§1303.13. Adjustments of aggregate production quotas. — Inbound Citations
21 C.F.R. § 1303.13
Statutory Authority
Cited by 5 regulations in release Current.
Citations to 21 C.F.R. § 1303.13 as a whole
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The Administrator may at any time reduce an individual manufacturing quota for a basic class of controlled substance listed in Schedule I or II which he has previously fixed in order to prevent the aggregate of the individual manufacturing quotas and import permits outstanding or to be granted from exceeding the aggregate production quota which has been established for that class pursuant of § 1303.11, as adjusted pursuant to § 1303.13. If a quota assigned to a new manufacturer pursuant to § 1303.23(b), or if a quota assigned to any manufacturer is increased pursuant to § 1303.24(c), or if an import permit issued to an importer pursuant to part 1312 of this chapter, causes the total quantity of a basic class to be manufactured and imported during the year to exceed the aggregate production quota which has been established for that class pursuant to § 1303.11, as adjusted pursuant to § 1303.13, the Administrator may proportionately reduce the individual manufacturing quotas and import permits of all other registrants to keep the aggregate production quota within the limits originally established, or, alternatively, the Administrator may reduce the individual manufacturing quota of any registrant whose quota is suspended pursuant to § 1303.24(b) or § 1301.36 of this chapter, or is abandoned pursuant to § 1303.27.
Citations to §1303.13(c)
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(a) In any case where the Administrator shall hold a hearing regarding the determination of an aggregate production quota pursuant to § 1303.11(c), or regarding the adjustment of an aggregate production quota pursuant to § 1303.13(c), the procedures for such hearing shall be governed generally by the rule making procedures set forth in the Administrative Procedure 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.
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(a) The Administrator may, in his sole discretion, and shall, if determined by the Administrator to be necessary under § 1303.11(c) or 1303.13(c) based on objection by a state, hold a hearing for the purpose of receiving factual evidence regarding any one or more issues (to be specified by him) involved in the determination or adjustment of any aggregate production quota.
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(b) Any interested person who desires to participate in a hearing on the determination or adjustment of an aggregate production quota, which hearing is ordered by the Administrator pursuant to § 1303.11(c) or § 1303.13(c) may do so by filing with the Administrator, within 30 days of the date of publication of notice of the hearing in the Federal Register, a written notice of his intention to participate in such hearing in the form prescribed in § 1316.48 of this chapter.
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(b) The hearing will commence at the place and time designated in the notice given pursuant to paragraph (a) of this section or in the notice of hearing published in the Federal Register pursuant to § 1303.11(c) or § 1303.13 (c), but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing.