Department of Health and Human Services May 28, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to BioFire Diagnostics, LLC for the BioFire Respiratory Panel 2.1 (RP2.1). FDA revoked this Authorization on March 17, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), in consideration of the De Novo classification order for the BioFire Respiratory Panel 2.1 (RP2.1) as a Class II (Special Controls) device under the generic name ``Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.'' The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by audio and web conference lines (300 audio and web conference lines are available). Registration is required. To register for this web conference, please go to: www.cdc.gov/hicpac. All registered participants will receive the meeting link and instructions shortly before the meeting.

This proposed rule proposes to delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing arrangement, of the final rule entitled, ``Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements'', published in the December 31, 2020 Federal Register. This proposed rule also proposes to delay for 2 years the April 1, 2022 effective date of inclusion (inclusion date) for U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) in the amended regulatory definitions of ``States'' and ``United States'' for purposes of the Medicaid Drug Rebate Program (MDRP), adopted in the interim final rule with comment period entitled, ``Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States'', published in the November 25, 2019 Federal Register to April 1, 2024. In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. We are requesting public comment on the proposed delays of applicable effective date and inclusion date discussed in greater detail below.