Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices 21889

Controlled substance Drug code Schedule

Desomorphine ...... 9055 I Dihydromorphine ...... 9145 I Heroin ...... 9200 I Morphine-N-oxide ...... 9307 I Normorphine ...... 9313 I Tilidine ...... 9750 I Alpha-methylfentanyl ...... 9814 I Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ...... 9821 I Methamphetamine ...... 1105 II Phenmetrazine ...... 1631 II Methylphenidate ...... 1724 II Amobarbital ...... 2125 II Pentobarbital ...... 2270 II Secobarbital ...... 2315 II Glutethimide ...... 2550 II Phencyclidine ...... 7471 II Phenylacetone ...... 8501 II Codeine ...... 9050 II Dihydrocodeine ...... 9120 II Diphenoxylate ...... 9170 II Ecgonine ...... 9180 II Ethylmorphine ...... 9190 II Hydrocodone ...... 9193 II Levorphanol ...... 9220 II Meperidine ...... 9230 II Meperidine intermediate-B ...... 9233 II Meperidine intermediate-C ...... 9234 II Dextropropoxyphene, bulk (non-dosage forms) ...... 9273 II 14-Hydroxmorphone ...... 9665 II Noroxymorphone ...... 9668 II Sufentanil ...... 9740 II Fentanyl ...... 9801 II

The company plans to import the pending applications according to of the requested registration, as listed controlled substances for sale to proposed regulations that, if finalized, provided in this notice. This notice does research facilities for drug testing and would govern the program of growing not constitute any evaluation or analysis. In reference to drug codes 7360 marihuana for scientific and medical determination of the merits of the (Marihuana) and 7370 research under DEA registration. application submitted. (Tetrahydrocannabinols) the company DATES: Registered bulk manufacturers of The applicant plans to manufacture plans to import a synthetic cannabidiol the affected basic class(es), and bulk active pharmaceutical ingredients and a synthetic tetrahydrocannabinols. applicants therefor, may file written (APIs) for product development and No other activities for these drug codes comments on or objections to the distribution to DEA-registered are authorized for this registration. issuance of the proposed registration on researchers. If the application for or before June 19, 2020. registration is granted, the registrant William T. McDermott, ADDRESSES: Written comments should would not be authorized to conduct Assistant Administrator. be sent to: Drug Enforcement other activity under this registration [FR Doc. 2020–08328 Filed 4–17–20; 8:45 am] Administration, Attention: DEA Federal aside from those coincident activities BILLING CODE 4410–09–P Register Representative/DPW 8701 specifically authorized by DEA Morrissette Drive, Springfield, Virginia regulations. DEA will evaluate the 22152. To ensure proper handling of application for registration as a bulk DEPARTMENT OF JUSTICE comments, please reference Docket No. manufacturer for compliance with all Drug Enforcement Administration DEA–621 in all correspondence, applicable laws, treaties, and including attachments. regulations and to ensure adequate [Docket No. DEA–621] SUPPLEMENTARY INFORMATION: The safeguards against diversion are in place. Bulk Manufacturer of Controlled Controlled Substances Act (CSA) prohibits the cultivation and As this applicant has applied to Substances Application: Bulk distribution of marihuana except by become registered as a bulk Manufacturer of Marihuana: Groff NA persons who are registered under the manufacturer of marihuana, the Hemplex LLC CSA to do so for lawful purposes. In application will be evaluated under the ACTION: Notice of application. accordance with the purposes specified criteria of 21 U.S.C. 823(a). DEA in 21 CFR 1301.33(a), DEA is providing proposes to conduct this evaluation in SUMMARY: The Drug Enforcement notice that the entity identified below the manner described in the rule Administration (DEA) is providing has applied for registration as a bulk proposed at 85 FR 16292, published on notice of an application it has received manufacturer of schedule I controlled March 23, 2020, if finalized. from an entity applying to be registered substances. In response, registered bulk In accordance with 21 CFR to manufacture in bulk basic class(es) of manufacturers of the affected basic 1301.33(a), DEA is providing notice that controlled substances listed in schedule class(es), and applicants therefor, may on February 28, 2020, Groff NA I. DEA intends to evaluate this and other file written comments on or objections Hemplex LLC, 100 Redco Avenue, Suite

