Full Text AA-96-003 ALCOHOL RESEARCH CENTER GRANTS NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA: AA-96-003 P.T. 34 Keywords: Alcohol/Alcoholism Biomedical Research, Multidiscipl Diagnosis, Medical Disease Prevention+ Treatment, Medical+ Health Services Delivery National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: November 1, 1996 Application Receipt Date: December 11, 1996 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides grant support for Alcohol Research Centers to conduct interdisciplinary research on alcoholism and alcohol abuse. The Center grants program is interrelated with and complementary to all other research support mechanisms and scientific activities that comprise the NIAAA programs of research on the nature, causes, and consequences of alcohol abuse and alcoholism, including diagnosis, treatment, prevention, and health services research related to prevention and treatment of alcoholism. The NIAAA currently supports 14 Centers and anticipates that the level of support for this program will not expand during this competition. Support for seven of the current five-year Center grant awards will expire in late 1997. Research within each of these seven Centers is organized around a central theme: genetic determinants of alcohol ingestion, neurobiology of alcohol in central nervous system effects, genetic approaches to alcohol neuropharmacology, alcohol effects on the cell, alcohol and pregnancy outcome, environmental factors in alcohol problem prevention and etiology in treatment of alcohol dependence. Applications for new Centers in these and other research areas will be accepted with applications from currently funded Centers seeking renewal support. 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, Alcohol Research Center Grants, is related to the priority area of alcohol abuse and alcoholism reduction. 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 Any domestic public (non-Federal) or private non-profit or for-profit institution may apply for a Center grant. However, the proposed Center must be affiliated with an institution, such as a university, medical center, or research center, that has the resources to sustain a long-term, coordinated research program. An applicant institution must demonstrate the ability to attract high-quality scientists from biomedical, behavioral, and/or social science disciplines who are willing to make a long-term commitment to research. An application must also have a detailed five-year plan for a proposed research program. In addition, the applicant must assure that research training opportunities will be available. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The Alcohol Research Centers Grant program is designed to complement the regular research project grants program of the NIAAA by providing long-term (typically, for five years) support for interdisciplinary research programs with a distinct focus on a particular theme relating to alcoholism, alcohol abuse, and other alcohol-related problems. The program is intended to encourage outstanding scientists from biomedical, behavioral, social science, and other relevant disciplines to bring a full range of expertise, approaches, and advanced technologies to the study of problems related to alcohol abuse and alcoholism. Center grants help to provide a stable environment for investigators to engage in alcohol research in a coordinated and integrated effort. A Center is expected to be a source of scientific excellence, provide leadership to the field, and, through sustained excellence, to become a significant regional or national research resource. In addition, the applicant institution is expected to afford opportunities for research training to persons from various disciplines and professions. A specialized Center (P50) is a comprehensive, broad-based multidisciplinary, multi-investigator, long-term program of combined research and research support activity planned around a specific major research objective or research theme. In addition to providing support for shared resources, this type of Center supports a full range of basic, developmental, clinical, and/or applied research components; allows for growth and development through pilot projects; and is intended to provide state-of-the-art leadership in the alcohol field. FUNDS AVAILABLE It is estimated that approximately $10 to 11 million will be available in FY 1998 to fund approximately seven Centers. The total cost (direct plus indirect) for a Center may not exceed $1.7 million per year. Continuation support in the future years is anticipated. RESEARCH OBJECTIVES All proposed research to be conducted within a Center must be clearly directed toward one or more of the following goals: prevalence, etiology, diagnosis, prediction, clinical course, management or treatment of alcohol abuse, alcoholism, or alcohol-related health problems; health services research; consequences of alcoholism or alcohol abuse; and factors that relate to prevention of alcohol abuse, alcoholism, or other problems associated with alcohol consumption. Some examples are research to improve knowledge of the impact of alcohol use on related health issues, such as cardiovascular integrity; infectious diseases; liver and gastrointestinal functioning; nicotine and other drug use; performance ability; neurological impairment; and mental disorders that co-occur with alcohol abuse disorders. The Alcohol Research Center grant provides a mechanism for fostering interdisciplinary cooperation in a group of established investigators conducting high-quality alcohol research. Therefore, existence of a strong research capability is fundamental to the establishment of a new Center or the continuation of an existing Center. A Center should be an identifiable organizational unit within an institutional or organizational structure such as a university, medical center, or a consortium of