Anti-Infective Drugs Advisory Committee; Notice of Meeting, 42096-42097 [E6-11772]

Download as PDF 42096 Federal Register / Vol. 71, No. 142 / Tuesday, July 25, 2006 / Notices provide the broadest range of flexibility and choices to Federal agencies and end users. C. Purpose The General Services Administration (GSA) is responsible for assisting Federal agencies with the implementation and use of digital signature technologies to enhance electronic access to government information and services by all eligible persons. In order to ensure that the ACES program certificates are issued to the proper individuals, GSA will continue to collect identity information from persons who elect to participate in ACES. D. Annual Reporting Burden Respondents: 1,000,000. Responses Per Respondent: 1. Hours Per Response: .25. Total Burden Hours: 250,000. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (VIR), 1800 F Street, NW., Room 4035, Washington, DC 20405, telephone (202) 501–4755. Please cite OMB Control No. 3090–0270, Access Certificates for Electronic Services (ACES), in all correspondence. Dated: July 18, 2006 Michael W. Carleton, Chief Information Officer. [FR Doc. E6–11760 Filed 7–24–06; 8:45 am] BILLING CODE 6820–DH–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0038] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Irradiation in the Production, Processing, and Handling of Food AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Irradiation in the Production, Processing, and Handling of Food’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug VerDate Aug<31>2005 19:44 Jul 24, 2006 Jkt 208001 Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. SUPPLEMENTARY INFORMATION: In the Federal Register of May 11, 2006 (71 FR 27503), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0186. The approval expires on June 30, 2009. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Dated: July 17, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–11776 Filed 7–24–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anti-Infective 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). The meeting will be open to the public. Name of Committee: Anti-Infective 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 September 11 and 12, 2006, from 8 a.m. to 5 p.m. Location: Hilton-Gaithersburg, Salons A, B, and C, 620 Perry Pkwy, Gaithersburg, MD. Contact Person: Sohail Mosaddegh, 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: sohail.mosaddegh@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington DC area), code 3014512530. Please call the Information Line for upto-date information on this meeting. The PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 background material will become available no later than the day before the meeting and will be posted on FDA’s Web site at https://www.fda.gov/ ohrms/dockets/ac/acmenu.htm under the heading ‘‘Anti-Infective Drugs Advisory Committee (AIDAC).’’ (Click on the year 2006 and scroll down to AIDAC meetings.) Agenda: On September 11, 2006, the committee will discuss new drug applications (NDAs) 21–931, garenoxacin mesylate tablets, 400 milligrams (mg) and 600 mg, and NDA 21–932, intravenous garenoxacin mesylate, 400 mg (200 milliliters (mL) of 2 mg/mL) and 600 mg (300 mL of 2 mg/ mL), proposed trade name GENINAX, submitted by Schering Corp., for the proposed treatment indications of acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections. On September 12, 2006, the committee will discuss supplemental new drug application (sNDA) 21–158/S–006, Factive (gemifloxacin mesylate) Tablets, submitted by Oscient Pharmaceuticals Corp., for the proposed treatment of acute bacterial sinusitis. 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 August 25, 2006. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2 p.m. on September 11, 2006, and between approximately 1 p.m. and 1:30 p.m. on September 12, 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 addresses of proposed participants and an indication of the approximate time requested to make their presentation on or before August 25, 2006. 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 Sohail Mosaddegh (see Contact Person) at least 7 days in advance of the meeting. E:\FR\FM\25JYN1.SGM 25JYN1 Federal Register / Vol. 71, No. 142 / Tuesday, July 25, 2006 / Notices Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 17, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–11772 Filed 7–24–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice. 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 the Committee: Obstetrics and Gynecology Devices Panel of the Medical Devices 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 August 29, 2006, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Montgomery Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact: Michael Bailey, Center for Devices and Radiological Health (HFZ– 470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–1180 or FDA Advisory Committee Information Hotline, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512524. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss, make recommendations, and vote on a premarket approval application for a non-invasive device for use as a complement to clinical breast examination in asymptomatic women between the ages of 30 to 39. Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at https://www.fda.gov/cdrh/ panel (click on ‘‘Upcoming CDRH Advisory Panel/Committee Meetings’’). Procedure: Interested persons may present data, information, or views, VerDate Aug<31>2005 18:02 Jul 24, 2006 Jkt 208001 orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 22, 2006. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 8:45 a.m., and between approximately 3:30 p.m. and 4 p.m. 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 addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 22, 2006. 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 AnnMarie Williams at least 7 days in advance of the meeting at 301–827–7291. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 17, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–11773 Filed 7–24–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical Devices 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: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 42097 Date and Time: The meeting will be held on August 24, 2006, from 8 a.m. to 5 p.m., and on August 25, 2006, from 9 a.m. to 5 p.m. Location: Holiday Inn, Walker/ Whetstone Rooms, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: David Krause, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–3090, ext. 141, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512519. Please call the Information Line for up-to-date information on this meeting. Agenda: On August 24, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients and a second PMA for the same device intended for use as a filler material to restore soft tissue facial contours such as nasolabial folds. On August 25, 2006, the committee will discuss and make recommendations on the reclassification, to Class II, of a Class III medical device: Cyanoacrylate tissue adhesive. Background information for this meeting, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at https://www.fda.gov/cdrh/panel (click on ‘‘Upcoming CDRH Advisory Panel/ Committee Meetings’’). Material for the August 24 and 25 sessions will be posted on August 23, 2006. Procedure: On August 24, 2006, from 8 a.m. to 5 p.m., and on August 25, 2006, from 9:30 a.m. to 5 p.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 August 10, 2006. On August 24, 2006, oral presentations from the public will be scheduled between approximately 8:30 a.m. and 9 a.m., approximately 11:45 a.m. and 12:15 p.m., approximately 1:45 p.m. and 2:15 p.m., and approximately 3:45 p.m. and 4:15 p.m. On August 25, 2006, oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. 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 E:\FR\FM\25JYN1.SGM 25JYN1

