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CPSC

RIN: 3041-AD84

Publication ID: Fall 2021

Title: ●Xofluza Petition
Abstract: On March 30, 2020, Genentech, Inc. submitted a petition requesting exemption from the special packaging requirements of the Poison Prevention Packaging Act (PPPA) for the prescription drug XOFLUZA™ (Baloxavir marboxil). Staff sent a briefing package to the Commission.
Agency: Consumer Product Safety Commission(CPSC)	Priority: Substantive, Nonsignificant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: Undetermined	Unfunded Mandates: Undetermined
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 15 U.S.C. 1472 15 U.S.C. 1474

Legal Deadline: None

Timetable:

Action	Date	FR Cite
Petition Docketed	10/05/2020
Staff Sent Briefing Package to Commission	09/01/2021
Commission Decision	09/08/2021
NPRM	09/16/2021	86 FR 51640
Staff sends final rule briefing package to Commission	09/00/2022

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: Undetermined
Federalism: Undetermined
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Cheryl Scorpio Project Manager, Directorate for Health Sciences Consumer Product Safety Commission National Product Testing and Evaluation Center, 5 Research Place, Rockville, MD 20850 Phone:301 987-2572