Bulk Manufacturer of Controlled Substances Applications: Bulk Manufacturers of Marihuana, 44920-44923 [2019-18456]

Download as PDF 44920 Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Notices Drug code Controlled substance jspears on DSK3GMQ082PROD with NOTICES AH-7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)) .............................................................................. Acetylmethadol ............................................................................................................................................................................ Allylprodine .................................................................................................................................................................................. Alphacetylmethadol except levo-alphacetylmethadol .................................................................................................................. Alphameprodine ........................................................................................................................................................................... Alphamethadol ............................................................................................................................................................................. Betacetylmethadol ....................................................................................................................................................................... Betameprodine ............................................................................................................................................................................ Betamethadol ............................................................................................................................................................................... Betaprodine ................................................................................................................................................................................. Dextromoramide .......................................................................................................................................................................... Dipipanone ................................................................................................................................................................................... Hydroxypethidine ......................................................................................................................................................................... Noracymethadol ........................................................................................................................................................................... Norlevorphanol ............................................................................................................................................................................ Normethadone ............................................................................................................................................................................. Racemoramide ............................................................................................................................................................................ Trimeperidine ............................................................................................................................................................................... 1-Methyl-4-phenyl-4-propionoxypiperidine .................................................................................................................................. Tilidine ......................................................................................................................................................................................... Para-Fluorofentanyl ..................................................................................................................................................................... 3-Methylfentanyl .......................................................................................................................................................................... Alpha-methylfentanyl ................................................................................................................................................................... Acetyl-alpha-methylfentanyl ......................................................................................................................................................... Beta-hydroxyfentanyl ................................................................................................................................................................... Beta-hydroxy-3-methylfentanyl .................................................................................................................................................... Alpha-methylthiofentanyl ............................................................................................................................................................. 