Importer of Controlled Substances Application: Sharp Clinical Services, LLC, 20701-20702 [2024-06179]

Download as PDF 20701 Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices 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 May 24, 2024. Such persons may also file a written request for a hearing on the application on or before May 24, 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 February 5, 2024, Promega Corporation, 3075 Sub Zero Parkway, Fitchburg, Wisconsin 53719, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Psilocybin ....................... Psilocyn .......................... I Drug code Schedule 7437 7438 I I I The company plans to bulk manufacture the listed controlled substances as Active Pharmaceutical Ingredients (API) for sale to its customers. No other activities for these drug codes are authorized for this registration. No other activities for these drug codes are authorized for this registration. Marsha Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–06189 Filed 3–22–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1338] Bulk Manufacturer of Controlled Substances Application: Usona Institute, Inc Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: 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 May 24, 2024. Such persons may also file a written request for a hearing on the application on or before May 24, 2024. 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 February 2, 2024, Usona Institute, Inc, 2780 Woods Hollow Road, Room 2413, Fitchburg, Wisconsin 53711, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Usona Institute, 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. SUMMARY: Controlled substance Drug code 5-Methoxy-N-N-dimethyltryptamine ....................................................................................................................................... Psilocybin ............................................................................................................................................................................... Psilocyn ................................................................................................................................................................................. The company plans to bulk manufacture the listed controlled substances for use in chemical process development as well as pre-clinical and clinical research. No other activities for these drug codes are authorized for this registration. Marsha Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–06184 Filed 3–22–24; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1341] Importer of Controlled Substances Application: Sharp Clinical Services, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Sharp Clinical Services, 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 SUMMARY: VerDate Sep<11>2014 18:08 Mar 22, 2024 Jkt 262001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 7431 7437 7438 Schedule I I I applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before April 24, 2024. Such persons may also file a written request for a hearing on the application on or before April 24, 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 E:\FR\FM\25MRN1.SGM 25MRN1 20702 Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices 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. In accordance with 21 CFR 1301.34(a), this is notice that on February 13, 2024, Sharp Clinical Services, LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020–8024, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Gamma Hydroxybutyric Acid. 3,4-Methylenedioxymethamphetamine. 5-Methoxy-N-Ndimethyltryptamine. Drug code Schedule 2010 I 7405 I 7431 I The company plans to import the listed controlled substances for distribution and clinical trials. 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. 2024–06179 Filed 3–22–24; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE 4410–09–P VerDate Sep<11>2014 18:08 Mar 22, 2024 Jkt 262001 DEPARTMENT OF LABOR Agency Information Collection Activities; Submission for OMB Review; Comment Request; Hydrostatic Testing Provision of the Standard on Portable Fire Extinguishers Notice of availability; request for comments. ACTION: The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited. DATES: The OMB will consider all written comments that the agency receives on or before April 24, 2024. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: Nicole Bouchet by telephone at 202– 693–0213, or by email at DOL_PRA_ PUBLIC@dol.gov. SUPPLEMENTARY INFORMATION: This information collection is associated with the hydrostatic testing of portable fire extinguishers. Persons performing the test are required to record their name, the date of the test, and the identifier of the extinguisher tested as evidence of completing the test. For additional substantive information about this ICR, see the related notice published in the Federal Register on January 9, 2024 (89 FR 1128). Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency’s estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology. SUMMARY: PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6. DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review. Agency: DOL–OSHA. Title of Collection: Hydrostatic Testing Provision of the Standard on Portable Fire Extinguishers. OMB Control Number: 1218–0218. Affected Public: Private Sector— Businesses or other for-profits. Total Estimated Number of Respondents: 5,869,911. Total Estimated Number of Responses: 5,217,699. Total Estimated Annual Time Burden: 504,377 hours. Total Estimated Annual Other Costs Burden: $210,664,596. (Authority: 44 U.S.C. 3507(a)(1)(D)) Nicole Bouchet, Certifying Official. [FR Doc. 2024–06152 Filed 3–22–24; 8:45 am] BILLING CODE 4510–26–P DEPARTMENT OF LABOR Agency Information Collection Activities; Submission for OMB Review; Comment Request; Certification of Medical Necessity Notice of availability; request for comments. ACTION: The Department of Labor (DOL) is submitting this Office of Workers’ Compensation Programs (OWCP)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited. DATES: The OMB will consider all written comments that the agency receives on or before April 24, 2024. SUMMARY: E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[Federal Register Volume 89, Number 58 (Monday, March 25, 2024)]
[Notices]
[Pages 20701-20702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06179]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1341]


Importer of Controlled Substances Application: Sharp Clinical 
Services, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Sharp Clinical Services, 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 
April 24, 2024. Such persons may also file a written request for a 
hearing on the application on or before April 24, 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

[[Page 20702]]

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 February 13, 2024, Sharp Clinical Services, LLC, 2400 
Baglyos Circle, Bethlehem, Pennsylvania 18020-8024, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid...............    2010  I
3,4-Methylenedioxy-                         7405  I
 methamphetamine.
5-Methoxy-N-N-dimethyltryptamine........    7431  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
distribution and clinical trials. 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 non-approved finished 
dosage forms for commercial sale.

Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-06179 Filed 3-22-24; 8:45 am]
BILLING CODE 4410-09-P
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