Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
Abstract
The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the Scope section of our regulation that provides for a regulatory hearing before the Agency to clarify when such hearings are available. We are proposing to revise the list of statutory provisions enumerated in the Scope section of the regulation by removing one statutory reference and adding a different statutory reference.
Federal Register Source
This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.
View Full Text on FederalRegister.gov →Opens in new tab · federalregister.gov
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Frequently Asked Questions
What is the 2024-21232 Federal Register document?
Document 2024-21232 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on September 20, 2024. The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the Scope section of our regulation that provides for a regulatory hearing before the Agency to clarify when such hearings are available. We are proposing to revise the list of statutory provisions enumerated in the Scope section of the regulation by removing one statutory reference and adding a different statutory reference. View the original at https://www.federalregister.gov/documents/2024/09/20/2024-21232/regulatory-hearing-before-the-food-and-drug-administration-general-provisions-amendments.
Is document 2024-21232 an economically significant rule?
No. Document 2024-21232 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.