Federal Register #2026-16597

HHS Regulatory Agenda: Healthcare, Drug Safety, and Public Welfare Rulemaking

This notice outlines the Department of Health and Human Services' (HHS) upcoming regulatory actions across its major agencies, impacting healthcare, drug safety, and public welfare programs. - Government Buyer: - Department of Health and Human Services (HHS) - Sub-agencies: Office for Civil Rights, SAMHSA, CDC, FDA, CMS, ACF - OEMs and Vendors Mentioned: - HHS and its sub-agencies (regulatory bodies, not commercial OEMs) - Products/Services Requested: - Regulatory updates for opioid use disorder treatment (methadone, buprenorphine) - Amendments to FDA regulations for clinical pharmacology, bioequivalence studies, and drug safety reporting - New requirements for drug importers, pediatric study plans, and laboratory quality systems - Enhanced transparency in direct-to-consumer advertising and patient medication information - Front-of-package nutrition labeling for foods - National standards for wholesale drug distributors and logistics providers - Manufacturing practice requirements for tobacco products - Annual updates to Medicare payment systems for hospitals, physicians, and outpatient services - Implementation of the Medicare Drug Price Negotiation Program - New eligibility verification for health insurance exchanges - Modernization of patient care quality standards and reduction of administrative burden - Revisions to Native American grant requirements, TANF work participation rates, and child protection standards in care facilities - Unique/Notable Requirements: - Focus on regulatory changes rather than procurement of physical products - Emphasis on improving drug safety, supply chain integrity, and healthcare payment systems - Multi-year and annual regulatory updates, with some rules effective in future years - No specific product part numbers or purchase quantities; all items are regulatory actions - Notable impact on manufacturers of drugs, biologics, tobacco products, and food labels

Description

The Department of Health and Human Services (HHS) issues a Regulatory Agenda as required by the Regulatory Flexibility Act of 1980 and Executive Order 12866. This agenda provides an inventory of rulemaking actions under development throughout the Department, offering summarized information about forthcoming regulatory actions for public review. The agenda reflects the priorities of the HHS Secretary and the current administration, focusing on health and human services improvements, regulatory changes, and policy priorities such as managing chronic disease, reducing healthcare costs, and protecting religious liberty in healthcare. It includes various proposed and final rules across multiple HHS agencies, including the Food and Drug Administration, Centers for Medicare & Medicaid Services, and Administration for Children and Families.

View original listing