COLLABORATIVE INITIATIVE ON FETAL ALCOHOL SPECTRUM DISORDERS RELEASE DATE: October 31, 2002 (Reissued as RFA-AA-07-004) (see NOT-AA-03-001) RFA: AA-03-002 National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) Letter of Intent Receipt Date: February 11, 2003 Application Receipt Date: March 11, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Scope and Organization o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements for Cooperative Agreements o Where to Send Inquiries o Letter of Intent o Submitting an Application 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) invites applications for a Consortium for the "Collaborative Initiative on Fetal Alcohol Spectrum Disorders"(CIFASD). The purpose of this Initiative is to inform and develop effective interventions and treatment approaches for Fetal Alcohol Spectrum Disorders (FASD) through a highly integrated multidisciplinary research approach involving basic, behavioral, and clinical investigators and projects. Furthermore, the objective is to integrate existing resources within the alcohol research community and also create new resources that are crucial for the success of the research questions to be addressed. CIFASD will also provide opportunities for collaboration between scientists in the alcohol field and prominent investigators from other research areas, resulting in the application of new ideas and technology to the study of alcohol-related fetal injury. RESEARCH OBJECTIVES Children with FASD exhibit an array of cognitive, behavioral, and emotional deficits that impair daily functioning in many domains. A summary of research findings can be found in the "10th Special Report to the U.S. Congress on Alcohol and Health". Chapter 5: Prenatal Exposure to Alcohol can be downloaded, in PDF format, from the NIAAA website (http://www.niaaa.nih.gov). The term Fetal Alcohol Spectrum Disorder (FASD) is used in this RFA to reflect the understanding that Fetal Alcohol Syndrome (FAS) and Fetal Alcohol Effects (FAE) or Alcohol Related Neurological Disorders (ARND) are terms that represent a spectrum of prenatal alcohol effects. These include the acknowledgement that the characteristic facial features develop as a result of alcohol exposure during early pregnancy and that equally devastating neurobehavioral, growth and emotional deficits can result from drinking in other trimesters. The goal of this Initiative is to develop definitive diagnoses of FASD and to develop effective behavioral and pharmacological therapies for those affected. The problems inherent in making progress toward the understanding of the underlying mechanisms of FASD and their diagnosis, treatment and prevention are many. Among them are the small numbers of similar age cases in any one site, the need for close collaboration between basic and clinical research scientists, and the need to exchange information quickly from research to practice and to transfer experiential knowledge from practice to research. This Initiative presents extraordinary opportunities to identify areas of discovery that build upon important recent developments in knowledge, available resources, and technology and that hold promise for making significant progress in research on Fetal Alcohol Spectrum Disorders. The novelty and scope of this Initiative should be used to narrow the enormous gap between discovery and the application of discoveries and to address alcohol related deficits in children. The primary focus of the Initiative should be the advancement of research progress through the generation of new knowledge rather than mere replication or minor modification of previous studies and theories. The RFA uses the cooperative agreement mechanism. The Initiative will include individual hypothesis-driven research projects, pilots or developmental research project process, and resource cores. To be effective, the Initiative should coordinate efforts that result in new and/or improved syntheses, theories, methods and interventions. The cores will provide essential infrastructure to facilitate rapid advances. The aim of this Initiative is to accelerate these areas of research by establishing an infrastructure to foster collaboration and coordinate basic, clinical and translational research. The multi-site collaborative Initiative may involve research scientists investigating prenatal neurobiological developmental abnormalities in FASD with those studying the subsequent postnatal behavioral deficits during early childhood and beyond. Research on genetic influences and on molecular techniques to reverse or block specific deleterious effects may be included. The development and testing of potential effective behavioral and pharmacotherapies discovered in preclinical settings needs to be tested at several clinical sites using small cohorts of same age similarly diagnosed children and rigorous protocols. The project will include the gathering of clinical data from studies of cohorts of FASD children in national and international settings where the prevalence is high. Coordinated Multi-disciplinary and Multi-site Research is needed in the following areas: I. Research, that directly informs pre-clinical and clinical studies, to understand how ethanol and its metabolism interferes with normal brain development, what are the more vulnerable regions and processes and the structure/function relationships affected by prenatal alcohol exposure, and what are the ensuing structure/function relationships. II. Research to better define and characterize the description of FASD specific core deficits in specific age and ethnic groups. III. Basic and pre-clinical studies to determine potential pharmacotherapies for intervening with affected children or preventing fetal alcohol injury. IV. Prenatal diagnosis of FASD through surrogate biomarkers and new imaging