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CPSC RIN: 3041-AD84 Publication ID: Fall 2023 
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).  The petition was docketed, and staff sent a briefing package to the Commission on September 1, 2021, recommending that the Commission grant the petition and issue a notice of proposed rulemaking (NPRM). On September 8, 2021, the Commission voted to grant the petition and publish an NPRM. On September 16, 2021, the NPRM was published and invited interested parties to submit written comments on the NPRM. The comment period closed on November 30, 2021. Staff is conducting data analysis and technical review in fiscal year 2024.

Agency: Consumer Product Safety Commission(CPSC)  Priority: Substantive, Nonsignificant 
RIN Status: Previously 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   
End of NPRM Comment Period  11/30/2021 
Staff Conducts Data Analysis and Technical Review  09/00/2024 
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