Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc, 60918-60919 [2024-16588]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 60918 Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices reserves the right to reject any or all bids and to withdraw an offer to lease an area, even after bids have been submitted. e. Issuance of a Lease: Following identification of the winning bid on a lease area, BOEM would notify the successful bidder and provide a set of official lease documents for signature. BOEM requires a successful bidder to sign and return the lease, pay the remainder of the bonus bid, if applicable, and file the required financial assurance within 10 business days of receiving the lease documents. Upon receipt of the required payments, financial assurance, and properly signed lease forms, BOEM may execute a lease with the successful bidder. 3. Noncompetitive Leasing Process: BOEM’s noncompetitive leasing process would include the following steps: a. Determination of No Competitive Interest: If, after evaluating all relevant information, BOEM determines there is no competitive interest in all or a portion of the RFCI Areas, it may proceed with the noncompetitive lease issuance process under 30 CFR 585.231(d) through (j), which includes the publication of a determination of no competitive interest in the Federal Register. Hecate Energy would be responsible for paying a fee for the processing costs under 30 CFR 585.112, including any environmental review that BOEM may require before lease issuance. Hecate Energy also would be responsible for submitting any required consistency certification and necessary data and information in a timely manner pursuant to 15 CFR part 930, subpart D, to the applicable State CZMA agency or agencies and BOEM. b. Review of Lease Request: BOEM would complete all required consultations and environmental analyses before issuing a lease noncompetitively. Further, BOEM would coordinate and consult, as appropriate, with relevant Federal agencies, federally recognized Tribes, affected State and local governments, and other affected or interested parties in formulating lease terms, conditions, and stipulations. c. Lease Issuance: After completing its review of the lease request, BOEM may offer one or two noncompetitive leases to Hecate Energy covering all or a portion of WEAs C and D. Within 10 business days of receiving the lease(s), Hecate Energy must execute them and provide a lease-specific bond or other authorized financial assurance in the amount of 12 months’ rent for each lease, under 30 CFR 585.516, to guarantee compliance with all terms and conditions of each lease. No later VerDate Sep<11>2014 18:51 Jul 26, 2024 Jkt 262001 than 45 days of receiving the executed lease(s) from BOEM, the lessee must pay BOEM the first 12 months’ rent for each lease. Elizabeth Klein, Director, Bureau of Ocean Energy Management. [FR Doc. 2024–16626 Filed 7–26–24; 8:45 am] BILLING CODE 4340–98–P DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Z-Wave Alliance Notice is hereby given that, on June 14, 2024, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (‘‘the Act’’), Z-Wave Alliance, Inc. (the ‘‘Joint Venture’’) filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act’s provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Consumer 2.0 DBA Rently.com, Los Angeles, CA; Hearo, Springfield, MO; and Nabu Casa, Inc., Dover, DE, have joined as parties to the venture. Also, System and Network Engineering Srl, Roma, ITALY; Swidget Corp., Kingston, CANADA; Sky Telecom Ingenieria S.L., Bilbao-Vizcaya, SPAIN; HELTUN, Inc., Los Altos Hills, CA; iGuard Home Solutions, Inc., Seattle, WA; Guangzhou MCOHome Technology Co., LTD., Guangzhou, PEOPLE’S REPUBLIC OF CHINA; Hangzhou Roombanker Technology Co., Ltd., Hangzhou City, PEOPLE’S REPUBLIC OF CHINA; Leak Intelligence LLC, Franklin, TN; SHENZHEN NEO ELECTRONICS CO., LTD., Shenzhen, PEOPLE’S REPUBLIC OF CHINA; EcoDim, Doetinchem, THE NETHERLANDS; ZWaveProducts.com, Iselin, NJ; SHARP FUKUYAMA SEMICONDUCTOR CO., LTD., Fukuyama, JAPAN; Sharp Corporation, Osaka-fu, JAPAN; JEEDOM SAS, Rillieux La Pape, FRANCE; Shenzhen Sunricher Technology Limited, Shenzhen, PEOPLE’S REPUBLIC OF CHINA; Springs Window Fashions, LLC, Middleton, WI; ZOME Energy Networks, Inc., Hollis, NH; Sentegrate Pty Ltd., NSW, AUSTRALIA; Beaumotica, Breda, THE NETHERLANDS; Smart Home SA, Gland, SWITZERLAND; Buffalo, Inc., PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Nagoya, JAPAN; Oy K1 Services Ab, Jakobstad, FINLAND; JV Innovation LLC, East Wakefield, NH; Hank Smart Tech Co. Ltd., Shenzhen, PEOPLE’S REPUBLIC OF CHINA; Duke Energy Business Services LLC, Charlotte, NC; Masonite Corporation, Tampa, FL; and Passiv UK Limited, Newbury, UNITED