[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76108-76109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26175]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-742]


Importer of Controlled Substances Application: Lyndra 
Therapeutics

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Lyndra Therapeutics 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

[[Page 76109]]

or before December 28, 2020. Such persons may also file a written 
request for a hearing on the application on or before December 28, 
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 22, 2020, Lyndra Therapeutics, 65 Grove 
Street, Suite 301, Watertown, Massachusetts 02472, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

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         Controlled substance              Drug code         Schedule
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Methadone.............................            9250               II
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    The company plans to develop the formulation and process, and then 
manufacture the finished oral dosage form for use in preclinical and 
human clinical trials under a research grant from National Institute on 
Drug Abuse. 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. 2020-26175 Filed 11-25-20; 8:45 am]
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