Importer of Controlled Substances Application: Mylan Inc., 4335-4336 [2024-01136]

Download as PDF Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices GEORGIA TENNESSEE Rockdale County Fountain Hill, Address Restricted, Conyers vicinity, SG100009953 Sumner County MASSACHUSETTS TEXAS Bristol County Bradford Durfee Textile School, 64 Durfee Street, Fall River, SG100009976 Aransas County Suffolk County Uphams Corner Historic District, Generally along Columbia Road from Annabel Street to the north to Bird Street to the south, Boston, SG100009975 Galveston County MISSISSIPPI K’nesseth Israel Synagogue, 100 West Sterling Avenue, Baytown, SG100009949 Rockport School, 619 North Live Oak Street, Rockport, SG100009945 Adams County Holy Family Catholic Church Historic District, (Civil Rights Resources of Natchez and Adams County, Mississippi MPS), Roughly, along Aldrich, Old D’Evereux, St. Catherine, Abbott and Byrne Sts., Natchez, MP95000855 NEVADA Clark County Leroy and Carrie Christensen House, 500 W. Van Buren Street, Las Vegas, SG100009944 Elko County El Rancho Hotel and Casino, 1629 Lake Avenue, Wells, SG100009943 Lincoln County Gem Theater, 648 Main Street, Pioche, SG100009942 New York County Our Lady of Victory National Shrine and Basilica Historic District, 777 Ridge Road and 781 Ridge Road, Lackawanna, SG100009962 khammond on DSKJM1Z7X2PROD with NOTICES VIRGINIA Onondaga County H.A. Moyer Factory Complex (Boundary Increase), (Industrial Resources in the City of Syracuse, Onondaga County, NY MPS), 1920 Park St, Syracuse, BC100009965 J.F. O’Connor Sales Company Garage, 1641 East Genesee Street, Syracuse, SG100009969 NORTH CAROLINA Orange County Navy Reserve Officers Training Corps (NRQTC) Naval Armory at UNC-Chapel Hill, 221 South Columbia St., Chapel Hill, SG100009948 Davidson County Litterer Laboratory (Additional Documentation), 631 2nd Ave., S., Nashville, AD78002581 Madison County Jackson Free Library (Additional Documentation), College and Church Sts., Jackson, AD75001769 Marshall County Cornersville Methodist Episcopal Church South (Additional Documentation), 100 S. Mulberry St., Cornersville, AD82003991 Wilson County Memorial Hall, Cumberland University (Additional Documentation), Cumberland University campus, Lebanon, AD77001301 Authority: Section 60.13 of 36 CFR part 60. Montgomery County Pilot School, 4449 Brush Creek Road/Route 617, Pilot, SG100009956 Roanoke INDEPENDENT CITY Norfolk & Western Class J No. 611 Locomotive, 303 Norfolk Avenue SW, Roanoke, SG100009961 Sherry A. Frear, Chief, National Register of Historic Places/ National Historic Landmarks Program. [FR Doc. 2024–01261 Filed 1–22–24; 8:45 am] BILLING CODE 4312–52–P Salem INDEPENDENT CITY Hart Motor Company, 1341 E. Main Street, Salem, SG100009960 DEPARTMENT OF JUSTICE A request for removal has been made for the following resource(s): [Docket No. DEA–1316] MASSACHUSETTS Importer of Controlled Substances Application: Mylan Inc. Drug Enforcement Administration Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: ARKANSAS Mylan 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. Pulaski County DATES: Additional documentation has been received for the following resource(s): Dutchess County Main Mall Historic District (Boundary Increase), (Poughkeepsie MRA), 293–317 Main St. and 3–6 Garden St., Poughkeepsie, BC100009967 Jkt 262001 Harris County Curtis, Allen Crocker, House-Pillar House, (Newton MRA), 26 Quinobequin Rd., Newton, OT86001787 Jaquith, Abraham, House, (First Period Buildings of Eastern Massachusetts TR), 161 Concord Rd., Billerica, OT90000166 Broome County State Street-Henry Street Historic District (Boundary Increase), 221 Washington Street to Lewis Street; 1 Lewis Street to Prospect Avenue; 212 State Street to CP Rail Systems track; East Clinton Street, Binghamton, BC100009963 17:41 Jan 22, 2024 Rosewood Cemetery, 2825 63rd Street, Galveston, SG100009946 Middlesex County NEW YORK VerDate Sep<11>2014 Scattersville Public School, 227 Scattersville Road, Portland, SG100009970 4335 Railroad Call Historic District (Additional Documentation), 108, 112, and 114 S. Pulaski St., Little Rock, AD97000749 NEW YORK Dutchess County Main Mall Historic District (Additional Documentation), (Poughkeepsie MRA), 315 Main Mall to 11 Garden St., Poughkeepsie, AD82001148. Onondaga County H.A. Moyer Factory Complex (Additional Documentation), (Industrial Resources in the City of Syracuse, Onondaga County, NY MPS), 1710 North Salina and 301 Wolf Sts., Syracuse, AD100007668 TENNESSEE Bradley County Hughes, W. J., Business House (Additional Documentation), 3202 Ocoee St., Cleveland, AD75001735 