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  5. Public Calendar: September 1-7, 2019
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: September 1-7, 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: 09/04/2019
Location: Washington, DC
Subject: Association of Clinical Research Organizations Board Meeting: Balancing Speed with Product Safety
FDA Participant/Group: LAURA CALIGUIRI;
Non FDA Participant/Group: Several board members from the Association of Clinical Research Organizations

Event Date: 09/05/2019
Location: Washington, DC
Subject: Research!America's National Health Research Forum: Vision and Priorites for FDA
FDA Participant/Group: PETER MARKS; LAURA CALIGUIRI;
Non FDA Participant/Group: Government, industry, academia, media and other invited guests

Event Date: 09/05/2019
Location: Washington, DC
Subject: Medical Device Innovation Consortium Annual Public Forum: Vision for FDA
FDA Participant/Group: Several FDA officials and staff
Non FDA Participant/Group: Media, government, industry and other registered guests

Official Name: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner

Event Date: 09/04/2019
Location: Alameda, CA
Subject: Ribbon-Cutting Ceremony for FDA's San Francisco Laboratory and District Office
FDA Participant/Group: DARREL WILMOTH; DONALD DEMERS; JAMES SIGG; MELINDA PLAISIER; GLENDA BARFELL; PAUL NORRIS; MEHRYAR EBRAHIMI;
Non FDA Participant/Group: Several FDA officials from the San Francisco Laboratory and district office; and local support staff

Event Date: 09/05/2019
Location: Standford, CA
Subject: Stanford Medical School Center for Digital Health Workshop: Real-World Evidence and Regulatory Innovation
FDA Participant/Group: JOSEPH FRANKLIN;
Non FDA Participant/Group: Academia, industry and the general public

Official Name: Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis

No Significant Event

Official Name: Lowell J. Schiller, Principal Associate Commissioner for Policy

No Significant Event

Official Name: Mark Abdoo, Acting Deputy Commissioner for Global Regulatory Operations and Policy

Event Date: 09/04/2019
Location: Silver Spring, MD
Subject: Pharmaceutical Manufacturing Quality
FDA Participant/Group: MARY LOU VALDEZ, LEIGH VERBOIS, KRISTAN CALLAHAN, JAY JARIWALA
Non FDA Participant/Group: Manoj Mohapatra (Embassy of India);

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

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

Event Date: 09/04/2019
Location: Silver Spring, MD
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: MICHAEL OEHLSEN; SUSAN MAYNE; PADMASHRI NALUBOLA; SANDI VERBOIS; MARK ABDOO; CAMILLE BREWER; CONRAD CHOINIERE; MARY LOU VALDEZ; STEVEN SOLOMON; DONALD PRATER; DENNIS KEEFE; STEVEN MUSSER;
Non FDA Participant/Group: Bernhard Url, Guilhem de Seze, Juliane Kleiner, Marta Hugas, Matthew Ramon (European Food Safety Authority);

Event Date: 09/05/2019
Location: Silver Spring, MD
Subject: FDA’s Draft Sprout Guidance and the Produce Safety Rule
FDA Participant/Group: SAMIR ASSAR; LAUREN BERKOWITZ; CHARLOTTE CHRISTIN; LARRY MORRIS; JOY JOHANSON; FAZILA SHAKIR;
Non FDA Participant/Group: Corey Caudill, Dan Caudill (Caudill Seed Company, Inc.); Bob Sanderson (International Sprout Growers Association); Mike Biagi (The Rotunda Group);

Event Date: 09/06/2019
Location: Silver Spring, MD
Subject: Gene Editing in the Food Supply
FDA Participant/Group: STEVEN MUSSER; CAITLIN BOON; DENNIS KEEFE; ROBERT MERKER; DONALD PRATER; JASON DIETZ; FELICIA ELLISON; MARY DITTO; LARRY MORRIS; KARI BARRETT; SUSAN MAYNE; NINA ZIMDAHL; CONRAD CHOINIERE;
Non FDA Participant/Group: Kate Houston, Randal Giroux (Cargill, Inc.); Greg Jaffe (Center for Science in the Public Interest); Corby Kummer (The Aspen Institute); Mike Taylor (Aspen Institute); Lloyd Timberlake (Mars, Inc.);

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: Laura Caliguiri, 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: 09/05/2019
Location: Rancho Palos Verdes, CA
Subject: Breakthrough in Science: Drug Development in the Era of Accelerated Scientific Insights
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Event Date: 09/06/2019
Location: Washington, DC
Subject: 11th Annual Rare Disease Scientific Workshop: Science of Small Trials in the Age of Biological Plausibility
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: 09/05/2019
Location: Washington, DC
Subject: Straight Talk: 2019 Research!America's National Health Research Forum: Leveraging Data to Accelerate Medical Progress
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Event Date: 09/05/2019
Location: Washington, DC
Subject: 11th Annual Rare Disease Scientific Workshop: Science of Small Trials in the Age of Biological Plausibilty: Regulatory Aspects of the Development of Products for Rare Diseases
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

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

Event Date: 09/04/2019
Location: Silver Spring, MD
Subject: In Vitro Clinical Tests
FDA Participant/Group: KATHERINE DONIGAN; BRITTANY SCHUCK; COURTNEY LIAS; ELIZABETH HILLEBRENNER; ELLEN FLANNERY; JENNIFER TOMASELLO; TOBY LOWE; DONALD ST PIERRE; TIMOTHY STENZEL;
Non FDA Participant/Group: Sandra Perreand (bioMérieux); Jamie Wolszon, Janet Trunzo , Susan Van Meter (Advanced Medical Technology Association); Nathan Brown (Akin Gump Strauss Hauer and Feld LLP); Brad Spring (Becton, Dickinson and Company); Danelle Miller (F. Hoffmann-La Roche Ltd); April Veoukas (Abbott );

Event Date: 09/06/2019
Location: Washington, DC
Subject: Medical Device Innovation Consortium Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

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

Event Date: 09/06/2019
Location: College Park, MD
Subject: Sodium Issues
FDA Participant/Group: ROBIN MCKINNON; CLAUDINE KAVANAUGH; LAURA CARROLL; JENNIFER DOOREN;
Non FDA Participant/Group: N/A

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: 09/04/2019
Location: Silver Spring, MD
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members from the European Food Safety Authority

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

No Significant Event

Official Name: Stacy Cline Amin, Chief Counsel

No Significant Event