Importer of Controlled Substances Application: Cedarburg Pharmaceuticals, 47521-47522 [2021-18233]

Download as PDF 47521 Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices Certain Laparoscopic Surgical Staplers, Reload Cartridges, and Components Thereof; Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Schedule for Filing Written Submissions on the Issues Under Review and on Remedy, Public Interest, and Bonding National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (‘‘the Act’’), Dynamic Spectrum Alliance, Inc. has 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, Apple, Cupertino, CA, and Strathmore University, Nairobi, KENYA have been added as parties to this venture. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Dynamic Spectrum Alliance, Inc. intends to file additional written notifications disclosing all changes in membership. On September 1, 2020, Dynamic Spectrum Alliance, Inc. 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 September 18, 2020 (85 FR 58390). The last notification was filed with the Department on May 4, 2021. A notice was published in the Federal Register pursuant to Section 6(b) of the Act on May 25, 2021 (86 FR 28150). U.S. International Trade Commission. ACTION: Correction of notice. Suzanne Morris, Chief, Premerger and Division Statistics, Antitrust Division. information in support of the claim to Laura Bryant, Gilcrease Museum, 1400 N Gilcrease Museum Road, Tulsa, OK 74127, telephone (918) 596–2747, email laura-bryant@utulsa.edu, by September 24, 2021. After that date, if no additional claimants have come forward, transfer of control of the sacred objects and/or objects of cultural patrimony to the Minnesota Chippewa Tribe, Minnesota (Mille Lacs Band) may proceed. The Gilcrease Museum is responsible for notifying the Minnesota Chippewa Tribe, Minnesota (Mille Lacs Band) that this notice has been published. Dated: August 11, 2021. Melanie O’Brien, Manager, National NAGPRA Program. [FR Doc. 2021–18270 Filed 8–24–21; 8:45 am] BILLING CODE 4312–52–P INTERNATIONAL TRADE COMMISSION [Investigation No. 337–TA–1167] AGENCY: Correction is made to notice 86 FR 46882, which was published on August 20, 2021. There is a typographical error in the investigation number on the first page caption section. The correct investigation number should read: Investigation No. 337–TA–1167. SUMMARY: [FR Doc. 2021–18264 Filed 8–24–21; 8:45 am] BILLING CODE P Drug Enforcement Administration [Docket No. DEA–872] khammond on DSKJM1Z7X2PROD with NOTICES Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Dynamic Spectrum Alliance, Inc. Notice is hereby given that, on August 10, 2021, pursuant to Section 6(a) of the VerDate Sep<11>2014 16:54 Aug 24, 2021 Jkt 253001 7360 7370 I I The company plans to bulk manufacture the listed controlled substances for the internal use intermediates or for sale to its customers. The company plans to manufacture the above-listed controlled substances in bulk to produce finished dosage forms and conduct research to develop new drug products and for clinical studies. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Brian S. Besser, Acting Assistant Administrator. PO 00000 Frm 00053 Fmt 4703 DEPARTMENT OF JUSTICE Sfmt 4703 [Docket No. DEA–864] Importer of Controlled Substances Application: Cedarburg Pharmaceuticals Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Benuvia Therapeutics Inc., 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 file written comments on or objections to the issuance of the proposed registration on SUMMARY: DEPARTMENT OF JUSTICE Schedule Drug Enforcement Administration Drug Enforcement Administration, Justice. ACTION: Notice of application. BILLING CODE 7020–02–P Marihuana ................................. Tetrahydrocannabinols ............. Drug code BILLING CODE P DEPARTMENT OF JUSTICE AGENCY: [FR Doc. 2021–18313 Filed 8–24–21; 8:45 am] Controlled substance [FR Doc. 2021–18234 Filed 8–24–21; 8:45 am] Bulk Manufacturer of Controlled Substances Application: Benuvia Therapeutics Inc. By order of the Commission. Issued: August 20, 2021. Lisa Barton, Secretary to the Commission. or before October 25, 2021. Such persons may also file a written request for a hearing on the application on or before October 25, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on July 1, 2021, Benuvia Therapeutics Inc., 2700 Oakmont Drive, Round Rock, Texas 78665, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Cedarburg Pharmaceuticals 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 file written SUMMARY: E:\FR\FM\25AUN1.SGM 25AUN1 47522 Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices comments on or objections to the issuance of the proposed registration on or before September 24, 2021. Such persons may also file a written request for a hearing on the application on or before September 24, 2021. 