3-Methylthiofentanyl ..................................................................................................................................................................... Thiofentanyl ................................................................................................................................................................................. Methamphetamine ....................................................................................................................................................................... Methylphenidate .......................................................................................................................................................................... Amobarbital .................................................................................................................................................................................. Pentobarbital ................................................................................................................................................................................ Secobarbital ................................................................................................................................................................................. Glutethimide ................................................................................................................................................................................. Nabilone ....................................................................................................................................................................................... 1-Phenylcyclohexylamine ............................................................................................................................................................ Phencyclidine ............................................................................................................................................................................... Phenylacetone ............................................................................................................................................................................. 1-Piperidinocyclohexanecarbonitrile ............................................................................................................................................ Alphaprodine ................................................................................................................................................................................ Dihydrocodeine ............................................................................................................................................................................ Ecgonine ...................................................................................................................................................................................... Ethylmorphine .............................................................................................................................................................................. Levomethorphan .......................................................................................................................................................................... Levorphanol ................................................................................................................................................................................. Meperidine ................................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) .......................................................................................................................... Levo-alphacetylmethadol ............................................................................................................................................................. Noroxymorphone ......................................................................................................................................................................... Racemethorphan ......................................................................................................................................................................... Alfentanil ...................................................................................................................................................................................... Remifentanil ................................................................................................................................................................................. Sufentanil ..................................................................................................................................................................................... Carfentanil ................................................................................................................................................................................... Tapentadol ................................................................................................................................................................................... The company plans to import the listed controlled substances for the manufacture of analytical reference standards and distribution to their research and forensic customers. Approval of permit application will occur only when the registrant’s activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale. VerDate Sep<11>2014 19:12 Aug 26, 2019 Jkt 247001 9551 9601 9602 9603 9604 9605 9607 9608 9609 9611 9613 9622 9627 9633 9634 9635 9645 9646 9661 9750 9812 9813 9814 9815 9830 9831 9832 9833 9835 1105 1724 2125 2270 2315 2550 