Department of Health and Human Services August 8, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Elemental Impurities in Drug Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Elemental Impurities in Drug Products.'' This guidance finalizes the draft guidance issued July 1, 2016, which provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with the implementation of International Council for Harmonisation (ICH) guidance for industry entitled ``Q3D Elemental Impurities'' (ICH Q3D). This guidance will also assist manufacturers of compendial drug products in responding to the issuance of the United States Pharmacopeia (USP) requirement for the control of elemental impurities.
[Docket No. FDA-2011-N-0776] HEADAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Merck Sharp & Dohme Corporation, et al.; Withdrawal of Approval of Four New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of four new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Meeting of the President's Council on Sports, Fitness, and Nutrition; Correction
The Department of Health and Human Services published a document in the Federal Register of July 27, 2018, concerning the upcoming annual meeting of the President's Council on Sports, Fitness, and Nutrition (PCSFN). The document contained an incorrect location and time.
Meeting of the President's Council on Sports, Fitness, and Nutrition; Correction
The Department of Health and Human Services published a document in the Federal Register of July 27, 2018, concerning the upcoming annual meeting of the President's Council on Sports, Fitness, and Nutrition (PCSFN). The document contained an incorrect location and time.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Final Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting Program
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019. This final rule also replaces the existing case-mix classification methodology, the Resource Utilization Groups, Version IV (RUG-IV) model, with a revised case-mix methodology called the Patient-Driven Payment Model (PDPM) beginning on October 1, 2019. The rule finalizes revisions to the regulation text that describes a beneficiary's SNF ``resident'' status under the consolidated billing provision and the required content of the SNF level of care certification. The rule also finalizes updates to the SNF Quality Reporting Program (QRP) and the Skilled Nursing Facility Value-Based Purchasing (VBP) Program.
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