In accordance with the provisions of Sections 552b(C)(6), Title 5, U.S.C. and 10(d) of Public Law 92-463, the meeting on September 14 was closed to the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds.

Council Members Present:

Cheryl J. Stephens Cherpitel, M.P.H., Dr.P.H.

Howard J. Edenberg, Ph.D.
Victor M. Hesselbrock, Ph.D.

Joannes B. Hoek, Ph.D.

Gail A. Jensen, Ph.D.

Mack C. Mitchell, M.D.

Stacia A. Murphy

Stephanie S. O’Malley, Ph.D.

James W. Payne, J.D.

Kenneth J. Sher, Ph.D.

Alan C. Swann, M.D.

Boris T. Tabakoff, Ph.D.

Hope Taft

Robert E. Taylor, M.D., Ph.D.

Ex-Officio Council Member Present:  CDR Frank A. Little, Sr.

Chairperson: Ting-Kai Li, M.D.

Executive Secretary:  Karen P. Peterson, Ph.D.

Senior Staff:

Faye Calhoun, D.P.A., M.S., Vivian B. Faden, Ph.D., Mark Goldman, Ph.D., Ralph W. Hingson, Sc.D., M.P.H., Bob Huebner, Ph.D., Robin Kawazoe, Stephen Long, Howard Moss, M.D., Antonio Noronha, Ph.D., Tina Vanderveen, Ph.D., Kenneth R. Warren, Ph.D., Samir Zakhari, Ph.D.

Other Attendees on September 15, 2005

Approximately 100 additional observers attended the open session, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the general public.

Call to Order of the Closed Session, September 14, 2005

Dr. Tina Vanderveen, Director, Office of Extramural Activities, called the closed session of the 110th meeting of the Council to order at 5:30 p.m. on Wednesday, September 14, 2005, for consideration of grant applications.  Dr. Vanderveen reviewed procedures and reminded Council members of regulations pertaining to conflict of interest and confidentiality.  Members absented themselves from the discussion and evaluation of applications from their own institutions and in situations involving any real, apparent, or potential conflict of interest.  The closed session adjourned at 7:05 p.m.

Call to Order of the Open Session and Introductions, September 15, 2005

Dr. Li called the open session to order on September 15, 2005, at 8:35 a.m. and welcomed participants. Members of the Council and the audience introduced themselves.

Director’s Report

Referring to the published “Director’s Report,” Dr. Li highlighted the following Institute activities:

• Budget.  The U.S. House of Representatives passed H.R. 3010, which set appropriations for NIH at $28.5 billion and for NIAAA at more than $440 million; this matched the President’s request for a 0.5 percent increase over FY2005 levels.  The Senate Appropriations Subcommittee approved a budget of $29.4 billion for NIH and $452 million for NIAAA, an increase of 3.2 percent over FY2005 levels.  Following a Senate vote, a House/Senate conference will resolve differences.

• Programmatic initiatives.  Dr. Li described a new initiative to address concerns about funding for new and young investigators, including taking steps to fund more fellowships, training, and mentoring opportunities, as well as to provide bridge funding between training and independence as investigators.  This initiative was also presented as part of Dr. Li’s plenary presentation at the annual Research Society on Alcoholism (RSA) meeting. 

• NIAAA staff update.  Michie Hesselbrock, Ph.D., has joined NIAAA during a sabbatical to work on the social work and nursing curricula as well as other activities. Dr. Li welcomed Robin Kawazoe, Senior Advisor to the Director.  Dr. Li announced the departure of Mahadev Murthy, Ph.D., who will join NIH’s National Center for Research Resources, and Harold Perl, Ph.D., who will serve as NIDA’s team leader for Behavioral Research, Dissemination, and Training in the Clinical Trials Network.

The NIH Director’s Award was presented to Antonio Noronha, Ph.D. and to Lorraine Gunzerath, Ph.D., as part of the Neuroscience Blueprint Team.  The award also was presented to the NESARC team, headed by Bridget F. Grant, Ph.D., Ph.D., and including S. Patricia Chou, Ph.D., Deborah Dawson, Ph.D., Roger Pickering, M.C.S., and Frederick Stinson, Ph.D.  Dr. Kunos won the Mechoulam Award from the International Cannabinoid Research Society. Tenure was awarded to Bin Gao, M.D., Ph.D., and Dr. Grant.  Pal Pacher, M.D., Ph.D., was selected for a tenure-track position.