7379 7460 7471 8501 8603 9010 9120 9180 9190 9210 9220 9230 9273 9648 9668 9732 9737 9739 9740 9743 9780 Dated: August 9, 2019. Neil D. Doherty, Acting Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2019–18455 Filed 8–26–19; 8:45 am] [Docket No. DEA–392] BILLING CODE 4410–09–P PO 00000 Schedule I I I I I I I I I I I I I I I I I I I I I I I I I I I I 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 Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Applications: Bulk Manufacturers of Marihuana ACTION: Notice of applications. The Drug Enforcement Administration (DEA) is providing SUMMARY: Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\27AUN1.SGM 27AUN1 jspears on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Notices notice of certain applications it has received from entities applying to be registered to manufacture in bulk a basic class of controlled substances listed in schedule I. Prior to making decisions on these pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration. In addition, this notice informs applicants that they may withdraw their applications if they no longer need to obtain a registration because of the recent amendments made by the Agriculture Improvement Act of 2018 to the definition of marihuana to no longer include ‘‘hemp’’ as defined by law. DATES: Registered bulk manufacturers of the affected basic classes, and applicants therefor, may file written comments on or objections to the issuance of the proposed registration on or before October 28, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152–2639. To ensure proper handling of comments, please reference ‘‘Docket No. DEA–392’’ in all correspondence, including attachments. 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 entities identified below have applied for registration as bulk manufacturers of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic classes, and applicants therefor, may file written comments on or objections to the issuance of the requested registrations, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the applications submitted. The applicants plan to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA-registered researchers. If their applications for registration are granted, the registrants would not be authorized to conduct other activity under those registrations, aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the applications for registration as bulk manufacturers for compliance with all applicable laws, treaties, and regulations and to ensure adequate VerDate Sep<11>2014 19:12 Aug 26, 2019 Jkt 247001 safeguards against diversion are in place. In particular, in accordance with the criteria specified in 21 U.S.C. 823(a), DEA is required, among other things, to maintain ‘‘effective controls against diversion . . . by limiting the . . . bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes.’’ 21 U.S.C. 823(a); see Lyle E. Craker;—Denial of Application, 74 FR 2101, 2118–23, 2127–33 (2009) (‘‘[A]n applicant seeking to become registered to bulk manufacture a schedule I or II controlled substance bears the burden of demonstrating that the existing registered bulk manufacturers of a given schedule I or II controlled substance are unable to produce an adequate and uninterrupted supply of that substance under adequately competitive conditions.’’), pet. for rev. denied, Craker v. DEA, 714 F.3d 17, 27–29 (1st Cir. 2013); see also Applications to Become Registered under the Controlled Substances Act to Manufacture Marijuana to Supply Researchers in the United States, 81 FR 53846, 53847 (Aug. 12, 2016) (‘‘As subsection 823(a)(1) provides, DEA is obligated to register only the number of bulk manufacturers of a given schedule I or II controlled substance that is necessary to ‘produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes.’ ’’). Thus, in accordance with the criteria of section 823(a), DEA anticipates evaluating the applications and, of those applications that it finds are compliant with relevant laws, regulations, and treaties, granting the number that the agency determines is necessary to ensure an adequate and uninterrupted supply of the controlled substances at issue under adequately competitive conditions. By registering these additional growers in accordance with the criteria of section 823(a), DEA anticipates that additional strains of marihuana will be produced and made available to researchers. This should facilitate research, advance scientific understanding about the effects of marihuana, and potentially aid in the development of safe and effective drug products that may be approved for marketing by the Food and Drug Administration. The applicants noticed below applied to become registered with DEA to grow PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 44921 marihuana as bulk manufacturers 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. Therein, DEA recognized the need to move past the single grower system and register additional growers. DEA has received 33 pending applications, as listed below; the most recent was filed in May 2019. Because the size of the applicant pool is unprecedented in DEA’s experience, the Agency has determined that adjustments to its policies and practices with respect to the marihuana growers program are necessary to fairly evaluate the applicants under the 823(a) factors, including 823(a)(1). In addition, since publication of the 2016 policy statement, the Department of Justice, in consultation with other federal agencies, has been