83 FR 34874 - Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 141 (July 23, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 141 (July 23, 2018)
| Page Range | 34874-34875 | |
| FR Document | 2018-15719 |
[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)] [Notices] [Pages 34874-34875] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15719] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC 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 August 22, 2018. Such persons may also file a written request for a hearing on the application on or before August 22, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement [[Page 34875]] Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ DRW, 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 delegated 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 June 18, 2018, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114, applied to be registered as an importer of the following basic class of controlled substance: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid.............. 2010 I ------------------------------------------------------------------------ The company plans to import finished dosage unit products containing gamma-hydroxybutyric acid for clinical trials, research, and analytical activities. Dated: July 12, 2018 John J. Martin, Assistant Administrator. [FR Doc. 2018-15719 Filed 7-20-18; 8:45 am] BILLING CODE 4410-09-P
![34874 Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices
filed. The Secretary will not accept a persons are advised that information on distribution of infringing products by
document for filing without a certificate this matter can be obtained by Diebold. Id.
of service. contacting the Commission’s TDD On December 22, 2017, the
The Commission has determined that terminal, telephone 202–205–1810. Commission instituted the subject
these reviews are extraordinarily enforcement proceeding based on a
complicated and therefore has SUPPLEMENTARY INFORMATION: On March complaint filed by Nautilus, alleging
determined to exercise its authority to 14, 2016, the Commission instituted the that Diebold violated the July 14, 2017,
extend the review period by up to 90 original investigation based on a remedial orders issued in the original
days pursuant to 19 U.S.C.1675(c)(5)(B). complaint filed by Nautilus Hyosung investigation and to determine what, if
Inc. (now Hyosung TNS Inc.) of Seoul, any, enforcement measures are
Authority: These reviews are being Republic of Korea, and Nautilus
conducted under authority of title VII of the appropriate. 82 FR 60762 (Dec. 22,
Hyosung America Inc. of Irving, Texas 2017). Diebold is named as a
Tariff Act of 1930; this notice is published
pursuant to section 207.62 of the (collectively, ‘‘Nautilus’’). 81 FR 13149 respondent, and OUII is named as a
Commission’s rules. (Mar. 14, 2016). Pertinent to this action, party. Id.
the complaint alleged violations of On June 22, 2018, the presiding
Issued: July 18, 2018.
section 337 of the Tariff Act of 1930, as administrative law judge issued Order
By order of the Commission. amended, 19 U.S.C. 1337, in the No. 46, the subject ID, which granted an
Lisa Barton, importation into the United States, the unopposed motion filed by Nautilus to
Secretary to the Commission. sale for importation into the United amend the complaint and the
[FR Doc. 2018–15708 Filed 7–20–18; 8:45 am] States, and the sale within the United Commission’s Notice of Enforcement
BILLING CODE 7020–02–P States after importation of certain Proceeding to reflect the corporate name
automated teller machines, ATM change of Nautilus Hyosung Inc. to
modules, components thereof, and Hyosung TNS Inc. No petitions for
INTERNATIONAL TRADE products containing the same by reason review of the subject ID were filed. The
COMMISSION of infringement of any of claims 1–3, 6, Commission has determined not to
[Investigation No. 337–TA–989 8, and 9 of U.S. Patent No. 8,523,235 review the subject ID.
(Enforcement)] (‘‘the ’235 patent’’). Id. The complaint The authority for the Commission’s
also alleged infringement of claims 1–3 determination is contained in section
Certain Automated Teller Machines, and 5 of U.S. Patent No. 7,891,551; 337 of the Tariff Act of 1930, as
ATM Modules, Components Thereof, claims 1 and 6 of U.S. Patent No. amended (19 U.S.C. 1337), and in part
and Products Containing the Same 7,950,655; and claims 1–4, 6, and 7 of 210 of the Commission’s Rules of
Commission Determination Not To U.S. Patent No. 8,152,165. Those claims Practice and Procedure (19 CFR part
Review an Initial Determination were subsequently terminated from the 210).
Amending the Complaint and Notice of investigation. See Order No. 11 (June 30, By order of the Commission.
Enforcement Proceeding To Reflect a 2016), Comm’n Notice of Non-Review Issued: July 17, 2018.
Corporate Name Change (July 27, 2016); Order No. 17 (July 21, Lisa Barton,
AGENCY: U.S. International Trade 2016), Comm’n Notice of Non-Review Secretary to the Commission.
