RFA-AI-98-008: CHRONIC FATIGUE SYNDROME COOPERATIVE RESEARCH CENTERS

Department of Health
and Human Services (HHS)

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CHRONIC FATIGUE SYNDROME COOPERATIVE RESEARCH CENTERS Release Date: April 13, 1998 RFA: AI-98-008 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: June 15, 1998 Application Receipt Date: October 14, 1998 APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED USING SPECIFIC INSTRUCTIONS IN AN NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" (September 1997). PURPOSE The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for the continuation and/or establishment of high-quality Chronic Fatigue Syndrome Cooperative Research Centers (CFS CRCs) that provide a multi-disciplinary, systematic, sustained approach to the study of CFS. A nucleus of CFS CRC investigators dedicated to use of standardized methodologies and collaborative efforts was established in 1991. The program was renewed in 1995. Currently, two CFS CRCs are supported. This RFA is the second recompetition. For the first time, eligibility is being extended to foreign organizations either as projects within a domestic CFS CRC or as a full Center. 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, Chronic Fatigue Syndrome Cooperative Research Centers, is related to the priority area of chronic disabling conditions. 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 and foreign 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Multiproject Cooperative Agreement (U19), an "assistance" mechanism, rather than an "acquisition" mechanism. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Essential elements of the multiproject cooperative agreement mechanism also include: (1) a minimum of three interrelated individual research projects organized around a central theme; (2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; (3) a single Principal Investigator who will be scientifically and administratively responsible for the group effort; (4) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded, although, Projects may be located at different institutions as subcontracts; and (5) support provided, as necessary, for "Core" resources or facilities, each of which is expected to be utilized by at least two research projects in order to facilitate the research effort. Details of the responsibilities, relationships and governance of a study funded under a cooperative agreement are discussed later in this document under the section "Terms and Conditions of Award." The total project period for an application submitted in response to this RFA may not exceed five years. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for this RFA will be $1.6 million. In fiscal year 1999, the NIAID plans to make approximately two 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 $800,000 in total (direct and indirect) costs in the first year without prior concurrence of the NIAID Scientific Coordinator, Dr. Sawyer (see INQUIRIES below). 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 Research spanning the last decade has established that CFS is an illness characterized by a multisystem syndrome. Although in some cases, CFS may be triggered by an infection, to date, no known infectious agents have been established as a specific cause of CFS. CFS is characterized by months of debilitating fatigue frequently associated with sore throat, low grade fever, myalgia, headache, gastrointestinal symptoms and tender lymph nodes. Several different scientific disciplines have provided clues as to CSF pathophysiology. Cognitive deficits, symptoms of depression and sleep disorders have been reported and abnormal brain images derived by different techniques have also been described. CFS patients are reported to have neuroendocrine response patterns which differ from those of controls. A subgroup of patients may suffer from treatable neurally mediated hypotension; however, conclusive studies are still in progress. CFS is diagnosed more frequently in women than in men. There have been numerous reports of specific immune abnormalities, but no single impairment has regularly been associated with the syndrome. There have been many formidable obstacles to the effective study of this syndrome, the most serious of which has been the lack of objective diagnostic criteria. Recently, there has been progress in the development of instruments which may differentiate CFS from other neuropsychiatric disorders such as depression. For the most part, CFS is still a diagnosis of exclusion resulting in extensive testing and referrals which often lead to expense and delay in making the diagnosis, a diagnosis for which management guidelines are the only remedy physicians can offer to patients. The CFS-CRCs established in FY 91/92 are the focal point of the NIAID-extramural CFS effort. The etiology and pathogenesis of this syndrome are not straightforward. Progress in these areas as well as in the areas of developing effective methods of diagnosis and treatment will require an interdisciplinary approach. The goal of the CFS-CRCs is consistent with the desire to foster interactions among the different relevant medical and basic science disciplines. It is hoped that the international component to this renewal will bring new perspectives and hypotheses to the CFS research arena. Research Objectives and Scope The purpose of this RFA is to support clinical centers of research excellence that use standardized methods for patient enrollment and data collection to pursue multidisciplinary coordinated projects to study the etiology, natural history, pathogenesis and treatment of CFS. Expertise in multiple scientific disciplines including but not limited