technologies in the mother-child unit. V. Research on the genetics and metabolism of the mother-child unit in determining susceptibility to fetal injury, and the influence of nutrition and other environmental factors on vulnerability. SCOPE AND ORGANIZATION OF CIFASD NIAAA recognizes the innovation, synergy, and conceptual advances that arise from interactions across scientific disciplines, methodologies, and levels of analysis. It is anticipated that under this Initiative knowledge will be generated and integrated from all levels of analysis using state-of-the-art techniques at each level. Expertise has become so sophisticated at any given level of analysis that integration at the level of individual investigators becomes very difficult to accomplish, particularly to a level of analysis outside of their domain. The CIFASD Initiative would induce such integration and significantly speed up the translation of such critical new information to the clinical condition. The incorporation of groups of scientists into a research consortium focused on the neurodevelopmental and behavioral aspects of Fetal Alcohol Spectrum Disorders will also offer additional advantages. The rapid and detailed exchange of information among CIFASD members will provide immediate opportunities for applying the Consortium expertise to profitable research arenas. The success of the proposed Initiative will thus relate to the presence of research expertise that uses the full gamut of basic biological, behavioral, clinical research, and psychopharmacology to study the neuroscience of FASD. Thus, information flowing both from the most basic molecular level to the human behavioral level and back again can be melded into optimally productive research protocols at multiple levels of endeavor with the focus on the neurobiology of alcohol-related fetal injury. Organization of the Consortium The following structure of CIFASD is envisioned. The CIFASD Consortium will consist of a cluster of integrated cooperative agreement research applications (U01s), appropriate and necessary core facilities (U24s), and will be led by a Consortium Coordinator. The proposed U24 core facilities must be fully justified and must support 1 or more companion U01 research projects. A highly integrated multidisciplinary research consortium will thus be formed from a group of investigators and clinicians (within and across institutions) whose scientific and technical expertise will enable them to interactively study the neurobehavioral effects of pre-natal alcohol exposure, approaches to their clinical management, and the basic neuroscience and neurobehavioral mechanisms that can contribute to an understanding and management of these problems. The approaches used will reflect the blend of experience and creativity of the CIFASD components and will be originated by these investigators. Through formation of CIFASD, the integrated research project component groups will have access through the core facilities to resources, data analyses, information, technologies, ideas, and expertise that are beyond the scope of any single research team. The consortium will also promote the support of pilot studies to quickly pursue innovative or unique research opportunities that may emerge as the research is in progress. In addition, the consortium will recruit complimentary expertise and approaches currently outside the realm of fetal alcohol research and establish state-of-the-art research resources and information networks for fetal alcohol research. The Consortium Coordinator is the scientist who assembles the integrated and collaborative research consortium and is responsible for submitting the cluster of applications in response to this RFA and for performance of the project. The Consortium Coordinator must be recognized in the area of fetal alcohol research, especially in one of the required interactive research areas or domains of CIFASD described below. Because a substantial level of effort will be necessary to manage a project of this magnitude, the Consortium Coordinator is expected to make a major commitment to directing, managing and executing the goals and collaborative nature of this project. The Consortium Coordinator application will be the lead application of the consortium and should include the Administrative Coordinating Core, together with the Administrative Management Plan, Plan for Data Sharing and Intellectual Property and the Pilot Project Component (more details are given elsewhere in this announcement). The lead application should discuss the theme and goals of the consortium and should include a scientific rationale for the various research project component and resource core applications that make up the consortium. It should further describe the benefits of the proposed integration between projects and how the individual applications complement each other to enhance the scientific goals of the consortium. Given that an important element of this Initiative is the collaboration between leading scientists in the fetal alcohol spectrum field and, as appropriate to assure the success of the effort, prominent investigators from other fields, the lead application should also discuss how the consortium has achieved that goal. It should describe how investigators not previously active in fetal alcohol research will participate in either the research project components or the resource core facilities applications of CIFASD. The lead application should also include a composite budget of the whole consortium in addition to its own individual budget. It is acceptable for the Consortium Coordinator to submit a research project component or a resource core application in addition to the lead application. While each application will originate from the principal investigator(s) research institution and