The Federal Register

Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals; Withdrawal

Wed, Dec 28 2005 11:00:00 GMT

The Food and Drug Administration (FDA) published in the Federal Register of August 28, 2003 (68 FR 51693), a direct final rule to amend the regulation on the designation of ingredients in dietary supplements by incorporating by reference the most recent editions of the references Herbs of Commerce and the International Code of Botanical Nomenclature. The direct final rule also would have added a sentence to this regulation codifying the requirements contained in the Farm Security and Rural Investment Act of 2002 (Public Law 107171) that restrict
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the use of the term ``ginseng'' as a common or usual name to botanicals within the genus ``Panax'' and limiting the use of the term ``ginseng'' to labeling and advertising of herbs or herbal ingredients classified within the genus ``Panax.'' FDA is withdrawing the direct final rule because the agency received significant adverse comment.

Designation of New Animal Drugs for Minor Uses or Minor Species; Reopening of the Comment Period

Wed, Dec 28 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is reopening until January 27, 2006, the comment period for the proposed rule published in the Federal Register of September 27, 2005 (70 FR 56394), proposing implementing regulations for designation of new animal drugs for minor uses and minor species under section 573 of the Federal Food, Drug, and Cosmetic Act (the act). FDA is reopening the comment period to update comments and to receive any new information.

Determination That DECADRON (Dexamethasone) Tablets, 1.5 Milligrams, Were Not Withdrawn From Sale for Reasons of

Wed, Dec 28 2005 11:00:00 GMT

The Food and Drug Administration (FDA) has determined that DECADRON (dexamethasone) tablets, 1.5 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dexamethasone tablets, 1.5 mg.

Animal Drug User Fee Act; Public Meeting

Wed, Dec 28 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Drug User Fee Act (ADUFA) to seek public comments relative to the program's overall performance and reauthorization as directed by Congress.

Date and Time: The public meeting will be held on February 24, 2006, from 9 a.m. to 5 p.m. Requests to make a presentation at the meeting must be received by February 10, 2006. Written comments regarding this meeting may be made by March 26, 2006, to the Division of Dockets Management (see Addresses).

Location: The meeting will be held at the DoubleTree Hotel, Plaza II and III, 1750 Rockville Pike, Rockville, MD 20852. Registration is not required to attend the meeting. Parking is limited, so we recommend arriving by subway (Metro rail) if possible. The DoubleTree Hotel is accessible from the Metro rail's red line at the Twinbrook station.