Full Text DK-97-011 INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUP NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFA: DK-97-011 P.T. 34 Keywords: Digestive Diseases & Disorders Clinical Trial National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: July 25, 1997 Application Receipt Date: August 26, 1997 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces the availability of a Request for Applications (RFA) to establish an Interstitial Cystitis Clinical Trials Group. The purpose of this RFA is to solicit applications from institutions interested in participating in a cooperative group to plan, direct, and conduct clinical trials in patients with interstitial cystitis (IC). This RFA will establish and maintain clinical centers required to perform multiple therapeutic trials, either sequentially or concurrently, for treatments of IC using common protocols with appropriate sample sizes. This RFA will also establish a Data Coordinating Center for the clinical trials group to coordinate the development of protocols for the trials and to support the collection, quality control, and analysis of the data. 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, Interstitial Cystitis Clinical Trials Group, relates to the priority areas of chronic disabling conditions and prevention services. 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 Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone number 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic institutions; public and private organizations (for-profit and non-profit), such as universities, colleges, hospitals, units of State and local government; and eligible agencies of the Federal government. Foreign institutions are not eligible to apply. Racial/ethnic minorities, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for these awards will be the cooperative agreement (U01). The cooperative agreement is an assistance mechanism in which substantial NIDDK scientific and programmatic involvement is anticipated during performance of the activity. Under the cooperative agreement, the NIDDK's purpose is to support and encourage the recipient's activities by working jointly with the awardees in a partnership role, but not to assume direction, prime responsibility, or dominance. Details of the responsibilities, relationships, and governance of a study funded under a cooperative agreement are described under the section entitled "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed five (5) years. The anticipated award date is March 1, 1998. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will also vary. At this time, the NIDDK has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The NIDDK plans to make five awards for clinical centers and one award for a Data Coordinating Center. Approximately $2,000,000 total cost (total cost = direct plus indirect costs) is expected to be available for the first year of support under this RFA. It is anticipated that the award for each clinical center will be about $275,000 total cost for the first year and the award for the Data Coordinating Center will be about $625,000 total cost for the first year. The number of awards to be made is dependent on the receipt of a sufficient number of applications of high scientific merit and availability of funds. Although this program is provided for in the financial plans of the NIDDK, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background Interstitial cystitis is often times a disabling disease characterized by bladder pain, urgency, frequency, nocturia, and dysuria. The disease primarily affects women, the female to male ratio being 9:1 in several studies. Realizing that IC was often misdiagnosed, workshops on IC held in 1987 and 1988 by the NIDDK resulted in the development of inclusion and exclusion criteria for patients being considered for research studies of the disease. Despite the development of these criteria, meaningful epidemiological studies on IC have not been conducted in the United States during the past decade. Thus, our knowledge about the epidemiology, natural history, and risk factors for IC is rudimentary. Moreover, the cause(s) of IC is not known. Because of this lack of information, the NIDDK initiated a prospective, clinical, longitudinal study on IC called "The Interstitial Cystitis Database (ICDB) Study." Begun in 1991, the ICDB Study, a cooperative agreement supported program, has enrolled over 600 women and men into this project that is scheduled to complete the follow-up of participants in the fall of 1997. A wealth of clinical, demographic, and pathological (bladder biopsies) information has been collected by ICDB Study investigators which has provided valuable insights into this disease. Based on the findings from the ICDB Study, investigators are now in a position to better characterize the spectrum of disease severity observed in IC patients and to consider outcome measures that are meaningful to these patients. In addition, the distribution of medical and non-traditional treatments utilized by ICDB Study participants has also been well documented. Because the etiology and pathophysiology of IC are not known, physicians are limited to treating the symptoms of IC patients. Although a number of medical therapies are available for treatments, neither their long-term effectiveness nor their specificity for the individual characteristics of the disease is well known. Many previous clinical trials for IC therapy have suffered from a number of design flaws including small sample size, lack of masking of treatment, short-term follow-up, ambiguous definitions of IC, absence of characterizing disease severity, and questionable endpoints. In addition, little is known about the effectiveness of medical treatments used in combination. The lack of conclusive outcomes from well-organized and conducted randomized clinical trials has resulted in many physicians using