• NIAAA research programs.  Extramural scientific staff participated in NIAAA’s first staff retreat to exchange ideas and set research priorities.  NIAAA staff played primary roles in activities at the Research Society on Alcoholism’s meeting, including participation in three day-long satellite symposia on a wide variety of topics.  Dr. Willenbring made a presentation at the College on Problems of Drug Dependence. With the American Psychological Association, Dr. Ellen Witt organized a symposium on gene-environment interactions. Additional collaborative efforts included a focus on the social work curriculum and a new initiative to develop a nursing education curriculum.  NIAAA is working on the Rapid Response to College Drinking Problems Program and, in collaboration with the Department of Justice’s Office of Juvenile Justice and Delinquency Prevention, Enforcing Underage Drinking Laws in Rural Communities, on which NIAAA will evaluate programs.  Three additional states have joined the underage drinking program, for a total of seven states.  The two new RFAs are “Structural Intervention, Alcohol Use, and Risk of HIV/AIDS,” and “Underage Drinking: Building Health Care System Responses.”

• Research reports. Of particular note are some publications prepared in collaboration with NIDA, including “Adult Antisocial Syndromes Common Among Substance Abusers” and “Low Alcohol Dose Decreases Brain Glucose Metabolism.”

• Outreach.  Dr. Li highlighted the activities of the Leadership to Keep Children Alcohol Free, including a major American Medical Association media briefing on alcohol dependence and the presentation of the well-received new publication “Helping Patients Who Drink Too Much: A Clinician’s Guide.”  He stated that NIAAA will base other documents on this publication to be suitable for other audiences in order to take the findings into the wider community.

• Multi-media products from NIAAA. Dr. Li noted newly released publications, including “Make a Difference: Talk to Your Child About Alcohol,” two issues of Alcohol Research & Health on screening and brief intervention, an “Alcohol Alert” on screening for alcohol use and alcohol-related problems, and a fact sheet for parents of college students.  Electronic media products include the award-winning PSA “Don’t Have To, Don’t Need To.”

• Global activities.  Recognizing that health problems are global, NIAAA plans to increase its activity with other countries, including such Pacific Rim nations as China, Taiwan, Japan, Australia, and New Zealand.  Dr. Li noted that he and Dr. Volkow have discussed conducting research on alcohol and drug abuse problems in Spanish-speaking populations on both the North and South American continents.

Discussion.  Dr. Hesselbrock commented that the European Society of Biomedical Research on Alcoholism offered positive feedback regarding the “Clinician’s Guide.” Dr. Moss pointed out that the AUDIT and the Clinician’s Guide have been translated into Spanish.

Dr. Tabakoff suggested including collaborations with international societies, particularly those on the Pacific Rim.  Dr. Li stated that this approach has been adopted.  Dr. Dan Vincent, American Academy of Family Physicians, noted the value of the “Clinician’s Guide” as a credible, powerful teaching tool for medical students and residents to help change physicians’ patterns in their practices.

Extramural Advisory Board Report on Mechanisms of Alcohol Action and Injury Team

Fulton T. Crews, Ph.D., Director, Bowles Center for Alcohol Studies, University of North Carolina–Chapel Hill, and Chair, NIAAA Extramural Advisory Board (EAB), presented the EAB’s recommendations from the Mechanisms of Alcohol Action and Injury Team. The Extramural Advisory Board met on May 24-25, 2005, with the charge to review portfolios to ensure their responsiveness to emerging trends and opportunities in science. Samir Zakhari, Ph.D., noted that Part I of the report to the EAB—and presentations at the May meeting—covered four themes, which he discussed as follows:

Theme 1.  Alcohol Metabolism and Consequences.  This section of the report describes how alcohol metabolism can cause tissue injury.  The report addressed the effects of ADH isozymes on in vivo pharmacokinetics; the potential use of miniature biosensors to determine the dynamics of in vivo alcohol and metabolite and adduct concentrations; the potential role of alcohol metabolism in addiction including whether acetaldehyde can form condensation products with indole and catechol neurotransmitters that can affect behavior and whether acetate has behavioral consequences.  Dr. Zakhari noted that Drs. Nora Volkow and Richard Veech have found that acetate can act as a source of energy for the brain.

