Importer of Controlled Substances Registration, 59645-59646 [2019-24105]

Download as PDF 59645 Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Notices Authority: 42 U.S.C. 6213; and 30 CFR 556.511–556.515. company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. Walter D. Cruickshank, Acting Director, Bureau of Ocean Energy Management. Dated: October 18, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–24052 Filed 11–4–19; 8:45 am] BILLING CODE 4310–MR–P [FR Doc. 2019–24107 Filed 11–4–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–536] Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: Organix, Inc. ACTION: Bulk Manufacturer of Controlled Substances Application: Noramco Inc. 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 on or before January 6, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on September 9, 2019, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801–2029 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Controlled substance Gamma Hydroxybutyric Acid ... Lysergic acid diethylamide ...... Marihuana ................................ Tetrahydrocannabinols ............ Dimethyltryptamine .................. Psilocybin ................................. Psilocyn .................................... Heroin ...................................... Morphine .................................. Drug code 2010 7315 7360 7370 7435 7437 7438 9200 9300 [Docket No. DEA–526] Schedule I I I I I I I I II ACTION: Notice of application. Registered bulk manufacturer of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 6, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: In accordance with 21 CFR 1301.33(a), this is notice that on August 6, 2019, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801– 4417 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Hydromorphone ....................... Hydrocodone ............................ Morphine .................................. Oripavine .................................. Thebaine .................................. Opium extracts ......................... Opium fluid extract ................... Opium tincture ......................... Opium, powdered .................... Opium, granulated ................... Oxymorphone .......................... Noroxymorphone ..................... Tapentadol ............................... khammond on DSKJM1Z7X2PROD with NOTICES 16:34 Nov 04, 2019 Jkt 250001 II II II II II II II II II II II II II Dated: October 22, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–24106 Filed 11–4–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug code Marihuana ................................ Tetrahydrocannabinols ............ Codeine-N-oxide ...................... Dihydromorphine ...................... Hydromorphinol ........................ Morphine-N-oxide .................... Amphetamine ........................... Methylphenidate ....................... Nabilone ................................... Phenylacetone ......................... Codeine .................................... Dihydrocodeine ........................ Oxycodone ............................... 7360 7370 9053 9145 9301 9307 1100 1724 7379 8501 9050 9120 9143 Schedule I I I I I I II II II II II II II [Docket No. DEA–530] Importer of Controlled Substances Registration ACTION: schedule I and II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Notice of registration. The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and II controlled substances. The companies listed below applied to be registered as an importers of various basic classes of schedule I and II controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted and no requests for a hearing were submitted for these notices. SUMMARY: Catalent Pharma Solutions, LLC ....................................................................................................................... Research Triangle Institute ............................................................................................................................... VerDate Sep<11>2014 9150 9193 9300 9330 9333 9610 9620 9630 9639 9640 9652 9668 9780 Schedule The company plans to manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for supply to its customers. In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. Companies The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable various basic classes of Drug code SUPPLEMENTARY INFORMATION: Controlled substance The company plans to synthesize the listed controlled substances for distribution to its customers. In reference to drug codes 7360 (marihuana) and 7370 (THC), the Controlled substance FR docket Published 84 FR 36945 84 FR 36941 July 30, 2019. July 30, 2019. May 1, 1971. The DEA investigated each of the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying E:\FR\FM\05NON1.SGM 05NON1 59646 Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Notices each company’s compliance with state and local laws, and reviewing each 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 DEA has granted a registration as an importer for schedule I and II controlled substances to the above listed companies. Dated: October 22, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–24105 Filed 11–4–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–527] Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceuticals, 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 on or before January 6, 2020. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on July 19, 2019, Halo Pharmaceutical Inc., 30 North Jefferson Road, Whippany, New Jersey 07981– 1030 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance khammond on DSKJM1Z7X2PROD with NOTICES Dihydromorphine ...................... Hydromorphone ....................... Drug code 9145 9150 Schedule I II The company plans to manufacture Hydromorphone (9150) for distribution to its customers. Dihydromorphone (9145) is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. Dated: October 22, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–24108 Filed 11–4–19; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 16:34 Nov 04, 2019 Jkt 250001 DEPARTMENT OF LABOR Agency Information Collection Activities; Comment Request; Requests for District Director Action ACTION: Notice. The Department of Labor (DOL) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, ‘‘Requests for District Director Action.’’ This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA). DATES: Consideration will be given to all written comments received by January 6, 2020. ADDRESSES: A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free by contacting Anjanette Suggs by telephone at 202– 354–9660 or by email at suggs.anjanette@dol.gov. Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Office of Workers’ Compensation, Division of Workers’ Compensation, Room S3323, 200 Constitution Avenue NW, Washington, DC 20210; by email: suggs.anjanette@dol.gov. FOR FURTHER INFORMATION CONTACT: Contact Anjanette Suggs by telephone at 202–354–9660 or by email at suggs.anjanette@dol.gov. SUPPLEMENTARY INFORMATION: The DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the OMB for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed. The Longshore and Harbor Workers’ Compensation Act (LHWCA) requires covered employers to secure the payment of compensation under the Act and its extensions by purchasing insurance from a carrier authorized by the Secretary of Labor to write Longshore Act Insurance, or becoming SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 authorized self-insured employers. Each authorized insurance carrier (or carrier seeking authorization) is required to establish annually that its Longshore obligations are fully secured either through an applicable state guaranty (or analogous fund), a deposit of security with the Division of Longshore and Harbor Workers’ Compensation (DLHWC), or a combination of both. Similarly, each authorized self-insurer (or employer seeking authorization) is required to fully secure its Longshore Act obligations by depositing security with DLHWC. These requirements are designed to assure the prompt and continued payment of compensation and other benefits by the responsible carrier or self-insurer to injured workers and their survivors. Forms LS–276, Application for Security Deposit Determination; LS–275–IC, Agreement and Undertaking (Insurance Carrier); and LS–275–SI, Agreement and Undertaking (Self-Insured Employer) are used to cover the submission of information by insurance carriers and self-insured employers regarding their ability to meet their financial obligations under the Longshore Act and its extensions. This information is currently approved through December 31, 2019. 33 U.S.C. 932 et seq. authorizes this information collection. This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB under the PRA approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. Interested parties are encouraged to provide comments to the contact shown in the ADDRESSES section. Written comments will receive consideration, and summarized and included in the request for OMB approval of the final ICR. In order to help ensure appropriate consideration, comments should mention OMB No. 1240–0005. Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. The DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments. The DOL is particularly interested in comments that: E:\FR\FM\05NON1.SGM 05NON1

Agencies

[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Notices]
[Pages 59645-59646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24105]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-530]


Importer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: The registrants listed below have applied for and been granted 
registration by the Drug Enforcement Administration (DEA) as importers 
of schedule I and II controlled substances.
    The companies listed below applied to be registered as an importers 
of various basic classes of schedule I and II controlled substances. 
Information on previously published notices is listed in the table 
below. No comments or objections were submitted and no requests for a 
hearing were submitted for these notices.

------------------------------------------------------------------------
          Companies                FR docket             Published
------------------------------------------------------------------------
Catalent Pharma Solutions,    84 FR 36945         July 30, 2019.
 LLC.
Research Triangle Institute.  84 FR 36941         July 30, 2019.
------------------------------------------------------------------------

    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of the listed registrants 
to import the applicable various basic classes of schedule I and II 
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 each of the 
company's maintenance of effective controls against diversion by 
inspecting and testing each company's physical security systems, 
verifying

[[Page 59646]]

each company's compliance with state and local laws, and reviewing each 
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 DEA has granted a registration as 
an importer for schedule I and II controlled substances to the above 
listed companies.

    Dated: October 22, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-24105 Filed 11-4-19; 8:45 am]
BILLING CODE 4410-09-P
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