Importer of Controlled Substances Application: Novitium Pharma LLC, 56634 [2020-20161]

Download as PDF 56634 Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices persons may also file a written request for a hearing on the application on or before November 13, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. In accordance with 21 CFR 1301.33(a), this is notice that on July 23, 2020, Cambridge Isotype Lab 50 Frontage Road, Andover, Massachusetts 01810– 5413, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Tetrahydrocannabinols ... Drug code 7370 Schedule I The company plans to synthetically bulk manufacture the controlled substance Tetrahydrocannabinols to produce analytical standards for distribution to its customers. No other activity for this drug code is authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2020–20160 Filed 9–11–20; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–711] Importer of Controlled Substances Application: Novitium Pharma LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Novitium Pharma LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug(s) information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before October 14, 2020. Such persons may also file a written request for a hearing on the application on or before October 14, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:51 Sep 11, 2020 Jkt 250001 be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on August 18, 2020, Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Drug code Lisdexamfetamine ... Levorphanol ............. 1205 9220 Schedule II II The company plans to import the listed controlled substance Lisdexamfetamine as a raw Active Pharmaceutical Ingredients (API) material for drug product development and research purposes only. The company may import Lisdexamfetamine API for research purposes only but not for the manufacturing of Food and Drug Administration (FDA)-approved products. The company plans to import the listed controlled substance Levorphanol to develop the manufacturing process for a drug product that will in turn be used to produce a tablet equivalent to the current brand product. 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 FDA-approved or nonapproved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. BILLING CODE P DEPARTMENT OF LABOR Employment and Training Administration Notice of a Change in Status of the Extended Benefit (EB) Program for Nevada Employment and Training Administration, Labor. AGENCY: Frm 00063 Fmt 4703 Notice. This notice announces a retroactive change in benefit period eligibility under the EB program for Nevada. The following change has occurred since the publication of the last notice regarding the State’s EB status: Based on Nevada’s State law, which provides for the temporary adoption of the optional TUR trigger during periods of 100 percent Federal financing, and data released by the Bureau of Labor Statistics on May 22, 2020, the seasonally-adjusted total unemployment rate for Nevada rose to meet the 8.0 percent threshold to trigger ‘‘on’’ to a high unemployment period in EB. The payable period for Nevada under the high unemployment period is retroactive to June 7, 2020, and eligibility for claimants has been extended from a potential duration of up to 13 weeks to a potential duration of up to 20 weeks in the EB program. The trigger notice covering state eligibility for the EB program can be found at: https://ows.doleta.gov/ unemploy/claims_arch.as Information for Claimants The duration of benefits payable in the EB program, and the terms and conditions on which they are payable, are governed by the Federal-State Extended Unemployment Compensation Act of 1970, as amended, and the operating instructions issued to the states by the U.S. Department of Labor. In the case of a state beginning an EB period, the State Workforce Agency will furnish a written notice of potential entitlement to each individual who has exhausted all rights to regular benefits and is potentially eligible for EB (20 CFR 615.13(c)(1)). Persons who believe they may be entitled to EB, or who wish to inquire about their rights under the program, should contact their State Workforce Agency. U.S. Department of Labor, Employment and Training Administration, Office of Unemployment Insurance Room S– 4524, Attn: Thomas Stengle, 200 Constitution Avenue NW, Washington, DC 20210, telephone number (202)– 693–2991 (this is not a toll-free number) or by email: Stengle.Thomas@dol.gov. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2020–20161 Filed 9–11–20; 8:45 am] PO 00000 ACTION: Sfmt 4703 Signed in Washington, DC. John Pallasch, Assistant Secretary for Employment and Training. [FR Doc. 2020–20192 Filed 9–11–20; 8:45 am] BILLING CODE 4510–FW–P E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Page 56634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20161]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-711]


Importer of Controlled Substances Application: Novitium Pharma 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Novitium Pharma LLC has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
Supplemental Information listed below for further drug(s) information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before October 14, 
2020. Such persons may also file a written request for a hearing on the 
application on or before October 14, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on August 18, 2020, Novitium Pharma LLC, 70 Lake Drive, 
East Windsor, New Jersey 08520, applied to be registered as an importer 
of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
         Controlled substance            Drug code        Schedule
------------------------------------------------------------------------
Lisdexamfetamine......................        1205  II
Levorphanol...........................        9220  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance 
Lisdexamfetamine as a raw Active Pharmaceutical Ingredients (API) 
material for drug product development and research purposes only. The 
company may import Lisdexamfetamine API for research purposes only but 
not for the manufacturing of Food and Drug Administration (FDA)-
approved products.
    The company plans to import the listed controlled substance 
Levorphanol to develop the manufacturing process for a drug product 
that will in turn be used to produce a tablet equivalent to the current 
brand product.
    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 FDA-approved or non-approved finished dosage forms for commercial 
sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-20161 Filed 9-11-20; 8:45 am]
BILLING CODE P
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