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. ADDRESSES: In accordance with 21 CFR 1301.34(a), this is notice that on January 20, 2021, Cedarburg Pharmaceuticals, 870 Badger Circle Drive, Grafton, Wisconsin 53024– 9436, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance khammond on DSKJM1Z7X2PROD with NOTICES Gamma Hydroxybutyric Acid .... Marihuana Extract ..................... Marihuana ................................. Drug code Schedule 2010 7350 7360 I I I I I The company plans to import Sodium Oxybate (derivative of GammaHydroxybutyric Acid) to support Euticals Inc. post procurement quota grand. The cannabidiol from Marihuana and Marihuana Extracts is intended for analytical purposes with tetramethylpyrazine. 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. Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2021–18233 Filed 8–24–21; 8:45 am] BILLING CODE P VerDate Sep<11>2014 16:54 Aug 24, 2021 Jkt 253001 activity for this drug code is authorized for this registration. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–890] [FR Doc. 2021–18238 Filed 8–24–21; 8:45 am] Importer of Controlled Substances Application: Johnson Matthey Inc. BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. AGENCY: ACTION: Brian S. Besser, Acting Assistant Administrator. Drug Enforcement Administration Notice of application. [Docket No. DEA–860] Johnson Matthey 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 file written comments on or objections to the issuance of the proposed registration on or before September 24, 2021. Such persons may also file a written request for a hearing on the application on or before September 24, 2021. DATES: 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. ADDRESSES: In accordance with 21 CFR 1301.34(a), this is notice that on July 23, 2021, Johnson Matthey Inc., 2003 Nolte Drive, West Deptford, New Jersey 08066–1742, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code Controlled substance Nabilone .......................... I 7379 Schedule I II The company plans to import Nabilone (7379) in order to accept the return of this controlled substance from a foreign customer who no longer has a demand for this substance. No other PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Bulk Manufacturer of Controlled Substances Application: Absolute Standards, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Absolute Standards, Inc., 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 file written comments on or objections to the issuance of the proposed registration on or before October 25, 2021. Such persons may also file a written request for a hearing on the application on or before October 25, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUMMARY: In accordance with 21 CFR 1301.33(a), this is notice that on May 31, 2021, Absolute Standards, Inc., 44 Rossotto Drive, Hamden, Connecticut 06514–1335, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance: SUPPLEMENTARY INFORMATION: Drug code Controlled substance Pentobarbital ................... I 2270 Schedule III The company plans to bulk manufacture the listed controlled substances for internal use and for sale to its customers. No other activities for these drug codes are authorized for this registration. Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2021–18230 Filed 8–24–21; 8:45 am] BILLING CODE P E:\FR\FM\25AUN1.SGM 25AUN1

Agencies

[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47521-47522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18233]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-864]


Importer of Controlled Substances Application: Cedarburg 
Pharmaceuticals

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Cedarburg Pharmaceuticals 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 file written

[[Page 47522]]

comments on or objections to the issuance of the proposed registration 
on or before September 24, 2021. Such persons may also file a written 
request for a hearing on the application on or before September 24, 
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 January 20, 2021, Cedarburg Pharmaceuticals, 870 
Badger Circle Drive, Grafton, Wisconsin 53024-9436, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid...............    2010  I
Marihuana Extract.......................    7350  I
Marihuana...............................    7360  I
------------------------------------------------------------------------

    The company plans to import Sodium Oxybate (derivative of Gamma-
Hydroxybutyric Acid) to support Euticals Inc. post procurement quota 
grand. The cannabidiol from Marihuana and Marihuana Extracts is 
intended for analytical purposes with tetramethylpyrazine. 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 non-approved finished 
dosage forms for commercial sale.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-18233 Filed 8-24-21; 8:45 am]
BILLING CODE P
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