PILOT PROJECTS FOR MODELS OF INFECTIOUS DISEASE AGENT STUDY (MIDAS) RELEASE DATE: March 13, 2003 RFA: GM-03-008 (Mission has been modified, see NOT-GM-06-106) (see reissue RFA-GM-05-011) National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.113, 93.172, 93.242, 93.273, 93.837, 93.859, 93.862 PUBLIC BRIEFING DATE: APRIL 23, 2003, 9 AM-12 PM, NATCHER CONFERENCE CENTER, NIH LETTER OF INTENT RECEIPT DATE: May 19, 2003 APPLICATION RECEIPT DATE: June 18, 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 General Medical Sciences (NIGMS) encourages applications for pilot research projects and database development for a new initiative, Models of Infectious Disease Agent Study (MIDAS). MIDAS will consist of a centralized database and a network of multidisciplinary scientists conducting computational and mathematical research to improve the ability to detect, control, and prevent emerging infectious diseases caused by naturally occurring or intentionally released pathogens, including those relevant to biodefense. The overall goal of this research initiative is to improve the nation's ability to respond to biological threats promptly and effectively. The two main objectives are (1) to develop computational tools to (a) model exposure to pathogens and their products, (b) carry out identification and surveillance of infectious diseases in a timely and cost-effective manner, (c) model the effectiveness and consequences of different intervention strategies, and (d) model the decontamination of facilities from pathogens and their products; and (2) to establish a centralized database to store, display, and make publicly available the tools and information developed, for the practical use of policymakers, public health professionals, and researchers. NIGMS will support multidisciplinary research teams that will develop mathematical and computational tools applied to the identification, control, prevention and treatment of emerging infectious diseases, including those of biodefense relevance. The MIDAS Network will comprise multiple Research Groups and an Informatics Group. It will be governed by a MIDAS Steering Committee consisting of members of the Research Groups and Informatics Group and scientists, from the National Institutes of Health (NIH) and other research institutions, who represent relevant fields of expertise. This initiative is a pilot effort in the organization of research centers for the modeling of emerging infectious diseases and biodefense responses. NIGMS is soliciting applications for Research Groups and the Informatics Group. Applicants may submit applications for support of a Research Group, the Informatics Group, or both. RESEARCH OBJECTIVES Background Policymakers and the public are increasingly concerned about bioterrorism and the emergence of new pathogens. The variety of scenarios possible in this arena complicates the challenge of confronting these threats. An important role of science is to rationalize the scenarios by collecting, analyzing, and interpreting relevant data and by developing models that can help responsible parties respond effectively to an emerging epidemic or a bioterrorist threat. The National Institute of Allergy and Infectious Diseases (NIAID) has a well-developed plan for biodefense research that includes six target areas: biology of the microbe, host response, vaccines, therapeutics, diagnostics, and research resources. The MIDAS Network and Database that will be supported by NIGMS will complement the experimental research supported by NIAID by adding a modeling component to the NIH research agenda in biodefense. MIDAS will rely on a network of researchers with demonstrated expertise in computational and mathematical methods, the biology of infectious disease systems, social networks, and environmental modeling. This type of interdisciplinary network is the most efficient approach for developing useful knowledge and tools to respond to a public health emergency involving emerging infectious diseases, either naturally occurring or bioterrorism-related. Details of the MIDAS organizational structure and the tasks and responsibilities of participants are described in detail under "Special Requirements." The U.S. scientific and public health communities need to improve their ability to identify and prevent the spread of diseases resulting from the emergence or intentional release of pathogens and their products. Epidemiological data collected during natural outbreaks in the past may be of limited use in the event of an attack, and new parameters for disease surveillance and control need to be identified. Overexposure to pathogens (or pathogen-related products), single and multiple introductions, genetic manipulation of the pathogen's virulence genes, or novel transmission routes may dramatically affect how a disease manifests itself and how it is transmitted. We might expect changes in the disease's initial signs and symptoms, incubation period, transmission rate, and morbidity and mortality. Development of new mathematical and computational tools to simulate novel complex scenarios will help researchers, public health professionals and policymakers improve their methods of disease identification, surveillance and forecasting, and their strategies for short- and long- term interventions. Specific Research Objectives To improve management of the identification and control of emerging infectious diseases that may arise naturally or from intentionally released pathogens, scientists and public health officials need a variety of models to understand and simulate the variety of complex scenarios possible. Specific research objectives for the MIDAS Network are to develop, validate, and implement use of the following: o Models of the transmission of bioterrorism agents or naturally occurring infectious disease agents, which include relevant and complex parameters such as environmental data and social networks o Models of the release, spread, and detection of naturally occurring agents and bioterrorism agents o Models for differential diagnosis of naturally occurring outbreaks and bioterrorism attacks, aimed to promote accurate detection of common infectious diseases, non-specific signs and symptoms, and shared symptoms among emerging infectious diseases and intentionally released pathogens o Models of interventions, such as quarantine, vaccination, and antimicrobial and antitoxin treatments o Models for the distribution of stockpiles and inventories of treatments, scheduling of response activities, and allocation and use of manpower and other resources o Models for evaluating the long-term consequences of response strategies, including the decontamination of facilities from pathogens and their products. This RFA invites the Research Groups to prepare proposals addressing two of the three major thematic areas, which are described below. Data relevant to the research will be integrated by the Informatics Group (see "Special Requirements"). Thematic Research Areas Awards made as a result of this RFA will be MIDAS pilot projects. NIGMS expects that these pilot projects will evolve into a large-scale research network. This MIDAS Network will focus on scientific knowledge and expertise in computational biology and mathematics applied to three thematic research areas: (I) Modeling of Host- Pathogen Systems, (II) Modeling of Disease Epidemiology and Forecasting Systems, and (III) Modeling of Response Systems. To promote cross-disciplinary research and develop multiple areas of expertise, NIGMS requests applicants to focus on mathematics and computational methods for the modeling of systems in at least two of the three thematic areas. Listed below are suggested, but not required, research topics for each area. I. MODELING OF HOST-PATHOGEN SYSTEMS Possible research topics include, but are not limited to: A. Modeling of microbial population structure, ecology, natural history, genome structure and evolution, of microbes relevant to biodefense (their model counterparts and engineered strains). Please refer to http://www.bt.cdc.gov/agent/agentlist.asp for a list of organisms that the Centers for Disease Control and Prevention (CDC) has placed in Category A, B, and C lists of biological threats. Applicants may choose to use data from these organisms or from other model systems. o Development of new and improved computational methods for phylogenetic reconstruction and analysis; modeling tools to achieve accurate population sampling. o Modeling of the evolution of microbial traits such as virulence, pathogenicity, immunogenicity, and drug resistance. B. Modeling of host factors that may play a role in disease onset and progression; modeling within host infectious agent dynamics. C. Modeling of the host response to overexposure to pathogens and their products. II. MODELING OF DISEASE EPIDEMIOLOGY AND FORECASTING SYSTEMS Examples of research topics include, but are not limited to: A. Modeling of climatic, geographic, epidemiological, entomological, and ecological data to evaluate disease transmission dynamics. o Exploration of the relationships among climate variability, geographic disease patterns, and pathogen, vector, reservoir, and host ecology and its impact on disease emergence and maintenance. o Use of remote sensing technology to characterize and monitor spatial and temporal patterns of emerging infectious diseases. B. Modeling of the evolution and adaptation of known pathogens, evolving pathogens, and engineered strains to new hosts and new environments. C. Modeling of insect migration patterns and disease transmission in vector-borne diseases. III. MODELING OF RESPONSE SYSTEMS Examples of research topics include, but are not limited to: A. Early Response: o Simulation and virtual environments to understand the dynamics of intentionally released pathogens and their products o Modeling of early detection of epidemics using unconventional parameters o Modeling transmission dynamics using simple and complex transmission routes, and single and multiple biological agents o Modeling structure and dynamics of social networks in disease transmission o Modeling differential diagnostic tools (including modeling parameters for establishing criteria to discriminate between intentionally released pathogens and naturally occurring outbreaks) B. Mid-term Response: o Modeling strategies for vaccination and treatment with antimicrobials and antitoxins, and methods for evaluating these strategies o Modeling deployment and administration of stockpiles of vaccines, antimicrobials, and antitoxins to affected areas; allocation of resources and manpower C. Long-term Response: o Modeling quantitative and qualitative effects of radiation- and chemically-induced damage to biological processes in viruses, prokaryotes, and eukaryotes from decontamination and inactivation procedures o Modeling dispersion of pathogens and their products in confined and open environments (e.g., office buildings, subway systems, hospitals, others) The specific roles of Research Groups and the Informatics Group are described in "Special Requirements" below. MECHANISM(S) OF SUPPORT The NIH U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." The earliest anticipated award date is April 2004. Based on continuing assessment of the need for and success of the program, NIGMS may reissue this announcement to add new components to the network. Institutions may submit applications for a Research Group, an Informatics Group, or both. If an institution chooses to apply for both a Research Group and the Informatics Group, it should submit two separate applications. To maintain its flexibility, NIH may choose to award one or the other application, or both. FUNDS AVAILABLE NIGMS intends to commit approximately $7 million in FY 04 to fund up to three new pilot projects and a database in response to this RFA. An applicant for a Research Group may request a project period of up to five years and a budget of up to $0.5 million direct costs per year, including direct costs for equipment and subcontracts. An applicant for an Informatics Group may request a project period of up to five years and a budget of up to $3 million direct costs per year, including direct costs for equipment and subcontracts. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of NIGMS 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 Domestic institutions 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. Foreign institutions may participate only as collaborating institutions. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop applications 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 Organizational Structure The MIDAS Network will comprise three components: a Steering Committee, Informatics Group, and Research Groups. The Steering Committee will be the main managing body for MIDAS. The committee will include representation from each of the Research Groups and the Informatics Group, as well NIH Scientist Administrators with relevant expertise. Outside expertise may be added as needed to ensure sufficient breadth and balance on the committee. NIH Scientist Administrators will not comprise more than 40% of the voting members of the Steering Committee. NIGMS will form the Steering Committee soon after awards are made. The Informatics Group is responsible for the design, development, implementation, and maintenance of the MIDAS database. The database will contain (a) comprehensive information about the systems being studied by the Research Groups and (b) results, tools, and models developed by the Research Groups. The group will consist of computational biologists, bioinformatics scientists, mathematicians, and statisticians. The Informatics Group will name its own advisory committee, which will consist of scientists from institutions outside the MIDAS Network who have appropriate expertise to evaluate the progress made toward achieving the MIDAS informatics goals and objectives. The Research Groups will be teams of multidisciplinary, collaborating scientists from one