Importer of Controlled Substances Application: United States Pharmacopeial Convention, 23582-23583 [2019-10668]

Download as PDF 23582 Federal Register / Vol. 84, No. 99 / Wednesday, May 22, 2019 / Notices Company FR docket Meridian Medical Technologies ....................................................................................................... Organic Standards Solutions International, LLC ............................................................................. SpecGx LLC .................................................................................................................................... 84 FR 7129 ............... 84 FR 13958 ............. 84 FR 13954 ............. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable basic classes of schedule I and II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each of the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing each company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I and schedule II controlled substances to the above listed companies. Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on March 8, 2019, United States Pharmacopeial, 12601 Twinbrook Parkway, Rockville, Maryland 20852–1717 applied to be registered as an importer of the following basic classes of controlled substances: Dated: May 7, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–10669 Filed 5–21–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: United States Pharmacopeial Convention 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 June 21, 2019. Such persons may also file a written request for a hearing on the application on or before June 21, 2019. 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 request for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette DATES: jbell on DSK3GLQ082PROD with NOTICES Controlled substance 17:29 May 21, 2019 Jkt 247001 PO 00000 Frm 00061 Fmt 4703 March 1, 2019. April 8, 2019. April 8, 2019. Drug code Methamphetamine ........................................................................................................................................................... Cathinone ........................................................................................................................................................................ Phenmetrazine ................................................................................................................................................................. Methylphenidate .............................................................................................................................................................. Amobarbital ...................................................................................................................................................................... Pentobarbital .................................................................................................................................................................... Secobarbital ..................................................................................................................................................................... Glutethimide ..................................................................................................................................................................... Methaqualone .................................................................................................................................................................. Lysergic acid diethylamide .............................................................................................................................................. 4-Methyl-2,5-dimethoxyamphetamine ............................................................................................................................. 3,4-Methylenedioxyamphetamine .................................................................................................................................... 4-Methoxyamphetamine .................................................................................................................................................. Phencyclidine ................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Phenylacetone ................................................................................................................................................................. Alphaprodine .................................................................................................................................................................... Anileridine ........................................................................................................................................................................ Cocaine ............................................................................................................................................................................ Codeine-N-oxide .............................................................................................................................................................. Dihydrocodeine ................................................................................................................................................................ Difenoxin .......................................................................................................................................................................... Diphenoxylate .................................................................................................................................................................. Heroin .............................................................................................................................................................................. Levomethorphan .............................................................................................................................................................. Levorphanol ..................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. VerDate Sep<11>2014 Published Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1 1105 1235 1631 1724 2125 2270 2315 2550 2565 7315 7395 7400 7411 7471 8333 8501 9010 9020 9041 9053 9120 9168 9170 9200 9210 9220 9230 9273 Schedule II I II II II II II II I I I I I II II II II II II I II I II I II II II II 23583 Federal Register / Vol. 84, No. 99 / Wednesday, May 22, 2019 / Notices Controlled substance Drug code Morphine-N-oxide ............................................................................................................................................................ Thebaine .......................................................................................................................................................................... Norlevorphanol ................................................................................................................................................................ Oxymorphone .................................................................................................................................................................. Noroxymorphone ............................................................................................................................................................. Alfentanil .......................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... The company plans to import the bulk control substances for distribution of analytical reference standards to its customers for analytical testing of raw materials. DEPARTMENT OF JUSTICE Dated: May 7, 2019. John J. Martin, Assistant Administrator. On May 16, 2019, the Department of Justice lodged a proposed Stipulation of Settlement and Order (‘‘Agreement’’) with the United States District Court for the District of Massachusetts in the lawsuit entitled United States v. Kayem Foods, Inc., Civil Action No. 1:19–cv– 11126. In this action, the United States filed a complaint alleging that Kayem Foods, Inc. (‘‘Kayem’’) violated Section 112(r)(7) of the Clean Air Act, 42 U.S.C. 7412(r)(7), at Kayem’s food processing facility located in Chelsea, Massachusetts. Section 112(r)(7) of the CAA, 42 U.S.C. 7412(r)(7), provides that the Administrator of the EPA is authorized to promulgate regulations requiring owners or operators of a stationary source at which a regulated substance is present in more than a threshold amount to, among other things, prepare and implement a risk management plan to detect and prevent or minimize accidental releases of regulated substances from the stationary source, and to provide a prompt emergency response to any such releases in order to protect human health and the environment. EPA has promulgated regulations to implement Section 112(r)(7), codified at 40 CFR part 68 (‘‘Part 68 Regulations’’). The Complaint alleges that Kayem violated the Part 68 Regulations in connection with the operation of its ammonia refrigeration system at its Chelsea facility and seeks the payment of civil penalties. The proposed Agreement resolves Kayem’s civil liability to the United States for the alleged violations in the Complaint. Pursuant to the proposed Agreement, Kayem will pay a penalty of $138,281. Injunctive relief is not required. The publication of this notice opens a period for public comment on the Agreement. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to [FR Doc. 2019–10668 Filed 5–21–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Foreign Claims Settlement Commission [F.C.S.C. Meeting and Hearing Notice No. 04–19] jbell on DSK3GLQ082PROD with NOTICES Sunshine Act Meeting The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR part 503.25) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of open meetings as follows: TIME AND DATE: Thursday, May 30, 2019, at 10:00 a.m. PLACE: All meetings are held at the Foreign Claims Settlement Commission, 601 D Street NW, Suite 10300, Washington, DC. STATUS: Open. MATTERS TO BE CONSIDERED: 10:00 a.m.—Oral hearings on Objection to Commission’s Proposed Decisions in Claim Nos. IRQ–II–346 and IRQ–II–365. 11:30 a.m.—Issuance of Proposed Decisions under the Guam World War II Loyalty Recognition Act, Title XVII, Public Law 114–328. CONTACT PERSON FOR MORE INFORMATION: Requests for information, or advance notices of intention to observe an open meeting, may be directed to: Patricia M. Hall, Foreign Claims Settlement Commission, 601 D Street NW, Suite 10300, Washington, DC 20579. Telephone: (202) 616–6975. Brian Simkin, Chief Counsel. [FR Doc. 2019–10735 Filed 5–20–19; 11:15 am] BILLING CODE 4410–BA–P VerDate Sep<11>2014 17:29 May 21, 2019 Jkt 247001 Notice of Lodging of Proposed Settlement Agreement Under the Clean Air Act PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 9307 9333 9634 9652 9668 9737 9740 Schedule I II II II II II II United States v. Kayem Foods, Inc.. No. 1:19–cv–11126 (D. Mass.) D.J. Ref. No. 90–5–2–1–11490. 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 email ....... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. By mail ......... During the public comment period, the 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 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 $2.75 (25 cents per page reproduction cost) payable to the United States Treasury. Robert Maher, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2019–10673 Filed 5–21–19; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF LABOR Employment and Training Administration Agency Information Collection Activities; Comment Request; State Training Provider Eligibility Collection ACTION: Notice. The Department of Labor’s (DOL’s), Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, ‘‘State Training Provider SUMMARY: E:\FR\FM\22MYN1.SGM 22MYN1

