[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61364-61365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21946]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1089]


Importer of Controlled Substances Application: Hybrid Pharma

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Hybrid Pharma has applied to be registered as an importer of 
basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY 
INFORMATION listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
November 10, 2022. Such persons may also file a written request for a 
hearing on the application on or before November 10, 2022.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal,

[[Page 61365]]

which provides the ability to type short comments directly into the 
comment field on the web page or attach a file for lengthier comments. 
Please go to https://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon submission of 
your comment, you will receive a Comment Tracking Number. Please be 
aware that submitted comments are not instantaneously available for 
public view on https://www.regulations.gov. If you have received a 
Comment Tracking Number, your comment has been successfully submitted 
and there is no need to resubmit the same comment. All requests for a 
hearing must 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. All requests for a hearing should also be sent to: Drug 
Enforcement Administration, Attn: Administrator, 8701 Morrissette 
Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on September 2, 2022, Hybrid Pharma, 1015 West Newport 
Center Drive, Suite 106A, Deerfield Beach, Florida 33442-7707, applied 
to be registered as an importer of the following basic class(es) of 
controlled substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Dimethyltryptamine.....................     7435  I
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    The company plans to import the listed controlled substance to 
manufacture dosage forms to support clinical trials. No other activity 
for this drug code 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.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-21946 Filed 10-7-22; 8:45 am]
BILLING CODE P