Importer of Controlled Substances Application: Almac Clinical Services Incorporate, 46903-46904 [2024-11817]

Download as PDF Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices 5. Commission vote on Inv. Nos. 701– TA–726 and 731–TA–1694 (Preliminary) (High Chrome Cast Iron Grinding Media from India). The Commission currently is scheduled to complete and file its determinations on June 10, 2024; views of the Commission currently are scheduled to be completed and filed on June 17, 2024. 6. Outstanding action jackets: None. CONTACT PERSON FOR MORE INFORMATION: Sharon Bellamy, Supervisory Hearings and Information Officer, 202–205–2000. The Commission is holding the meeting under the Government in the Sunshine Act, 5 U.S.C. 552(b). In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting. By order of the Commission. Issued: May 28, 2024 Sharon Bellamy, Supervisory Hearings and Information Officer. submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must 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. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. In accordance with 21 CFR 1301.34(a), this is notice that on April 29, 2024, Revvity, Inc., 120 East Dedham Street, Boston, Massachusetts 02118–2852, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: [FR Doc. 2024–12007 Filed 5–28–24; 4:15 pm] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled substance [Docket No. DEA–1378] Importer of Controlled Substances Application: Revvity, Inc. Lysergic Acid Diethylamide. Thebaine .......................... Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Revvity, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. SUMMARY: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for ddrumheller on DSK120RN23PROD with NOTICES1 DATES: VerDate Sep<11>2014 20:03 May 29, 2024 Jkt 262001 Drug code Schedule 7315 I 9333 II The company plans to import the listed controlled substances for bulk manufacturing into radioactive formulations for sale to its customers for research purposes. Drug code 9333 (Thebaine) will be used to import the Thebaine derivative Diprenorphine. No other activities for these drug codes are 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. Marsha L. Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–11822 Filed 5–29–24; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 46903 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1377] Importer of Controlled Substances Application: Almac Clinical Services Incorporate Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Almac Clinical Services Incorp (ACSI) has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information. SUMMARY: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must 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. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on May 6, 2024, Almac Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964, applied to be registered as an importer DATES: E:\FR\FM\30MYN1.SGM 30MYN1 46904 Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices of the following basic class(es) of controlled substance(s): Controlled substance Psilocybin ........................ Oxycodone ...................... Hydromorphone ............... Morphine .......................... Tapentadol ...................... Fentanyl ........................... Drug code Schedule 7437 9143 9150 9300 9780 9801 I II II II II II The company plans to import the listed controlled substances as finished dosage form units for clinical trials purposes only. No other activities for these drug codes are 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. Marsha L. Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–11817 Filed 5–29–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must 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. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. In accordance with 21 CFR 1301.34(a), this is notice that on April 16, 2024, Vici Health Sciences, LLC, 6655 Amberton Drive, Suite O, Elkridge, Maryland 21075–6202, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug Enforcement Administration I II Ibogaine ........................... Drug Enforcement Administration, Justice. ACTION: Notice of application. The company plans to import the listed controlled substance for use in clinical trials, research and analytical testing as well as dosage formulation development. 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 extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Vici Health Sciences, LLC has applied to be registered as an importer 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 submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to SUMMARY: VerDate Sep<11>2014 20:03 May 29, 2024 Jkt 262001 7260 Schedule Importer of Controlled Substances Application: Vici Health Sciences, LLC AGENCY: ddrumheller on DSK120RN23PROD with NOTICES1 Drug code Controlled substance [Docket No. DEA–1376] Marsha L. Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–11818 Filed 5–29–24; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1374] Importer of Controlled Substances Application: VA Cooperative Studies Program Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: VA Cooperative Studies Program has applied to be registered as an importer 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 submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must 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. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on April 12, 2024, VA Cooperative Studies Program, 2401 Centre Avenue South East, Albuquerque, New Mexico 87106, applied to be registered as an importer SUMMARY: E:\FR\FM\30MYN1.SGM 30MYN1

Agencies

[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Pages 46903-46904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11817]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1377]


Importer of Controlled Substances Application: Almac Clinical 
Services Incorporate

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Almac Clinical Services Incorp (ACSI) has applied to be 
registered as an importer 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 submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
July 1, 2024. Such persons may also file a written request for a 
hearing on the application on or before July 1, 2024.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to https://www.regulations.gov and follow the 
online instructions at that site for submitting comments. Upon 
submission of your comment, you will receive a Comment Tracking Number. 
Please be aware that submitted comments are not instantaneously 
available for public view on https://www.regulations.gov. If you have 
received a Comment Tracking Number, your comment has been successfully 
submitted and there is no need to resubmit the same comment. All 
requests for a hearing must 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. All requests for a hearing should also be 
sent to: Drug Enforcement Administration, Attn: Administrator, 8701 
Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on May 6, 2024, Almac Clinical Services Incorp (ACSI), 
25 Fretz Road, Souderton, Pennsylvania 18964, applied to be registered 
as an importer

[[Page 46904]]

of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Psilocybin..............................    7437  I
Oxycodone...............................    9143  II
Hydromorphone...........................    9150  II
Morphine................................    9300  II
Tapentadol..............................    9780  II
Fentanyl................................    9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances as 
finished dosage form units for clinical trials purposes only. No other 
activities for these drug codes are 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.

Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-11817 Filed 5-29-24; 8:45 am]
BILLING CODE P
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