42120 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 

revocation of registration) has been 

redelegated to the Assistant 

Administrator of the DEA Diversion 

Control Division (‘‘Assistant 

Administrator’’) pursuant to section 7 of 

28 CFR part 0, appendix to subpart R. 

In accordance with 21 CFR 

1301.34(a), this is notice that on July 18, 

2016, KVK–Tech, Inc., 110 Terry Drive, 

Newtown, Pennsylvania 18940 applied 

to be registered as an importer of 

Lisdexamfetamine (1205), a basic class 

of controlled substance listed in 

schedule II. 

The company plans to import the 

listed controlled substance in finished 

dosage form 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: August 28, 2017. 

Demetra Ashley, 

Acting Assistant Administrator. 

[FR Doc. 2017–18787 Filed 9–5–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Application: Spex Certiprep Group, 

LLC 

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 in 

accordance with 21 CFR 1301.34(a) on 

or before October 6, 2017. Such persons 

may also file a written request for a 

hearing on the application pursuant to 

21 CFR 1301.43 on or before October 6, 

2017. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for hearing must be 

sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. All request for hearing 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/LJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DRW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, dispensers, 

importers, and exporters of controlled 

substances (other than final orders in 

connection with suspension, denial, or 

revocation of registration) has been 

redelegated to the Assistant 

Administrator of the DEA Diversion 

Control Division (‘‘Assistant 

Administrator’’) pursuant to section 7 of 

28 CFR part 0, appendix of subpart R. 

In accordance with 21 CFR 

1301.34(a), this is notice that on October 

31, 2016, Spex Certiprep Group, LLC, 

203 Norcross Avenue, Metuchen, New 

Jersey 08840 applied to be registered as 

an importer of the following basic 

classes of controlled substances: 

Controlled substance Drug 

code Schedule 

Marihuana ............................... 7360 I 

Tetrahydrocannabinols ........... 7370 I 

The company plans to import the 

listed controlled substances for sale to 

research facilities for drug testing and 

analysis. 

In reference to drug codes 7360 

(marihuana) and 7370 (THC), the 

company plans to import a synthetic 

cannabidiol and a synthetic 

tetrahydrocannabinol. No other activity 

for these drug codes is authorized for 

this registration. 

Dated: August 28, 2017. 

Demetra Ashley, 

Acting Assistant Administrator. 

[FR Doc. 2017–18788 Filed 9–5–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Application: Mylan Pharmaceuticals, 

Inc. 

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 in 

accordance with 21 CFR 1301.34(a) on 

or before October 6, 2017. Such persons 

may also file a written request for a 

hearing on the application pursuant to 

21 CFR 1301.43 on or before October 6, 

2017. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for hearing must be 

sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. All requests for hearing 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/LJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DRW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, dispensers, 

importers, and exporters of controlled 

substances (other than final orders in 

connection with suspension, denial, or 

revocation of registration) has been 

redelegated to the Assistant 

Administrator of the DEA Diversion 

Control Division (‘‘Assistant 

Administrator’’) pursuant to section 7 of 

28 CFR part 0, appendix to subpart R. 

In accordance with 21 CFR 

1301.34(a), this is notice that on 

December 9, 2016, Mylan 

Pharmaceuticals, Inc., 781 Chestnut 

Ridge Road, Morgantown, West Virginia 

26505 applied to be registered as an 

importer of the following basic classes 

of controlled substances: 

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 the 

listed controlled substances in finished 

dosage form (FDF) from foreign sources 

for analytical testing and clinical trials 


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