[Federal Register Volume 85, Number 155 (Tuesday, August 11, 2020)]
[Notices]
[Page 48564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17435]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-696]


Importer of Controlled Substances Application: Catalent CTS, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Catalent, CTS LLC applied to be registered as an importer of 
the following basic class(es) of controlled substances: Gamma 
Hydroxybutyric Acid, Marihuana Extract, Marihuana, and 
Tetrahydrocannabinols.

DATES: 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 September 10, 
2020. Such persons may also file a written request for a hearing on the 
application on or before September 10, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on July 17, 2020, Catalent, CTS LLC, 10245 Hickman Mills 
Drive, Kansas City, Missouri 64137, applied to be registered as an 
importer of the following basic class(es) of controlled substances:

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                                           Drug
          Controlled substance             code          Schedule
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Gamma Hydroxybutyric Acid..............     2010  I
Marihuana Extract......................     7350  I
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
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    The company plans to import finished dosage unit products 
containing Gamma-Hydroxybutyric Acid and Marihuana Extracts for 
clinical trial studies. These Marihuana Extracts compounds are listed 
under drug code 7350. No other activity for these drug codes is 
authorized for this registration.
    Approval of permit applications will occur only when the 
registrant's business 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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-17435 Filed 8-10-20; 8:45 am]
BILLING CODE 4410-09-P