Commission. (August 16, 2016). The notice of
[FR Doc. 2018–15615 Filed 7–20–18; 8:45 am]
institution of the investigation named
ACTION: Notice. BILLING CODE 7020–02–P
Diebold Nixdorf, Incorporated and
SUMMARY: Notice is hereby given that Diebold Self-Service Systems, both of
the U.S. International Trade North Canton, Ohio (collectively,
‘‘Diebold’’), as respondents. 81 FR DEPARTMENT OF JUSTICE
Commission (‘‘the Commission’’) has
determined not to review an initial 13149; 82 FR 13501 (Mar. 13, 2017). The Drug Enforcement Administration
determination (‘‘ID’’) (Order No. 46) Office of Unfair Import Investigations
amending the complaint and Notice of (‘‘OUII’’) was not named as a party. 81 [Docket No. DEA–392]
Enforcement Proceeding to reflect a FR 13149.
Importer of Controlled Substances
corporate name change. On July 14, 2017, the Commission Application: Catalent Pharma
FOR FURTHER INFORMATION CONTACT: Ron found a section 337 violation as to the Solutions, LLC
Traud, Office of the General Counsel, ’235 patent and issued a limited
U.S. International Trade Commission, exclusion order (‘‘LEO’’) as well as cease ACTION: Notice of application.
500 E Street SW, Washington, DC and desist orders (‘‘CDOs’’). 82 FR
20436, telephone 202–205–3427. Copies 33513 (July 20, 2017). The LEO DATES: Registered bulk manufacturers of
of non-confidential documents filed in prohibits the unlicensed entry of the affected basic classes, and
connection with this investigation are or automated teller machines, ATM applicants therefore, may file written
will be available for inspection during modules, components thereof, and comments on or objections to the
official business hours (8:45 a.m. to 5:15 products containing the same that issuance of the proposed registration on
p.m.) in the Office of the Secretary, U.S. infringe one or more of claims 1–3, 6, or before August 22, 2018. Such persons
International Trade Commission, 500 E 8, and 9 of the ’235 patent that are may also file a written request for a
Street SW, Washington, DC 20436, manufactured by, or on behalf of, or are hearing on the application on or before
telephone 202–205–2000. General imported by or on behalf of Diebold August 22, 2018.
amozie on DSK3GDR082PROD with NOTICES1
information concerning the Commission Nixdorf, Incorporated, Diebold Self- ADDRESSES: Written comments should
may also be obtained by accessing its Service Systems, or any of their be sent to: Drug Enforcement
internet server at https://www.usitc.gov. affiliated companies, parents, Administration, Attention: DEA Federal
The public record for this investigation subsidiaries, agents, or other related Register Representative/DRW, 8701
may be viewed on the Commission’s business entities, or their successors or Morrissette Drive, Springfield, Virginia
electronic docket (‘‘EDIS’’) at https:// assigns. Id. The CDOs prohibit, among 22152. All requests for hearing must be
edis.usitc.gov. Hearing-impaired other things, the importation, sale, and sent to: Drug Enforcement
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![Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices 34875
Administration, Attn: Administrator, Drug 22152. All requests for hearing must be
Controlled substance Schedule
8701 Morrissette Drive, Springfield, code sent to: Drug Enforcement
Virginia 22152. All request for hearing Administration, Attn: Administrator,
Gamma Hydroxybutyric 2010 I 8701 Morrissette Drive, Springfield,
should also be sent to: (1) Drug
Acid. Virginia 22152. All request for hearing
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette should also be sent to: (1) Drug
The company plans to import finished
Drive, Springfield, Virginia 22152; and Enforcement Administration, Attn:
dosage unit products containing gamma-
(2) Drug Enforcement Administration, Hearing Clerk/LJ, 8701 Morrissette
hydroxybutyric acid for clinical trials,
Attn: DEA Federal Register Drive, Springfield, Virginia 22152; and
research, and analytical activities.
Representative/DRW, 8701 Morrissette (2) Drug Enforcement Administration,
Dated: July 12, 2018 Attn: DEA Federal Register
Drive, Springfield, Virginia 22152. John J. Martin, Representative/DRW, 8701 Morrissette
SUPPLEMENTARY INFORMATION: The Assistant Administrator. Drive, Springfield, Virginia 22152.
