Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc., 16497-16498 [2022-06162]

Download as PDF 16497 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / 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. In accordance with 21 CFR 1301.33(a), this is notice that on February 28, 2022, Johnson Matthey Pharmaceutical Materials, Inc., 2003 Nolte Drive, West Deptford, New Jersey 08066–1742, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): drug codes are authorized for this registration. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2022–06159 Filed 3–22–22; 8:45 am] BILLING CODE P SUPPLEMENTARY INFORMATION: Controlled substance jspears on DSK121TN23PROD with NOTICES1 Gamma Hydroxybutyric Acid. Marihuana ....................... Tetrahydrocannabinols ... Noroxymorphone ............ Difenoxin ......................... Amphetamine ................. Methamphetamine .......... Lisdexamfetamine .......... Methylphenidate ............. Nabilone ......................... ANPP (4-Anilino-Nphenethyl-4-piperidine). Norfentanyl (N-phenyl-N(piperidin-4-yl) propionamide). Cocaine .......................... Codeine .......................... Dihydrocodeine ............... Oxycodone ..................... Hydromorphone .............. Diphenoxylate ................. Ecgonine ......................... Hydrocodone .................. Levorphanol .................... Meperidine ...................... Methadone ...................... Methadone intermediate Morphine ......................... Thebaine ......................... Opium tincture ................ Oxymorphone ................. Noroxymorphone ............ Alfentanil ......................... Remifentanil .................... Sufentanil ........................ Tapentadol ...................... Fentanyl .......................... Drug code Schedule 2010 I 7360 7370 9145 9168 1100 1105 1205 1724 7379 8333 I I I I II II II II II II 8366 II 9041 9050 9120 9143 9150 9170 9180 9193 9220 9230 9250 9254 9300 9333 9630 9652 9668 9737 9739 9740 9780 9801 II II II II II II II II II II II II II II II II II II II II II II 20:07 Mar 22, 2022 Jkt 256001 Controlled substance Drug Enforcement Administration [Docket No. DEA–979] Importer of Controlled Substances Application: Sharp Clinical Services, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Sharp Clinical Services, 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 April 22, 2022. Such persons may also file a written request for a hearing on the application on or before April 22, 2022. ADDRESSES: The DEA 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. SUMMARY: The company plans to bulk manufacture the listed controlled substances for the internal use intermediates or for sale to its customers. 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 VerDate Sep<11>2014 DEPARTMENT OF JUSTICE In accordance with 21 CFR 1301.34(a), this is notice that on February 2, 2022, Sharp Clinical Services, Inc. 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020– 8024, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Gamma Hydroxybutyric Acid. 3,4Methylenedioxymethamphetamine. Drug code Schedule 2010 I 7405 I The company plans to import the listed control substances for clinical trials. 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. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2022–06161 Filed 3–22–22; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–984] Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Siemens Healthcare Diagnostics, 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 submit electronic comments on or objections to the issuance of the proposed registration on or before May 23, 2022. Such persons may also file a written request for a hearing on the application on or before May 23, 2022. ADDRESSES: The Drug Enforcement Administration (DEA) requires that all comments be submitted electronically SUMMARY: E:\FR\FM\23MRN1.SGM 23MRN1 16498 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / 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.’’ SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on January 17, 2022, Siemens Healthcare Diagnostics Inc., 100 GBC Drive, Mailstop 514, Newark, Delaware 19702–2461, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Ecgonine ......................... Drug code Schedule 9180 II The company plans to produce the listed controlled substance in bulk to be used in the manufacture of DEA exempt products. No other activities for these drug codes are authorized for this registration. Matthew J. Strait, Deputy Assistant Administrator. Controlled substance Psilocybin ..................... Psilocin ......................... Drug code 7437 7438 BILLING CODE P DEPARTMENT OF JUSTICE [FR Doc. 2022–06166 Filed 3–22–22; 8:45 am] [Docket No. DEA–986] BILLING CODE P Bulk Manufacturer of Controlled Substances Application: Usona Institute, Inc. DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: [Docket No. DEA–987] Usona Institute, 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 submit electronic comments on or objections to the issuance of the proposed registration on or before May 23, 2022. Such persons VerDate Sep<11>2014 20:07 Mar 22, 2022 Jkt 256001 I I Matthew J. Strait, Deputy Assistant Administrator. Drug Enforcement Administration SUMMARY: Schedule The company plans to bulk manufacture the listed controlled substances for use in chemical process development as well as pre-clinical and clinical research. [FR Doc. 2022–06162 Filed 3–22–22; 8:45 am] jspears on DSK121TN23PROD with NOTICES1 may also file a written request for a hearing on the application on or before May 23, 2022. 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on February 16, 2022, Usona Institute, Inc., 2780 Woods Hollow Road, Room 2413, Fitchburg, Wisconsin 53711, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Patheon API Manufacturing, 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. SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 9990 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 May 23, 2022. Such persons may also file a written request for a hearing on the application on or before May 23, 2022. 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on March 2, 2022, Patheon API Manufacturing, Inc., 309 Delaware Street, Greenville, South Carolina 29605–5420, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): DATES: Controlled substance Gamma Hydroxybutyric Acid. Tetrahydrocannabinols 5-Methoxy-N-NDimethyltryptamine. Alpha-Methyltryptamine Dimethyltryptamine ....... Psilocybin ..................... Psilocyn ........................ Thebaine ....................... Oxymorphone ............... Noroxymorphone .......... Drug code Schedule 2010 I 7370 7431 I I 7432 7435 7437 7438 9333 9652 9668 I I I I II II II The company plans to bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for distribution to its customers. In reference to dug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these drug codes are authorized for this registration. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2022–06167 Filed 3–22–22; 8:45 am] BILLING CODE P E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16497-16498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06162]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-984]


Bulk Manufacturer of Controlled Substances Application: Siemens 
Healthcare Diagnostics, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Siemens Healthcare Diagnostics, 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 submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
May 23, 2022. Such persons may also file a written request for a 
hearing on the application on or before May 23, 2022.

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

[[Page 16498]]

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.''

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on January 17, 2022, Siemens Healthcare Diagnostics 
Inc., 100 GBC Drive, Mailstop 514, Newark, Delaware 19702-2461, applied 
to be registered as a bulk manufacturer of the following basic 
class(es) of controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Ecgonine...............................    9180  II
------------------------------------------------------------------------

    The company plans to produce the listed controlled substance in 
bulk to be used in the manufacture of DEA exempt products. No other 
activities for these drug codes are authorized for this registration.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-06162 Filed 3-22-22; 8:45 am]
BILLING CODE P
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