PLANNING GRANTS: IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (PRE-ICMICs) Release Date: May 1, 2000 RFA: CA-01-010 National Cancer Institute Letter of Intent Receipt Date: July 14, 2000 Application Receipt Date: August 18, 2000 This Request for Applications (RFA) is a reissue of RFA CA-99-002 "Planning Grants: In Vivo Cellular and Molecular Imaging Centers (PRE-ICMICs)" which was released in the NIH Guide on March 30, 1999. PURPOSE The Biomedical Imaging Program, Division of Cancer Diagnosis and Treatment of the National Cancer Institute (NCI) invites applications for P20 planning grants that lead to the establishment of In Vivo Cellular and Molecular Imaging Centers. This Request for Applications (RFA) invites applications for P20 Planning Grants. Applicants should note that NCI anticipates the reissuance of an RFA ( to invite applications for P50 Center grants. While the NCI plans to proceed with this initiative, its publication and timing is not certain and depends on sufficient funds being available. This initiative is designed to capitalize on the extraordinary opportunity for studying cancer non-invasively in the living organism (animal or human), and in many cases, quantitatively due to recent advances in molecular imaging modalities, molecular and cellular biology. It will facilitate the interaction of scientists from a variety of fields such as, but not limited to: imaging sciences, chemistry, radiopharmaceutical chemistry, cell and molecular biology, pharmacology, computer science, biomedical engineering, immunology and neuroscience, and provide resources to conduct multidisciplinary research. This RFA describes the three-year, P20 Planning Grant for Pre-In Vivo Cellular and Molecular Imaging Centers (Pre-ICMICs). There are Institutions that have most of the separate scientific components necessary for productive interaction but have no track-record of performing multidisciplinary scientific research. The P20 will provide time and funds for these investigators to accomplish two phases of activity. Phase I will be designed for the formal establishment of an organizational and operational structure of the Pre-ICMIC. Phase II will provide the time and funds for the initiation of multidisciplinary Development projects, and for these newly-formed groups to complete recruitment efforts necessary for bringing in critical expertise. A related RFA is proposed for reissuance in the summer of 2000 and will make available 5-year P50 grants that will directly fund In Vivo Cellular and Molecular Imaging Centers (ICMIC). The previous RFA is located at the following URL: HEALTHY PEOPLE 2000 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, Planning Grants: In Vivo Cellular and Molecular Imaging Centers (PRE-ICMICs), is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010," at ELIGIBILITY REQUIREMENTS Applications for P20 Pre-ICMIC grants may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals and laboratories. Applications from foreign institutions will not be accepted. Foreign components of applications from domestic organizations will be accepted with adequate justification. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. No more than one Pre-ICMIC application will be accepted from any given Institution, nor will Institutions be allowed to submit a P20 application in response to this RFA and a P50 application in response to the ICMIC (see PURPOSE section above). Each Institution must determine in advance whether it will submit a P20 or a P50 grant. The Pre-ICMIC (P20) and the ICMIC (P50) will each require two distinct levels of existing resources. Each Institution must evaluate its existing research programs, and determine whether it will require a planning phase, or whether it has sufficient resources to support a P50 ICMIC. If an Institution submits an application for a P20 Planning Grant, an application from that same Institution for a P50 Center grant will not be accepted. Each of the lead investigators on both the P20 and P50 applications must be the principal investigator of a major, peer-reviewed, research project, such as an R01, a P01, or their equivalent from another funding agency. Applicants must therefore clearly define the scientific areas to be represented within the Pre-ICMIC, and for each scientific area, one or more investigators must be identified as assuming a leadership role. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) P20 Exploratory Grant Mechanism. These exploratory studies may lead to specialized or comprehensive centers (P50 - In Vivo Cellular and Molecular Imaging Centers). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for a P20 application submitted in response to this RFA may not exceed 3 years. The anticipated award date is March 1, 2001. FUNDS AVAILABLE This RFA is a one-time solicitation. NCI anticipates making approximately six 3-year awards, and plans to set aside $2.4 million total for the initial year"s funding. Annual budgets of $400,000 are suggested - applications exceeding $500,000 total cost limit will be considered unresponsive to the RFA and will be returned without further consideration. Funding in response to this RFA is dependent upon the receipt of a sufficient number of meritorious applications. Although this program is provided for in the financial plans of NCI, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. RESEARCH OBJECTIVES Background: Imaging sciences are at a stage in which human, anatomic imaging can occur in vivo at submillimeter resolution, and significant advances have occurred in molecular imaging modalities, including the nuclear medicine techniques of SPECT and PET, MR spectroscopy and optical imaging. At the same time, a myriad of new cancer-related genes and proteins are being uncovered at an increasing pace by molecular and cellular biologists. However, there remains a scientific gulf between basic scientists who discover new cancer genes and intracellular pathways, any of which could serve as a diagnostic or therapeutic target, and