Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute, 37251-37252 [2024-09783]

Download as PDF 37251 Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices Controlled substance Drug code ddrumheller on DSK120RN23PROD with NOTICES1 Nabilone ............................................................................................................................................................................... 1-Phenylcyclohexylamine .................................................................................................................................................... Phencyclidine ....................................................................................................................................................................... ANPP (4-Anilino-N-phenethyl-4-piperidine) ......................................................................................................................... Phenylacetone ..................................................................................................................................................................... 1-Piperidinocyclohexanecarbonitrile .................................................................................................................................... Alphaprodine ........................................................................................................................................................................ Anileridine ............................................................................................................................................................................ Cocaine ................................................................................................................................................................................ Codeine ............................................................................................................................................................................... Etorphine HCl ...................................................................................................................................................................... Dihydrocodeine .................................................................................................................................................................... Oxycodone ........................................................................................................................................................................... Hydromorphone ................................................................................................................................................................... Diphenoxylate ...................................................................................................................................................................... Ecgonine .............................................................................................................................................................................. Ethylmorphine ...................................................................................................................................................................... Hydrocodone ....................................................................................................................................................................... Levomethorphan .................................................................................................................................................................. Levorphanol ......................................................................................................................................................................... Isomethadone ...................................................................................................................................................................... Meperidine ........................................................................................................................................................................... Meperidine-intermediate-A .................................................................................................................................................. Meperidine intermediate-B .................................................................................................................................................. Meperidine intermediate-C .................................................................................................................................................. Metazocine .......................................................................................................................................................................... Methadone ........................................................................................................................................................................... Methadone intermediate ...................................................................................................................................................... Metopon ............................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) .................................................................................................................. Morphine .............................................................................................................................................................................. Oripavine ............................................................................................................................................................................. Thebaine .............................................................................................................................................................................. Dihydroetorphine ................................................................................................................................................................. Levo-alphacetylmethadol ..................................................................................................................................................... Oxymorphone ...................................................................................................................................................................... Noroxymorphone ................................................................................................................................................................. Phenazocine ........................................................................................................................................................................ Thiafentanil .......................................................................................................................................................................... Piminodine ........................................................................................................................................................................... Racemethorphan ................................................................................................................................................................. Racemorphan ...................................................................................................................................................................... Alfentanil .............................................................................................................................................................................. Remifentanil ......................................................................................................................................................................... Sufentanil ............................................................................................................................................................................. Carfentanil ........................................................................................................................................................................... Tapentadol ........................................................................................................................................................................... Bezitramide .......................................................................................................................................................................... Fentanyl ............................................................................................................................................................................... Moramide-intermediate ........................................................................................................................................................ The company plans to import analytical reference standards for distribution to its customers for research and analytics purposes. Placement of these drug codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. 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 non- VerDate Sep<11>2014 18:02 May 03, 2024 Jkt 262001 approved finished dosage forms for commercial sale. Marsha Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–09802 Filed 5–3–24; 8:45 am] BILLING CODE P PO 00000 7379 7460 7471 8333 8501 8603 9010 9020 9041 9050 9059 9120 9143 9150 9170 9180 9190 9193 9210 9220 9226 9230 9232 9233 9234 9240 9250 9254 9260 9273 9300 9330 9333 9334 9648 9652 9668 9715 9729 9730 9732 9733 9737 9739 9740 9743 9780 9800 9801 9802 Schedule 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 II II II II II II II II II II II II II II II II II II DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1349] Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Research Triangle Institute 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: Frm 00092 Fmt 4703 Sfmt 4703 E:\FR\FM\06MYN1.SGM 06MYN1 37252 Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices 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 July 5, 2024. Such persons may also file a written request for a hearing on the application on or before July 5, 2024. DATES: 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. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on March 11, 2024, Research Triangle Institute, 3040 East Cornwallis Road, Hermann Building, Room 106, Research Triangle Park, North Carolina 27709–2194, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code Controlled substance Tetrahydrocannabinols ... Schedule I 7370 II The company plans to bulk manufacture the listed controlled substance synthetically for distribution to its customers for research and as analytical reference standards. No other activities for this drug code are authorized for this registration. Marsha Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–09783 Filed 5–3–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1359] Importer of Controlled Substances Application: Restek Corporation Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Restek Corporation 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 June 5, 2024. Such persons may also file a written request for a SUMMARY: hearing on the application on or before June 5, 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 March 5, 2024, Restek Corporation, 110 Benner Circle, Bellefonte, Pennsylvania 16823–8433, applied to be registered as an importer of the following basic class(es) of controlled substance(s): ddrumheller on DSK120RN23PROD with NOTICES1 Controlled substance Drug code Amineptine ........................................................................................................................................................................... Mesocarb ............................................................................................................................................................................. 3-Fluoro-N-methylcathinone (3–FMC) ................................................................................................................................. Cathinone ............................................................................................................................................................................ Methcathinone ..................................................................................................................................................................... 4-Fluoro-N-methylcathinone (4–FMC) ................................................................................................................................. Para-Methoxymethamphetamine (PMMA), 1-(4–1245 I N methoxyphenyl)-N-methylpropan-2-amine .............................. Pentedrone (a-methylaminovalerophenone) ....................................................................................................................... Mephedrone (4-Methyl-N-methylcathinone ......................................................................................................................... 4-Methyl-N-ethylcathinone (4–MEC) ................................................................................................................................... Naphyrone ........................................................................................................................................................................... N-Ethylamphetamine ........................................................................................................................................................... Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2- 1478 I N amine) .......................................................................... N,N-Dimethylamphetamine .................................................................................................................................................. Fenethylline ......................................................................................................................................................................... Aminorex .............................................................................................................................................................................. 4-Methylaminorex (cis isomer) ............................................................................................................................................ 4,4′-Dimethylaminorex ......................................................................................................................................................... Gamma Hydroxybutyric Acid ............................................................................................................................................... Methaqualone ...................................................................................................................................................................... Mecloqualone ...................................................................................................................................................................... JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ...................................................................................................... SR–18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) .................................................... ADB–FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ................. 5-Fluoro-UR–144 and XLR11 [1-(5-Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone .................... VerDate Sep<11>2014 18:02 May 03, 2024 Jkt 262001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\06MYN1.SGM 06MYN1 1219 1227 1233 1235 1237 1238 1245 1246 1248 1249 1258 1475 1478 1480 1503 1585 1590 1595 2010 2565 2572 6250 7008 7010 7011 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 I

Agencies

[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37251-37252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09783]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1349]


Bulk Manufacturer of Controlled Substances Application: Research 
Triangle Institute

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Research Triangle Institute 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.

[[Page 37252]]


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 
July 5, 2024. Such persons may also file a written request for a 
hearing on the application on or before July 5, 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on March 11, 2024, Research Triangle Institute, 3040 
East Cornwallis Road, Hermann Building, Room 106, Research Triangle 
Park, North Carolina 27709-2194, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols..................    7370   I
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substance synthetically for distribution to its customers for research 
and as analytical reference standards. No other activities for this 
drug code are authorized for this registration.

Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-09783 Filed 5-3-24; 8:45 am]
BILLING CODE P
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