Peer Review Standards for Regulatory Science and Technical Information Science, Technology, and Law Program The National Academies Main Auditorium 2100 C Street, NW November 18, 2003 Agenda
9:00		Welcome and Introduction		Donald Kennedy, Editor in Chief, Science; Co-Chair, Science, Technology, and Law Program
9:10		Keynote Address		John D. Graham, Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget View Presentation (Powerpoint)
9:30		Questions
9:45		OSTP’s Role		Kathie L. Olsen, Associate Director for Science, White House Office of Science and Technology Policy
10:00		Questions
10:15		What is Peer Review? A Comparison of the Bulletin’s Model of Peer Review with Other Types of Peer Review
		Moderator:		Richard A. Meserve, President, Carnegie Institution of Washington
		Three Models: FDA, HEI, Science		Donald Kennedy, Editor in Chief, Science, President Emeritus, Stanford University
		The Conceptual Framework		Sheila S. Jasanoff, Pforzheimer Professor of Science and Technology Studies, John F. Kennedy School of Government, Harvard University View Presentation (PDF)
11:15		Questions
11:30		The Range of Agency Utilized, Generated, and Disseminated Scientific Information: academic research; agency research; warnings to the public; CBI; third party submissions
		Moderator:		Frederick R. Anderson, Jr., Partner, Cadwalader, Wickersham & Taft
		Speakers:		Paul Gilman, Assistant Administrator, Office of Research and Development, Environmental Protection Agency View Presentation (PDF)
				James Scanlon, Acting Deputy Assistant Secretary for Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services
				Claude LenFant, former Director, National Heart, Lung, and Blood Institute, National Institutes of Health
12:15		Questions
12: 30		Lunch
1:15		The Boundaries of the Bulletin: Scope, OIRA Involvement
		Speaker:		Alan B. Morrison, Public Citizen Litigation Group
1:45		Questions
2:00		Peer Review of Especially Significant Regulatory Information: Implications for Agency Peer Review Procedures—changes in practices; costs and delays; pre-peer review public comment
		Moderator:		Donald Kennedy; Editor in Chief, Science, President Emeritus, Stanford University
		Speakers:		James Mahoney, Assistant Secretary and Deputy Administrator for Oceans and Atmosphere, National Oceanic and Atmospheric Administration View Presentation (PDF)
				James D. Schaub, Director, Office of Risk Assessment and Cost-Benefit Analysis, Department of Agriculture View Presentation (PDF)
				David M. Michaels, Professor, Departments of Occupational and Environmental Health and Epidemiology, George Washington University School of Public Health, former Assistant Secretary for Environment, Safety, and Health, Department of Energy View Comments (PDF)
				Michael R. Taylor, Senior Fellow and Director, Risk, Resource, and Environment Division, Resources for the Future, former Deputy Commissioner for Policy, Food, and Drug Administration View Comments (PDF)
3:00		Questions
3:15		The Peer Reviewers’ Perspective: Implications for Scientists transparency; conflict of interest; burden; joint review; agency response; public comments
		Moderator:		John C. Bailar III, Professor Emerituts, Department of Health Studies, University of Chicago
		Speakers:		Warren M. Washington, Chair, National Science Board, Senior Scientist and Head, Climate Change Research Section, National Center for Atmospheric Research View Presentation (PowerPoint)
				Gilbert S. Omenn, Professor of Medicine, Genetics and Public Health, University of Michigan Medical School View Presentation (PDF)
				Thomas Louis, Professor, Department of Biostatics, Johns Hopkins Bloomberg School of Public Health
4:15		Questions
4:30		Integration of Peer Review with the Requirements of the Federal Advisory Committee Act and the Administrative Procedure Act
		Speaker:		Sidney A. Shapiro, Associate Dean for Research and John M. Rounds Professor of Law, The University of Kansas School of Law View Presentation (PDF)
4:50		Questions
5:00		Closing Remarks		Richard A. Meserve, President, Carnegie Institution of Washington