Department of Health and Human Services December 20, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Nexira; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Nexira has filed a petition proposing that the food additive regulations be amended to provide for the expanded safe use of acacia gum (gum arabic) in food.
Oral Dosage Form New Animal Drugs; Cyclosporine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of cyclosporine oral solution, USP (MODIFIED) for the control of feline allergic dermatitis.
Medicare and Medicaid Programs; Announcement of Application From Hospital Requesting Waiver for Organ Procurement Service Area
This notice with comment period announces a waiver request from Pioneer Community Hospital to participate in an Organ Procurement Organization (OPO) outside of its designated OPO. The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act) which provides that a hospital may obtain a waiver from the Secretary under certain conditions. This notice solicits comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Advisory Committees; Tentative Schedule of Meetings for 2012
The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2012. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the Agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.
Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments
The Food and Drug Administration (FDA) is seeking comments on specific issues related to its authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require or order safety labeling changes for approved prescription drug products based on new safety information that becomes available after a drug product is approved. The FD&C Act specifies the timeframes within which a safety labeling change must be submitted when required or ordered by the FDA, and timeframes for FDA to conclude its review and take regulatory action regarding safety labeling changes. FDA's regulations also provide procedures by which labeling changes that do not qualify as changes based on new safety information can be requested by FDA or by the holder of the drug approval. FDA is seeking public input to assist the Agency in establishing specific timeframes for implementing both types of labeling changes.
Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.'' This document describes FDA's intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations.
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