80 FR 22552 - Importer of Controlled Substances Application: Sigma-Aldrich International GMBH, Sigma Aldrich Co., LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 77 (April 22, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 77 (April 22, 2015)
| Page Range | 22552-22553 | |
| FR Document | 2015-09344 |
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)] [Notices] [Pages 22552-22553] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09344] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Sigma-Aldrich International GMBH, Sigma Aldrich Co., 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 in accordance with 21 CFR 1301.34(a) on or before May 22, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 22, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings 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, importer, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy 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 February 5, 2015, Sigma-Aldrich International GMBH, Sigma Aldrich Co. LLC, 3500 Dekalb Street, St. Louis, Missouri 63118 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Cathinone (1235)........................... I Methcathinone (1237)....................... I Mephedrone (4-Methyl-N-methylcathinone) I (1248). N-Ethylamphetamine (1475).................. I Aminorex (1585)............................ I Gamma Hydroxybutyric Acid (2010)........... I Methaqualone (2565)........................ I Alpha-ethyltryptamine (7249)............... I Ibogaine (7260)............................ I Lysergic acid diethylamide (7315).......... I Marihuana (7360)........................... I Tetrahydrocannabinols (7370)............... I Mescaline (7381)........................... I 4-Bromo-2,5-dimethoxyamphetamine (7391).... I 4-Bromo-2,5-dimethoxyphenethylamine (7392). I 4-Methyl-2,5-dimethoxyamphetamine (7395)... I 2,5-Dimethoxyamphetamine (7396)............ I 3,4-Methylenedioxyamphetamine (7400)....... I N-Hydroxy-3,4-methylenedioxyamphetamine I (7402). 3,4-Methylenedioxy-N-ethylamphetamine I (7404). 3,4-Methylenedioxymethamphetamine (7405)... I 4-Methoxyamphetamine (7411)................ I Bufotenine (7433).......................... I Diethyltryptamine (7434)................... I Dimethyltryptamine (7435).................. I Psilocybin (7437).......................... I Psilocyn (7438)............................ I 1-[1-(2-Thienyl)cyclohexyl]piperidine I (7470). N-Benzylpiperazine (7493).................. I MDPV (3,4-Methylenedioxypyrovalerone) I (7535). Heroin (9200).............................. I Normorphine (9313)......................... I Etonitazene (9624)......................... I Amphetamine (1100)......................... II Methamphetamine (1105)..................... II Methylphenidate (1724)..................... II Amobarbital (2125)......................... II Pentobarbital (2270)....................... II Secobarbital (2315)........................ II Glutethimide (2550)........................ II [[Page 22553]] Nabilone (7379)............................ II Phencyclidine (7471)....................... II Cocaine (9041)............................. II Codeine (9050)............................. II Oxycodone (9143)........................... II Hydromorphone (9150)....................... II Diphenoxylate (9170)....................... II Ecgonine (9180)............................ II Ethylmorphine (9190)....................... II Hydrocodone (9193)......................... II Levorphanol (9220)......................... II Meperidine (9230).......................... II Methadone (9250)........................... II Morphine (9300)............................ II Thebaine (9333)............................ II Opium, powdered (9639)..................... II Levo-alphacetylmethadol (9648)............. II Oxymorphone (9652)......................... II Fentanyl (9801)............................ II ------------------------------------------------------------------------ The company plans to import the listed controlled substances for sale to research facilities for drug testing and analysis. In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No other activity for this drug code is authorized for this registration. Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-09344 Filed 4-21-15; 8:45 am] BILLING CODE 4410-09-P
![22552 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
Register pursuant to Section 6(b) of the The company plans to import the connection with suspension, denial, or
Act on February 6, 2015 (80 FR 6768). listed substance as a raw material for revocation of registration) has been
updated testing purposes for EU redelegated to the Deputy Assistant
Patricia A. Brink,
customer requirements. Administrator of the DEA Office of
Director of Civil Enforcement, Antitrust
The company plans to import the Diversion Control (‘‘Deputy Assistant
Division.
listed controlled substance in finished Administrator’’) pursuant to section 7 of
[FR Doc. 2015–09317 Filed 4–21–15; 8:45 am]
dosage form (FDF) from foreign sources 28 CFR part 0, appendix to subpart R.