affiliated cooperating institutions. Unique scientific opportunities warrant collaboration with investigators in other centers and/or with scientists in institutions outside the United States. In such cases the director of the components in which collaborative activity with a foreign organization is proposed must be affiliated with a domestic institution. Center Components The following paragraphs describe the specific components of a Center application: Administrative Core Component A Center should promote synergistic interaction of broad and diverse elements that require clearly specified lines of authority and accountability by appropriate institutional officials. The purpose of the administrative core component is to provide the organizational framework for the management, direction, and coordination of the Center. The administrative core component must be managed by the Center Director or Scientific Director and may include funds for scientific enrichment activities such as special lectures, visiting scientists, symposia, seminars, workshops etc.; and for education and research dissemination activities for the public. Scientific Core Components Core components for this RFA are defined as shared research resources that enhance productivity or in other ways benefit a group of investigators working in alcohol-related research to accomplish the common goals of the Center. A core component is a laboratory, facility, service, or other resource that interacts synergistically with research projects of the Center. Research projects that use the core may be funded primarily from the Center grant award (Specialized Research Center), from other support mechanisms such as Research Project Grants, Program Projects, or a combination thereof, that have relevance to the NIAAA mission. Core components should provide investigators with some technique, instrumentation, service, or resource in a way that will enhance research progress and contribute to efficiency and effectiveness. Each core component is directed by an investigator with established expertise relative to the support or service to be provided, usually a faculty-level individual. Some examples of research support that core components typically provide are: (1) technology that implements automation or large batch preparation; (2) tissue and/or cell culture facilities; (3) complex instrumentation, e.g., electron microscopy, mass spectrometry, electrophysiology; (4) animal care and preparation; (5) service and training; (6) patient coordination; and (7) information processing, data management, and statistical services. Research Components Research components are individual scientific research projects, interrelated within the overall Center program so that the components contribute collectively to the goals of the Center program to a greater extent than if each project were pursued separately. Each research component must be a highly focussed project under the direction of a component director. The component director should be an established researcher of independent and scientifically recognized standing who is responsible for the scientific direction and conduct of the individual research component. A Center Director or Scientific Director may also serve as a component director. Pilot Project Component The purpose of pilot projects is to provide the Center with a flexible means to develop and explore new research activities or directions, and unique scientific opportunities that could evolve into independently funded research projects. These funds are not intended to supplement ongoing research projects. Pilot projects must be in a separate pilot project component that incorporates all of the pilot studies of the proposed Center grant. SPECIAL REQUIREMENTS The following paragraphs describe the Special Requirements for a Center application. Details for preparing the application are provided in the "Supplemental Instructions," which are available from the program staff listed under INQUIRIES. It is essential that applicants carefully adhere to the Supplemental Instructions. Center grant applications should be organized into discrete components that comprise a proposed program of research. Each component is either a research component or a core component for which a separate detailed budget is included in the application. The application must include an administrative core and at least three research components; it may also include shared scientific resource cores and/or a pilot project component. The minimum acceptable combined number of research components and core components is four (an administrative core and three research components). The maximum combined number of research components and core components, including a pilot project component, is 10. More than a total of 10 components is not acceptable even if some components are in operation for less than the five-year period. All proposed research components need not be ongoing at any one time, but may be phased in at different time points during the life of the proposed Center grant. At least 3 research components must be ongoing at all times, and no more than 10 research and/or core components may be proposed over the entire project period. This aspect should receive careful attention in the application and individual component preparation. The research plan for each core component and each research component is limited to 25 pages. Pages not used for one component may not be used to extend the page limit of other components/cores. These page limits do not apply to pilot projects. For pilot project requirements, see section entitled "Pilot Project Component," (below). Administrative Core Component The administrative core component plays a key role in the coordination and operation of the Center. This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally and in an interactive synergistic manner. An important function of this core is