Code of Federal Regulations Title 21. Food and Drugs § 21.112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked?

(1) We will notify a State, tribe, or a foreign country directly, in writing at the address identified in its petition, if we determine that a variance granted in response to its petition should be modified or revoked. Our direct, written notification will provide the State, tribe, or foreign country with an opportunity to request an informal hearing under part 16 of this chapter.

(2) We will publish a notice of our determination that a variance should be modified or revoked in the Federal Register. This notice will establish a public docket so that interested parties may submit written comments on our determination.

(3) When applicable, we will:

(1) We will consider requests for hearings by affected States, tribes, or foreign countries under part 16 of this chapter.

(2) We will consider written submissions submitted to the public docket from interested parties.

(1) On the basis of the administrative record, FDA will issue a written decision, as provided for under part 16 of this chapter.

(2) 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.