Importer of Controlled Substances Application: Peace of Mind Pharmaceuticals LLC, 13313-13314 [2022-04926]

Download as PDF jspears on DSK121TN23PROD with NOTICES1 Federal Register / Vol. 87, No. 46 / Wednesday, March 9, 2022 / Notices economy, the production of like or directly competitive articles in the United States, or United States consumers. In particular, the Commission is interested in comments that: (i) Explain how the articles potentially subject to the requested remedial orders are used in the United States; (ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders; (iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded; (iv) indicate whether complainant, complainant’s licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and (v) explain how the requested remedial orders would impact United States consumers. Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation. Any written submissions on other issues must also be filed by no later than the close of business, eight calendar days after publication of this notice in the Federal Register. Complainant may file replies to any written submissions no later than three calendar days after the date on which any initial submissions were due. No other submissions will be accepted, unless requested by the Commission. Any submissions and replies filed in response to this Notice are limited to five (5) pages in length, inclusive of attachments. Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (‘‘Docket No. 3608’’) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures 1). Please note the Secretary’s Office will accept only 1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_ filing_procedures.pdf. VerDate Sep<11>2014 17:44 Mar 08, 2022 Jkt 256001 electronic filings during this time. Filings must be made through the Commission’s Electronic Document Information System (EDIS, https:// edis.usitc.gov.) No in-person paperbased filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding filing should contact the Secretary at EDIS3Help@usitc.gov. Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for 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: March 4, 2022. Jessica Mullan, Attorney-Advisor. [FR Doc. 2022–04996 Filed 3–8–22; 8:45 am] BILLING CODE 7020–02–P 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 13313 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–980] Importer of Controlled Substances Application: Peace of Mind Pharmaceuticals LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Peace of Mind Pharmaceuticals LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTAL 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 April 8, 2022. Such persons may also file a written request for a hearing on the application on or before April 8, 2022. ADDRESSES: DEA 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 webpage 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 March 15, 2021, Peace of Mind Pharmaceuticals LLC, 3003 East 3rd Avenue, Suite B–109A, Denver, Colorado 80206–5110, applied to be registered as an importer of the DATES: E:\FR\FM\09MRN1.SGM 09MRN1 13314 Federal Register / Vol. 87, No. 46 / Wednesday, March 9, 2022 / Notices following basic class(es) of controlled substance(s): Controlled substance Pentobarbital .................. Drug code Schedule 2270 II The company plans to import the listed controlled substance as bulk active pharmaceutical ingredient (API) for distribution to compounding pharmacies. It is intended for pharmacies who seek to compound the material into dosage units that will be distributed to terminally ill patients for ‘‘medical aid in dying’’ (MAID) in U.S. states where MAID is authorized. No other activity for this drug code is authorized for this registration. Approval of permit applications can occur only when a 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. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2022–04926 Filed 3–8–22; 8:45 am] BILLING CODE 4410–09–P Under the proposed Settlement Agreement, Blue Line agrees to pay $175,000 to the DOI Natural Resource Damage Assessment and Restoration Fund, $25,000 to compensate for past assessment costs and $150,000 will be used for restoration activities to compensate the public for recreational and aquatic injuries. Blue Line will receive from the Trustees a covenant not to sue for the claims resolved by the settlement. The publication of this notice opens a period for public comment on the proposed Settlement Agreement. Comments on the proposed Settlement Agreement should be addressed to the Assistant Attorney General, Environment and Natural Resources Division and should refer to the CP Settlement Agreement, DJ No. 90–5–1– 1–12115. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: To submit comments: Send them to: By e-mail ...... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. By mail ......... DEPARTMENT OF JUSTICE jspears on DSK121TN23PROD with NOTICES1 Notice of Proposed Settlement Agreement Under the Oil Pollution Act Notice is hereby given that the United States of America, on behalf of the Department of the Interior (‘‘DOI’’) acting through the U.S. Fish and Wildlife Service, the State of Oregon represented by Oregon Department of Fish and Wildlife (‘‘ODFW’’), and the Confederated Tribes of the Siletz Indians (‘‘Tribes’’), (DOI, ODFW and Tribes collectively, the ‘‘Trustees’’), are providing an opportunity for public comment on a proposed Settlement Agreement (‘‘Settlement Agreement’’) among the Trustees and Blue Line Transportation Company, Inc. (‘‘Blue Line’’) . The settlement resolves the civil claims of the Trustees against Blue Line arising by virtue of their natural resource trustee authority under the Oil Pollution Act of 1990, 33 U.S.C. 2702 for injury to, impairment of, destruction of, and loss of, diminution of value of and/or loss of use of natural resources resulting from the January 27, 2001 discharge of approximately 5,800 gallons of No. 6 fuel oil from a fuel tanker, owned by Blue Line, on U.S. Highway 20, near Toledo, Oregon. VerDate Sep<11>2014 17:44 Mar 08, 2022 Jkt 256001 During the public comment period, the proposed Settlement Agreement may be examined and downloaded at this Justice Department website: https:// www.justice.gov/enrd/consent-decrees. We will provide a paper copy of the proposed Settlement Agreement upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $2.50 (25 cents per page reproduction cost) payable to the United States Treasury. Susan M. Akers, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2022–04960 Filed 3–8–22; 8:45 am] BILLING CODE 4410–15–P PO 00000 DEPARTMENT OF LABOR Employee Benefits Security Administration Proposed Exemptions From Certain Prohibited Transaction Restrictions Employee Benefits Security Administration, Labor. ACTION: Notice of proposed exemptions. AGENCY: This document contains notices of pendency before the Department of Labor (the Department) of proposed exemptions from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). If granted, these proposed exemptions allow designated parties to engage in transactions that would otherwise be prohibited provided the conditions stated there in are met. This notice includes the following proposed exemptions: D–12031, Midlands Management Corporation 401(k) Plan; D–12012, The DISH Network Corporation 401(k) Plan and the EchoStar 401(k) Plan; D–12048, The Children’s Hospital of Philadelphia Pension Plan for Union-Represented Employees. DATES: All interested persons are invited to submit written comments or requests for a hearing on the pending exemptions, unless otherwise stated in the Notice of Proposed Exemption, by April 25, 2022. ADDRESSES: All written comments and requests for a hearing should be sent to the Employee Benefits Security Administration (EBSA), Office of Exemption Determinations, U.S. Department of Labor, Attention: Application No., stated in each Notice of Proposed Exemption via email to e-OED@dol.gov or online through https:// www.regulations.gov by the end of the scheduled comment period. Any such comments or requests should be sent by the end of the scheduled comment period. The applications for exemption and the comments received will be available for public inspection in the Public Disclosure Room of the Employee Benefits Security Administration, U.S. Department of Labor, Room N–1515, 200 Constitution Avenue NW, Washington, DC 20210. See SUPPLEMENTARY INFORMATION below for additional information regarding comments. SUPPLEMENTARY INFORMATION: SUMMARY: Comments: In light of the current circumstances surrounding the COVID–19 pandemic Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
[Notices]
[Pages 13313-13314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04926]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-980]


Importer of Controlled Substances Application: Peace of Mind 
Pharmaceuticals LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Peace of Mind Pharmaceuticals LLC has applied to be registered 
as an importer of basic class(es) of controlled substance(s). Refer to 
Supplemental 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 8, 2022. Such persons may also file a written request for a 
hearing on the application on or before April 8, 2022.

ADDRESSES: DEA 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 webpage 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 March 15, 2021, Peace of Mind Pharmaceuticals LLC, 
3003 East 3rd Avenue, Suite B-109A, Denver, Colorado 80206-5110, 
applied to be registered as an importer of the

[[Page 13314]]

following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Pentobarbital..........................    2270  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance as bulk 
active pharmaceutical ingredient (API) for distribution to compounding 
pharmacies. It is intended for pharmacies who seek to compound the 
material into dosage units that will be distributed to terminally ill 
patients for ``medical aid in dying'' (MAID) in U.S. states where MAID 
is authorized. No other activity for this drug code is authorized for 
this registration.
    Approval of permit applications can occur only when a 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.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04926 Filed 3-8-22; 8:45 am]
BILLING CODE 4410-09-P
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