the administration of the budget. Through this component, the Center Director provides substantive leadership and manages the administrative core component. This component may also include the costs of scientific enrichment, education, and information dissemination activities. The administrative core should also provide for integration of Center functions. Scientific Core Components Each shared scientific resource component should be clearly described in terms of the services/resources to be provided to investigators. The description should include a discussion of the core's contributions to the research objectives of the Center. Relevant aspects of cost effectiveness, time-saving, and increased efficiency attributable to the existence of the cores should also be addressed. A core component may support Center grant research components and separately funded research project grants that are related to the Center's theme. Each separately funded research project associated with the Center and utilizing core facilities should have a brief description that includes its research objectives and how the Center's core facility will impact upon it. The minimum number of research components/projects supported by a core component is two. A core component director who has documented experience and scientific expertise relative to the purpose of the core must be designated for each core. This person should be an established scientist in his or her field. The description of the organization and mode of operation of the shared resource core should include discussion of quality control for the service or resource, and the procedures for evaluating and selecting projects eligible for use of the core facility. Training in complex techniques and methods should be described if they are functions in proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives. While, research per se is not conducted as part of the scientific core, quality assurance activities that evaluate the operation, resources, quality and utilization of the core and that are directed at problem identification and improvement of core functioning are appropriate. In renewal applications, ongoing or completed core activity that has enhanced or facilitated alcohol research should be described. Past performance and accomplishments of cores should be described, as should the effect of services provided by cores on investigators' productivity. Research Components For each proposed research component, a clear description of the major goals, objectives, and its integration with the other components in relation to the overall Center program should be provided. o The question(s) to be addressed and the hypotheses to be tested by the proposed research should be highly focused and fully explained. o A discussion of the design and procedures should describe the strategies proposed to accomplish the specific aims of the project and highlight innovative aspects of the approach. o A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention devoted to a description of necessary resources, subjects, clinical populations, tissue resources, etc., which will be involved in proposed studies. If core facilities are utilized, information on their use should be provided. Pilot Project Component The process for selecting pilot projects should be fully, though concisely described. For the first 2 years that funds are requested for pilot projects, the application must provide descriptions of the projects to be supported. For years 03-05, the application must provide the specific number of pilots planned in each year and a brief description of the anticipated direction of these pilots. While the specific number of pilot projects to be proposed is at the discretion of the applicant, requested funding for pilot studies may not exceed $100,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any one year. All proposed pilot projects need not be ongoing at any one time, but may be phased in at different points during the life of the proposed Center grant. It is recognized that the relative priority or need for specific pilot projects may change over the course of time. While the Center's framework for management of pilot funds and the mechanism for operating the program are left to the discretion of the Center, the application must provide specific information to enable adequate scientific evaluation by a peer review committee. The application should include: o A full description of the management of the pilot project component, including a description of the process to be followed by the Center Director in selecting new pilot projects and replacing projects in the application should it become necessary. o A full description of each pilot study proposed in the first two years, including its rationale, objectives, approach, investigators, and significance for the Center. A description of the number and anticipated direction of pilot projects in the 03-05 years, including their significance to the Center. The research description of any individual pilot project may not exceed five pages; the entire narrative for this Pilot Project Component may not exceed 25 pages irrespective of the number of pilot projects proposed. o For competing renewal applications, information should be provided in the pilot project component description on the past experience of the Center in utilizing pilot funds to further the goals. The narrative should include an assessment of the overall benefits derived from the availability of pilot resources. A budget should be submitted for the pilot project component as a whole for each year in which pilots are proposed. For years 01 and 02 this budget will reflect costs of pilots proposed in the application. For years 03-05 the budget will estimate cost based on the number and kind of work to be pursued. In addition, budget information should be provided for each individual pilot project including