or more institutions who have expertise in fields relevant to the thematic areas in which they are conducting research. Research Groups will conduct research in computational, mathematical, and engineering approaches to modeling data on emerging infectious diseases. Research Groups will not generate primary data; rather they will use existing sequence, genetic, epidemiological, clinical, climate, etc. information to conduct research. Each MIDAS Research Group should make a commitment to focus MIDAS research on specific tasks of national importance, should the need arise. Description and Tasks of the MIDAS Research Network Steering Committee The Steering Committee will oversee the organization and progress of MIDAS. The committee will make recommendations on how data should be collected and displayed and will encourage uniform and complete collection of data. The Steering Committee will oversee the development of the MIDAS Database and seek common guidelines and procedures for depositing information. The committee will set standards for data formats and nomenclatures and make recommendations for submitting data produced outside the MIDAS Network to the MIDAS Database. The Steering Committee also will identify scientific issues that need to be addressed and can establish information-gathering subcommittees to follow up on particular issues or needs. NIGMS may ask the MIDAS Network to conduct research related to scenarios, policy decisions, or events involving an emerging infectious disease or intentionally released pathogen. The Steering Committee will oversee implementation of these MIDAS tasks and may request additional resources for components of the Network. The Steering Committee will coordinate communications among all members of the MIDAS Network regarding data sharing, scientific and database issues, and other issues related to the MIDAS goal and objectives. The committee will coordinate the monthly telephone conference calls during which the Research Groups and the Informatics Group will present progress reports. The Steering Committee also will plan the annual meeting at NIH during which the members of the MIDAS Network will present their findings and address problems. The Steering Committee will establish policies for disseminating the models and results of MIDAS research to the larger scientific, policymaking, and public health communities. The committee will suggest time frames for making different datasets publicly available and will recommend restricted access to data when issues of national security are involved. The Steering Committee will establish data release policies, taking into consideration the plans proposed by the Research Groups and the Informatics Group. A comprehensive policy will be implemented throughout the MIDAS network. NIGMS expects applicants to define time frames for depositing data in public-domain databases as determined by the Steering Committee. Release policies may take into account the need for further experimentation to validate data, models, scripts, neural networks, and computational tools. Different time constraints may be defined for different datasets. Research Groups Research Groups will use existing or simulated datasets, as well as real-time information, to build computational models relevant to the goals of MIDAS. Because the components of host-pathogen systems are numerous and complex, models need to elucidate and predict their dynamic interactions. Modeling is needed to design new and improved parameters for disease surveillance and forecasting. In the absence of real data to support strategic planning for a bioterrorist attack, mathematical modeling is fundamental to the design of alternative intervention strategies and will help to guide training exercises, scenario building, risk assessment, resource allocation, health care management, and other activities. Ultimately, theoretical and practical frameworks will be used to anticipate, prevent, and plan responses to bioterrorist attacks. The same principles apply to the control and prevention of, or response to, emerging infectious diseases. As a self-assembled, cross-disciplinary team of investigators, each Research Group offers a unique blend and breadth of complementary research expertise. A Research Group will conceive, develop, and conduct research to improve knowledge relevant to the goal and objectives of MIDAS. Each Research Group must focus on developing and applying mathematical and computational tools to promote understanding of complex biological systems and their interactions. Research Groups will not generate primary data, except in the case of simulations. Each Research Group must identify a data liaison person to interact with the Informatics Group. This basic or bioinformatics scientist will advise the Informatics Group on the management and display of data generated or used by the Research Group. Research Groups are likely to develop their own (local) databases to meet their computational needs. They may request funds to support the design, testing, and validation of bioinformatics tools and the storage of data needed to accomplish their research objectives. Each Research Group will be required to use the standard data exchange format established by the Informatics Group for transmitting information among projects. Each Research Group must propose a data release policy and a separate plan that addresses intellectual property rights, both of which will be reviewed and may be modified by the Steering Committee. (For more detail on intellectual property, see the section under "Special Requirements.") Each Research Group will present monthly progress reports via a telephone conference convened by the Steering Committee for all members of the MIDAS Network. In addition, each Research Group will present its research findings at annual meetings of the network, which will be held in Bethesda, MD. Each Research Group is encouraged to have an independent advisory group to provide advice on scientific issues unique to the group's research program. Such a group should not be established until after an award is made. The Informatics Group The Informatics Group will support and extend the work of the Research Groups by collecting, organizing, and curating data relevant to the systems they are studying, providing computational and analytical tools, establishing data standards, creating simulations, designing tests to validate data and models, and making the results and models of the Research Groups publicly available. These tasks are described below. The Informatics Group will design, implement, and manage a centralized database to store and display information for the MIDAS Network and for allowing complex queries of data relevant to the Research Groups. The Informatics Group will work with the Research Groups and Steering Committee to identify, gather, organize, and curate information relevant to the MIDAS research projects. Research Groups may identify or submit this information; however, the Informatics