[Federal Register Volume 86, Number 22 (Thursday, February 4, 2021)]
[Notices]
[Page 8220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02315]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-773]


Importer of Controlled Substances Application: Mylan 
Pharmaceuticals Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Mylan Pharmaceuticals 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 8, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before March 8, 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 December 18, 2020, Mylan Pharmaceuticals Inc., 2898 
Manufacturers Road, Greensboro, North Carolina 27406-4600, 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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Remifentanil...........................   9739   II
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    The company plans to import the above-controlled substance as the 
Federal Drug Administration-approved drug product in finished dosage 
form for commercial distribution to its customers. 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).

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-02315 Filed 2-3-21; 8:45 am]
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