Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Irvine Labs, Inc., 10470-10471 [2020-03623]

Download as PDF 10470 Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 / Notices Controlled substance Drug code Fentanyl related-compounds as defined in 21 CFR 1308.11(h) ..................................................................................... Phenmetrazine ................................................................................................................................................................. Methylphenidate .............................................................................................................................................................. Amobarbital ...................................................................................................................................................................... Pentobarbital .................................................................................................................................................................... Secobarbital ..................................................................................................................................................................... Glutethimide ..................................................................................................................................................................... Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration Nabilone ........................................................................................................................................................................... 1-Phenylcyclohexylamine ................................................................................................................................................ Phencyclidine ................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Phenylacetone ................................................................................................................................................................. 1-Piperidinocyclohexanecarbonitrile ................................................................................................................................ Alphaprodine .................................................................................................................................................................... Anileridine ........................................................................................................................................................................ Coca Leaves .................................................................................................................................................................... Cocaine ............................................................................................................................................................................ Etorphine HCl .................................................................................................................................................................. Dihydrocodeine ................................................................................................................................................................ Diphenoxylate .................................................................................................................................................................. Ecgonine .......................................................................................................................................................................... Ethylmorphine .................................................................................................................................................................. Levomethorphan .............................................................................................................................................................. Levorphanol ..................................................................................................................................................................... Isomethadone .................................................................................................................................................................. Meperidine ....................................................................................................................................................................... Meperidine intermediate-A .............................................................................................................................................. Meperidine intermediate-B .............................................................................................................................................. Meperidine intermediate-C .............................................................................................................................................. Metazocine ...................................................................................................................................................................... Metopon ........................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. Dihydroetorphine ............................................................................................................................................................. Opium tincture ................................................................................................................................................................. Opium, powdered ............................................................................................................................................................ Opium, granulated ........................................................................................................................................................... Phenazocine .................................................................................................................................................................... Thiafentanil ...................................................................................................................................................................... Piminodine ....................................................................................................................................................................... Racemethorphan ............................................................................................................................................................. Racemorphan .................................................................................................................................................................. Alfentanil .......................................................................................................................................................................... Remifentanil ..................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... Carfentanil ....................................................................................................................................................................... Tapentadol ....................................................................................................................................................................... Bezitramide ...................................................................................................................................................................... Moramide-intermediate .................................................................................................................................................... The company plans to import small quantities of the listed controlled substances for the National Institute on Drug Abuse for research activities. The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. lotter on DSKBCFDHB2PROD with NOTICES Dated: February 6, 2020. William T. McDermott, Assistant Administrator. BILLING CODE 4410–09–P 18:30 Feb 21, 2020 Drug Enforcement Administration [Docket No. DEA–588] Jkt 250001 I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration. 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 24, 2020. DATES: Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Irvine Labs, Inc. ACTION: [FR Doc. 2020–03619 Filed 2–21–20; 8:45 am] VerDate Sep<11>2014 DEPARTMENT OF JUSTICE 9850 1631 1724 2125 2270 2315 2550 7365 7379 7460 7471 8333 8501 8603 9010 9020 9040 9041 9059 9120 9170 9180 9190 9210 9220 9226 9230 9232 9233 9234 9240 9260 9273 9334 9630 9639 9640 9715 9729 9730 9732 9733 9737 9739 9740 9743 9780 9800 9802 Schedule Notice of application. PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW 8701 Morrissette Drive, Springfield, Virginia 22152. To ensure proper handling of comments, please reference Docket No. DEA–588 in all correspondence, including attachments. ADDRESSES: The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA SUMMARY: E:\FR\FM\24FEN1.SGM 24FEN1 10471 Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 / Notices The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted. The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA registered researchers. If its application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place. As this applicant has applied to become registered as a Bulk Manufacturer of Marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a) as described in 84 FR 44920, published on August 27, 2019. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on May 30, 2019, Irvine Labs, Inc., 1864 Swan Circle, Costa Mesa, California 92626–4739 applied to be registered as a bulk manufacturer of the following basic class of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Marihuana Extract .. Marihuana ............... Tetrahydrocannabinols. Drug code 7350 7360 7370 Schedule I I I The applicant noticed above applied to become registered with DEA to grow marihuana as bulk manufacturer subsequent to a 2016 DEA policy statement that provided information on how it intended to expand the number of registrations, and described in general terms the way it would oversee those additional growers. Before DEA completes the evaluation and registration process for applicants to grow marihuana, DEA intends to propose regulations in the near future that would supersede the 2016 policy statement and govern persons seeking to become registered with DEA to grow marihuana as bulk manufacturers, consistent with applicable law, as described in 84 FR 44920. Dated: February 3, 2020. William T. McDermott, Assistant Administrator. Gamma Hydroxybutyric Acid. lotter on DSKBCFDHB2PROD with NOTICES Jkt 250001 2010 I I I Dated: January 31, 2020. William T. McDermott, Assistant Administrator. [FR Doc. 2020–03617 Filed 2–21–20; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2020–03623 Filed 2–21–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–595] [Docket No. DEA–585] Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc. ACTION: Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC ACTION: Notice of application. Notice of application. Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 24, 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 December 23, 2019, Patheon Pharmaceuticals, Inc., 2100 E Galbraith Road, Cincinnati, Ohio 45237–1625 applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance: SUPPLEMENTARY INFORMATION: 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 24, 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 January 9, 2020, Chemtos, LLC, 16713 Picadilly Court, Round Rock, Texas 78664–8544 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Drug code 3-Fluoro-N-methylcathinone (3–FMC) ..................................................................................................................................... Cathinone ................................................................................................................................................................................ Methcathinone ......................................................................................................................................................................... 4-Fluoro-N-methylcathinone (4–FMC) ..................................................................................................................................... Pentedrone (a-methylaminovalerophenone) ........................................................................................................................... Mephedrone (4-Methyl-N-methylcathinone) ............................................................................................................................ 4-Methyl-N-ethylcathinone (4–MEC) ....................................................................................................................................... 18:30 Feb 21, 2020 Schedule The Gamma Hydroxbutyric Acid will be produced during the process of converting gamma-butyrolactone into a new product for development. The company plans to manufacture the above-listed controlled substance as Active Pharmaceutical Ingredient (API) that will be further synthesized into dosage forms of a new product. No other activities for this drug code are authorized for this registration. Controlled substance VerDate Sep<11>2014 Drug code Controlled substance PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\24FEN1.SGM 24FEN1 1233 1235 1237 1238 1246 1248 1249 Schedule I I I I I I I