Group should be proactive in identifying and working with other data sources. Data should be managed so that it will be accessible and interpretable by users outside the Network who may be interested in this resource. Data will be obtained from a variety of sources, some from public databases. For example, the National Aeronautics and Space Administration compiles remote sensing and geodesy data (e.g., indices of spectral vegetation, land surface temperatures, and atmospheric moisture and rainfall) that have epidemiological and public health applicability. The Informatics Group must demonstrate its ability to obtain information for the MIDAS Database and provide links to other useful databases. The Informatics Group will establish, within six months of the award, a standard data exchange format that can be used by all members of the MIDAS Network and that will allow for maximum interoperability with other databases containing information relevant to the MIDAS goal and objectives. The Informatics Group also may establish links to other databases which may contain information that is relevant to MIDAS Research Groups. The Informatics Group also will deposit computational tools for data analysis for use by the MIDAS Research Groups and by the scientific community. These tools may include data mining and analysis tools, multidimensional classification tools, data clustering tools, visualization tools, scripts, computer algorithms, artificial networks, and computer software. The Informatics Group will make available to the scientific community, policymakers, and public health officials the products and results of the MIDAS Network. The Informatics Group will develop interfaces and tools suitable for members of the Research Groups, for other research scientists, for public health officials, for policymakers, and others. The MIDAS Database may be constructed, implemented, and utilized in a modular fashion as data become available. NIGMS does not plan to define the structure and content of the database. The MIDAS Network will be responsible for identifying the relevant information, structure, and supporting tools for the database. The Steering Committee will provide oversight for construction of the database and implementation of analytical tools. When recommended by the Steering Committee, data that are relevant to MIDAS Research Groups, but produced outside the MIDAS Network, can be submitted to the MIDAS Database. These data must meet the same standards of integrity, quality, and curation that are defined for the MIDAS Database. Although the MIDAS data can be organized in various ways, the database must provide data and computational resources for the three thematic research areas. Information for the modeling of host-pathogen systems will include data on biological, genetic, and disease systems of organisms related to emerging infectious diseases and biological weapons or their model counterparts. Information for the modeling of disease epidemiology and forecasting systems will include data on the natural history, ecology, population dynamics, evolution, and biogeography of emerging infectious disease agents and intentionally released pathogens and their model counterparts. The construction and validation of models of response systems will depend on establishment of an integrated connectivity between the host-pathogen and disease epidemiology and forecasting systems. Ideally, it will be possible to establish functional relationships among the data developed across the three thematic systems. The database should be designed to serve as a foundation for future hypothesis-driven experiments, which could uncover previously unsuspected correlations and perhaps help to identify new and accurate predictors of epidemics. The goal is to manage complex, interconnected data with unknown patterns and relationships, and to integrate these data while retaining their biological meaning. The Informatics Group will monitor the overall structure and operation of the database for data quality, accuracy, completeness, specificity, and non-redundancy. The group will define format and document files, as appropriate, to facilitate the comprehensive sharing of data within the scientific community and across federal agencies and to ensure connectivity with other databases. The Informatics Group will make available to the public extensive documentation about the data and computational tools, including statistical reports and analyses, as well as supporting documentation for analytical tools. The Informatics Group will be required to curate data according to guidelines established by the Steering Committee. The Steering Committee will conduct periodic reviews and may require frequent updates to ensure that the data are of high quality and relevance. Implementation of Web-based tools and public access to the database are crucial parts of the overall effort. The Informatics Group must propose a data release policy and a separate plan that addresses intellectual property rights, both of which will be reviewed and approved by the Steering Committee. (For more detail, see the section under "Special Requirements.") The Informatics Group may be called upon to generate sophisticated simulated data to test models and to collect real data to validate models. The Informatics Group will present monthly progress reports via a telephone conference call convened by the Steering Committee for all members of the MIDAS Network. In addition, the Informatics Group will report progress at annual meetings of the Network, which will be convened in Bethesda, MD. Definitions AWARDEE: The institution awarded a cooperative agreement. COOPERATIVE AGREEMENT (U01): A mechanism of support that allows NIH staff to have substantial programmatic involvement in coordination with awardees during the performance of planned activities. MODELS OF INFECTIOUS DISEASE AGENT STUDY (MIDAS): Research Groups and an Informatics Group, each funded by a separate cooperative agreement, working together to develop and promote use of computational biology and mathematical tools to better understand emerging infectious diseases (naturally occurring or resulting from the intentional release of pathogens) and response measures. MIDAS NETWORK: The Steering Committee, Research Groups, and Informatics Group. These groups will work cooperatively to meet the goals of the program; set and meet milestones; and produce and make available information, research results, and models to the scientific community, policymakers, and public health community. STEERING COMMITTEE: The main governing body of MIDAS. The members include representation from each of the Research Groups and the Informatics Group; NIH Scientist Administrators with appropriate scientific expertise; and selected scientists outside the MIDAS Network, as needed to provide additional expertise and breadth and balance on the committee. NIH representation on the Steering Committee will never compose a majority of the members. RESEARCH GROUP: A