[Federal Register Volume 90, Number 75 (Monday, April 21, 2025)]
[Notices]
[Page 16692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06787]



[[Page 16692]]

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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.

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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: [email protected], 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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