BILLING CODE P In accordance with 21 CFR
for analytical testing and clinical trials
in which the foreign FDF will be 1301.34(a), this is notice that on
compared to the company’s own February 5, 2015, Sigma-Aldrich
DEPARTMENT OF JUSTICE
domestically-manufactured FDF. This International GMBH, Sigma Aldrich Co.
Drug Enforcement Administration analysis is required to allow the LLC, 3500 Dekalb Street, St. Louis,
company to export domestically- Missouri 63118 applied to be registered
[Docket No. DEA–392] manufactured FDF to foreign markets. as an importer of the following basic
Dated: April 14, 2015. classes of controlled substances:
Importer of Controlled Substances
Application: Unither Manufacturing, Joseph T. Rannazzisi, Controlled substance Schedule
LLC Deputy Assistant Administrator.
[FR Doc. 2015–09337 Filed 4–21–15; 8:45 am] Cathinone (1235) .......................... I
ACTION: Notice of application. Methcathinone (1237) .................. I
BILLING CODE 4410–09–P
Mephedrone (4-Methyl-N- I
DATES: Registered bulk manufacturers of methylcathinone) (1248).
the affected basic class, and applicants N-Ethylamphetamine (1475) ........ I
DEPARTMENT OF JUSTICE Aminorex (1585) ........................... I
therefore, may file written comments on
or objections to the issuance of the Gamma Hydroxybutyric Acid I
Drug Enforcement Administration (2010).
proposed registration in accordance
[Docket No. DEA–392] Methaqualone (2565) ................... I
with 21 CFR 1301.34(a) on or before Alpha-ethyltryptamine (7249) ....... I
May 22, 2015. Such persons may also Ibogaine (7260) ............................ I
file a written request for a hearing on Importer of Controlled Substances
Lysergic acid diethylamide (7315) I
the application pursuant to 21 CFR Application: Sigma-Aldrich Marihuana (7360) ......................... I
1301.43 on or before May 22, 2015. International GMBH, Sigma Aldrich Tetrahydrocannabinols (7370) ..... I
Co., LLC Mescaline (7381) .......................... I
ADDRESSES: Written comments should
4-Bromo-2,5- I
be sent to: Drug Enforcement ACTION: Notice of application. dimethoxyamphetamine (7391).
Administration, Attention: DEA Federal 4-Bromo-2,5- I
Register Representative/ODXL, 8701 DATES: Registered bulk manufacturers of dimethoxyphenethylamine
Morrissette Drive, Springfield, Virginia the affected basic classes, and (7392).
22152. Request for hearings should be applicants therefore, may file written 4-Methyl-2,5- I
sent to: Drug Enforcement comments on or objections to the dimethoxyamphetamine (7395).
Administration, Attention: Hearing 2,5-Dimethoxyamphetamine I
issuance of the proposed registration in
Clerk/LJ, 8701 Morrissette Drive, (7396).
accordance with 21 CFR 1301.34(a) on 3,4-Methylenedioxyamphetamine I
Springfield, Virginia 22152. or before May 22, 2015. Such persons (7400).
SUPPLEMENTARY INFORMATION: The may also file a written request for a N-Hydroxy-3,4- I
Attorney General has delegated his hearing on the application pursuant to methylenedioxyamphetamine
authority under the Controlled 21 CFR 1301.43 on or before May 22, (7402).
Substances Act to the Administrator of 2015. 3,4-Methylenedioxy-N- I
the Drug Enforcement Administration ethylamphetamine (7404).
