Rules and Regulations. Notice; establishment of a public docket; request for comments

Agency: Food and Drug Administration, HHS
Action: Notice; establishment of a public docket; request for comments
Citation: FR Doc. 2024-31260 · Docket No. FDA-2024-N-5720

Summary

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Dates

The meeting will take place virtually on February 20, 2025, from 9 a.m. to 6 p.m. Eastern Time.

Supplementary Information

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. On February 20, 2025, the Committee will discuss and make recommendations regarding the benefits and risks of dermal fillers with new indications for use such as in the decolletage area. The discussion will include the following topics: (1) risks associated with new potential indications for use for dermal filler devices such as (a) the decolletage injection location and the potential impact of filler material on imaging studies ( e.g., breast cancer screening), and (b) anatomic locations that may require larger volume injections, (2) removal of dermal filler implant material, and (3) benefit-risk assessments, the informed decision process, and patient preference. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material and the link to the online teleconference and/or video conferencing meeting will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. All electronic and written submissions to the Docket (see ADDRESSES ) on or before January 30, 2025, will be provided to the Committee. Oral presentations from the public will be scheduled on February 20, 2025, between approximately 11:30 a.m. and 12:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 21, 2025. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 22, 2025. For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Artair Mallett at Artair.Mallett@fda.hh.gov or 301-796-9638, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform. This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. The conditions for issuance of a waiver under 21 CFR 10.19 are met. Dated: December 19, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024-31260 Filed 12-27-24; 8:45 am]