Importer of Controlled Substances Application: Research Triangle Institute
Research Triangle Institute has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for furthe...
Research Triangle Institute has applied to be registered as an
( printed page 31903)
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 June 24, 2022 Such persons may also file a written request for a hearing on the application on or before June 24, 2022.
ADDRESSES:
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, 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 March 11, 2022, Research Triangle Institute, 3040 East Cornwallis Road, Hermann Building, Room 106, Research Triangle Park, North Carolina 27709-0000, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
Controlled substance
Drug code
Schedule
3-Fluoro-N-methylcathinone (3-FMC)
1233
I
Cathinone
1235
I
Methcathinone
1237
I
4-Fluoro-N-methylcathinone (4-FMC)
1238
I
Para-Methoxymethamphetamine (PMMA), 1-(4- 1245 I N methoxyphenyl)-N-methylpropan-2-amine
1245
I
Pentedrone (α-methylaminovalerophenone)
1246
I
Mephedrone (4-Methyl-N-methylcathinone)
1248
I
4-Methyl-N-ethylcathinone (4-MEC)
1249
I
Naphyrone
1258
I
N-Ethylamphetamine
1475
I
N,N-Dimethylamphetamine
1480
I
Fenethylline
1503
I
Aminorex
1585
I
4-Methylaminorex (cis isomer)
1590
I
4,4′-Dimethylaminorex (4,4′-DMAR; 4,5-dihydro-4- 1595 I N methyl-5-(4-methylphenyl)-2-oxazolamine; 4-methyl-5- (4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine)
The company plans to import small quantities of the listed controlled substances for the National Institute on Drug Abuse for research activities. The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. 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.