Importer of Controlled Substances Application: Meridian Medical Technologies, LLC, 11996-11997 [2025-04043]

Download as PDF khammond on DSK9W7S144PROD with NOTICES 11996 Federal Register / Vol. 90, No. 48 / Thursday, March 13, 2025 / Notices Commission’s Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207). Please note the Secretary’s Office will accept only 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. Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list.—Pursuant to § 207.7(a) of the Commission’s rules, the Secretary will make BPI gathered in this review available to authorized applicants under the APO issued in the review, provided that the application is made by 45 days after publication of this notice. Authorized applicants must represent interested parties, as defined by 19 U.S.C. 1677(9), who are parties to the review. A party granted access to BPI following publication of the Commission’s notice of institution of the review need not reapply for such access. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO. Staff report.—The prehearing staff report in the review will be placed in the nonpublic record on August 21, 2025, and a public version will be issued thereafter, pursuant to § 207.64 of the Commission’s rules. Hearing.—The Commission will hold an in-person hearing in connection with the review beginning at 9:30 a.m. on September 11, 2025. Requests to appear at the hearing should be filed in writing with the Secretary to the Commission on or before 5:15 p.m. on September 4, 2025. Any requests to appear as a witness via videoconference must be included with your request to appear. Requests to appear via videoconference must include a statement explaining why the witness cannot appear in person; the Chairman, or other person designated to conduct the review, may in their discretion for good cause shown, grant such a request. Requests to appear as remote witness due to illness or a positive COVID–19 test result may be submitted by 3:00 p.m. the business day prior to the hearing. Further information about participation in the hearing will be posted on the Commission’s website at https:// www.usitc.gov/calendarpad/ calendar.html. A nonparty who has testimony that may aid the Commission’s deliberations VerDate Sep<11>2014 16:14 Mar 12, 2025 Jkt 265001 may request permission to present a short statement at the hearing. All parties and nonparties desiring to appear at the hearing and make oral presentations should attend a prehearing conference, if deemed necessary, to be held at 9:30 a.m. on September 10, 2025. Parties shall file and serve written testimony and presentation slides in connection with their presentation at the hearing by no later than noon on September 10, 2025. Oral testimony and written materials to be submitted at the public hearing are governed by § 201.6(b)(2), 201.13(f), and 207.24 of the Commission’s rules. Parties must submit any request to present a portion of their hearing testimony in camera no later than 7 business days prior to the date of the hearing. Written submissions.—Each party to the review may submit a prehearing brief to the Commission. Prehearing briefs must conform with the provisions of § 207.65 of the Commission’s rules; the deadline for filing is 5:15 p.m. on September 3, 2025. Parties shall also file written testimony in connection with their presentation at the hearing, and posthearing briefs, which must conform with the provisions of § 207.67 of the Commission’s rules. The deadline for filing posthearing briefs is 5:15 p.m. on September 19, 2025. In addition, any person who has not entered an appearance as a party to the review may submit a written statement of information pertinent to the subject of the review on or before 5:15 p.m. on September 19, 2025. On October 10, 2025, the Commission will make available to parties all information on which they have not had an opportunity to comment. Parties may submit final comments on this information on or before 5:15 p.m. on October 15, 2025, but such final comments must not contain new factual information and must otherwise comply with § 207.68 of the Commission’s rules. All written submissions must conform with the provisions of § 201.8 of the Commission’s rules; any submissions that contain BPI must also conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission’s rules. The Commission’s Handbook on Filing Procedures, available on the Commission’s website at https:// www.usitc.gov/documents/handbook_ on_filing_procedures.pdf, elaborates upon the Commission’s procedures with respect to filings. Additional written submissions to the Commission, including requests pursuant to § 201.12 of the Commission’s rules, shall not be accepted unless good cause is shown for PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff. In accordance with §§ 201.16(c) and 207.3 of the Commission’s rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service. The Commission has determined that this review is extraordinarily complicated and therefore has determined to exercise its authority to extend the review period by up to 90 days pursuant to 19 U.S.C. 1675(c)(5)(B). Authority: This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.62 of the Commission’s rules. By order of the Commission. Issued: March 10, 2025. Lisa Barton, Secretary to the Commission. [FR Doc. 2025–04012 Filed 3–12–25; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1500] Importer of Controlled Substances Application: Meridian Medical Technologies, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Meridian Medical Technologies, 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. 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 14, 2025. Such persons may also file a written request for a hearing on the application on or before April 14, 2025. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, DATES: E:\FR\FM\13MRN1.SGM 13MRN1 11997 Federal Register / Vol. 90, No. 48 / Thursday, March 13, 2025 / Notices 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. In accordance with 21 CFR 1301.34(a), this is notice that on January 17, 2025, Meridian Medical Technologies, LLC, 2555 Hermelin Drive, Saint Louis, Missouri 63144, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Drug code Schedule SUPPLEMENTARY INFORMATION listed below for further drug information. Morphine .......................... 9300 II DATES: The company plans to import the listed controlled substance for analytical purposes 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. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2025–04043 Filed 3–12–25; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1508] Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Patheon Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to 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 May 12, 2025. Such persons may also file a written request for a hearing on the application on or before May 12, 2025. 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 4, 2025, Patheon Pharmaceuticals Inc., 2110 East Galbraith Road, Cincinnati, Ohio 45237–1625 applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Drug code Gamma Hydroxybutyric Acid ............................................................................................................................................... The company plans to manufacture the above listed controlled substance as Active Pharmaceutical Ingredient that will be further synthesized into Food and Drug Administration-approved dosage forms. No other activity for this drug code is authorized for this registration. DEPARTMENT OF JUSTICE Matthew Strait, Deputy Assistant Administrator. AGENCY: khammond on DSK9W7S144PROD with NOTICES [FR Doc. 2025–04045 Filed 3–12–25; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 16:14 Mar 12, 2025 Drug Enforcement Administration [Docket No. DEA–1509] Importer of Controlled Substances Application: Fisher Clinical Services, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. Fisher Clinical Services, 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 SUMMARY: Jkt 265001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 2010 Schedule I applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before April 14, 2025. Such persons may also file a written request for a hearing on the application on or before April 14, 2025. 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\13MRN1.SGM 13MRN1

Agencies

[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Notices]
[Pages 11996-11997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04043]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1500]


Importer of Controlled Substances Application: Meridian Medical 
Technologies, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Meridian Medical Technologies, 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 14, 2025. Such persons may also file a written request for a 
hearing on the application on or before April 14, 2025.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal,

[[Page 11997]]

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 17, 2025, Meridian Medical Technologies, LLC, 
2555 Hermelin Drive, Saint Louis, Missouri 63144, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Morphine...............................    9300   II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance for 
analytical purposes 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.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-04043 Filed 3-12-25; 8:45 am]
BILLING CODE 4410-09-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.