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FDA PUBLIC CALENDAR

Food and Drug Administration
Office of Public Affairs
5600 Fishers Lane
Rockville, MD 20857

This public calendar is issued by the Food and Drug Administration. It lists meetings held by the FDA policy makers with persons outside the executive branch of the Federal Government.

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July 12, 2004

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FDA Official and Title

Date and Site

Other FDA Participants

Non-FDA Participants

Subject

Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs

6/15/04 Rockville, MD

Susan Bond, Dana Delman

Mark Achler, Rightsfield Solutions

Medical Information System

Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs

6/16/04 Rockville, MD

Susan Bond, Norris Alderson, David Lepay, Linda Huntington

Dr. Motimer Neufville and Dr. Richard Harpel, National Association of State Universitites and Land-Grant Colleges

Standards for Human Subject Protection in Clinical Trials

Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs

6/16/04 Rockville, MD

Beth Clarke

Miles White, Chairman of the Board and CEO, and Chairman-Elect PhRMA; Elaine Leavenworth, VP, Gov't Affairs, PhRMA

Various Issues

Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs

6/22/04 Washington, DC

Susan Bond, Janice Oliver, Barbara Schneeman, Felecia Satchell, Indya Mungo

Paul Abenante, American Bakers Assn, Peter Barton Hutt, Covington & Burling, Leonard Heflch, George Weston Bakeries, Inc., Lee Sanders, Am. Baker Assn.

Carbohydrate related nutrient content claims, Allergens Standards of Identity

Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs

6/30/04 Washington, DC

Susan Bond, Patricia Kuntze, Barbara Schneeman, Linda Pellicore, Robert Moore, Indya Mungo

Consumers Union: Janell Mayo Dunan, Charles Bell, Marvin Lipman

Unsafe Dietary Supplements

Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs

7/1/04 Washington, DC

Dan Troy, Susan Bond, Robert Brackett, Julie Schrimpf, Indya Mungo

Center for Science in the Public Interest: Michael Jacobson, Ben Cohen

Trans Fat

Dr. Robert Brackett, Director, Center for Food Safety and Applied Nutrition

5/12/04 College Park, MD

Janice Oliver, Deputy Director, Louis Carson, Deputy Director Food Security Staff

Tony Leany, Business Development; Thomas Billy, Food Safety Consultant, LLC

CABI Compendium Programs

Dr. Robert Brackett, Director, Center for Food Safety and Applied Nutrition

5/14/04 College Park, MD

Alan Rulis, OCD; Kathy Ellwood, ONPLDS; Greg Thompson, GC, Barbara Schneeman

Amie Guy, Nestle, Diane Brown, Michael Bloom, Mary Marr, Steve Steinborn

New Products from Nestle

Daniel E. Casciano, Ph.D., Director, National Center for Toxicological Research

6/28/04 Little Rock, AR

None

University of Arkansas for Medical Sciences: Martin Hauer-Jensen, M.D., Ph.D., FACS; Aubrey J. Hough, Jr., Ph.D.

Bioterrorism

Daniel E. Casciano, Ph.D., Director, National Center for Toxicological Research

7/8/04 Jefferson, AR

NCTR Division and Program Directors: Thomas Flammang, Ralph Kodell, Weida Tong, Martha Moore, James Fuscoe, Fred Kadlubar, Luke Ratnasinghe, Sherry Ferguson, Carl Cerniglia, Robert Turesky, Yvonne Dragan, Paul Howard, William Allaben

University of Arkansas at Fayetteville: Bob Smith, Collis Geren, Jerry Foote, Ralph Henry, Wayne Kuenzel, Josh Sakon, Rick Ulrich

Presentation and tour of the NCTR facility. Discussion on possible research collaboration.

Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine

7/7/04 Rockville, MD

Dr. Beaulieu, Dr. Vaughn, Dr. Marnane, Dr. Martinez, CVM; Eric Blumberg, David Mednick, OCC

Andrew L. Winstrom, Randy Mapes

Mtg. w/Pennfield Oil, two NADA packages.

Linda Tollefson, Deputy Director, Center for Veterinary Medicine,

7/9/04 Rockville, MD

Katherine Weld, CVM, Karen Lampe, CVM, Jeff Gilbert, DVM, Julia Punderson, CVM, Mark Robinson, CVM, Steve Vaughn, CVM, Tracey Forfa, CVM; Nadine Steinberg, OC

Dr. James Peters, Dr. Ronald Dalrymple, Mr. Jeremy Mathers, Ms. Sondra Flick

Mtg. w/Alpharma to discuss subtherapeutic penicillans.

Daniel E. Troy, Chief Counsel

6/8/04 Rockville, MD

None

Kimberly M. Thompson, Harvard School of Public Health

Harvard Case Studies

Daniel E. Troy, Chief Counsel

6/29/04 Rockville, MD

Rick Blumberg, OCC; Steve Silverman, Fred Richman, CDER

David L. Rosen, Gray Cary; Thomas Heck, Craig Collard, Carolina Pharmaceuticals; Philip Pesin, Pesin & Associates

Carolina Pharmaceuticals-Humibid

Daniel E. Troy, Chief Counsel

7/6/04 Rockville, MD

Coleen Klasmeier

Peter Barton Hutt, Covington & Burling, Tom Donegan, CTFA

Cosmetic Regulation

Susan F. Wood, Ph.D., Assistant Commissioner for Women's Health, Office of Women's Health

5/25/04 Rockville, MD

None

Audrey Sheppard, Interim Executive Director, Jacobs Institute of Women's Health; Diane James, Executive Director, Jacobs Institute of Women's Health

Introduction to the New Executive Director of Jacobs Institute of Women's Health

Susan F. Wood, Ph.D., Assistant Commissioner for Women's Health, Office of Women's Health

7/12/04 Rockville, MD

None

Personal Products Company: Gaetan Rouleau, VP Global Regulatory affairs; Terry A. Glass, Director, Women's Health Regulatory Affairs; Charles Wajszczuk, M.D., Worldwide Medical Director, Women's Health; Brinda Wiita, Ph.D., Executive Director, New Business; Joan Casalvieri, Ph.D., Director, Toxicology

Company product planning; company was seeking OWH input on product development.

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