Dr. Zakhari explained that ingested alcohol can cause intracellular stress.  The human body’s homeostatic mechanism can defend against this stress, which will result in adaptation, and can then result in tissue damage—as can intercellular stress.  Alcohol can affect receptor function and ion channels and cause damage.  Dr. Zakhari explained the mechanisms by which adducts and the formation of reactive oxygen species can cause tissue damage. 

Theme 2.  Research Strategies and Tools: From Genomics to Systems Biology, discussed an “-omics” approach to how alcohol relates to tissue damage that integrates genetic, biological, and clinical data.

Theme 3.  Mechanisms of Tissue Injury, Protection, and Repair, identified the types and sources of free radicals produced in alcohol metabolism.  It also focused on immune function in alcohol-induced tissue damage; discussed the protective effects of moderate alcohol use on the cardiovascular system, glucose metabolism, and central nervous system (CNS); and discussed mechanisms of cell regeneration, with a focus on the cell cycle, stem cells, and growth factors.

Theme 4.  Developmental Vulnerability to Alcohol-Induced Tissue Damage, discussed the mechanisms of alcohol-related fetal injury, including oxidative stress, excitotoxicity, cell adhesion, and glial function.  It also highlighted adolescent drinking patterns and the primary concerns of interaction with body growth and endocrine function, brain maturation, and CNS function, and increased risk of alcohol dependence; and identified similarities between alcohol-related tissue injury and aging in a discussion of the mechanisms of tissue damage by calcium regulation and oxidative stress.

Dr. Zakhari stated that the ultimate goals for research in alcohol metabolism are to understand the basic mechanisms of injury and addiction to develop means of prevention and treatment.

Dr. Crews presented the recommendations of the EAB:

1.     Common and interactive mechanisms of alcohol-induced injury and impairment of repair across tissues, organs, and systems.

a.       Opportunities exist to better understand alcoholic tissue injury related to endocrine, immune, nervous, gastrointestinal, cardiovascular, renal, adipose, and other systems that contribute to health and pathology.  Studies should include investigations of how alterations in one organ system relate to alcoholic injury in other systems and to overall pathology.  The roles of known mechanistic factors in rendering injurious effects across different organ systems should be examined by identifying their effects on gene transcription, translation, and cellular biology.  Both the acute and chronic effects of alcohol-induced tissue injury require investigation to better understand the progressive nature of alcoholic pathology.  Interactions between different organs under acute and chronic alcohol exposure need to be explored to improve the understanding of how pathological mechanisms underlie adverse effects of alcohol on multiple organs.

b.       In addition to the interaction of multiple physiological systems contributing to alcohol-induced injury, there are common factors that may contribute to injury across multiple organ systems.  These factors include redox state, metabolites, adducts, cytokines, oxidant stress, hypermetabolism, low energy state, common intracellular signaling processes, and altered immune function. There are opportunities to better understand how alcohol-induced alterations in cellular metabolism, formation of biologically active agents, and other modifiers of cell biology contribute to progressive cellular and multiple tissue pathology. This could create opportunities in therapies designed to reverse and/or block alcoholic tissue injury.

c.      The effects of ethanol on natural mechanisms of regeneration and repair are also key issues, to which new techniques in stem cell biology can contribute.

2.      Drinking patterns should be examined in relation to tissue injury.  Tissue injury is likely to be affected by both peak alcohol levels and total exposure, so accurate measurements of alcohol and metabolite concentrations (both peak and area under the curve) are needed to better understand both acute and chronic mechanisms of injury.  Opportunities exist for discoveries that provide technology to better follow BAC and metabolite measures over time.  These include biosensor technologies and isotope-labeled ethanol.  Studies should be encouraged to gather more detailed data on the pattern of alcohol exposure and the relationship to tissue injury.

3.     Mechanisms of alcohol toxicity across the lifespan.

a.      Opportunities exist to better understand the role of developmental factors (especially during adolescence) on the risk of developing alcoholism, behavioral pathology, and/or organ injury.

b.       Age-related factors in susceptibility to alcohol-related injury and impairment of repair in the fetus, adolescent, adult, and geriatric populations should be explored, including studies that link exposures and injuries that can be years apart in humans.  Identification of treatments that prevent the onset or progression of organ-specific damage at different times across the lifespan is important.

