October 26-27, 2022: Common and Plastic Surgical procedure Units Panel of the Medical Units Advisory Committee Assembly Announcement – 10/26/2022

September 27, 2022


Date:
October 26 – 27, 2022
Time:
9:00 AM
– 3:00 PM
ET

Middle Date Time Location
CDRH October 26, 2022
October 27, 2022
9:00 a.m. – 6:15 p.m.
9:00 a.m. – 3:00 p.m.
Please word that because of the affect of
this COVID-19 pandemic, all assembly
members might be becoming a member of this advisory
committee assembly by way of an internet
teleconferencing platform held
by way of webcast solely.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Meals and Drug Administration

[Docket No. FDA-2022-N-0589]

Common and Plastic Surgical procedure Units Panel of the Medical Units Advisory Committee; Discover of Assembly; Institution of a Public Docket; Request for Feedback

AGENCY:  Meals and Drug Administration, HHS.

ACTION:  Discover; institution of a public docket; request for feedback.

SUMMARY:  The Meals and Drug Administration (FDA) pronounces a forthcoming public advisory committee assembly of the Common and Plastic Surgical procedure Units Panel of the Medical Units Advisory Committee.  The final operate of the committee is to offer recommendation and proposals to FDA on regulatory points.  The assembly might be open to the general public.  FDA is establishing a docket for public touch upon this doc.

DATES:  The assembly might be held just about on October 26, 2022, from 9 a.m. Jap Time to six:15 p.m. Jap Time and October 27, 2022, from 9 a.m. Jap Time to three p.m. Jap Time.

ADDRESSES:  Please word that because of the affect of the COVID-19 pandemic, all assembly members might be becoming a member of this advisory committee assembly by way of an internet teleconferencing platform.  Solutions to generally requested questions, together with data relating to particular lodging because of a incapacity, could also be accessed at:  https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FDA is establishing a docket for public touch upon this assembly. The docket quantity is FDA-2022-N-0589.  The docket will shut on November 28, 2022.  Both digital or written feedback on this public assembly have to be submitted by November 28, 2022.  Please word that late, premature filed feedback is not going to be thought-about.  The https://www.laws.gov digital submitting system will settle for feedback till 11:59 p.m. Jap Time on the finish of November 28, 2022. Feedback acquired by mail/hand supply/courier (for written/paper submissions) might be thought-about well timed if they’re acquired on or earlier than that date. 

Feedback acquired on or earlier than October 11, 2022, might be offered to the committee. Feedback acquired after that date might be considered by FDA.  Within the occasion that the assembly is cancelled, FDA will proceed to guage any related functions or data, and take into account any feedback submitted to the docket, as applicable. 

Chances are you’ll submit feedback as follows: 

Digital Submissions

Submit digital feedback within the following approach:

  • Federal eRulemaking Portal:  https://www.laws.gov.  Comply with the directions for submitting feedback.  Feedback submitted electronically, together with attachments, to https://www.laws.gov might be posted to the docket unchanged.  As a result of your remark might be made public, you’re solely chargeable for making certain that your remark doesn’t embody any confidential data that you just or a 3rd get together could not want to be posted, equivalent to medical data, your or anybody else’s Social Safety quantity, or confidential enterprise data, equivalent to a producing course of.  Please word that in the event you embody your identify, contact data, or different data that identifies you within the physique of your feedback, that data might be posted on https://www.laws.gov.
  • If you wish to submit a remark with confidential data that you don’t want to be made accessible to the general public, submit the remark as a written/paper submission and within the method detailed (see “Written/Paper Submissions” and “Directions”). 

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand supply/Courier (for written/paper submissions):  Dockets Administration Employees (HFA-305), Meals and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper feedback submitted to the Dockets Administration Employees, FDA will submit your remark, in addition to any attachments, apart from data submitted, marked and recognized, as confidential, if submitted as detailed in “Directions.”

Directions:  All submissions acquired should embody the Docket No. FDA-2022-N-0589 for “Common and Plastic Surgical procedure Units Panel of the Medical Units Advisory Committee; Discover of Assembly; Institution of a Public Docket; Request for Feedback.”  Obtained feedback, these filed in a well timed method (see ADDRESSES), might be positioned within the docket and, apart from these submitted as “Confidential Submissions,” publicly viewable at https://www.laws.gov or on the Dockets Administration Employees between 9 a.m. and 4 p.m., Monday by Friday, 240-402-7500.

  • Confidential Submissions–To submit a remark with confidential data that you don’t want to be made publicly accessible, submit your feedback solely as a written/paper submission.  It is best to submit two copies whole.  One copy will embody the data you declare to be confidential with a heading or cowl word that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.”  FDA will assessment this copy, together with the claimed confidential data, in its consideration of feedback.  The second copy, which can have the claimed confidential data redacted/blacked out, might be accessible for public viewing and posted on https://www.laws.gov.  Submit each copies to the Dockets Administration Employees.  If you don’t want your identify and get in touch with data be made publicly accessible, you may present this data on the duvet sheet and never within the physique of your feedback and you will need to determine the data as “confidential.”  Any data marked as “confidential” is not going to be disclosed besides in accordance with 21 CFR 10.20 and different relevant disclosure regulation.  For extra details about FDA’s posting of feedback to public dockets, see 80 FR 56469, September18, 2015, or entry the data at:  https://www.govinfo.gov/content material/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket:  For entry to the docket to learn background paperwork or the digital and written/paper feedback acquired, go to https://www.laws.gov and insert the docket quantity, present in brackets within the heading of this doc, into the “Search” field and comply with the prompts and/or go to the Dockets Administration Employees, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:  Candace Nalls, Middle for Units and Radiological Well being, Meals and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm 5216, Silver Spring, MD 20993-0002, 301-636-0510, [email protected], or FDA Advisory Committee Data Line, 1-800-741-8138 (301-443-0572 within the Washington, DC space).  A discover within the Federal Register about final minute modifications that affect a beforehand introduced advisory committee assembly can’t all the time be revealed shortly sufficient to offer well timed discover.  Due to this fact, it is best to all the time examine the FDA’s web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll all the way down to the suitable advisory committee assembly hyperlink, or name the advisory committee data line to study attainable modifications earlier than the assembly.