engaged in a policy review process to ensure that the marihuana growers program is consistent with applicable laws and treaties. That review process remains ongoing; however, it has progressed to the point where DEA is able to issue Notices of Application. Over the course of this policy review process, the Department of Justice has also determined that adjustments to DEA’s policies and practices related to the marihuana growers program may be necessary. Accordingly, before DEA completes this evaluation and registration process, 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. DEA notes that, as the result of a recent amendment to federal law, certain forms of cannabis no longer require DEA registration to grow or manufacture. The Agriculture Improvement Act of 2018, Public Law 115–334, which was signed into law on December 20, 2018, changed the definition of marihuana under the CSA. As amended, the definition of marihuana no longer includes ‘‘hemp,’’ which is defined as ‘‘the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.’’ 7 U.S.C. 1639o(1). Pursuant to the amended definition, cannabis plant material which contains 0.3 percent or less delta9 tetrahydrocannabinol (THC) on a dry E:\FR\FM\27AUN1.SGM 27AUN1 44922 Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Notices weight basis is not a controlled substance and does not require a DEA registration to grow. Accordingly, if any of the below-listed applicants have applied for a DEA registration exclusively for the purpose of growing cannabis that contains no more than 0.3 percent delta-9 THC on a dry weight basis, including cannabis that contains cannabidiol (CBD) and falls below the delta-9 THC threshold, the applicants no longer require DEA registration for that purpose. If desired, these applicants may respond in writing with a request who wish to withdraw their application may do so by sending a letter to: Drug Enforcement Administration, Attn: Regulatory/DRG, 8701 Morrissette Drive, Springfield, VA 22152–2639. List of Applications Received In accordance with 21 CFR 1301.33(a), DEA is providing notice that on the following dates, the following entities applied to be registered as bulk manufacturers of the following basic classes of controlled substances: Applicant Address Controlled substance 2/6/17 7218737 Delaware Inc ..................... Marihuana ......................................... 7360 I 5/11/17 A and C Laboratories ....................... 50 Otis Street, Westborough, MA 01581. 155 Federal Street, Suite 700, Boston, MA 02110. Marihuana extract, Marihuana, Tetrahydrocannabinols. I 2/14/18 Abatin Cultivation Center .................. Marihuana extract, Marihuana .......... 12/30/ 16. 1/4/18 Annac Medical Center LLC .............. 3/16/17 11/2/16 Biopharmaceutical Research Company, LLC. Cannamed Pharmaceuticals, Inc ..... 2146 Queens Chapel Rd., Washington, DC 20018. 5172 W Patrick Lane, Suite 100, Las Vegas, NV 89117–8911. 1425 Plain City—Gorgesville Road, Bldg. JS–1–009, Powell, OH 43065–9647. 11045 Commercial Parkway, Castroville, CA 95012–3209. 27120 Ocean Gateway, Salisbury, MD 21803. 7350, 7360, 7370 7360 3/13/17 Columbia Care NY, LLC ................... Marihuana extract ............................. 5/3/18 Contract Pharmacal Corp ................. Eastman Business Park, Bldg. 12, 4th Floor, 1669 Lake Ave., Rochester, NY 14615. 135 Adams Avenue, Hauppauge, NY 11788. 8/2/17 Confederated Tribes of the Colville .. 11/10/ 16. Fraunhofer USA ................................ 7/31/14 10/22/ 18. Gary Gray DBA Complex Pharmacist Owner. GB Sciences, Inc. DBA GB Sciences Nevada, LLC. P.O. Box 150, 21 Colville Street, Nespelem, WA 99155. Center for Molecular Biotechnology, 9 Innovation Way, Newark, DE 19711. P.O. Box 2522, 1721 W Burrel Ave., Visalia, CA 93279–2522. 3550 W Teco Ave., Las Vegas, NV 89118–6876. 4/27/17 Green Leaf Inc .................................. 4614 Halibut Point Rd., Sitka, AK 99835. Marihuana extract, Marihuana, Tetrahydrocannabinols. 11/23/ 16. 8/30/16 Hawaii Agriculture Research Institute Marihuana extract ............................. 5/22/17 JT Medical, LLC ............................... 5/5/17 Maridose LLC ................................... 10/3/16 MCRGC LLC .................................... 94–340 Kunia Road, Kunia, HI 96759–0100. 190 Eagle Ford Dr., Pleasanton, TX 78064. 598 South Juniata St., Box 311, Lewistown, PA 17044–0311. 23378 Barlake Dr., Boca Raton, FL 33433. 811 Western Ave., Manchester, ME 04351. 9/12/16 Medpharm Research, LLC ............... Marihuana extract, Marihuana .......... 12/27/ 18. 1/17/17 MMJ Biopharma Cultivation ............. 4/5/17 National Center for Development of Natural Products. 4880 Havana St., Denver, CO 80239. 14930 Reflection Key Circle, Apt. 2511, Fort Myers, FL 33907. 123 Alton Rd., Miami Beach, FL 33139. The University of Mississippi, 135 Coy Waller Lab Complex, P.O. Box 1848, University, MS 38677. Date jspears on DSK3GMQ082PROD with NOTICES to withdraw their applications. Upon receipt of a request to withdraw an application that is received no later than November 1, 2019, DEA will refund all related application fees paid by the applicant. In addition, any listed applicants who no longer wish to obtain registration for any other reason may also request to withdraw their application in writing, and DEA will refund all related application fees paid by the applicant, provided the withdrawal is received no later than November 1, 2019. Applicants Battelle Memorial Institute ................ Hemp CBD LLC ................................ Modern Pharmacy, LLC ................... VerDate Sep<11>2014 19:12 Aug 26, 2019 Jkt 247001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 Marihuana extract, Marihuana .......... Drug Code Sch. I 7350, 7360 7360, 7370 I Marihuana extract ............................. 7350 I Marihuana extract, Marihuana, Tetrahydrocannabinols. 7350, 7360, 7370 7350 I Marihuana, Tetrahydrocannabinols .. Marihuana extract, Marihuana, Tetrahydrocannabinols. I I Marihuana, ........................................ 7350, 7360, 7370 7360 I Marihuana extract ............................. 7350 I Marihuana, Tetrahydrocannabinols .. 7360, 7370 7350, 7360, 7370 7350, 7360, 7370 7350 I Marihuana extract, Marihuana, Tetrahydrocannabinols. Marihuana, Tetrahydrocannabinols .. Marihuana extract, Marihuana .......... Marihuana, Tetrahydrocannabinols .. Marihuana extract, Marihuana, Tetrahydrocannabinols. Marihuana, Tetrahydrocannabinols .. Marihuana extract, Marihuana .......... Marihuana extract ............................. E:\FR\FM\27AUN1.SGM 27AUN1 7360, 7370 7350, 7360 7360, 7370 7350, 7360, 7370 7350, 7360 7360, 7370 7350, 7360 7350 I I I I I I I I I I I I 44923 Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Notices Applicant Address Controlled substance 5/2/19 Nuvue Pharma, LLC ......................... Marihuana ......................................... 7360 I 3/31/17 Pharmacann LLC .............................. Marihuana ......................................... 7360 I 11/8/16 PS Patients Collective, Inc ............... Marihuana, Tetrahydrocannabinols .. Scientific Botanical Pharmaceutical, Inc. 11/29/ 16. 10/3/16 Scottsdale Research Institute ........... Marihuana extract ............................. I Marihuana ......................................... 7360 I 9/21/18 Trail Blazin’ Productions ................... Marihuana ......................................... 7360 I 2/21/17 Ultra Rich CBD ................................. Marihuana extract ............................. 7350 I 11/1/17 University of California, Davis .......... Marihuana ......................................... 7360 I 2/22/17 University of Massachusetts ............. 1225 W Deer Valley Rd., Phoenix, AZ 85027. 21617 N 9th Avenue, Phoenix, AZ 85027. 2005 Division St., Bellingham, WA 98226. 30 Rockcreek Rd., Orovada, NV 89425. One Shields Avenue, EH&S Hoagland Hall 276, Davis, CA 95616. 80 Campus Center Way, Amherst, MA 01003–9246. 7360, 7370 7350, 7360, 7370 7350 I 1/13/17 4740 Dillion Drive, Pueblo, CO 81008–2112. 1010 Lake St., 2nd Fl., Oak Park, IL 60301–1132. 36555 Bankside Drive, Cathedral City, CA 92234. 1225 W Deer Valley Rd., Phoenix, AZ 85027. Marihuana extract ............................. 7350 I Date The Giving Tree Wellness Center .... Dated: August 22, 2019. Neil D. Doherty, Acting Assistant Administrator, Deputy Assistant Administrator. [FR Doc. 2019–18456 Filed 8–26–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Medical Support Notice—Part B Notice of availability; request for comments. ACTION: The Department of Labor (DOL) is submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ‘‘National Medical Support Notice—Part B,’’ to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited. DATES: The OMB will consider all written comments that agency receives on or before September 26, 2019. 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 of charge from the RegInfo.gov website at https:// www.reginfo.gov/public/do/ PRAViewICR?ref_nbr=201907-1210-001 jspears on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:12 Aug 26, 2019 Jkt 247001 Marihuana extract, Marihuana, Tetrahydrocannabinols. (this link will only become active on the day following publication of this notice) or by contacting Frederick Licari by telephone at 202–693–8073, TTY 202– 693–8064, (these are not toll-free numbers) or by email at DOL_PRA_ PUBLIC@dol.gov. Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–EBSA, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202–395–5806 (this is not a toll-free number); or by email: OIRA_submission@omb.eop.gov. Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW, Washington, DC 20210; or by email: DOL_PRA_PUBLIC@dol.gov. FOR FURTHER INFORMATION CONTACT: Frederick Licari by telephone at 202– 693–8073, TTY 202–693–8064, (these are not toll-free numbers) or by email at DOL_PRA_PUBLIC@dol.gov. SUPPLEMENTARY INFORMATION: This ICR seeks to extend PRA authority for the National Medical Support Notice—Part B information collection. Section 609 of the Employee Retirement Income Security Act (ERISA) and regulations at 29 CFR 2590.609–2 establish a National Medical Support Notice to provide group health benefits coverage pursuant to Qualified Medical Child Support Orders. Part B, Medical Support Notice to Plan Administrator, is a notice from PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 Drug Code Sch. I an employer to a benefits plan administrator to implement coverage of children under ERISA covered group health plans. ERISA section 609(a) authorizes this information collection. See 29 U.S.C. 1169(a). 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. The DOL obtains OMB approval for this information collection under Control Number 1210– 0113. OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on August 31, 2019. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on March 27, 2019 (84 FR 11573). Interested parties are encouraged to send comments to the OMB, Office of E:\FR\FM\27AUN1.SGM 27AUN1

