SMALL ANIMAL IMAGING RESOURCE PROGRAMS Release Date: July 31, 2000 (see reissuance RFA-CA-04-011) RFA: CA-01-012 National Cancer Institute Letter of Intent Receipt Date: October 19, 2000 Application Receipt Date: November 28, 2000 This Request for Applications (RFA) is a reissue of RFA-CA-98-023 "Small Animal Imaging Resource Programs" which was released in the NIH Guide on August 20, 1998. PURPOSE The National Cancer Institute (NCI) invites applications from extramural and intramural investigators for Small Animal Imaging Resource Programs (SAIRPs). These grants will support (a) shared imaging research resources to be used by cancer investigators, (b) research related to small animal imaging technology, and (c) training of both professional and technical support personnel interested in the science and techniques of small animal imaging. SAIRPs will enhance capabilities for conducting basic, clinical, and translational cancer research relevant to the mission of the NCI. Major goals of this initiative are to increase efficiency, synergy, and innovation of such research and to foster research interactions that cross disciplines, approaches and levels of analysis. Building and strengthening such links holds great potential for better understanding cancer, and ultimately, for better treatment and prevention. For this RFA, teams composed of NIH intramural investigators are encouraged to submit intramural project applications to become components of the network, but they may not request or receive funds from this program (Potential intramural applicants please see RESEARCH OBJECTIVES Background Small animal models, particularly genetically engineered mice, are increasingly recognized as powerful discovery tools in cancer research. The potential that could be realized by the use of animal models has not yet fully been realized. One of the limitations is the need to sacrifice the animals to perform tissue or molecular analysis. This prevents researchers from observing in vivo the natural or perturbed evolution of the processes under study. Functional, molecular, and morphologic quantitative imaging techniques are an important tool for providing data about biochemical, genetic or pharmacological processes in vivo, and repetitively in the same animal. Neoplasms have an intrinsic spatially distributed nature. That is, tumors develop in different sites, metastasize to other sites and are internally heterogeneous. To study tumors one must make spatially distributed measurements. Imaging is a means of making and displaying spatially coherent measurements and is therefore a key resource for studying the development, growth and therapeutic response of neoplasms. One of the important research directions for imaging research is to provide quantitative information in the setting of cancer diagnosis and therapy. Quantitation of image data for small animals will lead the way to application of quantitative methods in human beings. A major limitation to studying tumors in model systems with current imaging techniques is the limited availability of small animal imaging systems. Most biomedical imaging devices have been optimized for human studies and have suboptimal spatial resolution for small animals and their tumors. However, imaging techniques can be scaled down to yield very high resolution and signal sensitivity for in vivo images of mouse-sized organs. Furthermore, there are some applications of imaging techniques that could provide valuable knowledge from small animal models, but are not feasible for human subjects. Therefore, in order to take full advantage of the small animal tumor models being developed, it has been recommended that dedicated small animal imaging laboratories be developed. The NCI recognizes the importance, synergy and innovation that often evolve from research crossing disciplines, approaches, and levels of analysis. The SAIRP award is envisioned as enhancing such multidisciplinary activities by supporting coordinated shared research resources for NIH-funded investigators performing cancer research. The use of such shared resources can increase efficiency in an area of research by eliminating unnecessary duplication of effort and/or the support of research resources (e.g., costly equipment) that might be needed in, but not fully utilized by, the activities of any one research grant. Shared-resource laboratories can stimulate new research directions by providing access to equipment, services, and other resources that might not otherwise be available. Finally, shared research resources which are properly coordinated will promote research interactions and collaborations that cross disciplines, technical and theoretical approaches, and levels of analysis, including interactions across basic and clinical cancer research. Such interactions often have results that exceed the sum of the contributing activities. For this reason, participation of scientifically diverse base grants are strongly encouraged and, all else being equal, applications for SAIRPs with such scientific diversity will be given higher priority for funding consideration. Objectives and Scope SAIRPs will offer a unique opportunity for multidisciplinary teams within the cancer research community to address critical cancer research questions. Small Animal Imaging Resource Programs (SAIRP) will provide: Multiple imaging technologies for small animals, emphasizing, but not limited to, those technologies which can provide biochemical, genetic or pharmacological information in vivo. Technology research and development on innovative new imaging technologies appropriate for small animals, as well as refinement and development of technologies already established. Capabilities and personnel to assist in the development and/or production of necessary probes for the imaging technologies provided. Capabilities and personnel to aid in small animal anesthesia and care, as well as to consult on the optimal use of animals in connection with the imaging experiments. Training for both professional and technical personnel in the techniques and methodologies of small animal imaging. Structure The structure of the SAIRP must reflect the need to ensure that the small animal imaging technologies