Department of Health and Human Services December 11, 2020 – Federal Register Recent Federal Regulation Documents

The Social Security Act prohibits a physician-owned hospital from expanding its facility capacity, unless the Secretary of the Department of Health and Human Services grants the hospital's request for an exception to that prohibition after considering input on the hospital's request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services has received a request from a physician-owned hospital for an exception to the prohibition against expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the physician-owned hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition against expansion of facility capacity.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR have been provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA) is correcting a notice entitled ``Qualification Process for Drug Development Tools; Guidance for Industry; Availability'' that appeared in the Federal Register of November 25, 2020. The document announced the availability of a final guidance for industry and FDA staff that met the 21st Century Cures Act's requirement to issue guidance on this qualification process and elaborated on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other drug development tools. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is announcing the availability of three device-specific final guidance documents for the Safety and Performance Based Pathwayspecifically, ``Spinal Plating SystemsPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff,'' ``Orthopedic Non-Spinal Metallic Bone Screws and Washers Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff,'' and ``Magnetic Resonance (MR) Receive-only CoilPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidances identified in this notice were developed in accordance with the final guidance entitled ``Safety and Performance Based Pathway.''

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 25, 2022.

The Food and Drug Administration (FDA or we) is announcing that a temporary permit has been issued to Bongards Creameries (the applicant) to market test several pasteurized standardized cheeses that deviate from the U.S. standards of identity for cheese products. The temporary permit will allow the applicant to evaluate commercial viability of the products and to collect data on consumer acceptance of the products.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the 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.