21 CFR §1.934

1. (a)We will provide the following notifications:
   1. (1)We will notify the entity that initially requested the waiver, in writing at the address identified in its petition, if we determine that a waiver granted in response to its petition should be modified or revoked.
   2. (2)We will publish a notice of our determination that a waiver should be modified or revoked in the Federal Register. This notice will establish a public docket so that interested parties may submit written submissions on our determination.
2. (b)We will consider timely written submissions submitted to the public docket from interested parties.
3. (c)We will publish a notice of our decision in the Federal Register. The effective date of the decision will be the date of publication of the notice.