4.       Determination of the genetic, behavioral, and environmental factors governing individual differences in susceptibility to alcohol-induced injury. Opportunities exist for identification of critical genetic, behavioral, and environmental risk factors that govern susceptibility to alcohol-induced injury. These factors may include nutrition, genetics, inflammation, psychiatric disease, tobacco, exposure to other pharmaceutical and nonpharmaceutical agents, and the amount and pattern (constant vs. binge) of drinking.  Individual differences in vulnerability to disease should include psychiatric disease and neurodegeneration, as well as liver disease and tissue injury.  Collecting well-annotated genetic samples can aid in these studies.

5.       Alcohol as a co-factor in risk and protection for a variety of diseases, and the influence of alcohol on therapeutics.  The role of alcohol in contributing to diseases with multiple causes should be explored via partnership with other institutes, with NIAAA focusing on alcohol-unique mechanisms and/or alcohol-critical mechanisms involved in diseases associated with alcohol consumption. There are opportunities to build initiatives across institutes focused on diseases where alcohol is a co-factor in causation or protection, or might influence therapy (either directly or through alcohol-induced damage to key organs such as liver and brain).  The influence of alcohol on medications, including polypharmacy for the elderly, is important.  One example is the investigation of synergistic alcohol effects with viral hepatitis and tobacco on the incidence of liver cancer. Opportunities for discovery also exist on the interactions among obesity, diabetes, and alcohol. Biomarkers of organ injury, particularly at early stages of disease, should be explored.  Well-annotated tissue banks and repositories can contribute to this effort by allowing genetic, genomic, and proteomic studies, and should be encouraged. Animal models can be used to discover markers of early disease and to test early treatment strategies.

6.       Use new and existing tools and technology in appropriate circumstances. While it is not appropriate for the Institute to sponsor major efforts directed toward development of general technologies (genomic, proteomic, metabolomic, imaging), the use of such technologies as imaging (brain, liver, fetus), genomics, proteomics, metabolomics, and biocomputational models to investigate targeted questions related to alcohol action and injury should be encouraged. Development of specific biosensor technology for ethanol and metabolites is warranted, as noted above, and could provide opportunities to understand how alcohol pathology relates to the pattern of blood ethanol concentration (BEC).

7.       Institute initiatives that could advance these areas include proactive efforts to link different kinds of studies and to support extensions of existing studies.  These could include promoting supplements for banking well-annotated samples from epidemiological or treatment studies that utilize genetic, genomic, and/or proteomics techniques, and banking and encouraging sharing of tissues from human subjects and animal models that have undergone different treatments. Program officers could encourage collaboration across disciplines, possibly using small supplements to cover costs.

Discussion.  To Ms. Murphy’s question about next steps, Dr. Li explained that NIAAA and the EAB conduct portfolio reviews and identify critical research themes in order to set priorities, achieve transparency regarding the determination of research directions, and, incidentally, to recognize the depth of scientific expertise among NIAAA staff, who constitute cross-cutting teams to create synergy in putting the priorities into practice. Dr. Li suggested a future Council discussion about promotion of mechanisms to promote young investigators’ careers.  Dr. Hoek expressed concern about an artificial separation of technology and new development that might discourage investigators from participating in the forefront of science because it is considered to be development.  Dr. Edenberg stated that the thrust of the recommendation was to encourage use of new and existing tools, while avoiding major new instrument design. Dr. Swann observed that NIAAA’s opportunity is large in proportion to its budget.

Concurrence.  The Council voted unanimously to accept the EAB’s recommendations on the mechanisms of alcohol action and injury.

New Research Tools in Genomics

Francis S. Collins, M.D., Ph.D., Director, National Human Genome Research Institute, described genomics developments relevant to multiple conditions.  He acknowledged NIAAA’s partnership in ensuring that shared resources were generated quickly.  For the first six years after the Genome Project’s inception in 1990, it focused on improving technologies and building physical and genetic maps of the human genome, as well as focusing on model organisms.  In 1996-97, the Project piloted the sequencing of human DNA, and scaled up considerably by 1999.  By summer 2000, a draft version of the human genome was completed; in February 2001 an analysis of that draft sequence was published; and in April 2003—the 50th anniversary of Watson and Crick’s discovery of the double helix—an essentially complete version of the human genome was in hand; a full description of this work was published in 2004.