available for access or under development through this mechanism are pushing the state of the art. In addition, the SAIRP should explore the broadest range of cancer research related applications appropriate. The primary purpose of each SAIRP is to support coordinated shared research resources and related research to enhance the capabilities of NIH-supported investigators to pursue cancer research relevant to the mission of the NCI. A SAIRP is characterized as follows: SAIRPs and SAIRP-related research represent shared research resources and activities that can include services (e.g., software development, histological processing, bio-statistical support), equipment (e.g., image analysis systems, multi-channel recording equipment), and other resources (e.g., use of animal handling facilities, access to supercomputing centers, time on scanners, other clinical research resources). SAIRPs must benefit the base grants that they serve and are expected to increase efficiency, promote new research directions and foster interactions and synergy among investigators. SAIRPs may also be used by those not in base grants, particularly to the extent that they provide opportunities for young investigators, women and minorities. If this is planned, rationale for such usage and for selection of such investigators should be provided. SAIRPs must address the training of professional and technical individuals within the institution as well as from outside in the techniques of small animal imaging. Resource The SAIRP should use approximately one half to two thirds of its resources and time to provide imaging services and collaboration to cancer-related research projects. As part of the initial application, there must be commitments from at least three cancer-related research projects [R01, FIRST (R29), program project (P01), relevant consortia (U01) and/or MERIT (R37) grants],or R01-equivalent cancer-related awards from other agencies, that will use the small animal imaging resource at the beginning of year 2. After implementation, the applicants would be expected to form similar collaborations with at least three additional cancer-related research projects by the beginning of the third year of the SAIRP award. At the time of application, applicants must give evidence of potential to form these additional collaborations. Collaboration with at least six other research projects using small animals within 2 years after the award is a MINIMUM requirement. Collaboration with more than six research projects is strongly encouraged. Applicants must demonstrate that at the time of application they have available at least one state-of-the-art imaging technology optimized for small animals. In addition, they must show evidence of experience with in vivo imaging of small animals using the available technology. Applicants must provide plans for providing at least one additional imaging technology for small animals within the first year of the award. This could be acquired commercially or developed in-house. Funds to acquire or develop this additional imaging technology may be included in the budget of year 1 of the application. Imaging Technology Research The SAIRP should use approximately one third to one half of its resources and time for research and development of small animal imaging technology. This could be further development and optimization of existing technologies or exploration of novel technologies. Methods to produce valid quantitative results would be particularly encouraged. Funds for small animal imaging technology research may be included in the application budget for all years of the award. Training A plan for training of individuals including basic scientists, clinicians, technologists and support personnel interested in learning the techniques and science of small animal imaging must be included. Some of the trainees must come from institutions other than the awardee institution. The training should include both didactic and hands-on instruction. Governance The Director of the SAIRP must have a demonstrated capability to organize, administer and direct the shared resource. Applicants must describe their plan for governance, and methods to be used to evaluate and select protocols to support with the SAIRP. It is suggested that a scientific advisory board of collaborators and other cancer investigators would be established for this purpose. The expertise of the scientific advisors and the structure of the board should be discussed, but the advisors do not need to named in the application. Two years after the award there will be a review by NCI program staff to confirm that: two or more small animal imaging technologies have been implemented and are operational, collaboration with a minimum of six cancer- related research projects requiring imaging data from small animals is in progress, developmental research on small animal imaging systems is in progress. If these components do not exist or are insufficient, the award will be phased out. Research Support The following are examples of ancillary research capabilities for which funding could be requested in SAIRP application. This list of examples is not meant to be comprehensive or exclusive of other possibilities. Contrast agent support: synthesize agents that can be used by investigators to differentially label normal or abnormal structures, or make evident specific processes in tumor imaging studies. Supercomputer support: fund access to high performance platforms and technical assistance in optimizing algorithms used in analyzing very large data sets resulting from high resolution imaging, 3D and 4D imaging, etc. Informatics support: funds to support the purchase as well as research and development of tools and approaches for data storage, retrieval, analysis, visualization and manipulation. Imaging instrument support: purchase equipment, supplies, and service contracts needed for small animal imaging. Research animal support: support of laboratory facilities to provide the animal imaging operations. Biostatistics support: support for statistical consultation in experimental design and data analysis for small animal imaging. Activities Supported An overall budget for the SAIRP should be provided, as well as budgets for each of the proposed imaging instruments, including instrument-related research. Direct costs may be requested that are essential for the support of the SAIRPs and must be fully documented and justified, salary support for administrative costs should be kept at a minimum. The SAIRP investigators will organize a public meeting in year 3, open to all interested researchers. Attendance at this meeting should be budgeted for. SPECIAL REQUIREMENT A budget item to support travel of two persons to an annual meeting of individuals from all the funded SAIRPs should be included. MECHANISM OF SUPPORT Small Animal Imaging Resource Programs will be supported by the resource- related research projects (R24) mechanism. This mechanism is used to support projects that enhance capabilities of resources to contribute to extramural research of the Public Health Service. