SPECIALIZED PROGRAM OF RESEARCH EXCELLENCE IN HUMAN CANCER

Release Date:  September 23, 1999

PA NUMBER:  PAR-99-167

National Cancer Institute

Letter of Intent Receipt Dates:  At least sixty days prior to the specified
receipt dates below.

Application Receipt Dates:  
Breast and Prostate Cancer SPOREs:         February 1, 2000.
Lung and Prostate Cancer SPOREs:           June 1, 2000.
Prostate and Genitourinary Cancer SPOREs:  October 1, 2000.

PURPOSE

The Organ Systems Branch of the Office of the Deputy Director for Extramural
Science at the National Cancer Institute (NCI) invites grant applications
(P50) for Specialized Programs of Research Excellence (SPORE) in organ-
specific cancers.  Applicant institutions must be able to conduct the highest
quality balanced translational research on the prevention, etiology,
screening, diagnosis, and treatment of a specific organ-site cancer.  SPOREs
are at institutions that will make a strong commitment to the organization and
conduct of these programs.  SPORE applicants are judged on their current and
potential ability to translate basic research findings into innovative
research settings involving patients and populations.  A SPORE is also
encouraged to conduct research on rehabilitation and quality-of-life.  A SPORE
must develop and maintain human cancer tissue resources for the particular
organ-site that will benefit translational research, develop extended
collaborations in critical areas of research need with laboratory scientists
and clinical scientists within the institution and in other institutions, and
participate with other SPOREs on a regular basis to share positive and
negative information, assess scientific progress in the field, identify new
research opportunities, and promote inter-SPORE collaborations to resolve
areas of scientific controversy.  Each SPORE and the "networks" of SPOREs are
expected to conduct research that will have the most immediate impact possible
on reducing incidence and mortality of human cancer.  A SPORE should support a
mix of basic and clinical researchers whose formal interactive and
collaborative research efforts will result in new approaches for early
detection, diagnosis, therapy, and prevention and control.  The SPORE
mechanism is not intended to support basic research to the exclusion of
clinical research or vice versa.

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 Program Announcement ( PA),
Specialized Program of Research Excellence (SPORE) in Human Cancer, 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,
or at http://odphp.osophs.dhhs.gov/pubs/hp2000).

GUIDELINES OF THE SPORE PROGRAM

The following Eligibility Requirements, Application Procedures, and Review
Considerations summarize the general components and procedures for preparing a
SPORE application.  However, the NCI has developed SPECIAL GUIDELINES that
address programmatic, review and award concerns in detail that must be used
when preparing a SPORE application.  SPORE GUIDELINES CAN NOT BE SUPERSEDED BY
THIS OR ANY OTHER ANNOUNCEMENT.  Prospective applicants must request a copy of
the SPORE GUIDELINES from the program staff listed under INQUIRIES. SPORE
GUIDELINES are also available at the internet:
http://spores.nci.nih.gov/

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.  Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal Investigators.

Eligible institutions may include foreign components as full research
projects, or shared resources, or as part of a research project or shared
resources.  SPOREs may also use Developmental Funding to establish
collaborative research involving foreign components (see Required Components
below).  Participating foreign institutions must include provisions that
ensure adequate representation of women, minorities, and children in all
research components that involve clinical trials or any other type of human
intervention, in compliance with NIH policies.

To be considered eligible, applicant organizations must have: (1) a statement
of institutional commitment that addresses how the institution will
incorporate the SPORE high within its institutional priorities, (2) a minimum
of four independent investigators who are successful in obtaining
peer-reviewed research support (R01, P01, U01, U10 or equivalent) directly
related to the organ-specific cancer, and who together represent experience in
both laboratory and clinical research, (3) a minimum of four research
projects, representing a balance and diversity of translational approaches. 
At least one research project must focus on early detection, screening,
prevention, and/or population science.  All proposed research projects must be
led by co-investigators in basic and applied sciences who commit adequate
percent efforts to the translational research endeavors, (4) a qualified
principal investigator who is a scientific leader in the field, (5) access to
a patient care and service facility that serves a substantial cancer patient
population and, if the facility is not part of the parent institution, a
consortium agreement with an associated institution that assures adequate
access to cancer patients for clinical research, the statement must be signed
by the responsible officials of the applicant institution and the consortia
care facility, (6) both a developmental and career development programs, and
(7) appropriate shared resources to support the proposed translational
research of the SPORE.  Although an application must be submitted by a sole
applicant institution, subcontracted collaborative scientific arrangements
with scientists from other institutions may be included if these arrangements
are clearly delineated, and formally and officially confirmed by signed
statements from the responsible officials of each institution.  However, a
full institutional commitment must come from the applicant institution.

