Department of Health and Human Services November 22, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug Application
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for ACCUTANE (isotretinoin) Capsules held by Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ 07110- 1199. Hoffmann-La Roche Inc. notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Availability of Draft Toxicological Profiles
This notice announces the availability of the Toxicological Profile for Toxaphene (Update) and the Toxicological Profile for Trichlorobenzenes for review and comment. We are seeking public comments for review and potential inclusion in the profiles. These comments can include additional information or reports on studies about the health effects of toxaphene and trichlorobenzenes. ATSDR remains committed to providing a public comment period for these documents to best serve public health and our clients. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), section 104(i)(3), [42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare toxicological profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.
Intramammary Dosage Form New Animal Drugs; Cloxacillin Benzathine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplementary new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplement provides for minor revisions to labeling.
Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of the Term “Lead Free” in the Labeling of Pottery; and Proper Identification of Ornamental and Decorative Ceramicware; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of the Term `Lead Free' in the Labeling of Pottery; and Proper Identification of Ornamental and Decorative Ceramicware.'' FDA is issuing the guidance in response to recent findings of lead contamination of imported traditional pottery labeled as ``Lead Free.'' The guidance identifies several key practices that manufacturers of pottery may implement to help ensure that lead contamination of non- lead glazed (NLG) pottery will not occur and also reminds manufacturers of existing requirements for properly labeling certain ornamental and decorative ceramicware as not for use for food-handling purposes.
Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Correction
This document corrects a technical error that appeared in the proposed rule entitled ``Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes'' which was filed for public inspection on November 10, 2010.
Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes
We are proposing revisions to the Medicare Advantage (MA) program (Part C) and Prescription Drug Benefit Program (Part D) to implement provisions specified in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) (ACA) and make other changes to the regulations based on our continued experience in the administration of the Part C and D programs. These latter proposed revisions would clarify various program participation requirements; make changes to strengthen beneficiary protections; strengthen our ability to identify strong applicants for Parts C and D program participation and remove consistently poor performers; and make other clarifications and technical changes.
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