[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]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Applications: Bulk 
Manufacturers of Marihuana

ACTION: Notice of applications.

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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:

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                                                                                                  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.
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    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