[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Page 13927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04835]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 577]
Importer of Controlled Substances Application: Caligor Pharma
Services
ACTION: Notice of application.
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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 9, 2020.
Such persons may also file a written request for a hearing on the
application on or before April 9, 2020.
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 September 6, 2019, Caligor Coghlan Pharma Services,
1500 Business Park Drive, Unit B, Bastrop, Texas 78602, applied to be
registered as an importer of the following basic class(es) of
controlled substance:
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Controlled substance Drug code Schedule
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Tapentadol........................... 9780 II
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The company plans to import the listed controlled substance in
finished dosage form to be used in pediatric 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
business activity is consistent with what is authorized under 21 U.S.C.
952(a)(2). Authorization will not be extended to the import of FDA
approved or non-approved finished dosage forms for commercial use.
Dated: February 11, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-04835 Filed 3-9-20; 8:45 am]
BILLING CODE 4410-09-P