[Federal Register Volume 89, Number 116 (Friday, June 14, 2024)]
[Notices]
[Pages 50593-50594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13228]


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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.

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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.

[[Page 50594]]


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]
BILLING CODE 4164-01-P