§510.207. Disclosure of information submitted in a request. — 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).

(g) The requester may withdraw the request at any time before the notification provided for in § 510.207(a) of this chapter has been made publicly available.

(d) If the sponsor initially submitted a request for an import tolerance under § 510.205 of this chapter, FDA will make the complete regulatory method for ascertaining the marker residue in the target tissue publicly available pursuant to § 510.207(b) of this chapter.

(b) The Commissioner will provide public notification under § 510.207(b) that will specify the basis for the decision and will be effective at the time the information is made available to the public.