PLANNING GRANTS FOR NCI CANCER RESEARCH CENTERS

RELEASE DATE:  November 8, 2002

PA NUMBER:  PAR-03-022

EXPIRATION DATE:  January 17, 2003 unless reissued.

National Cancer Institute (NCI)  
 (http://nci.nih.gov/)

Letter of Intent Receipt Date: December 12, 2002
Application Receipt Date:  January 16, 2003

This Program Announcement (PA) replaces PAR-00-011, which was published in 
the NIH Guide of November 10, 1999.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA  

The Cancer Centers Branch (CCB), Office of the Deputy Director for Extramural 
Science (ODDES), of the National Cancer Institute (NCI) invites planning 
grant applications for the development of Cancer Research Centers in a 
variety of organizational settings.  The purpose is to expand the scientific, 
geographic and demographic diversity of the Cancer Centers Program of the NCI 
by encouraging research-oriented organizations to develop the qualities of a 
strong cancer research center and become competitive for a Cancer Center 
Support Grant.  Cancer center planning strategies may focus on a specific 
research theme (e.g. diagnosis, therapy, epidemiology) or integrate a broader 
spectrum of research that may include the basic, clinical, prevention and 
control, or population sciences.  All approaches to planning cancer centers 
are encouraged as long as they take advantage of the full range of the 
organization's capabilities. A copy of the Guidelines relevant to these 
awards is available at:
(http://www.cancer.gov/cancercenters/ccb_guidelines.html). NIH Grants 
policies apply to these awards. 

RESEARCH OBJECTIVES

Background

The Cancer Centers Program of the NCI currently supports multidisciplinary 
cancer research centers in a variety of institutions through the Cancer 
Centers Support Grant (P30) mechanism.  Since the National Cancer Act of 
1971, the legislative charge of the Program has been to support cancer 
centers that perform research in the basic, clinical, prevention and control, 
and population sciences; that promote and enhance multidisciplinary, 
interdisciplinary and translational research; and that influence how the 
results of research are coupled to medical practice in the communities and 
regions that they serve.  While every cancer center may not meet all of these 
broad expectations (i.e. some are specialized in their research approaches), 
all cancer centers are organized to take maximum advantage of their research 
capability and opportunities in such a way that they can have an impact on 
reducing cancer incidence, mortality and morbidity.

Research Goals and Scope

The strength of the NCI's Cancer Centers Program is founded in the diversity 
of academic, free-standing, and consortial institutions that have become NCI-
supported cancer centers.  The aim of this initiative is to ensure that the 
scientific, institutional, geographical and demographic diversity of the 
Program is maintained and expanded by encouraging new research-oriented 
organizations to apply for CCPGs and develop the research, leadership and 
organizational capabilities expected of an NCI cancer center.  The ultimate 
goal is to see new institutions become successful in competing for Cancer 
Center Support Grants and be designated as NCI cancer centers.

MECHANISM OF SUPPORT

Support for the planning and development of NCI cancer research centers will 
be through the National Institutes of Health (NIH) planning grant (P20) 
mechanism, which the NCI refers to in this PA as the Cancer Center Planning 
Grant (CCPG).  Applicants may request up to $250,000 in direct costs for the 
first year.  Cost-of-living increases may be requested for future years 
according to existing NCI policy.  Applicants may request up to five (5) 
years of support.  

Applicants will be responsible for the execution of all activities supported 
by this grant.  Applications submitted in response to this program 
announcement will compete with other CCPG applications submitted during the 
same fiscal year.  The time and amount of all CCPG awards will be contingent 
upon the recommendations of peer reviewers and the availability of funds.  
Awards will be administered under NIH grants policy as stated in the NIH 
Grants Policy Statement of March 2001.  

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic 
o Faith-based or community-based organizations

Organizations that either already have a Cancer Center Support Grant (CCSG) 
or are formal collaborators with other institutions that make up a CCSG-
supported cancer center are not eligible to apply for planning grants, as 
there can be only one CCSG per institution and/or set of institutions 
comprising the cancer center. If an institution was previously awarded a P20 
or a CCSG, it is not eligible to apply for a P20 until a minimum of three 
years has elapsed from the end date of the prior grant.   To be eligible, an 
institution must have a minimum base of $2,000,000 (direct costs) in peer-
reviewed, cancer research funding already in place at the time of 
application. This funding, which must be directly to the applicant 
institution or consortium of institutions that make up the cancer center,  
may include research grants, cooperative agreements, and contracts from the 
NCI, other NIH entities, the National Science Foundation, and the American 
Cancer Society.  Awards from other funding organizations that utilize a peer 
review and funding system equivalent to that of the NIH may also apply toward 
the minimum.  A list of approved organizations is available at 
http://www3.cancer.gov/cancercenters/funding.html or from the Cancer Centers 
Branch.

