View EO 12866 Meeting 0910-AI85

Title: Medical Devices; Laboratory Developed Tests

Agency/Subagency: 0910-HHS/FDA

Stage of Rulemaking: Proposed Rule Stage

Meeting Date/Time: 08/16/2023 12:30 PM

Requestor: Friends of Cancer Research Requestor's Name: Jeff Allen

Documents:

List of Documents
OMB Meeting Material - Friends of Cancer Research 8.16.23
Friends of Cancer Research Phase I TMB Harmonization Project JITC March 2020
Friends of Cancer Research Phase II TMB Harmonization Project Annals of Oncology Oct 2021

Attendees:

List of Attendees		Participation
•	Julie Wise - OMB	Teleconference
•	Elizabeth Ashley - OMB	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Ariel Seeley - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Sheri Walker - FDA	Teleconference
•	Cristina McLaughlin - FDA	Teleconference
•	Danielle Carnival - OSTP	Teleconference
•	Siyeon Lee - FDA	Teleconference
•	Dr. Hillary Stires - Friends of Cancer Research	Teleconference
•	Dr. Jeff Allen - Friends of Cancer Research	Teleconference
•	Dr. Mark Stewart - Friends of Cancer Research	Teleconference
•	Dr. Brittany McKelvey - Friends of Cancer Research	Teleconference