Document ID: FDA-2016-N-0584-0001
Agency: fda
Document Type: Notice
Title: Anesthetic and Analgesic Drug Products Advisory Committee, the
Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee; Notice of Meeting
Posted Date: 2016-02-19T05:00Z

[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8502-8503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03468]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0584]

Anesthetic and Analgesic Drug Products Advisory Committee, the 
Drug Safety and Risk Management Advisory Committee, and the Pediatric 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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    This notice announces a forthcoming meeting of public advisory 
committees of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Names of Committees: Anesthetic and Analgesic Drug Products 
Advisory Committee, the Drug Safety and Risk Management Advisory 
Committee, and the Pediatric Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 15, 2016, from 
8 a.m. to 5 p.m. and September 16, 2016, from 8 a.m. to 5 p.m.
    Addresses: FDA is opening a docket for public comment on this 
meeting. The docket number is FDA-2016-N-0584. The docket will open for 
public comment on February 19, 2016. The docket will close on September 
30, 2016. Interested persons may submit either electronic or written 
comments regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. All comments received will be posted 
without change, including any personal information provided. It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday. Comments received on 
or before August 31, 2016, will be provided to the committee before the 
meeting.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 
20993-0002. Answers to commonly asked questions including information 
regarding special accommodations due

[[Page 8503]]

to a disability, visitor parking, and transportation may be accessed 
at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Stephanie L. Begansky, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 
301-847-8533, email: AADPAC@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: The purpose of this public advisory committee meeting is to 
discuss the appropriate development plans for establishing the safety 
and efficacy of prescription opioid analgesics for pediatric patients, 
including obtaining pharmacokinetic data and the use of extrapolation.
    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 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 http://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 committees. 
All electronic and written submissions submitted to the docket (see 
ADDRESSES) on or before August 31, 2016, will be provided to the 
committees. Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. and 10:30 a.m. on September 16, 2016. 
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 
August 23, 2016. 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 August 24, 2016.
    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 Stephanie L. Begansky at least 7 days in advance of the 
meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://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. app. 2).

    Dated: February 16, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03468 Filed 2-18-16; 8:45 am]
BILLING CODE 4164-01-P