Importer of Controlled Substances Application: Unither Manufacturing LLC, 26944 [2021-10407]

Download as PDF 26944 Federal Register / Vol. 86, No. 94 / Tuesday, May 18, 2021 / Notices activity for this drug code is 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 nonapproved finished dosage forms for commercial sale. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–836] Importer of Controlled Substances Application: Lipomed Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: William T. McDermott, Assistant Administrator. Lipomed 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 information. SUMMARY: [FR Doc. 2021–10420 Filed 5–17–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE 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 June 17, 2021. Such persons may also file a written request for a hearing on the application on or before June 17, 2021. 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 March 29, 2021, Lipomed, 150 Cambridgepark Drive, Suite 705, Cambridge, Massachusetts 02140–2300, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DATES: Controlled substance jbell on DSKJLSW7X2PROD with NOTICES Ethylone .......................... Drug code Schedule I 7547 II The company plans to import the above controlled substance as analytical reference standards for distribution to its customers for research and analytical purposes. Placement of this drug code onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substance. No other VerDate Sep<11>2014 16:40 May 17, 2021 Jkt 253001 Drug Enforcement Administration [Docket No. DEA–833] Importer of Controlled Substances Application: Unither Manufacturing LLC be registered as an importer of the following basic class(es) of controlled substance(s): Drug code Controlled substance Methylphenidate .............. Schedule I 1724 III The company plans to import the listed controlled substance solely for updated analytical testing purposes for European customer requirements. This analysis is required to allow the company to export domesticallymanufactured finished dosage forms to foreign markets. 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 nonapproved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: [FR Doc. 2021–10407 Filed 5–17–21; 8:45 am] BILLING CODE P Unither Manufacturing LLC 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 file written comments on or objections to the issuance of the proposed registration on or before June 17, 2021. Such persons may also file a written request for a hearing on the application on or before June 17, 2021. 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 April 16, 2021, Unither Manufacturing LLC, 331 Clay Road, Rochester, New York 14623, applied to SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Office of Justice Programs [OMB Number 1121–0334] Agency Information Collection Activities; Proposed Collection Comments Requested; Reinstatement, With Change, of a Previously Approved Collection for Which Approval Has Expired: 2021 Survey of Campus Law Enforcement Agencies (SCLEA) Bureau of Justice Statistics, Office of Justice Programs, Department of Justice. ACTION: 60-Day notice. AGENCY: The Bureau of Justice Statistics, Office of Justice Programs, Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. DATES: Comments are encouraged and will be accepted for 60 days until July 19, 2021. FOR FURTHER INFORMATION CONTACT: If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or SUMMARY: E:\FR\FM\18MYN1.SGM 18MYN1

Agencies

[Federal Register Volume 86, Number 94 (Tuesday, May 18, 2021)]
[Notices]
[Page 26944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10407]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-833]


Importer of Controlled Substances Application: Unither 
Manufacturing LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Unither Manufacturing LLC 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 file written comments on or objections to 
the issuance of the proposed registration on or before June 17, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before June 17, 2021.

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 April 16, 2021, Unither Manufacturing LLC, 331 Clay 
Road, Rochester, New York 14623, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Methylphenidate........................    1724   II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance solely 
for updated analytical testing purposes for European customer 
requirements. This analysis is required to allow the company to export 
domestically-manufactured finished dosage forms to foreign markets.
    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-approved finished 
dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-10407 Filed 5-17-21; 8:45 am]
BILLING CODE P
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