[Federal Register Volume 85, Number 241 (Tuesday, December 15, 2020)]
[Notices]
[Pages 81220-81221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27509]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-753]


Importer of Controlled Substances Application: Adiramedica LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Adiramedica LLC has applied to be registered as an importer of 
a basic class of a controlled substance. Refer to Supplemental 
Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before January 14, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before January 14, 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 
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 October 14, 2020, Adiramedica LLC, 585 Turner 
Industrial Way, Aston, Pennsylvania 19014, applied to be registered as 
an importer of the following basic class of a controlled substance:

[[Page 81221]]



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                                           Drug
          Controlled substance             code          Schedule
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Tapentadol.............................     9780  II
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    The company plans to import Tapentadol in dosage form for clinical 
trials. No other activity for this drug code is authorized for this 
registration.
    Approval of permit applications 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 Food 
and Drug Administration-approved or non-approved finished dosage forms 
for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-27509 Filed 12-14-20; 8:45 am]
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