICATION PROCEDURES.
Applications are to be submitted on the research grant application
form PHS 398 (rev. 5/95) and will be accepted at the standard
deadlines for P01 applications as indicated in the application kit.
Application kits are available at most institutional offices of
sponsored research and may be obtained from the Office 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: ASKNIH@odrockm1.od.nih.gov.  The title and
number of the program announcement must be typed in line 2 of the
face page of the application and the YES box must be marked.
The completed original application and three legible copies must be
sent or delivered to:
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
In addition send two complete copies under separate cover to:
BETHESDA, MD  20892-7405
ROCKVILLE, MD  20852 (for express/courier service)
Telephone:  (301) 496-3428
FAX: (301) 402-0275
Applications will be assigned on the basis of established Public
Health Services referral guidelines.  Applications will be reviewed
for scientific and technical merit by an appropriate peer review
group convened by the Grants Review Branch of the Division of
Extramural Activities of NCI.  The second level of review will be
provided by the National Cancer Advisory Board.
Review criteria that will be used to assess the scientific merit of
an application are:
o  scientific and technical merit and originality of the proposed
o  appropriateness and adequacy of the experimental approach proposed
to carry out the research;
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
o  availability of the resources necessary to perform the research;
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
The initial review group will also 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.
Applications will compete for available funds with all other approved
applications assigned to the NCI.  The following will be considered
in making funding decisions:
o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Responsiveness to the goals and objectives of the PA
Inquiries concerning this PA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
James W. Jacobson, Ph.D.
Division of Cancer Treatment, Diagnosis and Centers
National Cancer Institute
6130 Executive Boulevard, Room 513, MSC 7388
Bethesda, MD  20892-7388
Telephone:  (301) 496-1591
FAX:  (301) 402-1037
Email:  JJ37D@NIH.GOV
Direct inquiries regarding fiscal matters to:
Ms. Teresa Mercogliano
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243, MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800, ext. 243
FAX:  (301) 496-8601
This program is described in the Catalog of Federal Domestic
Assistance No. 93.394, Cancer Detection and Diagnostic 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 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 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.  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.

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