Support will not be provided for applications with research activities focused
exclusively on basic research, or clinical research or trials, or
epidemiological research.

NCI program staff listed under INQUIRIES should be consulted if there are
questions regarding any of the above eligibility requirements or exclusions.

MECHANISM OF SUPPORT

Support of this program will be through the specialized center (P50) grant
mechanism.  This mechanism supports the full range of research and development
from basic to clinical and intervention studies.  The spectrum of activities
comprises a multidisciplinary approach on a specific disease entity or
biomedical problem.  These grants differ from traditional program project
grants in that they are more complex and flexible in terms of the activities
that can be supported.  In addition to support for multidisciplinary research
projects, support is also provided for pilot research projects, specialized
resources and shared core facilities.  Applicants will be responsible for the
planning, direction, and execution of the proposed SPORE program.  Awards will
be administered under NIH grants policy as stated in the NIH Grants Policy
Statement.

NCI policy for SPORE grants establishes the following limits to the requested
budgets:  New or competing renewal P50 SPORE applications may request a
maximum annual direct cost of $1.75 million and maximum annual total cost of
$2.75 million per individual SPORE.  In complying with the direct cost cap of
$1.75 million, the facilities and administrative costs related to subcontracts
to other institutions or organizations will not apply toward the direct cost
cap.  Applications can exceed these caps as a result of regular cost-of-living
increases (currently 3% per year) or special supplements approved by NCI.  A
SPORE grant application may request up to five years of funding.

Although this program is provided for in the financial plans of NCI, the award
of grants pursuant to this announcement is contingent upon the anticipated
availability of funds for this purpose.

RESEARCH OBJECTIVES

A SPORE must address the scientific information base and provide focal points
for sustaining and maintaining state-of-the-art research that will contribute
to improved detection, diagnosis, treatment and prevention of an organ-
specific cancer.  SPORES not only are expected to conduct a wide spectrum of
research activities, but also to contribute significantly to the development
of specialized research resources, the development of improved research model
systems and the expansion of the research base through collaborative research
with scientists and clinicians in other institutions locally and nationwide. 
The research supported through this program must have translational potential
or significance.  It must also demonstrate interdependence between basic and
clinical investigators in planning and implementing research and should
emphasize clinical application of basic research findings with patients and
populations.  Translational research also applies clinical findings to advance
basic research that ultimately may lead to hypothesis-driven clinical trials
or interventions.  It should be noted that clinical research that is not based
on nor derived from laboratory findings is not considered translational for
purposes of this program.

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 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994,  available on the web at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

Investigators may also obtain copies of the policy from the program staff
listed under INQUIRIES.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/funding/children/children.htm

LETTER OF INTENT

Prospective applicants are asked to submit at least sixty days prior to the
specified receipt date above, 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 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 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 the NCI contact for programmatic issues
at the address listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  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, email: grantsinfo@nih.gov.  For those applicants with Internet
access, the 398 kit may be found at
http://grants.nih.gov/grants/funding/phs398/phs398.html, In addition, the PA
number and title "SPORE" must be typed on line 2 of the face page of the
application form and the YES box must be marked.

Specific instructions for preparing a SPORE grant application are available
from the program staff listed under INQUIRIES.  These instructions are
contained in the SPORE GUIDELINES and must be used in preparing the
application. SPORE GUIDELINES are also available at the internet:
http://spores.nci.nih.gov/

Submit a signed typewritten original of the application, including the
checklist, and three signed exact photocopies, in one package 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, two additional copies of the application must be
sent to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Blvd.
Rockville, MD 20852 (for express/courier service)
Bethesda MD 20892-7407 (for U.S. Postal Service)

It is important to send these copies at the same time that the original and
three copies are sent to the Center for Scientific Review (CSR), otherwise,
the NCI cannot guarantee that the applications will be reviewed in competition
with other applications received by the receipt date.

