Notices. Notice of availability
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/register/2024/06/14/2024-13228·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4154-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2024-N-2422] Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability on its website of 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.” DATES: Submit electronic comments on the administrative order by July 29, 2024. ADDRESSES: Instructions for submitting comments are contained in the proposed order OTC000035. Comments must be submitted electronically on or before July 29, 2024. Comments submitted after this time will not be considered. FOR FURTHER INFORMATION CONTACT: Helen Lee, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0138. SUPPLEMENTARY INFORMATION: I. Background FDA is issuing the proposed administrative order (proposed order) to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter
(OTC)human use (OTC IAAA drug products), as currently described in Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (OTC Monograph M013), as set forth in the Final Administrative Order OTC000035. FDA is issuing the proposed order pursuant to section 505G(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h(b)(1)). OTC Monograph M013 describes the conditions under which over-the-counter
(OTC)internal analgesic, antipyretic, and antirheumatic drug products (OTC IAAA drug products) are generally recognized as safe and effective. OTC Monograph M013 is set forth in Final Administrative Order OTC000035, which was deemed established by sections 505G(b)(8) and 505G(k)(2)(B) of the FD&C Act, and was effective upon enactment of the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136) on March 27, 2020. The conditions described in OTC Monograph M013, as set forth in final order(s), may be amended, revoked, or otherwise modified in accordance with the procedures of section 505G(b) of the FD&C Act. The proposed order, if finalized, will amend Final Administrative Order 000035 (as set forth in the Order), to require addition of a warning to the labeling of OTC IAAA drug products containing acetaminophen. The warning would alert consumers that the use of acetaminophen may cause severe skin reactions. This proposed order also includes minor stylistic and formatting changes to improve the readability and presentation of OTC Monograph M013, including removing references to historical **Federal Register** documents because OTC monographs are no longer modified through notice and comment rulemaking. The proposed order can be accessed on the OTC Monographs@fda portal at *https://dps.fda.gov/omuf.* FDA established this IT system with a web portal that can be accessed through FDA's website. OTC Monographs@FDA provides a resource for the public to view Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs and view OTC Monographs. OTC Monographs@FDA also facilitates the ability for the public to submit, search, and view comments and data for Proposed and Interim Final Administrative Orders, except if otherwise specified. The proposed order contains instructions for commenting on the proposed order. II. Paperwork Reduction Act of 1995 The proposed order is issued under section 505G(b)(1) of the FD&C Act. Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act of 1995 (Chapter 35 of title 44, United States Code) does not apply to collections of information made under section 505G of the FD&C Act. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required for collections of information, if any, in a final order issued under section 505G that results from this proposed order. Dated: June 11, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-13228 Filed 6-13-24; 8:45 am]
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