Bulk Manufacturer of Controlled Substances Application: SpecGx LLC, 19990 [2023-06952]

Download as PDF 19990 Federal Register / Vol. 88, No. 64 / Tuesday, April 4, 2023 / Notices DEPARTMENT OF JUSTICE Controlled substance Drug code Schedule drug codes are authorized for this registration. 9634 9821 I I Matthew Strait, Deputy Assistant Administrator. Drug Enforcement Administration [Docket No. DEA–1176] Bulk Manufacturer of Controlled Substances Application: SpecGx LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: SpecGx 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 June 5, 2023. Such persons may also file a written request for a hearing on the application on or before June 5, 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 14, 2023, SpecGx LLC, 3600 North 2nd Street, Saint Louis, Missouri 63147–3457, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUMMARY: ddrumheller on DSK120RN23PROD with NOTICES1 Controlled substance Gamma Hydroxybutyric Acid. Tetrahydrocannabinols ... Psilocybin ....................... Codeine-N-oxide ............. Noroxymorphone ............ Difenoxin ......................... Morphine-N-oxide ........... Normorphine ................... Alphamethadol ................ Betamethadol ................. VerDate Sep<11>2014 Drug code Schedule 2010 I 7370 7437 9053 9145 9168 9307 9313 9605 9609 I I I I I I I I I 19:41 Apr 03, 2023 Jkt 259001 Norlevorphanol ............... Acetyl Fentanyl (N-(1phenethylpiperidin-4yl)-N-phenylacetamide). Butyryl Fentanyl .............. Fentanyl related-compounds as defined in 21 CFR 1308.11(h). Amphetamine ................. Methamphetamine .......... Lisdexamfetamine .......... Methylphenidate ............. Nabilone ......................... ANPP (4-Anilino-Nphenethyl-4-piperidine). Phenylacetone ................ Codeine .......................... Dihydrocodeine ............... Oxycodone ..................... Hydromorphone .............. Diphenoxylate ................. Ecgonine ......................... Hydrocodone .................. Levorphanol .................... Isomethadone ................. Meperidine ...................... Meperidine intermediateA. Meperidine intermediateB. Meperidine intermediateC. Methadone ...................... Methadone intermediate Dextropropoxyphene, bulk (non-dosage forms). Morphine ......................... Oripavine ........................ Thebaine ......................... Opium tincture ................ Opium, powdered ........... Oxymorphone ................. Noroxymorphone ............ Alfentanil ......................... Remifentanil .................... Sufentanil ........................ Tapentadol ...................... Fentanyl .......................... Amphetamine ................. Methamphetamine .......... Lisdexamfetamine .......... Methylphenidate ............. Pentobarbital .................. 4-Anilino-N-Phenethyl-4Piperidine (ANPP). Tapentadol ...................... Fentanyl .......................... [FR Doc. 2023–06952 Filed 4–3–23; 8:45 am] 9822 9850 I I 1100 1105 1205 1724 7379 8333 II II II II II II 8501 9050 9120 9143 9150 9170 9180 9193 9220 9226 9230 9232 II II II II II II II II II II II II 9233 II 9234 II 9250 9254 9273 II II II 9300 9330 9333 9630 9639 9652 9668 9737 9739 9740 9780 9801 1100 1105 1205 1724 2270 8333 II II II II II II II II II II II II II II II II II II 9780 9801 II II DEPARTMENT OF LABOR The company plans to bulk manufacture the listed controlled substances for sale to its customers as Active Pharmaceutical Ingredients (APIs) and Analytical Research Standards (ARS) for formulation and analytical development purposes. In reference to dug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these PO 00000 Frm 00088 Fmt 4703 BILLING CODE 4410–09–P Sfmt 4703 Occupational Safety and Health Administration [Docket No. OSHA–2018–0005] Whistleblower Stakeholder Meeting: Outreach and Training Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice of public meeting. AGENCY: The Occupational Safety and Health Administration (OSHA) is announcing a public meeting to solicit comments and suggestions from stakeholders on its outreach and training efforts in support of the whistleblower laws it enforces. DATES: The public meeting will be held on May 10, 2023, from 1:00 p.m. to 4:00 p.m., ET via Zoom. Persons interested in attending the meeting must register by May 3, 2023. In addition, comments relating to the ‘‘Scope of Meeting’’ section of this document must be submitted by May 24, 2023. ADDRESSES: Electronically: You may submit materials, including attachments, electronically at https:// www.regulations.gov, which is the Federal eRulemaking portal. Follow the on-line instructions for submissions. All comments should be identified with Docket No. OSHA–2018–0005. Registration to Attend and/or to Participate in the Meeting: If you wish to attend the public meeting, make an oral presentation at the meeting, or participate in the meeting, you must register using this link https:// www.eventbrite.com/e/whistlebloweroutreach-stakeholder-meeting-tickets558199739447 or this link for registration in Spanish https:// www.eventbrite.com/e/entradasreunion-para-partes-interesadas-sobrelos-denunciantes-que-son-trabajadores558210240857 by close of business on May 3, 2023. Each participant will be allowed to speak for up to 5 minutes. If there is extra time at the end of the meeting, participants may be given extra time to speak. There is no fee to register for the public meeting. After reviewing the requests to present, OSHA will contact each participant prior to the meeting to inform them of the speaking SUMMARY: E:\FR\FM\04APN1.SGM 04APN1

Agencies

[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Page 19990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06952]



[[Page 19990]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1176]


Bulk Manufacturer of Controlled Substances Application: SpecGx 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: SpecGx 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 
June 5, 2023. Such persons may also file a written request for a 
hearing on the application on or before June 5, 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 14, 2023, SpecGx LLC, 3600 North 2nd Street, 
Saint Louis, Missouri 63147-3457, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..............    2010  I
Tetrahydrocannabinols..................    7370  I
Psilocybin.............................    7437  I
Codeine-N-oxide........................    9053  I
Noroxymorphone.........................    9145  I
Difenoxin..............................    9168  I
Morphine-N-oxide.......................    9307  I
Normorphine............................    9313  I
Alphamethadol..........................    9605  I
Betamethadol...........................    9609  I
Norlevorphanol.........................    9634  I
Acetyl Fentanyl (N-(1-                     9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
Butyryl Fentanyl.......................    9822  I
Fentanyl related-compounds as defined      9850  I
 in 21 CFR 1308.11(h).
Amphetamine............................    1100  II
Methamphetamine........................    1105  II
Lisdexamfetamine.......................    1205  II
Methylphenidate........................    1724  II
Nabilone...............................    7379  II
ANPP (4-Anilino-N-phenethyl-4-             8333  II
 piperidine).
Phenylacetone..........................    8501  II
Codeine................................    9050  II
Dihydrocodeine.........................    9120  II
Oxycodone..............................    9143  II
Hydromorphone..........................    9150  II
Diphenoxylate..........................    9170  II
Ecgonine...............................    9180  II
Hydrocodone............................    9193  II
Levorphanol............................    9220  II
Isomethadone...........................    9226  II
Meperidine.............................    9230  II
Meperidine intermediate-A..............    9232  II
Meperidine intermediate-B..............    9233  II
Meperidine intermediate-C..............    9234  II
Methadone..............................    9250  II
Methadone intermediate.................    9254  II
Dextropropoxyphene, bulk (non-dosage       9273  II
 forms).
Morphine...............................    9300  II
Oripavine..............................    9330  II
Thebaine...............................    9333  II
Opium tincture.........................    9630  II
Opium, powdered........................    9639  II
Oxymorphone............................    9652  II
Noroxymorphone.........................    9668  II
Alfentanil.............................    9737  II
Remifentanil...........................    9739  II
Sufentanil.............................    9740  II
Tapentadol.............................    9780  II
Fentanyl...............................    9801  II
Amphetamine............................    1100  II
Methamphetamine........................    1105  II
Lisdexamfetamine.......................    1205  II
Methylphenidate........................    1724  II
Pentobarbital..........................    2270  II
4-Anilino-N-Phenethyl-4-Piperidine         8333  II
 (ANPP).
Tapentadol.............................    9780  II
Fentanyl...............................    9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for sale to its customers as Active Pharmaceutical 
Ingredients (APIs) and Analytical Research Standards (ARS) for 
formulation and analytical development purposes. In reference to dug 
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.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-06952 Filed 4-3-23; 8:45 am]
BILLING CODE 4410-09-P
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