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[Federal Register Volume 89, Number 217 (Friday, November 8, 2024)]
[Notices]
[Page 88787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25910]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4734]

Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, 
Bronchodilator, and Antiasthmatic 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) (OTC000036) entitled ``Amending Over-the-Counter 
Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic 
Drug Products for Over-the-Counter Human Use.'' This proposed order, if 
finalized, will amend Final Administrative Order OTC000026, to remove 
orally administered phenylephrine hydrochloride and phenylephrine 
bitartrate in an effervescent dosage as nasal decongestant active 
ingredients because they are not effective.

DATES: Submit electronic comments on the proposed administrative order 
by May 7, 2025.

ADDRESSES: The https://www.regulations.gov electronic filing system 
will accept comments until 11:59 p.m. Eastern Time at the end of May 7, 
2025. Please note that late, untimely filed comments will not be 
considered. Instructions for submitting comments are contained in the 
proposed order OTC000036, which can be viewed in the OTC Monographs@FDA 
portal at https://dps.fda.gov/omuf. Comments must be submitted 
electronically.

FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation 
and Research (HFD-600), Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0578.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this proposed order OTC000036 to amend the 
requirements for cold, cough, allergy, bronchodilator, and 
antiasthmatic drug products for over-the-counter (OTC) human use, as 
currently described in Over-the-Counter Monograph M012: Cold, Cough, 
Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-
Counter Human Use (OTC Monograph M012), as set forth in the Final 
Administrative Order OTC000026. 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 M012 describes the conditions under which OTC cold, 
cough, allergy, bronchodilator, and antiasthmatic drug products are 
generally recognized as safe and effective. OTC Monograph M012 is set 
forth in Final Administrative Order OTC000026, which was deemed 
established by section 505G(b)(8) 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 M012, 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 the conditions 
described in OTC Monograph M012 as set forth in the Final 
Administrative Order OTC000026 to remove orally administered 
phenylephrine hydrochloride and phenylephrine bitartrate in an 
effervescent dosage from OTC Monograph M012 as nasal decongestant 
active ingredients because they are not effective. This proposed order 
also includes minor stylistic and formatting changes to improve the 
readability and presentation of OTC Monograph M012, 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 viewed in the OTC Monographs@FDA portal 
at https://dps.fda.gov/omuf. The proposed order contains instructions 
for commenting on the proposed order. Comments to the proposed order 
must be submitted electronically to the Federal eRulemaking Portal at 
https://www.regulations.gov.
    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. In the future, OTC 
Monographs@FDA will facilitate the public's ability to submit, search, 
and view comments and data for Proposed and Interim Final Orders.

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 (PRA) (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 PRA is not required for collections of information, if any, in a 
final order issued under section 505G of the FD&C Act that results from 
this proposed order.

    Dated: October 31, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-25910 Filed 11-7-24; 8:45 am]
BILLING CODE 4164-01-P
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