SYSTEMS AND METHODS FOR SMALL ANIMAL IMAGING RELEASE DATE: November 18, 2002 RFA: EB-03-002 National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) LETTER OF INTENT RECEIPT DATE: January 16, 2003 APPLICATION RECEIPT DATE: February 13, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations: PURPOSE OF THIS RFA The National Institute of Biomedical Imaging and Bioengineering (NIBIB) invites investigator-initiated applications for NIH Research Project Grant (R01) awards to support interdisciplinary basic research or Exploratory/Developmental Research (R21) awards to support novel investigations related to the development of small animal imaging devices and methods that can be applied broadly to research on diverse biological or disease processes. A companion Program Announcement related to this initiative is available at (http://grants.nih.gov/grants/guide/pa-files/PA-03-031.html) for those eligible for the Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) program. The primary focus of this Request for Applications (RFA) is research and development related to devices, methods, and imaging agents for the investigation of biological and disease processes in small animals. The integration of systems and methods with complementary imaging and/or spectroscopy modalities is also included as appropriate to provide anatomic, physiologic, metabolic, and molecular-level information in small animal models of disease. The motivation for this RFA is that recent discoveries in genomics and molecular and cell biology have led to the development and wide use of small animal models of human disease. One of the limitations with the use of these models is the need to sacrifice large numbers of animals for ex vivo tissue and molecular analysis. Imaging instrumentation and methods that permit imaging on the scale of small animals offer an opportunity to address this problem by enabling noninvasive investigations of biological processes in vivo. This provides the potential for longitudinal studies in the same animal. This coupling of animal models of human disease with advances in imaging technology presents an extraordinary opportunity for biomedical imaging to play an important role in the early detection, diagnosis, and treatment of disease. Several dedicated small animal imaging systems have been developed and a few commercialized, although technological hurdles still exist that limit the realization of the full potential of small animal imaging for biomedical research and drug development. Progress is needed to improve throughput, sensitivity, and spatial and temporal resolution of small animal imaging devices, to provide quantitative information through improved reconstruction methods that incorporate models of physical effects, and to provide improved methods for system validation. System optimization incorporating the design of molecular probes that serve as links to particular biological processes in vivo is also a focus. Further improvements in system design, image processing and analysis software, and data sharing technology, coupled with improvements and innovations in animal handling techniques used during imaging, are needed to make small animal imaging technology more accessible to molecular biologists and pharmaceutical scientists desiring to use animal models as tools for biomedical research and drug discovery and development. The NIBIB seeks to improve health by promoting fundamental discoveries, design and development, and translation and assessment of technological capabilities in biomedical imaging and bioengineering enabled by relevant areas of physics, chemistry, mathematics, engineering, materials science, and computer science. RESEARCH OBJECTIVES The need to support the discovery and development of biomedical imaging methods was identified at several NIH workshops and conferences on biomedical imaging, including a June 25-26, 1999 symposium entitled "Biomedical Imaging Symposium: Visualizing the Future of Biology and Medicine" which was coordinated by the NIH Bioengineering Consortium (BECON). Three scientific areas were addressed at the symposium: (1) imaging at the cellular- and molecular-levels such as required for the early detection of disease; (2) imaging for the clinical diagnosis, staging, and recurrence of disease; and (3) imaging applied to therapeutic applications and monitoring for various disease processes. Additionally, small animal models of human disease, in particular mouse models, have been identified as valuable resources for the investigation of the underlying mechanisms of human disease. Small animal imaging provides the means to address all three priority areas through the non-invasive monitoring of biological processes, disease progression, and response to therapy, with the potential to provide a natural bridge to the clinical environment and contribute substantially to the development of human medicine. This BECON symposium also emphasized the need to support fundamental discovery and technical development of imaging technologies before specific disease- or organ-oriented applications are determined. These challenges can be accomplished effectively by multi-disciplinary teams from academia, national laboratories, and industry, with expertise in the quantitative, computational, and biomedical sciences. In addition, the need for appropriate research support mechanisms and NIH study section reviews that emphasize technology development with less emphasis on organ- or disease-specific clinical applications were identified. Consistent with the recommendations of the BECON symposium and the mission of the NIBIB, the goals of this RFA are directed at basic research and/or development of small animal imaging systems and methods. Research areas of interest include the improvement of existing devices and methods and the development of novel approaches to small animal imaging that enhance spatial or temporal resolution, measurement sensitivity, specificity, and throughput as required for the detection, diagnosis, or measurement of treatment efficacy for different disease processes. The scope of the RFA includes the integration of molecular imaging systems and methods with anatomical or other functional imaging and/or spectroscopy methods to provide more effective tools for biomedical research. The development of imaging or spectroscopy systems that have the flexibility to accommodate a variety of protocols for investigations of different diseases, and the development of platform-independent imaging methods for multi-center research is also a focus. The following research areas are examples of appropriate topics for applications in response to this RFA. This list is meant to be representative and not all-inclusive: o Development of small animal imaging systems that extend the capabilities of existing devices through improved spatial and temporal resolution, sensitivity, and throughput for screening applications. This research scope includes improvements to dedicated small animal imaging devices and adaptation of existing clinical devices, in addition to high-risk, high-gain research objectives such as new in vivo imaging and/or spectroscopy paradigms. Development of multi-modality imaging approaches that increase the range of information provided for enhanced image interpretation and improved quantification of biological processes in vivo are also within the scope of this RFA. Mathematical modeling of such systems and their performance is included as required for system optimization. o Development of improved methods for image reconstruction and processing, and the development of analytical tools for image analysis. An