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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 February 22, 2024. Such persons may also file a written request for a hearing on the application on or before February 22, 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 E:\FR\FM\23JAN1.SGM 23JAN1 4336 Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 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 December 5, 2023, Mylan Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505– 2362, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Amphetamine .................. Methylphenidate .............. Oxycodone ...................... Hydromorphone ............... Methadone ...................... Morphine .......................... Fentanyl ........................... Drug code Schedule 1100 1724 9143 9150 9250 9300 9801 II II II II II II II khammond on DSKJM1Z7X2PROD with NOTICES The company plans to import the above controlled substances as bulk active pharmaceutical ingredients for internal testing purposes only and finished dosage forms for analytical testing and distribution for clinical trials to support foreign market participation. 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 Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2024–01136 Filed 1–22–24; 8:45 am] BILLING CODE P VerDate Sep<11>2014 17:41 Jan 22, 2024 Jkt 262001 following basic class(es) of controlled substance(s): DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled substance [Docket No. DEA–1317] Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Mylan Pharmaceuticals, 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 February 22, 2024. Such persons may also file a written request for a hearing on the application on or before February 22, 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 December 6, 2023 Mylan Pharmaceuticals, Inc., 2898 Manufacturers Road, Greensboro, North Carolina 27406–4600, applied to be registered as an importer of the SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Remifentanil .................... Drug code Schedule 9739 II The company plans to import the above listed controlled substances in finished dosage form for commercial distribution to its customers. 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. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2024–01137 Filed 1–22–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 1315] Bulk Manufacturer of Controlled Substances Application: Invizyne Technologies, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Invizyne Technologies, Inc. has applied to be registered as a bulk manufacturer 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 submit electronic comments on or objections to the issuance of the proposed registration on or before March 25, 2024. Such persons may also file a written request for a hearing on the application on or before March 25, 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 SUMMARY: E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4335-4336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01136]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1316]


Importer of Controlled Substances Application: Mylan Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Mylan 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 
February 22, 2024. Such persons may also file a written request for a 
hearing on the application on or before February 22, 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

[[Page 4336]]

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 December 5, 2023, Mylan Inc., 3711 Collins Ferry 
Road, Morgantown, West Virginia 26505-2362, applied to be registered as 
an importer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Amphetamine.............................    1100  II
Methylphenidate.........................    1724  II
Oxycodone...............................    9143  II
Hydromorphone...........................    9150  II
Methadone...............................    9250  II
Morphine................................    9300  II
Fentanyl................................    9801  II
------------------------------------------------------------------------

    The company plans to import the above controlled substances as bulk 
active pharmaceutical ingredients for internal testing purposes only 
and finished dosage forms for analytical testing and distribution for 
clinical trials to support foreign market participation. 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 Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-01136 Filed 1-22-24; 8:45 am]
BILLING CODE P
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