Full Text AI-95-013 RESEARCH ON HANTAVIRUS AND OTHER EMERGING VIRAL THREATS NIH GUIDE, Volume 24, Number 13, April 7, 1995 RFA: AI-95-013 P.T. 34 Keywords: Viral Studies (Virology) Infectious Diseases/Agents National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: June 1, 1995 Application Receipt Date: July 20, 1995 PURPOSE The Virology Branch of the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for the establishment of Emerging Viruses Research Groups (EVRG). The purpose of this RFA is to encourage multi-disciplinary, collaborative research on emerging viral diseases in general, with a special emphasis on hantaviruses. These research groups should develop coordinated basic and applied research projects yielding new data that will enhance prediction, prevention, treatment, and control of emerging and re-emerging viral diseases threatening the U.S. Furthermore, EVRGs must have at least one of the component research projects dealing with hantaviruses, with at least one other component project focused on another emerging viral disease. Since other initiatives are available to support research on influenza, hepatitis, herpes, papilloma, respiratory syncytial, measles, and retroviruses/HIV, projects on these viruses will not be considered responsive to this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request For Applications (RFA), Research on Hantavirus and other Emerging Virus Threats, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic non-profit and for-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply, but may be part of a collaborative arrangement in a domestic application. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the program project (P01) grant. This mechanism supports broadly based multi-disciplinary research programs that have a well-defined central research focus or objective. An important feature of the program project is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The program project grant also can provide support for certain common resources, termed 'cores.' Such resources should be utilized by two or more projects within the program project. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period may not exceed four years. The earliest anticipated award date is April 1996. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $1.0 million. In Fiscal Year 1996, the NIAID plans to fund two EVRGs. The final number of awards to be made and level of support is dependent upon the availability of funds and receipt of a sufficient number of applications of high scientific merit. The initial year's total costs, including direct and indirect costs, should not exceed $500,000 for each award except for the optimal remote sensing projects (see special requirements). The usual PHS policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background The emergence of the AIDS epidemic and the appearance of hantavirus in the Southwestern U.S. have demonstrated the vulnerability of the U.S. to emerging viruses. The NIAID recently co-funded two studies by the Institute of Medicine dealing with emerging diseases (see: Institute of Medicine: Emerging Infections--Microbial Threats to Health in the United States, National Academy Press; and The U.S. Capacity to Address Tropical Infectious Disease Problems, National Academy Press). These studies warned that the threat posed by disease-causing microbes may be expected to continue and intensify in coming years. Factors influencing the pattern of emergence and distribution of infectious diseases in general include those associated with the microbial agent itself, the agent's hosts and vectors, and the environment in which agent and host interact. However, for many infectious agents, the specific factors contributing to emergence are poorly understood. Nonetheless, knowledge of these principles is essential in planning strategies to prevent, treat, and control these diseases. The overall objective of this RFA is to gain new knowledge about emerging viruses by supporting coordinated, multi- disciplinary research programs. The natural life cycle of many viruses is multi-faceted and in addition to the virus, may include one or several reservoir or amplifying hosts, and often an arthropod vector. A change affecting the interaction of these fundamental elements might lead to the emergence or re-emergence of a viral disease. Natural or man-made changes to the environment typically impact on virus vectors or hosts. A recent example of the role of natural changes in the environment contributing to the emergence of disease is the 1993 appearance of hantavirus in the Southwestern U.S. It is now thought that the virus in part emerged as a result of climatic and environmental conditions favorable for increased infected rodent populations. Nonetheless, man-made changes to the environment also lead to the emergence of disease. There have been several accounts of endemic viruses emerging and spreading as the result of such changes as: (a) development of dams and water projects resulting in altered water distribution patterns, (b) deforestation and changing land-use associated with the development of new communities, and (c) the introduction of new virus-amplifying hosts or the expansion of new vectors as the result of changing commercial practices. An example of the influence of man-made environmental changes is the 1987 epizootic of Rift Valley fever in the Senegal river basin, where the emergence of the virus from low level, endemic circulation closely coincided with beginning operation of a major new dam. It is thought that the virus emerged as a result of environmental changes favorable for increased or altered mosquito vector populations, and possibly changes in migration of herds of domestic animal hosts. Historically, commerce has often brought new viruses, vectors, or hosts into an area. A classic example is the spread of yellow fever in the western hemisphere in the 19th and early 20th century. Impending expansion of worldwide commercial trade may facilitate the emergence of new viruses, or increase the spread of previously known viruses to a more receptive environment. In some instances, viruses might emerge as the result of selection of new genetic strains and variants with increased infectiousness, virulence, or