Next steps for the Institute focus on learning how the genome works, and how to apply knowledge that for medical benefit.  The genome sequencing centers supported by NHGRI continue to sequence many other vertebrate genomes for comparison with humans, to determine which parts of the genome have been conserved, and are therefore most deserving of attention.  Dr. Collins stated that by Fall 2006, sequences of about 30 mammals in rough draft form will be available. Information from these 30 mammals will permit identification of any string of six bases or more in the human genome that have been under selection.  As costs decline and more sequences are added, the ultimate goal is to determine the level of selection that has been applied to every nucleotide in the human genome.  The most recently published sequence is that of the chimpanzee, humans’ closest relative (Nature, September 1, 2005).  Many interesting clues have emerged about areas that appear to be undergoing rapid evolutionary change.  Dr. Collins noted that all this genome data is freely accessible in public databases.

The Genome Institute is essentially working to create a Human Genome Translation Toolbox to understand the human genome, including a full complement of knockout mice in the database, a full collection of cDNA, siRNAs, and access to small molecules.  Dr. Collins noted NIAAA’s support for the Mammalian Gene Collection (MGC) project, the process of deriving and entering into public databases the full-length cDNAs for all well-characterized human and mouse genes; to date 70 percent of the effort has been accomplished.

Dr. Collins described some important current projects that NHGRI is undertaking.  The Knockout Mouse Project (KOMP) plans to take several hundred mouse knockouts purchased from the private sector and put them in public repositories with unrestricted access.  Each of these knockouts is extensively phenotyped.  In addition, two RFAs have been issued by a trans-NIH group for a five-year project to develop knockouts of the remaining approximately 20,000 genes.

The new Molecular Libraries Roadmap Initiative will help investigators access technology that was previously out of reach.  Nine centers, plus an intramural center, will do high-throughput screening of assays received from investigators, running the assays through a library ultimately of half a million small molecules.  The end product will be compounds that show activity as agonists or antagonists towards particular targets.  All centers will use the same compounds, and the PubChem database will hold all generated data.

Dr. Collins described the HapMap, an initiative designed to find the genes that contribute to common heritable conditions such as alcoholism and diabetes.  The International HapMap Project empowers a whole genome association approach, in which every gene is considered to be a candidate.  The approach involves a cost-effective strategy to find variants associated with a particular condition.  Across the genome, significant correlation exists in the kinds of combinations of alleles that occur in a stretch of DNA, and time and money are saved by testing a handful of SNPs in each neigborhood, instead of 60 or 80, to distinguish among the haplotypes that appear. Since Fall 2002, a catalog of 10 million common SNPs in the human genome have been generated, and the HapMap project has determined their local correlations.

Applications of HapMap to common diseases include the systematic analysis of candidate genes, which involves choosing SNPs to include the coding as well as flanking regions to seek an association; fine mapping under a linkage peak to find the associated haplotype; and whole genome association analysis.  The whole genome association approach requires an optimum set of 250,000 tag SNPs, 1,000 cases and 1,000 controls, with all DNAs genotyped for all SNPs.

The goal of the project is to be able ultimately to use the information for diagnostics, individualized preventive medicine, therapeutics, and pharmacogenomics.  Many pharmaceutical companies are depending on this research to validate drug targets. The work also will provide information about risks to people currently unaffected and who might benefit by lifestyle or environmental changes to reduce risk.

Dr. Collins concluded his presentation by stating that a host of new genomic resources in addition to HapMap are coming on line.  The HapMap project will reach completion in October 2005, and the potential to identify gene variants that contribute to common disease, including alcoholism, will open a new chapter in biomedical research.

Discussion.  Dr. Collins was asked questions related to the availability of tools for genetic and epigenetic studies.  Dr. Collins described a new Center of Excellence at Johns Hopkins, under the direction of Dr. Feinberg, that is specifically involved in the development of such tools.  In addition, Dr. Collins described the ENCODE project (Encyclopedia of DNA Elements).  This project involves 24 laboratories, all working on 30 megabases (1 percent of the genome) from 50 places in the genome, with data posted for the public on the Santa Cruz web site.  If ENCODE succeeds, the project will be increased in size and scope. In response to a follow-up question on the definition of epigenetics, Dr. Collins stated that epigenetics is the type of study of cell-to-cell heredity that involves changes that are not indicated by actual mutation.