ADDRESSES: Written comments should 3,4- I
(DEA), 28 CFR 0.100(b). Authority to
be sent to: Drug Enforcement Methylenedioxymethamphetam-
exercise all necessary functions with
Administration, Attention: DEA Federal ine (7405).
respect to the promulgation and 4-Methoxyamphetamine (7411) ... I
Register Representative/ODXL, 8701
implementation of 21 CFR part 1301, Bufotenine (7433) ......................... I
Morrissette Drive, Springfield, Virginia
incident to the registration of Diethyltryptamine (7434) .............. I
22152. Comments and requests for
manufacturers, distributors, dispensers, Dimethyltryptamine (7435) ........... I
hearings on applications to import
importers, and exporters of controlled Psilocybin (7437) .......................... I
narcotic raw material are not Psilocyn (7438) ............................. I
substances (other than final orders in
appropriate. 72 FR 3417 (January 25, 1-[1-(2- I
connection with suspension, denial, or
2007). Thienyl)cyclohexyl]piperidine
revocation of registration) has been
(7470).
redelegated to the Deputy Assistant SUPPLEMENTARY INFORMATION: The N-Benzylpiperazine (7493) ........... I
Administrator of the DEA Office of Attorney General has delegated his MDPV (3,4- I
Diversion Control (‘‘Deputy Assistant authority under the Controlled Methylenedioxypyrovalerone)
Administrator’’) pursuant to section 7 of Substances Act to the Administrator of (7535).
28 CFR part 0, appendix to subpart R. the Drug Enforcement Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Heroin (9200) ............................... I
In accordance with 21 CFR (DEA), 28 CFR 0.100(b). Authority to Normorphine (9313) ..................... I
1301.34(a), this is notice that on July 10, exercise all necessary functions with Etonitazene (9624) ....................... I
2014, Unither Manufacturing LLC, 331 respect to the promulgation and Amphetamine (1100) .................... II
Methamphetamine (1105) ............ II
Clay Road, Rochester, New York 14623 implementation of 21 CFR part 1301, Methylphenidate (1724) ................ II
applied to be registered as an importer incident to the registration of Amobarbital (2125) ....................... II
of methylphenidate (1724), a basic class manufacturers, distributors, dispensers, Pentobarbital (2270) ..................... II
of controlled substance listed in importer, and exporters of controlled Secobarbital (2315) ...................... II
schedule II. substances (other than final orders in Glutethimide (2550) ...................... II
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![Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22553
Controlled substance Schedule applications to import narcotic raw manufacturer of certain basic classes of
material are not appropriate. 72 FR 3417 controlled substances. No comments or
Nabilone (7379) ............................ II (January 25, 2007). objections were submitted to this notice.
Phencyclidine (7471) .................... II SUPPLEMENTARY INFORMATION: The The Drug Enforcement
Cocaine (9041) ............................. II Administration (DEA) has considered
Attorney General has delegated his
Codeine (9050) ............................. II the factors in 21 U.S.C. 823(a) and
Oxycodone (9143) ........................ II authority under the Controlled
Hydromorphone (9150) ................ II Substances Act to the Administrator of determined that the registration of
Diphenoxylate (9170) ................... II the Drug Enforcement Administration Cedarburg Pharmaceuticals, Inc. to
Ecgonine (9180) ........................... II (DEA), 28 CFR 0.100(b). Authority to manufacture the basic classes of
Ethylmorphine (9190) ................... II exercise all necessary functions with controlled substances is consistent with
Hydrocodone (9193) ..................... II respect to the promulgation and the public interest and with United
Levorphanol (9220) ...................... II implementation of 21 CFR part 1301, States obligations under international
Meperidine (9230) ........................ II incident to the registration of treaties, conventions, or protocols in
Methadone (9250) ........................ II effect on May 1, 1971. The DEA
manufacturers, distributors, dispenser,
Morphine (9300) ........................... II investigated the company’s maintenance
Thebaine (9333) ........................... II importers, and exporters of controlled
Opium, powdered (9639) ............. II substances (other than final orders in of effective controls against diversion by
Levo-alphacetylmethadol (9648) .. II connection with suspension, denial, or inspecting and testing the company’s
Oxymorphone (9652) ................... II revocation of registration) has been physical security systems, verifying the
Fentanyl (9801) ............................ II redelegated to the Deputy Assistant company’s compliance with state and
Administrator of the DEA Office of local laws, and reviewing the company’s
The company plans to import the Diversion Control (‘‘Deputy Assistant background and history.
listed controlled substances for sale to Administrator’’) pursuant to section 7 of Therefore, pursuant to 21 U.S.C.
