Federal Register - July 8, 2021
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Fuente: Federal Register
36160
Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Docket No. DEA863
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 classes of controlled substances. Refer to Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic classes, 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 1301.34a, this is notice that on May 18, 2021, Alcami Carolinas Corporation, 1726 North 23rd Street, Wilmington, North Carolina 284051822, applied to be registered as an importer of the following basic classes of controlled substances:
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 registrants business activity is consistent with what is authorized under 21 U.S.C. 952a2.
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. 202114533 Filed 7721; 8:45 am BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Docket No. DEA862
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 registrants business activity is consistent with what is authorized under 21 U.S.C. 952a2.
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. 202114530 Filed 7721; 8:45 am BILLING CODE 441009P
Aspen API, Inc. has applied to be registered as an importer of basic classes of controlled substances.
Refer to Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic classes, 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 1301.34a, 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 classes of controlled substances:
DEPARTMENT OF JUSTICE
Parole Commission Certification of Meeting Closure Pursuant to the Government in the Sunshine Act Pub. L. 94409 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 552bf1:
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.
552bc10 and d4 for applicable Parole Commission regulations see 28
CFR 16.203a10, 16.205a and 16.205b1. 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. 552bc3, 6 and 7 and 28 CFR
16.203a3, 6, and 7.
In witness whereof, I have signed this document and affixed the seal of the
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08JYN1