YEAR 2002

Release Date:  June 20, 2001

PA NUMBER:  PAR-01-110

National Cancer Institute

Letter of Intent Receipt Dates:
  Breast and Gynecological Cancer SPOREs:     December 1, 2001
  Lung, Leukemia, and Myeloma Cancer SPOREs:  April 1, 2002
  Prostate and Genitourinary Cancer SPOREs:   August 1, 2002

Application Receipt Dates:
  Breast and Gynecological Cancer SPOREs:     February 1, 2002
  Lung, Leukemia, and Myeloma Cancer SPOREs:  June 1, 2002
  Prostate and Genitourinary Cancer SPOREs:   October 1, 2002


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.  SPORE 
applicants are judged on their current and potential ability to move basic 
research findings into a clinical or population setting or, conversely, to 
take a finding from the clinic/population and expand upon it in the 
laboratory.  A SPORE must develop and maintain human cancer tissue resources 
for the particular organ-site that will benefit translational research, foster 
extended collaborations in critical areas of research need with laboratory and 
clinical scientists within the institution, as well as in other institutions, 
and participate with other SPOREs on a regular basis in sharing positive and 
negative findings, assessing scientific progress in the field, identifying new 
research opportunities, and promoting Inter-SPORE collaborations.  Each SPORE 
and the "network" 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, prevention and control of 
human cancer.  The SPORE mechanism is not intended to support basic research 
to the exclusion of clinical research or vice versa.

This Program announcement (PA) addresses only SPORE applications for organ 
sites specified to be received in the year 2002.  See announcement PAR-00-087 
which was released in the NIH Guide on April 6, 2000 
(https://grants.nih.gov/grants/guide/pa-files/PAR-00-087.html) for the 
receipt dates for SPORE applications associated with specific organ sites to 
be received in the year 2001.


A SPORE must 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 (or related group of cancers).  
SPOREs are expected not only to conduct a wide spectrum of research 
activities, but should also contribute significantly to the development of 
specialized research resources (or cores), improved research model systems, 
and collaborative research projects with other institutions. The research 
supported through this program must be translational in nature.  Translational 
research is defined as the movement of a laboratory discovery into a patient 
or population setting or the movement of an observation in a patient or 
population setting into a laboratory research environment.  Inherently, this 
process involves an interdependence between basic and applied investigators.  
It should be noted that clinical/ epidemiological research that does not 
include a laboratory component or capitalize upon a biological discovery 
relevant to human cancer is not considered translational for the purposes of 
this program. 


A SPORE is supported through the specialized center (P50) grant mechanism.  
This mechanism provides funding for a broad range of research and 
developmental activities, from basic to human intervention studies.  These 
grants are intended to promote multidisciplinary research focused upon a 
specific cancer (or related cancer) site(s).  SPORE grants differ from 
traditional Program Project (P01) grants in that they also provide support for 
pilot research projects and a career development program, as well as enable 
investigators more flexibility to modify their research activities when new 
opportunities arise.  Applicants are responsible for the planning, direction, 
and execution of their proposed SPORE.  

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.  The facilities and administrative costs related to subcontracts to 
other institutions or organizations are included in the total cost cap of 
$2.75 million, but not the direct cost cap of $1.75 million.  Applications can 
exceed these caps in subsequent years as a result of standard cost-of-living 
increases or special supplements approved by NCI.  A SPORE grant application 
may be submitted for up to five years of funding.


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 

Eligible institutions may include foreign components as full research 
projects, or shared resources, or as part of a research project.  SPOREs may 
also use developmental funds to establish collaborative research efforts with 
foreign entities.  Consortia agreements with 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 and must be in compliance with NIH policies.  

To be considered, applications must have: (1) a statement of institutional 
commitment that addresses how the SPORE will be given high priority within the 
institution, (2) a minimum of four independent principal investigators who are 
successful in obtaining peer-reviewed research support (e.g., R01, P01, U01, 
U10, U19, ACS, DOD, or equivalent) directly related to the cancer being 
investigated, and who, as a group, have expertise 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) a patient care 
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) a 
developmental research program, (7) a career development program, (8) a tissue 
resource, as well as (9) other shared resources designed to support the 
proposed translational objectives of the SPORE.  Although an application can 
only be submitted by a single institution, subcontracted collaborative 
arrangements with scientists from other institutions may be included if these 
arrangements are clearly delineated and officially confirmed by signed 
statements from the responsible official at each institution.  This 
circumstance, however, does not preclude the need for a full institutional 
commitment from the applicant organization. 