transmissibility This has been well-established as a cause for the emergence of new influenza outbreaks, and, in an analogous fashion, probably contributes to the emergence of other viruses, particularly, the bunyaviruses. Unfortunately, until research leads to effective prevention/treatment strategies, the initial population in which the virus emerges can be disproportionately affected. In the case of the emergence of hantavirus, 34.3 percent of the 102 well-documented cases have occurred in the Native American population, and the overall case fatality rate has been 52 percent. Major impediments in meeting these emerging virus threats are the recent decrease in the number of researchers addressing arthropod-borne and zoonotic viruses, and the formidable research problems posed by the need for input from several disciplines. This RFA is intended to stimulate: (1) basic and applied research that will help formulate coordinated strategies for anticipating, detecting, controlling, and preventing emergence or re-emergence of viral diseases; and (2) basic and applied research on the virus, on the infective process, and the host response to infection, which will be useful in development of vaccines and antiviral drugs. Objectives and Scope The overall objective of this RFA is to stimulate and expand research on emerging viruses by establishing multi-disciplinary, coordinated research groups. Unfortunately, gaps in the knowledge of emerging viruses remain in several areas, and there are limited numbers of researchers and laboratory groups studying these viruses. Thus, it is recognized that at this time, resources and basic data might not be available for each EVRG to comprehensively approach a full range of studies related to a virus. For some viruses, such as dengue, a relatively large amount of basic information exists, and focused research questions and detailed experimental strategies can be formulated. However, other emerging viruses, such as hantaviruses, have only recently been identified or implicated as a disease threat. The goals of appropriate, state-of-the-art research for those viruses will be less sophisticated, but no less important. Thus, it is anticipated that the general aims and the scope of research projects proposed under this RFA might vary significantly. Additionally, it is unlikely that any one laboratory center could provide a comprehensive research team; therefore, strong collaborative links will probably be integral to a successful EVRG. It is hoped that this program eventually will help build a critical mass of investigators with expertise in the varied laboratory, field, and clinically-based lines needed for the comprehensive study of emerging viral diseases. EVRGs should be broadly-based multi-disciplinary research programs that have a central research focus and a minimum of three inter- related research projects around this central theme. An important feature of the EVRGs should be the synergy that results from collaborative efforts. Thus, the EVRGs are encouraged to include coordinated multi-disciplinary projects. Furthermore, EVRGs must include at least one research project on hantaviruses and one other component project focused on another emerging viral disease. EVRG Program Directors are encouraged to propose research projects within, but not limited to, the general research areas listed below. All projects should be focused to yield new data significantly helpful in prediction, prevention, treatment, or control of emerging viral diseases. o Expansion of research on viral changes and adaptations influencing emergence. Studies might address issues of viral evolution leading to new or altered viruses with enhanced virulence or modified transmissibility or infectivity. o Extension of research on ecologic and environmental factors influencing disease emergence and distribution. Studies might include evaluation of: the influence of natural, man-made, or climate-induced environmental change on emerging viruses; the effects of alterations in host or vector population density and distribution on viral diseases; and the influence of public health practices, altered social/behavioral practices, or modern technological developments on virus distribution. o Establishment of research programs focusing on susceptible hosts and vectors and their roles during maintenance and emergence of viruses. Studies might include research on mechanisms of pathogenesis, or the natural association of the virus with a vector or host. Projects also could include initial development of new vaccines and antivirals for the protection of the individual from a specific virus. Studies might also lead to new prevention and control strategies that can be employed at a community level to ameliorate disease impact in the face of an epidemic. For example, an antiviral drug against flaviviruses might be useful, not only to the individual, but also as a community public health tool to prevent amplifying viremia in susceptible hosts and consequently reduce disease spread during a dengue epidemic. o Establishment of projects for pre-clinical evaluation of newly developed vaccines or antiviral therapies for emerging diseases. These might involve: identification of suitable animal models of disease to allow studies of potential prevention/treatment therapies; preliminary evaluation of candidate vaccines or antivirals; and initial development and testing of combinations of vaccines. o Development of research leading to improved surveillance of emerging viruses. The primary aim of the EVRGs will not be surveillance per se, but research such as the development of improved diagnostic reagents and assays. Budget and Related Issues Applications should budget appropriate funds to allow the Director of each EVRG and all EVRG Project Leaders to attend one meeting annually in Bethesda, MD with NIAID staff. SPECIAL REQUIREMENTS The P01 mechanism is used to support broadly-based multi-disciplinary research programs that have a well-defined central research focus or objective and a minimum of three inter-related research projects around this central theme. An important feature of the EVRGs therefore is the synergy that results from collaborative efforts among the interrelated individual scientifically meritorious projects, resulting