Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 43438-43439 [05-14750]

Download as PDF 43438 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis 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: Arthritis 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 6, 2005, from 8:30 a.m. to 4:30 p.m. Location: Food and Drug Administration, Center for Drug Evaluation and Research Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. Contact Person: Johanna M. Clifford, 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: cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512532. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss biologics license application (BLA) 125118/0, proposed trade name ORENCIA (abatacept), Bristol Myers Squibb, proposed indication for the treatment of moderately to severely active rheumatoid arthritis. When available, background materials for this meeting will be posted 1 business day before the meeting on FDA’s Web site at http://www.fda.gov/ohrms/dockets/ac/ acmenu.htm. (Click on the year 2005 and scroll down to Arthritis Advisory Committee.) 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 August 26, 2005. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m. Time allotted for each presentation may be limited. Those VerDate jul<14>2003 19:40 Jul 26, 2005 Jkt 205001 desiring to make formal oral presentations should notify the contact person before August 26, 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 Johanna Clifford 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: July 20, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–14751 Filed 7–26–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic 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: Endocrinologic and Metabolic 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 8 and 9, 2005, from 8 a.m. to 5 p.m. Location: Holiday Inn Washington Silver Spring, The Ballrooms, 8777 Georgia Ave., Silver Spring, MD. The hotel telephone number is 301–589– 0800. Contact Person: Cathy Groupe, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, e-mail: groupec@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512536. Please call the Information Line for up-to-date information on this meeting. When available, background materials for this meeting will be posted one business day prior to the meeting on FDA’s Web site at http://www.fda.gov/ ohrms/dockets/ac/acmenu.htm. (Click on the year 2005 and scroll down to Endocrinologic and Metabolic Drugs Advisory Committee.) Agenda: On September 8, 2005, the committee will discuss new drug application (NDA) 21–868, proposed trade name EXUBERA (insulin recombinant deoxyribonucleic acid (rDNA) origin powder for oral inhalation), 1 milligram (mg) and 3 mg powder for inhalation, Pfizer, Inc., for the treatment of adult patients with diabetes mellitus. On September 9, 2005, the committee will discuss NDA 21–865, proposed trade name PARAGLUVA (muraglitazar) Tablets, 2.5 mg and 5 mg, Bristol-Myers Squibb, for the treatment of type II diabetes mellitus. 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 August 31, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on both days. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 31, 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 John Lauttman at least 7 days in advance of the meeting at 301–827–7001. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). E:\FR\FM\27JYN1.SGM 27JYN1 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Notices Dated: July 20, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–14750 Filed 7–26–05; 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). The meeting will be open 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. Date and Time: The meeting will be held on August 25 and 26, 2005, from 8 a.m. to 6 p.m on both days. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., 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 25, 2005, the committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. On August 25 and 26, 2005, the committee will discuss and make recommendations on the classification of five preamendments medical devices: Bone wax, medical maggots, medicinal leeches, tissue expander, and wound dressing with a drug. Background information for this meeting, including the agenda and questions for the committee, will be made available at least 1 business day before the meeting VerDate jul<14>2003 19:40 Jul 26, 2005 Jkt 205001 on the Internet at http://www.fda.gov/ cdrh/panelmtg.html. 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 August 11, 2005. On August 25, 2005, oral presentations from the public will be scheduled between approximately 10:15 a.m. and 10:45 a.m., 1:45 p.m. and 2:15 p.m., and 4:30 p.m. and 5 p.m. On August 26, 2005, oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10 a.m., 1 p.m. and 1:30 p.m., and 3:45 p.m. and 4:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before 5 p.m. on August 11, 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 AnnMarie Williams at 240–276–0450, ext. 113, 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: July 20, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–14749 Filed 7–26–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0261] Draft Guidance for Industry on Nucleic Acid Testing for Human Immunodeficiency Virus Type 1 and Hepatitis C Virus: Testing, Product Disposition, and Donor Deferral and Reentry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00050 Fmt 4703 Sfmt 4703 43439 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV– 1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry,’’ dated July 2005. The draft guidance document provides information for blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for NAT on pooled or individual samples of human blood and blood component donations for HIV–1 ribonucleic acid (RNA) and HCV RNA. The draft guidance document is intended to encourage more effective testing of whole blood and blood component samples, and improved product and donor management based on the results of NAT and concurrent serologic testing for markers of HIV and HCV infection on donated whole blood and blood components. DATES: Submit written or electronic comments on the draft guidance by October 25, 2005 to ensure their adequate consideration in preparation of the final guidance. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Notices]
[Pages 43438-43439]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14750]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Endocrinologic and Metabolic 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: Endocrinologic and Metabolic 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 8 and 9, 2005, 
from 8 a.m. to 5 p.m.
    Location: Holiday Inn Washington Silver Spring, The Ballrooms, 8777 
Georgia Ave., Silver Spring, MD. The hotel telephone number is 301-589-
0800.
    Contact Person: Cathy Groupe, 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, e-mail: groupec@cder.fda.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512536. Please call the Information Line for up-to-date 
information on this meeting. When available, background materials for 
this meeting will be posted one business day prior to the meeting on 
FDA's Web site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. 
(Click on the year 2005 and scroll down to Endocrinologic and Metabolic 
Drugs Advisory Committee.)
    Agenda: On September 8, 2005, the committee will discuss new drug 
application (NDA) 21-868, proposed trade name EXUBERA (insulin 
recombinant deoxyribonucleic acid (rDNA) origin powder for oral 
inhalation), 1 milligram (mg) and 3 mg powder for inhalation, Pfizer, 
Inc., for the treatment of adult patients with diabetes mellitus. On 
September 9, 2005, the committee will discuss NDA 21-865, proposed 
trade name PARAGLUVA (muraglitazar) Tablets, 2.5 mg and 5 mg, Bristol-
Myers Squibb, for the treatment of type II diabetes mellitus.
    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 August 31, 
2005. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on both days. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before August 31, 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 John Lauttman at 
least 7 days in advance of the meeting at 301-827-7001.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).


[[Page 43439]]


    Dated: July 20, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-14750 Filed 7-26-05; 8:45 am]
BILLING CODE 4160-01-S