awards will be made to individual institutions, it is the responsibility of the Consortium Coordinator to submit the cluster of applications of the consortium together with the appropriate cover letter as one package (See the "Submitting an Application" section of the RFA, below). Research Project Components Specific research project components to be undertaken under the consortium will take the form of U01 grant applications and are expected to be integrated with the other research projects of CIFASD. These research project component applications are expected to address at least one of the research areas or domains, namely basic, neurobehavioral morphological/neuroanatomical, neuropharmacologic or early intervention domains (discussed in more detail below). It is anticipated that several of the applications within the consortium may address the same research domain, but will differ in emphasis, study population, approaches and research questions being addressed. Research project applications can request a maximum support period of five years. Applications should include a detailed budget and must follow the traditional PHS 398 application instructions. The research project applications may utilize the resources and the new technologies developed by one or more resource cores at one or more sites and advance the scientific goals of CIFASD. However, the research undertaken under a research project application can be performed at a research site other than the one housing the core site. Exploratory and developmental projects will also use the U19 mechanism but will be limited to three years of support and with a maximum budget of up to $100,000 direct costs per year. Pre-clinical and Clinical Morphological/Neuroanatomical and Neurobehavioral Research. Each project will be developed to serve as the bases for interactive collaborations with other components of CIFASD. Inter-related pre-clinical and clinical research projects will be designed to translate and apply findings from one component to others. Research areas include: Research to identify and analyze gross morphological characteristics of Fetal Alcohol Spectrum Disorders using state-of-the-art-imaging techniques to definitively characterize an FASD phenotype and how that phenotype may vary or remain constant across racial/ethnic groups For example, the use of three- dimensional facial photography and other techniques might be explored. Pre- clinical research to inform this investigation might be included. Clinical and pre-clinical research using electrophysiological, neurochemical, and other techniques is needed to explore the changes in neural circuitry underlying the various behavioral and cognitive deficits associated with prenatal exposure to alcohol. Molecular and biochemical studies that directly relate to genetic and biological vulnerability, biomarkers of exposure, and the development and testing of interventions to address the effects of prenatal alcohol exposure may be included. Animal models of alcohol-related fetal injury may be used to further elucidate the effects of prenatal exposure to alcohol on the function of the neural circuitry in regions of the brain which are especially vulnerable to alcohol during fetal development. Separate animal models may be needed depending on the specific phenomenon being studied and the appropriateness of the animal model. The behavioral manifestations of neurophysiologic effects will be of particular interest, since they will shed light on the mechanisms by which fetal alcohol exposure causes the psychological, cognitive, and behavioral deficits observed in individuals with FASD, and on effective approaches to remediating those deficits. Studies to determine the effects of prenatal environmental conditions influencing severity and locus of fetal injury, as well as genetically-based strain differences may be included. Youth with a history of prenatal exposure to alcohol must be evaluated within the consortia for level of emotional, psychological, and cognitive function. Specifically, performance on measures of frontal lobe function, executive function, response inhibition, and visuospatial, verbal and other aspects of memory may be evaluated to address the question of whether a set of core cognitive and behavioral deficits may be identified in individuals with prenatal alcohol exposure. The identification of specific and consistent differences between youth prenatally exposed to alcohol and matched controls will inform research on behavioral, educational and other interventions. An important goal of this component will be to identify and/or develop the most appropriate (sensitive and specific) assessment tools for identifying fetal alcohol injury. Intervention Research This research will extend and apply findings from the neurobehavioral and neurophysiological research conducted in this consortium with the aim of increasing the proportion of individuals with fetal alcohol injury who receive accurate diagnosis and appropriate research based interventions for their alcohol-related deficits Specifically, this research will seek to develop and evaluate the effectiveness of educational interventions on affected children. Most important, this approach will demonstrate how specific impairments associated with FASD identified in other research clusters in this consortium, particularly emotional disturbances and impairments in attention, language, sensory integration, and certain behavioral problems, may be modified by specific interventions in educational and other early child care settings. Resource Core Facilities A consortium may include one or more U24 resource cores to provide specific services or resources to multiple performance sites within the consortium. An Administrative Core is specifically required as part of the consortium. Other