RFA-AG-98-004: ALZHEIMER"S DISEASE DATA COORDINATING CENTER

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

ALZHEIMER"S DISEASE DATA COORDINATING CENTER Release Date: February 5, 1998 RFA: AG-98-004 P.T. National Institute on Aging Letter of Intent Receipt Date: May 15, 1998 Application Receipt Date: August 12 ,1998 PURPOSE The National Institute on Aging (NIA) invites cooperative agreement applications from qualified institutions for support of an Alzheimer"s Disease Data Coordinating Center (ADDCC) which is designed to serve as a shared research resource to facilitate research in Alzheimer"s disease (AD). The NIA Alzheimer"s Disease Centers (ADC) program is authorized by the Public Health Service Act, Section 445, and includes fourteen Alzheimer"s Disease Research Centers (ADRC) and thirteen Alzheimer"s Disease Core Centers (ADCC). Alzheimer"s disease research would benefit from analysis of combined data collected systematically from all of the existing ADCs and, eventually, from other sources where longitudinal data are collected. Such data on demented patients and unaffected, age- matched controls would support 1) clinical, molecular and pathological research on disease natural history, heterogeneity, diagnosis and clinical-pathological correlations, 2) demographic information important for policy research and 3) epidemiological research related to the identification of risk factors. At the present time, information is being collected and stored separately at the 27 Alzheimer"s Disease Centers. This planned initiative will help systematize data collection and analysis across centers and create a central data coordinating center where data from all ADCs can be combined, coordinated, and made available to researchers from the ADCs and to the wider research community. The data coordinating center will assemble, maintain, analyze and disseminate data, catalog brain tissue and other biological samples stored at the ADCs, serve as a study design and statistical consulting resource for ADCs utilizing the database, and coordinate semi-annual meetings of the ADCs to discuss progress and planning for shared initiatives. The primary objectives will be to : 1) establish and maintain a data base of clinical, pathological and biochemical information collected at the ADCs from persons with Alzheimer"s disease and related disorders and from unaffected age- matched controls, 2) provide assistance to investigators in planning and conducting research studies using the database, and 3) make available data and a catalog of tissues and other biological samples collected from AD patients and controls for use in epidemiological, clinical, molecular and pathological studies by qualified investigators. With the establishment of this data coordinating center, important and novel research issues can be addressed which would not be possible with the resources available at any one center. Research activities that use ADDCC resources may be supported through the usual National Institutes of Health (NIH) and other federal and non-federal sources for the funding of investigator-initiated applications. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Alzheimer"s Disease Data Coordinating Center, 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 Applications may be submitted by domestic organizations, public and private, 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. The applicant organization should have experience in functioning as a data coordinating center for clinical studies of a medical and/or behavioral nature, or in other large-scale data management and analysis projects and have knowledge about the unique characteristics of Alzheimer"s disease and related dementias, the NIA Alzheimer"s Disease Centers Program, and the status of current AD research, including important unanswered questions that could be addressed using the larger data sets. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01) , an assistance mechanism in which a substantial involvement between NIA program staff and the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIA"s purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partnership role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under this cooperative agreement are discussed later in this document under the section Terms and Conditions of Award . The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated award date is July 1, 1999. The ADDCC will be recompeted every five years, depending upon available funds. FUNDS AVAILABLE It is anticipated that one award for a Data Coordinating Center will be made, with an estimated total cost of $3,000,000 (including direct and indirect costs) in the first year. The award of the Cooperative Agreement pursuant to this RFA is contingent on the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background Alzheimer"s disease may presently affect up to 4 million older people in the United States. Although it is occasionally identified in persons in their forties and fifties, it is most frequently found in persons over the age of 65. It doubles in prevalence with every five years past the age of 65, thus, extending life by ten years quadruples the probability of the disease. Alzheimer"s disease is the most frequent cause of institutionalization for long-term care, it destroys the active, productive