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Notice: Animal drugs, feeds, and related products:
Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee, 74823 [05-24101] Food and Drug Administration
Originaltitel
Notice: Animal drugs, feeds, and related products: Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee
Notice: Animal drugs, feeds, and related products:
Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee, 74823 [05-24101] Food and Drug Administration
Copyright:
Public Domain
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Notice: Animal drugs, feeds, and related products:
Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee, 74823 [05-24101] Food and Drug Administration
Copyright:
Public Domain
Verfügbare Formate
Als PDF, TXT herunterladen oder online auf Scribd lesen
amendments thereto, is hereby ORLISTAT (tetrahydrolipstatin) DEPARTMENT OF HEALTH AND
withdrawn, effective December 27, capsules (60 milligrams (mg)), HUMAN SERVICES 2005. GlaxoSmithKline Consumer Healthcare, In a final rule published elsewhere in L.P., to promote weight loss in Food and Drug Administration this issue of the Federal Register, FDA overweight adults when used along with [FDA 225–05–8000] is amending the animal drug regulations a reduced calorie and low fat diet. The to reflect the withdrawal of approval of background material will become Memorandum of Understanding these NADAs. available no later than the day before Between the United States Food and Dated: December 7, 2005. the meeting and will be posted under Drug Administration and the C–Path Stephen F. Sundlof, NDAC or EMDAC’s docket site at http:// Institute Director, Center for Veterinary Medicine. www.fda.gov/ohrms/dockets/ac/ AGENCY: Food and Drug Administration, [FR Doc. 05–24103 Filed 12–15–05; 8:45 am] acmenu.htm (click on the year 2006 and HHS. BILLING CODE 4160–01–S scroll down to NDAC or EMDAC). ACTION: Notice. Procedure: Interested persons may SUMMARY: The Food and Drug present data, information, or views, DEPARTMENT OF HEALTH AND Administration (FDA) is providing orally or in writing, on issues pending notice of a memorandum of HUMAN SERVICES before the committees. Written understanding (MOU) between the Food and Drug Administration submissions may be made to the contact United States Food and Drug person by January 13, 2006. Oral Administration and the C–Path Joint Meeting of the Nonprescription presentations from the public will be Institute. The specific purpose of this Drugs Advisory Committee and the scheduled between approximately 1 MOU is to establish an overarching Endocrinologic and Metabolic Drugs p.m. and 2 p.m. Time allotted for each framework for collaboration between the Advisory Committee; Notice of Meeting presentation may be limited. Those parties. This framework will be based AGENCY: Food and Drug Administration, desiring to make formal oral on mutually agreed upon programs and HHS. presentations should notify the contact activities in the areas of applied person before January 13, 2006, and scientific research and training/ ACTION: Notice. education to foster the development of submit a brief statement of the general This notice announces a forthcoming nature of the evidence or arguments new evaluation tools to inform medical meeting of a public advisory committee they wish to present, the names and product development. The parties shall of the Food and Drug Administration addresses of proposed participants, and each leverage its own expertise and (FDA). The meeting will be open to the an indication of the approximate time resources to facilitate programs of public. requested to make their presentation. shared interests across the diverse Name of Committees: disciplines of therapeutics, biological Persons attending FDA’s advisory sciences, engineering and medical Nonprescription Drugs Advisory committee meetings are advised that the Committee (NDAC) and the devices in building applied research agency is not responsible for providing and training/education programs. The Endocrinologic and Metabolic Drugs access to electrical outlets. appropriate formal agreements will be Advisory Committee (EMDAC). General Function of the Committees: FDA welcomes the attendance of the executed as required by law for any To provide advice and public at its advisory committee activities that result from this recommendations to the agency on meetings and will make every effort to collaboration. FDA’s regulatory issues. accommodate persons with physical DATES: The agreement became effective Date and Time: The meeting will be disabilities or special needs. If you October 14, 2005. held on January 23, 2006, from 8 a.m. require special accommodations due to FOR FURTHER INFORMATION CONTACT: For to 5 p.m. a disability, please contact Darrell Lyons C–Path Institute: Raymond L. Woosley, Location: Holiday Inn Select at least 7 days in advance of the The Critical Path Institute, 4280 N. Bethesda, Versailles Ballrooms, 8120 meeting. Campbell Ave., #214, Tucson, AZ Wisconsin Ave., Bethesda, MD. The 85718, 520–547–3440, FAX: 520–547– hotel telephone number is 301–652– 3456, e-mail: rwoosley@c-path.org. 2000. Notice of this meeting is given under For The Food and Drug the Federal Advisory Committee Act (5 Administration: Mary I. Poos, Office Contact Person: Darrell Lyons, Center U.S.C. app. 2). of External Relations, Food and for Drug Evaluation and Research (HFD– Drug Administration (HF–10), 5600 Dated: December 2, 2005. 21), Food and Drug Administration, Fishers Lane, Rockville, MD 20857, 5600 Fishers Lane (for express delivery, Jason Brodsky, 301–827–2825, FAX: 301–827– 5630 Fishers Lane, rm. 1093), Rockville, Acting Associate Commissioner for External Relations. 3042, e-mail: mary.poos@fda.gov. MD 20857, 301–827–7001, FAX: 301– SUPPLEMENTARY INFORMATION: In 827–6776, e-mail: lyonsd@cder.fda.gov, [FR Doc. 05–24101 Filed 12–15–05; 8:45 am] accordance with 21 CFR 20.108(c), or FDA Advisory Committee BILLING CODE 4160–01–S which states that all written agreements Information Line, 1–800–741–8138 and MOUs between FDA and others (301–443–0572 in the Washington, DC shall be published in the Federal area) codes 3014512541 or 3014512536. Register, the agency is publishing notice Please call the Information Line for up- of this MOU. to-date information on this meeting. Agenda: The committees will Dated: December 7, 2005. consider the safety and efficacy of new Jeffrey Shuren, drug application (NDA) 21–887, Assistant Commissioner for Policy. proposing over-the-counter (OTC) use of BILLING CODE 4160–01–S
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Selection of The Appropriate Package Type Terms and Recommendations For Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers For Human Use
BS 1139-6-2005 Metal Scaffolding. Specification For Prefabricated Tower Scaffolds Outside The Scope of BS en 1004, But Utilizing Components From Such Systems