[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Notices]
[Pages 44749-44750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17310]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-883]


Importer of Controlled Substances Application: Catalent CTS, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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[[Page 44750]]

SUMMARY: Catalent CTS, LLC. has applied to be registered as an importer 
of basic class(es) of controlled substance(s). Refer to Supplementary 
Information listed below for further drug information.

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 13, 
2021. Such persons may also file a written request for a hearing on the 
application on or before September 13, 2021.

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 
request 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 9, 2021, Catalent CTS, LLC., 10245 Hickman Mills 
Drive, Kansas City, Missouri 64137-1418, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Gamma Hydroxybutyric Acid...............    2010  I
Marihuana Extract.......................    7350  1
Marihuana...............................    7360  1
Tetrahydrocannabinols...................    7370  I
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    The company plans to import the above controlled substances as 
dosage unit products for clinical trial studies. 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 Food Drug Administration-approved or non-approved finished dosage 
forms for commercial sale.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-17310 Filed 8-12-21; 8:45 am]
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