team of multidisciplinary, collaborating biological scientists, epidemiologists, clinical and health care managers, mathematicians, computational biologists, and statisticians (at one or several sites) employing a state-of-the-art, comprehensive approach to the study of emerging infectious diseases (naturally occurring or resulting from the intentional release of pathogens). INFORMATICS GROUP: A team of computational biologists, bioinformatics scientists, mathematicians, computer software engineers, and computer programmers responsible for the design, development, implementation, and maintenance of MIDAS information management. MIDAS DATABASE: A comprehensive database containing biological, epidemiological, and operations management information and computational tools and methods for appropriate storage, management, and display of this information. PRINCIPAL INVESTIGATOR: The person who assembles the project (for a Research Group or the Informatics Group) and is responsible for submitting the application in response to this RFA and for performance of the project. NIGMS PROGRAM DIRECTOR: NIGMS extramural staff person who provides stewardship for the awards, evaluates and implements the advice of the Steering Committee regarding allocation of NIH support, and coordinates the administrative management of MIDAS. NIH SCIENTIST ADMINISTRATORS: NIH extramural staff who, as voting members of the MIDAS Steering Committee, have a substantial role in coordinating the scientific activities of MIDAS and making recommendations based on their knowledge of other related NIH-supported research and resource activities. ARBITRATION PANEL: A panel formed as needed to review scientific or programmatic disagreements (within the scope of the award) that may arise between MIDAS investigators and NIH. The panel will be composed of three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a designee who has expertise in the relevant area who is chosen by the other two designees. When disagreements are between individuals, the awardee seeking arbitration may choose the first member of the panel. General Issues NIGMS has adopted several policies that are applicable to the MIDAS Network. Applicants must present plans to adhere to the policies, where appropriate. Research Training. In many cases, the research projects envisioned at this stage of MIDAS may not be appropriate as research training projects. Applicants planning to employ graduate students and/or postdoctoral research assistants on their project should address this training issue in their applications. NIGMS will give consideration to training opportunities if the project proposed involves substantial experimental work. Intellectual Property. Institutions and investigators are expected to share background technology and intellectual property on a non- exclusive and royalty-free basis with all participating institutions, as required to achieve the scientific goals of the collaborative research. In case an invention involves multiple institutions, the co- inventors are expected to cooperate in the filing of any resulting patent applications and in developing a plan to achieve commercial application of the technology. Applicants should present plans related to intellectual property rights, which should comply with the regulations mentioned above. Guidance for extramural investigators regarding intellectual property issues is available at http://ott.od.nih.gov. These plans will be reviewed by the MIDAS Steering Committee subsequent to an award. Plans may be modified to bring them into compliance with MIDAS policy. Data Release and Sharing of Results and Resources. The MIDAS Network will generate virtual and collected data and mathematical and computational tools. Grantees should plan on sharing theoretical and experimental findings with other members of the MIDAS Network at annual MIDAS meetings and at scientific meetings. Results and models will be made available through the MIDAS Database. Applicants must include in their applications a detailed description of their proposed guidelines for data release. The final data release policy will be established by the MIDAS Steering Committee. Because of the potential benefits of MIDAS to the larger research and public health community, NIGMS will enforce a policy for timely release of data, which will be implemented in consultation with the MIDAS Steering Committee. The data release policy proposed for the MIDAS Network will be subject to future modifications, to comply with evolving NIH guidelines. The data release policy for the MIDAS Network will be stated clearly on the Network's website. NIGMS expects that users of the released data will appropriately acknowledge their source. All data should be made publicly available no later than the submission for publication. The release of information on host-pathogen interactions, disease transmission, diagnosis, surveillance, forecasting, and control, and antimicrobial treatments for emerging infectious diseases should follow NIH guidelines. Because information on strategies for response preparedness, which include advanced planning and crisis planning, may involve issues of national security, some parts of the MIDAS Database may contain confidential or secure data, models, and tools. Management Plan. Management of the MIDAS Network will involve a significant commitment by Principal Investigators. NIGMS expects each Principal Investigator to devote substantial effort to the project. Applicants must propose a management plan that takes into account changes in focus and effort that may be needed during the three-year term of the award. In the event of an attack or the emergence of an infectious disease, NIGMS may ask the Principal Investigators of MIDAS Research Groups to apply their expertise to the public health emergency. In this case, the Principal Investigators may need to dedicate considerable effort to help resolve the crisis. Should this occur, NIGMS will be flexible in allowing the Principal Investigator to reorganize and reorient specific project goals and to renegotiate the scope of the grant to include new objectives. The awardee may also be able to request additional funding to cover costs that were not included in the initial application. The National Institute of Allergy and Infectious Diseases (NIAID) may take advantage of the MIDAS infrastructure to further its mission in biodefense by directly supporting MIDAS sites. The grantee institution will be eligible to receive such an award if the Principal Investigator's percentage of effort requested does not exceed 50 percent of his or her time and the scientific objectives of the projects funded by NIGMS and NIAID do not overlap. The NIAID and NIGMS Program Officers will carefully analyze these exceptional situations and, together with the MIDAS Steering Committee, make recommendations concerning additional funding or additional awards. Annual Meeting. NIGMS expects grantees in the MIDAS Network to attend an annual meeting in