21 Cfr 1315.34

§ 1315.34

21 CFR Ch. II (4–1–18 Edition)
Notice of Revocation

The foregoing power of attorney is hereby
revoked by the undersigned, who is authorized to sign the current application for registration of the above-named registrant
under the Controlled Substances Act or the
Controlled Substances Import and Export
Act. Written notice of this revocation has
been
given
to
the
attorney-in-fact
llllll this same day.
llllllllllllllllllllllll
(Signature of person revoking power)
Witnesses:
1. llllll
2. llllll
Signed and dated on the ll day of l,
(year), at llllll.

(d) A power of attorney must be executed by the person who signed the
most recent application for DEA registration or reregistration; the person
to whom the power of attorney is being
granted; and two witnesses.
(e) A power of attorney must be revoked by the person who signed the
most recent application for DEA registration or reregistration, and two
witnesses.
[73 FR 73555, Dec. 3, 2008]

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§ 1315.34

Obtaining an import quota.

(a) Any person who is registered to
import ephedrine, pseudoephedrine, or
phenylpropanolamine, or whose requirement of registration is waived
pursuant to § 1309.24(c) of this chapter,
and who desires to import during the
next calendar year any ephedrine,
pseudoephedrine, or phenylpropanolamine or drug products containing these
chemicals, must apply on DEA Form
488 for an import quota for the chemical. A separate application must be
made for each chemical desired to be
imported.
(b) The applicant must provide the
following information in the application:
(1) The applicant’s name and DEA
registration number.
(2) The name and address of a contact
person and contact information (telephone number, fax number, e-mail address).
(3) Name of the chemical and DEA
Chemical Code number.
(4) Type of product (bulk or finished
dosage forms).

(5) For finished dosage forms, the official name, common or usual name,
chemical name, or brand name, NDC
number, and the authority to market
the drug product under the Federal
Food, Drug and Cosmetic Act of each
form to be imported.
(6) The amount requested expressed
in terms of base.
(7) For the current and preceding two
calendar years, expressed in terms of
base:
(i) Distribution/Sales—name, address,
and registration number (if applicable)
of each customer and the amount sold.
(ii) Inventory as of December 31 (each
form—bulk, in-process, finished dosage
form).
(iii) Acquisition—imports.
(c) For each form of the chemical
(bulk or dosage unit), the applicant
must state the quantity desired for import during the next calendar year.
(d) DEA Form 488 must be filed on or
before April 1 of the year preceding the
calendar year for which the import
quota is being applied. Copies of DEA
Form 488 may be obtained from the Office of Diversion Control Web site, and
must be filed 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.
(e) The Administrator may at his discretion request additional information
from an applicant.
(f) On or before July 1 of the year
preceding the calendar year during
which the quota shall be effective, the
Administrator shall issue to each
qualified applicant an import quota authorizing him to import:
(1) All quantities of the chemical
necessary to manufacture products
that registered manufacturers are authorized to manufacture pursuant to
§ 1315.23; and
(2) Such other quantities of the
chemical that the applicant has applied to import and that are consistent
with his past imports, the estimated
medical, scientific, and industrial
needs of the United States, the establishment and maintenance of reserve

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Drug Enforcement Administration, Justice
stocks, and the total quantity of the
chemical that will be produced.
[72 FR 37448, July 10, 2007, as amended at 75
FR 10684, Mar. 9, 2010]

§ 1315.36 Amending an import quota.
(a) An import quota authorizes the
registered importer to import up to the
set
quantity
of
ephedrine,
pseudoephedrine, or phenylpropanolamine and distribute the chemical or
drug products on the DEA Form 488. An
importer must apply to change the
quantity to be imported.
(b) Any person to whom an import
quota has been issued may at any time
request an increase in the quota quantity by applying to the Administrator
with a statement showing the need for
the adjustment. The application must
be filed 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. The Administrator
may increase the import quota of the
person if and to the extent that he determines that the approval is necessary
to provide for medical, scientific, or
other legitimate purposes regarding
the chemical. The Administrator shall
specify a period of time for which the
approval is in effect or shall provide
that the approval is in effect until the
Administrator notifies the applicant in
writing that the approval is terminated.
(c) With respect to the application
under paragraph (b) of this section, the
Administrator shall approve or deny
the application within 60 days of receiving the application. If the Administrator does not approve or deny the application within 60 days of receiving it,
the application is deemed to be approved and the approval remains in effect until the Administrator notifies
the applicant in writing that the approval is terminated.
[72 FR 37448, July 10, 2007, as amended at 75
FR 10685, Mar. 9, 2010]

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Subpart E—Hearings
§ 1315.50 Hearings generally.
The procedures for the hearing related to assessment of annual needs or

§ 1315.56
to the issuance, adjustment, suspension, or denial of a manufacturing, procurement, or import quota are governed generally by the adjudication
procedures set forth in the Administrative Procedure Act (5 U.S.C. 551–559)
and specifically by section 1002 of the
Act (21 U.S.C. 952), by §§ 1315.52 through
1315.62 of this part, and by the procedures for administrative hearings
under the Act set forth in §§ 1316.41
through 1316.67 of this chapter.
§ 1315.52 Purpose of hearing.
(a) The Administrator may, in his
sole discretion, 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 assessment of national needs.
(b) If requested by a person applying
for or holding a procurement, import,
or individual manufacturing quota, the
Administrator shall hold a hearing for
the purpose of receiving factual evidence regarding the issues involved in
the issuance, adjustment, suspension,
or denial of the quota to the person,
but the Administrator need not hold a
hearing on suspension of a quota under
§ 1301.36 or § 1309.43 of this chapter separate from a hearing on the suspension
of registration under that section.
(c) Extensive argument should not be
offered into evidence, but rather presented in opening or closing statements of counsel or in memoranda or
proposed findings of fact and conclusions of law.
§ 1315.54 Waiver or modification of
rules.
The Administrator or the presiding
officer (with respect to matters pending before him) may modify or waive
any rule in this part by notice in advance of the hearing, if he determines
that no party in the hearing will be unduly prejudiced and the ends of justice
will thereby be served. Such notice of
modification or waiver shall be made a
part of the record of the hearing.
§ 1315.56 Request for hearing or appearance; waiver.
(a) Any applicant or registrant entitled to a hearing under § 1315.52 and
who desires a hearing on the issuance,

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