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

https://www.federalregister.gov/documents/2024/08/08/2024-17645/amending-over-the-counter-monograph-m013-internal-analgesic-antipyretic-and-antirheumatic-drug Today, the U.S. Food and Drug Administration issued a Federal Register notice reopening the comment period for its June 14, 2024, Proposed Administrative Order (OTC000035): Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use. FDA is also announcing the use of the Federal eRulemaking portal, commonly known as regulations.gov, for the submission of comments. Initially, FDA was seeking comments from the public through the OTC Monographs@FDA portal. However, technical difficulties prevented the electronic submission of comments through this portal. Therefore, we are reopening the comment period for the proposed order (OTC000035) and are instead accepting comments through the Federal eRulemaking Portal at https://www.regulations.gov.