Before applying for a P20, institutions are advised to assess the 
appropriateness of this grant mechanism relative to their goals, resources, 
and research capabilities.  Among the factors to be considered are the 
breadth and depth of their cancer-related research base; the number of 
researchers who may comprise the critical mass of investigators needed to 
develop research programs, and the likelihood that the planning activities 
will result in a cancer center sufficiently developed to successfully compete 
for a CCSG by the end of the project period of the P20 planning grant.  
Institutions are also advised to consult with various sources, including 
external advisors drawn from established cancer centers, institutions that 
have successfully transitioned from a P20 to a CCSG, and the NCI Cancer 
Centers Branch.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:  

Direct your questions about scientific/research issues to:

Linda K. Weiss, Ph.D.
Chief, Cancer Centers Branch
National Cancer Institute
6116 Executive Boulevard, Suite 700
Bethesda, Maryland 20892-8345
Telephone: (301) 496-8531
FAX: (301) 402-0181
email: lw187q@nih.gov
Written and telephone inquiries about Cancer Center Planning Grants and the 
Cancer Centers Program in general are encouraged.

Direct your questions about the peer review process to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8062, MSC 8239
Bethesda, MD 20892-8239
Rockville, MD 20852 (for express mail/courier service)
Email: ncidearefof@mail.nih.gov

Direct your questions about financial or grants management matters to:

Ms. Eileen Natoli
Grants Administration Branch
National Cancer Institute 
6120 Executive Boulevard, Room 242
Bethesda, MD 20892
Telephone: (301) 496-8791
FAX: (301) 496-8601
email: cm113g@nih.gov

PREAPPLICATION CONSULTATION

A preapplication consultation, while not required, is highly recommended.  
Experience has shown that applicants who participate in the consultation process 
generally present applications that fare better in the peer review process.  At 
the consultation, which may be in person or by video or telephone conference, 
NCI staff will advise on whether the P20 mechanism is the appropriate vehicle 
for support, based on the goals of the planned cancer center and its stage of 
development.  This is an opportunity for every potential applicant to take full 
advantage of the corporate experience of the Cancer Centers Branch. 

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this PA 

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 plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to the program staff (Dr. 
Linda K. Weiss) listed under INQUIRIES.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

The format for submission of a Cancer Center Planning Grant is detailed in 
NCI guidelines entitled, "Planning Grants for NCI-Supported Cancer Research 
Centers."  These guidelines can be obtained from the Cancer Centers Program 
website at:  http://www3.cancer.gov/cancercenters/ccb_guidelines.html or from 
the Cancer Centers Branch of the NCI (see INQUIRIES section).

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted on January 16, 2003.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, 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 same time of submission, please submit two additional copies of the 
application to:

Referral Officer 
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8062, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express mail/courier service)

APPLICATION PROCESSING: Applications must be received by the receipt date 
mentioned on the first page of this PA.  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 a 
substantial revision of an application already reviewed, but such application 
must include an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
for adherence to the guidelines of this PA by the NCI program staff.  
Applications not adhering to the guidelines of this PA, and those 
applications that are incomplete as determined by CSR or by NCI program 
staff, will be returned to the applicant without review. 

As part of the initial merit review:

o  All applications will receive a written critique
o  Applications may undergo a process in which only those deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o  Those that receive a priority score will undergo a second level review by 
the National Cancer Advisory Board.

REVIEW CRITERIA

The review criteria for CCPGs are outlined in the NCI guidelines entitled, 
"Planning Grants for NCI-Supported Cancer Research Centers".  These 
guidelines can be obtained from the Cancer Centers Program website at 
http://www3.cancer.gov/cancercenters/ccb_guidelines.html or from the Centers 
Branch of the NCI (see INQUIRIES section).

AWARD CRITERIA

Applications will compete for available funds with all other approved 
applications.  The following will be considered in making funding decisions: 

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS

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 sub- populations 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 indicating 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-
048.html); a complete copy of the updated Guidelines is available at: 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups, if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences. 

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 clear and compelling 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: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

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:  
http://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/.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 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 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals 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.

DATA AND SAFETY MONITORING

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 clinical trial. For details on the NCI Policy for Data and Safety 
Monitoring of Clinical Trials, see 
http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines

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, Planning Grants 
for Cancer Research Centers, is related to the priority area of 
cancer.  Potential applicants may obtain a copy of "Healthy People 2010", 2nd 
Edition, at http://www.health.gov/healthypeople/. 

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.397 and 93.121, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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