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Funding for NIH intramural applicants will be derived from existing intramural resources. This RFA is a one-time solicitation. Amended or competing continuation applications will be accepted only through future RFAs, the publication of which will be contingent upon program priorities and availability of funds. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. FUNDS AVAILABLE Approximately $20 million total cost will be available for the 5-year period of the award for all the SAIRPs. Approximately $5.9 million total cost will be available for the first year of this RFA, which should fund five resource related grants, including funds for adding small animal imaging equipment as described below, subsequent year funding would be less, because it would not fund equipment acquisition. Approximately $3.5 million total cost for all the SAIRPs will be available each year for years 2 through 5 of the award. It is anticipated that five awards will be supported through this RFA. Purchase or assembling of imaging equipment will be allowed in the first year only. The funds requested should be based on the requirements of the project and the requested costs must be fully justified. Each SAIRP will provide services, equipment and/or other research resources to the base grants, imaging technology research related to the SAIRP, in turn, will enhance the capabilities of the SAIRP. The coordinated use of shared resources increases the efficiency of cancer research, facilitates the use of new technologies and the pursuit of new lines of research, and promotes interdisciplinary and collaborative research. Although the financial plans of the NCI 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. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. 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. For this RFA, teams composed of NIH intramural investigators are encouraged to submit intramural project applications to become components of the Consortium, but they may not request or receive funds from this program (Potential intramural applicants please see Foreign institutions are not eligible for resource-related research project (R24) grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as SAIRP Directors and heads of laboratories. Applicants for SAIRPs may request support for a period of up to 5 years. By the beginning of the third year of the SAIRP award, each application for a SAIRP must serve a minimum of 6 cancer-related research projects (R01), FIRST (R29), program projects (P01), relevant consortia (U01) and/or MERIT (R37) grants (known as the base grants). Training grants (T32) and individual and institutional fellowship grants are not eligible for inclusion as base grants. R01-equivalent cancer- related awards from other agencies may be included as base grants. Only one SAIRP will be awarded to any single applicant organization, but base grants may be housed in multiple institutions. In general, each cancer-related research project grant should only serve as a base grant for one SAIRP. If well justified, activities and research may be located at sites and institutions other than that/those of the base grants and the SAIRP. For example, research related to a program might exist at a transgenic facility, supercomputer center, imaging facility, etc., which is neither at nor part of the institution applying for the SAIRP, nor at or part of any of the institutions housing the base grants. One intention of this initiative is to promote regional distribution of small animal imaging facilities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Barbara Y. Croft, Ph.D. Diagnostic Imaging Program National Cancer Institute 6130 Executive Boulevard, Room 800 Rockville, MD 20892-7440 Telephone: (301) 496-9531 FAX: (301) 480-5785 Email: Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC-8329 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8329 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: Direct inquiries regarding fiscal matters to: Kathleen J. Shino, M.B.A. Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800 ext. 248 FAX: (301) 496-8601 Email: LETTER OF INTENT Prospective applicants are asked to submit, by October 19, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone number, and e-mail address 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Barbara Croft by the letter of intent receipt date listed. SCHEDULE Letter of Intent Receipt: October 19, 2000 Application Receipt: November 28, 2000 Peer Review Date: March 2001 Review by NCAB Advisory Board: May 2001 Earliest Anticipated Start Date: July 1, 2001 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: For those applicants with internet access, the 398 kit may be found at The SAIRPs are intended to enhance the capabilities of scientists to pursue cancer research relevant to the mission of this Institute. The manner in which the proposed SAIRP will do this must be made clear in the application. The following sections should replace the Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and the Research Design and Methods sections of the traditional Research Plan in form PHS 398 (Rev. 4/98) (adhering to the 25-page limit): General Description of the SAIRP: Describe the SAIRP, existing small animal imaging instrument(s), proposed