90 FR 75 pg. 16692 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Amendment of Notice—Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement
Type: NOTICEVolume: 90Number: 75Page: 16692
Page: 16692Docket number: [Docket No. FDA-2024-N-5331]
FR document: [FR Doc. 2025-06787 Filed 4-18-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5331]
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Amendment of Notice-Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing an amendment to the notice of joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This meeting was announced in the Federal Register of December 9, 2024. The amendment is being made to reflect changes in the DATES , ADDRESSES , and Procedure portions of the document. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Jessica Seo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-7699, email: DSaRM@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION:
In the Federal Register of December 9, 2024 (89 FR 97625), FDA announced that a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee would be held on February 5, 2025. The following changes are being made:
On page 97625, in the third column, the DATES portion of the document is changed to read as follows:
DATES:
The meeting will be held on May 5, 2025, from 8 a.m. to 5 p.m. Eastern Time.
On page 97626, in the first column, the second paragraph in the ADDRESSES portion of the document is changed to read as follows:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2024-N-5331. The docket will close on May 4, 2025. 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 May 4, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
On page 97626, in the first column, the third paragraph, the first sentence is changed to read as follows:
Comments received on or before April 21, 2025, will be provided to the Committees.
On page 97627, in the first column, the Procedure portion of the document is changed to read as follows:
Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committees. All electronic and written submissions to the Docket (see ADDRESSES ) on or before April 21, 2025, will be provided to the Committees.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ) and 21 CFR part 14, relating to the advisory committees.
Dated: April 15, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-06787 Filed 4-18-25; 8:45 am]
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