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Acknowledgments The committee wishes first to acknowledge the early contribution of Trudy Bush, Ph.D., M.H.S., of the University of Maryland School of Medicine. Dr. Bush's insights were greatly appreciated but cut tragically short when she was suddenly deceased in early April of 2001. She is and will continue to be sorely missed. Many individuals assisted the committee with helpful advice and suggestions in the preparation of this interim report, and any list runs the risk of unintentional omissions. The committee particularly thanks two consultants, Sandra Berry, Director of the Survey Research Group of RAND, and Dr. David Madigan, Professor of Statistics at Rutgers University. Dr. John C. Bailar ITI, M.D., Ph.D, Professor Emeritus at the University of Chicago, provided advice on multiple occasions. The committee appreciates the support provided by the sponsor of the project, the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services. Many individuals from the CDC were most helpful, in particular the primary contact person, Randy Louchart, as well as David Ashford, Ph.D.; Betsy Cadwell, M.S.P.H.; Jose F. Cordero, M.D., M.P.H.; Deborah Gust, Ph.D.; Laurie Kamimoto, Ph.D.; Stacy Martin; Michael M. McNeil, M.D., M.P.H.; Gina Mootrey, D.O., M.P.H.; Nina Morano; Bradley Perkins, M.D.; Robert Pless, M.D.; Conrad Quinn, Ph.D.; Benjamin Schwartz, M.D.; Kristine Sheedy, Ph.D.; Robert Jacobson; and many others. The committee greatly appreciated the helpful information provided by Col. Arthur M. FriedIander, M.D., and LTC John D. Grabenstein, R.Ph., Ph.D., of the DoD; Vito Caserta, M.D., M.P.H., of the National Vaccine Injury Compensation Program, Health Resources and Services Administration, DHHS; Mr. Brent Jaquet, of the Office of Congressman C.W. Bill Young; and M. Miles Braun, M.D., M.P.H., Juli ClifforcI, and Karen Goldenthal, M.D., all of FDA. The committee thanks members ofthe public who attended the April Id, 2001, joint meeting with the Committee to Assess the Safety and Efficacy of the Anthrax Vaccine and acldressed the committees, inclucling Major (ret) Sonnie Bates; Capt. John Buck, M.D.; Col. (ret) Redmond Handy; Major Jon F. Irelan; Technical Sergeant Jeffrey Moore; Ms. Nancy Rugo; Master Sergeant (ret) Thomas Starkweather; Capt. Jean Tanner; and others who spoke that day. At the institute of Medicine, the study director greatly appreciated the assistance of Phillip Bailey, Sue Barron, Andrea Cohen, Lois Joellenbeck, Karen Kazmerzak, Linda Kilroy, X1
X11 CDC ANTHRAX VACCINE SAFETY & EFFICACY RESEARCH PROGRAM Janice Mehier, Saira Moini, Jennifer Otten, Bronwyn Schrecker, Sally Stanfield, anc! Vance Vines, among others. S. Renee Twombly helped in copy ecliting the report. REVIEWERS This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments anc} draft manuscript remain confidential to protect the integrity of the cleliberative process. We wish to thank the following individuals for their review of this report: ANN M. ARVINE, Lucile Salter Packard Professor of Pediatrics and Professor of Microbiology and Immunology, Stanford University WILLIAM DUMOUCHEL, Tuscon, Arizona STANLEY FALKOW, Professor, Department of Microbiology and Immunolgy, Stanford, University DENISE L. FAUSTMAN, Director, Immunobiology Laboratory, Associate Professor of Medicine, Massachusetts General Hospital-East MARY GRACE KOVAR, Research Vice-President, Epidemiology and Public Health, National Opinion Research Center, University of Chicago JOHN ROBBINS, Heart, Laboratory of Developmental and Molecular Immunity, National Institute of Chilct Health & Human Development, NTH PHILIP RUSSELL, Potomac, MD Although the reviewers listed above have proviclec3 many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Dr. F. Marc LaForce, Director, Basics Il. Arlington, VA, appointed by the Institute of Medicine anct Dr. Gilbert S. Omenn, appointed by the NRC's Report Review Committee, who was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.