Support will not be provided for applications containing research projects 
focused exclusively on basic research, epidemiological research, or clinical 

NCI program staff listed under INQUIRIES should be consulted if there are 
questions regarding eligibility or the required components of a SPORE.

Direct inquiries regarding programmatic issues to:

Jorge Gomez, M.D., Ph.D. (Leukemia, Myeloma, Prostate, and Genitourinary SPOREs)
Email:  jg1w@nih.gov

Linda Weiss, Ph.D. (Lung SPOREs)
Program Director
Email:  lw187q@nih.gov

Jane Fountain, Ph.D. (Breast and GYN SPOREs)
Program Director
Email:  jf227t@nih.gov

Organ Systems Branch
Office of Centers, Training, and Resources
Office of Deputy Director for Extramural Science
National Cancer Institute
6116 Executive Boulevard, Suite 7013, MSC 8347
Rockville, MD  20852 (for express/courier service)
Bethesda, MD  20892-7008 (for U.S. Postal Service)
Telephone:  (301) 496-8528
FAX:  (301) 402-5319

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

Direct inquiries regarding fiscal matters to:

Ms. Kelli Oster
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) 496-8627
Email:  kelli.oster@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Division of Extramural Activities
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-3428
Fax:  (301) 402-0275
Email:  tf12w@nih.gov


Prospective applicants are asked to submit 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 a 
subsequent application, the information that it contains allows the program 
staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent to the program staff (Drs. Jorge Gomez, 
Linda Weiss, or Jane Fountain) listed under INQUIRIES by the appropriate 
receipt date provided at the beginning of the PAR.


The NIH application form PHS 398 (rev. 4/98) is to be used when applying for 
these grants. Application forms and guidelines are available at: 
https://grants.nih.gov/grants/funding/phs398/phs398.html, most institutional 
offices of sponsored research, or 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: grantsinfo@nih.gov.  The title “SPORE in (Organ) Cancer” and 
number of the PA should be typed on line 2 of the face page of the application 
form and the YES box marked.

Funding for the performance of a Phase I or II clinical trial can be requested 
in a SPORE application.  All clinical trials supported or performed by NCI 
require some form of monitoring.  The method and degree of monitoring should 
be commensurate with the degree of risk involved in participation and the size 
and complexity of the trial.  Monitoring exists on a continuum from monitoring 
by the principal investigator/project manager or NCI program staff to an 
institutional Data and Safety Monitoring Board (DSMB).  These monitoring 
activities are distinct from the requirement for study review and approval by 
an Institutional Review Board (IRB).  For details about the Policy of the NCI 
for Data Safety Monitoring of Clinical Trials see 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH Guide 
Notice on “Further Guidance on a Data and Safety Monitoring for Phase I and II 
Trials” for additional information:  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available to 


The general components and procedures for preparing a SPORE application are 
outlined in this PA under Eligibility Requirements, Application Procedures, 
and Review Considerations. SPECIAL GUIDELINES that address programmatic, 
review and award concerns in more detail, however, must be followed when 
OR ANY OTHER ANNOUNCEMENT.  Prospective applicants should request a copy of 
the SPORE GUIDELINES from the program staff listed under INQUIRIES above or 
can view a copy at http://spores.nci.nih.gov/.

Submit the original signed application, including the checklist, and three 
signed photocopies (without appendices) to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040, MSC 7710
Bethesda, MD  20892-7710
(20817 for express service)

At the time of submission, two additional copies of the application, along 
with five copies of any appendices, must be sent to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC8329
Bethesda, MD  20892-8329
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 PAR 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 


Upon receipt, applications will be reviewed for completeness by the CSR and 
adherence to the guidelines of this PAR by NCI staff.  Incomplete applications 
or those that do not adhere to the SPORE guidelines will be returned to the 
applicant without further consideration.  

Applications that are complete and responsive to the PAR will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the Division of Extramural Activities of the NCI in accordance with the review 
criteria stated below. As part of the initial merit review, all applications 
will receive a written critique and may undergo a process in which only those 
applications deemed to have the highest scientific merit will be discussed, 
assigned a priority score, and receive a second level review by the National 
Cancer Advisory Board.


a.  Research Projects

Within the SPORE concept of translational research, reviewers will evaluate 
each research project using the five criteria listed below.  Each of these 
criteria will be addressed and considered by the reviewers in assigning a 
merit score to the project.  Note that the project does not need to be strong 
in all categories to be judged likely to have a major translational 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 
(e.g., correlative or hypothesis generating studies) but is essential to 
assess the relevance of a research finding in a clinical/population setting.  