research facilities for drug testing and 28 CFR part 0, appendix of subpart R. 823(a), and in accordance with 21 CFR
analysis. In accordance with 21 CFR 1301.33, the above-named company is
In reference to drug codes 7360 and 1301.34(a), this is notice that on August granted registration as a bulk
7370, the company plans to import a 29, 2014, Pharmacore, 4180 Mendenhall manufacturer of the basic classes of
synthetic cannabidiol and a synthetic Oaks Parkway, High Point, North controlled substances listed:
tetrahydrocannabinol. No other activity Carolina 27265 applied to be registered
for this drug code is authorized for this as an importer of poppy straw Controlled substance Schedule
registration. concentrate (9670), a basic class of
4-Anilino-N-phenethyl-4-piperidine
Dated: April 14, 2015. controlled substance listed in schedule (ANPP) (8333) .......................... II
Joseph T. Rannazzisi, II. Remifentanil (9739) ...................... II
Deputy Assistant Administrator. The company plans to import the Fentanyl (9801) ............................ II
listed controlled substance to
[FR Doc. 2015–09344 Filed 4–21–15; 8:45 am]
manufacture bulk controlled substance The company plans to manufacture
BILLING CODE 4410–09–P
intermediates for sale to its customers. the listed controlled substances in bulk
Dated: April 14, 2015. for distribution to its customers.
DEPARTMENT OF JUSTICE Joseph T. Rannazzisi, Regarding the drug code (8333), the
Deputy Assistant Administrator. company plans to manufacture this
Drug Enforcement Administration [FR Doc. 2015–09332 Filed 4–21–15; 8:45 am]
listed controlled substance for
[Docket No. DEA–392] commercial sale.
BILLING CODE 4410–09–P
Dated: April 14, 2015.
Importer of Controlled Substances Joseph T. Rannazzisi,
Application: PHARMACORE DEPARTMENT OF JUSTICE Deputy Assistant Administrator.
ACTION: Notice of application. [FR Doc. 2015–09350 Filed 4–21–15; 8:45 am]
Drug Enforcement Administration
BILLING CODE P
DATES: Registered bulk manufacturers of [Docket No. DEA–392]
the affected basic class, and applicants
therefore, may file written comments on Manufacturer of Controlled DEPARTMENT OF JUSTICE
or objections to the issuance of the Substances Registration: Cedarburg
proposed registration in accordance Pharmaceuticals, Inc. Drug Enforcement Administration
with 21 CFR 1301.34(a) on or before ACTION: Notice of registration. [Docket No. DEA–392]
May 22, 2015. Such persons may also
file a written request for a hearing on SUMMARY: Cedarburg Pharmaceuticals, Importer of Controlled Substances
the application pursuant to 21 CFR Inc. applied to be registered as a Application: Meridian Medical
1301.43 on or before May 22, 2015. manufacturer of certain basic classes of Technologies
ADDRESSES: Written comments should controlled substances. The DEA grants
be sent to: Drug Enforcement Cedarburg Pharmaceuticals, Inc. ACTION: Notice of application.
Administration, Attention: DEA Federal registration as a manufacturer of the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Register Representative/ODXL, 8701 controlled substances. DATES: Registered bulk manufacturers of
Morrissette Drive, Springfield, Virginia SUPPLEMENTARY INFORMATION: By notice the affected basic class, and applicants
22152. Request for hearings should be dated June 10, 2014, and published in therefore, may file written comments on
sent to: Drug Enforcement the Federal Register on June 17, 2014, or objections to the issuance of the
Administration, Attention: Hearing 79 FR 34553, Cedarburg proposed registration in accordance
Clerk/LJ, 8701 Morrissette Drive, Pharmaceuticals, Inc., 870 Badger with 21 CFR 1301.34(a) on or before
Springfield, Virginia 22152. Comments Circle, Grafton, Wisconsin 53024 May 22, 2015. Such persons may also
and requests for any hearings on applied to be registered as a file a written request for a hearing on
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Document Created: 2015-12-16 08:28:15
Document Modified: 2015-12-16 08:28:15
| 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 in accordance with 21 CFR 1301.34(a) on or before May 22, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 22, 2015. | |
| FR Citation | 80 FR 22552 |
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