Psychopharmacologic Drugs Advisory Committee; Notice of Meeting, 66545-66546 [E6-19248]

Download as PDF Federal Register / Vol. 71, No. 220 / Wednesday, November 15, 2006 / Notices The burden is based on the number of applications received in the last 3 years. Dated: November 9, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–19285 Filed 11–14–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. rmajette on PROD1PC67 with NOTICES1 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 Committees: Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on December 14, 2006, from 8 a.m. to 6 p.m. and on December 15, 2006, from 8 a.m. to 5 p.m. Location: Crowne Plaza/Silver Spring, The Ballrooms, 8777 Georgia Ave., Silver Spring, MD. The hotel telephone number is 301–589–0800. 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), codes 3014512530 or 3014512535. Please call the Information Line for up-to-date information on this meeting. Agenda: On both days, the committee will discuss the overall benefit to risk considerations for the approved product KETEK (telithromycin), new drug application (NDA) 21–144, with the current indications of: Acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, and community acquired pneumonia, manufactured by Sanofi-Aventis. VerDate Aug<31>2005 15:00 Nov 14, 2006 Jkt 211001 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 headings Anti-Infective Drugs Advisory Committee or Drug Safety and Risk Management Advisory Committee. (Click on the year 2006 and scroll down to the above named committee meetings.) Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. Written submissions may be made to the contact person on or before November 30, 2006. Oral presentations from the public will be scheduled between approximately 10 a.m. to 11 a.m. on December 15, 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 November 30, 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 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: November 8, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–19249 Filed 11–14–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0414] Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00050 Fmt 4703 Sfmt 4703 66545 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: Psychopharmacologic 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 December 13, 2006, from 8 a.m. to 5 p.m. Addresses: Electronic comments should be submitted tohttps:// www.fda.gov/dockets/ecomments. Select ‘‘2006N–0414 Suicidality data from Adult Antidepressant Trials’’ 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 December 1, 2006. All comments received will be posted without change, including any personal information provided. Comments received on or before December 1, 2006, will be provided to the committee before the meeting. Location: Hilton Washington DC/ Silver Spring, The Maryland Ballroom, 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: Cicely.Reese@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512544. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss the results of the FDA ongoing metaanalysis of suicidality data from adult antidepressant trials. 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 ‘‘Psychopharmacologic Drugs Advisory Committee (PDAC).’’ (Click on year 2006 and scroll down to PDAC meetings). Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written E:\FR\FM\15NON1.SGM 15NON1 66546 Federal Register / Vol. 71, No. 220 / Wednesday, November 15, 2006 / Notices submissions may be made to the contact person on or before November 21, 2006. Oral presentations from the public will be scheduled between approximately 10 a.m. and 12 noon. 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 November 21, 2006. 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 November 27, 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 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). 70 FR 61293–61294, October 21, 2005; and last amended at 71 FR 46237– 46238, August 11, 2006). This notice reflects changes to the organization and functions of the Office of the Administrator (RA), Office of Rural Health Policy (RH) and the Bureau of Primary Health Care (RC). Specifically, it moves the Intergovernmental Affairs function within the Office of Communication (RA6) from the Office of Administrator (OA) to the Office of Rural Health Policy (RH). Additionally, it moves the Black Lung Clinic Program and the Radiation Exposure Screening and Education Program from the Bureau of Primary Health Care (RC) to the Office of Rural Health Policy (RH). Dated: November 1, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–19248 Filed 11–14–06; 8:45 am] Section RA–20, Functions BILLING CODE 4160–01–S Office of Communication (RA6) DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration rmajette on PROD1PC67 with NOTICES1 Statement of Organization, Functions and Delegations of Authority This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (DHHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; amended at 67 FR 46519, July 15, 2002; 68 FR 787–793, January 7, 2003, 68 FR 64357–64358, November 13, 2003; at 69 FR 56433–56434, September 21, 2004; VerDate Aug<31>2005 15:00 Nov 14, 2006 Jkt 211001 Chapter RA—Office of the Administrator Section RA–10, Organization The Offices under the Immediate Office of the Administrator consist of the following components: (1) Immediate Office of the Administrator (RA); (2) Office of Equal Opportunity and Civil Rights (RA2); (3) Office of Planning and Evaluation (RA5); (4) Office of Communications (RA6); (5) Office of Minority Health and Health Disparities (RA9); (6) Office of Legislation (RAE); (7) Office of Information Technology (RAG); and (8) Office of International Health Affairs (RAH). Delete the functional statement for the Office of Communications (RA6) in its entirety and replace it with the following: Provides leadership and general policy and program direction for, and conducts and coordinates communications and public affairs activities of the Agency. Specifically: (1) Serves as focal point for coordination of Agency communications activities with those of other health agencies within the Department of Health and Human Services and with field, State, local, voluntary and professional organizations; (2) develops and implements national communications initiatives to inform and educate the public, health care professionals, policy makers and the media; (3) coordinates, researches, writes and prepares speeches and audiovisual presentations for the HRSA Administrator and staff; (4) provides communication and public PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 affairs expertise and staff advice and support to the Administrator in program and policy formulations and execution consistent with policy direction established by the Assistant Secretary for Public Affairs; (5) develops and implements policies and procedures related to external media relations and internal employee communications including those for the development, review, processing, quality control, and dissemination of Agency communications materials, including exhibits and those disseminated electronically; (6) serves as Communications and Public Affairs Officer for the Agency including establishment and maintenance of productive relationships with the news media; (7) coordinates the implementation of the Freedom of Information Act for the Agency; and (8) manages audio visual and multimedia activities in support of communications efforts through multiple media formats. Chapter RH—Office of Rural Health Policy Section RH–10, Organization The Office of Rural Health Policy is headed by the Associate Administrator who reports directly to the Administrator, HRSA. Specifically, this notice amends the functional statement by adding responsibility for the Black Lung Clinic Program; Radiation Exposure Screening and Education Program, and Intergovernmental Affairs. Section RH –20, Functions Delete the functional statement for the former Rural Health Policy (RH) in its entirety and replace with the following: The Office of Rural Health Policy (RH) serves as a focal point within the Department and as a principal source of advice to the Administrator and Secretary for coordinating efforts to strengthen and improve the delivery of health services to populations in the Nation’s rural areas and border areas, providing leadership and interacting with stakeholders in the delivery of health care to underserved and at risk populations. Specifically, the Office of Rural Health Policy is organized around the following primary issue areas: Delivery of Health Services: (1) Collects and analyzes information regarding the special problems of rural health care providers and populations; (2) works with States, State hospital associations, private associations, foundations, and other organizations to focus attention on, and promote solutions to problems related to the delivery of health services in rural communities; (3) provides staff support E:\FR\FM\15NON1.SGM 15NON1