to: medicine, immunology, virology, pathophysiology, neurology, endocrinology and epidemiology may be helpful in furthering our understanding of CFS. It is not expected that expertise in all these areas be available at a single institution. Input from the NIAID Scientific Coordinator will facilitate technology transfer, assist in the identification of expert consultants, collaborators and resources, enhance communication between awardees and help to ensure that pilot studies funded through the CFS CRC program will complement and not unnecessarily duplicate existing or planned research endeavors. SPECIAL REQUIREMENTS A. Study Organization The Cooperative Research Center Program requires cooperation between CRC Directors and the NIAID Scientific Coordinator to maintain a close collaboration and communication among the CFS CRCs and the Program Officers across the National Institutes of Health responsible for the scientific discipline appropriate to the projects. B. CFS CRC External Advisory Board The CFS CRC funds may be used to support activities related to acquiring scientific advise from experts in the field. These advisory groups should be constituted after the grant award has been made and should not be named in the application. The NIAID Scientific Coordinator will be a member of each External Advisory Board. C. CFS CRC Annual Meeting Successful applicants will be expected to participate in annual workshops in Bethesda, MD. Participants in the workshops will share CFS research advances and discuss CFS research needs and opportunities with the CRC Directors and other CRC principal investigators as well as with other investigators active in CFS research or working in relevant related areas. SUPPORT FOR TRAVEL TO THE WORKSHOP MUST BE INCLUDED IN THE CRC BUDGET REQUEST. D. Clinical Trials A Data Safety and Monitoring Board (DSMB) is required when Phase III clinical trials are to be supported. The members of the DSMB shall be approved by the NIAID Scientific Coordinator. Projected costs associated with the DSMB meetings need to be included in the CFS CRC budget. TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the multiproject cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID Scientific Coordinator. A. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below. Awardees will retain custody of and have primary rights to data developed under this award, subject to Government rights of access consistent with current DHHS, PHS and NIH policies. The CRC Director (the Principal Investigator for the CRC) shall specify criteria for patient selection, but at a minimum all CRC CFS patients enrolled must meet inclusion and exclusion criteria comparable to those specified by CDC and NIH so that studies at different CRCs can be compared (Fukuda KF, Straus SF, Hickie I, et al., Ann Intern Med. 1994; 121:953-959). The CRC Director will have ultimate responsibility for the coordination of efforts within the CRC and ensuring that the results obtained are analyzed appropriately and published in a timely manner. However, it will be the responsibility of each CRC Project Leader (the Principal Investigator for an individual research project within the CRC) to plan and conduct the research stipulated in the project proposal. NIAID may periodically review and generate internal reports from data and progress reports developed under this cooperative agreement. The data obtained will, however, be the property of the awardee. The multi-disciplinary and cooperative nature of the CFS CRCs creates an extraordinary opportunity for information exchange and scientific advancement in high quality CFS research. It is expected that awardees will take advantage of this opportunity by participating in both formal events established expressly for this purpose and informal investigator-initiated dialogues. B. NIAID Staff Responsibilities NIAID staff assistance will be provided by a Program Officer who will serve as NIAID's Scientific Coordinator. The NIAID Scientific Coordinator will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The NIAID Scientific Coordinator will be the Program Officer designated to administer the CFS CRC program, currently in the DMID. Release of set-aside funds for pilot studies will require approval of the NIAID Scientific Coordinator. During the award period, the NIAID Scientific Coordinator will work closely with the CRC Director TO FACILITATE BUT NOT DIRECT THE ACTIVITIES OF THE CRC. It is anticipated that decisions in all activities outlined within this RFA will be reached by consensus of the investigators and the NIAID Scientific Coordinator. NIAID will facilitate research at CFS CRCs through the following: o assistance in overall research planning, data analysis and reporting; o facilitation of information exchange between CFS CRCs and other CFS grantees and investigators; o reduction of duplication of efforts by CFS CRCs and other NIAID awardees; o assistance in development of standardization procedures applicable to current and future CFS CRCs and in other grantees with regard to case definition, laboratory procedures, selection of reagents, etc.; o facilitation of access to new research reagents and technologies; o assistance in review and approval of pilot studies; o identification of experts and other important resources not otherwise available to the CFS CRCs; o assistance in locating potential replacements for key personnel vacancies including Principal Investigators, Project Leaders and Co-Investigators. o membership on the External Advisory Board C. Collaborative Responsibilities The CRC Directors, Project Leaders, and NIAID Scientific Coordinator will communicate regularly by teleconference or at CFS related conferences, to