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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