Agencies

[Federal Register Volume 84, Number 99 (Wednesday, May 22, 2019)]
[Notices]
[Pages 23582-23583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10668]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: United States 
Pharmacopeial Convention

ACTION: Notice of application.

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

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 June 21, 2019. Such 
persons may also file a written request for a hearing on the 
application on or before June 21, 2019.

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 
request 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: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on March 
8, 2019, United States Pharmacopeial, 12601 Twinbrook Parkway, 
Rockville, Maryland 20852-1717 applied to be registered as an importer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
           Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Methamphetamine..........................            1105  II
Cathinone................................            1235  I
Phenmetrazine............................            1631  II
Methylphenidate..........................            1724  II
Amobarbital..............................            2125  II
Pentobarbital............................            2270  II
Secobarbital.............................            2315  II
Glutethimide.............................            2550  II
Methaqualone.............................            2565  I
Lysergic acid diethylamide...............            7315  I
4-Methyl-2,5-dimethoxyamphetamine........            7395  I
3,4-Methylenedioxyamphetamine............            7400  I
4-Methoxyamphetamine.....................            7411  I
Phencyclidine............................            7471  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)            8333  II
Phenylacetone............................            8501  II
Alphaprodine.............................            9010  II
Anileridine..............................            9020  II
Cocaine..................................            9041  II
Codeine-N-oxide..........................            9053  I
Dihydrocodeine...........................            9120  II
Difenoxin................................            9168  I
Diphenoxylate............................            9170  II
Heroin...................................            9200  I
Levomethorphan...........................            9210  II
Levorphanol..............................            9220  II
Meperidine...............................            9230  II
Dextropropoxyphene, bulk (non-dosage                 9273  II
 forms).

[[Page 23583]]

 
Morphine-N-oxide.........................            9307  I
Thebaine.................................            9333  II
Norlevorphanol...........................            9634  II
Oxymorphone..............................            9652  II
Noroxymorphone...........................            9668  II
Alfentanil...............................            9737  II
Sufentanil...............................            9740  II
------------------------------------------------------------------------

    The company plans to import the bulk control substances for 
distribution of analytical reference standards to its customers for 
analytical testing of raw materials.

    Dated: May 7, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-10668 Filed 5-21-19; 8:45 am]
 BILLING CODE 4410-09-P