ALCOHOL RESEARCH CENTER GRANTS RELEASE DATE: June 23, 2004 RFA Number: RFA-AA-05-001 EXPIRATION DATE: December 17, 2004 (This PA has been modified, see RFA-AA-07-002 and RFA-AA-07-003) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Alcohol Abuse and Alcoholism (NIAAA) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.891 Letter of Intent Receipt Date: November l5, 2004 Application Receipt Date: December 16, 2004 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanism(s)of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides grant support for Alcohol Research Centers to conduct and foster interdisciplinary research on alcoholism and alcohol abuse. The Alcohol Research Centers program is interrelated with, and complementary to, all other research support mechanisms and scientific activities that comprise 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, or any other emerging areas in genomics, metabolomics, or proteomics. Centers are designed to stimulate and encourage application of a wide array of approaches, perspectives and technologies to the understanding of alcoholism, alcohol abuse, and alcohol-related disorders. Support for four of the current 5-year Center grant awards will expire in late 2005 and early 2006. Research within each of these Centers is organized around a central theme: genetics of neuroadaptation to alcohol; translation of neuroscience research results to clinical application; pharmacological and behavioral therapies for alcoholism and comorbid disorders; epidemiology of consumption patterns, trends and alcohol related problems in the general population. Applications for new centers in these and other priority research areas such as improving prevention interventions and treatment effectiveness or mechanisms of alcohol action and injury will be accepted with applications from currently funded centers seeking renewal support. 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; basic research on consequences of alcoholism or alcohol abuse; statistical modeling of predicted or forecasted outcomes utilizing existing data sets; and factors that relate to prevention of alcohol abuse, alcoholism, or other problems associated with alcohol consumption. Some examples include research to improve knowledge of the impact of alcohol use on related health fields such as human development, growth and aging; cardiovascular integrity and functioning; disease pathogenesis and progression; population mortality; attributable risk; long-term utilization of alcohol-related health services; liver and gastrointestinal functioning; nicotine and other drug use; performance ability; neurological impairment; mental disorders that co-occur with alcohol abuse disorders and potential benefits of non-abusive alcohol beverage consumption. The Alcohol Research Center grant provides a mechanism for fostering interdisciplinary cooperation within and among 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 including sharing of resources and expertise warrant collaboration with investigators from other centers or settings and/or with scientists in institutions outside the United States. In these cases the director of the component(s) in which collaborative activity with a foreign organization is proposed should be affiliated with a domestic institution. Center Components The following paragraphs describe the specific components of a Center Grant 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, symposia, seminars, and workshops for research faculty and staff. 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. Cores should primarily be used to support projects which are part of the Center Grant award, but they may also be used for 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 relevant 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 production, 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 focused 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. Education Component (for P60 applications) Comprehensive centers (P60) must include at least one component which supports activities designed to translate research findings into health care practice, public information dissemination, or education curricula or programs for students, health professionals and community agencies. Such activities may require a substantial portion of the first year for planning and development with actual implementation beginning near the second year and continuing in subsequent years. These projects shall in a meaningful way reflect the Center's program of research. The following examples are types of projects that may be undertaken but are not intended to be limiting: Translational Research: The development of collaborative partnerships to advance the alcohol research field through translation of insights and findings from basic and pre-clinical research to test hypotheses regarding treatment and prevention of alcohol disorders; to improve interventions with alcohol affected individuals in clinical practices, health care or community settings; or the development of innovative interventions to study the effects of services for diverse populations in disparate social, cultural and environmental contexts. Dissemination of Scientific Information and Research Progress: Dissemination of scientific knowledge through educational efforts directed to the public, patient populations, professionals and para- professionals; providing information to educational institutions, the media and other appropriate organizations/groups; and educational programs for specific audiences, e.g., children, women, elderly etc. Dissemination of scientific knowledge through the establishment of research and research training collaborations for the purpose of expanding the capacity of other institutions including minority serving institutions, in developing rigorous alcohol research programs. All translational and educational projects should have specific objectives and include a method of assuring the effectiveness of the effort. 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 proposed for all five years of the center grant including likely topics for replacement of completed pilot studies. MECHANISMS OF SUPPORT This Request for Applications (RFA) will utilize the NIH P50 and P60 mechanisms. 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 5 years) support for interdisciplinary research programs with a distinct focus on a particular theme related to alcoholism, alcohol abuse, and other alcohol-related problems. The program is intended to encourage outstanding scientists from biomedical, behavioral, quantitative, social sciences and other relevant disciplines to bring a full range of expertise, approaches, technologies and creativity 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, integrated and synergistic effort. Centers are expected to be sources of scientific excellence, provide leadership to the field, and, through sustained excellence, to become significant regional or national research resources. In addition, they are expected to attract promising and established investigators and to provide training, career development and mentoring opportunities to persons from various disciplines and professions. A specialized center (P50) is an integrated, 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. A comprehensive center (P60) expands the specialized center program of research and research training by inclusion of additional components or elements developed in conjunction with available community based agencies, institutions, facilities and resources. Projects could include community education and alcohol information dissemination to the public and education for medical and allied health care professionals concerning the problems of detection, diagnosis, treatment and prevention of alcohol dependence and alcohol abuse. While not all of these areas must be represented in one center, the community education or information dissemination project proposed should be a comprehensive approach and have a clear relationship to the research theme of the center. FUNDS AVAILABLE It is estimated that approximately $8.0 million dollars will be available in FY 2006 to fund four or five Centers. The total cost (direct plus Facilities and Administrative (F&A) costs) for a Center may not exceed $1.8 million per year for a P50 and $2.0 million per year for a P60. Continuation support in future years is anticipated. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based organizations In addition, 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, clinical and/or social science disciplines that are willing to make a long-term commitment to research, and must assure that research-training opportunities will be available. An application must also have a detailed 5-year plan for a proposed research program. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The individual named as principal investigator for the Center grant will also serve as Director of the Center. This individual must demonstrate the ability to organize, administer, and direct the Center, and have sufficient authority to allocate space, personnel, and other resources essential to the Center. SPECIAL REQUIREMENTS The following paragraphs describe the Special Requirements for a Center application. Details for preparing the application are provided in the Supplemental Instructions (see Item 11) 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, education on translational research component for P60s, 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. An education component does not count toward this total. More than a total of 10 components are not acceptable even if some components are in operation for less than the 5-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 three 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. Education components do not count toward the required three research components. This aspect should receive careful attention in the application and individual component preparation. The research plan for each core component, each research component, and each education 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 and education activities for faculty and staff. 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, timesaving, and increased efficiency attributable to the existence of the cores should also be addressed. A core component should support Center grant research components and may also support 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 to be 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, biological models, existing data sets, etc., which will be involved in proposed studies. If core facilities are utilized, information on their use should be provided. Education Component (for P60 applications) For each education/translation component, a clear description of the major goals, objectives, and its integration with the research components in relation to the overall center program should be provided. Specific projects for translational education/information dissemination activities should be described. While the specific number of education projects is at the discretion of the applicant, requested funding for education component activities may not exceed $100,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any one year. A staffing plan and rationale for organization of this component should be presented. Methods, techniques, and technologies to be used for proposed activities should be defined as well as the targeted audience or participants. Issues of cultural sensitivity with regard to intended audience should be addressed. When appropriate, activities should be designed to effectively reach underserved populations and/or subgroups based on age or gender. o The scientific knowledge base and research topics or areas upon which proposed translational activities will be developed should be identified and explained. o A discussion of the design, plans and procedures for development including time lines should describe strategies proposed to accomplish specific aims of the project(s). Innovative aspects of the approach to be used should be highlighted. o A description of the resources, facilities, agencies, and/or institutions with working arrangements to plan, implement and conduct the proposed activities should be fully elaborated. Particular attention must be devoted to a description of necessary resources, including specialized expertise, and the target audience or participants who will derive benefit from the activity. If core facilities or services are utilized, information on their use should be provided. o A description of plans to evaluate the success and/or effectiveness of educational translational activities with emphasis on their impact on knowledge, attitudes, and behaviors should be described. Pilot Project Component The process for selecting pilot projects should be fully, thoroughly, and 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 1 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 sufficient 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 utilized by the Center Director in soliciting and selecting pilot projects. The process to be followed in selecting new projects and/or projects to replace those proposed in the application, should it become necessary, must also be fully described. o A full description of each pilot study proposed in the first 2 years, including its rationale, objectives, approach, investigators, and significance for the Center. A brief description (2 to 3 Pages) and anticipated direction of pilot projects planned for 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 on past experience in utilizing pilot funds to further Center goals. This should include an assessment of 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 and for each individual project. For years 01 and 02 the budget will reflect costs of pilots proposed in the application. Budget information provided for each project anticipated for the 03-05 years should reflect best estimate costs based on number and kind of pilot projects to be pursued. Supplemental Instructions provide 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. Collaborative activities with other NIAAA Alcohol Research Centers should be described along with a list of joint accomplishments. 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 other 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. 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 center 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 and educational 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. These 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 management 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 aspect and 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 pre-doctoral 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, epidemiological, 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. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Antonio Noronha, Ph.D. Division of Neuroscience and Behavior National Institute on Alcohol Abuse and Alcoholism National Institutes of Health, DHHS 5635 Fishers Lane MSC 9304 Room 2055 Bethesda, MD 20892-9304 Telephone: (301) 443-7722 FAX: (301) 443-1650 Email: Kathy Salaita, Sc.D. Division of Epidemiology and Prevention National Institute on Alcohol Abuse and Alcoholism National Institutes of Health, DHHS 5635 Fishers Lane MSC 9304 Room 2078 Bethesda, MD 20892-9304 Telephone: (301) 443-0633 FAX: (301) 443-8614 Email: o Direct your questions about peer review issues to: Ernestine Vanderveen, Ph.D. Acting Chief, Scientific Review Branch Office of Scientific Affairs ATTN: RFA AA-05-001 National Institute on Alcohol Abuse and Alcoholism National Institutes of Health, DHHS 5635 Fishers Lane, MSC 9304 Room 3038 Bethesda, MD 20892-9304 Telephone: (301) 443-2531 FAX: (301) 443-6077 Email: o Direct your questions about financial or grants management matters to: Judy Fox Grants Management Branch National Institute on Alcohol Abuse and Alcoholism National Institutes of Health, DHHS 5635 Fishers Lane MSC 9304 Room 3023 Bethesda, MD 20892-9304 Telephone: (301) 443-4704 FAX: (301) 443-3891 Email: LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Chief, Scientific Review Branch Office of Scientific Affairs ATTN: RFA AA-05-001 National Institute on Alcohol Abuse and Alcoholism National Institutes of Health, DHHS 5635 Fishers Lane, MSC 9304 Room 3038 Bethesda, MD 20892-9304 FAX: (301) 443-6077 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SUPPLEMENTARY INSTRUCTIONS Supplemental instructions for preparing your application may be found on the NIAAA website at: USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The RFA label is also available at: SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included in the application materials. At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Chief, Scientific Review Branch Office of Scientific Affairs ATTN: RFA AA-05-001 National Institute on Alcohol Abuse and Alcoholism National Institutes of Health, DHHS 5635 Fishers Lane, MSC 9304 Room 3038 Bethesda, MD 20892-9304 (Send express or courier deliveries to Rockville, MD 20852-1705) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAAA. Incomplete and/or nonresponsive applications will not be reviewed. 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, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the NIAAA National Advisory Council. 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, education component, all other core components, and the pilot component as applicable. This review will also include an assessment of the academic and physical environment and special considerations, e.g., compliance with human subjects and animal welfare requirements, and compliance with policies concerning inclusion of women, minorities and children in clinical research study populations. A) ADMINISTRATIVE CORE 1) 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 Scientific qualifications and ability of the directors of the research components, education components, and core components and their commitment to the center 2) Arrangements and Organizational Structure o Processes to facilitate and monitor attainment of Center objectives o Plans for communication and cooperation among investigators 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 should that become necessary B) 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 C) RESEARCH COMPONENTS o Significance: Does this study address an important problem? If the proposed aims are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the investigator acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigators: Is each investigator appropriately trained and well- suited to carry out this work? Is the work proposed appropriate to the experience level of the component director and other researchers? (if any)? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success of the project? Does the proposed research take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? D) EDUCATION/TRANSLATIONAL COMPONENTS (for P60 applications) o Significance: Does this project address an important topic? If the proposed aims are achieved, how will the level of science based knowledge be enhanced? What will be the effect of these projects on knowledge, attitudes and behaviors? o Approach: Are the conceptual framework, design, methods, and evaluations adequately developed, well-integrated, and appropriate to the aims of the project? Does the project director acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigators: Is each investigator appropriately trained and well- suited to carry out this work? Is the work proposed appropriate to the experience level of the component director and other professional staff (if any)? o Environment: Does the environment in which the work will be done contribute to the probability of success of the project? Does the proposed project take advantage of unique features of the academic and community resources and employ useful collaborative arrangements? Is there evidence of institutional support? E) PILOT PROJECT COMPONENT 1) 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 2) Individual Pilot Projects o Importance of topic o Grounding in the literature or empirical findings o Reasonableness of the approach o Potential to develop into full-scale independent project o Qualifications of the project director F) CENTER AS AN INTEGRATED WHOLE 1) Significance o Significance of the overall research goals o Development of a well-defined central theme o Multidisciplinary and interdisciplinary scope 2) Coordination and Cohesiveness o Interrelatedness of administrative core, scientific cores, research components and education 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 3) 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 4) Potential 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 5) 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 ADDITIONAL Review CONSIDERATIONS For the Center as a whole and all components/cores. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration of the project in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the research proposed in the application. Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data-sharing plan in their application. The reasonableness of the data-sharing plan, or the rationale for not sharing research data, will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 15, 2004 Application Receipt Date: December 16, 2004 Peer Review Date: April-June 2005 Council Review: September 18, 2005 Earliest Anticipated Start Date: December 1, 2005 AWARD CRITERIA Center grant funds may be requested for support of core components, individual research components and education 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 for investigators and staff 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 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 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, research support and education activities of the Center program, and must be in conformance with HHS cost principles (encompassed in 45 CFR Part 74) and the NIH Grants Policy Statement (effective 10/98). 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 related to training activities. Research, research information dissemination and training activities associated with the Center may receive additional funding from Federal sources as well as from State and local sources. The 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 NIH policy. 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. Applications recommended by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific merit of the application as determined by peer review, 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 5-year project periods with separate fiscal awards made annually. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. ( Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (; a complete copy of the updated Guidelines are available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at 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 Federal Regulations at Title 42 CFR Part 549, "Grants for National Alcohol Research Centers" and NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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