[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Page 4941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01816]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-947]


Bulk Manufacturer of Controlled Substances Application: Siegfried 
USA, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Siegfried USA, LLC. has applied to be registered as a bulk 
manufacturer 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 April 1, 2022 
Such persons may also file a written request for a hearing on the 
application on or before April 1, 2022.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on December 8, 2021, Siegfried USA, LLC., 33 Industrial 
Park Road, Pennsville, New Jersey 08070-3244, applied to be registered 
as a bulk manufacturer 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
Dihydromorphine.........................     9145  I
Hydromorphinol..........................     9301  I
Amphetamine.............................     1100  II
Lisdexamfetamine........................     1205  II
Methylphenidate.........................     1724  II
Amobarbital.............................     2125  II
Pentobarbital...........................     2270  II
Secobarbital............................     2315  II
Phenylacetone...........................     8501  II
Codeine.................................     9050  II
Oxycodone...............................     9143  II
Hydromorphone...........................     9150  II
Hydrocodone.............................     9193  II
Methadone...............................     9250  II
Methadone intermediate..................     9254  II
Morphine................................     9300  II
Oripavine...............................     9330  II
Thebaine................................     9333  II
Opium tincture..........................     9630  II
Oxymorphone.............................     9652  II
Tapentadol..............................     9780  II
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    The company plans to manufacture the above-listed controlled 
substance in bulk for development of a new active pharmaceutical 
ingredient (API) and validation for a Drug Master File submission to 
the Food and Drug Administration. No other activity for this drug code 
is authorized for this registration.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022-01816 Filed 1-28-22; 8:45 am]
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