cores may be added as needed to support the consortium. The proposed U24 core facilities must be fully justified and must support 1 or more companion U01 research projects. Each core may be located at multiple physical sites. Examples of potential cores include an Administrative Coordinating Core, an Imaging Core, and an Informatics Cores to provide facilities for central processing of information generated at different sites. All information obtained will be shared by the Research Components. In the case of a single core shared among several sites, an application should be submitted from each of the sites with a detailed scientific rationale and budget for that core site. The Consortium Coordinator should clearly detail, as part of the Administrative Management Plan, the number, location and specialties of the sites comprising every core facility. Each core component is expected to be directed by an investigator with established expertise relative to the support or service provided, usually a faculty-level individual. Administrative Coordinating Core: The Administrative Coordinating Core will provide the organizational framework for the management, direction, and overall coordination of the consortium. It will coordinate use of core resources to the Research Project Components and acquire and direct data from the Research Components to an Informatics Core. The Consortium Coordinator will manage the administrative core. The Administrative Coordinating Core will include an Administrative Management plan (See below) and this core will also be responsible for the collaborative responsibilities such as the functions of the four membered Scientific Advisory Panel and the overseeing of a Steering Committee to help develop interactive protocols, evaluate results, and suggest future directions. The core will also administer the Pilot Projects Component of CIFASD (discussed below) as well as the sharing of data and information between the CIFASD components. This core is responsible for scientific enrichment activities such as workshops for the researchers and investigators of CIFASD. In addition, the core will be responsible for organizing an annual meeting of the CIFASD investigators. Imaging Core: This core may provide imaging services to the components. Such a core could focus on multiple imaging technologies. Technology research and development of innovative new imaging technologies appropriate for FASD research in humans and/or appropriate animal models, as well as refinement and development of technologies already established may also be an additional focus of this core. Informatics Core: This type of core collects and stores data generated by the Research Project Components and can provide an interactive user interface for all components. It will devise methods for integrating data from different levels of analysis from the molecular to the behavioral levels. This component will provide input to the design of projects and coordinate the combining of data and the analysis of data across and within components, where appropriate. In addition, it will be responsible for creating a database to support each component. With the establishment of these databases, there is also a need for additional refinement of bioinformatic tools (such as developing interoperable informatics software packages) to facilitate extraction and efficient dissemination of information from these databases. Consistent with NIH policy (https://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm and https://grants.nih.gov/grants/policy/policy.htm), it is expected that the databases developed will be available for use by non-Consortia member investigators. Applicants will need to develop a plan to be approved by the Institute indicating how they will comply with the policy. Pilot Project Component: Pilot projects provide the consortium with a flexible means to develop and explore quickly 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 projects. Pilot projects must be in a separate pilot project component that incorporates all of the pilot studies of the proposed consortium and should be included in the Consortium Coordinator's application. The total costs for the Pilot Project component should not exceed $150,000 per year. The process for selecting pilot projects should be fully, though concisely described. For the first 2 years that funds are requested for pilot projects, the application must provide descriptions of the projects to be supported. It is recognized that some pilot funds will be reserved for the support of research opportunities that arise during the course of the year. For years 3- 5, it may not be possible to provide descriptions of the pilot projects to be supported, since some of these projects will develop on the basis of scientific breakthroughs or directions occurring at the time. However, the application must provide the specific number of pilots planned in each year. While the specific number of pilot projects to be proposed is at the discretion of the Principal Investigator, requested direct cost funding for each pilot study may not exceed $30,000 per year. All proposed pilot projects for a funding period need not be ongoing at any one time, but may be phased in at different points during the course of the year. It is recognized that the relative priority or need for specific pilot projects may change over time. While the consortium's framework for management of pilot funds and the mechanism for operating the program are left to the discretion of the Consortia Coordinator, the application must provide specific information to enable adequate scientific evaluation by a peer review committee. The application should include: a full description of the management of the pilot project component, including a description of the process to be followed by the consortium's program coordinator in selecting new pilot projects and replacing projects should it become necessary. A full description of each pilot study proposed in the first 2 years will include its rationale, objectives, approach, investigators, and significance for the consortium. A description of the number and anticipated direction of pilot projects in the 3- 5 years will be provided including their significance to the consortium. 