21 Cfr 1315.22

Drug Enforcement Administration, Justice
(e) The Administrator may, but is
not required to, hold a public hearing
on one or more issues raised by the
comments and objections filed with
him. In the event the Administrator
decides to hold such a hearing, he shall
publish a notice of the hearing in the
FEDERAL REGISTER. The notice shall
summarize the issues to be heard and
set the time for the hearing, which
shall not be less than 10 days after the
date of publication of the notice.
(f) After consideration of any comments or objections, or after a hearing
if one is ordered by the Administrator,
the Administrator shall issue and publish in the FEDERAL REGISTER the final
order determining the assessment of
annual needs for the chemical. The
order shall include the findings of fact
and conclusions of law upon which the
order is based. The order shall specify
the date on which it shall take effect.
A notice of the publication shall be
mailed simultaneously to each person
registered as a manufacturer or importer of the chemical.

Subpart C—Individual
Manufacturing Quotas

nshattuck on DSK9F9SC42PROD with CFR

§ 1315.21 Individual
manufacturing
quotas.
The Administrator shall, on or before
July 1 of each year, fix for and issue to
each person registered to manufacture
in bulk ephedrine, pseudoephedrine, or
phenylpropanolamine who applies for a
manufacturing quota an individual
manufacturing quota authorizing that
person to manufacture during the next
calendar year a quantity of that chemical. Any manufacturing quota fixed
and issued by the Administrator is subject to his authority to reduce or limit
it at a later date pursuant to § 1315.26
and to his authority to revoke or suspend it at any time pursuant to
§§ 1301.36, 1309.43, 1309.44, or 1309.45 of
this chapter.
§ 1315.22 Procedure for applying for
individual manufacturing quotas.
Any person who is registered to manufacture ephedrine, pseudoephedrine,
or phenylpropanolamine and who desires to manufacture a quantity of the
chemical must apply on DEA Form 189
for a manufacturing quota for the

§ 1315.22
quantity of the chemical. Copies of
DEA Form 189 may be obtained from
the Office of Diversion Control Web
site, and must be filed (on or before
April 1 of the year preceding the calendar year for which the manufacturing quota is being applied) with the
UN Reporting & Quota Section, Diversion Control Division, Drug Enforcement Administration. See the Table of
DEA Mailing Addresses in § 1321.01 of
this chapter for the current mailing address. A separate application must be
made for each chemical desired to be
manufactured. The applicant must
state the following:
(a) The name and DEA Chemical
Code Number, as set forth in part 1310
of this chapter, of the chemical.
(b) For the chemical in each of the
current and preceding 2 calendar years,
(1) The authorized individual manufacturing quota, if any;
(2) The actual or estimated quantity
manufactured;
(3) The actual or estimated net disposal;
(4) The actual or estimated inventory
allowance pursuant to § 1315.24; and
(5) The actual or estimated inventory
as of December 31.
(c) For the chemical in the next calendar year,
(1) The desired individual manufacturing quota; and
(2) Any additional factors that the
applicant finds relevant to the fixing of
the individual manufacturing quota,
including any of the following:
(i) The trend of (and recent changes
in) the applicant’s and the national
rates of net disposal.
(ii) The applicant’s production cycle
and current inventory position.
(iii) The economic and physical availability of raw materials for use in manufacturing and for inventory purposes.
(iv) Yield and stability problems.
(v) Potential disruptions to production (including possible labor strikes).
(vi) Recent unforeseen emergencies
such as floods and fires.
[72 FR 37448, July 10, 2007, as amended at 73
FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9,
2010]

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