life of its victims and devastates their families financially and emotionally. In 1993, it was estimated that the United States spent as much as 100 billion dollars/year for the direct and indirect costs of care for patients with Alzheimer"s disease. Both the Executive and Legislative Branches of the Federal Government have expressed concern about the enormity of the problem posed by this disease and, with the growth of the elderly population, the prospect of an even greater problem in the future. Congressional concern about Alzheimer"s disease has focused on funding for research on the causes and treatment of the disease, and on the cost of care. Congress directed the National Institutes of Health, and in particular the National Institute on Aging, to foster further research related to Alzheimer"s disease. The long-range development plans for AD research have included several strategies. One of the most prominent was the development of a cadre of Alzheimer"s Disease Centers to support a multi-faceted approach to AD including clinical and other core services, research on basic mechanisms and clinical course of the disease, and professional and public information and education activities. The ADCs provide to university investigators and research groups well characterized patients and controls, information about patients and families, and tissue and biological specimens for use in research projects. Collection of data from these resources in a central data center will provide opportunities for new and larger scale collaborative studies on Alzheimer"s disease than were possible in the individual ADCs. B. Research Goals and Scope Applications should present a plan for a data coordinating center which includes approaches to the following activities and any others that would complement the functions outlined here: 1) Data Coordination a. assume responsibility for the minimum common database (tracking approximately 50 variables) currently in existence to which all ADCs contribute basic demographic, clinical and pathological information about patients in a standard format, to gradually expand this database and plan links to ADC databases which will include information of greater depth and breadth about the clinical, pathological, genetic and demographic status of the patients and controls. Expansion will entail surveying all existing ADC database structures and proposing ways to integrate common variables and index non-conforming variables in a central database. This will include setting up the central database and collecting, editing, verifying, reformatting and assisting in the analysis of the data. The ADDCC will assure quality control and provide appropriate detailed data reports to the steering committee and the NIA at regular intervals, b. propose a plan for orderly transfer of the data from the Interim Data Center, currently in operation, to the new Coordinating Center and to the NIA or another Data Coordinating Center at the end of the funding period, if necessary, c. propose a time frame for complete data migration from all ADCs to the ADDCC, d. facilitate ADC participation in further data sharing efforts and studies using the databases, e. develop protocols for data collection, formatting and transmission to and from individual ADCs and the ADDCC f. propose a mechanism to protect the rights of individual Centers to conduct studies on patients recruited to that Center while still contributing clinical and pathological core data to the Coordinating Center, g. prepare a catalog of all tissues, biological specimens, cell lines, reagents and molecular probes available from each of the ADCs and distribute the catalog to investigators both within and outside of the ADCs, h. develop and maintain a comprehensive set of procedures to assure data quality and also procedures to assure confidentiality of subjects i. develop training programs to educate ADDCC staff and ADC staff about operating procedures with the goal of maximizing efficiency of data operations, j. develop procedures to publicize the kind of data available in the ADDCC and the procedures for getting access to it. 2) Consultation on study design and statistical analysis a. provide statistical advice and consultation on study design to investigators involved in studies approved by the Steering Committee and to encourage maximum use of the data, collected by the data center b. provide assistance in planning for recruitment of individuals for prospective epidemiological, genetic and clinical studies, 3) Coordination of meetings and reports a. establish a steering committee to oversee ADDCC operations made up of representatives from the ADCs, specialized consultants, the Principal Investigator of the ADDCC and NIA staff, The steering committee must be kept informed and approve of any changes in policy, b. organize at least two meetings each year of the ADDCC Steering Committee and also organize regular teleconferences to allow the steering committee to monitor operations and approve changes in procedures, provide administrative support to semi-annual meetings of the ADC Directors and annual meetings of the ADC Administrators, Education and Neuropathology Core leaders, c. prepare regular reports as defined by the steering committee and the NIA and special reports when requested, d. develop a Manual of Operations in conjunction with the Steering Committee, 4.) Pilot studies a. provide funding for pilot or feasibility studies involving joint efforts between one or more of the ADCs and the ADDCC, and using data from or specimens cataloged by the ADDCC, C. Minimum Requirements for the Staff of the Data Coordinating Center 1) Staff must be prepared to cooperate in all data coordination activities with the NIA and the ADCs. 2) The key staff must demonstrate prior experience in complex large-scale collaborative studies and have experience arranging logistical services for complex studies. 