2019-01513. Importer of Controlled Substances Application: Microgenics Corporation Thermo Fisher Scientific
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Start Preamble
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 March 11, 2019. Such persons may also file a written request for a hearing on the application on or before March 11, 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 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
End Preamble Start Supplemental InformationSUPPLEMENTARY 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 October 23, 2018, Microgenics Corporation/Thermo Fisher Scientific located at 46500 Kato Rd., Fremont, California 94538, applied to be registered as an importer of the below listed basic classes of controlled substance listed in schedules I and II.
Controlled substance Drug code Schedule Cathinone 1235 I Start Printed Page 2576 Mephedrone (4-Methyl-N-methylcathinone) 1248 I Gamma Hydroxybutyric Acid 2010 I Methaqualone 2565 I Mecloqualone 2572 I 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3-methylbutanoate 7021 I AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) 7023 I AB-CHMINACA (N-(1-amino-3-methyl-1->oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide 7031 I MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) 7032 I 5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) 7033 I ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) 7035 I APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide 7048 I AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) 7201 I Lysergic acid diethylamide 7315 I Marihuana 7360 I Tetrahydrocannabinols 7370 I 3,4-Methylenedioxyamphetamine 7400 I 3,4-Methylenedioxy-N-ethylamphetamine 7404 I 3,4-Methylenedioxymethamphetamine 7405 I 2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C-I) 7518 I MDPV (3,4-Methylenedioxypyrovalerone) 7535 I 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I-NBOMe) 7538 I Butylone 7541 I Pentylone 7542 I alpha-pyrrolidinopentiophenone (α-PVP) 7545 I Normorphine 9313 I AH-7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)) 9551 I Acetylmethadol 9601 I Alphamethadol 9605 I Ketobemidone 9628 I Noracymethadol 9633 I Para-Fluorofentanyl 9812 I 3-Methylfentanyl 9813 I Alpha-methylfentanyl 9814 I Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) 9821 I 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide 9825 I 3-Methylthiofentanyl 9833 I Cyclopropyl Fentanyl 9845 I Fentanyl related-compounds as defined in 21 CFR 1308.11&h) 9850 I Amphetamine 1100 II Methamphetamine 1105 II Methylphenidate 1724 II Amobarbital 2125 II Pentobarbital 2270 II Secobarbital 2315 II Phencyclidine 7471 II Cocaine 9041 II Codeine 9050 II Dihydrocodeine 9120 II Oxycodone 9143 II Hydromorphone 9150 II Ecgonine 9180 II Hydrocodone 9193 II Levorphanol 9220 II Meperidine 9230 II Meperidine intermediate-B 9233 II Methadone 9250 II Dextropropoxyphene, bulk (non-dosage forms) 9273 II Morphine 9300 II Thebaine 9333 II Levo-alphacetylmethadol 9648 II Oxymorphone 9652 II Carfentanil 9743 II Tapentadol 9780 II Fentanyl 9801 II The company plans to import the listed controlled substances for feasibility studies for new products and cross reactivity studies for existing products. The products will serve as raw materials for InVitro Diagnostic quantitative assay.
Start SignatureDated: December 21, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-01513 Filed 2-6-19; 8:45 am]
BILLING CODE 4410-09-P
Document Information
- Published:
- 02/07/2019
- Department:
- Drug Enforcement Administration
- Entry Type:
- Notice
- Action:
- Notice of application.
- Document Number:
- 2019-01513
- 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 March 11, 2019. Such persons may also file a written request for a hearing on the application on or before March 11, 2019.
- Pages:
- 2575-2576 (2 pages)
- Docket Numbers:
- Docket No. DEA-392
- PDF File:
- 2019-01513.Pdf