Importer of Controlled Substances Application: Meridian Medical Technologies, 68473-68474 [2019-27093]

Download as PDF 68473 Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices INTERNATIONAL TRADE COMMISSION [Investigation No. 731–TA–1443 (Final)] Carbon and Alloy Steel Threaded Rod From Taiwan; Supplemental Schedule for the Final Phase of an Anti-Dumping Duty Investigation United States International Trade Commission. ACTION: Notice. AGENCY: DATES: December 10, 2019. lotter on DSKBCFDHB2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Kristina Lara ((202) 205–3386), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearingimpaired persons can obtain information on this matter by contacting the Commission’s TDD terminal on (202) 205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205–2000. General information concerning the Commission may also be obtained by accessing its internet server (https:// www.usitc.gov). The public record for these investigations may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. SUPPLEMENTARY INFORMATION: Effective August 7, 2019, the Commission established a general schedule for the conduct of the final phase of its investigations on carbon and alloy steel threaded rod (‘‘threaded rod’’) from China, India, Taiwan, and Thailand,1 following a preliminary determination by the U.S. Department of Commerce (‘‘Commerce’’) that imports of threaded rod from Thailand were being sold at less than fair value (LTFV) in the United States.2 Notice of the scheduling of the final phase of the Commission’s investigations and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register of August 27, 2019 (84 FR 44916). The hearing was held in Washington, DC, on October 15, 2019, and all persons who requested the opportunity were permitted to appear in person or by counsel. On October 21, 2019, Commerce issued a final affirmative determination of sales at LTFV and critical circumstances with respect to imports of threaded rod from Thailand.3 The Commission issued its final affirmative determination regarding LTFV imports of threaded rod from Thailand on December 5, 2019. On December 9, 2019, Commerce issued its final affirmative determination that imports of threaded rod from Taiwan were being sold at LTFV in the United States.4 Accordingly, the Commission currently is issuing a supplemental schedule for its antidumping investigation on imports of threaded rod from Taiwan. This supplemental schedule is as follows: The deadline for filing supplemental party comments on Commerce’s final antidumping duty determination is December 17, 2019. Supplemental party comments may address only Commerce’s final antidumping duty determination regarding imports of threaded rod from Taiwan. These supplemental final comments may not contain new factual information and may not exceed five (5) pages in length. The supplemental staff report in the final phase of this investigation regarding subject imports from Taiwan will be placed in the nonpublic record on January 3, 2019; and a public version will be issued thereafter. For further information concerning this investigation see the Commission’s notice cited above and the Commission’s Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207). Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission’s rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff. In accordance with sections 201.16(c) and 207.3 of the Commission’s rules, each document filed by a party to the investigation must be served on all other parties to the investigation (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. Authority: This investigation is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission’s rules. By order of the Commission. 1 84 FR 44916, August 27, 2019. FR 38597, August 7, 2019. 3 84 FR 56162, October 21, 2019. 2 84 VerDate Sep<11>2014 19:21 Dec 13, 2019 4 84 Jkt 250001 PO 00000 FR 67258, December 9, 2019. Frm 00082 Fmt 4703 Sfmt 4703 Issued: December 10, 2019. Lisa Barton, Secretary to the Commission. [FR Doc. 2019–26975 Filed 12–13–19; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–564] Importer of Controlled Substances Application: Meridian Medical Technologies ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 15, 2020. Such persons may also file a written request for a hearing on the application on or before January 15, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on November 13, 2019, Meridian Medical Technologies, 2555 Hermelin Drive, Saint Louis, Missouri 63144 applied to be registered as an importer of the following basic class of controlled substance: DATES: Controlled substance Drug code Schedule Morphine ......................... 