Full Text AI-94-019 TROPICAL DISEASE RESEARCH UNITS NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA: AI-94-019 P.T. Keywords: National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: May 24,1994 Application Receipt Date: July 21, 1994 PURPOSE The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for program project grants to conduct multidisciplinary research leading to the development and evaluation of new strategies to prevent and control diseases caused by protozoan and helminth parasites. Programs will focus on one of the following areas: (1) development of vaccines for infection and disease; (2) discovery of drug targets and development of new chemotherapeutic agents for treating and preventing parasitic infections; or (3) development of new approaches for interruption of the parasite life cycle at the level of the invertebrate (vector) host. 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), Tropical Disease Research Units (TDRU), is related to the priority areas of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic for-profit and non-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. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanism of support will be the program project (P01) grant. This mechanism supports broadly based multidisciplinary 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 project period may not exceed five years. At this time, the NIAID is administratively limiting the duration of P01 grants to four years; this administrative limitation may change in the future. The earliest anticipated award date is May 1995. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for this RFA will be $2.4 million. In fiscal year 1995, the NIAID plans to fund approximately three to four program projects related to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications may not request budgets in excess of $500,000 direct costs in the first year or more than four percent annual inflationary increases for future years. 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. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA. RESEARCH OBJECTIVES Background Parasitic diseases continue to represent tremendous public health problems, especially for people living in the tropics where parasites are responsible for deaths and impaired growth and development of children and debilitating, chronic diseases among adults. Additionally, parasitic infections have been increasingly recognized as responsible for diseases in the United States and other industrialized countries. Of special interest to clinicians and public health workers in developed nations is the occurrence of severe disease in individuals who acquired an infection congenitally or as a result of immunosuppression. Prevention and treatment of parasitic diseases remain problematic. In many cases, currently available drugs exhibit either excessive toxicity or inadequate efficacy. Moreover, several previously useful compounds are no longer effective due to the spread of drug resistant parasite variants. Vaccines do not exist for any human parasitic infection. Environmental changes, notably those associated with land and water management practices, have led to the emergence or re-emergence of parasitic diseases, especially those that are vector-borne. Currently, the parasitology and tropical disease program in the DMID, NIAID, consists primarily of investigator initiated research project grants focusing on the biology (molecular and cellular biology, immunology, and biochemistry) of the medically important protozoa and helminths as well as the invertebrate vectors. Biological material in support of schistosomiasis and filariasis research is available through repository contracts funded by the NIAID. In addition, the NIAID also supports several special programs for studies on parasitic and other tropical diseases. A program to begin in 1994 will address the development of immunotherapeutic interventions for parasitic diseases. The International Centers for Tropical Disease Research (ICTDR) network coordinates all of the NIAID's activities in the area of tropical infectious diseases. Within the ICTDR network, studies in areas endemic for tropical parasitic diseases are funded through its International Collaboration in Infectious Disease Research (ICIDR) and Tropical Medicine Research Center (TMRC) programs. Available resources in endemic areas supported by the ICIDR and TMRC programs may provide opportunities for field testing of new intervention strategies as they arise. This RFA represents a continuation of a third major component of NIAID's ICTDR network, the Tropical Disease Research Units (TDRU) program which was initiated in 1980 and designed to stimulate advanced biomedical research on the five parasitic diseases (filariasis, leishmaniasis, malaria, schistosomiasis, and trypanosomiasis) that form the basis of the World Health Organization's Special Programme for Research and Training in Tropical Disease (TDR). Since the inception of the TDRU program, much has been learned about the biology of these and other parasites as a result of the dramatic advances in molecular and cellular biology and immunology. The study of these organisms has led to the identification and characterization of new mechanisms and structures (e.g., lipid anchored proteins, novel forms of RNA processing, gene rearrangements, and gene expression). The study of parasite interactions with the vertebrate host has also led to a greater understanding of the role of T-cell subsets and cytokines in pathology and protection. Likewise, the study of the interactions with the invertebrate host has led to a new appreciation of the role of the vector in parasite transmission. These recent advances in the understanding of the basic biology of these parasites and host-parasite interactions have created unique opportunities for discovering and evaluating new means of controlling the mortality and morbidity associated with parasitic infections. The NIAID recognizes that substantial advances have been made during this time in the understanding of other parasitic diseases, such as amebiasis, giardiasis and cryptosporidiosis, and that these diseases also represent significant global public health concerns. Therefore, for the purposes of this recompetition, the NIAID will expand the scope of the TDRU program to encompass all medically important human parasitic diseases. TDRUs will provide a resource for concerted efforts for the development and preclinical testing of new intervention strategies for parasitic diseases. Components of the TDRU program will have the opportunity to work with other members of the ICTDR network to move promising vaccination, chemotherapeutic or vector control strategies toward clinical or field trials. Scope of Research The NIAID wishes to support multidisciplinary, state of the art biomedical research units to serve as foci for innovative research on medically important parasites or their vectors, leading to new intervention strategies to control the public health impact of diseases caused by protozoa and helminths. For the purpose of this RFA, intervention strategies to be considered are: (1) vaccines to prevent infection and/or disease; (2) chemotherapeutic agents to prevent and/or treat infection; and (3) methods to control invertebrate vectors or interrupt the parasite's life cycle in the vector. The entire program project grant, consisting of three or more projects as well as cores, must address the development of one of these intervention strategies. While limited to a single intervention strategy, the program project may focus, however, on one or more parasitic infections. The entire program project should be designed to address the common goal in a cohesive manner. Thus, responsive programs would be those in which each project provides information necessary to determine the utility of the single intervention strategy chosen as the overall program objective and/or develop the strategy for application. Each application must clearly define the mechanisms to be used to ensure integration and exchange of information among the different projects of the program in pursuit of this single goal. Areas of study relevant