Notice2024-17645
Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period
Primary source
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Published
August 8, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 153 (Thursday, August 8, 2024)</title>
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[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64929-64930]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://dps.fda.gov/omuf">https://dps.fda.gov/omuf</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
The reopened comment period will close on September 27, 2024.
The proposed order (OTC000035) remains available in the OTC
Monographs@FDA portal at <a href="https://dps.fda.gov/omuf">https://dps.fda.gov/omuf</a>. 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 <a href="https://dps.fda.gov/omuf">https://dps.fda.gov/omuf</a>. 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]
BILLING CODE 4164-01-P
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