Department of Health and Human Services December 1, 2017 – Federal Register Recent Federal Regulation Documents

Medicare Program; Cancellation of Advancing Care Coordination Through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model: Extreme and Uncontrollable Circumstances Policy for the Comprehensive Care for Joint Replacement Payment Model
Document Number: 2017-25979
Type: Rule
Date: 2017-12-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule cancels the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) Incentive Payment Model and rescinds the regulations governing these models. It also implements certain revisions to the Comprehensive Care for Joint Replacement (CJR) model, including: Giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model; technical refinements and clarifications for certain payment, reconciliation and quality provisions; and a change to increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (Advanced APM) track. An interim final rule with comment period is being issued in conjunction with this final rule in order to address the need for a policy to provide some flexibility in the determination of episode costs for providers located in areas impacted by extreme and uncontrollable circumstances.
Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications
Document Number: 2017-25920
Type: Notice
Date: 2017-12-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 68 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Nominations to the Presidential Advisory Council on HIV/AIDS
Document Number: 2017-25915
Type: Notice
Date: 2017-12-01
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the Office of HIV/AIDS and Infectious Disease Policy in the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to four- year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV infection and AIDS. The functions of the Council are solely advisory in nature.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-25911
Type: Notice
Date: 2017-12-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Determination That METICORTEN (Prednisone) Tablets, 1 Milligram and 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-25900
Type: Notice
Date: 2017-12-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that METICORTEN (prednisone) tablets, 1 milligram (mg) and 5 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
National Committee on Vital and Health Statistics: Teleconference
Document Number: 2017-25895
Type: Notice
Date: 2017-12-01
Agency: Department of Health and Human Services
Draft-National Occupational Research Agenda for Transportation, Warehousing and Utilities
Document Number: 2017-25876
Type: Notice
Date: 2017-12-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Transportation, Warehousing and Utilities for public comment. To view the notice and related materials, visit https:/ /www.regulations.gov and enter CDC-2017-0114 in the search field and click ``Search.''