Importer of Controlled Substances; Notice of Application, 19594-19595 [E9-9782]

Download as PDF pwalker on PROD1PC71 with NOTICES 19594 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices presentations should attend a prehearing conference to be held at 9:30 a.m. on May 28, 2009 at the U.S. International Trade Commission Building. Oral testimony and written materials to be submitted at the hearing are governed by sections 201.6(b)(2) and 201.13(f) of the Commission’s rules. Written submissions.—Each party is encouraged to submit a prehearing brief to the Commission. The deadline for filing prehearing briefs is May 28, 2009. Parties may also file posthearing briefs. The deadline for filing posthearing briefs is June 8, 2009. In addition, any person who has not entered an appearance as a party to the investigation may submit a written statement of information pertinent to the consideration of market disruption or threat thereof and/or remedy on or before June 8, 2009. Parties may submit final comments on market disruption on or before June 16, 2009 and on remedy on or before June 24, 2009. Final comments shall contain no more than ten (10) double-spaced and single-sided pages of textual material. All written submissions must conform with the provisions of section 201.8 of the Commission’s rules; any submissions that contain confidential business information must also conform with the requirements of section 201.6 of the Commission’s rules. The Commission’s rules authorize filing submissions with the Secretary by facsimile or electronic means only to the extent permitted by section 201.8 of the rules (see Handbook for Electronic Filing Procedures, https:// www.usitc.gov/secretary/ fed_reg_notices/rules/documents/ handbook_on_electronic_filing.pdf). Persons with questions regarding electronic filing should contact the Secretary (202–205–2000). In accordance with section 201.16(c) of the Commission’s rules, each document filed by a party to the investigation must be served on all other parties to the investigation (as identified by the service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service. Remedy.—No separate hearing on the issue of remedy will be held. Those parties wishing to present arguments on the issue of remedy may do so orally at the hearing or in their prehearing or posthearing briefs or other written submissions. Authority: This investigation is being conducted under the authority of section 421 of the Trade Act of 1974; this notice is published pursuant to section 206.3 of the Commission’s rules. VerDate Nov<24>2008 17:48 Apr 28, 2009 Jkt 217001 By order of the Commission. Marilyn R. Abbott, Secretary to the Commission. Issued: April 24, 2009. William R. Bishop, Acting Secretary to the Commission. [FR Doc. E9–9760 Filed 4–28–09; 8:45 am] 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) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance BILLING CODE P an opportunity for a hearing. Therefore, in accordance with Title 21 DEPARTMENT OF JUSTICE Code of Federal Regulations § 1301.34(a), this is notice that on Drug Enforcement Administration February 20, 2009, Meridian Medical Technologies, 2555 Hermelin Drive, St. Importer of Controlled Substances; Louis, Missouri 63144, made Notice of Application application by renewal to the Drug This is notice that on March 10, 2009, Enforcement Administration (DEA) to Penick Corporation, 33 Industrial Park be registered as an importer of Road, Pennsville, New Jersey 08070, Morphine (9300), a basic class of made application by renewal to the controlled substance listed in schedule Drug Enforcement Administration II. (DEA) for registration as an importer of The company plans to import the basic classes of controlled products for research experimentation substances listed in schedule II. or clinical use and analytical testing. Drug Schedule Any bulk manufacturer who is presently, or is applying to be, Coca Leaves (9040) ..................... II Raw Opium (9600) ....................... II registered with DEA to manufacture Poppy Straw (9650) ...................... II such basic class of controlled substance may file comments or objections to the Concentrate of Poppy Straw (9670) ........................................ II issuance of the proposed registration and may, at the same time, file a written The company plans to import the request for a hearing on such listed controlled substances to application pursuant to 21 CFR 1301.43 manufacture bulk controlled substance and in such form as prescribed by 21 intermediates for sale to its customers. CFR 1316.47. As noted in a previous notice Any such comments or objections published in the Federal Register on being sent via regular mail should be September 23, 1975 (40 FR 43745), all addressed, in quintuplicate, to the Drug applicants for registration to import a Enforcement Administration, Office of basic class of any controlled substances in schedule I or II are, and will continue Diversion Control, Federal Register to be, required to demonstrate to the Representative (ODL), 8701 Morrissette Deputy Assistant Administrator, Office Drive, Springfield, Virginia 22152; and of Diversion Control, Drug Enforcement must be filed no later than May 29, Administration, that the requirements 2009. for such registration pursuant to 21 This procedure is to be conducted 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 satisfied. 