TROPICAL DISEASE RESEARCH UNITS Release Date: February 20, 1998 RFA: AI-98-004 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 31, 1998 Application Receipt Date: June 17, 1998 APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN AN NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS." PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites applications for program project (P01) 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 RFA, Tropical Disease Research Units (TDRUs), is related to the priority area(s) 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 202-512-1800). 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. 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 type of award supports broadly based multidisciplinary research programs that have a well-defined central research focus or objective. An important feature is that the interrelationships among the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project was pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The award also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the award. Responsibility for the planning, direction, and execution of the proposed projects 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 1999. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for this RFA will be $2.5 million. In fiscal year 1999, the NIAID plans to make four awards 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 $625,000 in total (direct and indirect) costs in the first year. 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 they are responsible for deaths and impaired growth and development among children as well as for debilitating, chronic diseases among adults. Additionally, parasitic infections have been recognized with increasing frequency 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 their 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 and/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 parasitology research supported by the DMID, NIAID, is largely conducted under 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 on the biology of invertebrate vectors. Research reagents in support of schistosomiasis, filariasis and malaria research are available through repository contracts funded by NIAID (http://www.niaid.nih.gov/reposit/default.htm). In addition, the Institute also supports several special programs for studies on parasitic and other tropical diseases. The International Centers for Tropical Disease Research (ICTDR) network serves to coordinate many of the Institute'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. In addition, NIAID is developing a network of clinical trial sites in endemic areas for evaluation of malaria vaccines or therapies. This RFA represents a continuation of another major component of NIAID's ICTDR network, the Tropical Disease Research Units (TDRUs) program which was initiated in 1980 and was originally 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 Diseases (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 in immunology. Recent advances in our understanding of the basic biology of parasites and of host-parasite interactions have created unique opportunities for discovering and evaluating new means of controlling the mortality and morbidity associated with parasitic infections. Recognizing that substantial advances have been made in the understanding of many parasitic diseases of significant global public health impact, in 1995 NIAID expanded the scope of the TDRU program to encompass all medically important human parasitic diseases. Under the current renewal, TDRUs will be expected to provide a resource for concerted efforts in 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. Research Objectives and Scope The NIAID wishes to support multidisciplinary, state of the art biomedical research units focused on development and preclinical testing of 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: i) vaccines to prevent infection and/or disease; ii) chemotherapeutic agents to prevent and/or treat infection; and iii) methods to control invertebrate vectors or to 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. In addition to being limited to a single intervention strategy, the program project must focus on a single parasitic infection. Within this focus, studies on human pathogens are preferred but studies on animal pathogens that are recognized to provide relevant models of human disease will also be acceptable. 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 for further development of the single intervention strategy chosen as the overall program objective and/or evaluation of its utility in an appropriate in vitro or in vivo system. Each application must clearly define the mechanisms to be used to ensure integration and information exchange among the different projects of the program in pursuit of this single goal. Studies relevant to this program include, but are not restricted to, the following: identification of structures, pathways or functions in medically relevant protozoa or helminth pathogens, that could serve as new targets for chemotherapeutic or immunologic intervention, and development of methods to evaluate their utility; o identification of host-pathogen interactions involved in protective immunity or immunopathogenesis, leading to development and testing of experimental vaccines/immunotherapies; o use of improved methods for antigen delivery/presentation or enhancement of protective immunity to design anti-parasite vaccines; o identification of mechanisms of susceptibility and resistance to antiparasitic agents (including structural biological studies of essential parasite enzymes and pathways) and development of novel methods to reverse or bypass this process; o identification of methods to interrupt parasite transmission in invertebrate vectors of human parasitic infections. Each application must provide an experimental plan which 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 reduction in 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 & Operating Consortium Grants, January, 1989." These are available from the individuals listed under INQUIRIES, below. 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 available on the NIAID Website at http://www.niaid.nih.gov/ictdr. 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. 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 are provided that inclusion is inappropriate with respect to the health of the subjects of 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 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 the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from Dr. Gottlieb (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 31, 1998, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, 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. Madelon Halula at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997); this brochure is available from NIAID staff listed in INQUIRIES below an via the WWW at: http://www.niaid.nih.gov/ncn/grants/ multibron.htm Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: asknih@od.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number "AI-98-004" and the words "Tropical Disease Research Units" must be typed in. Applications must be received by June 17,1998. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/95) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. 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. 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. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contact under INQUIRIES). Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided 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 mail or courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Halula at the address listed under INQUIRIES. Concurrent submission of an R01 and a Component Project of a Multi-project Application: Current NIH policy permits a component research project of a multi- project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project 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 multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. The brochure presents specific instructions for sections of the PHS 398 (rev. 5/95) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions on pages 5-20 of the PHS 398 booklet. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review and for responsiveness by NIAID staff. 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 the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The general criteria for P01 grant applications are presented in the NIAID brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997). Additional review criteria specific to this RFA are: o The project is centered around a well-focused goal related to development and preclinical testing of an intervention strategy to control the public health impact of a parasitic disease; each project contributes to that goal. o The project addresses the development of one such intervention strategy, and focuses on a single parasitic infection AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance, and the availability of funds. The totality of the awarded projects will reflect the diversity of medically relevant protozoan and helminth parasites, as well as the diversity of possible intervention approaches. 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 NIAID brochure "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" as well as inquiries regarding programmatic (eligibility and research scope) issues, may be directed to: Michael Gottlieb, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A-12 Bethesda, MD 20892-7630 Telephone: (301) 496-2544 FAX: (301) 402-0659 Email: mg35s@nih.gov Direct inquiries regarding preparation of the application and review issues, and address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dr. Madelon Halula Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C-16 Bethesda, MD 20892-7610 Telephone: (301)402-2636 FAX: (301) 402-2638 Email: mh30x@nih.gov Direct inquiries regarding fiscal matters to: Mr. Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B-35 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Email: tb22j@nih.gov Schedule Letter of Intent Receipt Date: March 31, 1998 Application Receipt Date: June 17,1998 Scientific Review Date: October 1, 1998 Advisory Council Date: January 25, 1999 Earliest Date of Award: May 1, 1999 AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is Sec. 93.856, Microbiology and Infectious Diseases Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems 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 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.
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |