Bulk Manufacturer of Controlled Substances Application: Eli-ElSohly Laboratories, 61364 [2022-21945]

Download as PDF 61364 Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices khammond on DSKJM1Z7X2PROD with NOTICES Determinations Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, NYU Dentistry has determined that: • The human remains described in this notice represent the physical remains of eight individuals of Native American ancestry. • There is a relationship of shared group identity that can be reasonably traced between the human remains and the La Jolla Band of Luiseno Indians, California (previously listed as La Jolla Band of Luiseno Mission Indians of the La Jolla Reservation); Pala Band of Mission Indians (previously listed as Pala Band of Luiseno Mission Indians of the Pala Reservation, California); Pauma Band of Luiseno Mission Indians of the Pauma & Yuima Reservation, California; Pechanga Band of Indians (previously listed as Pechanga Band of Luiseno Mission Indians of the Pechanga Reservation, California); Rincon Band of Luiseno Mission Indians of Rincon Reservation, California; Santa Ynez Band of Chumash Mission Indians of the Santa Ynez Reservation, California; and the Soboba Band of Luiseno Indians, California. Requests for Repatriation Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in ADDRESSES. Requests for repatriation may be submitted by: 1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice. 2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization. Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after November 10, 2022. If competing requests for repatriation are received, NYU Dentistry must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. NYU Dentistry is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice. Authority: Native American Graves Protection and Repatriation Act, 25 VerDate Sep<11>2014 17:37 Oct 07, 2022 Jkt 259001 U.S.C. 3003, and the implementing regulations, 43 CFR 10.9, § 10.10, and § 10.14. Dated: September 27, 2022. Melanie O’Brien, Manager, National NAGPRA Program. [FR Doc. 2022–22041 Filed 10–7–22; 8:45 am] BILLING CODE 4312–52–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1088] Bulk Manufacturer of Controlled Substances Application: Eli-ElSohly Laboratories Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Eli-ElSohly Laboratories, 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 December 12, 2022. Such persons may also file a written request for a hearing on the application on or before December 12, 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 August 19, 2022, EliElSohly Laboratories, 5 Industrial Park Drive, Oxford, Mississippi 38655–5343, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUMMARY: PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 Controlled substance Marihuana Extract ........ Marihuana ..................... Tetrahydrocannabinols Dihydromorphine .......... Amphetamine ............... Methamphetamine ........ Cocaine ........................ Codeine ........................ Dihydrocodeine ............. Oxycodone ................... Ecgonine ....................... Thebaine ....................... Drug code 7350 7360 7370 9145 1100 1105 9041 9050 9120 9143 9180 9333 Schedule I I I I II II II II II II II II The company plans to manufacture the listed controlled substances for product development and reference standards. In reference to drug codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to isolate these controlled substances from procured 7350 (Marihuana Extract). In reference to drug code 7360, no cultivation activities are authorized for this registration. In reference to drug code 9333 (Thebaine), the company plans to manufacture a Thebaine derivative. No other activities for these drug codes are authorized for this registration. Kristi O’Malley, Assistant Administrator. [FR Doc. 2022–21945 Filed 10–7–22; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1089] Importer of Controlled Substances Application: Hybrid Pharma Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Hybrid Pharma 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. 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 November 10, 2022. Such persons may also file a written request for a hearing on the application on or before November 10, 2022. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, DATES: E:\FR\FM\11OCN1.SGM 11OCN1

Agencies

[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Page 61364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21945]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1088]


Bulk Manufacturer of Controlled Substances Application: Eli-
ElSohly Laboratories

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Eli-ElSohly Laboratories, 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 
December 12, 2022. Such persons may also file a written request for a 
hearing on the application on or before December 12, 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 August 19, 2022, Eli-ElSohly Laboratories, 5 
Industrial Park Drive, Oxford, Mississippi 38655-5343, applied to be 
registered as a bulk manufacturer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana Extract......................     7350  I
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
Dihydromorphine........................     9145  I
Amphetamine............................     1100  II
Methamphetamine........................     1105  II
Cocaine................................     9041  II
Codeine................................     9050  II
Dihydrocodeine.........................     9120  II
Oxycodone..............................     9143  II
Ecgonine...............................     9180  II
Thebaine...............................     9333  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
for product development and reference standards. In reference to drug 
codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company 
plans to isolate these controlled substances from procured 7350 
(Marihuana Extract). In reference to drug code 7360, no cultivation 
activities are authorized for this registration. In reference to drug 
code 9333 (Thebaine), the company plans to manufacture a Thebaine 
derivative. No other activities for these drug codes are authorized for 
this registration.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-21945 Filed 10-7-22; 8:45 am]
BILLING CODE P
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