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A, Red Lion, Pennsylvania 17356–1436, Attn: DEA Federal Register Controlled substance Drug Schedule applied to be registered as a bulk code Representative/DPW, 8701 Morrissette manufacturer of the following basic Drive, Springfield, Virginia 22152. class(es) of controlled substances: Marihuana ...... 7360 I Tetrahydrocannabinols .... 7370 I SUPPLEMENTARY INFORMATION: In Amphetamine ...... 1100 II Drug accordance with 21 CFR 1301.34(a), this Controlled substance code Schedule Lisdexamfetamine ...... 1205 II is notice that on January 30, 2020, Pentobarbital ...... 2270 II ANPP (4-Anilino-N- 8333 II Purisys, LLC, 1550 Olympic Drive, marihuana ...... 7360 I Athens, Georgia 30601–1602 applied to tetrahydrocannabinols ..... 7370 I phenethyl-4-piperidine). Codeine ...... 9050 II be registered as an importer of the Oxycodone ...... 9143 II following basic class(es) of controlled The applicant’s notice above applied Hydromorphone ...... 9150 II substances: to become registered with DEA to grow Hydrocodone ...... 9193 II marihuana as a bulk manufacturer Meperidine ...... 9230 II Drug subsequent to a 2016 DEA policy Morphine ...... 9300 II Controlled substance code Schedule statement that provided information on Fentanyl ...... 9801 II how it intended to expand the number Marihuana Extract ...... 7350 I of registrations, and described in general The company plans to manufacture Marihuana ...... 7360 I terms the way it would oversee those the above controlled substances as bulk Tetrahydrocannabinols ... 7370 I additional growers. In order to complete active pharmaceutical ingredients (APIs) Nabilone ...... 7379 II the evaluation and registration process for use in product development and for Phenylacetone ...... 8501 II for applicants to grow marihuana, DEA distribution to its customers. In Levorphanol ...... 9220 II has proposed regulations that, if reference to drug codes 7360 Thebaine ...... 9333 II finalized, would supersede the 2016 (Marihuana) and 7370 Poppy Straw Con- 9670 II policy statement and govern persons (Tetrahydrocannabinols), the company centrate. seeking to become registered with DEA plans to bulk manufacture these drugs Tapentadol ...... 9780 II to grow marihuana as a bulk as synthetics. No other activities for these drug codes are authorized for this manufacturer, consistent with The company plans to import drug registration. applicable law. The proposed code 8501, Phenylacetone and drug regulations are available at 85 FR 16292. William T. McDermott, code 9670, Poppy Straw Concentrate to William T. McDermott, Assistant Administrator. bulk manufacture other controlled Assistant Administrator. [FR Doc. 2020–08330 Filed 4–17–20; 8:45 am] substances for distribution to its [FR Doc. 2020–08334 Filed 4–17–20; 8:45 am] BILLING CODE 4410–09–P customers. The company plans to BILLING CODE 4410–09–P import impurities of buprenorphine that have been determined by DEA to be DEPARTMENT OF JUSTICE captured under drug code 9333, DEPARTMENT OF JUSTICE Drug Enforcement Administration Thebaine. In reference to drug codes 7360, Marihuana and 7370, Drug Enforcement Administration [Docket No. DEA–609] Tetrahydrocannabinols the company plans to import a Synthetic Cannabidiol Importer of Controlled Substances [Docket No. DEA–622] Application: Purisys, LLC and a Synthetic Tetrahydrocannabinol. No other activity for these drug codes is Bulk Manufacturer of Controlled ACTION: Notice of application. authorized for this registration. Substances Application: AMRI Placement of these drugs codes on the Rensselaer, Inc. DATES: Registered bulk manufacturers of company’s registration does not the affected basic class(es), and ACTION: Notice of application. translate into automatic approval of applicants therefore, may file written subsequent permit applications to comments on or objections to the DATES: Registered bulk manufacturers of import controlled substances. Approval issuance of the proposed registration on the affected basic class(es), and of permit applications will occur only or before May 20, 2020. Such persons applicants therefore, may file written when the registrant’s business activity is may also file a written request for a comments on or objections to the consistent with what is authorized hearing on the application on or before issuance of the proposed registration on under 21 U.S.C. 952(a)(2). Authorization May 20, 2020. or before June 19, 2020. will not extend to the import of FDA- ADDRESSES: Written comments should ADDRESSES: Written comments should approved or non-approved finished be sent to: Drug Enforcement dosage forms for commercial sale. be sent to: Drug Enforcement Administration, Attention: DEA Federal Administration, Attention: DEA Federal Register Representative/DPW, 8701 William T. McDermott, Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia Morrissette Drive, Springfield, Virginia Assistant Administrator. 22152. All requests for a hearing must [FR Doc. 2020–08270 Filed 4–17–20; 8:45 am] 22152. be sent to: Drug Enforcement BILLING CODE 4410–09–P SUPPLEMENTARY INFORMATION: In Administration, Attn: Administrator, accordance with 21 CFR 1301.33(a), this 8701 Morrissette Drive, Springfield, is notice that on March 9, 2020, AMRI Virginia 22152. All request for a hearing Rensselaer, Inc., 33 Riverside Avenue, should also be sent to: (1) Drug Rensselaer, New York 12144–2951, Enforcement Administration, Attn: applied to be registered as a bulk Hearing Clerk/OALJ, 8701 Morrissette manufacturer of the following basic Drive, Springfield, Virginia 22152; and class(es) of controlled substances: (2) Drug Enforcement Administration,

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