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. OTHER ELEMENTS OF THE INTEGRATED AND COLLABORATIVE PROJECT – CIFASD Administrative and Project Management Plans: The Consortium Coordinator must include an Administrative Management Plan that outlines the policies and procedures for access of participating investigators to the collaborative project resources. The application should address the flow of information within the project, the integration among individual projects and plans for how the information will be integrated into the solution of the overall scientific theme or question being addressed. The application must include a Project Management Plan, including an ongoing evaluation plan, to ensure consistent forward progress of the project. The mechanism to add new participating investigators and dealing with members whose association with the project has not been productive should be documented in the proposal. The plan should also include proposed methods for information dissemination both within the collaborative project and to the scientific community. Furthermore, the application will include a mechanism to consider and respond to concerns of the scientific community directly affected by the operation and impact of the project. A discussion of scientific community views will be part of the agenda for annual meetings of the Steering Committee with the Scientific Advisory Panel. Plan for Data Sharing and Intellectual Property: NIH requires applicants who respond to this RFA to develop and propose specific plans for sharing the data and materials generated through the large-scale collaborative project. This requirement addresses the interests of the Government in the availability of, and access to, the results of publicly funded research. The initial review group will comment on the proposed plans. In addition, as one of the criteria for award, NIAAA staff will also consider the adequacy of the plans. Because dissemination is a critical and important aspect of this RFA, the proposed sharing and data release plans, after negotiation with the applicant when necessary, will be made a condition of the award. The members of the consortium should disclose to the Steering Committee their ties to profit- making organizations to aid the project in avoiding conflict of interest situations. Applicants are also reminded that the grantee institution is required to disclose each subject invention to NIAAA within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters. MECHANISM(S) OF SUPPORT The NIH (U01 and U24) awards are cooperative agreement award mechanisms in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award" FUNDS AVAILABLE The NIAAA intends to commit approximately $3,500,000 in FY 2003 to fund a consortium of cooperative agreements in response to this RFA. An applicant may request a project period up to a maximum of 5 years support. There is a cap of $2,400,000 in direct costs for the consortium or cluster of applications responding to this RFA for the first year budget period (with a maximum increase in cost in subsequent years of three percent). Because the nature and scope of the research proposed in response to this RFA might vary, it is anticipated that the size of awards to individual applications in the consortium will vary also. Although this program is provided for in the financial plans of the NIAAA, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of applications of outstanding scientific and technical merit. 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 NIH grants policy limitations and approval by NIAAA staff. This RFA is a one-time solicitation. The total project period for an application submitted in response to this RFA may not exceed 5 years, with an anticipated award date of September, 2003. In addition, meritorious Research Components from other peer reviewed applications not funded through the consortium may be added to the funded consortium at the discretion of NIAAA and taking into account budget limitations and input from its National Advisory Council as may be required. ELIGIBILITY REQUIREMENTS 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 o Faith-based or community-based organizations 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. SPECIAL REQUIREMENTS FOR COOPERATIVE AGREEMENTS Cooperative Agreement Terms and Conditions of Award The following Terms and Conditions will be incorporated into the award statement and will be provided to the Consortium Coordinator, to the principal investigators of the individual research components and core facilities, and to the appropriate institutional officials at the time of award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIAAA programmatic involvement with the awardees is anticipated during performance of the activities. Under the cooperative agreement, the NIAAA supports and stimulates the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Awardees should comply with their institutional intellectual property policies and practices as approved in the award. However, awardees will be expected to share (make available) these data openly with the scientific community. 