3) The Principal Investigator and/or other key staff must present evidence in the form of publications or descriptions of previous experience that demonstrates their knowledge of Alzheimer"s disease and related dementias research and familiarity with the AD research literature including genetics, epidemiology, molecular pathogenesis and clinical course of the disease. 4) The PI and /or key staff must demonstrate familiarity with the structure and operations of NIA Alzheimer"s Disease Centers. 5) The Principal Investigator must be willing to commit at least 25% effort to this Coordinating Center. 6) The Principal Investigator and other staff must have appropriate expertise and capability in biostatistics, data management, data analysis, and project management. 7) The Center staff must have the ability to assist in designing protocols, study manuals and data collection systems, including distributed data entry and plans for data analysis. 8) The Center staff must have experience in developing and maintaining data quality control systems. 9) The Center staff should have the ability to generate regular reports for studies approved by the Steering Committee, for use of the NIA, or other special reports as needed. 10) The Center staff must demonstrate successful experience in assisting clinical investigators prepare manuscripts for publication that utilize data gathered from collaborative research. 11) The Center staff must provide evidence of their prior management capability for the following: a) to estimate appropriate and reasonable resources needed for individual projects in its role as a Data Coordinating Center, b) to manage resources efficiently during the research, c) to adjust assigned resources to changing demands as the research work progresses, d) to keep NIA informed of changes of resource allocations, and e) to subcontract with affiliated ADCs or other outside organizations. SPECIAL REQUIREMENTS Terms and Conditions of Award The Alzheimer"s Disease Data Coordinating Center will be an identifiable organizational unit formed by a single institution or a consortium of cooperating institutions. Such a center will involve the interaction of broad and diverse elements. Therefore, lines of authority and sanction by the appropriate institutional officials must be clearly specified. The administrative and funding instrument used for the ADDCC 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 awardee for the project as a whole, although specific tasks and activities in carrying out the activity will be shared between the awardee and the NIA Program Official. The following terms and conditions will be incorporated into the award statement and provided to the 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. A. Awardee Rights and Responsibilities The awardee will have substantial and lead responsibilities in all tasks and activities. These include data collection, quality control, final data analysis, and assistance with preparation of publications. The awardee agrees to work cooperatively with the ADCs and agrees to accept guidance from the ADDCC Steering Committee and to follow the Manual of Operations approved by the Steering Committee. B. NIA Staff Responsibilities The NIA will name a Program Official from within the Dementias of Aging Branch of the Neuroscience and Neuropsychology of Aging Program whose function will be to assist the Principal Investigator and the Steering Committee in oversight of the Coordinating Center. The Program Official will be a non-voting member of the steering committee and all key study group subcommittees. The Program Official will have substantial scientific-programmatic involvement including participation in database development, budget monitoring, identification of relevant research questions, selection of pilot studies, modification of protocols, quality control, data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The prime responsibility for these activities resides with the awardee although specific tasks and activities in overseeing the studies will be shared between the awardee and the NIA Program Official. The NIA reserves the right to terminate or curtail the award in the event of a lapse in data reporting, quality control, or other major breach of the protocol. C. Collaborative Responsibilities The ADDCC Steering Committee will include the ADDCC Principal Investigator, the NIA Program Official, the three members of the ADC Directors" Executive Committee and three additional ADC Directors elected from the ADC Directors group. Two other outside members with data center expertise shall be appointed by the Steering Committee. A Chairperson will be elected from the membership of the Steering Committee. The Principal Investigator of the ADDCC and the NIA Program Official