a trial-and-error approach to therapy and this management has led many IC patients to seek non-traditional approaches to control their disease. Based on the findings from the ICDB Study, the NIDDK has determined that a series of randomized, controlled multicenter clinical trials studying well-characterized patients and measuring meaningful subjective and objective endpoints, are now feasible to evaluate the effectiveness of currently available and newly developed medical therapies for patients with IC. B. Research Goals and Scope The purpose of this RFA is to initiate a collaborative study of treatment interventions for IC. This program will provide a mechanism to establish and maintain Clinical Centers which will perform multiple therapeutic trials in patients with IC. The therapeutic trials may involve investigational drugs, approved agents not currently used, drugs currently used in treatment of IC, or non-drug approaches. It is expected that these trials will take place in five Clinical Centers over a period of five years. The Clinical Centers will randomize approximately 1,000 participants for the various clinical trials conducted during the lifetime of this program. The data collection activities of the Clinical Centers will be supported by a single Data Coordinating Center. C. Study Design It is envisioned that over the five-year period, several multicenter clinical trials will be developed and implemented by the Principal Investigators. The individual Clinical Centers within the IC Clinical Trials Group should emphasize clinical trials that can be conducted under mutually agreed upon protocols. The study population is envisioned to be IC patients encompassing a broad range of age groups and consisting of appropriate gender and minority representation. Patients with a broad range of disease severity should also be included. Applicants for both Clinical Centers and the Data Coordinating Center should propose two examples (conducted either concurrently or sequentially) of clinical protocols requiring multicenter participation that they consider important. For each example applicants should submit concept documents not more than four pages long, that briefly outline the rationale and background of the proposed clinical trials, study design, type of patients to be included in the protocols, eligibility criteria, and baseline and outcome measures. For each of the clinical protocols, Clinical Center applicants should discuss the characteristics and number of potential participants that would be available from their own geographic region. The topics for the Clinical Trials Group will be proposed and prioritized by the Steering and Planning Committee based on protocols submitted and approved during review, but the actual number of clinical trials conducted will be dependent upon availability of funds. STUDY COMPONENTS 1. Clinical Centers A Clinical Center is an institution that is actively involved in the recruitment, evaluation, treatment, and follow-up of study participants. It should consist of an interdisciplinary team of clinical investigators and appropriate personnel, such as a research coordinator and clerical staff. An application for a Clinical Center should provide evidence that the investigators are capable of recruiting a sufficient number of participants for the proposed trials. Applicants for Clinical Centers should describe the target population from which they expect to randomize the required number of study participants and plans for recruitment of women and minorities. Clinical Centers will be required to submit protocol data expeditiously. Clinical Centers must work in concert with the Data Coordinating Center to implement procedures for data audits and other data quality control procedures as established by the study protocol. The Principal Investigator and Co-Investigators in each Clinical Center should be skilled in collaborative clinical investigation. There should be evidence of strong institutional support for the Clinical Center, including adequate space in which to conduct clinic activities and office space for staff. An organizational structure for the Clinical Center should be set forth in the application delineating lines of authority and responsibility for dealing with problems in all general areas as well as stated willingness to follow the stated common protocols. The applicant should include a succinct discussion of previous relevant investigational efforts. The applicant should also discuss in detail the recruitment strategies to procure the expected number of randomized participants, approaches to attain high levels of adherence to the interventions, and high rates of follow-up. Specific plans for recruitment of minority participants must also be discussed. 2. Data Coordinating Center The Data Coordinating Center will have primary responsibility for collecting, editing, storing, and analyzing data generated by the Clinical Centers. It should be prepared to assume a key role in overseeing implementation and adherence to the study protocol, and assuring quality control of the data collected. The Data Coordinating Center will be expected to provide appropriate biostatistical, data management, and coordination expertise. The Data Coordinating Center also will be expected to provide appropriately detailed reports to the Steering and Planning Committee and to the External Advisory Committee at regular intervals and will be responsible for the logistics and planning of the meeting of these committees and their subcommittees. Applicants for the Data Coordinating Center should provide a detailed description of prior experience in multicenter studies. 3. Steering and Planning Committee The primary governing body of the study will be the Steering and Planning Committee comprised of each of the Principal Investigators of the Clinical Centers and the Data Coordinating Center, the Chairperson of the Steering and Planning Committee, and the NIDDK Project Scientist (described in detail under Terms and Conditions). 