HHS Rules & Proposed Rules

FDA Proposes Reclassifying TB Immunity Tests to Class II

The Food and Drug Administration (FDA) has proposed reclassifying certain Mycobacterium tuberculosis cell-mediated immunity tests and immune response enzyme-linked immunospot tests from Class III to Class II. This reclassification would subject these diagnostic tests to less stringent regulatory controls.

HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs

The Department of Health and Human Services (HHS) has published updated guidelines for federal workplace drug testing programs. The rule confirms that current authorized drug testing panels and required report nomenclature remain in effect.

HHS Benefit Parameters for 2027 and Basic Health Program Correction

The Department of Health and Human Services (HHS) has issued a proposed rule detailing benefit and payment parameters for the 2027 benefit year. This notice also includes a correction to the Basic Health Program. The rule outlines key parameters affecting health insurance marketplaces and programs.

HHS Proposes Rescinding LGBTQI+ Child Placement Rule

The Department of Health and Human Services (HHS) has proposed rescinding the Designated Placement Requirements under Titles IV-E and IV-B for LGBTQI+ children. This proposed rule seeks public comment on the removal of these requirements.

FDA Final Rule: Standardized NDC Format and Barcode Requirements

The Food and Drug Administration (FDA) has issued a final rule standardizing the National Drug Code (NDC) format and revising drug label barcode requirements. This rule aims to enhance drug tracking and safety. The effective date for this rule is March 7, 2033.

Kemin Industries Food Additive Petition for Animal Use

The Food and Drug Administration (FDA) is seeking public comment on a food additive petition filed by Kemin Industries, Inc. for animal use. The comment period for this proposed rule closes on April 3, 2026.

Opioid Use Disorder Medication Treatment Correction

The Department of Health and Human Services has issued a correction to its rule on Medications for the Treatment of Opioid Use Disorder. This correction clarifies specific provisions within the existing regulation, ensuring accurate implementation and adherence.