are ineligible to serve as chair. A staff member from the NIA Grants and Contracts Management Office will serve in an advisory capacity to the committee. The functions of the Steering Committee are to oversee the expansion of the minimum database and the setting up of the data center, approve operating procedures and changes in operating procedures, identify, prioritize, and review study topics, consider the relevant research questions and available resources, review proposals for feasibility studies submitted for funding by the ADDCC, consult with and advise the leadership of the ADDCC and the NIA and monitor the data center"s progress in meeting goals, help the ADDCC analyze and interpret data from studies associated with the ADDCC, and approve the composition of a publications committee. The Steering Committee can act as the Publications Committee or it may select a Publications Committee, composed of representatives from the ADCs, that will make decisions about publication policies including authorship and will review all manuscripts before publication. The awardee will be required to accept and implement the procedures approved by the Steering Committee. D. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between recipient and the NIA may be brought to arbitration. An arbitration panel will be composed of three independent members - one selected by the Steering Committee, a second member selected by NIA, 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, 42 CFR Part 50, Subpart D and HHS regulation, 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 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 reprinted in the NIH GUIDE FOR GRANTS and CONTRACTS, Volume 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by May 15 , 1998, a letter of intent that includes a descriptive title of the proposed ADDCC, the name, address, and phone number of the Principal Investigator, the identities of other key personnel, and the number and title of this RFA. A letter of intent is not an absolute requirement, is not binding, and does not enter into the review of subsequent applications. The information that it contains is helpful in planning for the review of the applications. It allows NIA staff to estimate the potential review workload and to avoid conflicts of interest in the selection of reviewers. The letter of intent is to be sent to Dr. Creighton Phelps at the address listed under INQUIRIES. APPLICATION PROCEDURES The application should be prepared using instructions in this RFA. Prior to submission of the formal application, consultation with NIA program staff concerning the technical aspects of preparing the application is strongly encouraged. A page limit of 75 pages for the research plan in applications responding to this RFA should not be exceeded. The current version of the research grant application form PHS 398 is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, from the World Wide Web at http://grants.nih.gov/grants/funding/funding.htm, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892- 7910, telephone (301) 710-0267, Email: [email protected]. To identify these applications as being in response to the RFA, the RFA label available in the Application Form 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. In addition the RFA title: "ALZHEIMER"S DISEASE DATA COORDINATING CENTER" and the RFA number must be typed on line 2 of the face page of the application. Submit a signed original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040-MSC 9205 Bethesda, MD 20892-7710 Bethesda, MD 20817-7710 (for courier/overnight service) At the time of submission, two additional copies of the application and any appendices must be sent to: Dr. Mary Nekola Chief, Scientific Review Office National Institute on Aging Gateway Building - Room 2C212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892-9205 ATTN: Alzheimer Data Coordinating Center Applications must be received by August 12, 1998. If an application is received after that date, it will be returned to the applicant without review. CONTENT OF APPLICATION The application should have 1) an introduction 2) a description of capabilities and experience of the key personnel, 3) a research plan for the first five years of the data center, and 4) a budget with justification of all expenses. The description and research plan must incorporate the following minimum requirements. A. Description of Capabilities and Experience 1. Describe the applicant organization"s facilities, resources, and how the staff"s strengths in biostatistics, data management, data analysis, and project management skills have been used in previous, successful large-scale collaborative research. 2. Describe the extent of involvement of the Principal Investigator in previous large-scale, collaborative research. 3. Describe the knowledge and experience of the Principal Investigator and/or other staff in research on Alzheimer"s disease and related dementias and knowledge of the structure and operations of the NIA Alzheimer"s Disease Centers. 4. Describe the experience of the key personnel in assisting protocol design, data entry procedures and manual preparation, and in data collection for previous large-scale, complex research projects. 5. Describe the experience of the applicants in data quality control in previous large-scale, collaborative research. 