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Federal Register / Vol. 71, No.

231 / Friday, December 1, 2006 / Notices 69589

parties provide such information in gaining access to the Commission Dated: November 21, 2006.
their hearing testimony and pre- and should contact the Secretary at 202– Joseph T. Rannazzisi,
posthearing briefs and other 205–2000. Deputy Assistant Administrator, Office of
submissions, to the extent they can. By order of the Commission. Diversion Control, Drug Enforcement
Statements and Briefs: In lieu of or in Issued: November 28, 2006. Administration.
addition to participating in the hearing, [FR Doc. E6–20337 Filed 11–30–06; 8:45 am]
Marilyn R. Abbott,
interested parties are invited to submit BILLING CODE 4410–09–P
Secretary to the Commission.
written statements or briefs concerning
this investigation in accordance with [FR Doc. E6–20374 Filed 11–30–06; 8:45 am]
the requirements in the ‘‘Submissions’’ BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE
section below. Any pre-hearing briefs or
statements should be filed not later than Drug Enforcement Administration
5:15 p.m., April 10, 2007; the deadline
for filing post-hearing briefs or DEPARTMENT OF JUSTICE Manufacturer of Controlled
statements is 5:15 p.m., May 2, 2007. Substances; Notice of Application
Submissions: All written submissions, Drug Enforcement Administration
Pursuant to § 1301.33(a) of Title 21 of
including requests to appear at the Importer of Controlled Substances; the Code of Federal Regulations (CFR),
hearing, statements, and briefs, should Notice of Registration this is notice that on April 25, 2006,
be addressed to the Secretary, United Chattem Chemicals, Inc., 3801 St. Elmo
States International Trade Commission, By Notice dated August 15, 2006 and Avenue, Building 18, Chattanooga,
500 E Street, SW., Washington, DC published in the Federal Register on Tennessee 37409, made application by
20436. All written submissions must August 22, 2006, (71 FR 48946–48947), renewal to the Drug Enforcement
conform with the provisions of section Almac Clinical Services Incorporated Administration (DEA) to be registered as
201.8 of the Commission’s Rules of (ACSI) formerly known as Clinical Trial a bulk manufacturer of the basic classes
Practice and Procedure (19 CFR 201.8); Services, 2661 Audubon Road, of controlled substances listed in
any submission that contains Audubon, Pennsylvania 19403, made schedule I and II:
confidential business information must application by renewal to the Drug
also conform with the requirements of Enforcement Administration (DEA) to Drug Schedule
section 201.6 of the Commission’s Rules
be registered as an importer of the basic
of Practice and Procedure (19 CFR N–Ethylamphetamine (1475) I
classes of controlled substances listed in
201.6). Section 201.8 of the rules require 2,5–Dimethoxyamphetamine I
schedule II: (7396).
that a signed original (or a copy
designated as an original) and fourteen 4–Methoxyamphetamine I
Drug Schedule (7411).
(14) copies of each document be filed.
Difenoxin (9168) ..................... I
In the event that confidential treatment Oxycodone (9143) ........................ II Dihydromorphine (9145) ........ I
of the document is requested, at least Fentanyl (9801) ............................ II Amphetamine (1100) ............. II
four (4) additional copies must be filed, Methamphetamine (1105) ...... II
in which the confidential information The company plans to import small Methylphenidate (1724) ......... II
must be deleted. Section 201.6 of the quantities of the listed controlled Pentobarbital (2270) .............. II
rules requires that the cover of the substances in dosage form to conduct Secobarbital (2315) ................ II
document and the individual pages be Codeine (9050) ...................... II
clinical trials. Dihydrocodeine (9120) ........... II
clearly marked as to whether they are
the ‘‘confidential’’ or ‘‘nonconfidential’’ No comments or objections have been Oxycodone (9143) ................. II
version, and that the confidential received. DEA has considered the Hydromorphone (9150) .......... II
factors in 21 U.S.C. 823(a) and § 952(a) Diphenoxylate (9170) ............. II
business information be clearly Hydrocodone (9193) .............. II
identified by means of brackets. All and determined that the registration of
Almac Clinical Services Incorporation Meperidine (9230) .................. II
written submissions, except for Dextropropoxyphene, bulk II
confidential business information, will (ACSI) to import the basic classes of (non-dosage forms) (9273).
be made available for inspection by controlled substances is consistent with Morphine (9300) ..................... II
interested parties. the public interest and with United Thebaine (9333) ..................... II
In its request letter, the Committee States obligations under international Opium Extracts (9610) ........... II
stated that it intends to make the treaties, conventions, or protocols in Opium Fluid Extract (9620) .... II
Commission’s report available to the effect on May 1, 1971, at this time. DEA Opium Tincture (9630) ........... II
public in its entirety, and asked that the has investigated Almac Clinical Services Opium, Granulated (9640) ..... II
Incorporation (ACSI) to ensure that the Oxymorphone (9652) ............. II
Commission not include any
company’s registration is consistent Noroxymorphone (9668) ........ II
confidential business or national Opium, Powdered (9639) ....... II
security confidential information in the with the public interest. The Alfentanil (9737) ..................... II
report it sends to the Committee. The investigation has included inspection Sufentanil (9740) .................... II
report that the Commission sends to the and testing of the company’s physical Fentanyl (9801) ...................... II
Committee will not contain any such security systems, verification of the
information. Any confidential business company’s compliance with state and The company plans to manufacture
information received by the local laws, and a review of the the listed controlled substances in bulk
Commission in this investigation and company’s background and history. for distribution to its customers.
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used in preparing the report will not be Therefore, pursuant to 21 U.S.C. 952(a) Any other such applicant and any
published in a manner that would and 958(a), and in accordance with 21 person who is presently registered with
reveal the operations of the firm CFR 1301.34, the above named company DEA to manufacture such a substance
supplying the information. is granted registration as an importer of may file comments or objections to the
Persons with mobility impairments the basic classes of controlled issuance of the proposed registration
who will need special assistance in substances listed. pursuant to 21 CFR § 1301.33(a).

