3041-AD84 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 3041 Consumer Product Safety Commission CPSC 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 will conduct data analysis and technical review in fiscal year 2023.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined Undetermined Not Yet Determined 15 U.S.C. 1472 15 U.S.C. 1474 No 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 09/00/2023 Undetermined Undetermined Undetermined No No Cheryl Scorpio Project Manager, Directorate for Health Sciences 3041 301 987-2572 National Product Testing and Evaluation Center, 5 Research Place, Rockville MD 20850