Antiviral Drugs Advisory Committee; Notice of Meeting, 56831 [E8-22912]

Download as PDF Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices important tool for receiving information from interested parties and for sharing this information with the public. Similar information about planned guidance development is included in the annual agency-wide notice issued by FDA under its good guidance practices (§ 10.115(f)(5)). The CDRH list, however, will be focused exclusively on devicerelated guidances and will be made available on FDA’s Web site prior to the beginning of each FY from 2008 to 2012. To access the list of the guidance documents CDRH is considering for development in 2009, visit the FDA Web Site at https://www.fda.gov/cdrh/ mdufma/guidance/agenda/fy09.html. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Comments submitted to this docket may include draft guidance documents that stakeholders have prepared for FDA’s consideration. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. Dated: September 24, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–22911 Filed 9–29–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ebenthall on PROD1PC60 with NOTICES [Docket No. FDA–2008–N–0038] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Aug<31>2005 15:35 Sep 29, 2008 Jkt 214001 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 30, 2008, from 9 a.m. to 1 p.m. Location: Hilton Washington DC/ Silver Spring, The Ballrooms, 1750 Rockville Pike, Rockville, MD, 301– 468–1100. Contact Person: Paul Tran, 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, 301–827–6793, FAX: 301– 827–6776, e-mail: paul.tran@fda.hhs.gov, 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. 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 appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The meeting will be open to the public from 8 a.m. to 9 a.m., unless public participation does not last that long, from 9 a.m. to 1 p.m., the meeting will be closed to permit discussion of current and future advances on antiviral drugs which will include the review of trade secret and/or confidential information. 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 https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: On October 30, 2008, from 8 a.m. to 9 a.m., the meeting is open to the public. Interested persons may PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 56831 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 16, 2008. Oral presentations from the public will be scheduled between approximately 8 a.m. and 9 a.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 7, 2008. 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 8, 2008. Closed Committee Deliberations: On October 30, 2008, from 9 a.m. to 1 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)). During this session, the committee will be updated on current and future advances on antiviral drugs. 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 Paul Tran 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 https://www.fda.gov/oc/advisory/ default.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 19, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–22912 Filed 9–29–08; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\30SEN1.SGM 30SEN1

Agencies

[Federal Register Volume 73, Number 190 (Tuesday, September 30, 2008)]
[Notices]
[Page 56831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22912]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


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 30, 2008, from 9 
a.m. to 1 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 1750 
Rockville Pike, Rockville, MD, 301-468-1100.
    Contact Person: Paul Tran, 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-
6793, FAX: 301-827-6776, e-mail: paul.tran@fda.hhs.gov, 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. 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 appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the 
meeting.
    Agenda: The meeting will be open to the public from 8 a.m. to 9 
a.m., unless public participation does not last that long, from 9 a.m. 
to 1 p.m., the meeting will be closed to permit discussion of current 
and future advances on antiviral drugs which will include the review of 
trade secret and/or confidential information.
    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 https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    Procedure: On October 30, 2008, from 8 a.m. to 9 a.m., 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 contact person on 
or before October 16, 2008. Oral presentations from the public will be 
scheduled between approximately 8 a.m. and 9 a.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 7, 2008. 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 8, 2008.
    Closed Committee Deliberations: On October 30, 2008, from 9 a.m. to 
1 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)). 
During this session, the committee will be updated on current and 
future advances on antiviral drugs.
    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 Paul Tran 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 https://www.fda.gov/oc/advisory/
default.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 19, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-22912 Filed 9-29-08; 8:45 am]
BILLING CODE 4160-01-S

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