[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Page 30686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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