Department of Health and Human Services May 3, 2021 – Federal Register Recent Federal Regulation Documents

This notice announces the public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Wednesday, July 28, 2021 and Thursday, July 29, 2021. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the renewal of the information collection project ``Medical Office Survey on Patient Safety Culture Database.''

The Department of Health and Human Services (Department or HHS) and the Food and Drug Administration (FDA or Agency) are issuing this notice to withdraw the notice published in the Federal Register of January 15, 2021, announcing a Statement of Policy indicating that FDA will publish certain information regarding the timeline for its review of drug product applications. The Department and FDA are withdrawing the notice and revoking the Statement of Policy because, among other things, the notice did not account for all relevant considerations related to information that is already publicly available about FDA's review of drug applications.

This final rule extends the length of the Comprehensive Care for Joint Replacement (CJR) model through December 31, 2024 by adding an additional 3 performance years (PYs). PY 6 will begin on October 1, 2021 and end on December 31, 2022; PY 7 will begin on January 1, 2023 and end on December 31, 2023; and PY 8 will begin on January 1, 2024 and end on December 31, 2024. In addition, this final rule revises certain aspects of the CJR model including the episode of care definition, the target price calculation, the reconciliation process, the beneficiary notice requirements, and the appeals process. In addition, for PY 6 through 8, this final rule eliminates the 50 percent cap on gainsharing payments, distribution payments, and downstream distribution payments for certain recipients. This final rule extends the additional flexibilities provided to participant hospitals related to certain Medicare program rules consistent with the revised episode of care definition.

In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.