Bethesda, MD, to discuss their progress and results. Applications should include travel funds for the Principal Investigator and scientific team to attend these meetings. Monthly Conference Calls. NIGMS expects grantees in the MIDAS Network to hold monthly telephone conference calls to exchange and update information and to discuss scientific and database issues. The Steering Committee will coordinate conference calls, which will include the Principal Investigators of each Research Group the Informatics Group, and the NIGMS Program Director. Cooperative Agreement Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and will be provided to the Principal Investigator and the appropriate institutional official at the time of award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, DHHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local governments are eligible to apply), and other DHHS, PHS, and NIH grant administration policies: The administrative and funding instrument used for this program will be the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) of support when NIH anticipates having substantial programmatic involvement with awardees during performance of the activities. Under a cooperative agreement, the NIH aims to support and stimulate awardees' activities by involvement in and otherwise working jointly with the awardees in a partnership role. NIH does not assume direction, prime responsibility, or a dominant role in grant activities. Awardees have the dominant role and prime responsibility for the project as a whole, although responsibility for specific tasks and activities may be shared by awardees and the NIH through their participation on the MIDAS Steering Committee. 1. Principal Investigator Rights and Responsibilities The Principal Investigator will coordinate project activities scientifically and administratively at the grantee institution. The Principal Investigator will have primary responsibility for defining the details of the projects within the guidelines of this RFA GM-03-008 and for performing scientific activities. The Principal Investigator will agree to accept the close coordination, cooperation, and participation of NIH staff in the aspects of project management described under "NIH Scientist Administrators Responsibilities." Awardees agree to accept and implement the policies and guidelines of the MIDAS Steering Committee. Awardees will retain custody of, and have primary rights to, data developed under these awards, subject to Government rights of access consistent with current federal, DHHS, and NIH policies. Awardees should comply with their institution's policies and practices concerning intellectual property, as approved in the award. The Principal Investigator of a Research Group or the Informatics Group will: o Determine and coordinate research approaches and procedures o Set project milestones for the Research Group or Informatics Group o Implement policies and guidelines approved by the MIDAS Steering Committee o Submit data to the MIDAS Database according to policies established by the Steering Committee o Attend Steering Committee meetings o Contribute to the cooperative nature of the effort. 2. NIH Scientist Administrators Responsibilities: NIH Scientist Administrators with expertise in relevant areas will serve on the Steering Committee as representatives of the NIH extramural staff and will be substantially involved above and beyond normal stewardship. They will help guide the development of the MIDAS Network by providing overall advice and coordination. They will facilitate a partnership among NIH, the Research Groups, and the Informatics Group, and they will ensure that the directions taken by MIDAS are consistent with NIH missions and goals. The Scientist Administrators will make recommendations regarding support, to maintain a scientific balance between accomplishing the goal and objectives of MIDAS and addressing emerging research opportunities. NIH staff will facilitate, not direct, activities. Decisions will be reached through consensus with the Principal Investigators and other members of the MIDAS Steering Committee. The NIH Scientist Administrators will: o Share relevant expertise and overall knowledge o Help to coordinate activities among awardees o Be the information source for NIH-supported research and resources o Attend Steering Committee meetings o Contribute to the cooperative nature of the effort o Promote MIDAS research, results, tools, and methods to the scientific community, policymakers, and the public health community o Help to implement recommendations for allocating NIH support to grantees. 3. NIGMS Program Director The Program Director has day to day responsibility for administration of the project and stewardship of funds. The Program Director is a central contact for all scientific and fiscal issues and serves as a resource to the project regarding DHHS, NIH, and NIGMS recommendations and policies. The Program Director or designate will attend all Steering Committee meetings but is not a voting member of the Steering Committee. The Program Director will: o provide stewardship for the awards o evaluate and implement the advice of the Steering Committee regarding allocation of NIH support o ensure compliance with DHHS, NIH, and NIGMS policy o coordinate the administrative management of MIDAS 4. Collaborative Responsibilities the MIDAS Steering Committee The MIDAS Steering Committee is the managing body for MIDAS. Voting members will include representation from each Research Group and the Informatics Group, NIH Scientist Administrators with appropriate scientific expertise (e.g., computational biology, mathematics, epidemiology), and selected scientists from outside the MIDAS Network, as needed, to gain additional expertise and breadth and balance on the committee. NIH representation (Scientist Administrators) will not comprise more than 40% of the voting members on the Steering Committee. The NIGMS Program Director is not a member of the Steering Committee, but will facilitate formation of the group and will attend all meetings. Members of the Steering Committee who are MIDAS awardees must accept and implement guidelines and policies approved by the Steering Committee. Within approximately one month after NIGMS awards the cooperative agreements for MIDAS, the NIH Scientist Administrators and the Principal Investigators will meet (in person or by telephone conference call) to select the outside members of the Steering Committee and to elect a Chair for the committee. NIH staff may not serve as Chair. The NIGMS Program Director will schedule the first meeting of the Steering Committee. The Chair will be responsible for developing meeting agendas and chairing meetings. At the first meeting, the Steering Committee will decide on the schedule of meetings. The committee will meet twice each year, usually in Bethesda, MD. At approximately the same time as these meetings, the data liaison persons of the Research Groups and a representative of the Informatics Group also will meet, possibly in Bethesda, MD, or at the MIDAS Database site. The Steering Committee may establish subcommittees as necessary. The Steering committee also may add members, with the approval of the NIGMS Program Director. The Steering Committee will: o Serve as the main governing board of the MIDAS Network o Set milestones for the MIDAS Network o Assess progress within the MIDAS Network o Standardize the data format and nomenclature for the MIDAS database o Develop guidelines and policies for data sharing and release to public domains o Consider the views of other researchers o Contribute to the development of a cohesive effort o Alert NIH to scientific opportunities, emerging needs, and impediments. 