in a greater contribution to the overall program goals than if each project were pursued independently. The multi-project grant also provides support for certain common resources, termed 'Cores,' which must be utilized by two or more projects within the proposed program. EVRGs must have at least one component research project dealing with hantaviruses and one or more of the other projects in the program dealing with at least one other emerging viral disease. Recent advances in satellite remote sensing technology and in computerized geographic information systems (GIS) have been applied to the study of infectious diseases and their distribution. These tools have provided predictive data for purposes such as identifying geographic areas where there is an increased risk of vector-borne disease transmission. Investigators seeking to employ remote sensing in their studies of emerging viruses should clearly indicate this as a separate project in the application. This project will not be considered one of the three qualifying component projects for the Program (P01). This budget should be clearly identified and should not be considered part of the $500,000 limit indicated above. The National Aeronautics and Space Administration will consider support of these projects in conjunction with NIAID support of the EVRG. Applicants are strongly encouraged to contact Dr. James Meegan at the address listed under INQUIRIES below for more information. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from Dr. Meegan, listed under INQUIRIES below. Dr. Meegan may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by June 1, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address, and telephone number of the EVRG Director, a list of the key investigators and their institution(s), and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES It is highly recommended that Dr.Meegan be contacted in the early stages of the application. (see program contact in INQUIRIES below). Before preparing an application, the applicant should carefully read the new information brochure, "NIAID APPLICATION GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS." Instructions for formatting the application as outlined in the brochure must be followed carefully. Failure to follow the instructions may result in unnecessary delays in the review process. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). These application forms may be obtained from the institution's office of sponsored research or its equivalent and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package, to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier or express mail) At the time of submission, two additional exact copies of the grant application and five sets of appendix material must also be sent to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-19 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 Bethesda, MD 20852 (for express mail/courier service) Applications must be received by July 20, 1995. All components, subparts and sections of the application must be collated into the application, and the packages sent to the DRG and to the NIAID must each be complete in themselves. Applications that do not conform to the instructions contained in PHS 398 (rev. 9/91) application kit will be returned to the applicant. Current NIH policy permits a component research project of a multiproject grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multiproject application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multiproject grant. This is an NIH policy intended to preserve the scientific integrity of a multiproject grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multiproject grant must be aware of this policy before making a commitment to the EVRG Director and awarding institution. The original and three copies of the applications that are sent to the DRG must be received as a single package from the program director and conform to the instructions contained in PHS 398 (rev. 9/91) application kit otherwise the application will be returned to the applicant. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. REVIEW CONSIDERATIONS Review Method Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) for completeness and for responsiveness by NIAID staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration or review. Applications that are complete and responsive may be subjected to a triage by a peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID will remove from competition those applications judged to be non-competitive for award and will notify the EVRG Directors and institutional business officials. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The review criteria are stated in the NIAID GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS. In addition, the following criteria will apply: o the scientific and technical significance, merit, and originality of the research projects and anticipated contributions to the understanding of hantavirus and other emerging viral diseases; o the scientific expertise and experience of the EVRG Director, the Project Leaders and key project and core personnel; AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. James M. Meegan Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-15 6003 Executive Boulevard MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7453 FAX: (301) 402-0659 Email: jm75v@nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-19 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-8208 FAX: (301) 402-2638 Email: op2t@nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary Ledford Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-24 MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: ml28g@nih.gov Schedule Letter of Intent Receipt Date: June 1, 1995 Application Receipt Date: July 20, 1995 Scientific Review Date: November 1995 Advisory Council Date: January 1996 Earliest Award Date: April 1, 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856 Microbiology and Infectious Diseases Research. Awards are made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract 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 routing 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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