Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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.
Abstract as published in the Federal Register.
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