Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period

The Food and Drug Administration (FDA, the Agency, or we) is reopening the comment period for the proposed administrative order (proposed order) entitled "Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use", announced in the Federal Register of June 14, 2024. We are taking this action due to technical difficulties with the OTC Monographs@FDA portal. Because comments cannot be submitted to the OTC Monographs@FDA portal at this time, submit comments on proposed order (OTC000035) to the Federal eRulemaking portal (Docket No. FDA- 2024-N-2422).