Agencies

[Federal Register Volume 71, Number 142 (Tuesday, July 25, 2006)]
[Notices]
[Pages 42096-42097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11772]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Anti-Infective 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). The meeting will 
be open to the public.
    Name of Committee: Anti-Infective 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 September 11 and 12, 
2006, from 8 a.m. to 5 p.m.
    Location: Hilton-Gaithersburg, Salons A, B, and C, 620 Perry Pkwy, 
Gaithersburg, MD.
    Contact Person: Sohail Mosaddegh, 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: sohail.mosaddegh@fda.hhs.gov, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington DC area), code 3014512530. Please call the 
Information Line for up-to-date information on this meeting. The 
background material will become available no later than the day before 
the meeting and will be posted on FDA's Web site at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm under the heading ``Anti-Infective Drugs 
Advisory Committee (AIDAC).'' (Click on the year 2006 and scroll down 
to AIDAC meetings.)
    Agenda: On September 11, 2006, the committee will discuss new drug 
applications (NDAs) 21-931, garenoxacin mesylate tablets, 400 
milligrams (mg) and 600 mg, and NDA 21-932, intravenous garenoxacin 
mesylate, 400 mg (200 milliliters (mL) of 2 mg/mL) and 600 mg (300 mL 
of 2 mg/mL), proposed trade name GENINAX, submitted by Schering Corp., 
for the proposed treatment indications of acute bacterial exacerbation 
of chronic bronchitis, acute bacterial sinusitis, community-acquired 
pneumonia, complicated and uncomplicated skin and skin structure 
infections, and complicated intra-abdominal infections. On September 
12, 2006, the committee will discuss supplemental new drug application 
(sNDA) 21-158/S-006, Factive (gemifloxacin mesylate) Tablets, submitted 
by Oscient Pharmaceuticals Corp., for the proposed treatment of acute 
bacterial sinusitis.
    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 
August 25, 2006. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2 p.m. on September 11, 2006, and 
between approximately 1 p.m. and 1:30 p.m. on September 12, 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 addresses of proposed participants and 
an indication of the approximate time requested to make their 
presentation on or before August 25, 2006.
    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 Sohail Mosaddegh 
(see Contact Person) at least 7 days in advance of the meeting.

[[Page 42097]]

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 17, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11772 Filed 7-24-06; 8:45 am]
BILLING CODE 4160-01-S

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