Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period

---
identifier: "/us/fr/2024-17645"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period"
title_number: 0
title_name: "Federal Register"
section_number: "2024-17645"
section_name: "Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period"
positive_law: false
currency: "2024-08-08"
last_updated: "2024-08-08"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2024-17645"
document_type: "notice"
publication_date: "2024-08-08"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "89 FR 64929"
fr_volume: 89
docket_ids:
  - "Docket No. FDA-2024-N-2422"
comments_close_date: "2024-06-14"
fr_action: "Notice of availability; reopening the comment period."
---


#  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.

**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]

[^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.”

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.