the imaging scientists who could transform those discoveries into non-invasive means for a greater understanding of neoplasia in humans. Research Goals and Objectives: The formation of multidisciplinary research teams will stimulate and streamline cancer imaging research from inception to use in patient care. Each Institution will define the structure and research objectives that create the most synergistic and creative scientific interactions. An example of an ICMIC structure is described below. This is just an example, and other multidisciplinary formats are acceptable. Discovery, characterization and refinement of new genetic targets might occur in the molecular biology core with that information provided to a chemistry core where potential new imaging agents directed toward those targets will be designed. A computing/database core would support the chemistry core through molecular modeling and structure searches but would also obviously interface with the other cores such as in data analysis or image display. A biochemistry core might be responsible for aspects of agent development that encompass cell biology and pharmacology as well. Receptor and enzyme purification and in vitro assays would occur in this core, in addition to development of kinetic models for studying complex issues involving agent delivery and metabolism. Animal work from rodents to primates would occur in the imaging core, where the most promising potential agents would be tested. Pre-ICMICs will provide Institutions with the resources to set in place all of the components that would make them eventually competitive for a P50 ICMIC grant. The success of a Pre-ICMIC will ultimately be determined by the quality and dedication of the investigators involved in the project. An appropriate Pre- ICMIC Director must be selected, as well as a multidisciplinary leadership team of investigators who are committed to the success of the Pre-ICMIC. This group of investigators will be responsible for the definition of the research goals and objectives of the Pre-ICMIC, as well as ongoing activities. The lead investigators must each represent a major scientific component that will be involved in the Pre-ICMIC, and each must have an independent, proven track record of scientific accomplishment, but they do not need to demonstrate prior interactive research amongst themselves. During the course of the Pre-ICMIC award, the leadership team will be responsible for the design and implementation of two phases of activity. Phase I: Establishment of an Organizational Structure (no longer than 6 months). During the Phase I planning stage, the applicant group will define and implement a structure for a Pre-ICMIC. Organizational activities must occur, during which the group will be expected to define: 1) The organizational and operational structure of the Pre-ICMIC. This will include the establishment of a Scientific Steering Committee, composed of internal senior investigators, who will be responsible for the overall scientific direction of the Program, as well as mechanisms for involving a dynamic groups of investigators at all levels of experience. Individual Pre- ICMIC groups may consider the establishment of an external advisory committee as well. If this is the case, it is requested that this committee be described in the organizational section of the application, but that external candidates not be contacted prior to submission, or included by name in the application. 2) A plan for interactive Pre-ICMIC activities that will occur regularly over the entire course of the award. These interactions will be determined by the applicants, and emphasis will be placed on establishing creative, productive interactions. One example would be to establish a regularly scheduled forum at which investigators present a potential research idea to the entire group. Colleagues with a wide range of expertise would provide the investigator with immediate feedback on the scientific content, which would in turn provide a valuable educational experience for the audience. Meritorious ideas could be further refined by "revising and resubmitting" for a later forum. Most importantly, the investigator would have an audience full of potential collaborators who could be involved in a project from its inception. 3) A description of the core facilities necessary to support the scientific goals of the Pre-Program. Access to equipment and reagents is often a problem, especially for multi-disciplinary programs. The establishment of core resources dedicated to Pre-ICMIC-related Development Projects will provide this access. Initially, Pre-ICMIC core resources may simply be extensions of existing laboratories or facilities, and the definition of a core resource would vary considerably depending on the Development projects to be selected. 4) A model of the process for the selection, monitoring, funding and, if necessary, termination of Development Projects to be implemented in Phase II (see below). Phase II: Development Projects The organizational structure set in place during Phase I should be used to select two to three highly-interactive Developmental Projects to be accomplished in Phase II. These projects will be geared toward determining project feasibility, proof of principle and acquisition of preliminary data. These pilot studies must demonstrate newly-established collaborative efforts between two or more groups of investigators. The P20 application should contain no more than six three-page examples of possible Development projects. These projects will not be reviewed as traditional research projects. Rather, the proposed Development projects will serve as an indication of the priorities to be focused on by the group, a reflection of the decision-making abilities of the scientific leadership, and the initial ability of the group to interact productively and scientifically. The actual Development projects that are implemented may not necessarily be those that are submitted with the application, since the Phase