The Federal Register

Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications

Fri, Dec 16 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 15 new animal drug applications (NADAs) because the products are no longer manufactured or marketed. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADAs.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Dec 16 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications

Fri, Dec 16 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is withdrawing approval of 15 new animal drug applications (NADAs) because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the NADAs.

Joint Meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory

Fri, Dec 16 2005 11:00:00 GMT

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 301652 2000.

Contact Person: Darrell Lyons, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email: lyonsd@cder.fda.gov, or FDA Advisory Committee Information Line, 1800741813

Memorandum of Understanding Between the United States Food and Drug Administration and the C-Path Institute

Fri, Dec 16 2005 11:00:00 GMT

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 CPath 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.