1301.34(b), (c), (d), (e), and (f). As noted Dated: April 17, 2009. in a previous notice published in the Joseph T. Rannazzisi, Federal Register on September 23, 1975 Deputy Assistant Administrator, Office of (40 FR 43745–46), all applicants for Diversion Control, Drug Enforcement registration to import a basic class of Administration. any controlled substance listed in [FR Doc. E9–9778 Filed 4–28–09; 8:45 am] schedule I or II are, and will continue BILLING CODE 4410–09–P to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement DEPARTMENT OF JUSTICE Administration, that the requirements for such registration pursuant to 21 Drug Enforcement Administration U.S.C. 958(a), 21 USC § 823(a), and 21 Importer of Controlled Substances; CFR 1301.34(b), (c), (d), (e), and (f) are Notice of Application satisfied. Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 E:\FR\FM\29APN1.SGM 29APN1 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9782 Filed 4–28–09; 8:45 am] 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 the basic class of any controlled substance 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. 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), 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 Title 21 Code of Federal Regulations § 1301.34(a), this is notice that on March 10, 2009, Almac Clinical Services Inc. (ACSI), 2661 Audubon Road, Audubon, Pennsylvania 19403, has 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 pwalker on PROD1PC71 with NOTICES Oxycodone (9143) ........................ Fentanyl (9801) ............................ 17:48 Apr 28, 2009 BILLING CODE 4410–09–P Jkt 217001 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. Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9789 Filed 4–28–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated January 30, 2009, and published in the Federal Register on February 6, 2009 (74 FR 6309), Mallinckrodt Inc., 3600 North Second Street, St. Louis, Missouri 63147, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic Schedule classes of controlled substances listed in II schedule II: II The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes 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 comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than May 29, 2009. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR VerDate Nov<24>2008 Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9780 Filed 4–28–09; 8:45 am] 19595 Drug Schedule Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw (9650) ..................... Poppy Straw Concentrate (9670) II II II II II The company plans to import the listed controlled substances for the manufacture of controlled substances in bulk for distribution to its customers. 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 Mallinckrodt Inc. 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 Mallinckrodt Inc. 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 PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 By Notice dated December 22, 2008, and published in the Federal Register on December 31, 2008 (73 FR 80431), Norac Inc., 405 S. Motor Avenue, P.O. Box 577, Azusa, California 91702–3232, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Tetrahydrocannabinols (7370), a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance in bulk for formulation into the pharmaceutical controlled substance Marinol® for sale to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Norac Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Norac Inc. 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. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed. E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 74, Number 81 (Wednesday, April 29, 2009)]
[Notices]
[Pages 19594-19595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9782]


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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) 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 Title 21 Code of Federal Regulations 
Sec.  1301.34(a), this is notice that on February 20, 2009, Meridian 
Medical Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144, 
made application by renewal to the Drug Enforcement Administration 
(DEA) to be registered as an importer of Morphine (9300), a basic class 
of controlled substance listed in schedule II.
    The company plans to import products for research experimentation 
or clinical use and analytical testing.
    Any bulk 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 comments or objections being sent via regular mail should 
be addressed, in quintuplicate, to the Drug Enforcement Administration, 
Office of Diversion Control, Federal Register Representative (ODL), 
8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed 
no later than May 29, 2009.
    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 USC Sec.  823(a), 
and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.


[[Page 19595]]


    Dated: April 17, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-9782 Filed 4-28-09; 8:45 am]
BILLING CODE 4410-09-P
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