In response to a question regarding examples of effective data sharing, Dr. Collins cited the Molecular Libraries Roadmap project as an example of a means of preventing proprietary rights from interfering in such exchanges of information.  As a condition of receiving grant awards, the screening centers may not get intellectual property protection on small molecules that they identify in a screening assay.  As soon as the screen is completed, it goes into PubChem.  The real intellectual property value arrives farther downstream.

Board of Scientific Counselors

Kathleen Grant, Ph.D., Professor and Senior Scientist, Oregon Health Sciences University, and Chair, Board of Scientific Counselors, described how the Intramural Research Program is reviewed.  She noted that 8 percent of the NIAAA budget is dedicated to the intramural program, which funds research that is considered to be of higher risk than most research conducted in the extramural program.  The board’s goal is to provide a rigorous scientific review, offer feedback on the amount of support allocated, and determine whether the support aligns with scientific accomplishments. The board assesses quality, mainly retrospectively, on the basis of accomplishments; evaluates research for its overall goals, quality of research, and long-term objectives; and evaluates leadership of the branch chief.  The board provides evaluation and advice on the scientific direction of programs, comments on administration of program, allocation of resources, and conducts tenure review.

Board members are outside experts who serve five-year terms and attend annual meetings.  The scientific director, Dr. George Kunos, directs the review meetings and determines which laboratories will be reviewed, although, each must be reviewed within a four- to five-year period.  Criteria for reviews of intramural research include productivity, mentoring, research significance, approach, innovation, use of the NIH environment, and investigator training.  The board immediately reports the results of the program reviews orally to the NIAAA Director, the Division Director, and the Scientific Director.  A written report with majority and minority reviews also is submitted to the Scientific Director, who responds in writing to the board.  Provision is made for scientists who have undergone review to comment on the reviews.  The final product is sent to the Deputy Director for Intramural Research and the Director of NIH.

NIAAA’s College Drinking Initiative

Dr. Vivian Faden, Deputy Director, Division of Epidemiology and Prevention Research, NIAAA, presented an overview of the College Drinking Initiative and the initiative’s impact.  The task force, constituted in 1998, included college presidents, researchers, and students.  Its goals were to provide new, comprehensive analysis and data on the extent of the problem of college drinking, make science-based recommendations to presidents and administrators for actions to take, make recommendations for the research community, and encourage all stakeholders to use science-based information and rigorous methodology in all aspects of the response to the problem.

The task force’s report, “A Call to Action,” incorporated expert opinion on context and consequences, as well as prevention and treatment.  The report included an analysis of the extent of the problem, research-based recommendations for presidents and administrators, recommendations for future research, and recommendations to NIAAA for supporting future research.  The report reviewed the existing research on evidence of intervention’s effectiveness among college students, success with general populations that could be applied to college environments, evidence that made sense but had not yet been tested, and evidence of ineffectiveness.  Several materials were issued, including journal articles and brochures targeted to specific audiences such as parents or administrators, and a planning and evaluation handbook.

Following release of the report in 2002, NIAAA issued two RFAs.  The first one, “Alcohol-related Problems Among College Students: Epidemiology and Prevention,” awarded grants that focused on epidemiology, prevention, and data collection including secondary data analysis.  Another RFA, “Rapid Response to College Drinking Problems,” a two-part solicitation designed to take advantage of natural experiments on college campuses, capitalized on the need to take immediate steps and to evaluate those steps.  Researchers became part of a research team to arrive on campus, with colleges applying to partner with the researchers.  Awards were made to five grantees, and 15 applications were approved for funding of campuses. The programs currently are in their early phases.  NIAAA also created its increasingly popular collegedrinkingprevention.gov website, now undergoing redesign, which includes full reports from the initiative, online access to alcohol policies on campuses nationwide, an interactive body diagram with information on alcohol’s effects, and an expanded section for parents.  A new College Bulletin will update the report on research on individual and environmental interventions for college students.  Also included will be new statistics, NIAAA’s new definition of binge drinking, information on alcohol poisoning, a new chart of drinking patterns during freshman year, an update of the Rapid Response Program, and information about the Underage Steering Committee.

