Bulk Manufacturer of Controlled Substances Application: Groff Health, Inc., 87459-87460 [2023-27706]

Download as PDF 87459 Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices (Marihuana), and 7370 (Tetrahydrocannabinols) the company plans to bulk manufacture these drug codes as synthetic. No other activities for these drug codes are authorized for this registration. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–27708 Filed 12–15–23; 8:45 am] BILLING CODE P 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 November 28, 2023, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration Phenylacetone ................. Opium, raw ...................... Poppy Straw Concentrate [Docket No. DEA–1307] Importer of Controlled Substances Application: Siegfried USA, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Siegfried USA, LLC 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 January 17, 2024. Such persons may also file a written request for a hearing on the application on or before January 17, 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 khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:41 Dec 15, 2023 Jkt 262001 I Drug code Schedule 8501 9600 9670 II II II I The company plans to import the listed controlled substances to manufacture bulk Active Pharmaceuticals Ingredients 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. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–27705 Filed 12–15–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1306] Bulk Manufacturer of Controlled Substances Application: AJNA BioSciences Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 Controlled substance Psilocybin ........................ Psilocyn ........................... I Drug code Schedule 7437 7438 I I I The company plans to bulk manufacture by cultivating research Good Manufacturing Practices whole plant mushrooms containing Psilocybin (7437) and Psilocyn (7438) to support internal research, clinical trials, and analytical purposes as well as to distribute to their customers conducting schedule I clinical research. No other activities for these drug codes are authorized for this registration. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–27707 Filed 12–15–23; 8:45 am] BILLING CODE P AJNA BioSciences 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 February 16, 2024. Such persons may also file a written request SUMMARY: for a hearing on the application on or before February 16, 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 September 20, 2023, AJNA BioSciences, 8022 Southpark Circle, Suite 500, Littleton, Colorado 80120–5659, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1309] Bulk Manufacturer of Controlled Substances Application: Groff Health, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: E:\FR\FM\18DEN1.SGM 18DEN1 87460 Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices Groff Health, 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. DEPARTMENT OF LABOR 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 February 16, 2024. Such persons may also file a written request for a hearing on the application on or before February 16, 2024. Intertek Testing Services NA, Inc.: Application for Expansion of Recognition SUMMARY: DATES: 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. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on September 22, 2023, Groff Health, Inc., 2218 South Queen Street, York, Pennsylvania 17402–4631, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Psilocybin ........................ Psilocyn ........................... I Drug code Schedule 7437 7438 I I I The company plans to bulk manufacture the listed controlled substances for internal use or for sale to its customers. khammond on DSKJM1Z7X2PROD with NOTICES Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–27706 Filed 12–15–23; 8:45 am] BILLING CODE P VerDate Sep<11>2014 17:41 Dec 15, 2023 Jkt 262001 Occupational Safety and Health Administration [Docket No. OSHA–2007–0039] Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice. AGENCY: In this notice, OSHA announces the application of Intertek Testing Services NA, Inc., for expansion of the recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the agency’s preliminary finding to grant the application. DATES: Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before January 2, 2024. ADDRESSES: Submit comments by any of the following methods: Electronically: Submit comments and attachments electronically at https:// www.regulations.gov, which is the Federal eRulemaking Portal. Follow the instructions online for making electronic submissions. Docket: To read or download comments or other material in the docket, go to https://www.regulations.gov or the OSHA Docket Office. All documents in the docket (including this Federal Register notice) are listed in the https://www.regulations.gov index; however, some information (e.g., copyrighted material) is not publicly available to read or download through the website. All submissions, including copyrighted material, are available for inspection through the OSHA Docket Office. Contact the OSHA Docket Office at (202) 693–2350 (TTY (877) 889–5627) for assistance in locating docket submissions. Instructions: All submissions must include the agency name and the OSHA docket number (OSHA–2007–0039). OSHA places comments and other materials, including any personal information, in the public docket without revision, and these materials will be available online at https:// www.regulations.gov. Therefore, the agency cautions commenters about submitting statements they do not want made available to the public, or submitting comments that contain personal information (either about themselves or others) such as Social Security numbers, birth dates, and medical data. SUMMARY: PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 Extension of comment period: Submit requests for an extension of the comment period on or before January 2, 2024 to the Office of Technical Programs and Coordination Activities, Directorate of Technical Support and Emergency Management, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue NW, Room N–3653, Washington, DC 20210, or by fax to (202) 693–1644. FOR FURTHER INFORMATION CONTACT: Information regarding this notice is available from the following sources: Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office of Communications, phone: (202) 693– 1999 or email: meilinger.francis2@ dol.gov. General and technical information: Contact Mr. Kevin Robinson, Director, Office of Technical Programs and Coordination Activities, Directorate of Technical Support and Emergency Management, Occupational Safety and Health Administration, phone: (202) 693–1911 or email: robinson.kevin@ dol.gov. SUPPLEMENTARY INFORMATION: I. Notice of the Application for Expansion OSHA is providing notice that Intertek Testing Services NA, Inc. (ITSNA), is applying for expansion of the current recognition as a NRTL. ITSNA requests the addition of one test standard to the NRTL scope of recognition. OSHA recognition of a NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within the scope of recognition. Each NRTL’s scope of recognition includes: (1) the type of products the NRTL may test, with each type specified by the applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and productcertification activities for test standards within the NRTL’s scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification. The agency processes applications by a NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the agency E:\FR\FM\18DEN1.SGM 18DEN1

Agencies

[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87459-87460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27706]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1309]


Bulk Manufacturer of Controlled Substances Application: Groff 
Health, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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[[Page 87460]]

SUMMARY: Groff Health, 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 
February 16, 2024. Such persons may also file a written request for a 
hearing on the application on or before February 16, 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 September 22, 2023, Groff Health, Inc., 2218 South 
Queen Street, York, Pennsylvania 17402-4631, applied to be registered 
as a bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Psilocybin..............................    7437  I
Psilocyn................................    7438  I
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for internal use or for sale to its customers.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-27706 Filed 12-15-23; 8:45 am]
BILLING CODE P
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