KINGDOM, have withdrawn as parties to the venture. No other changes have been made in either the membership or the planned activity of the venture. Membership in this venture remains open, and the Joint Venture intends to file additional written notifications disclosing all changes in membership. On November 19, 2020, the Joint Venture filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to section 6(b) of the Act on December 1, 2020 (85 FR 77241). The last notification was filed with the Department on January 26, 2024. A notice was published in the Federal Register pursuant to section 6(b) of the Act on March 13, 2024 (89 FR 18438). Suzanne Morris, Deputy Director Civil Enforcement Operations, Antitrust Division. [FR Doc. 2024–16602 Filed 7–26–24; 8:45 am] BILLING CODE 4410–11–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1391] Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Galephar Pharmaceutical Research 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. 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 August 28, 2024. Such persons may also file a written request for a hearing on the application on or before August 28, 2024. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically SUMMARY: E:\FR\FM\29JYN1.SGM 29JYN1 60919 Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices 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. In accordance with 21 CFR 1301.34(a), this is notice that on June 12, 2024, Galephar Pharmaceutical Research Inc, #100 Carr 198 Industrial Park, Juncos, Puerto Rico 00777–3873 applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code Controlled substance ddrumheller on DSK120RN23PROD with NOTICES1 Hydromorphone ............. Morphine ........................ I 9150 9300 Schedule I II II The company plans to import the listed controlled substances for analytical 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. 2024–16588 Filed 7–26–24; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 18:51 Jul 26, 2024 Jkt 262001 DEPARTMENT OF JUSTICE Controlled substance Drug code Schedule 7315 I 7431 I 7437 7438 9780 I I II Drug Enforcement Administration [Docket No. DEA–1396] Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Catalent Pharma Solutions, 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 August 28, 2024. Such persons may also file a written request for a hearing on the application on or before August 28, 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 June 5, 2024, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114–1123, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Lysergic acid diethylamide. 5-Methoxy-N, Ndimethyltryptamine. Psilocybin ........................ Psilocyn ........................... Tapentadol ...................... The company plans to import the listed controlled substances as finished dosage unit products for clinical trials, research, and analytical activities. 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. 2024–16587 Filed 7–26–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1398] Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Cerilliant Corporation 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 submit electronic comments on or objections to the issuance of the proposed registration on or before September 27, 2024. Such persons may also file a written request for a hearing on the application on or before September 27, 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 SUMMARY: E:\FR\FM\29JYN1.SGM 29JYN1

Agencies

[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Pages 60918-60919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16588]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1391]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research Inc

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Galephar Pharmaceutical Research 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.

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 
August 28, 2024. Such persons may also file a written request for a 
hearing on the application on or before August 28, 2024.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically

[[Page 60919]]

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 June 12, 2024, Galephar Pharmaceutical Research Inc, 
#100 Carr 198 Industrial Park, Juncos, Puerto Rico 00777-3873 applied 
to be registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Hydromorphone..........................     9150  II
Morphine...............................     9300  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
analytical 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. 2024-16588 Filed 7-26-24; 8:45 am]
BILLING CODE 4410-09-P
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