Department of Health and Human Services August 31, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the revocation of 15 Emergency Use Authorizations (EUAs) (the Authorizations), including 12 Authorizations for decontamination systems for personal protective equipment, 1 Authorization for a bioburden reduction system for personal protective equipment, and 2 umbrella Authorizations for certain imported, non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators. FDA revoked the Authorizations for the decontamination and bioburden reduction systems for personal protective equipment on June 30, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. FDA revoked the umbrella Authorizations issued to manufacturers and other stakeholders of imported non-NIOSH approved filtering facepiece respirators manufactured in China (China FFR Authorization), and to manufacturers and other stakeholders of imported non-NIOSH approved filtering facepiece respirators (Imports FFR Authorization) on June 30, 2021, under the FD&C Act. The revocations, which each include an explanation of the reasons for the revocation, are reprinted in this document.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

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 proposed information collection project ``Ambulatory Surgery Center Survey on Patient Safety Culture Database.'' This proposed information collection was previously published in the Federal Register on May 25, 2021 and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to continue to collect information that will allow the Unaccompanied Children (UC) Program to monitor its care provider facilities for compliance with federal and state laws and regulations, licensing and accreditation standards, ORR policies and procedures, and child welfare standards. These information collections were originally approved under emergency approval for 6 months. This request is to continue data collection.