Department of Health and Human Services February 27, 2014 – Federal Register Recent Federal Regulation Documents
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Notice of Opportunity for Hearing on Compliance of Florida State Plan Provisions Concerning Payment for Outpatient Hospital Services With Title XIX (Medicaid) of the Social Security Act
This notice announces the opportunity for an administrative hearing to be held by April 28, 2014 at the CMS Atlanta Regional Office, 61 Forsyth Street SW., Suite 4T20, Atlanta, GA 30303-8909, to consider whether Florida provisions concerning payments for outpatient hospital services comply with the requirements of the Social Security Act as discussed in the [date of publication] letter sent to the state and published herein. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by March 31, 2014.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Advertisements
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 reporting requirements, including third party disclosure, contained in FDA's current regulations on prescription drug advertisements.
Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 69 new animal drug applications (NADAs) and 22 abbreviated new animal drug applications (ANADAs) for use of arsanilic acid, carbarsone, or roxarsone Type A medicated articles to manufacture combination drug Type B and Type C medicated feeds. This action is being taken at the sponsor's request because the products are no longer manufactured or marketed. FDA is also amending the animal drug regulations to remove entries describing conditions of use for combination drug medicated feeds for which no NADA is approved. This action is being taken to improve the accuracy of the regulations.
Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of 69 new animal drug applications (NADAs) and 22 abbreviated new animal drug applications (ANADAs) for use of arsanilic acid, carbarsone, or roxarsone Type A medicated articles to manufacture combination drug Type B and Type C medicated feeds. This action is being taken at the sponsor's request because the products are no longer manufactured or marketed.
New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; Sulfadimethoxine; Change of Sponsor; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor's address.
New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 54 approved new animal drug applications (NADAs) and 1 approved abbreviated new animal drug application (ANADA) for topical, intramammary, and certain other dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc.
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