Complete applications must be received by the specified receipt dates for the
respective organ sites.  If an application is received after that date, it
will be returned to the applicant without review.  The CSR will not accept any
application in response to this announcement 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. Applications must meet all
eligibility requirements summarized above and must address all programmatic
requirements further described in the SPORE GUIDELINES
(http://spores.nci.nih.gov/).

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR. 
Incomplete applications will be returned to the applicant without further
consideration.  Applications that are complete and responsive to the PA will
be evaluated for scientific and technical merit by an appropriate peer review
group convened by the National Cancer Institute in accordance with the review
criteria stated below.  As part of the initial merit review, a process will be
used by the initial review group in which applications 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.

In addition, if a required component(s) of an otherwise meritorious SPORE
application is of such low merit that it is not recommended for further
consideration by the peer review committee, the entire application will also
be unscored.  See section D of SPORE GUIDELINES
(http://spores.nci.nih.gov/) for a description of required
components of a SPORE

REVIEW CRITERIA

The factors to be considered in the evaluation of all applications are given
below.

a.  Individual Projects:

Within the SPORE concept of translational research, reviewers will evaluate
each research project using the five criteria listed below.  Each criterion
will be addressed and considered by the reviewers in assigning the overall
score project merit:

a.1.  Significance.  The importance of the translational research objective to
human cancer and its likelihood of completion within the project period.

a.2.  Approach.  The adequacy of the experimental design and methods to
achieve the research objectives, clear evidence of co-leadership by a basic
and more applied scientist in the conception, design and proposed
implementation of the project.

a.3.  Innovation.  Originality and novelty of the experimental design as it
relates to translational research.

a.4.  Investigators.  The qualifications of the basic and more applied co-
investigators to conduct the proposed research and the appropriateness of the
time commitments of each co-investigator to the conduct of the project.

a.5.  Environment. The scientific environment in which the translational
research work will be done, and the unique features, if any, of the
environment to support the proposed work.

The following additional factors will be evaluated for individual research
projects: (1)appropriateness of the budget to achieve the stated research
objectives, (2) evidence of full protection of human subjects for clinical
research components, and appropriate mechanisms for the rigorous management
and quality control of research data, (3) adequacy of plans to include both
genders, minorities and their subgroups, and children, as appropriate, to meet
the scientific goals of the research.

b.  Shared Resources (Cores)

b.1.  adequacy of the proposed plan and/or track record to develop and
maintain a human cancer site-specific tissue resource, store the tissue  and
distribute the tissue with appropriate pathological and clinical data,
adequacy of the proposed plan and/or track record to prioritize the
distribution of tissues within and outside the SPORE,

b.2. degree to which plans and/or track record indicate that shared resources
effectively and efficiently support (or will support) the research of the
SPORE in a manner that can not be supported through available national
resources,

b.3.  adequacy of the justification for each specialized resource relative to
its essential need for the conduct of SPORE research or pilot projects and
SPORE collaborative projects,

b.4.  adequacy of qualifications and performance (if applicable) of managers
of resources,

b.5.  appropriateness of the requested budgets to conduct each resource
operation.

c.  Career Development

c.1.  adequacy of the process and/or track record for selecting candidates for
career development who demonstrate potential for independent research careers
or who are established investigators and are changing the direction of their
research careers,

c.2.  adequacy of the procedures and/or track record to seek out and include
qualified minorities, women, and persons with disabilities in the career
development program,

c.3. current status and research activities of individuals who have been
supported by the career development program, if applicable,

c.4.  appropriateness of the budget relative to the proposed plans for
sustaining a significant activity in career development.

d.  Developmental Research Program

d.1.  adequacy of the process and/or track record for attracting new ideas for
pilot studies within and outside of the SPORE institution.

d.2. adequacy of the proposed process and/or track record for continuously
reviewing and funding a spectrum of pilot projects (e.g., research, technology
development, resources) for their quality and importance to translational
research that will have an impact on human cancer.