I selection process may determine other projects to be more meritorious. When the P20 groups submit their P50 application, it is expected that the Development projects will have generated sufficient data for meaningful interpretation. The results acquired during this phase will be a critical focus of the P50 review, since these results will be an important indication of how successfully the Pre-ICMIC group functioned to implement innovative research. SPECIAL REQUIREMENTS Funded Pre-ICMIC groups will be required to include in their first non- competing renewal (annual reports) 1) a description of the activities that occurred during Phase I, 2) the organizational and operational structure that was implemented including a detailed description of the process for selecting Development projects, and decisions regarding the establishment of core facilities, 3) a description of each of the Development projects that have been initiated, and the progress made on each of those projects. Subsequent non-competing renewals will be required to include a detailed report of organizational and operational activities as well as a progress report for each of the ongoing Development projects. 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 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 and is available 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 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 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. 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. LETTER OF INTENT Prospective applicants are asked to submit, by July 14, 2000, 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 Dr. Anne Menkens by the letter of intent receipt date listed. 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: Application kits are also available at the following URL: SPECIAL INSTRUCTIONS FOR PREPARATION OF THE APPLICATION All applications must be submitted on the form PHS-398 (rev.4/98). Budget: Applicants should submit two separate detailed budgets (Form Page 4-DD), and a single summary budget for the entire proposed period of support (Form Page 5- EE). The budgets should appear in the following order: Budget 1 (use Form Page 4-DD) should include all of the costs required for Phase I. The duration of Phase I may be determined by the applicants, but is not to exceed 6 months. Examples of acceptable Phase I costs would be salary support for the Program Director and key personnel involved in organizing the Pre-ICMIC, and costs associated with planning meetings. Budget 2 (use Form Page 4-DD) is to detail the costs associated with Phase II for the remainder of the first year. Phase II is specifically designed to implement the organizational structure of the Pre-ICMIC, initiate and carry out the multidisciplinary Development projects that will be selected during Phase I of the award, and complete necessary recruitment efforts. However, since the organizational structure and the final selection of the Development projects will not be completed until after the award has been made and Phase I has been completed, the budget for Phase II, by definition, will be projected rather than absolute. Acceptable Phase II costs would be continued salary support for the Pre-ICMIC Director and other ongoing organizational costs. In addition, it would be reasonable to select one or two Development projects as examples for estimated salary support for investigators involved in the Development projects, costs associated with equipment, supplies and core facilities designed to support the Development projects. Biographical Sketches and Other Support: All applications should describe the scientific and administrative experience of key personnel and should include and follow the PHS-398 form instructions for Biographical Sketches and Other Support information. In this case, key personnel includes the Pre-ICMIC Director, each of the investigators identified as a primary scientific leader, and each of the investigators involved with a submitted Development project. Resources: This section is to include a detailed description of the quality and variety of scientific resources available to accomplish the scientific goals of the Pre- ICMIC. RESEARCH PLAN (not to exceed a total of 45 pages): A) Major Research Objectives (8-10 pages). This section should concisely describe the Pre-ICMICs major research objectives, and should include descriptions of each of the scientific areas to be involved in the Pre-ICMIC, how they will be integrated, and the unique scientific opportunities that will be addressed. A description of the Director chosen to lead the Pre-ICMIC is to include his or her scientific qualifications and a demonstration of administrative and scientific leadership abilities. For each major scientific subdivision, an experienced investigator that will assume responsibility within the Pre-ICMIC must be identified. Senior investigators must demonstrate a strong track record of scientific accomplishment, and a willingness to effectively collaborate, and the application should clearly define the role that each of these investigators will play in Pre-ICMIC activities. For each participating investigator, a short description of his/her ongoing research and its potential relevance to the Pre-ICMIC is required. B) Phase I: Organizational Activities (8-10 pages) This section should include an example (model) of an organizational structure for the Pre-ICMIC. This model will not be a final structure, since that will be determined during Phase I. Instead, applicants should provide a detailed description of the activities that will take place during the Phase I period, and examples of how each topic might be addressed in the Phase II. Activities to be completed during Phase I include: a) finalization of an organizational structure of the Pre-ICMIC. This structure will include the establishment of relevant committees, composed of both internal and external senior investigators, who will be responsible for the overall scientific direction