Notice2024-13228
Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use
Primary source
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Published
June 14, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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."
Full Text
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<title>Federal Register, Volume 89 Issue 116 (Friday, June 14, 2024)</title>
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[Federal Register Volume 89, Number 116 (Friday, June 14, 2024)]
[Notices]
[Pages 50593-50594]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://dps.fda.gov/omuf">https://dps.fda.gov/omuf</a>. 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
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