Importer of Controlled Substances Application: Myonex Inc, 11558-11559 [2021-03919]

Download as PDF 11558 Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. In accordance with 21 CFR 1301.33(a), this is notice that on July 20, 2020, Chattem Chemicals 3801 Saint Elmo Avenue, Chattanooga, Tennessee 37409, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Drug code Gamma Hydroxybutyric Acid .... Marihuana ................................. Tetrahydrocannabinols ............. 4-Methoxyamphetamine ........... Dihydromorphine ....................... Norlevorphanol .......................... Amphetamine ............................ Methamphetamine .................... Lisdexamfetamine ..................... Methylphenidate ........................ ANPP (4-Anilino-N-phenethyl-4piperidine). Phenylacetone .......................... Cocaine ..................................... Codeine ..................................... Dihydrocodeine ......................... Oxycodone ................................ Hydromorphone ........................ Hydrocodone ............................. Levorphanol .............................. Meperidine ................................ Meperidine intermediate–A ....... Meperidine intermediate–B ....... Meperidine intermediate–C ....... Methadone ................................ Methadone intermediate ........... Morphine ................................... Oripavine ................................... Thebaine ................................... Opium, powdered ..................... Opium, granulated .................... Oxymorphone ........................... Noroxymorphone ...................... Racemethorphan ...................... Alfentanil ................................... Remifentanil .............................. Sufentanil .................................. Tapentadol ................................ Fentanyl .................................... Schedule 2010 7360 7370 7411 9145 9634 1100 1105 1205 1724 8333 I I I I I I II II II II II 8501 9041 9050 9120 9143 9150 9193 9220 9230 9232 9233 9234 9250 9254 9300 9330 9333 9639 9640 9652 9668 9732 9737 9739 9740 9780 9801 II II II II II II II II II II II II II II II II II II II II II II II II II II II [FR Doc. 2021–03836 Filed 2–24–21; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 17:04 Feb 24, 2021 Jkt 253001 Drug Enforcement Administration [Docket No. DEA–791] Bulk Manufacturer of Controlled Substances Application: S&B Pharma, Inc. Drug Enforcement Administration, Justice. AGENCY: ACTION: 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 April 26, 2021. Such persons may also file a written request for a hearing on the application on or before April 26, 2021. DATES: 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 November 11, 2020, S&B Pharma, Inc., 405 South Motor Avenue, Azusa, California 91702–3232, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Gamma Hydroxybutyric Acid .... Tetrahydrocannabinols ............. Amphetamine ............................ Methamphetamine .................... Lisdexamfetamine ..................... Methylphenidate ........................ Pentobarbital ............................. 4-Anilino-N-phenethyl-4-piperidine (ANPP). Tapentadol ................................ Fentanyl .................................... Drug code Schedule 7360 7370 1100 1105 1205 1724 2270 8333 I I II II II II II II 9780 9801 II II The company plans to manufacture the listed controlled substances in bulk for use in product development and for commercial sales to its customers. In reference to drug code 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture both as synthetic substances. No other Frm 00064 Fmt 4703 DEPARTMENT OF JUSTICE [Docket No. DEA798] Notice of application. Controlled substance BILLING CODE 4410–09–P Drug Enforcement Administration S&B Pharma, Inc., 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. PO 00000 William T. McDermott, Assistant Administrator. [FR Doc. 2021–03837 Filed 2–24–21; 8:45 am] SUMMARY: The company plans to manufacturer the listed controlled substances in bulk for distribution and sale to its customers. In reference to drug code 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as a synthetic. No other activities for this drug code are authorized for this registration. William T. McDermott, Assistant Administrator. activity for these drug codes is authorized for this registration. DEPARTMENT OF JUSTICE Sfmt 4703 Importer of Controlled Substances Application: Myonex Inc Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Myonex Inc 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: 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 March 29, 2021. Such persons may also file a written request for a hearing on the application on or before March 29, 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 request 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 January 6, 2021, Myonex Inc, 48 East Main Street, Norristown, Pennsylvania 19401–4915, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DATES: Controlled substance Amphetamine ................. Lisdexamfetamine .......... Methylphenidate ............. E:\FR\FM\25FEN1.SGM 25FEN1 Drug code Schedule 1100 1205 1724 II II II Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices Controlled substance Nabilone ......................... Oxycodone ..................... Hydromorphone .............. Hydrocodone .................. Morphine ......................... Oxymorphone ................. Fentanyl .......................... Drug code Schedule 7379 9143 9150 9193 9300 9652 9801 II II II II II II II The company plans to import the listed controlled substances for clinical trials, research, and analytical purposes. 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 the Food and Drug Administration (FDA)-approved or nonapproved finished dosage forms for commercial sale. No other activity for these drug codes is authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2021–03919 Filed 2–24–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act On February 18, 2021, the Department of Justice lodged a proposed consent decree with the United States District Court for the Eastern District of Wisconsin in the lawsuit entitled United States v. Wisconsin Public Service Corporation, Civil Action No. 21–cv–00211. The United States filed this lawsuit under the Comprehensive Environmental Response, Compensation and Liability Act (‘‘CERCLA’’). The complaint names Wisconsin Public Service Corporation (‘‘WPSC’’) as the defendant. The complaint requests recovery of costs that the United States incurred responding to releases of hazardous substances at the Wisconsin Public Service Corporation Manitowoc MGP Superfund Alternative Site in Manitowoc, Wisconsin. The complaint also seeks injunctive relief at operable unit 1 of the Site. In return, the United States agrees not to sue WPSC under sections 106 and 107 of CERCLA and Section 7003 of the Solid Waste Disposal Act, 42 U.S.C. 6901–6992 (also known as the Resource Conservation and Recovery Act (‘‘RCRA’’)). Commentors may request an VerDate Sep<11>2014 17:04 Feb 24, 2021 Jkt 253001 opportunity for a public meeting in the affected area, in accordance with Section 7003(d) of RCRA. The publication of this notice opens a period for public comment on the consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States v. Wisconsin Public Service Corporation, D.J. Ref. No. 90– 11–3–12152. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: To submit comments: Send them to: By email ....... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, D.C. 20044–7611. By mail ......... During the public comment period, the consent decree may be examined and downloaded at this Justice Department website: http:// www.usdoj.gov/enrd/Consent_ Decrees.html. We will provide a paper copy of the consent decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $43.50 (25 cents per page reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits and signature pages, the cost is $11.50. Patricia McKenna, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2021–03880 Filed 2–24–21; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE [OMB Number NEW] Agency Information Collection Activities; Proposed eCollection, eComments Requested; Law Enforcement Public Contact Data Collection Federal Bureau of Investigation, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 11559 Division, will be submitting the following information collection request to the Office of Management and Budget 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 April 26, 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 additional information, please contact Mrs. Amy C. Blasher, Unit Chief, Federal Bureau of Investigation, Criminal Justice Information Services Division, Module E–3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306; acblasher@fbi.gov. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Federal Bureau of Investigation, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection 1. Type of Information Collection: Establishment of a New Collection. 2. The Title of the Form/Collection: Law Enforcement Public Contact Data Collection. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: There is no form number for this collection. The applicable component within the Department of Justice is the Criminal Justice Information Services E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11558-11559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03919]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA798]


Importer of Controlled Substances Application: Myonex Inc

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Myonex Inc 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.

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 March 29, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before March 29, 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 
request 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 January 6, 2021, Myonex Inc, 48 East Main Street, 
Norristown, Pennsylvania 19401-4915, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Amphetamine............................    1100  II
Lisdexamfetamine.......................    1205  II
Methylphenidate........................    1724  II

[[Page 11559]]

 
Nabilone...............................    7379  II
Oxycodone..............................    9143  II
Hydromorphone..........................    9150  II
Hydrocodone............................    9193  II
Morphine...............................    9300  II
Oxymorphone............................    9652  II
Fentanyl...............................    9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
clinical trials, research, and analytical purposes. 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 the Food and Drug 
Administration (FDA)-approved or non-approved finished dosage forms for 
commercial sale. No other activity for these drug codes is authorized 
for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-03919 Filed 2-24-21; 8:45 am]
BILLING CODE P