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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-
048.html); a complete copy of the updated Guidelines is available at:
https://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:
https://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:
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/.
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
https://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
https://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.