Joint Meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 74823 [05-24101]

Download as PDF Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Notices amendments thereto, is hereby withdrawn, effective December 27, 2005. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs. Dated: December 7, 2005. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 05–24103 Filed 12–15–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Nonprescription Drugs Advisory Committee and the 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 Committees: Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). 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 January 23, 2006, from 8 a.m. to 5 p.m. Location: Holiday Inn Select Bethesda, Versailles Ballrooms, 8120 Wisconsin Ave., Bethesda, MD. The hotel telephone number is 301–652– 2000. Contact Person: Darrell Lyons, 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: lyonsd@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area) codes 3014512541 or 3014512536. Please call the Information Line for upto-date information on this meeting. Agenda: The committees will consider the safety and efficacy of new drug application (NDA) 21–887, proposing over-the-counter (OTC) use of VerDate Aug<31>2005 19:37 Dec 15, 2005 Jkt 208001 ORLISTAT (tetrahydrolipstatin) capsules (60 milligrams (mg)), GlaxoSmithKline Consumer Healthcare, L.P., to promote weight loss in overweight adults when used along with a reduced calorie and low fat diet. The background material will become available no later than the day before the meeting and will be posted under NDAC or EMDAC’s docket site at https:// www.fda.gov/ohrms/dockets/ac/ acmenu.htm (click on the year 2006 and scroll down to NDAC or EMDAC). 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 by January 13, 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 January 13, 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 Darrell Lyons 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: December 2, 2005. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. 05–24101 Filed 12–15–05; 8:45 am] BILLING CODE 4160–01–S PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225–05–8000] Memorandum of Understanding Between the United States Food and Drug Administration and the C–Path Institute AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the United States Food and Drug Administration and the C–Path Institute. The specific purpose of this MOU is to establish an overarching framework for collaboration between the parties. This framework will be based on mutually agreed upon programs and activities in the areas of applied scientific research and training/ education to foster the development of new evaluation tools to inform medical product development. The parties shall each leverage its own expertise and resources to facilitate programs of shared interests across the diverse disciplines of therapeutics, biological sciences, engineering and medical devices in building applied research and training/education programs. The appropriate formal agreements will be executed as required by law for any activities that result from this collaboration. DATES: The agreement became effective October 14, 2005. FOR FURTHER INFORMATION CONTACT: For C–Path Institute: Raymond L. Woosley, The Critical Path Institute, 4280 N. Campbell Ave., #214, Tucson, AZ 85718, 520–547–3440, FAX: 520–547– 3456, e-mail: rwoosley@c-path.org. For The Food and Drug Administration: Mary I. Poos, Office of External Relations, Food and Drug Administration (HF–10), 5600 Fishers Lane, Rockville, MD 20857, 301–827–2825, FAX: 301–827– 3042, e-mail: mary.poos@fda.gov. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the Federal Register, the agency is publishing notice of this MOU. Dated: December 7, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S Frm 00065 Fmt 4703 Sfmt 4703 74823 E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Notices]
[Page 74823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Joint Meeting of the Nonprescription Drugs Advisory Committee and 
the 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 Committees: Nonprescription Drugs Advisory Committee (NDAC) 
and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).
    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 January 23, 2006, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn Select Bethesda, Versailles Ballrooms, 8120 
Wisconsin Ave., Bethesda, MD. The hotel telephone number is 301-652-
2000.
    Contact Person: Darrell Lyons, 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: lyonsd@cder.fda.gov, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area) codes 3014512541 or 3014512536. Please call 
the Information Line for up-to-date information on this meeting.
    Agenda: The committees will consider the safety and efficacy of new 
drug application (NDA) 21-887, proposing over-the-counter (OTC) use of 
ORLISTAT (tetrahydrolipstatin) capsules (60 milligrams (mg)), 
GlaxoSmithKline Consumer Healthcare, L.P., to promote weight loss in 
overweight adults when used along with a reduced calorie and low fat 
diet. The background material will become available no later than the 
day before the meeting and will be posted under NDAC or EMDAC's docket 
site at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm (click on the 
year 2006 and scroll down to NDAC or EMDAC).
    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 by January 13, 
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 January 13, 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 Darrell Lyons 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: December 2, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-24101 Filed 12-15-05; 8:45 am]
BILLING CODE 4160-01-S

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