emphasis of the RFA is on technological advances that might enhance the capabilities of existing devices and increase the availability of small animal imaging devices and methods for biological research and drug discovery and development. o Development of complementary devices and methods for improved animal handling, including motion compensation and correction, imaging agent administration, blood sampling, anesthesia delivery, and animal maintenance and monitoring during imaging. Implantable sensor devices that take advantage of microelectromechanical (MEMS) and nanoelectromechanical (NEMS) systems are included. o In vivo investigations of imaging agents and high-affinity molecular probes for the imaging of biological processes in small animals, including improved methods for probe delivery and targeting. These studies may include the development of molecular probes for gene expression, cell tracking, enzyme action or other metabolic processes, or blood flow or drug distribution and action, with the potential to impact the study of several disease processes. Single or multiple imaging agents or multifunctional probes suitable for multi-modality imaging and/or spectroscopy are included. System optimization for imaging agents and molecular probes can be addressed where appropriate. Studies involving in vitro characterization of imaging agents and probes, and/or in vivo testing in human subjects, are not within the scope of this RFA. MECHANISM OF SUPPORT This RFA will use NIH R01 (Research Project Grant) award mechanism and the development/exploratory grant award mechanism (R21). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 2003. The R01 mechanism is recommended for applications that emphasize basic discovery or cross-cutting research that addresses specific aspects of small animal imaging. Research periods associated with the R01 proposals are limited to five years. The R21 Exploratory/Developmental Award supports exploratory or developmental research aimed at proof-of-principle for high-risk projects where no or very little preliminary data is available. An R21 application can be for up to two years with a maximum budget request of $150,000 direct costs per year and a maximum page limit of 10 pages. R21 applications are not renewable. If sufficient results are generated during the term of the award, investigators are encouraged to apply for further funding through the R01 mechanism (or other appropriate mechanisms). This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE The NIBIB intends to commit approximately $7,000,000 in FY 2003 to fund 20 to 30 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years for an R01 and a project period of up to 2 years for an R21. Budgets for direct costs of up to $150,000 per year will be accepted for an R21. There is no budget limitation for R01 applications. Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. Since the total costs for a subcontract or consortium are included in the direct cost request, one additional module of $25,000 may be requested for the facilities and administrative costs associated with third party agreements. Under these guidelines, R21 applications requesting $150,000 may request $175,000 to cover the facilities and administrative costs described above. A module requested for this purpose must be clearly identified in the budget justification section of the application, and will be restricted for this purpose only at the time of award. Although the financial plans of the NIBIB provides 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 this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS General Clinical Research Centers: Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources (NCRR) may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. Meetings: Principal Investigators will be required to attend an annual meeting organized by NIBIB. Please include travel to the Bethesda, MD area as part of the budget request. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct questions about scientific/research issues related to the NIBIB to: Brenda Korte, Ph.D. Division of Biomedical Imaging National Institute of Biomedical Imaging and Bioengineering NIH/DHHS 6707 Democracy Boulevard – Suite 200 Bethesda, MD 20892-5469 Telephone: 301-451-4774 Fax: 301-480-4973 Email: kortebr@nibib.nih.gov The National Institute of Mental Health, while not a sponsor of this program announcement, supports research and development similar to that solicited here, with particular interest in such projects relevant to brain research. Dr. Michael Huerta (mhuerta@helix.nih.gov, 301-443- 3563) is an appropriate contact at NIMH for such research interests. o Direct questions about peer review issues to: David T. George, Ph.D. Chief, Office of Scientific Review National Institute of Biomedical Imaging and Bioengineering NIH/DHHS 6707 Democracy Blvd., Suite 920 Bethesda, MD 20892-5469 Telephone: 301-451-4772 Fax: 301-480-4973 Email: dg174c@nih.gov o Direct questions about NIBIB financial management or grants management matters to: Ms. Florence Turska Grants Management Officer National Institute of Biomedical Imaging and Bioengineering NIH/DHHS 6707 Democracy Boulevard – Suite 900 Bethesda, MD 20892-5469 Telephone: 301-496-9314 Fax: 301-480-4974 Email: turskaf@nibib.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 by the date listed at the beginning of this document. The letter of intent should be sent to David T. George, Ph.D. at the address listed under WHERE TO SEND INQUIRIES. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 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 RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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 and all five collated sets of Appendix material must be sent to Dr. David T. George at the address listed under WHERE TO SEND INQUIRIES. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. 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. Principal investigators should not send supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you have not received such a letter within three weeks after submitting the application, contact Dr. David George at the address listed under WHERE TO SEND INQUIRIES. Please Note: As of November 27, 2001, all applications and other deliveries to the Center for Scientific Review must come via courier delivery or the USPS. Applications delivered by individuals to the Center for Scientific Review will no longer be accepted. For additional information, see the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NIBIB. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIBIB staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NIBIB in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the National Advisory Council for Biomedical Imaging and Bioengineering. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o R21 MECHANISM ONLY: Since the R21 mechanism is intended to encourage exploratory/developmental research, proposals submitted as an R21 will also be reviewed based on their high risk/high impact potential and whether or not the proposal is significantly distinct from those traditionally submitted through the R01 mechanism. o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 16, 2003 Application Receipt Date: February 13, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers 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 is related to one or more of the priority areas. 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 No. 93.286 and 93.287 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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