[Federal Register Volume 86, Number 128 (Thursday, July 8, 2021)]
[Notices]
[Page 36160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14530]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-862]


Importer of Controlled Substances Application: Aspen API, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Aspen API, 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 August 9, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before August 9, 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 May 5, 2021, Aspen API, Inc., 2136 Wolf Road, Des 
Plaines, Illinois 60018, applied to be registered as an importer of the 
following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
              Controlled substance                 Drug code   Schedule
------------------------------------------------------------------------
Remifentanil....................................       9739          II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance as a 
bulk active pharmaceutical ingredient (API) for distribution to 
manufacturers of finished dosage prescription drugs. 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 the Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-14530 Filed 7-7-21; 8:45 am]
BILLING CODE 4410-09-P