[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11558-11559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03919]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA798]


Importer of Controlled Substances Application: Myonex Inc

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Myonex Inc has applied to be registered as an importer of 
basic class(es) of controlled substance(s). Refer to Supplemental 
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 March 29, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before March 29, 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 January 6, 2021, Myonex Inc, 48 East Main Street, 
Norristown, Pennsylvania 19401-4915, 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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Amphetamine............................    1100  II
Lisdexamfetamine.......................    1205  II
Methylphenidate........................    1724  II

[[Page 11559]]

 
Nabilone...............................    7379  II
Oxycodone..............................    9143  II
Hydromorphone..........................    9150  II
Hydrocodone............................    9193  II
Morphine...............................    9300  II
Oxymorphone............................    9652  II
Fentanyl...............................    9801  II
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    The company plans to import the listed controlled substances for 
clinical trials, research, and analytical purposes. 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 the Food and Drug 
Administration (FDA)-approved or non-approved finished dosage forms for 
commercial sale. No other activity for these drug codes is authorized 
for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-03919 Filed 2-24-21; 8:45 am]
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