Department of Health and Human Services November 2023 – Federal Register Recent Federal Regulation Documents

This final rule describes the agency's actions on remand from the United States (U.S.) District Court for the District of Columbia to craft a remedy in light of the U.S. Supreme Court's decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), relating to the adjustment of Medicare payment rates for drugs acquired under the 340B Program from calendar year (CY) 2018 through September 27th of CY 2022.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA or the Agency), Center for Veterinary Medicine (CVM), is proposing to withdraw approval of all new animal drug applications (NADAs) providing for use of carbadox in medicated swine feed, for which Phibro Animal Health Corp., Glenpointe Centre East, Third Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666-6712, is the sponsor, and is announcing an opportunity for the holder of the NADAs to request a hearing on this proposal. This action is based on CVM's determination that there is no approved regulatory method to detect the residue of carcinogenic concern in the edible tissues of the treated swine.

This notice announces a $709.00 calendar year (CY) 2024 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2024 and on or before December 31, 2024.

HHS is proposing a revision to its floodplain management procedures to include climate science if an action takes place in a floodplain.

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 Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc. on behalf of Ecoflora SAS (Ecoflora).

This document sets forth proposed rules related to certain provisions of the No Surprises Act regarding the Federal independent dispute resolution (IDR) process, which was established as part of the Consolidated Appropriations Act, 2021 (CAA). These proposed rules would set forth new requirements relating to the disclosure of information that group health plans and health insurance issuers offering group or individual health insurance coverage must include along with the initial payment or notice of denial of payment for certain items and services subject to the surprise billing protections in the No Surprises Act. These proposed rules would also require plans and issuers to communicate information by using claim adjustment reason codes (CARCs) and remittance advice remark codes (RARCs), as specified in guidance, when providing any paper or electronic remittance advice to an entity that does not have a contractual relationship with the plan or issuer. This document also proposes to amend certain requirements related to the open negotiation period preceding the Federal IDR process, the initiation of the Federal IDR process, the Federal IDR dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees. This document also proposes to define bundled payment arrangements, amend requirements related to batched items and services, and amend the rules for extensions of timeframes due to extenuating circumstances. Additionally, this document proposes to require plans and issuers to register in the Federal IDR portal. In accordance with Federal law, a summary of these rules may be found at https://www.regulations.gov/.

The Food and Drug Administration (FDA or we) is proposing to amend our regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. This action is being taken because there is no longer a reasonable certainty of no harm from the continued use of BVO in food. Specifically, the proposed rule would revoke the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. There are no authorizations for other uses of BVO in food.

The Food and Drug Administration (FDA or the Agency) has identified certain class II clinical electronic thermometers that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with the procedures established by the 21st Century Cures Act. FDA will review any comments submitted within the 60-day comment period and will consider whether any modifications should be made to the exemption for certain clinical electronic thermometers prior to publication of its final determination in the Federal Register.

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 proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Occupational exposures to surgical smoke in veterinary personnel which will characterize occupational exposure to surgical smoke and related respiratory health effects in clinical veterinary settings and provide guidance on engineering controls to improve air quality in veterinary medicine/animal care personnel's work environment by reducing exposure to surgical smoke.