6. Present the applicant"s record in generating reports on data collection and performance in previous large-scale collaborative projects. 7. Summarize the applicant"s contributions in preparing manuscripts from previous large-scale, collaborative research. 8. Describe how logistical services and organizational support have been developed and utilized in managing resources and monitoring performance in previous large-scale, collaborative research. B. Research Plan 1. Describe the applicant"s conception of the role of the Data Coordinating Center in furthering Alzheimer"s disease research using large data sets. 2. Describe in detail examples of studies on Alzheimer"s disease etiology, pathogenesis and clinical course that would be feasible using an expanded data set, including any new data that would need to be collected for the studies. Include appropriate citations from the scientific literature. Describe the statistical methods to be used, the unique analytic challenges these studies may face, and strategies for dealing with these challenges 3. Provide a statement of intent to collaborate with all of the ADCs and the NIA consistent with the terms of the award. 4. Describe, in detail, plans for rapidly migrating data from the existing interim data center (information about the structure and function of the interim data center is available upon request) to the new data coordinating center, expansion of these data-sets, and plans for orderly transfer of the data to another center or the NIA at the end of the funding period, if necessary. 5. Describe the platform for the database, stages of development, and procedures for maintaining data integrity and assuring confidentiality. 6. Describe the nature of additional data, over the minimum data set, to be collected and a timetable for implementation of further data collection. 7. Propose an idealized staffing pattern for providing data coordinating functions from protocol design through analysis, reporting and dissemination. 8. Propose an operational structure for providing and coordinating the data functions for several research protocols simultaneously. 9. Propose an administrative and management structure that would support and enhance the operational structure. 10. Propose a plan to provide logistical support for the semiannual meetings of the Steering Committee of the ADDCC and the ADC directors in addition to annual meetings of the ADC administrators, and the Education and Neuropathology Core Leaders. 11. Propose methods to be used to assure effective communication among the ADDCC, the participating ADCs and the NIA using the capabilities of the Internet and World Wide Web while preserving confidentiality of data. 12. Describe a method for reimbursing individual ADC costs for collecting, preparing, and submitting data to the central data coordinating center. 13. Outline a process for soliciting, reviewing, and funding small feasibility studies which would involve collaboration among the ADCs using data coordinated by the ADDCC. 14. Propose a process for initial cataloging of all brain and other biological specimens and reagents banked by the ADCs and for preparing a biannual inventory of specimens from the ADCs. 15. Describe a proposed operating arrangement with the ADCs to determine how permission will be granted to access, use and publish data available in the data center. 16. Propose a charter for the Steering Committee, using information about its functions described in this RFA, which can then be modified and adopted by the Steering Committee once it is established. C. Budget Considerations All ADDCC proposals should request and provide justification for five years of support. The total costs (direct plus indirect) requested for applications for the ADDCC may not exceed $3,000,000 for the first year. Direct cost requests for subsequent years should reflect any projected growth and inflationary increases limited to no more than 3% per year. In addition to personnel, equipment, and supplies, budgeting should include funds for: - Feasibility studies - for ADCs and/or groups of ADCs to conduct cooperative pilot studies ($30,000 -$50,000/study ) using data collected by the ADCs (approximately 10% of budget) - Subcontracts to the ADCs for local cost recovery for expanded data collection, beyond the minimum data set, including formatting and preparation of data for transmission to the data center (approximately 50% of budget) - Costs for logistical arrangements (e.g., meeting room rental, audio video expenses, speaker expenses, etc.) of two meetings each year for the ADDCC Steering Committee and the ADC Directors, and one meeting each year for the ADC Administrators, Education Core and Neuropathology Core leaders. Travel funds for the Steering Committee Meeting (but not ADC meetings) should be budgeted as well as funds for regular teleconferences for the Steering Committee. - Costs for training ADC and ADDCC staff D. For consortium arrangements, the following information should be provided in the application: 1. A list of all proposed performance sites both at the applicant institution and at the collaborating institutions. 2. A separate, detailed budget for the initial and future years for each institution and, where appropriate, for each unit of activity at each institution. 