Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting, 3045-3046 [05-957]

Download as PDF Federal Register / Vol. 70, No. 12 / Wednesday, January 19, 2005 / Notices 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: Arthritis 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 February 16, 2005, from 8 a.m. to 6 p.m., and on February 17 and 18, 2005, from 8 a.m. to 5 p.m. Addresses: Electronic comments should be submitted to https:// www.fda.gov/dockets/ecomments. Select ‘‘2004N–0559—Overall Benefit to Risk Considerations for COX-2 Selective Nonsteroidal Anti-inflammatory Drugs and Related Agents’’ 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. Comments received by February 4, 2005, will be provided to the committee before the meeting. Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Kimberly Littleton Topper or Dornette Spell-LeSane, 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– 827–6801, e-mail: topperk@cder.fda.gov or spelllesaned@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), codes 3014512532 or 3014512535. Please call the Information Line for up-to-date information on this meeting. Agenda: The committees will discuss the overall benefit to risk considerations (including cardiovascular and gastrointestinal safety concerns) for COX-2 selective nonsteroidal antiinflammatory drugs and related agents. 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 ‘‘Arthritis Advisory Committee’’ or ‘‘Drug Safety and Risk Management Advisory Committee’’ (click on the year 2005 and scroll down to the above named committee meetings). VerDate jul<14>2003 15:11 Jan 18, 2005 Jkt 205001 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 Division of Dockets Management (see Addresses). Oral presentations from the public will be scheduled between approximately 1 p.m. and 3 p.m. on February 17, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 4, 2005, 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 Tony Slater at 301–827–7001, 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 11, 2005. William K. Hubbard, Associate Commissioner for Policy and Planning. [FR Doc. 05–958 Filed 1–18–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Transmissible Spongiform Encephalopathies 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: Transmissible Spongiform Encephalopathies Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 3045 Date and Time: The meeting will be held on February 8, 2005, from 8 a.m. to 5:30 p.m. Location: Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD. Contact Person: William Freas or Sheila D. Langford, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 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 3014512392. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss the following: (1) Risk assessments for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in plasma products, (2) possible vCJD risk from investigational coagulation Factor XI manufactured in the 1990s from plasma of donors residing in the United Kingdom, and (3) potential deferral of blood and plasma donors for history of transfusion in France and other European countries. 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 1, 2005. Oral presentations from the public will be scheduled between approximately 11:50 a.m. and 12:30 p.m., 3:15 p.m. and 3:30 p.m., and 4:15 p.m. and 4:35 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 3, 2005, 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 William Freas or Sheila D. Langford 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). E:\FR\FM\19JAN1.SGM 19JAN1 3046 Federal Register / Vol. 70, No. 12 / Wednesday, January 19, 2005 / Notices Dated: January 11, 2005. William K. Hubbard, Associate Commissioner for Policy and Planning. [FR Doc. 05–957 Filed 1–18–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Veterinary Medicine 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: Veterinary Medicine 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 January 31, 2005, from 8 a.m. to 5:30 p.m. Location: DoubleTree Hotel, Plaza II and III, 1750 Rockville Pike, Rockville MD. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV–3), Food and Drug Administration, 7519 Standish Pl., Rockville MD 20855, 301–827–4515, or e-mail: asindela@cvm.fda.gov. Please call the FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512548, for up-to-date information on this meeting. Agenda: The committee will discuss and make recommendations regarding the voluntary recall of the drug product, PROHEART 6 (NADA 141–189), manufactured by Fort Dodge Animal Health. The committee will also discuss the Center for Veterinary Medicine’s risk management strategy. The background material for this meeting will be posted on the Internet when available and no later than 1 business day before the meeting at https:// www.fda.gov/ohrms/dockets/ac/ 04acdocs.htm (Scroll down to the appropriate committee link). 