Full Text AA-94-008 ALCOHOL RESEARCH CENTER GRANTS NIH GUIDE, Volume 23, Number 22, June 10, 1994 RFA: AA-94-008 P.T. 04 Keywords: Alcohol/Alcoholism Biomedical Research, Multidiscipl National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: December 1, 1994 Application Receipt Date: January 19, 1995 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 four of the current five-year Center grant awards will expire in late 1995. Research within each of these four Centers is organized around a central theme, respectively, adolescent alcohol abuse, alcoholism treatment, epidemiology of alcohol problems, and pathologic effects of alcohol. 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 202-783-3238). 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. Women and minority investigators are encouraged to apply. 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 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 $6 to 7 million will be available in FY 1996 to fund approximately four Centers. The total cost 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. For example, research to improve knowledge of the impact of alcohol use on related health problems, such as liver and gastrointestinal disorders; nicotine and other drug abuse; neurological impairment; and mental disorders that co-occur with alcohol abuse disorders, is also encouraged. 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. 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 stated 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 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 general 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. 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 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 for the total project period. More than a total of 10 components is not acceptable even if some components are in operation for less than the five-year period. 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. 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 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 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. Research support or evaluation activity is appropriate for a core when it is directly related to improving operation, resources, quality, or utility of the core. In renewal applications, ongoing or completed core activity that has enhanced or facilitated 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. 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. Pilot Project Component Pilot projects should be adequately, though concisely described. For every year that funds are requested for pilot projects, the application must provide descriptions of the project to be supported. 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 also 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 should a need arise to replace any of the pilots contained in the application. o A full description of each proposed pilot study including its rationale, objectives, approach, investigators, and significance for the Center. The research description of any individual pilot project may not exceed eight pages; the entire narrative for this Pilot Project Component may not exceed 50 pages irrespective of the number of pilot projects proposed. o For competing renewal applications, information should be provided 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. In addition, budget information should be provided for each individual pilot project. 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 special instructions appended to this announcement. 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 the 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 established investigators with proven track records. 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. 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, and 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. STUDY POPULATIONS 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 9, 1994 (FR 59 11146-11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. 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 which 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, steering committees, and consultants may be included in the administrative core. Consultants for specific research components should be included in the budgets for those components. If committees other than the Program Advisory Committee are included, specific plans as to how the committees will be selected and how they will function should be presented in the application. 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. 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 December 1, 1994, 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 Rockville, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grant Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone 301-710-0267; and from the NIAAA program administrator named below under INQUIRIES. Applications must be received by January 19, 1995. The RFA label available in the PHS (rev. 9/91) 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 2a 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. Page limitations, including those for appendices, are specified in the Supplemental Instructions for Preparing an Alcohol Research Center Grant application. 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 Center 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 material. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 REVIEW CONSIDERATIONS The Division of Research Grants (DRG), NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If NIAAA staff find that the application is not responsive to the 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 NIAAA in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. 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 and all other core components. 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. 1. The Center as an Integrated Effort o The significance of the overall research goals and development of a well-defined central research theme. o Multidisciplinary scope of the Center. o Center cohesiveness, coordination, and interrelation; and the synergistic potential among the Center components and core units. o The qualifications, experience, and administrative competence of the Center Director; and his or her commitment and ability to devote substantial time and effort to the Center. o The scientific ability of the Scientific Director and his or her professional experience and leadership. o The justification of the core components in terms of accomplishing the Center objectives, and their usefulness to the research components and/or independently supported investigators who utilize the core services or facilities. o The justification of individual research components in terms of the overall research goals and the central research theme of the Center and their relation to other research components. o The scientific qualifications and ability of the directors of the research project components and/or the core components, the extent to which each of the directors will contribute to overall Center goals, and their commitment to the Center. o Administrative arrangements and organizational structure of the administrative core to facilitate and monitor attainment of Center objectives and maintain quality control of ongoing projects. These factors include: - plans for communication and cooperation among investigators involved in the Center; - mechanisms for allocation of funds and core resources and selecting meritorious replacement pilot projects if this becomes necessary; - quality control, oversight; - day-to-day management, long-term planning, and periodic evaluation; - contractual and consortium arrangements; and - procedures for replacement of key persons, if necessary. o Appropriateness of the overall budget for the work proposed in the Center. o Potential of the Center to become or maintain itself as a regional and national resource, including capacity to provide quality research training, opportunities for independent research career development, and plans for research information dissemination and education activities. o In addition, applications for renewal support will be evaluated in terms of the degree to which the Center has achieved stated goals with special attention to: - the scientific merit of completed research; - recruitment of new scientists into alcohol research; - development of a multidisciplinary research team; and - coalescence of the Center staff into an effective team. 2. Individual Research Components and Core Components, including the Pilot Project Component o The scientific and technical merit of each research component and each core component. o The significance of each research and core component and its relation to the central theme of the Center. o Evidence of quality control of proposed core component's services, resources, facilities. o The qualifications, experience, and commitment of the component director responsible for the research component and/or core component, including his or her ability to devote adequate time and effort to the Center. o The appropriateness of the budget request for each of the proposed research project components and/or core components, administrative core, and any pilot project core component. o For pilot projects, the potential of the proposed study as a building block in the development of future research. 3. Resources and Environment In addition to the scientific components, e.g., research project and core components, the initial review group will also evaluate: o The academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects and materials, and the potential for interaction with scientists from other departments and other institutions. o The institutional strength, stability, commitment to research and support for the Center, including fiscal responsibility and management capability to assist the Center Director and staff in complying with HHS, PHS, and NIH policies. o Opportunities for research training and education for persons from various disciplines and professions. 4. Other Considerations 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. 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 Rockville, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 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 Rockville, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 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 Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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