§1303.12. Reserved — Inbound Citations

(4) Projected demand for such class as indicated by procurement quotas requested pursuant to § 1303.12;

Any manufacturer assigned a procurement quota for any basic class of controlled substance listed in schedule I or II pursuant to § 1303.12 may at any time abandon their right to manufacture all or any part of such quota by filing a notice of such abandonment with the UN Reporting and Quota Section, Diversion Control Division, Drug Enforcement Administration in the online Quota Management System. The Administrator may, in their discretion, allocate such amount among the other manufacturers in proportion to their respective quotas.

(b) In any case where the Administrator shall hold a hearing regarding the issuance, adjustment, suspension, or denial of a procurement quota pursuant to § 1303.12, or the issuance, adjustment, suspension, or denial of an individual manufacturing quota pursuant to §§ 1303.21-1303.27, the procedures for such hearing shall be governed generally by the adjudication procedures set forth in the Administrative Procedures Act (5 U.S.C. 551-559) and specifically by section 306 of the Act (21 U.S.C. 826), by §§ 1303.32-1303.37, and by the procedures for administrative hearings under the Act set forth in §§ 1316.41-1316.67 of this chapter.

(a) Each controlled substance, or basic class thereof, has been assigned an “Administration Controlled Substances Code Number” for purposes of identification of the substances or class on certain Certificates of Registration issued by the Administration pursuant to §§ 1301.35 of this chapter and on certain order forms issued by the Administration pursuant to § 1305.05(d) of this chapter. Applicants for procurement and/or individual manufacturing quotas must include the appropriate code number on the application as required in §§ 1303.12(b) and 1303.22(a) of this chapter. Applicants for import and export permits must include the appropriate code number on the application as required in §§ 1312.12(a) and 1312.22(a) of this chapter. Authorized registrants who desire to import or export a controlled substance for which an import or export permit is not required must include the appropriate Administration Controlled Substances Code Number beneath or beside the name of each controlled substance listed on the DEA Form 236 (Controlled Substance Import/Export Declaration) which is executed for such importation or exportation as required in §§ 1312.18(c) and 1312.27(b) of this chapter.

(b) No individual manufacturing quota shall be required for registrants listed in § 1303.12(e).

(x) The originals of all written certifications of available procurement quotas submitted by other persons (as required by § 1303.12(f) of this chapter) relating to each order requiring the distribution of a basic class of controlled substance listed in Schedule I or II.