9300 II The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product, which is sold to European customers, meets the standards established by the European Pharmacopeia, administered by the E:\FR\FM\16DEN1.SGM 16DEN1 68474 Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices Directorate for the quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM for use as reference standards. DEPARTMENT OF JUSTICE [Docket No. DEA–553] The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. Authorization will not extend to the import of Food and Drug Administration approved or nonapproved finished dosage forms for commercial sale. Drug Enforcement Administration Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc. Dated: November 14, 2019. William T. McDermott, Assistant Administrator. Dated: December 2, 2019. William T. McDermott, Assistant Administrator. Drug Enforcement Administration [Docket No. DEA–560] [FR Doc. 2019–27094 Filed 12–13–19; 8:45 am] Importer of Controlled Substances Application: Novitium Pharma LLC ACTION: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 15, 2020. Such persons may also file a written request for a hearing on the application on or before January 15, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on July 18, 2018, Novitium Pharma, LLC., 70 Lake Drive, East Windsor, New Jersey 08520 applied to be registered as an importer of the following basic class of controlled substance: DATES: Levorphanol .............. Drug code 9220 19:21 Dec 13, 2019 BILLING CODE 4410–09–P Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 15, 2020. Such persons may also file a written request for a hearing on the application on or before January 15, 2020 ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on October 17, 2019, Mylan Pharmaceuticals Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Drug code Schedule Amphetamine ................. Methylphenidate ............. Oxycodone ..................... Hydromorphone .............. Methadone ...................... Morphine ......................... Fentanyl .......................... 1100 1724 9143 9150 9250 9300 9801 II II II II II II II Schedule II The company plans to import the controlled substance to develop the manufacturing process for a drug product that will in turn be used to VerDate Sep<11>2014 Notice of application. DATES: Notice of application. Controlled substance [FR Doc. 2019–27095 Filed 12–13–19; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P ACTION: Dated: December 3, 2019. William T. McDermott, Assistant Administrator. BILLING CODE 4410–09–P [FR Doc. 2019–27093 Filed 12–13–19; 8:45 am] lotter on DSKBCFDHB2PROD with NOTICES produce a tablet equivalent to the current brand product. Jkt 250001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration Jeffrey D. Olsen, M.D.; Decision and Order On August 2, 2016, a former Acting Administrator of the Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (OSC) and Immediate Suspension of Registration (ISO) to Jeffrey D. Olsen, M.D. (hereinafter, Registrant), of Newport Beach, CA. Order to Show Cause and Immediate Suspension of Registration (hereinafter collectively, OSC 2)), at 1; see also Government Exhibit (hereinafter, GX) 26, at 1–6. OSC 2 informed Registrant of the immediate suspension of his DEA Certificate of Registration (hereinafter, COR) FO6043638 pursuant to 21 U.S.C. 824(d) ‘‘because . . . [his] continued registration constitute[d] an imminent danger to the public health and safety.’’ Id. The substantive ground for the proceeding, as alleged in OSC 2, was that Registrant’s ‘‘continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f).’’ Id. (citing 21 U.S.C. 824(a)(4)). Specifically, the OSC alleged that Registrant issued numerous prescriptions outside the usual course of the professional practice of medicine in violation of 21 U.S.C. 841(a)(1) and 21 CFR 1306.04(a) and in violation of California law and the minimum standards of medical practice in California. Id. at 2–4. The OSC stated that ‘‘[Registrant’s] conduct, viewed as a whole, ‘completely betrayed any semblance of legitimate medical treatment.’’’ Id. at 4 (citing Jack A. Danton, D.O., 76 FR 60900, 60904 E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68473-68474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27093]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-564]


Importer of Controlled Substances Application: Meridian Medical 
Technologies

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before January 15, 2020. 
Such persons may also file a written request for a hearing on the 
application on or before January 15, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on November 13, 2019, Meridian Medical Technologies, 
2555 Hermelin Drive, Saint Louis, Missouri 63144 applied to be 
registered as an importer of the following basic class of controlled 
substance:

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

    The company manufactures a product containing morphine in the 
United States. The company exports this product to customers around the 
world. The company has been asked to ensure that its product, which is 
sold to European customers, meets the standards established by the 
European Pharmacopeia, administered by the

[[Page 68474]]

Directorate for the quality of Medicines (EDQM). In order to ensure 
that its product will meet European specifications, the company seeks 
to import morphine supplied by EDQM for use as reference standards.

    Dated: December 2, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-27093 Filed 12-13-19; 8:45 am]
 BILLING CODE 4410-09-P
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