Bulk Manufacturer of Controlled Substances Application: Purisys, LLC, 19325-19327 [2023-06687]

Download as PDF 19325 Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices suspension agreements took effect on March 17, 2023. The antidumping duty suspension agreement is based upon an agreement between Commerce and producers/exporters which account for substantially all imports of white grape juice concentrate from Argentina, in which each signatory producer/exporter has agreed to revise its prices to eliminate completely the injurious effects of exports of WGJC to the United States. The countervailing duty suspension agreement is based upon an agreement between Commerce and the Government of Argentina (‘‘GOA’’), wherein the GOA has agreed not to provide any new or additional export or import substitution subsidies on the subject merchandise and has agreed to restrict the volume of direct or indirect exports to the United States of WGJC from all Argentine producers/exporters in order to eliminate completely the injurious effects of exports of this merchandise to the United States. Accordingly, the U.S. International Trade Commission gives notice of the suspension of its antidumping and countervailing duty investigations involving imports of WGJC from Argentina, provided for in subheading 2009.69.00 of the Harmonized Tariff Schedule of the United States. DATES: March 24, 2023. ddrumheller on DSK120RN23PROD with NOTICES1 FOR FURTHER INFORMATION CONTACT: Ahdia Bavari (202–205–3191), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearingimpaired individuals are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal on 202– 205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202–205–2000. General information concerning the Commission may also be obtained by accessing its internet server (https:// www.usitc.gov). The public record for these investigations may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. Authority: These investigations are being suspended under authority of title VII of the Tariff Act of 1930 and pursuant to section 207.40(b) of the Commission’s Rules of Practice and Procedure (19 CFR 207.40(b)). This notice is published pursuant to section 201.10 of the Commission’s rules (19 CFR 201.10). By order of the Commission. VerDate Sep<11>2014 17:54 Mar 30, 2023 Jkt 259001 Issued: March 27, 2023. Lisa Barton, Secretary to the Commission. [FR Doc. 2023–06669 Filed 3–30–23; 8:45 am] BILLING CODE 7020–02–P INTERNATIONAL TRADE COMMISSION [USITC SE–23–018] Sunshine Act Meetings United States International Trade Commission. TIME AND DATE: April 7, 2023 at 11:00 a.m. PLACE: Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205–2000. STATUS: Open to the public. MATTERS TO BE CONSIDERED: 1. Agendas for future meetings: none. 2. Minutes. 3. Ratification List. 4. Commission vote on Inv. Nos. 701– TA–552 and 731–TA–1308 (Review) (Pneumatic Off-the-Road (OTR) Tires from India). The Commission currently is scheduled to complete and file its determinations and views of the Commission on April 27, 2023. 5. Outstanding action jackets: none. CONTACT PERSON FOR MORE INFORMATION: Sharon Bellamy, Acting 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. AGENCY HOLDING THE MEETING: 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 30, 2023. Such persons may also file a written request for a hearing on the application on or before May 30, 2023. 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 3, 2023, Sterling Pharma USA LLC., 1001 Sheldon Drive, Suite 101, Cary, North Carolina 27513– 2078, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Dimethyltryptamine ....... By order of the Commission. Issued: March 29, 2023. Lisa Barton, Secretary to the Commission. [FR Doc. 2023–06864 Filed 3–29–23; 4:15 pm] BILLING CODE 7020–02–P Drug code 7435 Schedule I The company plans to manufacture the above-listed controlled substance(s) to support clinical trials. No other activities for this drug code is authorized for this registration. Matthew Strait, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2023–06698 Filed 3–30–23; 8:45 am] Drug Enforcement Administration BILLING CODE P [Docket No. DEA–1174] Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC Bulk Manufacturer of Controlled Substances Application: Purisys, LLC Sterling Pharma USA LLC. has applied to be registered as a bulk PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 Drug Enforcement Administration [Docket No. DEA–1172] Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: SUMMARY: DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. AGENCY: E:\FR\FM\31MRN1.SGM 31MRN1 19326 ACTION: Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices Notice of application. Purisys, LLC, 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 30, 2023. Such persons may also file a written request for a SUMMARY: hearing on the application on or before May 30, 2023. 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, 2023, Purisys, LLC, 1550 Olympic Drive, Athens, Georgia 30601–1602, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): ddrumheller on DSK120RN23PROD with NOTICES1 Controlled substance Drug code Cathinone ........................................................................................................................................................................ Gamma Hydroxybutyric Acid ........................................................................................................................................... Ibogaine ........................................................................................................................................................................... Lysergic acid diethylamide .............................................................................................................................................. Marihuana Extract ........................................................................................................................................................... Marihuana ........................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................... 2,5-Dimethoxyamphetamine ............................................................................................................................................ 3,4-Methylenedioxyamphetamine .................................................................................................................................... 3,4-Methylenedioxy-N-ethylamphetamine ....................................................................................................................... 3,4-Methylenedioxymethamphetamine ............................................................................................................................ 5-Methoxy-N,N-dimethyltryptamine ................................................................................................................................. Diethyltryptamine ............................................................................................................................................................. Dimethyltryptamine .......................................................................................................................................................... Psilocybin ......................................................................................................................................................................... Psilocyn ........................................................................................................................................................................... 