5. Arbitration Process Any disagreements about scientific or programmatic matters within the scope of the award between award recipients and the NIH may be brought to arbitration. NIGMS will convene an Arbitration Panel composed of three members: a designee of the Steering Committee, who is chosen without NIH staff voting; one NIH designee; and a designee who has expertise in the relevant area and who is chosen by the other two designees. For disagreements between individuals, the awardee seeking arbitration may choose the first member of the panel. This special arbitration procedure does not affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulation 45 CFR Part 16. 6. Milestones and Evaluations Applicants should define yearly milestones in their applications. Awardees will have an opportunity to modify their milestones when they receive their awards. NIGMS will provide the awardees' milestones to the Steering Committee. NIGMS expects that milestones will be adjusted annually, at the anniversary dates of the award, to incorporate scientific accomplishments and progress in the field and to reflect recommendations of the Steering Committee. NIH Scientist Administrators may recommend augmenting any project, as discussed with the Steering Committee, or reducing or withholding funds for any project that substantially fails to meet milestones or to remain state- of-the-art. The Director, NIGMS, retains the right to call a meeting of advisors, which would most likely be members of the National Advisory General Medical Sciences Council or their designee(s), at any time to consult on the scientific progress of the MIDAS Network. As part of its fact finding, the advisors may want to attend a meeting of the Steering Committee. NIGMS will share any information or reports with other ICs participating in this initiative and with the Director, NIH. 7. Issues in Research Involving Human Subjects Human Subjects Research must meet the requirements of 45 CFR 46 "Protection of Human Subjects". Research supported in response to this initiative may include clinical and epidemiological data obtained from patients of different racial, ethnic, and socio-cultural populations or from individuals and families affected by particular infectious diseases. The study of emerging infectious diseases can lead to valuable knowledge of appropriate measures to identify, control, prevent, and treat these diseases. This value will be diminished if information is misinterpreted or misused to stigmatize or discriminate against defined populations. It is of paramount importance that the symptomatic or asymptomatic carrier statuses of all individuals remain strictly confidential. NIGMS expects awardees to ensure that the potential impact of the research on individuals and groups participating in the study, the potential risks of stigmatization and discrimination, the confidentiality of the data, and the benefits of the knowledge to be gained are addressed in the study protocol and informed consent process, and receive IRB approval. Investigators must obtain from all participants thorough, current, and clear informed consent and subjects must be informed that information generated from their samples may be deposited into the MIDAS Database. Before submitting data to public databases and/or the MIDAS Database, awardees must remove any information that would identify the individuals to whom the data pertain. 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: Irene Eckstrand, Ph.D. Division of Genetics and Developmental Biology National Institute of General Medical Sciences 45 Center Drive, Room 2AS.25K, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-0943 FAX: (301) 480-2228 Email: eckstrai@mail.nih.gov o Direct your questions about peer review issues to: Helen R. Sunshine, Ph.D. Chief, Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Room 3AN.12F, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 Email: sunshinh@nigms.nih.gov o Direct your questions about financial or grants management matters to: Joe Ellis Grants Administration Branch National Institute of General Medical Sciences 45 Center Drive, Room 2AN.32C, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5135 FAX: (301) 480-2554 Email: ellisj@mail.nih.gov PUBLIC BRIEFING Prospective applicants are invited to attend a public briefing on the MIDAS Research Network on April 23, 2003 in Bethesda, MD. NIH staff will explain the purpose of this RFA, provide instructions regarding the application process, and answer questions. Potential applicant institutions are urged to send a representative to this briefing, both to gather information and to exchange ideas with other potential applicants. Anyone who cannot attend the pre-application meeting will be provided with any distributed materials and a summary of the discussion. The meeting will be held as follows: April 23, 2003, 9 AM 12 PM Natcher Conference Center National Institutes of Health For further information about this meeting, contact the NIGMS Program Staff listed under INQUIRIES. 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: Irene Eckstrand, Ph.D. Division of Genetics and Developmental Biology National Institute of General Medical Sciences 45 Center Drive, Room 2AS.25K, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-0943 FAX: (301) 480-2228 Email: eckstrai@mail.nih.gov 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 Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Applicants may propose a Research Group or an Informatics Group by submitting an integrated application for either group. Applicants proposing both a Research Group and the Informatics Group must prepare separate applications for each group. Applicants should also address the information required in the SPECIAL REQUIREMENTS section above. Applicants should present a comprehensive and interdisciplinary team approach to the problem identified for study. The application should include a face page, description, consolidated budget, list of key personnel, biographical sketches, existing resources and facilities, and letters of collaboration. The page limit for the research plan (which should include specific aims, background and significance, preliminary studies, research design, and methods) is 60 pages. Applicants must