Department of Health and Human Services January 2022 – Federal Register Recent Federal Regulation Documents

This document corrects technical errors in the final rule with comment period that appeared in the Federal Register on November 16, 2021, titled ``Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model.''

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Becton, Dickinson & Company (BD) for the BioGX SARS-CoV-2 Reagents for BD MAX System, Boston Medical Center for the BMC-CReM COVID-19 Test, and Akron Children's Hospital for the Akron Children's Hospital SARS-CoV-2 Assay. FDA revoked these Authorizations on December 8, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox, a carcinogenic new animal drug used in swine feed.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). This final rule discontinues the publication in the Federal Register after each quarter of a list of PMA and HDE approvals and denials announced in that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA is taking this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process for announcing this information. We are also updating Agency contact information and statutory references in certain sections of the PMA and HDE regulations for purposes of accuracy, clarity, and consistency.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005. The rule is being finalized because these regulations are obsolete or no longer necessary to achieve public health goals.

Effective December 30, 2021, HRSA accepted recommended updates to the Bright Futures Periodicity Schedule, a HRSA-supported guideline for infants, children and adolescents for purposes of ensuring that non-grandfathered group and individual health insurance issuers provide coverage without cost sharing under the Public Health Service Act. The updates to the Bright Futures Periodicity Schedule are: A new category for sudden cardiac arrest and sudden cardiac death risk assessment, a new category for hepatitis B virus infection risk assessment, addition of suicide risk as an element of universal depression screening for children ages 12-21, and updated category title from ``Psychosocial/ Behavioral Assessment'' to ``Behavioral/Social/Emotional Screening,'' with no revision to the ages in which the screening occurs (newborn to 21 years). Finally, two clarifying references related to dental fluoride varnish and fluoride supplementation have been added, with no associated recommended changes to clinical practice or health insurance coverage. Please see https://mchb.hrsa.gov/maternal-child-health- topics/child-health/bright-futures.html for additional information.

This proposed rule would revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, Star Ratings, network adequacy, medical loss ratio reporting, special requirements during disasters or public emergencies, and pharmacy price concessions. This proposed rule would also revise regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0036, ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' This notice announces our intent to submit this previously approved information collection, which expires January 31, 2022, to OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This IC Extension solicits comments on the information collection requirements relating to the Aging and Disability Resource Center/No Wrong Door System (ADRC/NWD). The statutory authority for ADRC/NWD is contained in Title IV of the Older Americans Act (OAA), as amended by the Older Americans Act Amendments of 2006.

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. Since March 29, 2020, the U.S. government has been collecting data from hospitals and states to understand health care system stress, capacity, capabilities, and the number of patients hospitalized due to COVID-19. As the COVID-19 response continues to evolve, Federal needs for data are also evolving. The data elements within the collection are being altered to best meet the needs of the current response to COVID-19. This alteration includes the addition of data elements collecting more detailed information on pediatric hospitalizations, which will help to better understand pediatric hospital surge as well as inform epidemiologic surveillance to inform potential response actions. The alteration also includes making various data elements inactive for federal data collection based on current and anticipated future federal response needs, as well as reduce burden where possible. While inactive, these data elements will still be considered as remaining part of the data collection to allow jurisdictions to continue collecting the information if it is needed for their unique response needs.

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.