Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 70190 [2020-24465]

Download as PDF 70190 Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3 This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)). By order of the Commission. Issued: October 29, 2020. Lisa Barton, Secretary to the Commission. 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 January 4, 2021. Such persons may also file a written request for a hearing on the application on or before January 4, 2021. DATES: [FR Doc. 2020–24390 Filed 11–3–20; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–741] Bulk Manufacturer of Controlled Substances Application: Navinta LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on September 25, 2020, Navinta LLC 1499 Lower Ferry Road, Ewing, New Jersey 08618–1414, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Navinta 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. SUMMARY: Controlled substance Drug code 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Levomethorphan .............................................................................................................................................................. Levorphanol ..................................................................................................................................................................... Remifentanil ..................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... The company plans to bulk manufacture active pharmaceutical ingredients (API) quantities of the listed controlled substances for validation purposes and the Food and Drug Administration’s approval. No other activity for these drug codes is authorized for this registration. DEPARTMENT OF JUSTICE William T. McDermott, Assistant Administrator. AGENCY: Drug Enforcement Administration [Docket No. DEA–717] Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation [FR Doc. 2020–24465 Filed 11–3–20; 8:45 am] Drug Enforcement Administration, Justice. ACTION: Notice of application. BILLING CODE 4410–09–P SUMMARY: Cerilliant Corporation has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written In accordance with 21 CFR 1301.33(a), this is notice that on August 6, 2020, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665–2402, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES Drug code 3-Fluoro-N-methylcathinone (3–FMC) ............................................................................................................................. Cathinone ........................................................................................................................................................................ Methcathinone ................................................................................................................................................................. 4-Fluoro-N-methylcathinone (4–FMC) ............................................................................................................................. Pentedrone (a-methylaminovalerophenone) ................................................................................................................... Mephedrone (4-Methyl-N-methylcathinone) .................................................................................................................... 4-Methyl-N-ethylcathinone (4–MEC) ............................................................................................................................... Naphyrone ....................................................................................................................................................................... VerDate Sep<11>2014 18:16 Nov 03, 2020 Jkt 253001 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 II II II II II comments on or objections to the issuance of the proposed registration on or before January 4, 2021. Such persons may also file a written request for a hearing on the application on or before January 4, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. Controlled substance 2 All contract personnel will sign appropriate nondisclosure agreements. 8333 9210 9220 9739 9801 Schedule E:\FR\FM\04NON1.SGM 04NON1 1233 1235 1237 1238 1246 1248 1249 1258 Schedule I I I I I I I I

Agencies

[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Page 70190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24465]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-741]


Bulk Manufacturer of Controlled Substances Application: Navinta 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Navinta 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 file written comments on or objections to 
the issuance of the proposed registration on or before January 4, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before January 4, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on September 25, 2020, Navinta LLC 1499 Lower Ferry 
Road, Ewing, New Jersey 08618-1414, applied to be registered as an bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine             8333  II
 (ANPP).
Levomethorphan.....................            9210  II
Levorphanol........................            9220  II
Remifentanil.......................            9739  II
Fentanyl...........................            9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture active pharmaceutical 
ingredients (API) quantities of the listed controlled substances for 
validation purposes and the Food and Drug Administration's approval. No 
other activity for these drug codes is authorized for this 
registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-24465 Filed 11-3-20; 8:45 am]
BILLING CODE 4410-09-P
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