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CPSC | RIN: 3041-AD84 | Publication ID: Fall 2023 |
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). 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. |
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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 |
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Timetable:
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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 |