review progress, plan and design research activities, and establish CFS CRC priorities. The CFC External Advisory Board will be established by the CRC Director. The NIAID Scientific Coordinator will be a member of that Board. A Data Safety and Monitoring Board (DSMB) is required when Phase III clinical trials are to be supported. The members of the DSMB shall be selected by the awardee and approved by the NIAID Scientific Coordinator. In addition, each year, NIAID staff will coordinate one workshop at the NIH in Bethesda, Maryland (or at a site designated by NIAID). This workshop will provide a forum for CRC and other CFS research grant awardees to share research advances; to discuss CFS research needs and opportunities; and to develop collaborations. Funds for travel to these meetings must be included in the budget. D. Arbitration Any disagreement that may arise on scientific or programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the individual awardee in the event of an individual disagreement, a second member selected by the NIAID, and the third member with expertise in the relevant area and selected by the two prior members will be formed to review any scientific or programmatic issue that is significantly restricting progress. While the decisions of the Arbitration Panel are binding, these special arbitration procedures will in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 16. 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. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by June 15, 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 U19 cooperative agreements 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 Minimum Requirements for Application Investigators are urged to contact NIAID staff early in the development of the application. Particular attention should be given to the following areas when responding to the application instructions found in the brochure: o In describing the clinical and laboratory facilities available to the CRC, specific information should be included on the institution's present CFS patient load and projections for patients' willingness to participate in clinical investigations. A detailed account of case and control ascertainment procedures must be provided along with the inclusion and exclusion criteria to be used for enrollment. o A minimum of three projects must be proposed. The detailed description of each research project should demonstrate that it contributes to the attainment of the CRC's overall objectives. Preliminary results and evidence of feasibility should be provided if available. o Previously funded CRCs must submit a comprehensive progress report and carefully justify any plans for expansion. o The goal should be to mirror the CFS population with regard to gender in studies of CFS. Applications are urged to give added attention where feasible and appropriate to the inclusion of minorities in study populations. If minorities are not included in the study population, a clear rationale for their exclusion must be provided. o In addressing the Organization and Administration Structure of the CRC, the mutually reinforcing inter-relationships among the members of the CFS CRC and the contribution of each to fulfillment of CFS CRC objectives should be clearly described. This section must include an organizational chart showing the name, the organization and the scientific discipline of the Program Director, the Project Leaders (principal investigators of individual research projects), and other key personnel for the projects. o The application must include a signed letter of agreement from each collaborator and/or consultant to the program indicating: (1) willingness to participate in the program; and (2) the exact nature of the participation. o Plans to convene a CFS CRC External Advisory Board of experts in the field should be described. The Board will provide scientific advice to the CRC Director and Project Leaders. The Board will be constituted after award and should not be named in the application. BUDGET AND RELATED ISSUES A written commitment by the sponsoring institution which explicitly defines the institution's willingness and preparedness to commit resources to ensure development, function and maintenance of the proposed CFS CRC must be included in the application. This letter should be co-signed by the relevant departmental chairperson(s) and dean of the institution. In addition to support for personnel, supplies, travel to an annual CFS CRC workshop for the CRC Director and Project Leaders, and for the External Advisory Board and other necessary costs justified in the application for conducting CRC research projects, award funds may be utilized to support the following research- related activities: o SHARED ADMINISTRATIVE, CLINICAL AND RESEARCH RESOURCES: CFS CRCs may include funds for administration, equipment, supplies and services to expand and/or maintain clinical, laboratory, biostatistical and data management facilities which are shared by research staff from at least two CRC research projects. Costs associated with patient and control recruitment, enrollment, follow-up and data entry would be appropriate for a core budget. Any research-related cost for patient and control subject enrollment that is not eligible for third-party payment should be included in the budget as PATIENT CARE COSTS. The amounts requested for Core Support should be well justified and in keeping with the overall complexity and size of the budget. In any case, such costs may not duplicate or replace costs included in the institution's indirect cost base. Since the program cannot provide funds for new construction, adequate physical facilities must be available to meet the