include a proposed timeline and plan that set forth specific goals (milestones) to be achieved in the first, second, and third year of the award. Applicants should request resources commensurate with the goals they have proposed. Following the instructions in the PHS 398, section e. Human Subjects, plans for recruitment, informed consent, and protection of privacy and confidentiality of human subjects must be addressed clearly in the application, and reviewers will consider these plans during the review process. Other resources are the OPRR Institutional Review Board Guidebook Chapter 5 - Human Genetics Research (http://www.hhs.gov/ohrp/irb/irb_chapter5.htm) and other applicable sections, and the Ethical, Legal, and Social Issues (ELSI) Program of the National Human Genome Research Institute (NHGRI) (http://www.genome.gov/page.cfm?pageID=10001618), for information on protection of human subjects related to research in infectious diseases. NIH program staff (listed below) also can provide guidance on current NIH policies and practices in this area. Applicants may consider obtaining Certificates of Confidentiality and are encouraged to look at the Kiosk http://grants.nih.gov/grants/policy/coc/index.htm. Certificates of Confidentiality may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. All applicants should provide sufficient detail in all parts of the application to enable reviewers to readily and completely understand the proposed project and approach. Applications for a Research Group should include an overview section that defines the scope, research goals and objectives, and describes the rationale for selecting the particular areas of scientific concentration (i.e., at least two of the three thematic research areas previously defined in this RFA). Some components of a research project may be cores or resources that are integral to the entire group. Applications for the Informatics Group should include an overview section that defines the scope, research goals and objectives and describes a strategy for creating the MIDAS Database. Applicants should specify how they will design and develop the database and how they will make it available to users. Applicants for the Informatics Group should address all aspects of the database design, clearly explain and justify their proposed approaches, and give examples whenever possible. Specific issues to address include: optimal database design, timetable for database development, most appropriate nomenclature determined as possible and in advance, conditions for collecting biological information, timing for the submission of information, stages in the development of the database (e.g., raw versus finished data, validated versus invalidated data), validation of deposited information, mechanism(s) for correcting errors in the database, obtaining peer or editorial reviews of data, coordination of comments from scientific users, and identification and installation of appropriate database links. The applicant's plan also should describe in detail the computational tools and specific supporting documentation that the Informatics Group will design and make available to all members of the Network. In addition, applicants should address the following areas, as appropriate, in their applications: For a Research Group: o Describe the group's policies for data release into the MIDAS Database or other databases. o Identify a data liaison person who has appropriate expertise and who will interact with the Informatics Group o Describe how the reviews and comments of MIDAS scientists will be incorporated into the scope of the research project For the Informatics Group: o Describe the timing and method desired for receipt of information into the Database. o Provide evidence of communication or links with a proposed Research Group or similar site and assurance that appropriate expertise is available for interactions. For a Research Group or Informatics Group: o Describe your institution's intellectual property policies and practices, including policies for commercialization of discoveries, and the implications of these policies for the MIDAS project. o Identify any unique institutional resources, services, or facilities that would benefit the program o Describe any other support or projects that have a significant impact on this application o Describe plans for sharing any materials (e.g., software tools, microbiological samples) with other researchers. o Describe the mechanisms for administration of research activities within the group (e.g., regular meetings, staffing, data exchange, external evaluations). o Request funds for the Principal Investigator or designate to attend two Steering Committee meetings annually in Bethesda, MD. o Request funds for the database liaison person to meet with a representative of the Informatics Group two times annually in Bethesda, MD, or at the Informatics Group site. 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 must be sent to: Helen R. Sunshine, Ph.D. Chief, Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Room 3AN.12F, MSC 6200 Bethesda, MD 20892-6200 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 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. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NIGMS. 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 NIGMS 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 General Medical Sciences Council. 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 the 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 the application's overall score, weighting them as appropriate for each application. 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 this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 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? COOPERATION: Does the team demonstrate its willingness and capability to work with other members of the MIDAS Network to enhance the project's productivity? Are the plans for sharing research findings, tools, and methods among Network members adequate? 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: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below). 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. 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: May 19, 2003 Application Receipt Date: June 18, 2003 Peer Review Date: October/November 2003 Council Review: January 2004 Earliest Anticipated Start Date: April 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 o Program balance The NIH retains the flexibility to select and assemble components of the MIDAS Research Network that optimally blend the applicants' research areas, experience, creativity, collective knowledge, and combined expertise in the background sciences. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended _10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 Nos. 93.113, 93.172, 93.242, 93.273, 93.837, 93.859, 93.862, 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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