to this program include, but are not restricted to, the following: o cellular and molecular biology of medically relevant protozoa or helminth pathogens (e.g., cell biology, genetics, genome structure, gene expression, genetic manipulation) leading to identification of new immunogens, chemotherapeutic targets, etc. o parasite virulence factors and mechanisms of pathogenesis leading to the identification of new targets for chemotherapeutic or immunologic intervention o host-pathogen interactions leading to the identification of mechanisms of protective immunity o methods for improved antigen delivery/presentation or enhancement of protective immunity leading to the design of anti-parasite vaccines o parasite physiology, biochemistry and metabolism leading to a better understanding of susceptibility and resistance to antiparasitic agents (including structural biological studies of essential parasite enzymes and pathways) o invertebrate vectors leading to identification of methods to interrupt parasite transmission Each application must provide an experimental plan that details the methods that will be used to validate the utility of the chosen approach. The experimental plans must indicate, by use of a schedule or time table, when the appropriate validation strategy will be applied for evaluating the chosen approach as an intervention method. Examples of validation strategies include: o use of site-directed mutagenesis, gene knockouts, testing of specific inhibitors or antisense technology to establish the essential nature of a drug target in programs seeking to discover and develop new anti-parasitic agents, o examination of the inhibition of infection or of documented correlates of pathology in in vitro or in vivo model systems in programs seeking to develop vaccines or therapeutic agents, o examination of the inhibition of vectorial capacity for parasite transmission in programs seeking to develop control programs targeted at the level of the invertebrate vector. Programs may involve collaboration among investigators at several institutions. For example, programs involving more developmental aspects of the proposed studies may benefit from resources available through collaborative arrangements with private industry. Consortium arrangements should follow the NIH Guide outline in "Guidelines for Establishing and Operating Consortium Grants, January 1989." These are available from the individuals listed under INQUIRIES. SPECIAL REQUIREMENTS Institutions receiving TDRU awards are considered as Centers in the NIAID ICTDR network and TDRU program directors are designated as Center Directors in this network. A further description of the network is included as an appendix to this RFA and may be requested from the program staff listed under INQUIRIES. The application should budget appropriate funds to allow the TDRU program director to attend the annual meeting of the network, which is generally held in Bethesda in Spring. Attendance of other key personnel is encouraged, but not required. STUDY POPULATIONS 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 subpopulations 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 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) LETTER OF INTENT Prospective applicants are asked to submit, by May 24, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address, and telephone number of the Principal Investigator, 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 Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. In addition, applicants for multicomponent grants are strongly advised to read the information brochure "NIAID Program Project Grants and Multiproject Cooperative Agreements", available from Michael Gottlieb at the address listed under INQUIRIES. 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. For purposes of identification and processing, mark "YES" in item 2a on the face page of the application and type in the RFA number AI- 94-019 and the title "TROPICAL DISEASE RESEARCH UNITS." The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original 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. The signed, typewritten original of the application, including the Checklist, and three exact single-sided copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies and all five sets of appendices must also be sent to Dr. Olivia Preble at the address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants and Dr. Olivia Preble by July 21, 1994. Applications not received by July 21, 1994 will be considered non-responsive and will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of essentially identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedures Applications will be reviewed by DRG staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or nonresponsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group to determine relative scientific merit among the applications submitted in response to this RFA. The NIAID will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applications judged to be competitive for award will be reviewed further 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 for P01 grant applications are the review criteria for large, multicomponent, interdisciplinary program projects as outlined in the NIAID brochure entitled "NIAID Program Project Grants and Multiproject Cooperative Agreements." The program project grant application should include a justification for the appropriateness of that granting mechanism for the proposed project. The distinguishing features of a program project grant include: o A well-defined, unifying goal or problem area of research to which each project relates and contributes, thereby producing a research environment that allows each research effort to share the creative strengths of others. For the purpose of this TDRU program, the goal will be the development of one of the intervention strategies identified in the Scope of Research section above (i.e., chemical or biological strategies to prevent or treat infection, disease, or pathogen transmission via intermediate hosts). o A program director who possesses recognized scientific and administrative competence. He/she must demonstrate a substantial commitment to the program in time and effort thereby exercising leadership in providing overall direction and in upholding rigorous scientific conduct. o Each research project must, as assessed by peer review, stand on its own independent scientific merit, as well as complement other projects whenever feasible. o The projects require the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All investigators must contribute to and share the responsibilities of fulfilling the program objective. o Ability of the proposed research to provide knowledge of medically important parasitic diseases that will result in improvement in the methods to control these diseases. The appropriateness of the proposed experimental plan to validate the utility of the chosen strategy will be considered in this regard. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, the availability of funds, and program balance, including relevance to the control of public health problems. The totality of the awarded projects will reflect the diversity of the medically relevant protozoan and helminth parasites. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the brochure "NIAID Program Project Grants and Multiproject Cooperative Agreements," as well as inquiries regarding programmatic issues may be directed to: Michael Gottlieb, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A03 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7115 FAX: (301) 402-0804 Email: mg35s@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: Olivia Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Leslie Marsden Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: May 23, 1994 Application Receipt Date: July 21, 1994 Scientific Review Date: November 1994 Advisory Council Date: February 1995 Earliest Date of Award: May 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.856 - Microbiology and Infectious Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. .
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