those for the 03-05 years. See "Supplemental Instructions" for further information on pilot project description requirements. Renewal Applications A comprehensive progress report is required for competing continuation (renewal) applications. A statement must be included in the application regarding the progress made by the Center as a whole in its development as a national or regional research resource. In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal. More specific details are provided in the Supplemental Instructions. Facilities and Environment Applicants must demonstrate the availability of adequate laboratory, clinical, and office facilities needed to carry out the objectives of the proposed Center program. Although not required, it is desirable for all Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Reference facilities affording access to relevant literature must be readily available. It is expected that such reference facilities will be the primary repository of additional reference materials that may be obtained through Center funding. Relevant support services, including adequate data processing facilities, must also be readily accessible within or through the institution. Assurances of such support must be included with the proposal. Organization and Administration A Center must be an identifiable organizational unit with an administrative structure and clear lines of authority which will facilitate coordination among Center personnel to assure maximum accountability and efficiency in Center operations. An applicant must designate an institutional official to serve as principal investigator for the Center grant and as Director of the Center. The institutional appointment of this person must provide sufficient authority to allocate space, personnel, and other resources essential to the Center. This individual must demonstrate the ability to organize, administer, and direct the Center. The Director of the Center will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center. Overall program management, coordination, communication, progress assessment, and quality control are typically responsibilities of the Director and are facilitated through the administrative core. The administrative core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core. The applicant may also designate a Scientific Director who will be responsible to the Center Director and provide direct supervision of the scientific and operational aspects of the research program. Such a person should be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the research program. The Scientific Director will be responsible for assuring interaction and collaboration among scientists conducting research within the Center to facilitate a concerted approach to the research goals of the Center. The Scientific Director also will be responsible for the direct monitoring of ongoing research and for identifying (with the assistance of colleagues) research activities to be expanded or decreased and needs for additional resources or reallocation of resources. If the Center Director also serves as the Scientific Director, his or her functions as Scientific Director should also be described. Key professional staff, such as directors of individual research components and core components of the Center, should have the necessary training/experience to assure that the objectives and goals of the proposed studies will be achieved. Such persons must be independent investigators with scientifically recognized standing. A Program Advisory Committee shall be established and chaired by the Center Director. Its membership, selected by the Center Director from individuals outside the Center, should be composed of at least five members who should be identified in the application. Members should be persons of recognized scientific standing who are generally familiar with the Center's activities and represent a cross-section of disciplines that are relevant to the work of the proposed Center. It shall be the responsibility of this Committee to review and make recommendations to the Center Director on the conduct of all activities of the Center, including the conduct of pilot projects. If committees other than the Program Advisory Committee are included, specific plans regarding committee selection and function should be provided in the application. Training While the primary function of each Center is the conduct of high-quality interdisciplinary research, an important component related to the Center and its research efforts is the training of research and clinical personnel. The applicant institution must therefore demonstrate or give reasonable assurances that it has: (a) the capacity to train predoctoral and/or postdoctoral students for careers in alcohol research; and (b) the capacity to conduct programs of continuing education in the Center's designated research theme in the medical, behavioral, or health service fields. While the Center need not necessarily have formal training programs of its own, there must be specific provision for coordination between the Center and the training programs of the applicant institution and/or affiliated institutions. Center grant funds may not be used to pay stipends or other trainee costs; however, Center staff may participate in the development of training programs, and Center resources may be made available for use of trainees. