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HHS/FDA RIN: 0910-AI97 Publication ID: Spring 2024 
Title: ●Amendments to Regulatory Hearing Before the Food and Drug Administration 
Abstract:

The Food and Drug Administration (FDA) is issuing a direct final rule to amend the Scope section of our regulation that provides for a regulatory hearing before the Agency (21 CFR 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: Info./Admin./Other 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 16 (Revision)   
Legal Authority: 21 U.S.C. 371    21 U.S.C. 387f   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Direct Final Rule  09/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Robert Schwartz
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:877 287-1373
Email: ctpregulations@fda.hhs.gov