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Project Title:
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Ranking FDA Product Categories Based on Health Consequences, Phase I
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| PIN:
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BEST-K-08-03-A
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Major Unit:
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Division of Behavioral and Social Sciences and Education
Division on Earth and Life Studies
Institute of Medicine
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Sub Unit:
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Board on Environmental Studies & Toxicology
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RSO:
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Mantus, Ellen
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Subject/Focus Area:
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Ranking FDA Product Categories Based on Health Consequences
October 10, 2008 - October 11, 2008
PUBLIC SESSION: October 10, 2008
LOCATION:
The Hubert H. Humphrey Building, Room 800
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
(To attend the public session, you must preregister as soon as possible with Nola Golson via email (pgolson@nas.edu) or phone (202-334-1669) due to high security at the Hubert H. Humphrey Building.)
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If you would like to attend the sessions of this meeting that are open
to the public or need more information please contact:
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| Contact Name:
Nola Golson
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| Email:
pgolson@nas.edu
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| Phone:
202-334-1669
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Fax:
202-334-2752
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Agenda:
Board on Environmental Studies and Toxicology
NATIONAL RESEARCH COUNCIL
COMMITTEE ON RANKING FDA PRODUCT CATEGORIES BASED ON
HEALTH CONSEQUENCES, PHASE I
Public Meeting: October 10, 2008
The Hubert H. Humphrey Building, Room 800
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
(To attend the public session, you must preregister as soon as possible with Nola Golson via email (pgolson@nas.edu) or phone (202-334-1669) due to high security at the Hubert H. Humphrey Building.)
PUBLIC AGENDA
9:00
Purpose of Public Session and Introduction of Committee Members
R. Lawrence, Chair
9:10
HHS / FDA Expectations and Review of Issues
Benjamin E. Sasse
Assistant Secretary for Planning and Evaluation
U.S. Department of Health and Human Services
Randall Lutter
Deputy Commissioner for Policy
U.S. Food and Drug Administration
Review of FDA Product Categories
9:40
Human Foods, Including Direct and Indirect Food Additives
Leslye M. Fraser
Director, Office of Regulations, Policy and Social Sciences
Center for Food Safety and Applied Nutrition, FDA
10:10
Dietary Supplements
Leslye M. Fraser
Director, Office of Regulations, Policy and Social Sciences
Center for Food Safety and Applied Nutrition, FDA
10:30
BREAK
10:45
Cosmetics
Leslye M. Fraser
Director, Office of Regulations, Policy and Social Sciences
Center for Food Safety and Applied Nutrition, FDA
11:05
Drugs and Biologics Regulated as Drugs
H. Gregg Claycamp
Director, Division of Compliance Risk Management and Surveillance
Office of Compliance
Center for Drug Evaluation and Research, FDA
11:35
Biologic Products (Other Than Those Regulated as Drugs)
Robert Ball
Director, Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research, FDA
12:05
LUNCH BREAK
12:50
Veterinary Drugs
Barry Hooberman
Center for Veterinary Medicine, FDA
1:15
Animal Feeds and Pet Foods
Barry Hooberman
Center for Veterinary Medicine, FDA
1:35
Medical Devices
Abiy B. Desta
Network Leader for Science
Office of the Center Director
Center for Devices and Radiological Health, FDA
2:05
Radiation Emitting Products
Abiy B. Desta
Network Leader for Science
Office of the Center Director
Center for Devices and Radiological Health, FDA
Decision-Analysis Models and Risk Prioritization Frameworks
2:25
Introduction to Decision Analysis
Dennis M. Buede
Senior Principal and President
Innovative Decisions, Inc.
2:45
FDA Examples: Using Decision Analysis Frameworks for Prioritization Decisions
Kara Morgan
Senior Advisor for Risk Analysis
Office of Regulatory Affairs, FDA
3:15
Bayesian Approaches to the Value of Information: Implications for Regulating Health Care Technologies and Setting Research Priorities
Stephen Palmer
Senior Research Fellow
University of York
3:45
BREAK
4:00
Social Cost Model and Risk Ranking
Sandra Hoffman
Fellow
Resources for the Future
4:30
A Multi-Factorial Approach to Risk Prioritization
Julie Caswell
Professor, Chairperson of Dept. of Resource Economics
University of Massachusetts, Amherst
5:00
Open Microphone – Comments from the Audience
5:15
ADJOURN PUBLIC SESSION
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Closed Session Summary Posted After the Meeting
The following committee members were present at the closed sessions of the meeting:
Robert Lawrence (chair)
James Anderson
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Helen Jensen
Robin Keller
David Meltzer
Sanford Miller
Richard Platt
Kimberly Thompson
The following topics were discussed in the closed sessions:
1) Standard NRC discussion of policies, procedures, potential bias and conflict of interest.
2) Committee’s statement of task and its approach.
3) Information presented in the public session.
4) Schedule for future committee meetings.
The following materials (written documents) were made available to the committee in the closed sessions:
1. FDA. 2008. Considerations in Categorizing FDA-Regulated Products for Ranking Net Risks. Draft document received on July 1, 2008.
2. FDA. 2008. Suggestions for FDA product group categories. Draft document received on July 1, 2008.
3. Lutter, R. 2008. Setting Priorities at FDA. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
4. Fraser, L.M. 2008. Overview of CFSAN Regulated Products and Challenges. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008. NOTE: Presentation includes slides on dietary supplements and cosmetics.
5. Claycamp, H.G. 2008. Center for Drug Evaluation and Research. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
6.Ball, R. 2008. The Diversity and Complexity of Biological Products: Broad Range of Risks and Benefits for Public and Personal Health. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
7. Hooberman, B. 2008. Center for Veterinary Medicine. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
8. Desta, A.B. 2008. Medical Devices. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
9. Desta, A.B. 2008. Radiation Emitting Products. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
10. Buede, D. 2008. Introduction to Decision Analysis. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
11. Morgan, K. 2008. FDA Examples: Using Decision Analysis Frameworks for Prioritization Decisions. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
12. Palmer, S. 2008. Bayesian approaches to the value of information: Implications for regulating health care technologies and setting research priorities. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
13. Hoffman, S. 2008. Social Cost Modeling and Risk Ranking. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
14. Caswell, J. 2008. A Multi-factorial Approach to Risk Prioritization. Presentation to the National Research Council Committee on Ranking FDA Product Categories Based on Health Consequences, Washington, DC on October 10, 2008.
Date of posting of Closed Session Summary:
October 30, 2008
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