RFA-CA-01-020: SHARED RESOURCES FOR SCIENTISTS NOT AT NCI FUNDED CANCER CENTERS

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SHARED RESOURCES FOR SCIENTISTS NOT AT NCI FUNDED CANCER CENTERS Release Date: February 14, 2001 RFA: RFA-CA-01-020 National Cancer Institute Letter of Intent Receipt Date: June 5, 2001 Application Receipt Date: July 10, 2001 PURPOSE This Request for Application (RFA) requests applications to establish cancer- related research resources to provide new sources of technical support and research materials to advance cancer research. Increasing the availability of core resources is expected to improve the ability of cancer investigators to conduct research and to thereby facilitate scientific progress. To be eligible, applicant institutions must not have an NCI funded Cancer Center and the application must identify six or more NCI funded investigators who will utilize the services of the proposed resource. RESEARCH OBJECTIVES Background This initiative continues a trans-NCI effort to provide support for shared resources that was initiated with two program announcements issued in 1998 and 1999 (PAR98-092, PAR99-127). Applicable resources include but are not limited to complex technologies, specialized databases, instrumentation facilities, human tissue specimens, and animal models. These high-cost fundamental infrastructure needs can rarely be justified in NIH individual research project grant applications (e.g., RO1s). Support for shared resources is usually provided as part of: 1) National Cancer Institute (NCI) supported Cancer Centers or SPOREs, where shared resources benefit a wide range of basic, clinical, prevention and control research, 2) large multi-project program grants such as P01s, and 3) sophisticated shared equipment by the National Center for Research Resources (NCRR) at the NIH. These opportunities are limited and/or unavailable to approximately half of the NCI-supported investigators, particularly those at institutions that do not have NCI funded Cancer Centers. Objectives and Scope The objective of this RFA is to provide an equal opportunity to establish shared resources for scientists doing cancer relevant research in institutions that do not have an NCI funded Cancer Center. It is anticipated that the availability of core resources will be of increasing importance as more and more sophisticated, high cost methodologies and technologies are introduced and become essential to the biomedical research enterprise. Applicants can propose creating a completely new resource, adding a new component to an existing resource or expanding an existing resource to increase its cancer specific use. To the extent possible, the expected utilization of the resource should be estimated and the basis for those estimates provided in the application. The creation of a resource advisory group to oversee the operation of the resource is strongly encouraged. User charges are appropriate when their intent is to recapture costs of providing resource materials or services to the community. Appropriate resources include but are not limited to the following: o Tissue and Data Resources: Centralized facilities to provide human tissue specimens to a defined group of investigators. Applicants should demonstrate that the proposed tissue resource will improve access to otherwise unavailable specimens and/or provide increased economy over existing resources. o Unique database resources supporting research activities: Facilities to collect, store, analyze and quality control clinical and research data. Applicants should clearly describe the critical issues being addressed, the importance of the resource and the user community. o Agent development: Resources to provide radiopharmaceutical services, support IND-directed toxicology studies, or produce, supply, and/or evaluate novel therapeutic or diagnostic agents. For example, a core resource to provide researchers with clinical grade reagents (monoclonal antibody, recombinant protein, peptide or a unique linker) for their studies. o Assay support for research activities: Facilities to efficiently provide centralized high quality, standardized clinical or biological assays which will provide researchers with a uniform basis for comparison of their results. Applicants should detail critical factors (e.g., stability of samples, validation of assays, quality control) and demonstrate that samples can be transported, stored, and assayed and present plans to maintain data records and report results. o Animal models for diagnostic or therapeutic applications: Facilities to produce and distribute animal models (e.g., transgenic, knockout and xenograft models and animals susceptible to cancer of particular tumor sites) to a defined group of researchers. Funding may cover the additional costs of producing and delivering animal models. Commercial for-profit or not-for- profit animal suppliers are not eligible to apply. o Technology or instrumentation development: Core facilities to provide researchers with access to state-of-the-art instrumentation and technology for cancer research. The resource should be available to investigators other than the six identified NCI funded users at the applicant institution (see Special Requirements below). The resource can also be made available to users beyond the applicant institution or to the entire research community. For example, a defined group of eight NCI funded investigators could develop an effective shared collection and distribution system to provide efficient access to appropriate colon cancer specimens. If sufficient specimens were available, the resource could be made available to additional researchers, including those at other institutions. SPECIAL REQUIREMENTS Required NCI Funded Users: Applications for resources under this RFA must specify a group of six or more NCI funded users with appointments at the applicant institution. The application must identify the six users, document their NCI funding (grant number, PI, title, abstract and end date) and clearly justify their need for the resource. Applicants must clearly describe the impact of the technology or instrumentation on ongoing research projects. Requests for Equipment, Administrative or Technology Development Costs: Equipment and administrative and technology development costs are allowable under this RFA. However applicants must demonstrate that the requested funds clearly relate to developing a resource that provides investigators with products or services. Applications that request nothing more than the purchase of shared equipment or funds to cover administrative costs or funds to develop new technologies will not be considered responsive. