What process will FDA follow when waiving a requirement of this subpart on our own initiative?

(a) If FDA, on our own initiative, determines that a waiver of one or more requirements for an individual entity or type of entity is appropriate, we will publish a notice in the Federal Register setting forth the proposed waiver and the reasons for such waiver. The notice will establish a public docket so that interested persons may submit written comments on the proposal. (b) After considering any comments timely submitted, we will publish a notice in the Federal Register stating whether we are granting the waiver (in whole or in part) and the reasons for our decision. (c) Any waiver for a type of entity that FDA grants will become effective on the date that notice of the waiver is published in the Federal Register, unless otherwise stated in the notice.