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 January 21, 2005. Oral presentations from the public will be scheduled between approximately 1 VerDate jul<14>2003 15:11 Jan 18, 2005 Jkt 205001 p.m. and 2 p.m. on January 31, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by January 21, 2005, 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 Aleta Sindelar 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 11, 2005. William K. Hubbard, Associate Commissioner for Policy and Planning. [FR Doc. 05–956 Filed 1–18–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES • The Indian Health Professions Preparatory Scholarships authorized by section 103(b)(1) of the Indian Health Care Improvement Act (IHCIA), Public Law 94–437, as amended by Public Law 100–713, Public Law 102–573, and Public Law 104–313, CFDA #93.123. • The Indian Health Professions Pregraduate Scholarships section 103(b)(2) of the Indian Health Care Improvement Act (IHCIA), Public Law 94–437, as amended by Public Law 100– 713, Public Law 102–573, and Public Law 104–313, CFDA #93.971. • The Indian Health Professions Scholarship section 104 of the IHCIA, Public Law 94–437, as amended by Public Law 100–713, by Public Law 102–573, and by Public Law 104–313, CFDA #93.972. Full-time and part-time scholarships will be funded for each of the three scholarship programs. The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS-led activity for setting priority areas. This program announcement is related to the priority area of Education and CommunityBased Programs. Potential applicants may obtain a copy of Healthy People 2010, (Full Report; Stock No. 017–001– 00474–0) or Healthy People 2010 (Summary Report; Stock No. 017–001– 00473–1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402–9325 (Telephone (202) 783–3238). Indian Health Service II. Award Information [Funding Opportunity Number HHS–2005– IHS–SP–0001; CFDA Numbers: 93.123, 93.971, and 93.972] Awards under this initiative will be administered using the institutional grant mechanism of the IHS. Estimated Funds Available: An estimated $7.8 million will be available for FY 2005 awards. Anticipated Number of Awards: Approximately 200 awards will be made under the Health Professions Preparatory and Pregraduate Scholarship Programs for Indians. The awards are for 10 months in duration and the average award to a full-time student is approximately $23,000. An estimated 340 awards will be made under the Indian Health Scholarship (Professions) Program. The awards are for 12 months in duration and the average award to a full-time student is for approximately $25,000. In FY 2005, an estimated $3,410,000 is available for continuation awards, and an estimated $4,485,000 is available for new awards. Project Period—The project period will vary based on the type of scholarship for which the grantee applies. Health Professions Preparatory, Health Professions Pregraduate and Indian Health Professions Scholarship Programs; Announcement Type: Initial Key Dates: Application Deadline: March 28, 2005. Application Review: April 11–April 15, 2005. Application Notification: Third week of July 2005. Anticipated Award Start Date: August 31, 2005. I. Funding Opportunity Description The Indian Health Service (IHS) is committed to encouraging American Indians and Alaska Natives to enter the health professions and to assuring the availability of Indian health professionals to serve Indians. The IHS is committed to the recruitment of students for the following programs: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 70, Number 12 (Wednesday, January 19, 2005)]
[Notices]
[Pages 3045-3046]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Transmissible Spongiform Encephalopathies 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: Transmissible Spongiform Encephalopathies 
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 February 8, 2005, from 8 
a.m. to 5:30 p.m.
    Location: Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD.
    Contact Person: William Freas or Sheila D. Langford, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 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 3014512392. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss the following: (1) Risk 
assessments for potential exposure to the variant Creutzfeldt-Jakob 
disease (vCJD) agent in plasma products, (2) possible vCJD risk from 
investigational coagulation Factor XI manufactured in the 1990s from 
plasma of donors residing in the United Kingdom, and (3) potential 
deferral of blood and plasma donors for history of transfusion in 
France and other European countries.
    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 1, 
2005. Oral presentations from the public will be scheduled between 
approximately 11:50 a.m. and 12:30 p.m., 3:15 p.m. and 3:30 p.m., and 
4:15 p.m. and 4:35 p.m. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before February 3, 2005, 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 William Freas or 
Sheila D. Langford 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).


[[Page 3046]]


    Dated: January 11, 2005.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-957 Filed 1-18-05; 8:45 am]
BILLING CODE 4160-01-S

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