Department of Health and Human Services November 13, 2020 – Federal Register Recent Federal Regulation Documents

On July 28, 2018 the Center for State, Tribal, Local, and Territorial Support (CSTLTS), Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register announcing the Public Health Associate Program (PHAP) Alumni and Host Site Assessment. Written comments were to be received by September 28, 2020. The Docket Number that was included in the initial publication of this 60 Day Federal Register Notice was incorrect. CDC is announcing the reopening of the comment period.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' This guidance is intended to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine (CVM) to support new animal drug applications.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

This final rule advances CMS' efforts to streamline the Medicaid and Children's Health Insurance Program (CHIP) managed care regulatory framework and reflects a broader strategy to relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and innovation in the delivery of care. These revisions of the Medicaid and CHIP managed care regulations are intended to ensure that the regulatory framework is efficient and feasible for states to implement in a cost-effective manner and ensure that states can implement and operate Medicaid and CHIP managed care programs without undue administrative burdens.