Importer of Controlled Substances, Notice of Application; Meridian Medical Technologies, 15974-15975 [2013-05793]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES 15974 Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices Bishop’s Lodge Road, Tesuque, New Mexico, 87574. • Pojoaque—Pojoaque Valley School District Campus, West Wing Conference Room, 1574 State Road 502 West, Santa Fe, New Mexico 87506. • Santa Fe—Santa Fe Community College, Jemez Rooms 1&2, 6401 Richards Avenue, Santa Fe, New Mexico 87508. ˜ • Espanola—Northern New Mexico College, Cafeteria, 921 N. Paseo de ˜ ˜ Onate, Espanola, New Mexico 87532. • Taos—Taos Convention Center, Rio Grande Hall, Room A, 120 Civic Plaza, Taos, New Mexico 87571. FOR FURTHER INFORMATION CONTACT: Ms. Molly Thrash, Bureau of Reclamation, Albuquerque Area Office, 555 Broadway NE., Suite 100, Albuquerque, New Mexico, 87102; telephone (505) 462– 3702; facsimile (505) 462–3780; email sthrash@usbr.gov. Persons who use a telecommunications device for the deaf may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week to leave a message or question with the above individual. You will receive a reply during normal business hours. SUPPLEMENTARY INFORMATION: The Bureau of Reclamation is the lead Federal agency for preparation of the Pojoaque Basin Regional Water System Environmental Impact Statement (EIS). As such, Reclamation published a Notice of Intent to Prepare an EIS on February 24, 2012 (77 FR 11155). The U.S. Army Corps of Engineers, Bureau of Indian Affairs, U.S. Fish and Wildlife Service, Indian Health Service, New Mexico Department of Transportation, New Mexico Office of the State Engineer, County of Santa Fe, City of ´ Santa Fe, and the Pueblos of Nambe, Pojoaque, San Ildefonso, and Tesuque have been invited to participate as cooperating agencies. Other entities may be considered as necessary during the EIS process. Reclamation is proposing to plan, design, and construct the Pojoaque Basin Regional Water System in accordance with the Aamodt Litigation Settlement Act, which is Title VI of the Claims Resolution Act of 2010 (Pub. L. 111–291, Title VI; 124 Stat. 3065). The proposed project would divert, treat, and distribute potable water to the Pueblo and non-Pueblo residents of the Pojoaque Basin. The Regional Water System would consist of surface water diversion and water treatment facilities within the boundaries of San Ildefonso Pueblo on the Rio Grande and storage tanks, transmission and distribution VerDate Mar<15>2010 17:11 Mar 12, 2013 Jkt 229001 pipelines, and aquifer storage and recovery well fields that would supply up to 4,000 acre-feet of water annually to customers within the Pojoaque Basin. Additional Information on the project is available at the project Web site at PojoaqueBasinEIS.com. Public Scoping Scoping is an early, ongoing, and open public process for determining the relevant issues to be addressed in the EIS and for identifying any significant issues and suggested alternatives related to the proposed Federal action. Public comments on the scope and content of the EIS may be provided at the public meetings, submitted online through the project Web site, sent via email or facsimile, or mailed to the address shown below. To be most effectively considered, comments should be submitted by May 3, 2013. Public comments and/or requests to be added to the project mailing list will be accepted at all of the public scoping meetings or by any of the methods shown below: • Email: PojoaqueBasinEIS@usbr.gov. • Facsimile: (505) 462–3780. • Web site: PojoaqueBasinEIS.com. • Address: Bureau of Reclamation, Albuquerque Area Office, Suite 100 (ALB–842), 555 Broadway NE., Suite 100, Albuquerque, New Mexico, 87102. In addition to the public scoping meetings described above, Reclamation may host additional scoping meetings with Pueblo members at or near each of the four Pueblos. Government-togovernment consultation will continue with the Pueblo governments and coordination will continue with other Federal and State agencies. Special Assistance for Public Meetings If special assistance is required to participate in a particular scoping meeting, please contact Ms. Molly Thrash at (505) 462–3702, or via email at sthrash@usbr.gov. A telephone device for the hearing impaired is available at 1–800–877–8339. Please provide notification as far in advance as possible to enable Reclamation to secure the needed services. If a request cannot be honored, the requestor will be notified. Public Disclosure Before including your address, phone number, email address, or other personal identifying information in any communication, you should be aware that your entire comments—including your personal identifying information— may be made publicly available at any time. While you can ask us in your communication to withhold your personal identifying information from PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 public review, we cannot guarantee that we will be able to do so. Dated: January 16, 2013. Larry Walkoviak, Regional Director—Upper Colorado Region, Bureau of Reclamation. [FR Doc. 2013–05604 Filed 3–12–13; 8:45 am] BILLING CODE 4310–MN–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Application; Meridian Medical Technologies Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on January 8, 2013, 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 manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product sold to European customers meets standards established by the European Pharmacopeia, which is administered by the Directorate for the Quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM to use as reference standards. This is the sole purpose for which the company will be authorized by DEA to import morphine. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance listed in schedule II, which falls under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), 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 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 April 12, 2013. E:\FR\FM\13MRN1.SGM 13MRN1 Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices 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 substances in schedules 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: March 7, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration mstockstill on DSK4VPTVN1PROD with NOTICES Importer of Controlled Substances, Notice of Registration: Hospira Inc. By Notice dated December 14, 2012, and published in the Federal Register on December 21, 2012, 77 FR 75670, 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 Remifentanil for use in dosage form manufacturing. 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 Hospira Inc. to import the basic class of controlled substance 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 Hospira 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. 952(a) and 958(a), and in accordance with 21 17:11 Mar 12, 2013 Jkt 229001 Dated: March 7, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–05794 Filed 3–12–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances, Notice of Registration; Johnson Matthey, Inc., Pharmaceuticals Materials By Notice dated November 1, 2012, and published in the Federal Register on November 9, 2012, 77 FR 67397, Johnson Matthey, Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: [FR Doc. 2013–05793 Filed 3–12–13; 8:45 am] VerDate Mar<15>2010 CFR 1301.34, the above named company is granted registration as an importer of the basic class of controlled substance listed. Drug Schedule Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Methylphenidate (1724) ................ Codeine (9050) ............................. Oxycodone (9143) ........................ Diphenoxylate (9170) ................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... I II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. The Thebaine (9333) will also be used to manufacture other controlled substances for sale in bulk 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 Johnson Matthey Inc., Pharmaceuticals Materials to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Johnson Matthey Inc., Pharmaceuticals Materials to ensure that the company’s registration is consistent with the public interest. The investigation has included PO 00000 Frm 00048 Fmt 4703 Sfmt 9990 15975 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(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed. Dated: February 27, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–05799 Filed 3–12–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Job Clubs Study ACTION: Notice; correction. The Department of Labor published a document in the Federal Register of February 26, 2013, concerning request for comments on site visits to job clubs. The document contained incorrect dates. SUMMARY: FOR FURTHER INFORMATION CONTACT: Contact Ben Seigel by telephone at 202– 693–6032 (this is not a toll-free number) or by email at CFBNP@dol.gov. Correction In the Federal Register of February 26, 2013, in FR Doc. 2013–04391, on page 13086, in the second column, correct the DATES caption to read: Written comments must be submitted to the office listed in the addressee section on or before April 27, 2013. DATES: Signed at Washington, DC, this 5th day of March, 2013. Irasema Garza, Acting Assistant Secretary for Policy, U.S. Department of Labor . [FR Doc. 2013–05775 Filed 3–12–13; 8:45 am] BILLING CODE P E:\FR\FM\13MRN1.SGM 13MRN1

Agencies

[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15974-15975]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05793]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances, Notice of Application; 
Meridian Medical Technologies

    Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this 
is notice that on January 8, 2013, 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 manufactures a product containing morphine in the 
United States. The company exports this product to customers around the 
world. The company has been asked to ensure that its product sold to 
European customers meets standards established by the European 
Pharmacopeia, which is administered by the Directorate for the Quality 
of Medicines (EDQM). In order to ensure that its product will meet 
European specifications, the company seeks to import morphine supplied 
by EDQM to use as reference standards. This is the sole purpose for 
which the company will be authorized by DEA to import morphine.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic class of controlled 
substance listed in schedule II, which falls under the authority of 
section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the 
circumstances set forth in 21 U.S.C. 958(i), 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 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 April 12, 2013.

[[Page 15975]]

    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 substances 
in schedules 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: March 7, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-05793 Filed 3-12-13; 8:45 am]
BILLING CODE 4410-09-P