Agencies

[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Notices]
[Pages 44920-44923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18456]

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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Bulk Manufacturer of Controlled Substances Applications: Bulk
Manufacturers of Marihuana

ACTION: Notice of applications.

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

SUMMARY: The Drug Enforcement Administration (DEA) is providing

[[Page 44921]]

notice of certain applications it has received from entities applying
to be registered to manufacture in bulk a basic class of controlled
substances listed in schedule I. Prior to making decisions on these
pending applications, DEA intends to promulgate regulations that govern
the program of growing marihuana for scientific and medical research
under DEA registration. In addition, this notice informs applicants
that they may withdraw their applications if they no longer need to
obtain a registration because of the recent amendments made by the
Agriculture Improvement Act of 2018 to the definition of marihuana to
no longer include ``hemp'' as defined by law.

DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefor, may file written comments on or objections to the
issuance of the proposed registration on or before October 28, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152-2639. To ensure
proper handling of comments, please reference ``Docket No. DEA-392'' in
all correspondence, including attachments.

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 entities identified below have applied for
registration as bulk manufacturers of schedule I controlled substances.
In response, registered bulk manufacturers of the affected basic
classes, and applicants therefor, may file written comments on or
objections to the issuance of the requested registrations, as provided
in this notice. This notice does not constitute any evaluation or
determination of the merits of the applications submitted.
The applicants plan to manufacture bulk active pharmaceutical
ingredients (APIs) for product development and distribution to DEA-
registered researchers. If their applications for registration are
granted, the registrants would not be authorized to conduct other
activity under those registrations, aside from those coincident
activities specifically authorized by DEA regulations. DEA will
evaluate the applications for registration as bulk manufacturers for
compliance with all applicable laws, treaties, and regulations and to
ensure adequate safeguards against diversion are in place.
In particular, in accordance with the criteria specified in 21
U.S.C. 823(a), DEA is required, among other things, to maintain
``effective controls against diversion . . . by limiting the . . . bulk
manufacture of such controlled substances to a number of establishments
which can produce an adequate and uninterrupted supply of these
substances under adequately competitive conditions for legitimate
medical, scientific, research, and industrial purposes.'' 21 U.S.C.
823(a); see Lyle E. Craker;--Denial of Application, 74 FR 2101, 2118-
23, 2127-33 (2009) (``[A]n applicant seeking to become registered to
bulk manufacture a schedule I or II controlled substance bears the
burden of demonstrating that the existing registered bulk manufacturers
of a given schedule I or II controlled substance are unable to produce
an adequate and uninterrupted supply of that substance under adequately
competitive conditions.''), pet. for rev. denied, Craker v. DEA, 714
F.3d 17, 27-29 (1st Cir. 2013); see also Applications to Become
Registered under the Controlled Substances Act to Manufacture Marijuana
to Supply Researchers in the United States, 81 FR 53846, 53847 (Aug.
12, 2016) (``As subsection 823(a)(1) provides, DEA is obligated to
register only the number of bulk manufacturers of a given schedule I or
II controlled substance that is necessary to `produce an adequate and
uninterrupted supply of these substances under adequately competitive
conditions for legitimate medical, scientific, research, and industrial
purposes.' '').
Thus, in accordance with the criteria of section 823(a), DEA
anticipates evaluating the applications and, of those applications that
it finds are compliant with relevant laws, regulations, and treaties,
granting the number that the agency determines is necessary to ensure
an adequate and uninterrupted supply of the controlled substances at
issue under adequately competitive conditions. By registering these
additional growers in accordance with the criteria of section 823(a),
DEA anticipates that additional strains of marihuana will be produced
and made available to researchers. This should facilitate research,
advance scientific understanding about the effects of marihuana, and
potentially aid in the development of safe and effective drug products
that may be approved for marketing by the Food and Drug Administration.
The applicants noticed below applied to become registered with DEA
to grow marihuana as bulk manufacturers 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. Therein, DEA recognized the
need to move past the single grower system and register additional
growers. DEA has received 33 pending applications, as listed below; the
most recent was filed in May 2019. Because the size of the applicant
pool is unprecedented in DEA's experience, the Agency has determined
that adjustments to its policies and practices with respect to the
marihuana growers program are necessary to fairly evaluate the
applicants under the 823(a) factors, including 823(a)(1).
In addition, since publication of the 2016 policy statement, the
Department of Justice, in consultation with other federal agencies, has
been engaged in a policy review process to ensure that the marihuana
growers program is consistent with applicable laws and treaties. That
review process remains ongoing; however, it has progressed to the point
where DEA is able to issue Notices of Application. Over the course of
this policy review process, the Department of Justice has also
determined that adjustments to DEA's policies and practices related to
the marihuana growers program may be necessary. Accordingly, before DEA
completes this evaluation and registration process, 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.
DEA notes that, as the result of a recent amendment to federal law,
certain forms of cannabis no longer require DEA registration to grow or
manufacture. The Agriculture Improvement Act of 2018, Public Law 115-
334, which was signed into law on December 20, 2018, changed the
definition of marihuana under the CSA. As amended, the definition of
marihuana no longer includes ``hemp,'' which is defined as ``the plant
Cannabis sativa L. and any part of that plant, including the seeds
thereof and all derivatives, extracts, cannabinoids, isomers, acids,
salts, and salts of isomers, whether growing or not, with a delta-9
tetrahydrocannabinol concentration of not more than 0.3 percent on a
dry weight basis.'' 7 U.S.C. 1639o(1). Pursuant to the amended
definition, cannabis plant material which contains 0.3 percent or less
delta-9 tetrahydrocannabinol (THC) on a dry