1. Awardee Responsibilities a. Consortium Coordinator's Responsibilities: The Consortium Coordinator will coordinate project activities scientifically and administratively at the awardee institution. The Consortium Coordinator will have the overall responsibility for the scientific and technical direction and the administration and overall operation of the consortium. To assist the Consortium Coordinator with the governing of the project, a steering committee will be established from among the participating investigators and NIAAA staff. The Consortium Coordinator will chair the steering committee. As for all participating investigators, the Consortium Coordinator must abide by the operating rules and guidelines developed by the steering committee. The Consortium Coordinator will agree to accept participation of NIAAA staff in those aspects of management of the project described under "NIAAA Program Official's Responsibilities." The Consortium Coordinator will also ensure the timely dissemination of information generated by the consortium component projects to both the consortium project members and the scientific public. b. Participating Investigator Responsibilities: In addition to the Consortium Coordinator, as well as principal investigators (PIs) of individual research project components and core facilities of the consortium, each research project component will include a team of investigators who will contribute to and benefit from participation in the consortium. These members of the consortium will be referred to collectively as participating investigators. They will receive separate awards and have control over their own operating budgets. The PI of the individual research project award and the resource core award will be responsible for the scientific and technical direction of the project, as well as for following consortium policies and rules. Participating investigators must also agree to abide by the policies and rules set up for the collaborative research consortium. It is expected that over the period of the award, additional applications for participation in the consortium will be submitted to NIAAA for review and award consideration, as deemed appropriate by the Consortium Coordinator and steering committee and with the approval of the NIAAA program official; these additions will be reported in the annual progress report. 2. NIAAA Staff Responsibilities Two NIAAA Staff Collaborators will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the Staff Collaborators. The two NIAAA Staff Collaborators will have voting membership (one vote) on the Steering Committee and, as determined by that committee, its subcommittees. The NIAAA Staff Collaborators will coordinate and facilitate the CIFASD Consortium programs, will attend and participate as a voting member in all meetings of the CIFASD Steering Committee, and will provide liaison between the Steering Committee, the CIFASD Consortium, and the NIAAA. The NIAAA Staff Collaborators will assist the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action. The NIAAA Program Official is responsible for normal program stewardship and will review the scientific progress of individual components, review components for compliance with the operating policies developed by the Steering Committee, and may recommend withholding of support, suspension, or termination of an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee. The NIAAA Program Official will attend the Steering Committee meetings as a non-voting member. 3. Collaborative Responsibilities Scientific Advisory Panel The CIFASD project will include an external scientific advisory panel whose purpose is to meet annually with the Consortium Coordinator and the steering committee to assess progress and provide feedback to the CIFASD investigators and NIAAA on proposed goals for the next year of support. The members will be designated by the NIAAA in consultation with the steering committee, after the award has been made, and will be drawn from research scientists not involved in the project. The NIAAA staff collaborators will attend the meeting of the scientific advisory panel as members of the steering committee, but will not be members of the scientific advisory panel. The scientific advisory panel will meet at least once a year immediately prior to the submission of the annual progress report. Steering Committee The NIAAA staff collaborators and the awardees that comprise the CIFASD will be responsible for forming a Steering Committee as defined below. The Steering Committee will be the main governing board. It will develop collaborative protocols, and to set priorities, define parameters for study, identify technological impediments to success and strategies to overcome them. The Steering Committee will be composed of the Consortium Coordinator, principal investigators of the research project components and core facilities, and the NIAAA staff collaborators. The members of the Steering Committee will each have one vote. The chairperson of the steering committee will be the Consortium Coordinator. NIAAA reserves the right to appoint additional members of NIAAA staff as nonvoting members of the Steering Committee and Subcommittees. The Steering Committee may, when deemed necessary, invite additional, non- voting scientific advisors to the meetings at which research priorities and opportunities are discussed. NIAAA reserves the right to augment the scientific or consumer expertise of the Steering Committee when necessary. There will be two Steering Committee meetings initially (during the first two years of support), one in the Washington, D.C. area, and the other at a time and site agreed upon by the Steering Committee and the NIAAA. In years 3-5, the Steering Committee will meet once a year. The first meeting of CIFASD will be a Planning Meeting, which will take place in the Washington, D.C. area shortly after award of the grants. At the Planning Meeting, the Committee will: a) determine the size of the Steering Committee and the representation of