Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc., 23069-23070 [2017-10234]

Download as PDF 23069 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices Controlled substance Drug code JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) ....................................................................................................................... JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) .............................................................................. JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) ...................................................................................................... UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .................................................................. JWH-073 (1-Butyl-3-(1-naphthoyl)indole) ........................................................................................................................ Lysergic acid diethylamide .............................................................................................................................................. 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C–T–7) .............................................................................................. 3,4-Methylenedioxyamphetamine .................................................................................................................................... 3,4-Methylenedioxy-N-ethylamphetamine ....................................................................................................................... 3,4-Methylenedioxymethamphetamine ............................................................................................................................ MDPV (3,4-Methylenedioxypyrovalerone) ....................................................................................................................... Methylone (3,4-Methylenedioxy-N-methylcathinone) ...................................................................................................... Desomorphine ................................................................................................................................................................. Norlevorphanol ................................................................................................................................................................ Phencyclidine ................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. Noroxymorphone ............................................................................................................................................................. Sufentanil ......................................................................................................................................................................... Tapentadol ....................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... The company plans to manufacture small quantities of the listed controlled substances in bulk for distribution to its customers. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10231 Filed 5–18–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 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 SUPPLEMENTARY INFORMATION: [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials, Inc. 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 in accordance with 21 CFR 1301.33(a) on or before July 18, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: Notice of application. 7019 7118 7122 7144 7173 7315 7348 7400 7404 7405 7535 7540 9055 9634 7471 9273 9668 9740 9780 9801 Drug code Amphetamine ................................................................................................................................................................... Methylphenidate .............................................................................................................................................................. Nabilone ........................................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Alfentanil .......................................................................................................................................................................... Remifentanil ..................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... asabaliauskas on DSK3SPTVN1PROD with NOTICES I I I I I I I I I I I I I I II II II II II II 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 1301.33(a), this is notice that on September 26, 2016, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Service, 25 Patton Road, Devens, Massachusetts 01434 applied to be registered as a bulk manufacturer of the following basic classes controlled substances: Controlled substance The company plans to utilize this facility to manufacture small quantities of the listed controlled substances in bulk for distribution to its customers as well as to conduct analytical testing in support of the company’s primary manufacturing facility in West Deptford, New Jersey. Schedule 1100 1724 7379 9193 9737 9739 9740 Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. II II II II II II II DEPARTMENT OF JUSTICE [FR Doc. 2017–10233 Filed 5–18–17; 8:45 am] Schedule [Docket No. DEA–392] Drug Enforcement Administration BILLING CODE 4410–09–P Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic class, and applicants DATES: VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 23070 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before June 19, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before June 19, 2017. 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 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. ADDRESSES: 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 of subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on November 10, 2016, Galephar Pharmaceutical Research, Inc., #100 Carr 198, Industrial Park, Juncos, Puerto Rico 00777–3873 applied to be registered as an importer of hydromorphone (9150), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance in finished dosage form for clinical trials, research and analytical purposes. The import of this class of controlled substance will be granted only for analytical testing, research, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale. asabaliauskas on DSK3SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10234 Filed 5–18–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Whatever LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before June 19, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before June 19, 2017. 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 Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests 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. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). 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 DATES: PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 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 October 16, 2015, Whatever LLC, 4370 N. Randall Street, Flagstaff, Arizona 86004 applied to be registered as an importer of opium poppy (9650), a basic class of controlled substance listed in schedule II. The company plans to import opium poppy (9650), for dried floral decorative arrangements. Approval of permit application will occur only when the registrant’s business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10243 Filed 5–18–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals 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 in accordance with 21 CFR 1301.33(a) on or before July 18, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: 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 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. DATES: E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23069-23070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10234]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research, Inc.

ACTION: Notice of application.

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

DATES: Registered bulk manufacturers of the affected basic class, and 
applicants

[[Page 23070]]

therefore, may file written comments on or objections to the issuance 
of the proposed registration in accordance with 21 CFR 1301.34(a) on or 
before June 19, 2017. Such persons may also file a written request for 
a hearing on the application pursuant to 21 CFR 1301.43 on or before 
June 19, 2017.

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 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 redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix of subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
November 10, 2016, Galephar Pharmaceutical Research, Inc., #100 Carr 
198, Industrial Park, Juncos, Puerto Rico 00777-3873 applied to be 
registered as an importer of hydromorphone (9150), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, research and analytical 
purposes.
    The import of this class of controlled substance will be granted 
only for analytical testing, research, and clinical trials. This 
authorization does not extend to the import of a finished FDA approved 
or non-approved dosage form for commercial sale.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10234 Filed 5-18-17; 8:45 am]
BILLING CODE 4410-09-P
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