Importer of Controlled Substances Application: Pfizer, Inc., 13746-13747 [2024-03709]

Download as PDF 13746 Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on January 10, 2024, S&B Pharma LLC DBA Norac Pharma, 405 South Motor Avenue, Azusa, California 91702, applied to be registered as an importer of the following basic class(es) of controlled substance(s): approved finished dosage forms for commercial sale. Marsha Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–03683 Filed 2–22–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug code Controlled substance [Docket No. DEA–1326] 4-Anilino-N-phenethyl-4piperidine (ANPP). Tapentadol ..................... Importer of Controlled Substances Application: S&B Pharma LLC DBA Norac Pharma Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: S&B Pharma LLC DBA Norac Pharma 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, ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:19 Feb 22, 2024 Jkt 262001 I Schedule 8333 II 9780 III The company plans to import intermediate forms of Tapentadol (9780) for further manufacturing prior to distribution to its customers. The company plans to import ANNP (8333) to bulk manufacture other controlled substances for distribution to its customers. 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. 2024–03718 Filed 2–22–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1319] Bulk Manufacturer of Controlled Substances Application: Patheon API Services Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. for a hearing on the application on or before April 23, 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on December 21, 2023, Patheon API Services Inc., 101 Technology Place, Florence, South Carolina 29501, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Dimethyltryptamine ........ Psilocybin ...................... Psilocyn ......................... Amphetamine ................ Methadone ..................... Drug code 7435 7437 7438 1100 9250 Schedule I I I II II The company plans to bulk manufacture the above controlled substances to support customers’ clinical trials. No other activities for these drug codes are authorized for this registration. Marsha Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–03686 Filed 2–22–24; 8:45 am] BILLING CODE P AGENCY: DEPARTMENT OF JUSTICE Patheon API Services Inc. 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 SUMMARY: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Drug Enforcement Administration [Docket No. DEA–1325] Importer of Controlled Substances Application: Pfizer, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Pfizer, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information SUMMARY: E:\FR\FM\23FEN1.SGM 23FEN1 13747 Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices listed below for further drug information. 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): DATES: Drug code Controlled substance ddrumheller on DSK120RN23PROD with NOTICES1 Pentobarbital ................. I 2270 Schedule I 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). VerDate Sep<11>2014 17:19 Feb 22, 2024 Jkt 262001 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 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): Drug Enforcement Administration Controlled substance [Docket No. DEA–1321] Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: 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 SUMMARY: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Methylphenidate .............. Tapentadol ...................... I Drug code Schedule 1724 9780 II II I 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 Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: 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 SUMMARY: E:\FR\FM\23FEN1.SGM 23FEN1

Agencies

[Federal Register Volume 89, Number 37 (Friday, February 23, 2024)]
[Notices]
[Pages 13746-13747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03709]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1325]


Importer of Controlled Substances Application: Pfizer, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Pfizer, Inc. has applied to be registered as an importer of 
basic class(es) of controlled substance(s). Refer to Supplementary 
Information

[[Page 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):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             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 non-approved 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
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