View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

CPSC RIN: 3041-AD84 Publication ID: Fall 2021 
Title: ●Xofluza Petition 

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
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