Code of Federal Regulations Title 21. Food and Drugs § 21.1.934 What procedures apply if we determine that a waiver should be modified or revoked?

(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) 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.