[[Page 44922]]

weight basis is not a controlled substance and does not require a DEA
registration to grow. Accordingly, if any of the below-listed
applicants have applied for a DEA registration exclusively for the
purpose of growing cannabis that contains no more than 0.3 percent
delta-9 THC on a dry weight basis, including cannabis that contains
cannabidiol (CBD) and falls below the delta-9 THC threshold, the
applicants no longer require DEA registration for that purpose. If
desired, these applicants may respond in writing with a request to
withdraw their applications. Upon receipt of a request to withdraw an
application that is received no later than November 1, 2019, DEA will
refund all related application fees paid by the applicant.
In addition, any listed applicants who no longer wish to obtain
registration for any other reason may also request to withdraw their
application in writing, and DEA will refund all related application
fees paid by the applicant, provided the withdrawal is received no
later than November 1, 2019. Applicants who wish to withdraw their
application may do so by sending a letter to: Drug Enforcement
Administration, Attn: Regulatory/DRG, 8701 Morrissette Drive,
Springfield, VA 22152-2639.

List of Applications Received

In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on the following dates, the following entities applied to be registered
as bulk manufacturers of the following basic classes of controlled
substances:

----------------------------------------------------------------------------------------------------------------
Drug
Date Applicant Address Controlled substance Code Sch.
----------------------------------------------------------------------------------------------------------------
2/6/17........... 7218737 Delaware Inc.... 50 Otis Street, Marihuana.............. 7360 I
Westborough, MA 01581.
5/11/17.......... A and C Laboratories.... 155 Federal Street, Marihuana extract, 7350, I
Suite 700, Boston, MA Marihuana, 7360,
02110. Tetrahydrocannabinols. 7370
2/14/18.......... Abatin Cultivation 2146 Queens Chapel Rd., Marihuana extract, 7360 I
Center. Washington, DC 20018. Marihuana.
12/30/16......... Annac Medical Center LLC 5172 W Patrick Lane, Marihuana extract, 7350, I
Suite 100, Las Vegas, Marihuana. 7360
NV 89117-8911.
1/4/18........... Battelle Memorial 1425 Plain City-- Marihuana, 7360, I
Institute. Gorgesville Road, Bldg. Tetrahydrocannabinols. 7370
JS-1-009, Powell, OH
43065-9647.
3/16/17.......... Biopharmaceutical 11045 Commercial Marihuana extract...... 7350 I
Research Company, LLC. Parkway, Castroville,
CA 95012-3209.
11/2/16.......... Cannamed 27120 Ocean Gateway, Marihuana extract, 7350, I
Pharmaceuticals, Inc. Salisbury, MD 21803. Marihuana, 7360,
Tetrahydrocannabinols. 7370
3/13/17.......... Columbia Care NY, LLC... Eastman Business Park, Marihuana extract...... 7350 I
Bldg. 12, 4th Floor,
1669 Lake Ave.,
Rochester, NY 14615.
5/3/18........... Contract Pharmacal Corp. 135 Adams Avenue, Marihuana extract, 7350, I
Hauppauge, NY 11788. Marihuana, 7360,
Tetrahydrocannabinols. 7370
8/2/17........... Confederated Tribes of P.O. Box 150, 21 Marihuana,............. 7360 I
the Colville. Colville Street,
Nespelem, WA 99155.
11/10/16......... Fraunhofer USA.......... Center for Molecular Marihuana extract...... 7350 I
Biotechnology, 9
Innovation Way, Newark,
DE 19711.
7/31/14.......... Gary Gray DBA Complex P.O. Box 2522, 1721 W Marihuana, 7360, I
Pharmacist Owner. Burrel Ave., Visalia, Tetrahydrocannabinols. 7370
CA 93279-2522.
10/22/18......... GB Sciences, Inc. DBA GB 3550 W Teco Ave., Las Marihuana extract, 7350, I
Sciences Nevada, LLC. Vegas, NV 89118-6876. Marihuana, 7360,
Tetrahydrocannabinols. 7370
4/27/17.......... Green Leaf Inc.......... 4614 Halibut Point Rd., Marihuana extract, 7350, I
Sitka, AK 99835. Marihuana, 7360,
Tetrahydrocannabinols. 7370
11/23/16......... Hawaii Agriculture 94-340 Kunia Road, Marihuana extract...... 7350 I
Research Institute. Kunia, HI 96759-0100.
8/30/16.......... Hemp CBD LLC............ 190 Eagle Ford Dr., Marihuana, 7360, I
Pleasanton, TX 78064. Tetrahydrocannabinols. 7370
5/22/17.......... JT Medical, LLC......... 598 South Juniata St., Marihuana extract, 7350, I
Box 311, Lewistown, PA Marihuana. 7360
17044-0311.
5/5/17........... Maridose LLC............ 23378 Barlake Dr., Boca Marihuana, 7360, I
Raton, FL 33433. Tetrahydrocannabinols. 7370
10/3/16.......... MCRGC LLC............... 811 Western Ave., Marihuana extract, 7350, I
Manchester, ME 04351. Marihuana, 7360,
Tetrahydrocannabinols. 7370
9/12/16.......... Medpharm Research, LLC.. 4880 Havana St., Denver, Marihuana extract, 7350, I
CO 80239. Marihuana. 7360
12/27/18......... MMJ Biopharma 14930 Reflection Key Marihuana, 7360, I
Cultivation. Circle, Apt. 2511, Fort Tetrahydrocannabinols. 7370
Myers, FL 33907.
1/17/17.......... Modern Pharmacy, LLC.... 123 Alton Rd., Miami Marihuana extract, 7350, I
Beach, FL 33139. Marihuana. 7360
4/5/17........... National Center for The University of Marihuana extract...... 7350 I
Development of Natural Mississippi, 135 Coy
Products. Waller Lab Complex,
P.O. Box 1848,
University, MS 38677.

