Department of Health and Human Services July 26, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 23 of 23
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Revised Analyses and Proposed Reference Substances for In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants
NICEATM announces the availability of revised analyses for four in vitro test methods proposed for detecting ocular corrosives and severe irritants [the Bovine Corneal Opacity and Permeability (BCOP) assay, the Hen's Egg TestChorion Allantoic Membrane (HET-CAM), the Isolated Rabbit Eye (IRE) assay, and the Isolated Chicken Eye (ICE) assay]. A revised list of proposed reference substances for validation studies on in vitro test methods for identifying ocular corrosives and severe irritants is also available. The revised analyses and list of proposed reference substances are provided in an addendum that is applicable to each of four draft Background Review Documents (BRDs) that were released to the public on November 3, 2004. The NICEATM invites public comment on the information provided in this addendum. Copies of the draft BRDs and addendum may be obtained on the ICCVAM/ NICEATM Web site (https://iccvam.niehs.nih.gov see ``Reports & Background Documents''), or by contacting NICEATM at the address given below.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Petitions for Exemption From Preemption
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Petitions for Exemption From Preemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Oral Dosage Form New Animal Drugs; Tiamulin Liquid Concentrate
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for use of tiamulin concentrate solution to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia.
Determination of Regulatory Review Period for Purposes of Patent Extension; CLARINEX
The Food and Drug Administration (FDA) has determined the regulatory review period for CLARINEX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Listing of Color Additives Exempt From Certification; Tomato Lycopene Extract and Tomato Lycopene Concentrate
The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of tomato lycopene extract and tomato lycopene concentrate as color additives in foods. This action is in response to a petition filed by LycoRed Natural Products Industries.
Ophthalmic and Topical Dosage Form New Animal Drugs; Doramectin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for a period of protection from reinfestation with two species of external parasites following topical administration of doramectin solution on cattle.
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