Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory C – FDA.gov

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Advisory Committee Meeting

Center Date Time Location
CDER February 15, 2022 9:30 a.m. to 5:00 p.m. Eastern Time Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Live Video
Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committees will be asked to discuss new drug application (NDA) 213231, for tramadol hydrochloride injection, submitted by Avenue Therapeutics, Inc., for the management of moderate to moderately severe pain in adults in a medically supervised healthcare setting. The issues for the committees to discuss include the clinical relevance of tramadol hydrochloride injection, an opioid intended for management of acute pain in a medically supervised healthcare setting, when its onset of action is delayed, and its proposed dosing is a fixed-dosing regimen. 
Meeting Materials

FDA intends to make background material available to the public no later than two (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.  Background material and the link to the online teleconference meeting room will be available at 2022 Meeting Materials, Anesthetic and Analgesic Drug Products Advisory Committee Scroll down to the appropriate advisory committee meeting link.  The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
FDA is establishing a docket for public comment on this meeting.  The docket number is FDA-2021-N-1353.  The docket will close on February 14, 2022.  Submit either electronic or written comments on this public meeting by February 14, 2022.  Please note that late, untimely filed comments will not be considered.  Electronic comments must be submitted on or before February 14, 2022.  The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 14, 2022.  Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 
Comments received on or before February 1, 2022 will be provided to the committee(s).  Comments received after that date but by February 14, 2022 will be taken into consideration by FDA.  In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments as follows:  
Electronic Submissions

Submit electronic comments in the following way:
•    Federal eRulemaking Portal:  https://www.regulations.gov.  Follow the instructions for submitting comments.  Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged.  Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process.  Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
•    If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). 
Written/Paper Submissions

Submit written/paper submissions as follows:
Instructions:  All submissions received must include the Docket No. FDA-2021-N-1353 for “Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”  Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500.  
Docket:  For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Oral presentations from the public will be scheduled between approximately 2:00 p.m. to 3:00 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 24, 2022.
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 25, 2022.
Webcast Information
CDER plans to provide a free of charge, live webcast of the February 15, 2022, joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee.  If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible.  Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2022 Meeting Materials, Anesthetic and Analgesic Drug Products Advisory Committee
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
Contact Information
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue 
WO31-2417
Silver Spring, MD  20993-0002
Phone:  301-796-2894
FAX:  301-847-8533
Email:  AADPAC@fda.hhs.gov
 
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.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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 the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings 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. app.2).
02/25/2022
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