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69590 Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices

Any such written comments or Office of Diversion Control, Drug Any manufacturer who is presently,
objections being sent via regular mail Enforcement Administration, or is applying to be, registered with DEA
should be addressed, in quintuplicate, Washington, DC 20537, Attention: DEA to manufacture such basic class of
to the Deputy Assistant Administrator, Federal Register Representative/ODL; or controlled substance may file comments
Office of Diversion Control, Drug any being sent via express mail should or objections to the issuance of the
Enforcement Administration, be sent to DEA Headquarters, Attention: proposed registration and may, at the
Washington, DC 20537, Attention: DEA DEA Federal Register Representative/ same time, file a written request for a
Federal Register Representative/ODL; or ODL, 2401 Jefferson-Davis Highway, hearing on such application pursuant to
any being sent via express mail should Alexandria, Virginia 22301; and must be 21 CFR 1301.43 and in such form as
be sent to DEA Headquarters, Attention: filed no later than January 2, 2007. prescribed by 21 CFR 1316.47.
DEA Federal Register Representative/ This procedure is to be conducted Any such written comments or
ODL, 2401 Jefferson-Davis Highway, simultaneously with and independent objections being sent via regular mail
Alexandria, Virginia 22301; and must be of the procedures described in 21 CFR should be addressed, in quintuplicate,
filed no later than January 30, 2007. 1301.34(b),(c),(d),(e) and (f). As noted in to the Deputy Assistant Administrator,
Dated: November 21, 2006. a previous notice published in the Office of Diversion Control, Drug
Federal Register on September 23, 1975, Enforcement Administration,
Joseph T. Rannazzisi,
(40 FR 43745–46), all applicants for Washington, DC 20537, Attention: DEA
Deputy Assistant Administrator, Office of
registration to import a basic class of Federal Register Representative/ODL; or
Diversion Control, Drug Enforcement
Administration. any controlled substance listed in any being sent via express mail should
schedule I or II are, and will continue be sent to DEA Headquarters, Attention:
[FR Doc. E6–20339 Filed 11–30–06; 8:45 am]
to be required to demonstrate to the DEA Federal Register Representative/
BILLING CODE 4410–09–P
Deputy Assistant Administrator, Office ODL, 2401 Jefferson-Davis Highway,
of Diversion Control, Drug Enforcement Alexandria, Virginia 22301; and must be
DEPARTMENT OF JUSTICE Administration, that the requirements filed no later than January 2, 2007.
for such registration pursuant to 21 This procedure is to be conducted
Drug Enforcement Administration U.S.C. 958(a), 21 U.S.C. 823(a), and 21 simultaneously with and independent
CFR 1301.34(b),(c),(d),(e) and (f) are of the procedures described in 21 CFR
Importer of Controlled Substances; satisfied. 1301.34(b), (c), (d), (e) and (f). As noted
Notice of Application in a previous notice published in the
Dated: November 21, 2006. Federal Register on September 23, 1975,
Pursuant to 21 U.S.C. 958(i), the Joseph T. Rannazzisi, (40 FR 43745–46), all applicants for
Attorney General shall, prior to issuing Deputy Assistant Administrator, Office of registration to import a basic class of
a registration under this Section to a Diversion Control, Drug Enforcement any controlled substance listed in
