Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals, Inc., 47176 [2024-11879]

Download as PDF 47176 Federal Register / Vol. 89, No. 106 / Friday, May 31, 2024 / Notices chromium-coated steel sheet from Japan would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. Background The Commission instituted this review on June 1, 2023 (88 FR 35920) and determined on September 5, 2023 that it would conduct a full review (88 FR 64464, September 19, 2023). Notice of the scheduling of the Commission’s review and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register on October 30, 2023 (88 FR 74209). The Commission conducted its hearing on April 9, 2024. All persons who requested the opportunity were permitted to participate. The Commission made this determination pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determination in this review on May 28, 2024. The views of the Commission are contained in USITC Publication 5507 (May 2024), entitled Tin- and Chromium-Coated Steel Sheet from Japan: Investigation No. 731–TA–860 (Fourth Review). Controlled substance Drug code Psilocybin ............... Levorphanol ............ By order of the Commission. Issued: May 28, 2024. Lisa Barton, Secretary to the Commission. I 7437 9220 Schedule I I II 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. [FR Doc. 2024–12014 Filed 5–30–24; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Matthew J. Strait, Deputy Assistant Administrator. Drug Enforcement Administration [FR Doc. 2024–11879 Filed 5–30–24; 8:45 am] [Docket No. DEA–1365] 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. 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 30, 2024. Such persons Importer of Controlled Substances Application: Royal Emerald Pharmaceuticals AGENCY: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES may also file a written request for a hearing on the application on or before July 30, 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 April 9, 2024, 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): VerDate Sep<11>2014 17:22 May 30, 2024 Jkt 262001 listed below for further drug information. 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 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 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 April 10, 2024, Royal Emerald Pharmaceuticals, 14011 Palm Drive, Building B, Desert Hot Spring, California 92240–6845, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DATES: [Docket No. DEA–1380] Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Royal Emerald Pharmaceuticals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Controlled substance Marihuana Extract .. Marihuana ............... Tetrahydrocannabinols. Drug code 7350 7360 7370 Schedule I I I The company plans to import Marihuana seeds and immature Marihuana plants in the form of Active Pharmaceutical Ingredients (API) and botanical raw materials for Drug Enforcement Administration-approved E:\FR\FM\31MYN1.SGM 31MYN1

Agencies

[Federal Register Volume 89, Number 106 (Friday, May 31, 2024)]
[Notices]
[Page 47176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11879]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1365]


Bulk Manufacturer of Controlled Substances Application: ANI 
Pharmaceuticals, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: 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.

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 30, 2024. Such persons may also file a written request for a 
hearing on the application on or before July 30, 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 April 9, 2024, 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):

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Psilocybin...........................        7437  I
Levorphanol..........................        9220  II
------------------------------------------------------------------------

    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 J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-11879 Filed 5-30-24; 8:45 am]
BILLING CODE P
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