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Agenda

The committees will be asked to discuss new drug application (NDA) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss whether this product should be approved.

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 web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s web site after the meeting. Background material is available at: 2018 Meeting Materials, Anesthetic and Analgesic Drug Products Advisory Committee.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2018–N–0875. The docket will close on May 21, 2018. Submit either electronic or written comments on this public meeting by May 21, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 21, 2018. 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 May 8, 2018 will be provided to the committees. Comments received after that date but by May 21, 2018 will be taken into consideration by FDA. 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:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA–2018–N–0875 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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 Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 April 30, 2018.

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 May 1, 2018.

Webcast Information

CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center. Therefore, CDER will not be providing a webcast of the May 22, 2018 joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

Contact Information

• Moon Hee V. Choi, PharmD
  Center for Drug Evaluation and Research
  Food and Drug Administration
  10903 New Hampshire Avenue
  WO31-2417
  Silver Spring, MD 20993-0002
  
  Phone: 301-796-9001
  Fax: 301-847-8533
  Email: [email protected]

• 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.

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 web site and call the FDA Advisory Committee Information Line 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.

For press inquiries, please contact the Office of Media Affairs at [email protected] 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 Moon Hee V. Choi at (301) 796-9001 at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

Information about the College Park Marriott Hotel and Conference Center can be accessed at: https://www.marriott.com/hotels/travel/wasum-college-park-marriott-hotel-andconference-center/.

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).

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