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research resource grant (R24). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years. The anticipated award date is April 1, 2002. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. Budget Caps: Institutional Cap: An institution may submit more than one application, but the sum of all direct cost resource support, including third party Facilities and Administrative (F&A) costs, requested cannot exceed 10% of its total NCI direct cost research base at the time of submission (funding for all grant and contract mechanisms for the fiscal year in which the application is submitted). If multiple research grants are submitted, each must have a different principal investigator and must provide substantially different products or services. While the same individuals may be listed among the six NCI supported users on more than one application, their need for each resource must be clearly justified. This cap applies only to annual regular operating costs and does not include the one-time purchase of equipment. Individual Cap: Applications in response to this RFA are limited to $200,000 direct cost including any requested equipment. Projects that exceed this amount must provide evidence of funding from another source for costs in excess of the individual cap. FUNDS AVAILABLE The NCI intends to commit approximately $3,000,000 in FY 2002 to fund 10 to 15 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $200,000 per year, excluding Facility and Administrative costs on consortium arrangements. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NC I provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Institutions with currently funded P30 Cancer Center Support Grants are not eligible. Only domestic institutions are eligible to apply. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Roger L. Aamodt, Ph.D. Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, Room 6035A Bethesda, MD 20892-7399 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-7147 FAX: (301) 402-7819 Email: ra32u@nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Debbie Dunne Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Rockville, MD 20852 (express/courier) Bethesda, MD 20892-7399 Telephone: (301) 496-3154 FAX: (301) 496-8601 Email: Dunned@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit, by June 5, 2001, 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 RFA 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 NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Roger Aamodt at the address listed under INQUIRIES by the letter of intent receipt date. SCHEDULE Letter of Intent Receipt: June 5, 2001 Application Receipt: July 10, 2001 Peer Review Date: October/November 2001 Review by NCAB Advisory Board: February 2002 Earliest Anticipated Start Date: April 2002 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Applications 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 301/710-0267, email: grantsinfo@nih.gov. For those applicants with Internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Applicants should completely describe the proposed resource, identify potential users and clearly document their procedures for determining who may have access to the products or services that will be provided by the resource. It is important that the application clearly describes the user community and the benefits of the proposed resource to that community. Plans to manage the resource, set standards, provide quality control and address other critical factors must also be provided. 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 (20817 for express service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Applications must be received by July 10, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the National Cancer Institute. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of 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 second level review by the National Cancer Advisory Board (NCAB). The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a better priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. 1. Significance: o Does the proposed resource address an important scientific need? o Is the need for the proposed resource adequately justified? o What is the evidence that user needs could not have been easily satisfied in other ways? o What is the added benefit of the resource to the user projects? o Will the resource materially advance progress in the field? 2. Innovation: o Does this application propose a new type of resource not previously available? o Does this resource propose novel or improved methods, such as more effective means of collection, information storage and retrieval, or advertisement and utilization strategies? 3. Approach: (Plans to oversee operation of the resource and organizational plans for implementing them.) o Is the conceptual framework for the resource well thought out? o Are appropriate plans in place for record-keeping and/or acquiring reagents, biological constructs, animals, assays, specimens, data, technologies, etc.? o What procedures are in place for evaluating requests to use the resource? o What plans are described to assure quality control and equitable access to the resource? 4. Investigators: What are the qualifications of the resource leader(s) and key personnel to organize and maintain the resource, maintain quality control and equitable access, and manage record-keeping. 5. Environment: Is the environment adequate? For example, describe the adequacy of the facilities and equipment for the resource, and outside scientific expertise, if any, to advise on governance, management and function of the resource. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection of humans, animals or the environment., to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications assigned to the NCI. The following will be considered in making funding decisions: Quality of the proposed resource as determined by peer review, availability of funds, and program priority. 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 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. Investigators may also obtain copies of these policies 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 policy that was 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. 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. 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 RFA, SHARED RESOURCES FOR SCIENTISTS NOT AT NCI FUNDED CANCER CENTERS, is related to priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.393, 93.394, 93.395, 93.396 and 93.399. 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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