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U.S. Department of Health and Human Services

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UPDATED TIME, AGENDA AND PUBLIC PARTICIPATION INFORMATION: May 10, 2012: Antiviral Drugs Advisory Committee Meeting Announcement

UPDATED INFORMATION
The end time for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) meeting has been extended to 6:30 p.m. The Agenda portion regarding the new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. should read "new drug application (NDA) 21-752." The Procedure portion is changed to a two hour open public hearing from approximately 1:45 p.m. to 3:45 p.m. The deadline for submitting comments to the docket has been extended such that comments received on or before May 3, 2012, will be provided to the committee before the meeting. There are no other changes.

Time
The time should be updated to read: "8:00 a.m. to 6:30 p.m."

Agenda:
The agenda should be updated to read as follows: "On May 10, 2012, the committee will discuss an efficacy supplement for new drug application (NDA) 21-752, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection."

Public Participation Information:
The sentence "Oral presentations from the public will be scheduled between approximately 2 p.m. to 3 p.m." should be updated to read "Oral presentations from the public will be scheduled between approximately 1:45 p.m. to 3:45 p.m." The sentence “Comments received on or before April 26, 2012, will be provided to the committee before the meeting” should be updated to read “Comments received on or before May 3, 2012, will be provided to the committee before the meeting.

 

ORIGINAL INFORMATION

Center Date Time Location
CDER May 10, 2012
 
8:00 a.m. to 5:30 p.m.
 

FDA White Oak Campus
Building 31

The Great Room (Room 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland

Agenda

On May 10, 2012, the committee will discuss an efficacy supplement for new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

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

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • FDA is opening a docket for public comment on this meeting. The docket number is FDA-2012-N-0218. The docket will open for public comment on March 14, 2012. The docket will close on May 17, 2012. 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. 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 April 26, 2012, will be provided to the committee before the meeting.
  • Oral presentations from the public will be scheduled between approximately 2 p.m. to 3 p.m. on May 10, 2012. 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 April 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 April 19, 2012.

Webcast Information

CDER plans to provide a free of charge, live webcast of the May 10, 2012, meeting of the Antiviral 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, Antiviral 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.

Contact Information

  • Yvette Waples, 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: AVAC@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 Yvette Waples at (301) 796-9001 at least 7 days in advance of the meeting.

Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: Public Meetings at the FDA White Oak Campus

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).