4. External Advisory Committee An independent committee supported by the NIDDK and composed of experts in urology, biostatistics, clinical trials, and bioethics who are not otherwise involved in the study will be established to review periodically the progress of the study (described in detail under Terms and Conditions). This Committee will also be responsible for reviewing the acceptability of initial data quality monitoring plans established by the Steering and Planning Committee and the subsequent monitoring of data quality by means of reports prepared by the Data Coordinating Center. 5. Project Scientist The NIDDK will identify a Project Scientist for the study. The Project Scientist will assist the Steering and Planning Committee and External Advisory Committee in carrying out the study (described in detail under Terms and Conditions). 6. Study Phases The timetable for the study may be subdivided into three phases over a five-year period. There may be some overlap in functions within each of the phases, and the time estimates are only approximations. The purpose of the phases is to provide broad guidelines of the total scope of work to be accomplished for this RFA. Phase I: Planning and development of the clinical trial group infrastructure, protocol development; months 1 to 12. Phase II: Patient recruitment; protocol implementation, further protocol development; months 13 to 60. Phase III: Data Analysis; report preparation; protocol development and recruitment for next studies; months 24-60. The first twelve months of the study (Phase I) may be devoted to planning and development of the clinical trials group infrastructure and committee structure. Possible objectives for the Steering and Planning Committee are to determine patient eligibility criteria for initial clinical trials; train staff in procedures; help set up data acquisition and consent forms; define terms and outcome measures; develop a manual of operations, questionnaires, procedures for quality control; determine priorities for protocol development; and begin to develop specific protocols. The Data Coordinating Center will also play a key role in the planning and development stage. Possible objectives for the planning and development stage for the Data Coordinating Center, in addition to assisting Clinical Centers in their planning and organization of the clinical trials group, are to help develop study protocols, randomization and analytic plans; select a data acquisition, transfer, and management system; develop procedures for quality control, training, and certification; develop and produce a Manual of Operations; and take the lead for the orderly accumulation and transmission of data for the clinical trials group. In Phase II, the Clinical Centers will select and prioritize common protocols, proceed with subject recruitment and protocol implementation for the first studies ,and concurrently develop additional protocols. Possible objectives for Phase II for the Data Coordinating Center are to assist the Clinical Centers with respect to completing protocol development, patient recruitment, randomization, data acquisition, and ongoing quality control. In Phase III, after the last patients in the first study have completed their follow-up measurements, Clinical Centers will review their data and assist the Data Coordinating Center in the close-out of the initial study. Initiation of patient accrual will begin for the next studies, and protocol development will continue for subsequent trials. Depending upon the sample sizes and resources available to the Clinical Centers and the Data Coordinating Center, it may be possible to conduct two or more trials concurrently. The Data Coordinating Center will continue with its activities in data management, editing, data analysis, and protocol development. It will also support manuscript preparation through data analysis, statistical consultation, editorial tasks, and coordination of meetings. 7. Budget Applications for the Clinical Centers and the Data Coordinating Center must include a year-by-year budget that is adequately justified. For a Clinical Center, the budget should request support for the minimum number of full-and/or part-time staff to successfully carry out the proposed trials. A Clinical Center could include a Principal Investigator, Co-Investigator, Study Coordinator, and Data Entry Clerk. The budget should include support for travel for two key investigators to attend bi-monthly Steering and Planning Committee Meetings during Phase I and quarterly meetings during Phase II. Steering and Planning Committee Meetings will be held in the Washington, D.C. area. Travel for centralized training of the study coordinator and data entry clerk must also be budgeted (assume central training to be held in the Washington, D.C. annually during years 1 through 5). For applications for the Data Coordinating Center, the budget should also include the time and effort of key personnel needed to conduct the trials and the required number of and cost of computers to be used at the Clinical Centers for distributed data entry. Travel to Washington, D.C. for External Advisory Committee Meetings (two per year), Steering and Planning Committee Meetings (six in Year 1-Phase I and three annually in Phases II and III -Budget Years 2-5), and site visits (five visits for years 2-5) is to be included in the budget. The Data Coordinating Center should also budget for travel for the Chairperson of the Steering and Planning Committee (six meetings in Year 1 and three in Years 2-5). SPECIAL REQUIREMENTS Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to each Principal Investigator as well as to the institutional officials at the time of the award. These terms are in addition to, not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92, and other HHS, PHS, and NIH