SPECIALIZED PROGRAM OF RESEARCH EXCELLENCE IN HUMAN CANCER FOR THE YEAR 2001

Release Date:  April 6, 2000

PA NUMBER:  PAR-00-087

National Cancer Institute
National Institute of Dental and Craniofacial Research

Letter of Intent Receipt Dates:
Skin and Prostate Cancer SPOREs:                             December 1, 2000
Gastrointestinal and Prostate Cancer SPOREs:                 April 1, 2001
Brain, Head and Neck, Lymphoma, and Prostate Cancer SPOREs:  August 1, 2001

Application Receipt Dates:
Skin and Prostate Cancer SPOREs:                             February 1, 2001
Gastrointestinal, and Prostate Cancer SPOREs:                June 1, 2001
Brain, Head and Neck, Lymphoma, and Prostate Cancer SPOREs:  October 1, 2001

The National Institute of Dental and Craniofacial Research (NIDCR) and NCI 
both have interest in supporting translational research in head and neck 
cancer.  Consequently, NIDCR and NCI will co-fund scientifically meritorious 
Head and Neck Cancer SPOREs.

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.

This Program announcement (PA) only addresses SPORE applications for organ 
sites specified to be received in year 2001.  See program announcement PAR-
99-167, which was released in the NIH Guide on September 23, 1999 
(http://grants.nih.gov/grants/guide/pa-files/PAR-99-167.html) for the receipt 
dates for SPORE applications associated with specific organ sites to be 
received in year 2000.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS 
led national activity for setting priority areas. This PA, Specialized 
Program of Research Excellence in Human Cancer For the Year 2001, is related 
to one or more of the priority areas. Potential applicants may obtain a copy 
of "Healthy People 2010" at http://www.health.gov/healthypeople/.

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 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. 

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) developmental programs (7) career development programs, 
and (8) appropriate shared resources to support the proposed translational 
research of the SPORE.  Although an application must be submitted by a single 
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, career development programs, 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.  The facilities and administrative costs 
related to subcontracts to other institutions or organizations will not apply 
toward the direct cost cap of $1.75 million. 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 program 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.  Translational research is the movement of a laboratory 
discovery into a patient or population research setting or the movement of an 
observation in a patient or population setting into a laboratory research 
environment. 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 20, 
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.  Program staff may also provide additional relevant 
information concerning the policy.

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/guide/notice-files/not98-024.html

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 IC staff to estimate 
the potential review workload and to plan the review.

The letter of intent is to be sent to the program staff (Dr. George Gomez) 
listed under INQUIRIES by the letter of intent receipt date listed in the 
heading of the PA.

APPLICATION PROCEDURES

By NIH policy, potential new applicants intending to submit a SPORE 
application requesting $500,000 or more in direct costs in any year must 
contact the Organ Systems Branch of NCI and obtain agreement from program 
staff to accept the application for review and consideration of an award. 
When the application is eventually submitted, it must be accompanied by a 
cover letter identifying the program staff member who agreed to accept the 
application. 

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) 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 
301/435-0714, E-mail: grantsinfo@nih.gov. For those applicants with internet 
access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm

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 on  the Internet: 
http://spores.nci.nih.gov/

All applications for NIH funding must be self-contained within specified page 
limitations.  Unless otherwise specified in an NIH solicitation, Internet 
addresses (URLs) should not be used to provide information necessary to the 
review because reviewers are under no obligation to view the Internet sites.  
Reviewers are cautioned that their anonymity may be compromised when they 
directly access an Internet site (see 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html).

The title and number of the program announcement must be typed in Section 2  
on the face page of the application and the Yes box must be marked.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed 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
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8062, MSC 8239
Bethesda, MD  20892-8239
Rockville, MD  20852 (for express/courier 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 PA that is essentially the same as one 
currently pending initial review, unless the applicant withdraws the pending 
application.  The CSR 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. 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 adhere to the guidelines of 
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, 
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.

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 .  Following scientific-technical review, the 
applications will receive a second-level review by the appropriate national 
advisory council.

REVIEW CRITERIA

The criteria to be used in the evaluation of grant applications are listed 
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 initial review group will also examine: the appropriateness of proposed 
project budget and duration, the adequacy of plans to include both genders 
and minorities and their subgroups, and children as appropriate for the 
scientific goals of the research and plans for the recruitment and retention 
of subjects, the provisions for the protection of human and animal subjects, 
and the safety of the research environment.

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 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:

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
6116 Executive Boulevard, Suite 7008,  MSC 8347
Rockville, MD  20852 (for express/courier service)
Bethesda, MD 20892-7008 (for U.S. Postal Service)
Telephone:  (301) 496-8528
Email: jg1w@nih.gov

Ann L. Sandberg, Ph.D.
Chief, Neoplastic Diseases Branch
Division of Extramural Research
National Institute of Dental and Craniofacial Research 
National Institutes of Health
Bethesda, MD 20892
Tel:	301-594-2419
FAX:	301-480-8318
email:	ann.sandberg@nih.gov

Questions of a general programmatic nature may be submitted to the e-mail 
address of the Organ Systems Branch that is utilized to answer these 
inquiries:  nciosb-r@mail.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Eileen Natoli
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) 496-8791
Email: natolie@gab.nci.nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Division of Extramural Activities
6116 Executive Boulevard, Room 8062, MSC 8239
Bethesda, MD  20892-8239
Rockville, MD  20852 (for express/courier service)
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 Nos. 
93.397 and 93.121.  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 grants policies and Federal Regulations 42 CFR 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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