Rules and Regulations. Notice of application

337 words·~2 min read·/register/2020/10/27/2020-23766

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BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-736] Importer of Controlled Substances Application: Mylan Pharmaceuticals AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of application. SUMMARY: Mylan Pharmaceuticals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 27, 2020.

Such persons may also file a written request for a hearing on the application on or before November 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 7, 2020, Mylan Pharmaceuticals, Incorporated, 3711 Collins Ferry Road, Morgantown, West Virginia 26505-2362, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Drug code Schedule Amphetamine 1100 II Methylphenidate 1724 II Oxycodone 9143 II Hydromorphone 9150 II Methadone 9250 II Morphine 9300 II Fentanyl 9801 II The company plans to import finished dosage forms for analytical testing and distribution for clinical trials. No other activity for these drug codes is authorized for this registration. 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 Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2020-23766 Filed 10-26-20; 8:45 am]