Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc., 49888-49889 [2022-17361]

Download as PDF 49888 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices purposes of this Investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3 This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)). By order of the Commission. Issued: August 8, 2022. Katherine Hiner, Acting Secretary to the Commission. [FR Doc. 2022–17298 Filed 8–11–22; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1067] Importer of Controlled Substances Application: Cambridge Isotope Laboratories, Inc. 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 July 18, 2022, Cambridge Isotope Laboratories, 50 Frontage Road, Andover, Massachusetts 01810–5413, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Gamma Hydroxybutyric Acid. Tetrahydrocannabinols .. Morphine ........................ Cambridge Isotope Laboratories 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 September 12, 2022. Such persons may also file a written request for a hearing on the application on or before September 12, 2022. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, Drug code Schedule 2010 I 7370 9300 I II jspears on DSK121TN23PROD with NOTICES SUMMARY: 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 The company plans to import the listed controlled substances for preparation of analytical standards and formulations. In reference to drug codes 7370 (Tetrahydrocannabinols), the company plans to import a synthetic Tetrahydrocannabinol. 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. Kristi O’Malley, Assistant Administrator. [FR Doc. 2022–17364 Filed 8–11–22; 8:45 am] BILLING CODE P PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1065] Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Galephar Pharmaceutical Research, 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. SUMMARY: 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 September 12, 2022. Such persons may also file a written request for a hearing on the application on or before September 12, 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 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 July 28, 2022, Galephar Pharmaceutical Research, Inc., 100 Carr 198 Industrial Park, Juncos, Puerto Rico 00777–3873, applied to be registered as DATES: E:\FR\FM\12AUN1.SGM 12AUN1 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices an importer of the following basic class(es) of controlled substance(s): Controlled substance Hydromorphone ............. Drug code 9150 Schedule II The company plans to import the listed controlled substance in finished dosage form for analytical purpose only. 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. 2022–17361 Filed 8–11–22; 8:45 am] BILLING CODE P DEPARTMENT OF LABOR Agency Information Collection Activities; Formative Data Collections for DOL Research Notice of availability; request for comments. ACTION: The Department of Labor (DOL) is submitting this Chief Evaluation Office (CEO)-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 September 12, 2022. SUMMARY: 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. 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, jspears on DSK121TN23PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 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. FOR FURTHER INFORMATION CONTACT: Nicole Bouchet by telephone at 202– 693–0213, or by email at DOL_PRA_ PUBLIC@dol.gov. SUPPLEMENTARY INFORMATION: The Chief Evaluation Office of DOL seeks approval of this generic clearance to allow DOL to conduct a variety of formative data collections. Under this generic clearance, DOL would engage in a variety of formative data collections with researchers, practitioners, technical assistance providers, service providers and potential participants throughout the field to fulfill the following goals: (1) inform the development of DOL research, (2) maintain a research agenda that is rigorous and relevant, (3) ensure that research products are as current as possible and (4) inform the provision of technical assistance. DOL envisions using a variety of techniques including semi-structured discussions, focus groups, surveys, and telephone or inperson interviews in order to reach these goals. The findings from this data collection can inform and support future and current research but that are not highly systematic or intended to be statistically representative or otherwise generalizable. For additional substantive information about this ICR, see the related notice published in the Federal Register on March 8, 2021 (86 FR 13401). 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. PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 49889 Agency: DOL–CEO. Title of Collection: Formative Data Collections for DOL Research. OMB Control Number: 1290–0NEW. Affected Public: Individuals or Households. Total Estimated Number of Respondents: 5,500. Total Estimated Number of Responses: 5,500. Total Estimated Annual Time Burden: 5,500 hours. Total Estimated Annual Other Costs Burden: $0. (Authority: 44 U.S.C. 3507(a)(1)(D)) Nicole Bouchet, Senior PRA Analyst. [FR Doc. 2022–17335 Filed 8–11–22; 8:45 am] BILLING CODE 4510–26–P NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES National Endowment for the Humanities Meeting of Humanities Panel National Endowment for the Humanities; National Foundation on the Arts and the Humanities. ACTION: Notice of meeting. AGENCY: The National Endowment for the Humanities (NEH) will hold seven meetings, by videoconference, of the Humanities Panel, a federal advisory committee, during September 2022. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and the Humanities Act of 1965. DATES: See SUPPLEMENTARY INFORMATION for meeting dates. The meetings will open at 8:30 a.m. and will adjourn by 5:00 p.m. on the dates specified below. FOR FURTHER INFORMATION CONTACT: Elizabeth Voyatzis, Committee Management Officer, 400 7th Street SW, Room 4060, Washington, DC 20506; (202) 606–8322; evoyatzis@neh.gov. SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.), notice is hereby given of the following meetings: SUMMARY: 1. Date: September 1, 2022 This video meeting will discuss applications on the topic of U.S. History, for the Digital Projects for the Public: Prototyping Grants program, submitted to the Division of Public Programs. E:\FR\FM\12AUN1.SGM 12AUN1

Agencies

[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49888-49889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17361]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1065]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Galephar Pharmaceutical Research, 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 
September 12, 2022. Such persons may also file a written request for a 
hearing on the application on or before September 12, 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 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 July 28, 2022, Galephar Pharmaceutical Research, 
Inc., 100 Carr 198 Industrial Park, Juncos, Puerto Rico 00777-3873, 
applied to be registered as

[[Page 49889]]

an importer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Hydromorphone..........................     9150  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance in 
finished dosage form for analytical purpose only. 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 non-approved finished dosage forms for 
commercial sale.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-17361 Filed 8-11-22; 8:45 am]
BILLING CODE P
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