10388 Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on December 15, 2021, 

Mylan Inc., 3711 Collins Ferry Road, 

Morgantown, West Virginia 26505– 

2362, applied to be registered as an 

importer of the following basic class(es) 

of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Amphetamine .................. 1100 II 

Methylphenidate .............. 1724 II 

Oxycodone ...................... 9143 II 

Hydromorphone ............... 9150 II 

Methadone ...................... 9250 II 

Morphine .......................... 9300 II 

Fentanyl ........................... 9801 II 

The company plans to import finished 

dosage forms for analytical testing and 

distribution for clinical trials. 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 the Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

Matthew J. Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2022–03907 Filed 2–23–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–960] 

Importer of Controlled Substances 

Application: Myonex Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

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 28, 2022. Such persons 

may also file a written request for a 

hearing on the application on or before 

March 28, 2022. 

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 December 10, 2021, 

Myonex Inc., 100 Progress Drive, 

Horsham, Pennsylvania 19044, applied 

to be registered as an importer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

Amphetamine .................. 1100 II 

Lisdexamfetamine ........... 1205 II 

Methylphenidate .............. 1724 II 

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. 

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. 

Matthew J. Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2022–03903 Filed 2–23–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–953] 

Bulk Manufacturer of Controlled 

Substances Application: Benuvia 

Therapeutics Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Benuvia Therapeutics 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. 

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 April 25, 2022. Such persons 

may also file a written request for a 

hearing on the application on or before 

April 25, 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 November 16, 2021, 

Benuvia Therapeutics Inc., 2700 

Oakmont Drive, Round Rock, Texas 

78665, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug code Schedule 

Tetrahydrocannabinols .................................................................................................................................................... 7370 I 

3,4-Methylenedioxyamphetamine .................................................................................................................................... 7400 I 

3,4-Methylenedioxymethamphetamine ............................................................................................................................ 7405 I 

5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................. 7431 I 

Dimethyltryptamine .......................................................................................................................................................... 7435 I 

Psilocybin ......................................................................................................................................................................... 7437 I 

Psilocyn ........................................................................................................................................................................... 7438 I 

5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................. 7439 I 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 10389 

The company plans to bulk 

manufacture the listed controlled 

substances for the internal use 

intermediates or for sale to its 

customers. The company plans to 

manufacture the above-listed controlled 

substances in bulk to produce finished 

dosage forms and conduct research to 

develop new drug products and for 

clinical studies. In reference to drug 

code 7370 (Tetrahydrocannabinols), the 

company plans to bulk manufacture this 

drug as a synthetic. No other activities 

for these drug codes are authorized for 

this registration. 

Matthew J. Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2022–03897 Filed 2–23–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–956] 

Bulk Manufacturer of Controlled 

Substances Application: Johnson 

Matthey Pharmaceutical Materials Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Johnson Matthey 

Pharmaceutical Materials 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. 

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 April 25, 2022. Such persons 

may also file a written request for a 

hearing on the application on or before 

April 25, 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 November 5, 2021, 

Johnson Matthey Pharmaceutical 

Materials Inc., 25 Patton Road, Devens, 

Massachusetts 01434, applied to be 

registered as a bulk manufacturer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

Amphetamine .................. 1100 II 

Methylphenidate .............. 1724 II 

Nabilone .......................... 7379 II 

Hydrocodone ................... 9193 II 

Levorphanol ..................... 9220 II 

Thebaine .......................... 9333 II 

Alfentanil .......................... 9737 II 

Remifentanil ..................... 9739 II 

Sufentanil ......................... 9740 II 

The company plans to support its 

other manufacturing facilities located in 

West Deptford, New Jersey and 

Conshohocken, Pennsylvania with 

manufacturing and analytical testing. In 

reference to drug code 9333 as bulk, the 

company plans to manufacture a 

Thebaine derivative for distribution to 

its customers. No other activities for 

these drug codes are authorized for this 

registration. 

Matthew J. Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2022–03901 Filed 2–23–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–958] 

Importer of Controlled Substances 

Application: Noramco Coventry LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Noramco Coventry 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 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 28, 2022. Such persons 

may also file a written request for a 

hearing on the application on or before 

March 28, 2022. 

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 September 29, 2021, 

Noramco Coventry LLC, 498 

Washington Street, Coventry, Rhode 

Island 02816, applied to be registered as 

an importer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Tetrahydrocannabinols .... 7370 I 

Methylphenidate .............. 1724 II 

Oxycodone ...................... 9143 II 

Hydromorphone ............... 9150 II 

Hydrocodone ................... 9193 II 

Morphine .......................... 9300 II 

Opium, raw ...................... 9600 II 

Oxymorphone .................. 9652 II 

Poppy Straw Concentrate 9670 II 

The company plans to import Opium, 

raw (9600), and Poppy Straw 

Concentrate (9670) in order to bulk 

manufacture-controlled substances in 

Active Pharmaceutical Ingredient (API) 

form. The company will use the 

imported narcotic raw materials in 

ancillary activities including process 

development and analytical studies. 

Noramco does not anticipate 

redistributing the imported narcotic raw 

materials domestically to other 

registered bulk manufacturers. The 

company plans to import the other 

listed controlled substances for internal 

reference standards use only. 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. 

Matthew J. Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2022–03902 Filed 2–23–22; 8:45 am] 

BILLING CODE P 


jspears on DSK121TN23PROD with NOTICES1