small animal imaging instrument(s), and ancillary capabilities existing and proposed. Describe the provision of imaging services and the small animal imaging research and development proposed. Describe the plans for training of professionals and technical support personnel. General Description of the Base Grants of the SAIRP (Not to exceed 1 page for each base grant participating in the SAIRP): Provide an overview of the research goals and approaches used in each of the base grants and the manner in which the SAIRP award will benefit the research activities of the base grants. In addition, describe the specific ways in which the SAIRP will increase efficiency, promote new research directions and foster research interactions and synergy of cancer-related research. Finally, for each of the base grants, the following must be provided: the grant number, title, name of the PI, grantee organization, the project period end date, and the direct cost budget for the year on which the budget of the SAIRP application is based. Operational Plan: Describe arrangements required to implement the SAIRP, including the manner in which priority for imaging facility access and use is decided, the operational and administrative role of the director of the imaging facility, etc. This section is especially important for those applications proposing an offsite facility. Imaging Equipment Descriptions: Describe the purpose of each component, describe imaging technology-related research including the manner in which it is expected to enhance the capabilities of the imaging instruments, and clearly indicate the space, facilities, resources, services, technical and professional expertise and support that the applicant institution will provide. Describe the specific manner in which each component will relate to the base grants. For each component, describe the level of use by the base grants, starting in year 3 of the award, each imaging technology must be used by at least three of the base grants. Ancillary Capabilities Describe the specific ancillary capabilities requested and how they will enhance the SAIRP. Training Program Describe a dedicated plan for the training of individuals in the science of small animal imaging. A plan for training of individuals such as basic scientists, clinicians, technologists, and support personnel interested in learning the techniques and science of small animal imaging is required. Examples of training for research scientists or clinicians might be in the form of, but not limited to, full-time or part-time post-doctoral fellowships. Examples of training for support personnel might be in the form of, but not limited to, short-term courses. Some of the trainees must come from institutions other than the awardee institution. The training should be comprehensive and include both didactic and hands-on instruction. Table of Contents The table of contents should reflect the actual contents of the application and should not copy the categories of PHS 398 Form Page 3. Budget and Financial Information Break out the budget contribution for each proposed small animal imaging instrument. The budget and the proposed research and resource provision should be aligned. Appendix: All instructions in the Form 398 application kit apply. 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: has been modified to allow for this change. Please note this is in pdf format. 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 8062, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Applications must be received by November 28, 2000. 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 NCI. 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 NCI 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 a second level review by the National Cancer Advisory Board. 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 application address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of this resource program on the concepts or methods that drive this field? What is the likelihood that the proposed SAIRP will increase efficiency, promote new research directions, facilitate interactions across disciplines and levels of analysis, and/or across theoretical and technological approaches? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the SAIRP? Does the applicant acknowledge potential problem areas and consider alternative tactics? How will the effectiveness of the SAIRP in achieving its goals be judged? 3. Innovation. Does the imaging research project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the imaging research project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to manage the SAIRP and carry out the research? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Has the principal investigator assembled the appropriate team to manage the SAIRP and conduct the proposed research? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 6. Relationship to base grants: Will the SAIRP significantly enhance the capabilities of the base grants to pursue cancer research relevant to the NCI? Is there participation of scientifically diverse base grants? 7. Training: The application will also be reviewed on the merit of a plan to provide a comprehensive and balanced didactic and hands-on training experience. This should include a plan for the training of individuals from the awardee institution as well as from other institutions throughout the country in the science of small animal imaging. The initial review group will also examine: the appropriateness of proposed project budget and duration, the provisions for the protection of animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete with other applications received in response to this RFA. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program balance. 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: 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: Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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, Small Animal Imaging Resource Programs, is related to priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394. 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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