§510.210. Revocation of an import tolerance. — Inbound Citations

(c) If FDA concludes on the basis of the threshold assessment or at a later time during the approval process or during the review of a request for an import tolerance that the data show that the sponsored compound and its metabolites should not be subject to this subpart, FDA will continue to consider the compound for approval under the general safety provisions of the Federal Food, Drug, and Cosmetic Act for risks other than cancer or continue its review of the import tolerance request under the provisions of §§ 510.201 through 510.213 of this chapter (Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food).

(c) An interested person who wishes to rely on information not included in the administrative record shall submit either a petition to amend an import tolerance under § 510.205 or to revoke an import tolerance under § 510.210 and § 10.25 of this chapter.

(c) A tolerance established in an approved NADA or conditionally approved CNADA will supersede an existing import tolerance. In the event the conditionally approved CNADA is not renewed or is withdrawn, or such drug does not achieve approval under section 512 of the Federal Food, Drug, and Cosmetic Act within 5 years following the date of the conditional approval, the Agency will reinstate the import tolerance unless § 510.210(a)(1) or (a)(2) is applicable at that time.

(c) A tolerance established in an approved NADA or conditionally approved CNADA will supersede an existing import tolerance. In the event the conditionally approved CNADA is not renewed or is withdrawn, or such drug does not achieve approval under section 512 of the Federal Food, Drug, and Cosmetic Act within 5 years following the date of the conditional approval, the Agency will reinstate the import tolerance unless § 510.210(a)(1) or (a)(2) is applicable at that time.