Notices. Notice of application
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/register/2019/12/27/2019-27954A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-552] Importer of Controlled Substances Application: Myoderm 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 January 27, 2020. Such persons may also file a written request for a hearing on the application on or before January 27, 2020.
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 a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 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: In accordance with 21 CFR 1301.34(a), this is notice that on October 14, 2019, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401-4915 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Drug code Schedule Amphetamine 1100 II Lisdexamfetamine 1205 II Methylphenidate 1724 II Nabilone 7379 II Oxycodone 9143 II Hydromorphone 9150 II Hydrocodone 9193 II Morphine 9300 II Oxymorphone 9652 II Fentanyl 9801 II The company plans to import the listed controlled substances for clinical trials, research, and analytical purposes. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale. Dated: November 13, 2019. William T. McDermott, Acting Assistant Administrator. [FR Doc. 2019-27954 Filed 12-26-19; 8:45 am]
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