Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 5344 [E6-1224]

Download as PDF 5344 Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices ‘‘Psychopharmacologic Drugs Advisory Committee’’ meeting. Agenda: The committee will discuss new drug application (NDA) 20–717, S– 019, PROVIGIL (100 milligrams (mg), 200 mg, 85 mg, 170 mg, 255 mg, 340 mg, and 425 mg) Tablets, Cephalon, Inc.; the proposed indication is for the treatment of attention deficit hyperactivity disorder (ADHD). 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 by March 15, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 15, 2006, 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. 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: January 24, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–1222 Filed 1–31–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee; Notice of Meeting cchase on PROD1PC60 with NOTICES 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 VerDate Aug<31>2005 17:49 Jan 31, 2006 Jkt 208001 (FDA). The meeting will be open to the public. Name of Committee: Vaccines and Related Biological Products 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 via teleconference on February 17, 2006, from 1 p.m. to 5:30 p.m. Location: National Institutes of Health (NIH) campus, Food and Drug Administration, Bldg. 29B, conference rooms A and B, 8800 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend. A speakerphone will be provided at the specified location for public participation in this meeting. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the internet at https://www.nih.gov/about/visitor/ index.htm. (FDA has verified the Web site addresses, but we are not responsible for subsequent changes to the Web sites after this document publishes in the Federal Register.) Visitors must show two forms of identification such as a Federal employee badge, driver’s license, passport, green card, etc. If you are planning to drive to and park on the NIH campus, you must enter at the South Dr. entrance of the campus which is located on Wisconsin Ave. (the medical center metro entrance), and allow extra time for vehicle inspection. Detailed information about security procedures is located at https:// www.nih.gov/about/visitorsecurity.htm. Due to the limited available parking, visitors are encouraged to use public transportation. Contact Person: Christine Walsh or Denise Royster, Food and Drug Administration, Center for Biologics Evaluation and Research (HFM–71), 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will review and discuss the selection of strains to be included in the influenza virus vaccine for the 2006–2007 season. 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 by February 10, 2006. Oral PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 presentations from the public will be scheduled between approximately 3:30 p.m. and 4:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 10, 2006, 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. 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 Christine Walsh or Denise Royster 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: January 24, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–1224 Filed 1–31–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; The Leukocyte Antibodies Prevalence (LAP) Study SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Leukocyte Antibodies Prevalence (LAP) Study. Type of Information Collection Request: NEW. Need and Use of Information Collection: The two current hypotheses for pathogenesis of transfusion-related acute lung injury (TRALI) include the development of acute pulmonary insufficiency from immune and non-immune causes. The immune mediated mechanism E:\FR\FM\01FEN1.SGM 01FEN1

Agencies

[Federal Register Volume 71, Number 21 (Wednesday, February 1, 2006)]
[Notices]
[Page 5344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1224]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Vaccines and Related Biological Products 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: Vaccines and Related Biological Products 
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 via teleconference on 
February 17, 2006, from 1 p.m. to 5:30 p.m.
    Location: National Institutes of Health (NIH) campus, Food and Drug 
Administration, Bldg. 29B, conference rooms A and B, 8800 Rockville 
Pike, Bethesda, MD. This meeting will be held by teleconference. The 
public is welcome to attend. A speakerphone will be provided at the 
specified location for public participation in this meeting. Important 
information about transportation and directions to the NIH campus, 
parking, and security procedures is available on the internet at http:/
/www.nih.gov/about/visitor/index.htm. (FDA has verified the Web site 
addresses, but we are not responsible for subsequent changes to the Web 
sites after this document publishes in the Federal Register.) Visitors 
must show two forms of identification such as a Federal employee badge, 
driver's license, passport, green card, etc. If you are planning to 
drive to and park on the NIH campus, you must enter at the South Dr. 
entrance of the campus which is located on Wisconsin Ave. (the medical 
center metro entrance), and allow extra time for vehicle inspection. 
Detailed information about security procedures is located at https://
www.nih.gov/about/visitorsecurity.htm. Due to the limited available 
parking, visitors are encouraged to use public transportation.
    Contact Person: Christine Walsh or Denise Royster, Food and Drug 
Administration, Center for Biologics Evaluation and Research (HFM-71), 
1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512391. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will review and discuss the selection of 
strains to be included in the influenza virus vaccine for the 2006-2007 
season.
    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 by February 10, 
2006. Oral presentations from the public will be scheduled between 
approximately 3:30 p.m. and 4:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before February 10, 
2006, 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.
    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 Christine Walsh or 
Denise Royster 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: January 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-1224 Filed 1-31-06; 8:45 am]
BILLING CODE 4160-01-S

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