bulk manufacturer of a controlled Administration. schedule I or II are, and will continue
substance in schedule I or II and prior [FR Doc. E6–20336 Filed 11–30–06; 8:45 am] to be, required to demonstrate to the
to issuing a regulation under 21 U.S.C. BILLING CODE 4410–09–P Deputy Assistant Administrator, Office
952(a)(2)(B) authorizing the importation of Diversion Control, Drug Enforcement
of such a substance, provide Administration, that the requirements
manufacturers holding registrations for DEPARTMENT OF JUSTICE for such registration pursuant to 21 USC
the bulk manufacture of the substance 958(a), 21 U.S.C. § 823(a), and 21 CFR
an opportunity for a hearing. Drug Enforcement Administration
1301.34(b), (c), (d), (e) and (f) are
Therefore, in accordance with 21 CFR satisfied.
1301.34(a), this is notice that on Importer of Controlled Substances;
September 27, 2006, Formulation Notice of Application Dated: November 21, 2006.
Technologies LLC., 11400 Burnet Road, Joseph T. Rannazzisi,
Pursuant to 21 U.S.C. § 958(i), the Deputy Assistant Administrator, Office of
Suite 4010, Austin, Texas 78758, made
Attorney General shall, prior to issuing Diversion Control, Drug Enforcement
application to the Drug Enforcement
a registration under this Section to a Administration.
Administration (DEA) to be registered as
bulk manufacturer of a controlled [FR Doc. E6–20335 Filed 11–30–06; 8:45 am]
an importer of Fentanyl (9801), a basic
substance in schedule I or II, and prior
class of controlled substance listed in BILLING CODE 4410–09–P
to issuing a regulation under 21 U.S.C.
schedule II.
The company plans to import the 952(a)(2)(B) authorizing the importation
listed controlled substance for clinical of such a substance, provide DEPARTMENT OF JUSTICE
trials, research, analytical purposes, and manufacturers holding registrations for
distribution to its customers. the bulk manufacture of the substance Drug Enforcement Administration
Any manufacturer who is presently, an opportunity for a hearing.
Therefore, in accordance with 21 CFR Manufacturer of Controlled
or is applying to be, registered with DEA Substances; Notice of Application
to manufacture such basic class of 1301.34(a), this is notice that on
controlled substances may file September 12, 2006, Hospira, Inc., 1776 Pursuant to § 1301.33(a) of Title 21 of
comments or objections to the issuance North Centennial Drive, McPherson, the Code of Federal Regulations (CFR),
of the proposed registration and may, at Kansas 67460–1247, made application this is notice that on August 16, 2006,
the same time, file a written request for by renewal to the Drug Enforcement ISP Freetown Fine Chemicals, Inc., 238
a hearing on such application pursuant Administration (DEA) to be registered as South Main Street, Assonet,
an importer of Remifentanil (9739), a
rmajette on PROD1PC67 with NOTICES1

to 21 CFR 1301.43 and in such form as Massachusetts 02702, made application


prescribed by 21 CFR 1316.47. basic class of controlled substance listed by renewal to the Drug Enforcement
Any such written comments or in schedule II. Administration (DEA) to be registered as
objections being sent via regular mail The company plans to import a bulk manufacturer of the basic classes
should be addressed, in quintuplicate, Phenylacetone to manufacture of controlled substances listed in
to the Deputy Assistant Administrator, Amphetamine. schedule I and II:

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