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. Terms and Conditions of Support Center grant funds may be requested for support of core components and individual research components associated with the Center program. Administrative core resources may include, for example, salaries of personnel responsible for management of the Center, program enrichment activities such as special lectures, visiting scientists, symposia, seminars, workshops, etc., and costs related to dissemination of research information to the scientific community and lay public. Funds may be requested for costs associated with individual research components that are part of the Center program. Examples of such costs include: research staff salaries, supplies, travel, special consultation, research patient costs, publication costs, and the like. Funds also may be requested for the allowable indirect costs of the applicant organization. In addition, costs of advisory committees and consultants may be included in the administrative core. Consultants for specific research components should be included in the budgets for those components. Alcohol Research Center grant funds may be used only for costs that are necessary to carry out the research and research support activities of the Center program, and must be in conformance with HHS cost principles (encompassed in 45 CFR Part 74) and the Public Health Service Grants Policy Statement (rev. 4/94). This publication should be available from your office of sponsored research. Funds provided under this program may not be used for the purchase of land; nor for the purchase, construction, preservation, or repair of any building. However, costs of alteration and renovation of existing facilities necessary to accomplish the objectives of the grant may be allowed subject to PHS grants policy limitations. Funds provided through Center grants may not be used for support of trainee stipends, fees, or other expenses directly relating to training activities. Support will be provided for a period of up to five years (renewable for subsequent periods) subject to continued availability of funds and scientific progress. Applicants may request up to $1.7 million total cost (including direct and indirect costs combined) per year. The actual amount of support awarded will depend upon consideration of factors listed under AWARD CRITERIA. The Center grant is neither expected nor intended to cover all costs of running a successful Alcohol Research Center program. Research and training activities associated with the Center may receive additional funding from Federal sources as well as from State and local sources. NIAAA expects and encourages the institution and scientists attracted to such Centers to seek and compete actively for such funding. Research staff in funded Centers may submit applications for independent research project grants for support of research projects that do not overlap with their Center project(s). Centers will be required to submit detailed annual progress reports including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modifications in long-term research plans. Also required are reporting of inventions, reports of expenditures, final reports, and other reports in accordance with PHS policy. LETTER OF INTENT Prospective applicants are asked to submit, by November 1, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAAA 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: Ernestine Vanderveen, Ph.D. Centers Program National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office 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@odrockm1.od.nih.gov; and from NIAAA staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Page limits and limits on size of type are strictly enforced. Non-conforming applications will be returned without being reviewed. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH Division of 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 should be included in the application materials. Submit a signed, typewritten original of the application, including the checklist and three signed photocopies as well as sets of appendix materials 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 plus appendices must also be sent to: RFA AA-96-003 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Bethesda, MD 20852 (for express/courier service) FAX: (301) 443-6077 Applications must be received by December 11, 1996. If an application is received after that 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration as will any application that is not responsive to the RFA. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit based upon the review criteria that follow by an appropriate peer review group (initial review) convened by NIAAA in accordance with the following peer review procedures. All applications will receive a written critique. The initial peer review process will be used to determine the most competitive applications; site visits and/or applicant interviews may be used to further evaluate the latter group of applications. Issues to be considered in applicant interviews/site visits will be determined by NIAAA, will be consistent for all applications interviewed and/or site visited, and are likely to be limited to consideration of issues related solely to the management and cohesiveness of the Center as an integrated whole. All applications will receive a second level review by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria The initial review for scientific and technical merit of applications will emphasize two major aspects: (1) review of the Center as an integrated research effort focused on a central theme, including the administrative core; and (2) the review of each research component, all other core components, and the pilot component as applicable. The review will also include an assessment of the academic and physical environment and special considerations, e.g., compliance with human subject and animal welfare requirements, and compliance with policies concerning inclusion of women and minorities in clinical research study populations. ADMINISTRATIVE CORE AND CENTER AS AN INTEGRATED WHOLE SIGNIFICANCE OF THE CENTER o Significance of the overall research goals o Development of a well-defined central theme o Multidisciplinary scope INTEGRATION OF THE CENTER o Center coordination and cohesiveness o Interrelatedness of cores and components with each other o Usefulness of scientific core components to research components and to independently supported investigators who use them o Synergistic potential among Center components and core units o Justification for each research component in terms of the central theme and the overall research goals of the Center o Justification for each scientific core component in terms of accomplishing center objectives QUALIFICATIONS OF KEY STAFF o Qualifications, experience, commitment and administrative competence of the Center Director o Ability of the Center Director to devote substantial time and effort to the Center o Scientific ability of the Scientific Director and his or her professional experience and leadership o Ability of the Scientific Director to devote substantial time and effort to the Center o Scientific qualifications and ability of the directors of the research components and core components and their commitment to the center ADMINISTRATIVE CORE ARRANGEMENTS AND ORGANIZATIONAL STRUCTURE o Processes to facilitate and monitor attainment of Center objectives o Plans for communication and cooperation among investigators involved in the Center o Quality control and oversight mechanisms for ongoing projects o Day-to-day management o Long-term management and periodic evaluation of goal attainment o Contractual and consortium arrangements (as applicable) o Procedures for replacement of key personnel, if necessary POTENTIAL OF THE CENTER AS A RESOURCE o Potential of the Center to become or maintain itself as a regional and national resource o Capacity to provide quality research training, opportunities for independent research career development o Plans for research information dissemination and educational activities RESOURCES AND ENVIRONMENT o Institutional strength, stability, commitment to research, and support of the Center, including fiscal responsibility and management capability to assist the Center Director and staff in complying with DHHS, PHS, and NIH policies. o Opportunities for research training and education for persons from various disciplines and professions o Potential for interaction with scientists from other departments and institutions o Academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects, and materials. RENEWAL APPLICATIONS o Degree to which the Center achieved stated goals with special attention to - scientific merit of completed research - recruitment of new scientists into alcohol research - development of a multidisciplinary team - coalescence of Center staff into an effective team RESEARCH COMPONENTS o Significance of the research o Scientific and technical merit o Qualifications, experience, and commitment of the component director o Adequacy of component director's time and effort o Adequacy of the resources and environment SCIENTIFIC CORE COMPONENTS o Need/justification for the core service/resource o Scientific and technical merit of the service/resource provided o Plans for resource allocation o Quality control procedures o Qualifications, experience, and commitment of the component director o Adequacy of component director's time and effort o Adequacy of the resources and environment PILOT PROJECT COMPONENT o Adequacy of the selection process for new and replacement pilot projects o Monitoring and oversight procedures and continuation decisions o Adequacy of the resources and environment for all projects o For INDIVIDUAL PILOT PROJECTS - Importance of topic - Grounding in the literature or empirical findings - Reasonableness of the approach - Potential to develop into an full-scale independent project - Qualifications of the project director OTHER CONSIDERATIONS: For the Center as a whole and all components/cores o When an application proposes research or research-related activity that involves potential risks to human subjects, animals, and/or the environment, the adequacy of the proposed means for protecting against such risks must be demonstrated for each component. o Specific statements addressing compliance with NIH policies on inclusion of women and minorities in studies involving human subjects. o Adequacy of the budget request for the work proposed. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall merit of the application, as well as such considerations as program balance, relevance to the mission and goals of NIAAA, research program priorities, equitable geographic distribution, continuity of support, and availability of funds. Awards will be made for up to five-year project periods with separate fiscal awards made annually. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ernestine Vanderveen, Ph.D. Centers Program National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvander@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Edward Ellis Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Email: eellis@willco.niaaa.nih.gov RELATIONSHIP TO NIAAA In view of the special significance of this program, close coordination and communication between the NIAAA staff and staff of the Alcohol Research Centers is intended. The NIAAA program official will have responsibility for maintaining liaison with appropriate Center leadership, serving as resource consultant to the Center program, and keeping NIAAA staff informed on progress and accomplishments of the Centers. In addition, the program official with other NIAAA staff and consultants will, from time to time, make on-site visits for purposes of program coordination and exchange of information. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.891. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464J, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 549, "Grants for National Alcohol Research Centers;" Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of Human Subjects." 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 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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