§808.20. Application. — Inbound Citations

(a) Upon receipt of an application for an exemption from preemption submitted in accordance with § 808.20, the Commissioner shall notify the State or political subdivision of the date of such receipt.

(c) An exemption that has been revoked may be reinstated, upon request from the State or political subdivision, if the Commissioner, in accordance with the procedures in § 808.25, determines that the grounds for revocation are no longer applicable except that the Commissioner may permit abbreviated submissions of the documents and materials normally required for an application for exemption under § 808.20.

(2) The Food and Drug Administration, in its discretion and after consultation with the State or political subdivision, may treat a request by a State or political subdivision for an advisory opinion as an application for exemption from preemption under § 808.20.

(2) An exemption may be revoked upon a finding that there has occurred a change in the bases listed in § 808.20(c)(4) upon which the exemption was granted.

(4) An exemption may be revoked if a State or local jurisdiction fails to submit records as provided in § 808.20(c)(6).