Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Notices 39127 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing should 

also be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on May 10, 2022, 

Adiramedica, LLC., 585 Turner 

Industrial Way, Aston Pennsylvania 

19014, applied to be registered as an 

importer of the following basic class(es) 

of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Tapentadol ...................... 9780 II 

The company plans to import 

Tapentadol in finished dosage form for 

clinical trials. No other activity for this 

drug code is authorized for this 

registration 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. 

Kristi O’Malley, 

Assistant Administrator. 

[FR Doc. 2022–14036 Filed 6–29–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1031] 

Bulk Manufacturer of Controlled 

Substances Application: American 

Radiolabeled Chem 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: American Radiolabeled Chem 

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 submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before August 29, 2022. Such 

persons may also file a written request 

for a hearing on the application on or 

before August 29, 2022. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on May 24, 2022, 

American Radiolabeled Chem, 101 Arc 

Drive, Saint Louis, Missouri 63146– 

3502, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Gamma Hydroxybutyric Acid 2010 I 

Ibogaine ................................. 7260 I 

Lysergic acid diethylamide .... 7315 I 

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

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

1-[1-(2- 

Thienyl)cyclohexyl]piperidine.

7470 I 

Noroxymorphone ................... 9145 I 

Heroin .................................... 9200 I 

Normorphine .......................... 9313 I 

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

Methamphetamine ................. 1105 II 

Amobarbital ............................ 2125 II 

Phencyclidine ......................... 7471 II 

Phenylacetone ....................... 8501 II 

Cocaine .................................. 9041 II 

Codeine .................................. 9050 II 

Dihydrocodeine ...................... 9120 II 

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

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

Ecgonine ................................ 9180 II 

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

Meperidine ............................. 9230 II 

Metazocine ............................. 9240 II 

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

Dextropropoxyphene, bulk 

(non-dosage forms).

9273 II 

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

Oripavine ................................ 9330 II 

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

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

Phenazocine .......................... 9715 II 

Carfentanil .............................. 9743 II 

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

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 small quantities of the 

above-listed controlled substances as 

radiolabeled compounds for 

biochemical research. No other 

activities for these drug codes are 

authorized for this registration. 

Kristi O’Malley, 

Assistant Administrator. 

[FR Doc. 2022–14040 Filed 6–29–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1030] 

Importer of Controlled Substances 

Application: Aurobindo Pharma USA, 

Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Aurobindo Pharma USA, 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 submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before August 1, 2022. Such 

persons may also file a written request 

for a hearing on the application on or 

before August 1, 2022. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. All 

requests for a hearing must 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. All requests for a hearing should 


jspears on DSK121TN23PROD with NOTICES1
39128 Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Notices 

also be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on May 11, 2022, 

Aurobindo Pharma USA, Inc., 6 

Wheeling Road, Dayton, New Jersey 

08810–1526, applied to be registered as 

an importer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

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

The company plans to import 

Remifentanil (9739) in bulk form for 

research and development. No other 

activity for this drug code is authorized 

for this registration. No other 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. 

Kristi O’Malley, 

Assistant Administrator. 

[FR Doc. 2022–14035 Filed 6–29–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Notice Lodging of Proposed Consent 

Decree Amendment Under the Clean 

Water Act 

On June 23, 2022, the Department of 

Justice lodged a proposed Second 

Amendment to Consent Decree 

(‘‘Second Amendment’’) with the 

United States District Court for the 

Northern District of Ohio in the lawsuit 

entitled United States and State of Ohio 

v. City of Toledo, Ohio, Civil Action No. 

3:91–7646. This is a corrected notice of 

lodging, which included Appendix A to 

the proposed Second Amendment, 

which was not included in the original 

lodging, which was filed on April 19, 

2022. 

The Court entered a consent decree in 

this case on December 16, 2002, which 

resolved violations the United States 

and State of Ohio alleged under the 

Clean Water Act and Toledo’s 

wastewater treatment discharge permit 

for the City of Toledo’s (the ‘‘City’’) 

discharges from the City’s treatment 

plant and sewer system. The consent 

decree, as subsequently amended in 

2011, required Toledo, pertinent to the 

Second Amendment to: (1) expand 

treatment plant capacity to handle the 

greater amounts of sewage combined 

with storm water or snowmelt arriving 

at the treatment plant during such wet 

weather periods; (2) implement a Long 

Term Control Plan to reduce the 

discharges of combined stormwater and 

sanitary sewage from the portions of 

Toledo’s sewer system known as the 

City’s combined sewer system, which 

among other things, requires Toledo to 

construct extensions to tunnels that 

store such combined sewage during 

periods of rain or snowmelt for 

transport to the City’s wastewater 

treatment plant following such periods; 

and (3) study the effectiveness of 

pathogen removal in the wet weather 

system Toledo constructed at its 

wastewater treatment plant pursuant to 

the consent decree. 

The proposed Second Amendment 

requires the City to construct separate 

storm sewers instead of the Swan Creek 

North Tunnel Extension. The storm 

sewer construction is intended to 

reduce congestion in Toledo’s combined 

sewer system more than the tunnel 

extension would, resulting in fewer 

combined sewage discharges and less 

total volume of sewer overflows into 

Swan Creek. Second, the Second 

Amendment authorizes changes in one 

of the discharge locations from the 

combined sewer system located near 

Jamie Farr Park after three combined 

sewer outfalls are combined into one. 

Both locations are at the Maumee River; 

they are about 0.4 miles apart. The 

original planned consolidated outfall 

was located southeast of the intersection 

of Summit Street and Galena Street, 

while the location of the consolidated 

outfall under this amendment is located 

southeast of the intersection of Summit 

Street and Columbus Street. The 

original planned consolidated outfall 

was located southeast of the intersection 

of Summit Street and Galena Street, 

while the new one is located southeast 

of the intersection of Summit Street and 

Columbus Street. Third, the amendment 

allows the City to conclude the 

pathogen removal study early, after the 

parties realized that undertaking any 

additional study would not provide 

additional information pertinent to 

pathogen removal issues. 

The publication of this notice opens 

a period for public comment on the 

Second Amendment. Comments should 

be addressed to the Assistant Attorney 

General, Environment and Natural 

Resources Division, and should refer to 

United States and State of Ohio v. City 

of Toledo, D.J. Ref. No. 90–5–1–1–3554. 

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. 

By mail ......... Assistant Attorney General, 

U.S. DOJ—ENRD, P.O. 

Box 7611, Washington, DC 

20044–7611. 

During the public comment period, 

the Second Amendment may be 

examined and downloaded at this 

Justice Department website: http://

www.justice.gov/enrd/consent-decrees. 

We will provide a paper copy of the 

Second Amendment 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 $7.25 (25 cents per page 

reproduction cost) payable to the United 

States Treasury. 

Patricia McKenna, 

Assistant Section Chief, Environmental 

Enforcement Section, Environment and 

Natural Resources Division. 

[FR Doc. 2022–13950 Filed 6–29–22; 8:45 am] 

BILLING CODE 4410–15–P 

DEPARTMENT OF JUSTICE 

[OMB Number 1117–0029] 

Agency Information Collection 

Activities; Proposed eCollection, 

eComments Requested; Extension 

Without Change of a Previously 

Approved Collection; Annual 

Reporting Requirement for 

Manufacturers of Listed Chemicals 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: 30-Day notice. 

SUMMARY: The Department of Justice, 

Drug Enforcement Administration 

(DEA), is 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. 

The proposed information collection 

was previously published in the Federal 

Register on May 6, 2022, allowing for a 

60-day comment period. No comments 

were received. 


jspears on DSK121TN23PROD with NOTICES1