Bulk Manufacturer of Controlled Substances Application: National Center for Natural Products Research NIDA MPROJECT, 13522-13523 [2018-06323]

Download as PDF 13522 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices issuance of the proposed registration on or before April 30, 2018. Such persons may also file a written request for a hearing on the application on or before April 30, 2018. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. customers. No other activity for these drug codes are authorized for this registration. [FR Doc. 2018–06320 Filed 3–28–18; 8:45 am] BILLING CODE 4410–09–P Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2018–06324 Filed 3–28–18; 8:45 am] ADDRESSES: 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 manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on February 2, 2018, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, NJ 08070 applied to be registered as an importer of the following basic classes of controlled substances: sradovich on DSK3GMQ082PROD with NOTICES Controlled substance Opium, raw ....... Poppy Straw Concentrate. Drug code 9600 9670 19:09 Mar 28, 2018 [Docket No. DEA–392] DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing LLC ACTION: II II 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 May 29, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on December 7, 2017, Insys Manufacturing LLC, 2700 Oakmont Drive, Round Rock, Texas 78665 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: DATES: Jkt 244001 Controlled substance Drug code Marihuana ......... Tetrahydrocannabinols. 7360 7370 Schedule I I The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Drug Enforcement Administration [Docket No. DEA–392] Notice of application. Schedule The company plans to import the listed controlled substances to manufacture bulk active pharmaceuticals ingredients (API) for distribution to its customers. VerDate Sep<11>2014 BILLING CODE 4410–09–P Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: National Center for Natural Products Research NIDA MPROJECT 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 May 29, 2018. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on October 18, 2017, National Center for Natural Products Research NIDA MPROJECT, University of Mississippi, 135 Coy Waller Complex, P.O. Box 1848, University, Mississippi 38677–1848 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: E:\FR\FM\29MRN1.SGM 29MRN1 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices Controlled substance Drug code Marihuana Extract. Marihuana ......... Tetrahydrocannabinols. Schedule 7350 I 7360 7370 I I The company plans to bulk manufacture the listed controlled substances to make available to the National Institute on Drug Abuse (NIDA) a supply of bulk marihuana for distribution to research investigators in support of the national research program needs. No other activities for these drug codes are authorized for this registration. Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on February 18, 2015, S&B Pharma, Inc., DBA NORAC Pharma, 405 S. Motor Avenue, Azusa, CA 91702 applied for renewal of their registration as an importer of the following basic classes of controlled substances: [FR Doc. 2018–06323 Filed 3–28–18; 8:45 am] BILLING CODE 4410–09–P 4-Anilino-N-phenethyl-4piperidine (ANPP). Tapentadol ...................... DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: S&B Pharma, 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 April 30, 2018. Such persons may also file a written request for a hearing on the application on or before April 30, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 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 sradovich on DSK3GMQ082PROD with NOTICES DATES: VerDate Sep<11>2014 19:09 Mar 28, 2018 Drug code Controlled substance Jkt 244001 Schedule 8333 II 9780 II The company plans to import the controlled substances in bulk for the manufacture of other controlled substances for its customers. Tapentadol (9780) will be imported in Intermediate form to bulk manufacture Tapentadol for distribution to its customers. No other activity for these drug codes will be allowed. Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. BILLING CODE 4410–09–P Notice of Lodging of Proposed Consent Decree Under the Clean Air Act On March 23, 2018, the Department of Justice lodged a proposed consent decree with the United States District Court for the District of North Dakota in the lawsuit entitled United States of America v. XTO Energy Inc., Civil Action No. 1:18–cv–00060. The lawsuit seeks injunctive relief and civil penalties for violations of the Clean Air Act and the Federal Implementation Plan for Oil and Natural Gas Well Production Facilities; Fort Berthold Indian Reservation at well pads owned and operated by XTO Energy Inc. (‘‘XTO’’) on the Fort Berthold Indian Reservation in North Dakota. The violations relate to alleged failures to adequately design, operate, Fmt 4703 Sfmt 4703 To submit comments: Send them to: pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ–ENRD, P.O. Box 7611, Washington, DC 20044–7611. By mail ......... DEPARTMENT OF JUSTICE Frm 00055 and maintain storage tank vapor control systems, resulting in emissions of volatile organic compounds (‘‘VOC’’) and other pollutants to the atmosphere. The proposed consent decree covers all 20 of XTO’s well pads on the Fort Berthold Indian Reservation. The proposed decree requires XTO to perform injunctive relief, including conducting engineering evaluations of the vapor control systems at each of the well pads to ensure that they are adequately sized and designed. XTO must also complete one environmental mitigation project, estimated to cost at least $425,000, and pay a $320,000 civil penalty. Entering into and fully complying with the proposed consent decree would release XTO from past civil liability at the tanks systems as associated vapor control systems for violations of the Fort Berthold FIP relating to VOC emissions from storage tanks. The publication of this notice opens a period for public comment on the consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States of America v. XTO Energy Inc., D.J. Ref. No. 90–5–2–1–11656. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: By email ....... [FR Doc. 2018–06322 Filed 3–28–18; 8:45 am] PO 00000 13523 During the public comment period, the consent decree may be examined and downloaded at this Justice Department website: https:// www.justice.gov/enrd/consent-decrees. We will provide a paper copy of the consent decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ— ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $17.00 (25 cents per page E:\FR\FM\29MRN1.SGM 29MRN1

Agencies

[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Pages 13522-13523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06323]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: National 
Center for Natural Products Research NIDA MPROJECT

ACTION: Notice of application.

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DATES: 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 May 29, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW 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 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on 
October 18, 2017, National Center for Natural Products Research NIDA 
MPROJECT, University of Mississippi, 135 Coy Waller Complex, P.O. Box 
1848, University, Mississippi 38677-1848 applied to be registered as a 
bulk manufacturer of the following basic classes of controlled 
substances:

[[Page 13523]]



------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Marihuana Extract..................            7350  I
Marihuana..........................            7360  I
Tetrahydrocannabinols..............            7370  I
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances to make available to the National Institute on Drug Abuse 
(NIDA) a supply of bulk marihuana for distribution to research 
investigators in support of the national research program needs. No 
other activities for these drug codes are authorized for this 
registration.

    Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06323 Filed 3-28-18; 8:45 am]
 BILLING CODE 4410-09-P
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