Attorney General has delegated his [FR Doc. 2018–15719 Filed 7–20–18; 8:45 am]
SUPPLEMENTARY INFORMATION: The
authority under the Controlled BILLING CODE 4410–09–P Attorney General has delegated his
Substances Act to the Administrator of authority under the Controlled
the Drug Enforcement Administration Substances Act to the Administrator of
(DEA), 28 CFR 0.100(b). Authority to DEPARTMENT OF JUSTICE
the Drug Enforcement Administration
exercise all necessary functions with (DEA), 28 CFR 0.100(b). Authority to
Drug Enforcement Administration
respect to the promulgation and exercise all necessary functions with
implementation of 21 CFR part 1301, [Docket No. DEA–392] respect to the promulgation and
incident to the registration of implementation of 21 CFR part 1301,
manufacturers, distributors, dispensers, Importer of Controlled Substances
incident to the registration of
Application: VHG Labs DBA LGC
importers, and exporters of controlled manufacturers, distributors, dispensers,
Standards
substances (other than final orders in importers, and exporters of controlled
connection with suspension, denial, or ACTION: Notice of application. substances (other than final orders in
revocation of registration) has been connection with suspension, denial, or
delegated to the Assistant Administrator DATES: Registered bulk manufacturers of revocation of registration) has been
of the DEA Diversion Control Division the affected basic classes, and redelegated to the Assistant
(‘‘Assistant Administrator’’) pursuant to applicants therefore, may file written Administrator of the DEA Diversion
section 7 of 28 CFR part 0, appendix to comments on or objections to the Control Division (‘‘Assistant
subpart R. issuance of the proposed registration on Administrator’’) pursuant to section 7 of
or before August 22, 2018. Such persons 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR may also file a written request for a In accordance with 21 CFR
1301.34(a), this is notice that on June hearing on the application on or before 1301.34(a), this is notice that on April
18, 2018, Catalent Pharma Solutions, August 22, 2018. 13, 2018, VHG Labs DBA LGC
LLC, 3031 Red Lion Road, Philadelphia, ADDRESSES: Written comments should Standards, 3 Perimeter Road,
Pennsylvania 19114, applied to be be sent to: Drug Enforcement Manchaster NH 03103 applied to be
registered as an importer of the Administration, Attention: DEA Federal registered as an importer of the
following basic class of controlled Register Representative/DRW, 8701 following basic classes of controlled
substance: Morrissette Drive, Springfield, Virginia substances:
Controlled substance Drug code Schedule
3-Fluoro-N-methylcathinone (3-FMC) ...................................................................................................................... 1233 I
Cathinone ................................................................................................................................................................ 1235 I
Methcathinone ......................................................................................................................................................... 1237 I
4-Fluoro-N-methylcathinone (4-FMC) ...................................................................................................................... 1238 I
Pentedrone (a-methylaminovalerophenone) ........................................................................................................... 1246 I
Mephedrone (4-Methyl-N-methylcathinone) ............................................................................................................ 1248 I
4-Methyl-N-ethylcathinone (4-MEC) ........................................................................................................................ 1249 I
Naphyrone ............................................................................................................................................................... 1258 I
N-Ethylamphetamine ............................................................................................................................................... 1475 I
4-Methylaminorex (cis isomer) ................................................................................................................................ 1590 I
Methaqualone .......................................................................................................................................................... 2565 I
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ........................................................................................... 6250 I
SR-18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) ........................................ 7008 I
APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide ...................................................... 7048 I
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) ........................................................................................... 7081 I
SR-19 (Also known as RCS–4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole ............................................................. 7104 I
JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ...................................................................... 7118 I
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) .............................................................................................. 7122 I
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .......................................................... 7144 I
amozie on DSK3GDR082PROD with NOTICES1
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) ............................................................................................... 7201 I
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) .............................................................................................. 7203 I
Ibogaine ................................................................................................................................................................... 7260 I
Lysergic acid diethylamide ...................................................................................................................................... 7315 I
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) ........................................................................................ 7348 I
Marihuana ................................................................................................................................................................ 7360 I
Mescaline ................................................................................................................................................................ 7381 I
2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C-T-2 ) .................................................................................... 7385 I
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Document Created: 2018-07-21 00:48:48
Document Modified: 2018-07-21 00:48:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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 August 22, 2018. Such persons may also file a written request for a hearing on the application on or before August 22, 2018. | |
| FR Citation | 83 FR 34874 |
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