primary needs of the CRC. Please read pages 17-18 of the NIAID booklet Multiproject Grants. o BIOSTATISTICAL SUPPORT: The budget should include adequate biostatistical support to ensure sound study design, data collection and data analysis procedures. o OTHER BUDGETABLE ITEMS: Budget requests may also include limited investigator travel and costs for publication. o DEVELOPMENTAL FUND FOR PILOT STUDIES: Applicants may request that $40,000 in direct costs be made available annually in a Developmental Fund for pilot studies. This Developmental Fund would be set aside and restricted solely to cover salaries and other research costs for small pilot studies to follow-up on new observations and novel hypotheses. It is envisioned that availability of funds for pilot studies would increase flexibility and responsiveness to important new scientific observations and medical reports. Pilot studies need not be restricted to the awardee institution. IT IS EMPHASIZED THAT INDIVIDUAL CRC RESEARCH PROJECTS ARE DISTINCT FROM PILOT STUDIES AWARDED FROM THE DEVELOPMENTAL FUND. The direct costs may not exceed $40,000 for any single pilot study. The duration of support for each study typically would be 1 year, but may be up to 3 years, unless the study is independently funded through a traditional research grant (R01) award prior to the end of the 3-year period. In these instances, the pilot study must be terminated, and unexpended funds must be returned to the Developmental Fund. Funds reserved for pilot projects may not be rebudgeted into other budget categories except in unusual circumstances and following approval from the Grants Management Specialist and the Scientific Coordinator. The CRC must maintain detailed records of disbursements and expenditures from the Developmental Fund. Procedures for soliciting and selection of pilot studies should be described if developmental funds are requested. It is anticipated that pilot studies and their budgets recommended by the CFS CRC Director will be reviewed and selected by a local review committee. Studies involving Human Subjects will require prior approval by the Institutional Review Board like all other NIH supported projects. Budgets for pilot projects submitted by the CRC Director must be countersigned by the institutional financial officer. Finally, release of funds set aside for this purpose will require approval of the NIAID Scientific Coordinator. PILOT STUDIES PER SE, UNLIKE THE INDIVIDUAL CRC RESEARCH PROJECTS, SHOULD NOT BE DESCRIBED IN THE CRC APPLICATION. Only the solicitation process and selection method (institutional review process) and review criteria to be used need be described. Examples of criteria are scientific merit of the proposal, medical relevance and need for data to advance the research objectives of the CRC. The $40,000 annual direct costs should be entered in the OTHER category in the Consolidated Budget (see pages 15 and 21 in NIAID’s INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS. Applications are to be submitted on the 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 Resources, 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-98-008" and the words "Chronic Fatigue Syndrome Cooperative Research Centers" must be typed in. Applications must be received by October 14, 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/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. Madelon 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 U19 cooperative agreements 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 listed under INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm This brochure presents specific instructions for sections of the PHS 398 (rev. 5/95) application form that should be completed differently than usual. 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 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 U19 multiproject cooperative agreement applications are presented in the NIAID brochure, INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS. Additional review criteria specific to this RFA are: Appropriateness and adequacy of clinical facility with accessible patient populations that are appropriate for answering CFS research questions and are available for follow-up. Appropriateness and adequacy of characterization of cases and controls, of recruitment and retention procedures, and of data and specimen collection and analysis methods. Evidence that the CRC Director and project directors have sufficient experience and expertise to make a significant contribution to the establishment of standardized procedures for studying CFS. 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. 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 (research scope and eligibility) issues, may be directed to: Leigh A. Sawyer, DVM, MPH Division of Microbiology and Infectious Disease National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A15 Bethesda, MD 20892-7630 Telephone: (301) 496-7453 FAX: (301) 402-0659 Email: ls98a@nih.gov Direct inquiries regarding preparation of the application and review issues, 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 4C16 Bethesda, MD 20892-7610 Telephone: (301) 402-2636 FAX: (301) 402-2638 Email: mh30x@nih.gov Direct inquiries regarding fiscal matters to: Todd C. Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B35 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Email: tb22j@nih.gov Schedule Letter of Intent Receipt Date: June 15, 1998 Application Receipt Date: October 14, 1998 Scientific Review Date: February 1999 Advisory Council Date: May 24, 1999 Earliest Date of Award: August 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.

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