The initiative’s impact includes increased media attention and awareness; increased attention to the issue among college and university administrators, measured by required online courses, review of college alcohol policies, and participation in Rapid Response studies; and redesign by the Higher Education Center of its alcohol prevention training program, based on the task force recommendations.  Some college presidents stated that they have redirected resources to strategies with a strong research base, including motivational interviewing instead of scaring students; acknowledged the need for concerted and coordinated effort to change the culture of drinking, which leads students to harm themselves; and noted the persistence of the serious problem of alcohol abuse and misuse on college campuses.  The initiative has served as a catalyst for NIAAA to increase its focus on a developmental approach to underage drinking, reflecting a growing national trend to address the issue. In addition, Congress identified NIAAA as the lead science agency for the Interagency Coordinating Council for Preventing Underage Drinking.

As part of its Underage Drinking Initiative, NIAAA will publish a briefing book as a supplement to Alcohol Research & Health.  Three workgroups, each covering a specific age range, are preparing developmentally focused reports.  NIAAA has issued a new RFA, “Underage Drinking: Building Health Care System Responses.”

NIAAA Planning/Budget Retreat and NIAAA Strategic Plan 2006-2010

Dr. Kenneth Warren, Director, Office of Scientific Affairs, NIAAA, reported on the Institute’s July 2005 Budget/Planning Retreat.  The Retreat is a new activity that integrates the work of the Institute’s transdisciplinary research teams, the functions of the Extramural Advisory Board, and special expert work groups, and provides updates to NIAAA’s five-year strategic plan.  This pilot retreat for FY2007 provided an opportunity for all scientific staff to engage in the process of initiative selection for the next budget cycle, thereby providing transparency in the planning and budget process, providing information about activities across the Institute, and fostering a sense of shared purpose among all NIAAA scientists.

Semi-annual retreats are planned for future years: a winter retreat will focus on principles and potential initiatives two years hence; and at the summer retreat, priority initiatives will be discussed and selected.  In February 2006 retreat participants will begin to develop the FY2008 budget. Initiative selections made at the retreat the following summer will be part of the Congressional Justification for that year.

At the July 2005 retreat NIAAA’s Budget Officer presented a forecast of available funds for new initiatives.  NIAAA balances funding for new initiatives with the need to maintain the payline.  Transdisciplinary research teams and extramural divisions presented information on 53 potential new and expanded initiatives.  Council provides the most important input into the planning process, supplemented by EAB recommendations, transdisciplinary research team reports, congressional language, and the upcoming strategic plan.  The retreat’s outputs are NIAAA’s research priorities.

At a follow-up meeting of team leaders and Division Directors, eight new or expanded priority initiatives were selected and developmental activities identified.  Future retreat activities include opportunities for presentation of reworked initiatives that were not previously selected, incorporation of guidance from NIAAA’s new strategic plan, and EAB guidance.

Dr. Warren updated the Council on NIAAA’s five-year strategic plan.  Once a draft document is completed and accepted within the Institute, NIAAA will invite a working group of Council and the EAB to review the document prior to public comment.  Public comments will be directed back to the Council working group and Institute staff for further consideration.

Consideration of the May Minutes

The Council unanimously accepted the minutes, as submitted, of the Council meeting held on May 25-26, 2005.

Ex-officio Member and Liaison Representative Reports

CDR Little noted that the Department of Defense expects to appoint a permanent ex-officio member shortly.  He noted that service representatives convened with management representatives of the Government’s health care provider to review potential research initiatives on alcoholism that would involve service members and family members.

Public Comment

Navoneel Dayanand, LL.M., Program Associate, National Organization on Fetal Alcohol Syndrome (NOFAS), acknowledged NIAAA’s collaboration on several projects and its contributions to clinical research.  He noted that Sens. Mikulski and Johnson will introduce legislation on fetal alcohol spectrum disorders (FASD) that focuses on community groups and enhancement of research for FASD, and calls on agencies to participate in advancing work on the issue.  Dr. Li noted that Dr. Calhoun has led an interagency initiative on FASD.  Dr. Warren stated that NIAAA has met with NOFAS leadership on joint activities over the years, including the District of Columbia’s FAS Prevention and Public Education Initiative.  Mr. Dayanand added that because of NIAAA, every person in Illinois received materials on FASD and an African American PSA campaign is regularly aired on Cox Cable.

Appreciation

Dr. Li acknowledged the contributions of Dr. Edenberg upon his departure from the Council.

Adjournment

Dr. Li adjourned the meeting at 2:20 p.m.

CERTIFICATION

I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.