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HHS/FDA RIN: 0910-AJ18 Publication ID: 2026 
Title: ●Amendments to Regulatory Hearing Before the Food and Drug Administration 
Abstract:

The Food and Drug Administration is issuing a final rule to amend the Scope section of its regulation that provides for a regulatory hearing before the Agency (21 CFR Part 16, part 16). This rule revises the list of statutory provisions enumerated in section 16.1(b)(1) by replacing one statutory reference with a different statutory reference under the same section of the same statute.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Deregulatory 
CFR Citation: 21 CFR 16   
Legal Authority: 21 USC 371    21 USC 387f   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Final Rule  08/00/2026 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Matt Brenner
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Email: askctp@fda.hhs.gov