Importer of Controlled Substances Application: Alcami Carolinas Corporation, 36160 [2021-14533]

Download as PDF 36160 Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–863] Importer of Controlled Substances Application: Alcami Carolinas Corporation Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Alcami Carolinas Corporation 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 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 May 18, 2021, Alcami Carolinas Corporation, 1726 North 23rd Street, Wilmington, North Carolina 28405–1822, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUMMARY: Controlled substance lotter on DSK11XQN23PROD with NOTICES1 Psilocybin ..................... Psilocyn ........................ Pentobarbital ................ Thebaine ....................... Drug code 7437 7438 2270 9333 Schedule I I II II The company plans to import the listed controlled substances in bulk for the manufacturing of capsules/tablets for Phase II clinical trials. The company plans to import derivatives of Thebaine that have been determined by DEA to be VerDate Sep<11>2014 16:47 Jul 07, 2021 Jkt 253001 captured under drug code (9333) Thebaine. No other activity for these 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 extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2021–14533 Filed 7–7–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–862] Importer of Controlled Substances Application: Aspen API, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 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 nonapproved 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 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, SUMMARY: Illinois 60018, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DEPARTMENT OF JUSTICE Parole Commission Certification of Meeting Closure Pursuant to the Government in the Sunshine Act (Pub. L. 94–409) [5 U.S.C. Section 552b] I, Helen H. Krapels, General Counsel of the United States Parole Commission, certify, pursuant to 5 U.S.C. Section 552b(f)(1): In my opinion a meeting of the Commission to be held on Tuesday, July 13, 2021 at approximately 2:00 p.m., at the U.S. Parole Commission, 90 K Street NE, Washington, DC 20530, could be closed to the public in the event that a majority of the Commissioners present vote to close said meeting at the beginning thereof, with the vote properly recorded. The exemptions of the Government in the Sunshine Act that may allow closing the meeting to the public 5 U.S.C. 552b(c)(10) and (d)(4) (for applicable Parole Commission regulations see 28 CFR 16.203(a)(10), 16.205(a) and 16.205(b)(1)). In addition, the following laws and regulations may apply to exempt disclosure to the public portions of the subject matter of this meeting: 5 U.S.C. 552b(c)(3), (6) and (7) and 28 CFR 16.203(a)(3), (6), and (7). In witness whereof, I have signed this document (and affixed the seal of the E:\FR\FM\08JYN1.SGM 08JYN1

Agencies

[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: 2021-14533]



[[Page 36160]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-863]


Importer of Controlled Substances Application: Alcami Carolinas 
Corporation

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Alcami Carolinas Corporation 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 
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 May 18, 2021, Alcami Carolinas Corporation, 1726 
North 23rd Street, Wilmington, North Carolina 28405-1822, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Psilocybin.............................     7437  I
Psilocyn...............................     7438  I
Pentobarbital..........................     2270  II
Thebaine...............................     9333  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
bulk for the manufacturing of capsules/tablets for Phase II clinical 
trials. The company plans to import derivatives of Thebaine that have 
been determined by DEA to be captured under drug code (9333) Thebaine. 
No other activity for these 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 extend to the import 
of Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-14533 Filed 7-7-21; 8:45 am]
BILLING CODE P
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