Document ID: FDA-2013-N-0001-0085
Agency: fda
Document Type: Notice
Title: Antiviral Drugs Advisory Committee; Notice of Meeting
Posted Date: 2013-09-16T04:00Z

[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Pages 56900-56901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22427]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Antiviral Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Antiviral Drugs 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 October 25, 2013, 
from 8 a.m. to 5 p.m.
    Location: Sheraton Silver Spring Hotel, Cypress Ballroom, 8777 
Georgia Ave., Silver Spring, MD. The hotel phone number is 301-589-
0800.
    Contact Person: Karen Abraham-Burrell, Food and Drug 
Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 
301-796-9001, FAX: 301-847-8533, email: AVAC@fda.hhs.gov, 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.
    Agenda: The committee will discuss new drug application (NDA) 
204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by 
Gilead Sciences, Inc., with a proposed indication for the treatment 
of chronic hepatitis C infection, in combination with other agents 
in adult patients with genotypes 1 to 6 and/or adult patients 
awaiting liver transplantation.
    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 
October 9, 2013. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. 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 
October 1, 2013. 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

[[Page 56901]]

hearing session. The contact person will notify interested persons 
regarding their request to speak by October 2, 2013.
    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 Karen Abraham-
Burrell 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: September 10, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-22427 Filed 9-13-13; 8:45 am]
BILLING CODE 4160-01-P