5-Methyoxy-N,N-diisopropyltryptamine ............................................................................................................................ Codeine-N-oxide .............................................................................................................................................................. Dihydromorphine ............................................................................................................................................................. Heroin .............................................................................................................................................................................. Hydromorphinol ............................................................................................................................................................... Morphine-N-oxide ............................................................................................................................................................ Normorphine .................................................................................................................................................................... Norlevorphanol ................................................................................................................................................................ Amphetamine ................................................................................................................................................................... Lisdexamfetamine ............................................................................................................................................................ Methylphenidate .............................................................................................................................................................. Pentobarbital .................................................................................................................................................................... Nabilone ........................................................................................................................................................................... Cocaine ............................................................................................................................................................................ Codeine ........................................................................................................................................................................... Dihydrocodeine ................................................................................................................................................................ Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Ecgonine .......................................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Levorphanol ..................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Meperidine intermediate-A .............................................................................................................................................. Meperidine intermediate-B .............................................................................................................................................. Meperidine intermediate-C .............................................................................................................................................. Methadone intermediate .................................................................................................................................................. Methadone intermediate .................................................................................................................................................. Morphine .......................................................................................................................................................................... Oripavine ......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... Opium tincture ................................................................................................................................................................. Opium, powdered ............................................................................................................................................................ Opium, granulated ........................................................................................................................................................... Oxymorphone .................................................................................................................................................................. Noroxymorphone ............................................................................................................................................................. Alfentanil .......................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... Carfentanil ....................................................................................................................................................................... Tapentadol ....................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... VerDate Sep<11>2014 17:54 Mar 30, 2023 Jkt 259001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1 1235 2010 7260 7315 7350 7360 7370 7396 7400 7404 7405 7431 7434 7435 7437 7438 7439 9053 9145 9200 9301 9307 9313 9634 1100 1205 1724 2270 7379 9041 9050 9120 9143 9150 9180 9193 9220 9230 9232 9233 9234 9250 9254 9300 9330 9333 9630 9639 9640 9652 9668 9737 9740 9743 9780 9801 Schedule I I I I I I I I I I I I I I I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II 19327 Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices The company plans to bulk manufacture the listed controlled substances for the production of active pharmaceutical ingredients (API) and analytical reference standards for sale to its customers. The company plans to manufacture the above listed controlled substances as clinical trial and starting materials to make compounds for distribution to its customers. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–06687 Filed 3–30–23; 8:45 am] BILLING CODE P 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 February 22, 2023, PerkinElmer, 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): DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration Lysergic Acid Diethylamide. Thebaine ....................... [Docket No. DEA–1167] Importer of Controlled Substances Application: PerkinElmer, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: PerkinElmer, 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 May 1, 2023. Such persons may also file a written request for a hearing on the application on or before May 1, 2023. 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:54 Mar 30, 2023 Jkt 259001 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 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. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–06696 Filed 3–30–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration 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 30, 2023. Such persons may also file a written request for a hearing on the application on or before May 30, 2023. 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 3, 2023, ANI Pharmaceuticals, Inc., 70 Lake Drive, East Windsor, New Jersey 08520, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): DATES: Controlled substance Psilocybin ..................... Levorphanol .................. Drug code 7437 9220 Schedule I I The company plans to bulk manufacture the listed controlled substances for the internal use or for sale to its customers. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–06700 Filed 3–30–23; 8:45 am] [Docket No. DEA–1173] BILLING CODE P Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals, Inc. DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. ACTION: Notice of application. Drug Enforcement Administration ANI Pharmaceuticals, 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. Importer of Controlled Substances Application: Lyndra Therapeutics AGENCY: SUMMARY: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 [Docket No. DEA–1165] Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Pages 19325-19327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06687]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1172]