Grants Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U01), 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 the cooperative agreement concept, the dominant role and prime responsibility for the planned activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the activity will be shared among the awardees and NIDDK Project Scientist. A. Awardee Rights and Responsibilities Awardees will have substantial and lead responsibilities in all tasks and activities. These include protocol development, patient recruitment and follow-up, data collection, quality control, final data analysis and interpretation, and preparation of publications. The awardee agrees to work cooperatively with the other Clinical and Data Coordinating Centers and agrees to follow the common protocol and Manual of Operations developed by the Steering Committee. The awardee also agrees to transmit all study data to a central Data Coordinating Center for combination and analysis. Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government (e.g., NIDDK, NIH, or PHS) rights or access consistent with current HHS, PHS, and NIH policies. B. NIDDK Staff Responsibilities The NIDDK will name a Project Scientist from within the Division of Kidney, Urologic and Hematologic Diseases whose function will be to assist the Steering and Planning Committee and External Advisory Committee in carrying out the study. The Project Scientist will be a voting member of all key study group subcommittees and will serve as Executive Secretary of the External Advisory Committee. The Project Scientist will have substantial scientific-programmatic involvement in quality control, interim data analysis, safety monitoring, and final data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The dominant role and prime responsibility for these activities resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Scientist. The NIDDK Project Scientist will have voting membership on the Steering and Planning Committee and, as determined by that committee, its subcommittees. The NIDDK reserves the right to terminate or curtail the study (or an individual award) in the event of substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, reaching a major study endpoint substantially before schedule with persuasive statistical significance or human subject ethical issues that may dictate a premature termination. C. Collaborative Responsibilities A Steering and Planning Committee, composed of the Principal Investigators of each Clinical Center, the Principal Investigator of the Data Coordinating Center, and the NIDDK Project Scientist will be the main governing board of the study and will have primary responsibility for developing common study designs, protocols and manuals; facilitating the conduct and monitoring of studies, and reporting study results. Each Principal Investigator from a Clinical Center and the Data Coordinating Center as well as the NIDDK Project Scientist, will have one vote. The chairperson, who will be someone other than an NIDDK staff member, will be selected by the Steering and Planning Committee. Subcommittees will be established by the Steering and Planning Committee, as it deems appropriate; the Project Scientist will serve on subcommittees as he/she deems appropriate. The collaborative protocols will be developed by the Steering and Planning Committee. Data will be submitted centrally to the Data Coordinating Center. Protocols will define access to data and publications. An independent External Advisory Committee, to be appointed by the NIDDK, will review progress at least annually and report to the NIDDK. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering and Planning Committee. D. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between recipients and the NIDDK may be brought to arbitration. An arbitration panel will be composed of three members - one selected by the Steering and Planning Committee (with the NIDDK member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NIDDK, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation 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 is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 1003-43). 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 in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. LETTER OF INTENT Prospective applicants are asked to submit, by July 25, 1997, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application is submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows the NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: CHIEF, REVIEW BRANCH DIVISION OF EXTRAMURAL ACTIVITIES National Institute of Diabetes, Digestive, and Kidney Diseases 45 CENTER DRIVE ROOM 6AS-37F MSC 6600 BETHESDA, MD 20892-6600 FAX: (301)480-3505 Email: hagana@ep.niddk.nih.gov APPLICATION PROCEDURES Applications must 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 Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail: asknih@odrockm1.od.nih.gov. The RFA label in the 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. For purposes of identification and processing, item 2 of the face page of the application must be marked "YES" and the RFA number and the words "Interstitial Cystitis Clinical Trials Group" must be typed in. Submit a signed, typewritten original of the application, including the Checklist, and three signed 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 express/courier service) At the time of submission, two additional copies of the application must be sent to: CHIEF, REVIEW BRANCH DIVISION OF EXTRAMURAL ACTIVITIES National Institute of Diabetes, Digestive, and Kidney Diseases 45 CENTER DRIVE ROOM 6AS-37F MSC 6600 BETHESDA, MD 20892-6600 Applications must be received by August 26,1997. If an application is received after this date it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS 398 applications instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion for evaluation of a study. Other considerations, such as the ability to recruit minority participants and geographic location, will be part of the evaluation criteria. Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NIDDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Review Criteria Applicants are encouraged to submit and describe their own ideas about how best to meet the goals of the cooperative study and their specific protocols. The Initial Review Group evaluates the merit of each grant application according to specific criteria. The principal criteria for the initial review of all research applications, as required in the PHS Scientific Peer Review Regulations, include: 1. scientific, technical, or medical significance and originality of the proposed research; 2. appropriateness and adequacy of the experimental approach and methodology to be used; 3. qualifications of the Principal Investigator and staff in the area of research; 4. the Principal Investigator's experience and record in previous research activity; 5. reasonable availability of resources; 6. reasonableness and adequacy of justification of the proposed budget and duration of support; 7. adequacy of the proposed means for protecting against adverse effects upon humans, vertebrate animals, or the environment. The evaluation of applications for Clinical Centers and the Data Coordinating Center will be based primarily on the scientific merit of the proposed studies. Specific criteria for review of applications will be as follows: For Clinical Centers: 1. The scientific merit of the proposed study design(s) to address the objectives of the RFA. 2. Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the operation of a Clinical Center in the proposed Clinical Trial Group. Evaluation will include the following: familiarity with and experience in recruiting participants in a randomized trial; handling laboratory specimens; working in collaboration with other investigators under a common protocol; ability to implement study procedures; and meticulous and expeditious handling of study data. 3. Documentation of access to patient population(s) from which a substantial number of trial participants can be recruited in sufficient numbers to meet the goals specified in the RFA. 4. Ability to recruit representative minority populations. 5. Understanding and awareness of the scientific, ethical, and practical issues underlying the proposed trials and appropriateness of plans to deal with them. 6. Responsible budgeting and staffing and distribution of available resources appropriate for the work proposed. 7. Adequacy of the proposed facility and space. 8. Evidence of the degree of institutional commitment and support for the proposed program, including the relative position of the proposed project staff within the applicant's organizational structure. 9. Willingness to carry out a developed study protocol. 10. Adequacy of plans to ensure accurate collection and timely transmission of study data. For the Data Coordinating Center: 1. The scientific merit of the proposed approach to study design, data collection and management for interventions as outlined in the RFA. 2. Documentation of the specific competence and private experience of professional, technical, and administrative staff pertinent to the trial. Prior experience in similar studies, in the collection of data and patient specimens from multiple locations, as well as experience in monitoring the quality and timeliness of such data, should be demonstrated. 3. Demonstrable knowledge of the potential problems associated with the conduct of this study and possible solutions must be demonstrated. 4. Suitability of proposed data management and data analysis plans. 5. Ability to design, implement and maintain a distributed data entry system for the Clinical Centers. 6. The approach to and likelihood of soliciting cooperation from the participating Clinical Centers and exercising appropriate leadership in matters of study design and protocol revisions, and data acquisition, management, and analysis. Specific plans for ensuring quality control of data collection across all study sites are required. 7. Appropriateness of the budget for the work proposed. 8. The adequacy of the proposed facility, technical hardware, and space. 9. The organizational and administrative structure of the proposed program. 10. Evidence of the degree of commitment and support of the organization/institution for the proposed program, including the relative position of the proposed project staff within the applicant's organizational structure. AWARD CRITERIA Applications recommended by the National Diabetes and Digestive and Kidney Diseases Advisory Council will be considered for award based upon (a) scientific and technical merit; (b) program balance, including in this instance sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; (c) availability of funds; (d) appropriate minority representation in the trial; and (e) geographic balance among clinical centers. SCHEDULE Letter of Intent Receipt Date: July 25, 1997 Application Receipt Date: August 26, 1997 Special Review Committee: October/November 1997 NIDDK Advisory Council: February 4-5, 1998 Anticipated Award Date: March 1, 1998 INQUIRIES Written and telephone Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: John W. Kusek, Ph.D. or Leroy M. Nyberg, Ph.D., M.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DRIVE MSC 6600 BETHESDA, MD 20892-6600 Telephone (301) 594-7717 Email: kusekj@ep.niddk.nih.gov or nybergl@ep.niddk.gov Direct inquiries regarding fiscal and administrative matters to: Trude Hilliard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DRIVE Room 6AN-44B MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8859 FAX: (301) 480-3504 Email: hilliardt@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free work place 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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