Agencies

[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10470-10471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03623]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-588]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturers of Marihuana: Irvine Labs, Inc.

ACTION: Notice of application.

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SUMMARY: The Drug Enforcement Administration (DEA) is providing notice 
of an application it has received from an entity applying to be 
registered to manufacture in bulk basic classes of controlled 
substances listed in schedule I. Prior to making decisions on this and 
other pending applications, DEA intends to promulgate regulations that 
govern the program of growing marihuana for scientific and medical 
research under DEA registration.

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 April 24, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW 8701 
Morrissette Drive, Springfield, Virginia 22152. To ensure proper 
handling of comments, please reference Docket No. DEA-588 in all 
correspondence, including attachments.

[[Page 10471]]


SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) 
prohibits the cultivation and distribution of marihuana except by 
persons who are registered under the CSA to do so for lawful purposes. 
In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is 
providing notice that the entity identified below has applied for 
registration as a bulk manufacturer of schedule I controlled 
substances. In response, registered bulk manufacturers of the affected 
basic classes, and applicants therefore, may file written comments on 
or objections of the requested registration, as provided in this 
notice. This notice does not constitute any evaluation or determination 
of the merits of the application submitted.
    The applicant plans to manufacture bulk active pharmaceutical 
ingredients (APIs) for product development and distribution to DEA 
registered researchers. If its application for registration is granted, 
the registrant would not be authorized to conduct other activity under 
this registration aside from those coincident activities specifically 
authorized by DEA regulations. DEA will evaluate the application for 
registration as a bulk manufacturer for compliance with all applicable 
laws, treaties, and regulations and to ensure adequate safeguards 
against diversion are in place.
    As this applicant has applied to become registered as a Bulk 
Manufacturer of Marihuana, the application will be evaluated under the 
criteria of 21 U.S.C. 823(a) as described in 84 FR 44920, published on 
August 27, 2019.
    In accordance with 21 CFR 1301.33(a), DEA is providing notice that 
on May 30, 2019, Irvine Labs, Inc., 1864 Swan Circle, Costa Mesa, 
California 92626-4739 applied to be registered as a bulk manufacturer 
of the following basic class of controlled substances:

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

    The applicant noticed above applied to become registered with DEA 
to grow marihuana as bulk manufacturer subsequent to a 2016 DEA policy 
statement that provided information on how it intended to expand the 
number of registrations, and described in general terms the way it 
would oversee those additional growers. Before DEA completes the 
evaluation and registration process for applicants to grow marihuana, 
DEA intends to propose regulations in the near future that would 
supersede the 2016 policy statement and govern persons seeking to 
become registered with DEA to grow marihuana as bulk manufacturers, 
consistent with applicable law, as described in 84 FR 44920.

    Dated: February 3, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-03623 Filed 2-21-20; 8:45 am]
BILLING CODE 4410-09-P