Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
other · Food and Drug Administration · Rule · Published 2024-09-20 · Effective 2025-02-03 · 89 FR 77019
Document
Document number
2024-21231
Federal Register citation
89 FR 77019
CFR reference
21 CFR 16
Type
Rule
Action
Direct final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2024-09-20
Effective date
2025-02-03
HHS docket
Docket No. FDA-2024-N-3654
Abstract
The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency in order to clarify when such hearings are available. We are revising the list of statutory provisions enumerated in the Scope section of the regulation by adding one statutory reference and removing a different statutory reference. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.