Department of Health and Human Services December 9, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Proposed Amendment to the Monograph
The Food and Drug Administration (FDA) is issuing a proposed rule to amend the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA is issuing this proposed rule after considering information submitted in a citizen petition. This proposal is part of FDA's ongoing review of OTC drug products.
Oral Dosage Form New Animal Drugs; Sulfadimethoxine Soluble Powder
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 Cross Vetpharm Group Ltd. The ANADA provides for the oral use of sulfadimethoxine soluble powder to create a solution administered as a drench to cattle or in the drinking water of chickens, turkeys, or cattle for the treatment of coccidiosis or various bacterial diseases.
Food Ingredient Solutions, LLC; Filing of Color Additive Petition
The Food and Drug Administration (FDA) is announcing that Food Ingredient Solutions, LLC, has filed a petition proposing that the color additive regulations be amended to expand the use of sodium copper chlorophyllin to include foods generally (with the exception of meat, poultry, fish, and standardized foods) and to include fescue grass as a permitted source.
Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole Nitrate Cream; Miconazole Nitrate Lotion; Miconazole Nitrate Spray
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 First Priority, Inc. The ANADA provides for topical use of miconazole nitrate as a spray or lotion on dogs and cats for the treatment of certain fungal infections.
Solicitation of New Safe Harbors and Special Fraud Alerts
In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
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