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.
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 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 |
| 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.
Dated: December 21, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-01513 Filed 2-6-19; 8:45 am]
BILLING CODE 4410-09-P