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: Stephen M. Hahn, M.D., Commissioner of Food and Drugs

Event Date: 11/30/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: DAYLE CRISTINZIO; PATRIZIA CAVAZZONI; PETER MARKS; BETH FRITSCH;
Non FDA Participant/Group: Several members of the Association of American Medical Colleges and other invited attendees

Event Date: 12/03/2020
Location: Rockville, MD
Subject: Facility Tour and Discussion
FDA Participant/Group: Several FDA staff participated
Non FDA Participant/Group: Several On Demand Pharmaceuticals staff and Defense Advanced Research Projects Agency staff

Event Date: 12/04/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: Several FDA staff participated
Non FDA Participant/Group: Several members of the Vaccinate Your Family staff and health care practitioners

Event Date: 12/04/2020
Location: Virtual
Subject: National Academy of Medicine Town Hall on COVID-19 Vaccines
FDA Participant/Group: DAYLE CRISTINZIO;
Non FDA Participant/Group: Members of the National Academy of Medicine, government, industry and other invited guest

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

Event Date: 12/01/2020
Location: Virtual
Subject: Clinical Trials Transformation Inititative (CTTI) - Clinical Trials Modernization Meeting
FDA Participant/Group: JOSEPH FRANKLIN; ANTOINETTE COLEMAN; KRISTEN MILLER;
Non FDA Participant/Group: Leanne Madre, Lorri Bingham, Pamela Tenaerts (Clinical Trials Transformation Initiative);

Event Date: 12/01/2020
Location: Virtual
Subject: Accelerating Appplication Programming Interface (APIs) in Healthcare: A Year in Review and Momentum for 2021; Speaker: Safety Reporting for Investigational New Drugs
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, government, and other stakeholders

Event Date: 12/01/2020
Location: Virtual
Subject: Drafting Process for National Academies of Medicine Publication Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Peter Lee (Microsoft); David Shaywitz (Astounding HealthTech);

Event Date: 12/02/2020
Location: Virtual
Subject: American Council for Technology and Industry Advisory Council (ACT-IAC) Health Innovation Day; Speaker: Keynote Fireside Chat
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 12/02/2020
Location: Virtual
Subject: National Academy of Medicine Digital Health Sector Author Group Call
FDA Participant/Group: N/A
Non FDA Participant/Group: Ariana Bailey, Mahnoor Ahmed (National Academy of Medicine); Adiseshu Gundlapalli (Centers for Disease Control); Peter Lee (Microsoft); Subha Madhavan (Georgetown); David Shaywitz (Astounding HealthTech);

Event Date: 12/03/2020
Location: Virtual
Subject: Reagan-Udall Foundation: COVID-19 Evidence Accelerator Collaborative Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Official Name: Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs

No Significant Event

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

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

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

Event Date: 11/30/2020
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members of National Association of State Departments of Agriculture

Event Date: 12/01/2020
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several senior officials and staff from the Canadian Food Inspection Agency and Health Canada

Event Date: 12/02/2020
Location: Virtual
Subject: Proposed Rule for Requirements for Additional Traceability Records for Certain Foods
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Consumers, food industry, academia, state and federal government

Event Date: 12/04/2020
Location: Virtual
Subject: Food Safety and Consumer Education
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members from Disney, the Partnership for Food Safety Education, and United States Department of Agriculture

Event Date: 12/04/2020
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: LARRY MORRIS; CAITLIN BOON;
Non FDA Participant/Group: Kyle Kinner, Sandra Eskin (The Pew Charitable Trusts);

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

No Significant Event

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Heidi Rebello, Acting Associate Commissioner for External Affairs

No Significant Event

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

Official Name: Patrizia Cavazzoni, M.D., Acting Director, Center for Drug Evaluation and Research

No Significant Event

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

Event Date: 11/30/2020
Location: Virtual
Subject: Systemic Immunogenicity Considerations for AAV (Adeno-Associated Virus) Mediated Gene Therapy: Introductory Remarks
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Attendees of the National Center for Advancing Translational Sciences / Center for Biologics Evaluation and Research Workshop

Event Date: 11/30/2020
Location: Virtual
Subject: Lunchtime Lecture Series: Ethical Issues in Pediatric Gene Therapy Clinical Trials
FDA Participant/Group: N/A
Non FDA Participant/Group: Representatives of the New York University Grossman School of Medicine Working Group on Pediatric Gene Therapy and Medical Ethics

Event Date: 12/01/2020
Location: Virtual
Subject: COVID-19 Vaccines
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the American Society of Health Pharmacists webinar

Event Date: 12/02/2020
Location: Virtual
Subject: Answering Your Questions About Forthcoming COVID-19 Vaccines
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Adult Vaccine Access Coalition Town Hall

Event Date: 12/03/2020
Location: Virtual
Subject: COVID-19 Vaccine Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of the American Medical Association

Event Date: 12/04/2020
Location: Virtual
Subject: COVID-19 Vaccines
FDA Participant/Group: N/A
Non FDA Participant/Group: Representatives from the Service Employees International Union (SEIU) Healthcare Division Leadership Board

Event Date: 12/04/2020
Location: Virtual
Subject: Vaccine Safety Systems and COVID-19
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Attendees of the National Vaccine Advisory Committee Meeting

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

Event Date: 12/03/2020
Location: Virutal
Subject: Alliance for a Stronger FDA; Speaker: CDRH’s Priorities and Digital Health Initiatives
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

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: 12/04/2020
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: ASHLEY STEEL; SIOBHAN DELANCEY; SUSAN BRIGHT-PONTE; PATRICK MCDERMOTT; ANTONIA MONIQUE SENNETT; WILLIAM FLYNN; NADINE STEINBERG; MARGARET OELLER; MATTHEW LUCIA; NEAL BATALLER;
Non FDA Participant/Group: Members of The Pew Charitable Trusts

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