Bulk Manufacturer of Controlled Substances Application: Noramco, 66589 [2021-25578]

Download as PDF 66589 Federal Register / Vol. 86, No. 223 / Tuesday, November 23, 2021 / Notices Not all the potential respondents will submit information in any given year, and some may submit multiple times. Total Estimated Number of Annual Responses: 7,454. Estimated Completion Time per Response: Varies from 30 minutes to 48 hours, depending on activity. Total Estimated Number of Annual Burden Hours: 95,488. Respondent’s Obligation: Mandatory. Frequency of Collection: Generally, on occasion. Total Estimated Annual Nonhour Burden Cost: $10,547,442. An agency may not conduct, or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Kirk Malstrom, Chief, Regulations and Standards Branch. [FR Doc. 2021–25538 Filed 11–22–21; 8:45 am] BILLING CODE 4310–VH–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–924] Importer of Controlled Substances Application: Mylan Technologies, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Mylan Technologies, Inc. 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 December 23, 2021. Such persons may also file a written request for a hearing on the application on or before December 23, 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: lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:09 Nov 22, 2021 Jkt 256001 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 October 22, 2021, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478– 2266, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Drug code Controlled substance Methylphenidate ....... Fentanyl .................... I 1724 9801 Schedule I II II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically manufactured FDF. This analysis is required to allow the company to export domestically manufactured finished dosage form to foreign markets. No other activity for these drug codes 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. Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2021–25575 Filed 11–22–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–925] Bulk Manufacturer of Controlled Substances Application: Noramco Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Noramco, 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 SUMMARY: PO 00000 Frm 00075 Fmt 4703 Sfmt 9990 applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 24, 2022. Such persons may also file a written request for a hearing on the application on or before January 24, 2022. 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 October 19, 2021, Noramco, 500 Swedes Landing Road, Wilmington, Delaware 19801–4417, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Marihuana ................................. Tetrahydrocannabinols ............. Dihydromorphine ....................... Hydromorphinol ......................... Amphetamine ............................ Lisdexamfetamine ..................... Methylphenidate ........................ Nabilone .................................... Codeine ..................................... Dihydrocodeine ......................... Oxycodone ................................ Hydromorphone ........................ Hydrocodone ............................. Morphine ................................... Oripavine ................................... Thebaine ................................... Opium extracts .......................... Opium fluid extract .................... Opium, tincture ......................... Opium, powdered ..................... Opium, granulated .................... Oxymorphone ........................... Noroxymorphone ...................... Tapentadol ................................ Drug code Schedule 7360 7370 9145 9301 1100 1205 1724 7379 9050 9120 9143 9150 9193 9300 9330 9333 9610 9620 9630 9639 9640 9652 9668 9780 I I I I II II II II II II II II II II II II II II II II II II II II The company plans to bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for supply to its customers. In reference to dug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2021–25578 Filed 11–22–21; 8:45 am] BILLING CODE P E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Notices]
[Page 66589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25578]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-925]


Bulk Manufacturer of Controlled Substances Application: Noramco

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Noramco, 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 24, 
2022. Such persons may also file a written request for a hearing on the 
application on or before January 24, 2022.

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 October 19, 2021, Noramco, 500 Swedes Landing Road, 
Wilmington, Delaware 19801-4417, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana...............................    7360  I
Tetrahydrocannabinols...................    7370  I
Dihydromorphine.........................    9145  I
Hydromorphinol..........................    9301  I
Amphetamine.............................    1100  II
Lisdexamfetamine........................    1205  II
Methylphenidate.........................    1724  II
Nabilone................................    7379  II
Codeine.................................    9050  II
Dihydrocodeine..........................    9120  II
Oxycodone...............................    9143  II
Hydromorphone...........................    9150  II
Hydrocodone.............................    9193  II
Morphine................................    9300  II
Oripavine...............................    9330  II
Thebaine................................    9333  II
Opium extracts..........................    9610  II
Opium fluid extract.....................    9620  II
Opium, tincture.........................    9630  II
Opium, powdered.........................    9639  II
Opium, granulated.......................    9640  II
Oxymorphone.............................    9652  II
Noroxymorphone..........................    9668  II
Tapentadol..............................    9780  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances as an Active Pharmaceutical Ingredient (API) for supply to 
its customers. In reference to dug codes 7360 (Marihuana), and 7370 
(Tetrahydrocannabinols), the company plans to bulk manufacture these 
drugs as synthetic. No other activities for these drug codes are 
authorized for this registration.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-25578 Filed 11-22-21; 8:45 am]
BILLING CODE P
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