21 CFR § 112.181 - What procedures apply if FDA determines that an approved variance should be modified or revoked?

(a) We will provide the following notifications:

(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:

(i) Notify in writing any States, tribes, or foreign countries where a variance applies to similarly situated persons of our determination that the variance should be modified or revoked;

(ii) Provide those States, tribes, or foreign countries with an opportunity to request an informal hearing under part 16 of this chapter; and

(iii) Include in the Federal Register notice described in paragraph (a)(2) of this section public notification of our decision to modify or revoke the variance granted to States, tribes, or foreign countries in which similarly situated persons are located.

(b) We will consider submissions from affected States, tribes, or foreign countries and from other interested parties as follows:

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

(i) If FDA grants a hearing, we will provide the State, tribe, or foreign country with an opportunity to make an oral submission. We will provide notice on our Web site of the hearing, including the time, date, and place of the hearing.

(ii) If more than one State, tribe, or foreign country requests an informal hearing under part 16 of this chapter about our determination that a particular variance should be modified or revoked, we may consolidate such requests (for example, into a single hearing).

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

(c) We will provide notice of our final decision as follows:

(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.