Bulk Manufacturer of Controlled Substances Application: Purisys, 
LLC

AGENCY: Drug Enforcement Administration, Justice.

[[Page 19326]]


ACTION: Notice of application.

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

SUMMARY: Purisys, LLC, 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 30, 2023. Such persons may also file a written request for a 
hearing on the application on or before May 30, 2023.

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, 2023, Purisys, LLC, 1550 Olympic Drive, 
Athens, Georgia 30601-1602, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
           Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Cathinone................................            1235  I
Gamma Hydroxybutyric Acid................            2010  I
Ibogaine.................................            7260  I
Lysergic acid diethylamide...............            7315  I
Marihuana Extract........................            7350  I
Marihuana................................            7360  I
Tetrahydrocannabinols....................            7370  I
2,5-Dimethoxyamphetamine.................            7396  I
3,4-Methylenedioxyamphetamine............            7400  I
3,4-Methylenedioxy-N-ethylamphetamine....            7404  I
3,4-Methylenedioxymethamphetamine........            7405  I
5-Methoxy-N,N-dimethyltryptamine.........            7431  I
Diethyltryptamine........................            7434  I
Dimethyltryptamine.......................            7435  I
Psilocybin...............................            7437  I
Psilocyn.................................            7438  I
5-Methyoxy-N,N-diisopropyltryptamine.....            7439  I
Codeine-N-oxide..........................            9053  I
Dihydromorphine..........................            9145  I
Heroin...................................            9200  I
Hydromorphinol...........................            9301  I
Morphine-N-oxide.........................            9307  I
Normorphine..............................            9313  I
Norlevorphanol...........................            9634  I
Amphetamine..............................            1100  II
Lisdexamfetamine.........................            1205  II
Methylphenidate..........................            1724  II
Pentobarbital............................            2270  II
Nabilone.................................            7379  II
Cocaine..................................            9041  II
Codeine..................................            9050  II
Dihydrocodeine...........................            9120  II
Oxycodone................................            9143  II
Hydromorphone............................            9150  II
Ecgonine.................................            9180  II
Hydrocodone..............................            9193  II
Levorphanol..............................            9220  II
Meperidine...............................            9230  II
Meperidine intermediate-A................            9232  II
Meperidine intermediate-B................            9233  II
Meperidine intermediate-C................            9234  II
Methadone intermediate...................            9250  II
Methadone intermediate...................            9254  II
Morphine.................................            9300  II
Oripavine................................            9330  II
Thebaine.................................            9333  II
Opium tincture...........................            9630  II
Opium, powdered..........................            9639  II
Opium, granulated........................            9640  II
Oxymorphone..............................            9652  II
Noroxymorphone...........................            9668  II
Alfentanil...............................            9737  II
Sufentanil...............................            9740  II
Carfentanil..............................            9743  II
Tapentadol...............................            9780  II
Fentanyl.................................            9801  II
------------------------------------------------------------------------


[[Page 19327]]

    The company plans to bulk manufacture the listed controlled 
substances for the production of active pharmaceutical ingredients 
(API) and analytical reference standards for sale to its customers. The 
company plans to manufacture the above listed controlled substances as 
clinical trial and starting materials to make compounds for 
distribution to its customers. No other activities for these drug codes 
are authorized for this registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-06687 Filed 3-30-23; 8:45 am]
BILLING CODE P
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