Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories, 23067-23068 [2017-10241]

Download as PDF 23067 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices [Docket No. DEA–392] 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 2, 2016, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237 applied to be registered as a bulk manufacturer of gamma hydroxybutyric acid (2010) a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance for product development. Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. 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 March 21, 2017, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, Texas 78665 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... I I The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for these drug codes is authorized for this registration. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10230 Filed 5–18–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [FR Doc. 2017–10238 Filed 5–18–17; 8:45 am] ACTION: Notice of application. BILLING CODE 4410–09–P Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before July 18, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW 8701 DATES: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before July 18, 2017. 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 March 3, 2017, Eli-Elsohly Laboratories, Mahmoud A. Elsohly Ph. D., 5 Industrial Park Drive, Oxford, Mississippi 38655 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories ACTION: Notice of application. asabaliauskas on DSK3SPTVN1PROD with NOTICES Controlled substance Drug code Marihuana Extract ........................................................................................................................................................... Marihuana ........................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................... Dihydromorphine ............................................................................................................................................................. Amphetamine ................................................................................................................................................................... Methamphetamine ........................................................................................................................................................... Cocaine ............................................................................................................................................................................ Codeine ........................................................................................................................................................................... Dihydrocodeine ................................................................................................................................................................ Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Ecgonine .......................................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Morphine .......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00115 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 7350 7360 7370 9145 1100 1105 9041 9050 9120 9143 9150 9180 9193 9300 9333 Schedule I I I I II II II II II II II II II II II 23068 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices The company plans to manufacture the listed controlled substances for product development and reference standards. In reference to drug codes 7360 (marihuana) and 7370 (THC) the company plans to isolate these controlled substances from procured 7350 (marihuana extract). In reference to drug code 7360 no cultivation activities are authorized for this registration. No other activities for these drug codes are authorized for this registration. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10241 Filed 5–18–17; 8:45 am] BILLING CODE P 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. Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before July 18, 2017. 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 DATES: 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 January 20, 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: Controlled substance Drug code Marihuana Extract ........................................................................................................................................................... Marihuana ........................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................... 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. DEPARTMENT OF JUSTICE Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. DATES: [FR Doc. 2017–10239 Filed 5–18–17; 8:45 am] asabaliauskas on DSK3SPTVN1PROD with NOTICES BILLING CODE P Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before July 18, 2017. 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 Drug code Mephedrone (4-Methyl-N-methylcathinone) .................................................................................................................... Methaqualone .................................................................................................................................................................. JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ................................................................................................... 5-Flouro-UR-144 and XLR11 [1-(5-Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ................. 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00116 Fmt 4703 Sfmt 4703 I I I 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 July 5, 2016, Chemtos, LLC, 14101 W. Highway 290, Building 2000B, Austin, Texas 78737–9331 applied to be registered as a bulk manufacturer for the following basic classes of controlled substances: Controlled substance VerDate Sep<11>2014 7350 7360 7370 Schedule E:\FR\FM\19MYN1.SGM 19MYN1 1248 2565 6250 7011 Schedule I I I I

Agencies

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23067-23068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10241]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Eli-
Elsohly Laboratories

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic class, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.33(a) on or before July 18, 2017.

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 March 
3, 2017, Eli-Elsohly Laboratories, Mahmoud A. Elsohly Ph. D., 5 
Industrial Park Drive, Oxford, Mississippi 38655 applied to be 
registered as a bulk manufacturer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Marihuana Extract..................            7350  I
Marihuana..........................            7360  I
Tetrahydrocannabinols..............            7370  I
Dihydromorphine....................            9145  I
Amphetamine........................            1100  II
Methamphetamine....................            1105  II
Cocaine............................            9041  II
Codeine............................            9050  II
Dihydrocodeine.....................            9120  II
Oxycodone..........................            9143  II
Hydromorphone......................            9150  II
Ecgonine...........................            9180  II
Hydrocodone........................            9193  II
Morphine...........................            9300  II
Thebaine...........................            9333  II
------------------------------------------------------------------------


[[Page 23068]]

    The company plans to manufacture the listed controlled substances 
for product development and reference standards. In reference to drug 
codes 7360 (marihuana) and 7370 (THC) the company plans to isolate 
these controlled substances from procured 7350 (marihuana extract). In 
reference to drug code 7360 no cultivation activities are authorized 
for this registration. No other activities for these drug codes are 
authorized for this registration.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10241 Filed 5-18-17; 8:45 am]
 BILLING CODE P