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  5. Public Calendar: September 22-28, 2019
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: September 22-28, 2019

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.

Official Name: Norman E. Sharpless, M.D. (Acting), Commissioner of Food and Drugs

Event Date: 09/23/2019
Location: Silver Spring, MD
Subject: The Personal Care Products Council: Ways to Advance Cosmetic Reform
FDA Participant/Group: LINDSAY TOBIAS; DAYLE CRISTINZIO; LINDA KATZ; SUSAN MAYNE; KEAGAN LENIHAN; ANDREW TANTILLO; ERIC FLAMM; ERIKA ANDERSON; THERESA MICHELE; STEPHANIE SOCGFACK;
Non FDA Participant/Group: Brian Heindl, Josh Glasser (Colgate-Palmolive Company); Wade Ackerman (Covington & Burling); Kara Carscaden (The Estee Lauder Companies); Lezlee Westine, Meredith Simpson (Personal Care Products Council); Anne Crews (Mary Kay Inc.); Darrel Jodrey, Kevin Whelan (Johnson & Johnson); Taryn Looney (Chanel, INC); Tonya Kemp (Amway Corporation); Marian Gahagan (Merle Norman Cosmetics); Kelly Molinari (L'Oreal);

Event Date: 09/26/2019
Location: Silver Spring, MD
Subject: I AM ALS
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members from I AM ALS

Official Name: Amy Abernethy, M.d.,Ph.D, Deputy Commissioner for Policy, Planning, Legislation, and Analysis

Event Date: 09/25/2019
Location: San Francisco, CA
Subject: Rock Health Summit; Panelist: The Next Frontier of Digital Drug Discovery
FDA Participant/Group: JOSEPH FRANKLIN;
Non FDA Participant/Group: Meeting attendees from industry, academia, and the general public

Official Name: Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs

Event Date: 09/23/2019
Location: Silver Spring, MD
Subject: Danish Medicines Agency: Rondomized Trials, AI, and Machine Learning
FDA Participant/Group: GIDEON BLUMENTHAL; JESSICA BERRELLEZ; PADMASHRI NALUBOLA; SHANNON THOR;
Non FDA Participant/Group: Jakob Gold, Jens Quartarolo, Nikolai Brun, Thomas Snederovitz (Danish Medicines Agency);

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Dara Corrigan, Deputy Commissioner for Policy, Planning, Legislation, and Analysis

Event Date: 09/23/2019
Location: Silver Spring, MD
Subject: Discussion on Randomized Trials, AI and Machine Learning
FDA Participant/Group: RITA NALUBOTA, GIDEON BLUMENTHAL, SHANNON THOR, JESSICA BERRELLEZ
Non FDA Participant/Group: Thomas Senderovitz, Jakob Gold Nikolai Brun, Jens Piero Quartarolo (Danish Medicines Agency);

Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response

Event Date: 09/26/2019
Location: College Park, MD
Subject: Food Safety Issues
FDA Participant/Group: N/A
Non FDA Participant/Group: Lauren Dunn (NBC News);

Event Date: 09/27/2019
Location: Silver Spring, MD
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: LARRY MORRIS; JEFFREY FARRAR;
Non FDA Participant/Group: Anita Landy, Ed Foster, Jeff Grant, Mark Killian (Arizona Department of Agriculture);

Event Date: 09/27/2019
Location: Silver Spring, MD
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: NINA ZIMDAHL;
Non FDA Participant/Group: Carletta Ooton (Amazon);

Official Name: Lowell Schiller, Principal Associate Commissioner for Policy

No Significant Event

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

No Significant Event

Official Name: Melinda Plaisier, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Mary Lou Valdez, M.S.M., Associate Commissioner for International Programs

No Significant Event

Official Name: John Kalavritinos, Associate Commissioner for External Affairs

No Significant Event

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

Official Name: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research

Event Date: 09/23/2019
Location: Bethesda, MD
Subject: Drug Information Association: Biosimilars Conference: Keynote Address
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Event Date: 09/23/2019
Location: Washington, DC
Subject: Rare Diseases Forum and Workshop on Lessons from Oncology
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Event Date: 09/24/2019
Location: Washington, DC
Subject: Friends of Cancer Research Awards and Reception
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

Event Date: 09/24/2019
Location: New Haven, CT
Subject: Yale Cancer Center Grand Rounds: Advances in Chimeric Antigen Receptor-T Cells
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Event Date: 09/25/2019
Location: Silver Spring, MD
Subject: Transfusion Transmissible Infections Monitoring System Steering Committee: Status of the Transfusion Transmissible Infections Monitoring System Project
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several stakeholders from industry; government

Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

Event Date: 09/26/2019
Location: Silver Spring, MD
Subject: In Vitro Clinical Test (IVCT)
FDA Participant/Group: COURTNEY LIAS; TIMOTHY STENZEL; ELLEN FLANNERY; BRITTANY SCHUCK; JENNIFER TOMASELLO; TOBY LOWE; KATHERINE DONIGAN;
Non FDA Participant/Group: Will Finn (Warde Medical Laboratory); Jeff Jacobs, Matthew Schulze (American Society for Clinical Pathology); Gary Procop (Cleveland Clinic);

Event Date: 09/27/2019
Location: Silver Spring, MD
Subject: Digital Therapeutics (DTx)
FDA Participant/Group: ANGELA KRUEGER; OWEN FARIS; MATTHEW DIAMOND; ELIZABETH HILLEBRENNER; BAKUL PATEL;
Non FDA Participant/Group: Anil Jina (Akili Interactive Labs); Nate Brown (Akin Gump LLP); Megan Coder (Digital Therapeutics Alliance); Yuri Maricich (Pear Therapeutics);

Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

No Significant Event

Official Name: Mitchell R. Zeller, J.D., Director, Center for Tobacco Products

No Significant Event

Official Name: Steven Solomon, Director, Center for Veterinary Medicine

Event Date: 09/23/2019
Location: Rockville, MD
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: KRISTINA GODDARD; MATTHEW LUCIA; RANDALL GNATT; JULI ANN PUTNAM; WILLIAM FLYNN; ANNE NORRIS; SIOBHAN DELANCEY; ANTONIA MONIQUE SENNETT; ASHLEY STEEL; ELLEN HART; TIMOTHY SCHELL;
Non FDA Participant/Group: American Veterinary Medical Association

Event Date: 09/26/2019
Location: Rockville, MD
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: JENNIFER ERICKSON; JEANETTE MURPHY; SIOBHAN DELANCEY; CHARLOTTE CONWAY; TIMOTHY SCHELL; ANTONIA MONIQUE SENNETT; DAVID EDWARDS; ANNE NORRIS;
Non FDA Participant/Group: American Feed Industry Association

Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research

Event Date: 09/24/2019
Location: Ispra, Italy
Subject: Global Coalition for Regulatory Science Research Executive Committee Meeting
FDA Participant/Group: WILLIAM SLIKKER; JUSTIN WIENCEK; WEIDA TONG; ANIL KUMAR PATRI; SHRADDHA THAKKAR;
Non FDA Participant/Group: Foreign government officials

Event Date: 09/25/2019
Location: Stersa, Itlay
Subject: Global Summit on Regulatory Science
FDA Participant/Group: NATHANIEL KOONCE; JUSTIN WIENCEK; ANIL KUMAR PATRI; WILLIAM SLIKKER; SHRADDHA THAKKAR; WEIDA TONG;
Non FDA Participant/Group: Government, industry, academia, and other invited guests

Official Name: Stacy Cline Amin, Chief Counsel

No Significant Event