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FDA Reopens Comment Period for Proposed Order Regarding OTC Monograph Drugs Containing Acetaminophen

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.

[READ THE FEDERAL REGISTER NOTICE]

Starting on August 8, submit any comments regarding the proposed order addressed in this notice to the public docket (Docket No. FDA-2024-N-2422) available at https://www.regulations.gov until September 29, 2024.

Additional information

• Read the proposed administrative order at OTC Monographs@FDA.
• For more information about the proposed order, read FDA’s statement.
• For answers to frequently asked questions about OTC monograph drugs and the administrative order process, visit the OTC Monographs @ FDA
• For more information about acetaminophen, visit FDA’s consumer page and questions and answers page on the topic.

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