[Federal Register Volume 75, Number 85 (Tuesday, May 4, 2010)]
[Notices]
[Pages 23782-23783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10384]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Drug Safety and Risk Management Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Drug Safety and Risk Management Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 14, 2010, from
8 a.m. to 5 p.m.
Location: The Marriott Inn and Conference Center, University of
Maryland and University College (UMUC), The Ballrooms, 3501 University
Blvd. East, Adelphi, MD. The conference center telephone number is 301-
985-7300.
Contact Person: Elaine Ferguson, e-mail:
[email protected] (contact information through June 8, 2010,
Elaine Ferguson c/o Melanie Whelan, Food and Drug Administration, 10903
New Hampshire Ave., WO51-6100, Silver Spring, MD 20993-0002, telephone:
301-827-7001, FAX: 301-847-8742), (contact information beginning June
9, 2010: Elaine Ferguson c/o Christine Shipe, Food and Drug
Administration, 10903 New Hampshire Ave., WO31-2419, Silver Spring, MD
20993-0002, telephone: 301-0796-9001, FAX: 301-847-8532), or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512535. 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 appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On September 14, 2010, the committee will discuss the abuse
potential of the drug dextromethorphan and the public health benefits
and risks of dextromethorphan use as a cough suppressant in
prescription and nonprescription drug products. The Department of
Health and Human Services received a request from the Drug Enforcement
Administration for a scientific and medical evaluation and scheduling
recommendation for dextromethorphan in response to the increased
incidence of abuse, especially among adolescents.
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 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
August 30, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 2 p.m. Those desiring to make 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 20, 2010. 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
23, 2010.
Persons attending FDA's advisory committee meetings are advised
that the
[[Page 23783]]
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 Elaine Ferguson 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: April 27, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-10384 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S