individual research project and resource core awardees on the Steering Committee; b) draft a charter, the purpose of which is to define the administrative policies and procedures for oversight of the project, the process for monitoring compliance with those policies and procedures, and the process for recommending that the NIAAA act on evidence of non-compliance of any consortium component with Steering Committee policies; c) agree upon the terms of the charter; d) discuss the approaches that were proposed in the individual component and core applications, any relevant new information, and set initial priorities for research and for new technologies to be developed; and, e) discuss and set initial standards for validation of findings and derived models. At the first meeting each year, the Steering Committee will formulate plans for any new pilot projects to be funded. They will discuss projects to be pursued jointly with funds set aside from the pilot projects budget. At subsequent meetings, the Steering Committee will refine the scientific objectives and characterization and validation strategies of FASD, as necessary, consistent with progress in the CIFASD consortium components and other laboratories, and with the goals of identifying available models with sufficient promise for further analysis. The Steering Committee may establish subcommittees as it deems appropriate. The NIAAA Program Official and the other NIAAA/NIH staff may serve on subcommittees. Awardees will be required to accept actions and recommendations approved by the Steering Committee. 4. Arbitration Any disagreement that may arise on scientific or programmatic matters (within the scope of the collaborative mechanism award) between awardees and the NIAAA may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Steering Committee (with the NIAAA Program Official not voting), or by the individual awardee in the event of an individual disagreement; a second member selected by the NIAAA; and, the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Deidra Roach Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard; Suite 302 Bethesda, MD 20892-7003 (office) 301 443-5820 (fax) 301 480-2358 Email: droach@willco.niaaa.nih.gov Dr. Faye Calhoun Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard; Suite 302 Bethesda, MD 20892-7003 (office) 301-443-2593 (fax) 301-480-2358 Email: fcalhoun@willco.niaaa.nih.gov o Direct your questions about peer review issues to: Eugene G. Hayunga, Ph.D. Chief, Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-4375 Fax: (301) 443-6077 o Direct your questions about financial or grants management matters to: Judy Fox Chief, Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 (301) 443-4704 (telephone) (301) 443-3891 (fax) Email: jsimons@willco.niaaa.nih.gov 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: Extramural Project Review Branch ATTN: RFA AA-03-002 Office of Scientific Affairs, NIAAA 6000 Executive Boulevard, Suite 409 Bethesda, MD 20892-5452 (for express/courier service: Rockville, MD 20852) Telephone: (301) 443-4375 FAX: (301) 443-6077 by the letter of intent receipt date listed. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: See the "Scope and Organization of CIFASD" section of the RFA, above, for descriptions of the consortium components and application requirements for the research project and resource core components of the consortium. Each application submitted as part of a consortium must clearly indicate whether it is to be considered as a U01 research project or U24 resource core. Research applications should state "(U01 Research Project)" after the title of the project in box 1 of the PHS 398. Core applications should state "(U24 Core)" after the title in box 1 of the PHS 398. The U24 application submitted by the consortium coordinator must be accompanied by a cover letter that identifies the total number of applications in the consortium and the principal investigator for each research project and resource core. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. 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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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) At the time of submission, two additional copies of the application must be sent to: RFA: AA-03-002 Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) FAX: (301) 443-6077 APPLICATION PROCESSING: Applications must be received by 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAAA. Incomplete applications will be returned to the applicant 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 NIAAA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the NIAAA National Advisory Council. REVIEW CRITERIA Upon receipt, each cluster of applications will be reviewed for completeness by the Center for Scientific review (CSR) and for responsiveness by the NIAAA. Incomplete and/or non-responsive applications will be returned to the applicant 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 scientific merit review, a process may be used by the initial review group in which applications receive a written critique and 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, assigned a priority score, and receive a second level review by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria for the Consortium Coordinator Application (lead application and overall consortium) The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed multidisciplinary Initiative will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. a. Significance: Does this interactive multidisciplinary consortium project address a complex biological problem of overarching significance to biomedical science that would be difficult to address by separate grants? If the aims of the overall consortium are achieved, how will the scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Do the arrangements for data sharing maximize the impact of the interactive consortium project? b. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the scientific aims of the collaborative project? Does the applicant acknowledge potential problem areas and consider alternative tactics or designs? Is the project management plan adequate? Is the administrative framework appropriate? Do milestones articulate key indicators set for appropriate times that will demonstrate significant forward progress for the consortium project? Are the plans to monitor and evaluate progress of the consortium project adequate? Are the plans to share the data and findings within the consortium and the larger scientific community adequate? c. Innovation: Does the project employ novel concepts, approaches, theories, or methods? Are the aims original and innovative? Will the multidisciplinary collaborative consortium challenge existing paradigms or develop new methodologies or technologies? Will the multidisciplinary consortium attack a problem in a significantly new way? d. Investigators: Is the Consortium Coordinator's major research activity within the research area of the multidisciplinary consortium? Is the Consortium Coordinator well suited to the scientific and administrative leadership required to carry out this work? Is the level of effort proposed for the Consortium Coordinator appropriate? Is the work proposed appropriate to the experience level of the multidisciplinary consortium's research and technical staff? Are the research project component applications of the participating investigators within the area of the multidisciplinary consortium? Are the participating investigators well chosen for their roles in the collaborative project? e. Environment. Do the scientific environments in which the work will be done contribute to the probability of success? Are support personnel and resources in place to advance the work? Will the proposed multidisciplinary consortium take advantage of unique features of the scientific environments of the component projects? Is there evidence of institutional support? Are the requested core facilities critical to achieving the scientific goals of the multidisciplinary consortium; are they cost effective? Is access to the core facilities appropriate? f. Budget: Is the requested budget and estimation of time to completion of the study appropriate for the proposed research? In accordance with NIH policy, all applications will 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 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 project proposed in the application. Review Criteria for Core Resources Consideration of the technical merit of the core units will include: a. Facilities within the resource cores compared to the state-of-the-art. The contributions of the resource cores to fulfilling the goals of the consortium. b. The adequacy of the approaches, methods and operational procedures for interacting with the consortium investigators. c. The extent to which resource core units promote greater collaboration and cohesiveness among the participating investigators. d. Qualifications, experience, and commitment to the consortium mission of the investigators responsible for the core resources and their abilities to devote the required time and effort to the program. e. Appropriateness of the budgetary requests. Review Criteria for Research Project Components The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of each research project application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the criteria listed below will be addressed and considered in assigning the score for a research project, weighting them as appropriate for each project. Note that the project does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. In their evaluations, reviewers will comment on: a. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the achieving the goals of the collaborative projects or consortium? Will the project tie or enhance the independent work of the participating investigator to the collaborative project, or will the project add an essential missing aspect to the collaborative project? b. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? c. 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? d. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? e. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? In addition to the above criteria, in accordance with NIH policy, all individual scientific projects will 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 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 project proposed in the application. The scientific review group will also examine the provisions for the protection of human subjects and the safety of the research environment. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 11, 2003 Application Receipt Date: March 11, 2003 Peer Review Date: May-June 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 29, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review). o availability of funds. o programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 (https://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 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. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 https://grants.nih.gov/grants/funding/children/children.htm. 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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. 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. 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 http://www.health.gov/healthypeople. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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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