Department of Health and Human Services March 6, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to update agency contacts for patent information and patent notifications and to correct an inaccurate cross-reference. This action is being taken to ensure accuracy and clarity in the agency's regulations.
Determination of Regulatory Review Period for Purposes of Patent Extension; ARRANON
The Food and Drug Administration (FDA) has determined the regulatory review period for ARRANON 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; Proposed Collection; Comment Request; Gluten-Free Labeling of Food Products Experimental Study
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary consumer study entitled ``Gluten-Free Labeling of Food Products Experimental Study.''
New Animal Drugs; Change of Sponsor; Methoxyflurane
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Schering-Plough Animal Health, Inc., to Medical Developments International, Ltd.
Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the regulations which state that protocols for samples of biological products must be submitted to the agency.
Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products for Over-the-Counter Human Use; Technical Amendment
We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for over-the-counter (OTC) skin protectant astringent drug products. This amendment clarifies that aluminum acetate solutions, produced by dissolving aluminum sulfate tetradecahydrate and calcium acetate monohydrate in powder or tablet form in water, are generally recognized as safe and effective (GRASE) and not misbranded as astringent drug products. The amendment also describes how manufacturers should relabel these products to comply with the FM. We are issuing this amendment in response to a citizen petition (CP) that we received from a manufacturer of OTC astringent drug products. This final rule is part of our ongoing review of OTC drug products.
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