3. A composite budget for all units of activity at each institution for each year, as well as a composite budget for the total proposed budget for each year. 4. An explanation of the programmatic, fiscal, and administrative arrangements made between the grantee institution and the collaborating institutions. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and responsiveness by NIA. Incomplete applications will be returned to the applicant without further consideration. If NIA staff find that the application is not responsive (those that fail to include all required components, request amounts that exceed allowable limits, or are not directed to the goals of this RFA), it will be returned 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 NIA. As part of this merit review, a process may be used 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 reviewed in detail by an initial peer review group and also receive a second level of review by the National Advisory Council on Aging. Applications determined to be "non-competitive for funding" will be so designated, and an abbreviated summary report noting the major weaknesses will be sent to the principal investigator and the application withdrawn. The factors to be considered in the evaluation of the merit of each application are listed below Each application must be thorough and complete enough to stand on its own and should be prepared as if no site visit will occur. Additional materials or revisions will not be accepted after the receipt date. It is strongly recommended that Institutional Review Board (IRB) and, if appropriate, Institutional Animal Care and Use Committee (IACUC) approval be secured before the application is submitted. Otherwise, it is the applicant"s responsibility to ensure these certifications are sent to the Scientific Review Office, NIA, within 60 days of the receipt date. Applications failing to comply with this requirement will be returned without review. There will be no further notifications on this issue. Review Criteria: Listed below are the major review criteria to be used in the evaluation of ADDCC applications: 1. The organizational and administrative structure of the proposed program including evidence of the degree of commitment and support of the organization/institution for the proposed program and the relative positions of the proposed project staff within the applicant"s organizational structure. 2. The scientific merit of the proposed approach to data collection, management and coordination, as outlined in the RFA. Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the data center. Prior experience should be demonstrated in similar studies, for the collection of data from multiple locations, as well as experience in monitoring the quality and timeliness of such data. 3. Documentation of the specific competence and previous experience of professional staff with the unique features of Alzheimer"s disease and related dementias research and the NIA Alzheimer"s Disease Centers Program. The extent to which uses for data collected in the Center demonstrate an understanding of this complex disease process and logical approaches to answering questions fundamental to the disease. 4. Demonstrable knowledge of the potential problems associated with the conduct of this project and possible solutions. 5. Suitability of proposed data management and data analysis plans, the adequacy of the proposed facility and technical hardware and appropriateness of the budget for the work proposed. 6. The approach to, and likelihood of, soliciting cooperation from the ADCs while exercising appropriate leadership in matters of study design, protocol revisions, data acquisition, management, and analysis. Specific plans for ensuring quality control of data collection and confidentiality across all study sites are required. 7. Suitability of a plan to assume management of data already collected by the Interim Data Center, for a rapid and orderly transition from the current system to a new system, and for transferring data to a new grantee at the end of the award period or to the NIA, if necessary. 8. Suitability of plans to manage a pilot studies program including solicitation , review and funding of pilot or feasibility studies. 9. Suitability of plans for managing meetings of the steering committee and the ADC meetings. AWARD CRITERIA Applications recommended by the National Advisory Council on Aging will be considered for award based upon (1) scientific and technical merit, (2) program balance, including in this instance sufficient compatibility of features to make a successful collaborative program a reasonable likelihood, and (3) availability of funds. INQUIRIES Letters of intent and inquiries regarding programmatic issues should be directed to: Dr. Creighton H. Phelps Dementias of Aging Branch National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307 - MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: [email protected] Direct inquiries regarding fiscal matters to: Linda Whipp Grants Management Office National Institute on Aging Gateway Building, Room 2N-212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. 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 Public Health Service (PHS) strongly encourages all grant 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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