[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64929-64930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17645]


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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; Reopening the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening the comment period.

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[[Page 64930]]

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
reopening the comment period for 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'', announced in the Federal Register of June 
14, 2024. We are taking this action due to technical difficulties with 
the OTC Monographs@FDA portal. Because comments cannot be submitted to 
the OTC Monographs@FDA portal at this time, submit comments on proposed 
order (OTC000035) to the Federal eRulemaking portal (Docket No. FDA-
2024-N-2422).

DATES: FDA is reopening the comment period on proposed order 
(OTC000035) announced in the Federal Register of June 14, 2024 (89 FR 
50593). Electronic comments or written comments must be submitted by 
September 27, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 27, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Other than using the Federal eRulemaking Portal to submit comments 
(instead of the OTC Monographs@FDA portal), follow the instructions for 
submitting comments on the proposed order (OTC000035) available in the 
OTCMonographs@FDA portal at https://dps.fda.gov/omuf.

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: In the Federal Register of June 14, 2024 (89 
FR 50593), FDA announced the availability of proposed order (OTC000035) 
entitled ``Amending Over-the-Counter Monograph M013: Internal 
Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-
Counter Human Use.'' The proposed administrative order (proposed 
order), if finalized, will amend the requirements for internal 
analgesic, antipyretic, and antirheumatic drug products for over-the-
counter (OTC) human use, 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).\1\
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    \1\ OTC Monograph M013 is currently set forth in the Final 
Administrative Order OTC000027. We note that at 89 FR 50593 at 
50594, the notice of availability for the proposed order to amend 
OTC Monograph M013 erroneously referred to ``Final Administrative 
Order OTC000027'' as ``Final Administrative Order OTC000035.''
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    Interested persons were originally given until July 29, 2024, to 
comment on the proposed order (OTC000035) via the OTC Monographs@FDA 
portal. However, as of June 14, 2024, technical difficulties prevented 
the electronic submission of comments through the OTC Monographs@FDA 
portal. Therefore, we are reopening the comment period for the proposed 
order (OTC000035) and are instead accepting comments through the 
Federal eRulemaking Portal. Accordingly, submit comments on the 
proposed order (OTC000035) electronically using Docket No. FDA-2024-N-
2422 in the Federal eRulemaking Portal at https://www.regulations.gov. 
The reopened comment period will close on September 27, 2024.
    The proposed order (OTC000035) remains available in the OTC 
Monographs@FDA portal at https://dps.fda.gov/omuf. Other than using the 
Federal eRulemaking Portal to submit comments (instead of the OTC 
Monographs@FDA portal), follow the instructions for submitting comments 
on the proposed order (OTC000035) available in the OTC Monographs@FDA 
portal at https://dps.fda.gov/omuf. The proposed order contains general 
instructions for commenting, which otherwise remain applicable.

    Dated: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17645 Filed 8-7-24; 8:45 am]
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