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 budgets and durations, 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. Tumor Bank/Tissue Resources

b.1.a.  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, 

b.1.b.  adequacy of the proposed plan and/or track record to prioritize the 
distribution of tissues within and outside the SPORE,

b.1.c.  evidence of experienced and available personnel dedicated to the 
activities of tissue collection, quality control of tissue specimens, tissue 
storage, tissue distribution, collection of initial and follow-up clinical 
information, data entry, and maintenance of database and computer networks,

b.1.d.  adequacy of proposed plan and/or track record to obtain informed 
written consent for all prospectively collected tissues,

b.1.e.  appropriateness of the budget to conduct and integrate tissue banking 

b.2. Other Resources 

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

b.2.b.  demonstration that the resource is essential to the success of the 

b.2.c.  adequacy of qualifications and performance (if applicable) of resource 

b.2.d.  appropriateness of the requested budgets to conduct each resource 

c.  Developmental Research Program

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

c.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) based on their potential relevance to translational 
research and impact on human cancer.

c.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,

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

d.  Career Development Program

d.1.  adequacy of the plan, in general, to sustain significant activity for 
career development of translational research scientists,

d.2.  adequacy of the process and/or track record for selecting candidates for 
independent careers in translational research,

d.3.  adequacy of the process and/or track record to seek out and include 
qualified minorities, women, and persons with disabilities in the career 
development program,

d.4.  current status and research activities of individuals who have been 
supported by the career development program, if applicable, 

d.5.  appropriateness of the budget relative to the proposed plans for 
sustaining a significant effort in career development.

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 

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 utilizing the advice 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.  a balance and diversity of research activities with a minimum of four 
scored projects of which at least one is devoted to early detection, 
screening, prevention, and/or population science,

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

e.6.  effectiveness of and/or plans for integrating SPORE research and  
resources with existing Cancer Center programs (e.g., use of clinical data and 
safety management systems, biostatistical cores, etc.),

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. 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.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,

e.10. 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.

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 and in participating in committees to assess current scientific 
issues, research activities, and priorities.


Each component of the SPORE will be given a score.  A single numerical 
priority score will then be assigned to the SPORE application as a whole. 
Although this score will be based primarily 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.  The 
overall score will be weighted as follows:

o  60%   scientific merit and innovation
o  15%   evidence of interdependent, multidisciplinary design and conduct of 
the research
o  15%   potential for impacting on the disease
o  10%   institutional commitment 

If a required component(s) of an otherwise meritorious SPORE application is of 
such low merit that it is not recommended for further consideration (NRFC) by 
the peer review committee, the entire application will also receive a NRFC.  
See Section I.E. of SPORE GUIDELINES (http://spores.nci.nih.gov/) for a more 
detailed description of each of the required components of a SPORE.


Applications will compete for available funds with all other recommended 
applications assigned to that Institution/Center (IC).  The following will be 
considered in making a final funding decision: quality of the proposed 
application as determined by peer review, availability of funds, and program 


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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research", published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
a complete copy of the updated Guidelines is available at 

All projects involving human subjects must include a recruitment plan for 
women and minorities as well as a minority and gender inclusion table with 
estimated accrual numbers.  Copies of these tables can be found in the PHS 398 
(re. 4/98) guidelines 
(https://grants.nih.gov/grants/funding/phs398/instructions2/p3_definitions.htm - gender).  


It is the policy of the 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," published in the NIH Guide for Grants and 
Contracts on March 6, 1998, and available at the following URL address: 

Investigators may also obtain copies of the policies on women and minorities 
or children from the program staff listed under INQUIRIES.  Program staff may 
also provide any additional relevant information concerning these policies.


All investigators proposing research involving human subjects should read the 
NIH policy on education in the protection of human research participants now 
required for all investigators, which is published in the NIH Guide for Grants 
and Contracts, June 5, 2000 (Revised August 25, 2000), available at the 
following URL address:  
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in research 
is now available online at http://cme.nci.nih.gov/.


The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
Applicants may wish to place data collected under this RFA (PA) in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the application. 
In addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.


All applications for NIH funding must be self-contained within specified page 
limitations.  Unless otherwise noted 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


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 2002, 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/.

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 

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