Manufacturer of Controlled Substances; Notice of Application, 69589-69590 [E6-20339]

Download as PDF 69589 rmajette on PROD1PC67 with NOTICES1 Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices parties provide such information in their hearing testimony and pre- and posthearing briefs and other submissions, to the extent they can. Statements and Briefs: In lieu of or in addition to participating in the hearing, interested parties are invited to submit written statements or briefs concerning this investigation in accordance with the requirements in the ‘‘Submissions’’ section below. Any pre-hearing briefs or statements should be filed not later than 5:15 p.m., April 10, 2007; the deadline for filing post-hearing briefs or statements is 5:15 p.m., May 2, 2007. Submissions: All written submissions, including requests to appear at the hearing, statements, and briefs, should be addressed to the Secretary, United States International Trade Commission, 500 E Street, SW., Washington, DC 20436. All written submissions must conform with the provisions of section 201.8 of the Commission’s Rules of Practice and Procedure (19 CFR 201.8); any submission that contains confidential business information must also conform with the requirements of section 201.6 of the Commission’s Rules of Practice and Procedure (19 CFR 201.6). Section 201.8 of the rules require that a signed original (or a copy designated as an original) and fourteen (14) copies of each document be filed. In the event that confidential treatment of the document is requested, at least four (4) additional copies must be filed, in which the confidential information must be deleted. Section 201.6 of the rules requires that the cover of the document and the individual pages be clearly marked as to whether they are the ‘‘confidential’’ or ‘‘nonconfidential’’ version, and that the confidential business information be clearly identified by means of brackets. All written submissions, except for confidential business information, will be made available for inspection by interested parties. In its request letter, the Committee stated that it intends to make the Commission’s report available to the public in its entirety, and asked that the Commission not include any confidential business or national security confidential information in the report it sends to the Committee. The report that the Commission sends to the Committee will not contain any such information. Any confidential business information received by the Commission in this investigation and used in preparing the report will not be published in a manner that would reveal the operations of the firm supplying the information. Persons with mobility impairments who will need special assistance in VerDate Aug<31>2005 13:50 Nov 30, 2006 Jkt 211001 gaining access to the Commission should contact the Secretary at 202– 205–2000. By order of the Commission. Issued: November 28, 2006. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E6–20374 Filed 11–30–06; 8:45 am] BILLING CODE 7020–02–P Dated: November 21, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6–20337 Filed 11–30–06; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated August 15, 2006 and published in the Federal Register on August 22, 2006, (71 FR 48946–48947), Almac Clinical Services Incorporated (ACSI) formerly known as Clinical Trial Services, 2661 Audubon Road, Audubon, Pennsylvania 19403, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug Schedule Oxycodone (9143) ........................ Fentanyl (9801) ............................ II II The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and § 952(a) and determined that the registration of Almac Clinical Services Incorporation (ACSI) to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated Almac Clinical Services Incorporation (ACSI) to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on April 25, 2006, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Building 18, Chattanooga, Tennessee 37409, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule I and II: Drug N–Ethylamphetamine (1475) 2,5–Dimethoxyamphetamine (7396). 4–Methoxyamphetamine (7411). Difenoxin (9168) ..................... Dihydromorphine (9145) ........ Amphetamine (1100) ............. Methamphetamine (1105) ...... Methylphenidate (1724) ......... Pentobarbital (2270) .............. Secobarbital (2315) ................ Codeine (9050) ...................... Dihydrocodeine (9120) ........... Oxycodone (9143) ................. Hydromorphone (9150) .......... Diphenoxylate (9170) ............. Hydrocodone (9193) .............. Meperidine (9230) .................. Dextropropoxyphene, bulk (non-dosage forms) (9273). Morphine (9300) ..................... Thebaine (9333) ..................... Opium Extracts (9610) ........... Opium Fluid Extract (9620) .... Opium Tincture (9630) ........... Opium, Granulated (9640) ..... Oxymorphone (9652) ............. Noroxymorphone (9668) ........ Opium, Powdered (9639) ....... Alfentanil (9737) ..................... Sufentanil (9740) .................... Fentanyl (9801) ...................... Schedule I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR § 1301.33(a). E:\FR\FM\01DEN1.SGM 01DEN1 69590 Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL; or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than January 30, 2007. Dated: November 21, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6–20339 Filed 11–30–06; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration rmajette on PROD1PC67 with NOTICES1 Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II and prior to issuing a regulation under 21 U.S.C. 952(a)(2)(B) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on September 27, 2006, Formulation Technologies LLC., 11400 Burnet Road, Suite 4010, Austin, Texas 78758, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Fentanyl (9801), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance for clinical trials, research, analytical purposes, and distribution to its customers. Any manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substances may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Deputy Assistant Administrator, VerDate Aug<31>2005 13:50 Nov 30, 2006 Jkt 211001 Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL; or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than January 2, 2007. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b),(c),(d),(e) and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745–46), all applicants for registration to import a basic class of any controlled substance listed in schedule I or II are, and will continue to be required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 CFR 1301.34(b),(c),(d),(e) and (f) are satisfied. Dated: November 21, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6–20336 Filed 11–30–06; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. § 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under 21 U.S.C. 952(a)(2)(B) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on September 12, 2006, Hospira, Inc., 1776 North Centennial Drive, McPherson, Kansas 67460–1247, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import Phenylacetone to manufacture Amphetamine. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Any manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL; or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than January 2, 2007. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d), (e) and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745–46), all applicants for registration to import a basic class of any controlled substance listed in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 USC 958(a), 21 U.S.C. § 823(a), and 21 CFR 1301.34(b), (c), (d), (e) and (f) are satisfied. Dated: November 21, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6–20335 Filed 11–30–06; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on August 16, 2006, ISP Freetown Fine Chemicals, Inc., 238 South Main Street, Assonet, Massachusetts 02702, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule I and II: E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 71, Number 231 (Friday, December 1, 2006)]
[Notices]
[Pages 69589-69590]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20339]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  1301.33(a) of Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on April 25, 2006, Chattem 
Chemicals, Inc., 3801 St. Elmo Avenue, Building 18, Chattanooga, 
Tennessee 37409, made application by renewal to the Drug Enforcement 
Administration (DEA) to be registered as a bulk manufacturer of the 
basic classes of controlled substances listed in schedule I and II:

------------------------------------------------------------------------
                   Drug                               Schedule
------------------------------------------------------------------------
N-Ethylamphetamine (1475)................  I
2,5-Dimethoxyamphetamine (7396)..........  I
4-Methoxyamphetamine (7411)..............  I
Difenoxin (9168).........................  I
Dihydromorphine (9145)...................  I
Amphetamine (1100).......................  II
Methamphetamine (1105)...................  II
Methylphenidate (1724)...................  II
Pentobarbital (2270).....................  II
Secobarbital (2315)......................  II
Codeine (9050)...........................  II
Dihydrocodeine (9120)....................  II
Oxycodone (9143).........................  II
Hydromorphone (9150).....................  II
Diphenoxylate (9170).....................  II
Hydrocodone (9193).......................  II
Meperidine (9230)........................  II
Dextropropoxyphene, bulk (non-dosage       II
 forms) (9273).
Morphine (9300)..........................  II
Thebaine (9333)..........................  II
Opium Extracts (9610)....................  II
Opium Fluid Extract (9620)...............  II
Opium Tincture (9630)....................  II
Opium, Granulated (9640).................  II
Oxymorphone (9652).......................  II
Noroxymorphone (9668)....................  II
Opium, Powdered (9639)...................  II
Alfentanil (9737)........................  II
Sufentanil (9740)........................  II
Fentanyl (9801)..........................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for distribution to its customers.
    Any other such applicant and any person who is presently registered 
with DEA to manufacture such a substance may file comments or 
objections to the issuance of the proposed registration pursuant to 21 
CFR Sec.  1301.33(a).

[[Page 69590]]

    Any such written comments or objections being sent via regular mail 
should be addressed, in quintuplicate, to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Attention: DEA Federal Register 
Representative/ODL; or any being sent via express mail should be sent 
to DEA Headquarters, Attention: DEA Federal Register Representative/
ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must 
be filed no later than January 30, 2007.

    Dated: November 21, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E6-20339 Filed 11-30-06; 8:45 am]
BILLING CODE 4410-09-P