Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices 13747 

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 March 25, 2024. Such 

persons may also file a written request 

for a hearing on the application on or 

before March 25, 2024. 

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 

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 January 24, 2024, 

Pfizer, Inc. 45 Eastern Point Road, 

Groton, Connecticut 06340–5157, 

applied to be registered as an importer 

of the following basic class(es) of 

controlled substance(s): 

Controlled substance Drug 

code Schedule 

Pentobarbital ................. 2270 II 

The company plans to import the 

listed controlled substances as finished 

dosage to support internal research 

purposes. No other activities for these 

drug codes are 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. 

Marsha Ikner, 

Acting Deputy Assistant Administrator. 

[FR Doc. 2024–03709 Filed 2–22–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1321] 

Importer of Controlled Substances 

Application: Janssen Pharmaceuticals 

Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Janssen Pharmaceuticals 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 March 25, 2024. Such 

persons may also file a written request 

for a hearing on the application on or 

before March 25, 2024. 

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 

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 December 7, 2023, 

Janssen Pharmaceuticals Inc., 1440 

Olympic Drive, Buildings 1–5 & 7–14, 

Athens, Georgia 30601–1645, applied to 

be registered as an importer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

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

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

The company plans to import 

intermediates classified under 

Tapentadol (9780) for further 

manufacturing to the controlled 

substance Tapentadol respectively, prior 

to distribution to customers. No other 

activity for these drug codes are 

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. 

Marsha Ikner, 

Acting Deputy Assistant Administrator. 

[FR Doc. 2024–03689 Filed 2–22–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1327] 

Bulk Manufacturer of Controlled 

Substances Application: S&B Pharma 

LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: S&B Pharma LLC 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 April 23, 2024. Such 

persons may also file a written request 


ddrumheller on DSK120RN23PROD with NOTICES1

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