of the Program. b) Establishment of ongoing, interactive, multidisciplinary activities, such as seminars, workshops, forums, etc. c) Determine the process for the selection, implementation, monitoring, and if necessary, termination of Development projects to be initiated in Phase II (see below). d) Definition of the core facilities necessary to support the scientific goals of the Pre- ICMIC, how these core facilities will be maintained, how the decision to add or terminate a core facility will be made, and how resources will be allocated to the selected Development projects. e) Since the P20 Planning Grants are designed to support the organization of a multidisciplinary group, it is expected that the critical mass of investigators already exists at the Institution. Recruitment of one or two investigators in defined scientific area(s) may be required. If this is the case, applicants must identify the particular scientific area(s), and describe and justify recruitment plans in detail. C) Phase II: Development Projects (may not exceed 24 pages total) When the P20 application is submitted, it must contain no more than six four- page examples of possible Development projects to be implemented during Phase II. These projects should be geared toward determining project feasibility, proof of principle and acquisition of preliminary data. These Development studies must demonstrate collaborative efforts between two or more groups of investigators, with a focus on imaging technologies, and newly-established collaborations. Each of these examples should include: 1) Title 2) Investigator names, and areas of scientific expertise 3) Hypothesis and Specific Aim(s) 4) Background and Significance. Included in this section should be a description of the unique scientific opportunity made possible by this collaboration. 5) Research Design and Methods D) Institutional commitment (1-2 pages) Examples of Institutional support could be contribution to the support of salaries and/or equipment and reagent purchases required by investigators during the Phase II planning stage. The Institution could also make a commitment to the Program to provide common laboratory and/or administrative space, both during the planning phase and in the event that a successful P50 grant is awarded. If recruitment of investigator(s) is necessary, the Institutions plans for this effort, and clear demonstration of its commitment must be included. 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 B ETHESDA, 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 Bethesda MD 20892-7399 Rockville, MD 20850 (for express/courier service) Applications must be received by August 18, 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. 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. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. 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. 1. Significance. - Does this application bring together sufficient expertise to address important scientific problems? - If the Pre-ICMIC is established, how will scientific knowledge be advanced? - What will be the effect of the Pre-ICMIC on the concepts or methods that drive this field? 2. Approach. - Is the conceptual organizational and operational framework reasonable? - Is it well-integrated and appropriate to the aims of the project? - Does the applicant acknowledge potential problem areas and consider alternative tactics? - Does the proposed approach support the possibility of the Pre-ICMIC being ready to compete for a P50 ICMIC Grant within the time frame of the proposed planning period? 3. Innovation. - Does the Pre-ICMIC employ novel approaches or methods for facilitating scientific interaction? - Do the proposed Development projects establish new, multidisciplinary collaborations, and are the projects original and innovative? - Does the Pre-ICMIC group challenge existing paradigms or develop new methodologies or technologies? 4. Investigators. - Is the Pre-ICMIC Director and lead investigators appropriately trained and well suited to the organizational and scientific responsibilities associated with this project? - If there are plans to recruit investigator(s), are those plans reasonable and necessary and can those efforts be completed in a timely manner, such that the recruited investigator(s) can make meaningful contributions to the Pre-ICMIC? 5. Environment. - Is there evidence of significant commitment of the institution to fulfilling the objectives of the Pre-ICMIC? - Does the scientific environment in which the work will be done contribute to the probability of success? - If collaborative inter-institutional arrangements are proposed, is there a convincing demonstration that these interactions will be consistent enough to meet the needs of the Pre- ICMIC 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 Pre-ICMIC awards will be based primarily on the basis of scientific merit as determined by peer review, availability of funds, and programmatic priorities. Schedule Letter of Intent Receipt Date: July 14, 2000 Application Receipt Date: August 18, 2000 Peer Review: October/ November, 2000 Review by NCAB Advisory Board: February 2001 Anticipated Award Date: March 1, 2001 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: Anne E. Menkens, Ph.D. Biomedical Imaging Program National Cancer Institute Executive Plaza North, Suite 800 Bethesda, MD 20892 Telephone: (301) 496-9531 FAX: (301) 480-5785 Email: Direct inquiries regarding referral issues to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC 8239 Rockville, MD 20852 (express courier) Bethesda MD 20892-8239 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: Direct inquiries regarding fiscal matters to: Ms. Eileen M. Natoli Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892-7340 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8601 Email: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnostic Research. 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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