E6-12890. Antiviral Drugs 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). 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 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: [phone], e-mail: [e-mail], 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.