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U.S. Department of Health and Human Services

Advisory Committees

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November 9, 2012: Nonprescription Drugs Advisory Committee Meeting Announcement

UPDATED LOCATION AND WEBCAST INFORMATION: November 9, 2012: Nonprescription Drugs Advisory Committee Meeting Announcement

Updated Information (as of 10/5/2012):


The location for this meeting has changed from the DoubleTree by Hilton Hotel Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland to FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland. Also, CDER now plans to provide a free of charge, live webcast of the meeting. All other information remains the same.

 

CenterDateTimeLocation
CDERNovember 9, 20128:00 a.m. - 5:00 p.m.

FDA White Oak Campus
Building 31
Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue Silver Spring, Maryland

Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the FDA White Oak Campus.

Webcast Information

CDER plans to provide a free of charge, live webcast of the November 9, 2012, meeting of the Nonprescription Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2012 Meeting Materials, Nonprescription Drugs Advisory Committee

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

UPDATED CONTACT INFORMATION: November 9, 2012: Nonprescription Drugs Advisory Committee Meeting Announcement

Updated Information (as of 9/26/2012):
The contact person for this meeting has changed from Glendolynn S. Johnson to Minh Doan. All other information remains the same.

Contact Information

The contact information should be updated to read as follows:

  • Minh Doan, Pharm.D.
    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
    E-mail: NDAC@fda.hhs.gov
  • 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. 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 Minh Doan at (301) 796-9001 at least 7 days in advance of the meeting.

ORIGINAL INFORMATION

CenterDateTimeLocation
CDERNovember 9, 20128:00 a.m. to 5:00 p.m.

DoubleTree by Hilton Hotel

Washington DC/Silver Spring

The Ballrooms

8727 Colesville Road
Silver Spring, Maryland

Agenda
 
On November 9, 2012, the committee will discuss data submitted by MSD Consumer Care, Inc. to support new drug application (NDA) 202211, for the partial switch from prescription to over-the-counter (OTC) of the oxybutynin transdermal system (proposed trade name OXYTROL FOR WOMEN). The proposed OTC use is "treats overactive bladder in women." The data to be discussed will include a summary of the postmarketing experience with the oxybutynin transdermal system, and the results of consumer studies, including label comprehension studies, self-selection studies, and an actual use study. The committee will be asked to consider whether the data support the appropriate and safe use of oxybutynin transdermal system by OTC consumers.
 
Meeting Materials
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:
2012 Meeting Materials, Nonprescription Drugs Advisory Committee
 
Public Participation Information
 
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 October 26, 2012.
  • Oral presentations from the public will be scheduled between approximately 1 p.m. and 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 October 18, 2012.
 
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 October 19, 2012.
 
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 November 9, 2012, Nonprescription Drugs Advisory Committee meeting.
 
Contact Information
 
Glendolynn S. Johnson, Pharm.D.
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
E-mail: NDAC@fda.hhs.gov
 
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. 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 Glendolynn S. Johnson at (301) 796-9001 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 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).