[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Notices]
[Pages 45569-45570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12890]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0219]


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). At least one 
portion of the meeting will be closed 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 19, 2006, from 8 
a.m. to 4 p.m. and on October 20, 2006, from 8 a.m. to 4 p.m.
    Addresses: Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Select ``2006N-0219--Clinical Trial 
Design Issues in the Development of Products for Treatment of Chronic 
Hepatitis C'' and follow the prompts to

[[Page 45570]]

submit your statement. Written comments should be submitted to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business 
on October 5, 2006. All comments received will be posted without 
change, including any personal information provided. Comments received 
on or before October 5, 2006, will be provided to the committee before 
the meeting.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
    Contact Person: Cicely Reese, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 
20857, 301-827-7001, FAX: 301-827-6776, e-mail: 
[email protected], or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014512531. Please call the Information Line for up-to-date information 
on this meeting.
    Agenda: On both days, the committee will discuss clinical trial 
design issues in the development of products for treatment of chronic 
hepatitis C infection. This meeting is being convened in response to 
the growing number of products in development for this indication. The 
primary objectives for committee deliberations are to discuss issues 
relating to the identification of appropriate control arms, populations 
for study, endpoints, and long-term followup. On October 20, 2006, the 
meeting will be open to the public from 8 a.m. to 12 noon, unless 
public participation does not last that long; from 1 p.m. to 4 p.m., 
the meeting will be closed to permit discussion and review of trade 
secret and/or confidential information.
    The background material will become available no later than 1 
business day before the meeting and will be posted on FDA's Web site at 
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2006 
and scroll down to the Antiviral Drugs Advisory Committee meeting.)
    Procedure: On 0ctober 19, 2006, from 8 a.m. to 4 p.m. and on 
October 20, 2006, from 8 a.m. to 12 noon, the meeting is open to the 
public. 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 Division of Dockets Management on or 
before October 5, 2006, as previously stated (see Addresses). Oral 
presentations from the public will be scheduled between approximately 1 
p.m. and 2 p.m. on October 19, 2006. Time allotted for each 
presentation may be limited. 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 contact information of proposed participants, 
and an indication of the approximate time requested to make their 
presentation on or before October 5, 2006.
    Closed Presentation of Data: On October 20, 2006, from 1 p.m. to 4 
p.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
    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 Cicely Reese at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12890 Filed 8-8-06; 8:45 am]
BILLING CODE 4160-01-S