SHARED RESOURCES FOR SCIENTISTS OUTSIDE NCI CANCER CENTERS Release Date: July 13, 1999 PA NUMBER: PAR-99-127 National Cancer Institute Letter of Intent Receipt Date: October 21, 1999 Application Receipt Date: November 18, 1999 This program announcement (PA) replaces PAR-98-092, which was published in NIH Guide on July 23, 1998. PURPOSE Successful cancer research depends on the availability of and access to shared resources. These 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. Support for shared resources is usually provided to: 1) members of National Cancer Institute (NCI) supported Cancer Centers or SPOREs, where shared resources benefit a wide range of basic, clinical, prevention and control research; 2) investigators in large multi-project program grants such as P01s; and 3) groups that justify their need for sophisticated equipment to the National Center for Research Resources (NCRR) at the NIH. These opportunities are limited and unavailable to approximately half of the NCI-supported investigators, particularly those at institutions without NCI funded Cancer Centers. The objective of this PA is to provide institutions that do not have NCI funded Cancer Centers or planning grants with additional shared resource support. Increasingly, the availability of core resources can be expected to improve the ability to conduct research and thereby facilitate scientific progress. This PA requests applications to establish cancer-related research resources to provide new sources of technical support and research materials to advance cancer research. To be eligible, applicants must identify six or more NCI funded investigators (principal investigators of R01 or P01 grants or NCI contracts) who will utilize the services of the proposed resource. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Shared Resources for Scientists Outside NCI Cancer Centers, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800), or at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Applications may be submitted by 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. Foreign institutions are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. All applicants must document that at least six NCI funded R01, P01 or N01 principal investigators have need for the proposed resource. In addition to the core user group of six or more funded investigators, the resource should be made available to additional users at the applicant institution and may be opened to investigators at other institutions. Applications will only be accepted from institutions that currently are not supported by NCI Cancer Center Support Grants (CCSGs or P30) or Cancer Center Planning Grants (P20). NOTE that there is also a cap on the direct cost amount of all applications from any applicant institution, based on the total NCI funding received by that institution. MECHANISM OF SUPPORT This PA 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 PA may not exceed 5 years. The anticipated award date is July 2000. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. This PA is one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. BUDGET CAP: The funds requested should be based on the requirements of the project and the requested costs should be fully justified. NCI direct cost support for each individual application will be limited to $200,000. For projects whose costs exceed $200,000, the availability of the necessary additional institutional or other support must be documented in a letter of commitment from the applicant institution or from another funding source. An institution may submit multiple applications, but the sum of all direct cost resource support, including third party indirect 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). 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. The 10% institutional cap applies only to annual regular operating costs and does not include a one-time purchase of equipment. RESEARCH OBJECTIVES Background Applications are sought to establish resources to facilitate cancer research. Applications for resources under this PA must define a group of six or more NCI funded investigators located at the applicant institution. The need for the resource by the defined group of funded investigators must be clearly justified, the six or more users identified and their NCI funding documented (grant number, PI, title, abstract and end date) in the application. The resource should be made available to other investigators at the applicant institution and may be made available to other 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 there were sufficient specimens available, the resource could be made available to additional researchers, including those at other institutions. The creation of a resource advisory group is strongly encouraged. In addition applicants should clearly document the procedures that they will put in place to determine who may have access to products or services from the proposed resource. User charges are appropriate when the intent is to recapture costs of providing resource materials or services to the community. To the extent possible, the expected utilization of the resource should be estimated and the basis for those estimates provided in the application Appropriate resources include, but are not limited to the following: - 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. - 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. - 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. - 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. - Animal models for diagnostic or therapeutic applications: Facilities to produce and distribute to a defined group of researchers animal models (e.g., transgenic, knockout and xenograft models and animals susceptible to cancer of particular tumor sites). 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. - Technology or instrumentation development: Core facilities to provide researchers with access to state-of-the-art instrumentation and technology for cancer research. Applicants must clearly describe the impact of the technology or instrumentation on ongoing research projects. Applications to purchase conventional shared equipment or to develop new technologies will be considered unresponsive. 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 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 "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the web at the following URL address: https://grants.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. 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: https://grants.nih.gov/grants/funding/children/children.htm LETTER OF INTENT Prospective applicants are asked to submit, by October 21, 1999, 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 NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the program staff listed under INQUIRIES. 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 https://grants.nih.gov/grants/forms.htm The PA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 PA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. 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 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636, MSC-7399 Rockville, MD 20852 (express courier) Bethesda MD 20892-7399 Applications must be received by November 18, 1999. 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 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 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. Incomplete applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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 a second level review by the National Cancer Advisory Board. Review Criteria 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 high 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. 1. Significance: Does the proposed resource address an important scientific need? Is that need adequately justified? Could the need have been easily satisfied in other ways? Will the resource add benefit to the user projects? Will the resource support progress in the field? 2. Innovation: Does this application propose a resource not previously available to the researcher users? Does this resource propose creative 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.) Are the conceptual framework, design, methods and analyses for the resource adequately developed well integrated and appropriate to the aims of the project? Are appropriate plans in place for acquiring reagents, biological constructs, animals, assays, specimens, data, technologies, etc. And or recordkeeping? Are procedures in place for evaluating requests to use the resource and assuring equitable access? Are plans described for appropriate quality control of the resource products or services? 4. Investigators: Are the qualifications of the resource leader(s) and key personnel well suited to organize and maintain the resource, maintain quality control and equitable access, and manage record keeping? 5. Environment: Does the environment contribute to the probability of success? Are the facilities and equipment for the resource adequate? Is outside scientific expertise available to advise on governance, management and function of the resource? Does the proposed resource take advantage of unique features of the institutional environment or employ useful collaborative arrangements? Is there evidence of institutional support for this resource? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment. 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. SCHEDULE Letter of Intent Receipt Date: October 21, 1999 Application Receipt Date: November 18, 1999 Review by NCAB Advisory Board: June 2000 Earliest Anticipated Start Date: July 2000 INQUIRIES Inquiries are strongly encouraged to determine the responsiveness of proposed applications to the PA. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Roger L. Aamodt, Ph.D. Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, Room 700 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 Executive Plaza North, Room 636 6130 Executive Blvd., MSC-7399 Rockville, MD 20852 (express courier) Bethesda MD 20892-7399 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Ms. Kelli Oster Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7399 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-7800 Ext. 261 FAX: (301) 496-8601 Email: kelli.oster@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394, 93.395. Awards are made under authorization of the Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 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 and contract 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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