[[Page 44923]]

5/2/19........... Nuvue Pharma, LLC....... 4740 Dillion Drive, Marihuana.............. 7360 I
Pueblo, CO 81008-2112.
3/31/17.......... Pharmacann LLC.......... 1010 Lake St., 2nd Fl., Marihuana.............. 7360 I
Oak Park, IL 60301-1132.
11/8/16.......... PS Patients Collective, 36555 Bankside Drive, Marihuana, 7360, I
Inc. Cathedral City, CA Tetrahydrocannabinols. 7370
92234.
1/13/17.......... Scientific Botanical 1225 W Deer Valley Rd., Marihuana extract, 7350, I
Pharmaceutical, Inc. Phoenix, AZ 85027. Marihuana, 7360,
Tetrahydrocannabinols. 7370
11/29/16......... Scottsdale Research 1225 W Deer Valley Rd., Marihuana extract...... 7350 I
Institute. Phoenix, AZ 85027.
10/3/16.......... The Giving Tree Wellness 21617 N 9th Avenue, Marihuana.............. 7360 I
Center. Phoenix, AZ 85027.
9/21/18.......... Trail Blazin' 2005 Division St., Marihuana.............. 7360 I
Productions. Bellingham, WA 98226.
2/21/17.......... Ultra Rich CBD.......... 30 Rockcreek Rd., Marihuana extract...... 7350 I
Orovada, NV 89425.
11/1/17.......... University of One Shields Avenue, EH&S Marihuana.............. 7360 I
California, Davis. Hoagland Hall 276,
Davis, CA 95616.
2/22/17.......... University of 80 Campus Center Way, Marihuana extract...... 7350 I
Massachusetts. Amherst, MA 01003-9246.
----------------------------------------------------------------------------------------------------------------

Dated: August 22, 2019.
Neil D. Doherty,
Acting Assistant Administrator, Deputy Assistant Administrator.
[FR Doc. 2019-18456 Filed 8-26-19; 8:45 am]
BILLING CODE 4410-09-P

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