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  5. Public Calendar: June 6-12, 2021
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: June 6-12, 2021

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: Janet Woodcock, M.D., Acting Commissioner

Event Date: 06/08/2021
Location: Virtual
Subject: FDA Closer to Zero Action Plan Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Scott Faber (Environmental Working Group); Eve Gartner (Earthjustice); Laura MacLeery (Center for Science in the Public Interest); Mike Belliveau (Defend Our Health); Charlotte Brody (Healthy Babies Bright Futures); Tom Neltner (Environmental Defense Fund); Brian Ronholm (Consumer Reports);

Event Date: 06/09/2021
Location: Virtual
Subject: Trial Updates and Protocols
FDA Participant/Group: PETER STEIN;
Non FDA Participant/Group: Parties involved in Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)

Event Date: 06/11/2021
Location: Virtual
Subject: COVID-19 Dialogues
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members of PhRMA and staff

Official Name: Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs

Event Date: 06/09/2021
Location: Virtual
Subject: Biosimilars User Fee Act (BsUFA) Negotiations Mid-Cycle Review
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives from industry and congressional staff

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

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

Event Date: 06/08/2021
Location: Virtual
Subject: Hyperledger Global Forum 2021; Speaker: New Era of Smarter Food Safety Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry leaders in finance, banking, supply chains, manufacturing, and technology

Event Date: 06/08/2021
Location: Virtual
Subject: FY 2022 Food Safety Budget Initiatives and Priorities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Senate Appropriations Agriculture Sub-Committee staff

Event Date: 06/09/2021
Location: Virtual
Subject: Food Safety Summit South Africa 2021; Speaker: Future of Food Safety
FDA Participant/Group: N/A
Non FDA Participant/Group: Food safety and quality managers from South Africa and other countries

Event Date: 06/09/2021
Location: Virtual
Subject: Highfield's Virtual Food Safety Conference; Speaker: New Era of Smarter Food Safety Update
FDA Participant/Group: N/A
Non FDA Participant/Group: International food safety experts and organizations

Event Date: 06/10/2021
Location: Virtual
Subject: Safe Food Coalition Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several executives from across the consumer associations, and scientific and technical staff from industry

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

Event Date: 06/07/2021
Location: Virtual
Subject: Private-Public Partnership in Food Safety Arena
FDA Participant/Group: N/A
Non FDA Participant/Group: University of Maryland Joint Institute for Food Safety and Applied Nutrition

Event Date: 06/11/2021
Location: Virtual
Subject: Potential Addition of Veterinary Medicine Facilities to the Scope of the Mutual Recognition Agreement (MRA)
FDA Participant/Group: JOSEPH RIERAS; KRISTAN CALLAHAN; MICHAEL OEHLSEN; THERESA MULLIN; STEVEN SOLOMON; MATTHEW SCHERER; SUSAN LASKA;
Non FDA Participant/Group: Representatives from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Erica Jefferson, Associate Commissioner for External Affairs

No Significant Event

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

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

Event Date: 06/11/2021
Location: Virtual
Subject: COVID Engagement
FDA Participant/Group: MELISSA SAFFORD; ELENI ANAGNOSTIADIS; PETER MARKS; DAYLE CRISTINZIO; JULIA TIERNEY; BETH FRITSCH;
Non FDA Participant/Group: Alexander Hardy, Levi Garraway (Genentech); Rick Moscicki (PhRma); Bill Mezzanotte (Behring); Dave Reese (Amgen);

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

Event Date: 06/08/2021
Location: Virtual
Subject: Food and Drug Law Intitute's 2021 Regenerative Medicine Conference; Regenerative Medicine: Regulatory, Legal, and Compliance Challenges for Cell and Gene Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the FDLI 2021 Regenerative Medicine Conference

Event Date: 06/09/2021
Location: Virtual
Subject: Public Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Public Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments

Event Date: 06/09/2021
Location: Virtual
Subject: New York City Bronx Community Board 8 Meeting - Health, Hospitals & Social Services Committee; State of COVID-19 Vaccinations
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of NYC Bornx Community Board 8 Meeting - Health, Hospitals & Social Services Committee

Event Date: 06/11/2021
Location: Virtual
Subject: International Food Information Council Assembly 2021 Mid-Year Meeting; The COVID-19 Vaccines: Where We Are and What to Expect Next
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the IFIC Assembly 2021 Mid-Year Meeting

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

Event Date: 06/10/2021
Location: Virtual
Subject: SAFE Health Technology
FDA Participant/Group: SARA BRENNER;
Non FDA Participant/Group: Ken Mayer (SAFE Health); John (Jack) Lewin (Lewin and Associates LLC);

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

Event Date: 06/07/2021
Location: Virtual
Subject: Center for the Assessment of Tobacco Regulations (CAsToR) Symposium; Keynote Speaker: The Role of Simulation Modeling in Tobacco Research and Regulation: Yesterday, Today and Tomorrow
FDA Participant/Group: MITCHELL ZELLER;
Non FDA Participant/Group: Industry, academia, and other stakeholders

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

Event Date: 06/07/2021
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: ANTONIA MONIQUE SENNETT; PATRICK MCDERMOTT; CINDY BURNSTEEL; ERROL STRAIN; CLAUDINE KABERA; ASHLEY STEEL; CHARLI LONG; ANNE NORRIS; JEFFREY GILBERT; AMBER MCCOIG; JOHN MUSSMAN; WILLIAM FLYNN; LESLIE KENNA; TIMOTHY SCHELL; NEAL BATALLER; REGINA TAN; SIOBHAN DELANCEY; JULI ANN PUTNAM; NADINE STEINBERG; MATTHEW LUCIA; RON MILLER; JOSHUA HAYES;
Non FDA Participant/Group: Representatives from Keep Antibiotics Working (KAW)

Event Date: 06/08/2021
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: WILLIAM FLYNN; TIMOTHY SCHELL; CHARLOTTE CONWAY; SIOBHAN DELANCEY; MARLA KELLER; AMBER MCCOIG; TRACEY FORFA; ANNE NORRIS; JENNIFER ERICKSON; DAVID EDWARDS; ANTONIA MONIQUE SENNETT; JEANETTE MURPHY;
Non FDA Participant/Group: Representatives from American Feed Industry Association (AFIA)

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

No Significant Event

Official Name: Mark Raza, J.D., Acting Chief Counsel

No Significant Event

 

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