# Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
> **Food and Drug Administration** · Direct final rule. · Published 2024-09-20 · Effective 2025-02-03 · 89 FR 77019
## Document
- **Document number:** 2024-21231
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 89 FR 77019
- **CFR reference:** 21 CFR 16
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2024/09/20/2024-21231/regulatory-hearing-before-the-food-and-drug-administration-general-provisions-amendments)
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