SUPPLEMENTARY INFORMATION:

Agenda:  The assembly displays might be heard, seen, captioned, and recorded by an internet teleconferencing platform.  On day 1, October 26, 2022, within the morning, the committee will focus on and make suggestions on the classification proposal for tissue expanders, that are at present unclassified preamendments units, to be class III (basic controls and premarket approval), and breast implant sizers, that are at present unclassified preamendments units, to be class II (basic and particular controls).  Within the afternoon on the primary day, the committee will focus on and make suggestions on the classification proposals for wound dressings with animal-derived supplies, absorbable artificial wound dressings, and hemostatic wound dressings that both comprise or don’t comprise thrombin, or different organic merchandise, that are all at present unclassified preamendments units, to be class II (basic and particular controls).

On day 2, October 27, 2022, the committee will focus on and make suggestions on the classification proposals for nail protheses, that are at present unclassified preamendments units, to be class I (basic controls); and ultrasonic surgical devices, reprocessed ultrasonic surgical scalpels, and ultrasonic neurosurgical fragmentation and aspiration units, that are all at present unclassified preamendments units, to be class II (basic and particular controls).

FDA intends to make background materials accessible to the general public no later than 2 enterprise days earlier than the assembly.  If FDA is unable to submit the background materials on its web site previous to the assembly, the background materials might be made publicly accessible on FDA’s web site on the time of the advisory committee assembly, and the background materials might be posted on FDA’s web site after the assembly.  Background materials is offered at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.  Scroll all the way down to the advisory committee assembly hyperlink.

Process:   individuals could current information, data, or views, orally or in writing, on points pending earlier than the committee.  All digital and written submissions submitted to the Docket (see ADDRESSES) on or earlier than October 11, 2022, might be offered to the committee.  Oral displays from the general public might be scheduled on October 26, 2022, between roughly 9:30 a.m. and 10 a.m. Jap Time, and a couple of p.m. and a couple of:30 p.m. Jap Time, and on October 27, 2022, between roughly 9:30 a.m. and 10 a.m. Jap Time. These people keen on making formal oral displays ought to notify the contact individual and submit a short assertion of the final nature of the proof or arguments they want to current, the names and addresses of proposed members, and a sign of the approximate time requested to make their presentation on or September 30, 2022.  Time allotted for every presentation could also be restricted.  If the variety of registrants requesting to talk is bigger than might be fairly accommodated through the scheduled open public listening to session, FDA could conduct a lottery to find out the audio system for the scheduled open public listening to session.  The contact individual will notify individuals relating to their request to talk by October 3, 2022.

For press inquiries, please contact the Workplace of Media Affairs at [email protected] or 301-796-4540.

FDA welcomes the attendance of the general public at its advisory committee conferences and can make each effort to accommodate individuals with disabilities.  When you require lodging because of a incapacity, please contact Ann Marie Williams, at [email protected] or 301-796-5966 not less than 7 days prematurely of the assembly.

FDA is dedicated to the orderly conduct of its advisory committee conferences. Please go to our web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct throughout advisory committee conferences.

Discover of this assembly is given underneath the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated:  September 9, 2022.

Lauren Ok. Roth,

Affiliate Commissioner for Coverage.
 


A discover within the Federal Register about final minute modifications that affect a beforehand introduced advisory committee assembly can’t all the time be revealed shortly sufficient to offer well timed discover. Due to this fact, it is best to all the time examine the company’s web site or name the committee’s Designated Federal Officer (see Contact Data) to study attainable modifications earlier than coming to the assembly.

Individuals attending FDA’s advisory committee conferences are suggested that the company isn’t chargeable for offering entry to electrical retailers. FDA welcomes the attendance of the general public at its advisory committee conferences and can make each effort to accommodate individuals with disabilities. When you require lodging because of a incapacity, please contact the committee’s Designated Federal Officer (see Contact Data) not less than 7 days prematurely of the assembly.

Solutions to generally requested questions together with data relating to particular lodging because of a incapacity could also be accessed at: Widespread Questions and Solutions about FDA Advisory Committee Conferences.

FDA is dedicated to the orderly conduct of its advisory committee conferences. Please go to our Website online at Public Conduct Throughout FDA Advisory Committee Conferences for procedures on public conduct throughout advisory committee conferences.

Discover of this assembly is given underneath the Federal Advisory Committee Act (5 U.S.C. app.2).

See also  Zozo Championship 2022 picks, predictions, greatest bets, odds: PGA insider says again Collin Morikawa