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

The Administrator of the World Trade Center (WTC) Health Program received four petitions (Petitions 031, 036, 039, and 053) to add amyotrophic lateral sclerosis (ALS) to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by petitioners, the Administrator determined that there is insufficient evidence to support taking further action at this time regarding ALS. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2024. The animal drug regulations are also being amended to improve their accuracy and readability.

The Department of Health and Human Services ("HHS" or "Department") herein publishes the panels of Schedule I and II drugs and biomarkers authorized for testing in Federal workplace drug testing programs. The Department has revised the drug testing panels for both urine and oral fluid, and revised required nomenclature for laboratory and Medical Review Officer Reports.

The Food and Drug Administration (FDA or we) proposes to require front-of-package nutrition labels on most foods that must bear a Nutrition Facts label. This action, if finalized, would require the display of a compact informational box containing certain nutrient information on the principal display panel. The box would provide consumers, including those who have lower nutrition knowledge, with standardized, interpretive nutrition information that can help them quickly and easily identify how foods can be part of a healthy diet. We also propose to amend certain nutrient content claim regulations to align with current nutrition science and avoid within-label inconsistencies.

The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria." The draft guidance document provides blood establishments that collect blood and blood components with FDA's revised recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The guidance recommends selectively testing blood donations from donors at risk for malaria using an FDA-licensed donor screening nucleic acid test (NAT) for Plasmodium species (spp.), the causative agents of malaria. The draft guidance, when finalized, is intended to supersede the document entitled "Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria," dated December 2022.

The Food and Drug Administration (FDA, the Agency, or we) is soliciting comments from the public, particularly veterinarians, related to the use of cannabis-derived products (CDPs) in animals, with an emphasis on cannabidiol (CBD) products and general trends associated with those products, including information about: usage trends (e.g., product selection, indications, etc.), quality standards, benefits of use, potential drug interactions, adverse events and safety problems, and toxicological concerns. This information will enhance the Center for Veterinary Medicine's (CVM's) knowledge of potential safety signals associated with these products, in addition to aiding our understanding of veterinarians' experiences related to the use of CDPs for their animal patients.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the "generic" clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low-burden, and uncontroversial collections," do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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 requesting information and data about the manufacturing processes and ingredients used to make certain dairy products referred to as high-protein yogurt, Greek yogurt, or Greek-style yogurt in this document. We are taking this action, in part, because the yogurt standard of identity may not align with certain manufacturing processes and ingredients used to concentrate protein to manufacture these products. We intend to use the information and data to help determine what type(s) of actions, if any, should be taken.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

The Food and Drug Administration (FDA or we) is requesting information on industry practices related to poppy seeds, such as information about growing, harvesting, processing, and distribution of poppy seeds, including industry practices to reduce the opiate alkaloid content of poppy seeds. We are taking this action, in part, because we have received reports of adverse events related to the use of some poppy seed products. We intend to use the information to help determine what type(s) of actions, if any, we should take to help ensure that poppy seed products do not pose a health risk when consumed.

On January 8, 2025, we published a Federal Register Notice requesting nomination letters for the CIIHE TAC delegates. This correcting amendment corrects two errors: the submission deadline and the notification timeframe for nominee selection.

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 (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.

HHS and USDA invite the public to provide written comments on two reports: The Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD) Alcohol Intake and Health (AIH) draft report and The National Academies of Sciences, Engineering, and Medicine's (NASEM) Review of Evidence on Alcohol and Health report.

This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2026 benefit year user fee rates for issuers that participate in the HHS-operated risk adjustment program and the 2026 benefit year user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes requirements related to modifications to the calculation of the Basic Health Program (BHP) payment; and changes to the Initial Validation Audit (IVA) sampling approach and Second Validation Audit (SVA) pairwise means test for HHS-RADV. It also addresses HHS' authority to engage in compliance reviews of and take enforcement action against lead agents of insurance agencies for violations of HHS' Exchange standards and requirements; HHS' system suspension authority to address noncompliance by agents and brokers; an optional fixed-dollar premium payment threshold; permissible plan-level adjustment to the index rate to account for cost-sharing reductions (CSRs); reconsideration standards for certification denials; changes to the approach for conducting Essential Community Provider (ECP) certification reviews; a policy to publicly share aggregated, summary- level Quality Improvement Strategy (QIS) information on an annual basis; and revisions to the medical loss ratio (MLR) reporting and rebate requirements for qualifying issuers that meet certain standards.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on the National Health Service Corps (NACNHSC) will hold public meetings for the 2025 calendar year (CY). Information about NACNHSC, agendas, and materials for these meetings can be found on the NACNHSC website at: https:// www.hrsa.gov/advisory-committees/national-health-service-corp s.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.