d.3.  general quality of the pilot projects provided by the SPORE to
demonstrate the effectiveness of the process and/or track record of funding
pilot projects,

d.4.  appropriateness of the budget relative to the needs and demonstrated
capabilities of the SPORE.

e.  Overall Program Organization and Capability:

e.1.  scientific qualifications and involvement of the SPORE Principal
Investigator, as well as his/her demonstrated scientific and administrative
leadership capabilities, adequacy of the time commitment of the Principal
Investigator,

e.2.  adequacy of the planning and evaluation process to include: determining
translational research productivity of existing projects and resources,
discontinuing activities of low productivity, initiating new activities in
response to important translational research opportunities, establishing
collaborations, and the use of external advisors,

e.3.  adequacy of access to patients and populations for conducting current
and projected therapeutic, prevention, detection and control research,

e.4. degree to which the organization and leadership of the SPORE promote and
facilitate scientific interactions between projects, pilot projects, etc., and
effective use of the SPORE infrastructure (e.g., tissue bank, other shared
resources) in the conduct of research,

e.5.  effectiveness of and/or plans for promoting interdisciplinary scientific
interaction,

e.6.  effectiveness of and/or plans for integrating SPORE research and
resources with existing Cancer Center programs,

e.7.  adequacy of tangible institutional commitments that will enable and
facilitate the research objectives of the SPORE (e.g., special facilities,
recruitments, discretionary resources such as dollars and space),

e.8.  facilitation of technology transfer, management of the intellectual
property rights of the SPORE under the requirements of the Bayh-Dole Act and
NIH funding agreements,

e.9. written assurance that SPORE interactions with commercial entities will
uphold the principles of academic freedom, including the ability of SPORE
investigators to collaborate freely, and to send and receive biomedical
research materials without restriction to other scientific researchers.

f.  Interactions with Other SPOREs

f.1.  adequacy of plans (new application) or progress (competing renewal
applications) to promote and maintain communication and integration of
scientific projects of mutual interest with other SPOREs,

f.2.  willingness to interact with other SPOREs and with the NCI in sharing
information, in assessing scientific progress, in identifying new research
opportunities and in establishing scientific priorities.

Overall Evaluation and Scoring of Applications

A single numerical priority score will be assigned to the SPORE application as
a whole after discussing  all of the review elements listed above.  The score
will be based on the overall quality of the research projects, the career
development program and the developmental research program, the overall
effectiveness and adequacy of shared resources, the overall program
organization and capability, and the plans for interactions with other SPOREs. 
Although primary emphasis will be placed on scientific merit and progress
where applicable (competing renewal applications), significant consideration
will also be given to interdisciplinary interactions, potential for impacting
on the disease, inter-SPORE collaborations and institutional commitment.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications.  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

Written and telephone inquiries concerning the objectives and scope of this
program announcement are encouraged.  NCI program staff welcome the
opportunity to clarify any issues and discuss the most recent policies of the
NCI relative to funding issues, potential problems in meeting eligibility
requirements or clarification of the peer review process before the final
application is submitted.

For inquiries regarding programmatic issues, contact:

Jorge Gomez, M.D., Ph.D.
Organ Systems Branch
Office of Centers, Training, and Resources
Office of Deputy Director for Extramural Science
National Cancer Institute
Executive Plaza North, Suite 512
6130 Executive Boulevard  MSC 7386
Rockville, MD  20852-7386 (for express/courier service)
Bethesda, MD 20892-7399 (for U.S. Postal Service)
Telephone:  (301) 496-8528
Email: jg1w@nih.gov

For fiscal or administrative matters, contact:

Carolyn Mason
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard  MSC 7150
Rockville, MD 20852-7150 (for express/courier service)
Bethesda, MD  20892-7150
Telephone:  (301) 496-7239
Email: cm113g@nih.gov

For inquiries regarding review issues, contact:

Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Rockville, MD 20852 (for express/courier service)
Bethesda MD 20892-7407
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.
13.397.  Awards are made under authorization of Sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and administered
under NIH grant policies and Federal Regulations 42 CFR Part 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 PHS strongly encourages all grant 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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