21 CFR §1.1440

1. (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.
2. (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.
3. (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.