80 FR 30686 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 103 (May 29, 2015)

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. Name of Committees: Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. General Function of the Committees: To provide advice and recommendations to the Agency on FDA's regulatory issues.

[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Page 30686]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13004]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.
    Name of Committees: Drug Safety and Risk Management Advisory 
Committee and the Anesthetic and Analgesic Drug Products Advisory 
Committee.
    General Function of the Committees: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.

DATES: Date and Time: The meeting will be held on July 7, 2015, from 8 
a.m. to 5 p.m. and July 8, 2015, from 8 a.m. to 4:30 p.m.

ADDRESSES: 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 to a disability, 
visitor parking, and transportation may be accessed at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: 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 protected], 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: The committees will discuss the results of post-marketing 
studies evaluating the misuse and/or abuse of reformulated OXYCONTIN 
(oxycodone hydrochloride) extended-release tablets, supplemental new 
drug application (sNDA) 022272, manufactured by Purdue Pharma L.P. The 
committees will discuss whether these studies have demonstrated that 
the reformulated OXYCONTIN product has had a meaningful impact on abuse 
of OXYCONTIN.
    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 committee. 
Written submissions may be made to the contact person on or before June 
22, 2015. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 10:30 a.m. on July 8, 2015. 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 June 
12, 2015. 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 June 15, 2015.
    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 
physical disabilities or special needs. If you require special 
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: May 26, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-13004 Filed 5-28-15; 8:45 am]
BILLING CODE 4164-01-P