Importer of Controlled Substances Registration: Alkermes Gainesville LLC, 60864-60865 [2014-24032]

Download as PDF 60864 Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES The Commission advises the Secretary and the NPS on matters relating to the management and development of Acadia National Park, including but not limited to the acquisition of lands and interests in lands (including conservation easements on islands) and the termination of rights of use and occupancy. The Commission is composed of 16 members appointed by the Secretary, as follows: (a) Three members at large; (b) three members appointed from among individuals recommended by the Governor of Maine; (c) four members appointed from among individuals recommended by each of the four towns on the island of Mount Desert; (d) three members appointed from among individuals recommended by each of the three Hancock County mainland communities of Gouldsboro, Winter Harbor, and Trenton, and; (e) three members appointed from among individuals recommended by each of the three island towns of Cranberry Isles, Swans Island, and Frenchboro. Members of the Commission will receive no pay, allowances, or benefits by reason of their service on the Commission. However, while away from their homes or regular places of business in the performance of services for the Commission as approved by the Designated Federal Officer, members will be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under 5 U.S.C. 5703. Individuals who are Federally registered lobbyists are ineligible to serve on all FACA and non-FACA boards, committees, or councils in an individual capacity. The term ‘‘individual capacity’’ refers to individuals who are appointed to exercise their own individual best judgment on behalf of the government, such as when they are designated Special Government Employees, rather than being appointed to represent a particular interest. Seeking Nominations for Membership We are seeking nominations for commission members in the following category: Members at large. Nominations should include a resume providing an adequate description of the nominee’s qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Commission and permit the Department to contact a potential member. VerDate Sep<11>2014 17:27 Oct 07, 2014 Jkt 235001 Members are appointed by the Secretary for a term not to exceed three years. The terms of the three members at large of the Commission expire on September 28, 2014. The Commission last met on June 2, 2014, and usually meets three times per year, generally in June, September, and February. Meetings may take place at such times as designated by the Designated Federal Officer. Members are expected to make every effort to attend all meetings. Members may not appoint deputies or alternates. Controlled substance Dated: September 26, 2014. Alma Ripps, Chief, Office of Policy. [FR Doc. 2014–24044 Filed 10–7–14; 8:45 am] BILLING CODE 4310–EE–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Fisher Clinical Services, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before November 7, 2014. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before November 7, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of importers, of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the DATES: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, subpart R, App. In accordance with 21 CFR 1301.34(a), this is notice that on December 13, 2013, Fisher Clinical Services, Inc., 700A–C Nestle Way, Breinigsville, Pennsylvania 18031–1522 applied to be registered as an importer of the following basic classes of controlled substances: Methylphenidate (1724) ................ Levorphanol (9220) ...................... Noroxymorphone (9668) .............. Tapentadol (9780) ........................ Schedule II II II II The company plans to import the listed substances for analytical research, testing, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. Dated: October 1, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–24081 Filed 10–7–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Alkermes Gainesville LLC ACTION: Notice of registration. Alkermes Gainesville LLC applied to be registered as an importer of a basic class of controlled substance. The DEA grants Alkermes Gainesville LLC registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated June 10, 2014, and published in the Federal Register on June 17, 2014, 79 FR 34551, Alkermes Gainesville LLC, 1300 Gould Drive, Gainesville, Georgia 30504, applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice. The Drug Enforcement Administration (DEA) has considered SUMMARY: E:\FR\FM\08OCN1.SGM 08OCN1 60865 Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices the factors in 21 U.S.C. 823,952(a) and 958(a) and determined that the registration of Alkermes Gainesville LLC 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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 Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to import the above listed controlled substance for analytical research and testing. The import of the above listed basic class of controlled substance would be granted only for analytical testing and clinical testing. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. Dated: October 1, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–24032 Filed 10–7–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Austin Pharma, LLC ACTION: No comments or objections were submitted to this notice. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Austin Pharma, LLC to manufacture 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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: Controlled substance Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Schedule I I The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for distribution and new product development to its customers. The company plans to bulk manufacture a synthetic tetrahydrocannabinol. In reference to drug code 7360, the company plans to manufacture a synthetic cannabinol in bulk for sale to its customers. The controlled substance will be further synthesized to bulk manufacture a synthetic tetrahydrocannabinol (7370). No other activity for this drug code is authorized for this registration. Dated: October 2, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–24018 Filed 10–7–14; 8:45 am] Notice of registration. BILLING CODE 4410–09–P Austin Pharma, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Austin Pharma, LLC registration as a manufacturer of those controlled substances. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32322, Austin Pharma, LLC, 811 Paloma Drive, Suite C, Round Rock, Texas 78665–2402, applied to be registered as a manufacturer of certain basic classes of controlled substances. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:27 Oct 07, 2014 Jkt 235001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Siemens Healthcare Diagnostics, Inc. ACTION: Siemens Healthcare Diagnostics, Inc., applied to be registered as a manufacturer of certain PO 00000 Frm 00062 Fmt 4703 Sfmt 9990 By notice dated May 2, 2014, and published in the Federal Register on May 15, 2014, 79 FR 27936, Siemens Healthcare Diagnostics, Inc., Attn: RA, 100 GBC Drive, Mailstop 514, Newark, Delaware 19702, applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Siemens Healthcare Diagnostics, Inc., to manufacture 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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: SUPPLEMENTARY INFORMATION: Controlled substance Tetrahydrocannabinols (7370) ..... Ecgonine (9180) ........................... Morphine (9300) ........................... Schedule I II II The company plans to produce the listed controlled substances in bulk to be used in the manufacture of reagents and drug calibrator controls which are DEA exempt products. In reference to drug code 7370 the company plans to bulk manufacture a synthetic tetrahydrocannabinol. No other activity for this drug code is authorized for this registration. Dated: October 1, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–24035 Filed 10–7–14; 8:45 am] Notice of registration. SUMMARY: basic classes of controlled substances. The DEA grants Siemens Healthcare Diagnostics, Inc. registration as a manufacturer of those controlled substances. BILLING CODE 4410–09–P E:\FR\FM\08OCN1.SGM 08OCN1

Agencies

[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Pages 60864-60865]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24032]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Alkermes 
Gainesville LLC

ACTION: Notice of registration.

-----------------------------------------------------------------------

SUMMARY: Alkermes Gainesville LLC applied to be registered as an 
importer of a basic class of controlled substance. The DEA grants 
Alkermes Gainesville LLC registration as an importer of this controlled 
substance.

SUPPLEMENTARY INFORMATION: By notice dated June 10, 2014, and published 
in the Federal Register on June 17, 2014, 79 FR 34551, Alkermes 
Gainesville LLC, 1300 Gould Drive, Gainesville, Georgia 30504, applied 
to be registered as an importer of a certain basic class of controlled 
substance. No comments or objections were submitted for this notice.
    The Drug Enforcement Administration (DEA) has considered

[[Page 60865]]

the factors in 21 U.S.C. 823,952(a) and 958(a) and determined that the 
registration of Alkermes Gainesville LLC 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. The DEA investigated the company's 
maintenance of effective controls against diversion by inspecting and 
testing the company's physical security systems, verifying the 
company's compliance with state and local laws, and reviewing 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 Noroxymorphone (9668), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the above listed controlled substance 
for analytical research and testing.
    The import of the above listed basic class of controlled substance 
would be granted only for analytical testing and clinical testing. This 
authorization does not extend to the import of a finished FDA approved 
or non-approved dosage form for commercial distribution in the United 
States.

    Dated: October 1, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-24032 Filed 10-7-14; 8:45 am]
BILLING CODE 4410-09-P