Agencies

[Federal Register Volume 71, Number 220 (Wednesday, November 15, 2006)]
[Notices]
[Pages 66545-66546]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0414]


Psychopharmacologic 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: Psychopharmacologic 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 December 13, 2006, from 
8 a.m. to 5 p.m.
    Addresses: Electronic comments should be submitted tohttps://
www.fda.gov/dockets/ecomments. Select ``2006N-0414 Suicidality data 
from Adult Antidepressant Trials'' 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 
December 1, 2006. All comments received will be posted without change, 
including any personal information provided. Comments received on or 
before December 1, 2006, will be provided to the committee before the 
meeting.
    Location: Hilton Washington DC/Silver Spring, The Maryland 
Ballroom, 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: Cicely.Reese@fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512544. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss the results of the FDA ongoing 
meta-analysis of suicidality data from adult antidepressant trials. 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 ``Psychopharmacologic 
Drugs Advisory Committee (PDAC).'' (Click on year 2006 and scroll down 
to PDAC meetings).
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written

[[Page 66546]]

submissions may be made to the contact person on or before November 21, 
2006. Oral presentations from the public will be scheduled between 
approximately 10 a.m. and 12 noon. 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 November 21, 2006. 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 November 
27, 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 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: November 1, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-19248 Filed 11-14-06; 8:45 am]
BILLING CODE 4160-01-S

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