Department of Health and Human Services August 26, 2022 – Federal Register Recent Federal Regulation Documents

This document includes final rules under the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021 (CAA). The document finalizes certain disclosure requirements relating to information that group health plans, and health insurance issuers offering group or individual health insurance coverage, must share about the qualifying payment amount (QPA) under the interim final rules issued in July 2021, titled Requirements Related to Surprise Billing; Part I (July 2021 interim final rules). Additionally, this document finalizes select provisions under the October 2021 interim final rules, titled Requirements Related to Surprise Billing; Part II (October 2021 interim final rules), to address certain requirements related to consideration of information when a certified independent dispute resolution (IDR) entity makes a payment determination under the Federal IDR process.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Poison Center Collaborations for Public Health Emergencies. This proposed collection will allow CDC to quickly characterize potential exposures identified through the National Poison Data System (NPDS), help determine potential risk factors, identify illnesses related to the public health emergency, and improve the public health response to the incident.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA) is announcing the issuance of one, and revocation of three, Emergency Use Authorizations (EUAs) (the Authorizations) issued to STS Lab Holdco (a subsidiary of Amazon.com Services LLC) (``STS''). FDA issued one Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by STS, for the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19, and the subsequent declaration on February 4, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is listed in this document, and further information can be accessed on FDA's website from the links indicated. FDA is also announcing the subsequent revocation of the Authorization issued to STS for the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2. In addition, FDA is announcing the revocation of the Authorizations issued to STS for the Amazon Multi- Target SARS-CoV-2 Real-Time RT-PCR DTC Test and Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test. FDA issued and revoked the Authorizations under the FD&C Act. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.