and Human Services (HHS)
EXPIRED
SMALL ANIMAL IMAGING RESOURCE PROGRAMS RELEASE DATE: October 2, 2003 RFA Number: RFA-CA-04-011 (This RFA has been reissued, see RFA-CA-07-004) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institute of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.394 LETTER OF INTENT RECEIPT DATE: November 18, 2003 APPLICATION RECEIPT DATE: December 18, 2003 This Request for Applications (RFA) is a reissue of RFA-CA-01-012 "Small Animal Imaging Resource Programs" which was released in the NIH Guide on July 31, 2000. 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 Supplementary Instructions 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 Cancer Institute (NCI) invites applications from extramural 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. Small Animal Imaging Resource Programs (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. RESEARCH OBJECTIVES Background Small animal models, particularly genetically engineered mice, are increasingly recognized as powerful discovery tools in cancer research. One of the limitations of the use of experimental animals 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. Animal models of cancer formation and treatment allow identification of tumor biology and provide tumor-bearing animals for testing therapeutics. Combining imaging with animal modeling allows the animals to be used as their own controls, and permits acquisition of molecular data from tumors that are interacting on a molecular level with their microenvironment. It is clear that the expression of genes in tumors and their surrounding tissues is different in situ than it is in excised or cultured preparations. In vivo molecular imaging is evolving to be a form of in vivo assay reporting the molecular activity in tumor and normal cells. Furthermore, anatomic and functional imaging are valuable in population studies of genetically engineered mice to indicate which mice are expressing tumors, how many tumors are present in a given animal, and where they are located. In experiments for which temporal changes are a variable of interest, without imaging data one would need a cohort of mice for each data point. Imaging allows the study of a cohort of animals for the entire course of an experiment, which might include tumor initiation, growth, treatment, and re- growth. In vivo imaging facilitates the use of fewer animals, better control of the experiments, and acquisition of data from the tumor-host system. The characterization and use of genetically engineered mice, stimulated by The Mouse Models of Human Cancer Consortium, is entering a new era with emphasis on utilization of mouse models. Small animal imaging is essential to gain full knowledge about the model and its behavior under experimental conditions. The SAIR program thus far has been very successful, with a number of different achievements. Animal imaging research and its inclusion in funded grants has increased. The technology required for animal imaging, often more demanding than that for human imaging because of the resolution required, has been advanced. The techniques of animal imaging have been disseminated more widely, encouraging yet more use of animal imaging in cancer research. Because there is a need to build on the progress that has been made and to continue encouraging the use of imaging in characterizing and employing the valuable resource of engineered small animals, especially mice, this program is being continued. 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 (SAIRPs) will provide: Multiple imaging technologies for small animals, emphasizing, but not limited to, those technologies which can provide biochemical, genetic, pathological or pharmacological information related to malignancy 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 cancer-related imaging experiments. Training for both professional and technical personnel in the techniques and methodologies of cancer-related 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 cancer research. 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 cancer-related 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 cancer- related 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, 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 by the beginning of year two. 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 cancer- related research projects using small animals within two years after the award is a MINIMUM requirement. Collaboration with more than six cancer- related 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 one 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 cancer-related 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 be named at the time the application is submitted. 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 a 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 cancer-related 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. MECHANISM OF SUPPORT This RFA will use the NIH 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. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is July 1, 2004. 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. This RFA uses just-in-time concepts. It also uses the non-modular budgeting format. Follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NCI intends to commit approximately $4.5 million total cost in FY2004 to fund five new and/or competitive continuation grants in response to this RFA which includes funds for adding small animal imaging equipment as described below; subsequent year funding would be less, because it would not fund equipment acquisition. Approximately $3.45 million total cost for all the SAIRPs will be available each year for years two through five of the award. Approximately $18.3 million total cost will be available for the five-year period of the award for all the SAIRPs. 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 cancer-related research, and promotes interdisciplinary and collaborative research. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the 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. 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 institutions o Foreign institutions are not eligible to apply. 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 six cancer-related research projects (R01, R21/R33 or R33), 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. 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 Describe the specific manner in which each component proposed will relate to the base grants. For each component, describe the level of use by the base grants; starting in year three of the award, each imaging technology must be used by at least three of the cancer-related base grants. A budget item to support travel of two persons to an annual meeting of individuals from all the funded SAIRPs should be included. 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 your questions about scientific/research issues to: Barbara Y. Croft, Ph.D. Cancer Imaging Program National Cancer Institute 6130 Executive Boulevard, Room 6064 Bethesda, MD 20892-7412 Telephone: (301) 496-9531 FAX: (301) 480-3507 Email: [email protected] o Direct your questions about peer review issues to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041, MSC-8329 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8329 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: [email protected] o Direct your questions about financial or grants management matters to: Kelli Oster Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-8621 FAX: (301) 496-8601 Email: [email protected] 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: Barbara Y. Croft, Ph.D. Cancer Imaging Program National Cancer Institute 6130 Executive Boulevard, Room 6064 Bethesda, MD 20892-7412 Telephone: (301) 496-9531 FAX: (301) 480-3507 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. SUPPLEMENTARY INSTRUCTIONS: The SAIRPs are intended to enhance the capabilities of scientists to pursue cancer research relevant to the mission of the National Cancer 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. 5/2001), 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 cancer-related 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 cancer-related Base Grants of the SAIRP (Not to exceed 1 (one) 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 Principal Investigator, grantee organization, the project period end date, and the direct cost budget for the year for which the description in 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 three of the award, each imaging technology must be used by at least three of the cancer-related 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 cancer-related 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. 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/labels.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 copies of the appendix material must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before December 18, 2003. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NCI. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, the reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 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? 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? 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? 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. 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? 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? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (See url in Federal Citations, below.) 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: November 18, 2003 Application Receipt Date: December 18, 2003 Peer Review Date: March 2004 NCAB Review Date: June 2004 Earliest Anticipated Start Date: July 1, 2004 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 SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 PA 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. 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, Small Animal Imaging Resource Programs, is related to priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm 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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