FDA PUBLIC CALENDAR

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

FDA Official and Title	Date	Location	Other FDA Participants	Non-FDA Participants	Subject
February 11-15, 2008
Andrew von Eschenbach, Commissioner, Food and Drugs	2/12/08	Rockville, MD	Susan Winckler, David Acheson, Randy Lutter, Joseph Grogan, Steve Sundlof, Robert Buchanan, Gene LeClerc, Carl Sciacchitano, Kate Cook, Jeffrey Senger, Michele Mital, Irene Chan, Kristy Moran	Henry Nordhoff, Dan Kacians, Paul Gargan, James Hogan (Gen-Probe Incorporated)	To discuss Gen-Probe’s Advances in Food Safety Testing
John Dyer, Deputy Commissioner for Operations and Chief Operating Officer	2/11/08 through 2/15/08	N/A	N/A	N/A	No significant meetings
Murray Lumpkin, Deputy Commissioner for International and Special Programs	2/14/08	Rockville, MD	Mathew Eckel	Pfizer (Global Regulatory Policy): David Verbraska, Kerstin Franzen, Michael Maher, Melissa Tassinari, Dennis Strickland, William Murphy, Nick Sykes, Patricia Newborg	General International Regulatory Issues
Randall Lutter, Deputy Commissioner for Policy	2/11/08	Philadelphia, PA	N/A	Leonard Davis Institute of Health Economics Students	Economics of Pharm, Biotech and Medical Device Industries
Randall Lutter, Deputy Commissioner for Policy	2/13/08	New York, New York	N/A	Registered Attendees	DTC Screenings and Rulemaking, Drug Safety Provisions of FDAAA, Risk Communications
Janet Woodcock, Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer and Acting Director, Center for Drug Evaluation and Research	2/5/08	Bethesda, MD	Suzanne Fitzpatrick, Yolanda Jones, Devaraya Jagannath, Haile Yancy	Daniel Krewski (U of Ottawa); Harold Zenick (EPA); John Howard (CDC); George Corcoran (SOT)	ICCVAM Symposium (Interagency Coordinating Committee on the Validation of Alternative Methods)
Janet Woodcock, Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer and Acting Director, Center for Drug Evaluation and Research	2/7/08	Rockville, MD	Rachel Behrman, Leonard Sacks, Melissa Robb	Kevin Cevasco, Beth Everett, Vicky Bowen, David Hardison (SAIC Health Solutions)	Pharmacovigilance
Janet Woodcock, Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer and Acting Director, Center for Drug Evaluation and Research	2/7/08	Rockville, MD	Dan Schultz, Steve Gutman, Gerald Masoudi, Randy Lutter, Joe Grogan, Courtney Harper	Mara Aspinall (Genzyme Genetics); Sharon Terry (Genetic Alliance); Kim Popovits (Genomic Health); Paul Kim (Foley, Hoag, & Elliott); Paul Radensky (McDermott, Will, & Emery); Christine Bump (Hyman, Phelps, & McNamara)	In Vitro Diagnostic Multivariate Index Assays and Analyte Specific Reagents
Margaret Glavin, Associate Commissioner, Office of Regulatory Affairs	2/11/08 through 2/15/08	N/A	N/A	N/A	No significant meetings
Jesse Goodman, Director, Center for Biologics Evaluation and Research	2/11/08 through 2/15/08	N/A	N/A	N/A	No significant meetings
Daniel Schultz, Director, Center for Devices and Radiological Health	2/13/08	Washington, DC	conference	conference	ChallengSpeech: CRT 2008: FDA on DES Approval for 2008 and Beyond
Daniel Schultz, Director, Center for Devices and Radiological Health	2/15/08	Rockville, MD	Tim Ulatowski, Murray Malin, Kimber Richter, Kevin McBryde, Carolyn Neuland, Betty Collins, Paul Tilton, Larry Spears, Shirley Zeigler, Ron Nowalk, Herb Lerner, Mike Verdi	Baxter; Ira Davis, medical Director Clinical Affairs, Mark Jackson, VP Global Quality, Daniel Jacob, Medical Director, Product Surveillance, Sarah Prichard, VP Global Medical Affairs, Cheryl White, Corp. VP Global Quality and Ed Basile, King and Spalding	various medical device issues
Stephen Sundlof, Center for Food Safety and Applied Nutrition	2/6/08	College Park, MD	Nega Beru, Director, Office of Food Safety, Leslye Fraser, Director, Office of Regulations, Policy and Social Sciences, Dianne Benjamin, Policy Analyst, EOS, Joseph Baca, Director, Office of Compliance	Elizabeth Fay, Director of Public Policy, Cargill Company, Joseph Scimeca, Director of Global Regulatory Affairs, Cargill, Leslie L. Curry, Cargill	Stevia Food Ingredient
Bernadette Dunham, Director, Center for Veterinary Medicine	2/12/08	Washington, DC	N/A	Joel Newman	Various issues of concern to the animal feed industry.
Bernadette Dunham, Director, Center for Veterinary Medicine	2/14/08	Washington, DC	David Wardrop	Animal Agriculture Coallition	Proposed 2009 Budget for CVM
Bernadette Dunham, Director, Center for Veterinary Medicine	2/15/08	Rockville, MD	Dr. Daniel McChesney	Joel Newman	Codex comments on the proposal for a feed ban task force
William Slikker, Director, National Center for Toxicological Research	2/14/08	Atlanta, GA	James Fuscoe, Leming Shi, Weida Tong, James J. Chen	Researchers from DHHS and EPA	The 1st Inter-Agency Computational Toxicology Colloquium
Gerald Masoudi, Chief Counsel	2/11/08	Washington, D.C.	Jeffrey Senger, Heidi Gertner, Julie Finegan, Seth Ray, OCC	Petr Barton Hutt, Michael Labson, Heather Banuelos, Covington & Burlington; David Long, Doreen Frank, Adams REspiratory Therapeutics	Approval Issues
Gerald Masoudi, Chief Counsel	2/14/08	Rockville, MD	Jeffrey Senger, Ann Wion, Louisa Nickerson, OCC; Michael Landa, Laura Tarantino,CFSAN	Joseph Levitt, Chris Handman, Hogan & Hartson	Section 912 Implementation

horizonal rule