Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 3335 

1This authority has been delegated from the 

Attorney General to the DEA Administrator by 28 

CFR 0.100, and subsequently redelegated to the 

Deputy Assistant Administrator pursuant to 28 CFR 

0.104 and Section 7 of the appendix to subpart R 

of part 0. 

Square, 145 N Street NE, Mail Stop 3.E– 

405A, Washington, DC 20530. 

Dated: January 14, 2022. 

Melody Braswell, 

Department Clearance Officer for PRA, U.S. 

Department of Justice. 

[FR Doc. 2022–01104 Filed 1–20–22; 8:45 am] 

BILLING CODE 4410–FY–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–372] 

Exempt Chemical Preparations Under 

the Controlled Substances Act 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Order with opportunity for 

comment. 

SUMMARY: The applications for exempt 

chemical preparations received by the 

Drug Enforcement Administration 

between April 1, 2021, and June 30, 

2021, as listed below, were accepted for 

filing and have been approved or denied 

as indicated. 

DATES: Interested persons may file 

written comments on this order in 

accordance with 21 CFR 1308.23(e). 

Electronic comments must be 

submitted, and written comments must 

be postmarked, on or before March 22, 

2022. Commenters should be aware that 

the electronic Federal Docket 

Management System will not accept 

comments after 11:59 p.m. Eastern Time 

on the last day of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–372’’ on all correspondence, 

including any attachments. 

Electronic comments: Drug 

Enforcement Administration encourages 

that all comments be submitted through 

the Federal eRulemaking Portal, which 

provides the ability to type short 

comments directly into the comment 

field on the web page or to attach a file 

for lengthier comments. Please go to 

http://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon completion 

of your submission you will receive a 

Comment Tracking Number for your 

comment. Please be aware that 

submitted comments are not 

instantaneously available for public 

view on 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. 

Paper comments: Paper comments 

that duplicate the electronic submission 

are not necessary and are discouraged. 

Should you wish to mail a comment in 

lieu of an electronic comment, it should 

be sent via regular or express mail to: 

Drug Enforcement Administration, 

Attention: DEA Federal Register 

Representative/DRW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Ph.D., Diversion 

Control Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

8201. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and made available for 

public inspection online at http://

www.regulations.gov and in the DEA’s 

public docket. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. The Freedom of 

Information Act applies to all comments 

received. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want posted online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. 

Comments containing personal 

identifying information and confidential 

business information identified as 

directed above will generally be made 

publicly available in redacted form. If a 

comment has so much confidential 

business information that it cannot be 

effectively redacted, all or part of that 

comment may not be made publicly 

available. Comments posted to http://

www.regulations.gov may include any 

personal identifying information (such 

as name, address, and phone number) 

included in the text of your electronic 

submission that is not identified as 

directed above as confidential. 

An electronic copy of this document 

is available at http://

www.regulations.gov for easy reference. 

Legal Authority 

Section 201 of the Controlled 

Substances Act (CSA) (21 U.S.C. 811) 

authorizes the Attorney General, by 

regulation, to exempt from certain 

provisions of the CSA certain 

compounds, mixtures, or preparations 

containing a controlled substance, if he 

finds that such compounds, mixtures, or 

preparations meet the requirements 

detailed in 21 U.S.C. 811(g)(3)(B).1 The 

Drug Enforcement Administration 

(DEA) regulations at 21 CFR 1308.23 

and 1308.24 further detail the criteria by 

which the DEA Assistant Administrator 

may exempt a chemical preparation or 

mixture from certain provisions of the 

CSA. The Assistant Administrator may, 

pursuant to 21 CFR 1308.23(f), modify 

or revoke the criteria by which 

exemptions are granted and modify the 

scope of exemptions at any time. 

Exempt Chemical Preparation 

Applications Submitted Between April 

1, 2021, and June 30, 2021 

The Assistant Administrator received 

applications between April 1, 2021, and 

June 30, 2021, requesting exempt 

chemical preparation status detailed in 

21 CFR 1308.23. Pursuant to the criteria 

stated in 21 U.S.C. 811(g)(3)(B) and in 

21 CFR 1308.23, the Assistant 

Administrator has found that each of the 

compounds, mixtures, and preparations 

described in Chart I below is intended 

for laboratory, industrial, educational, 

or special research purposes and not for 

general administration to a human being 

or animal and either: (1) Contains no 

narcotic controlled substance and is 

packaged in such a form or 

concentration that the packaged 

quantity does not present any 

significant potential for abuse; or (2) 

contains either a narcotic or nonnarcotic controlled substance and one or 

more adulterating or denaturing agents 

in such a manner, combination, 

quantity, proportion, or concentration 

that the preparation or mixture does not 

present any potential for abuse and, if 

the preparation or mixture contains a 

narcotic controlled substance, is 

formulated in such a manner that it 

incorporates methods of denaturing or 

other means so that the preparation or 


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3336 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 

mixture is not liable to be abused or 

have ill effects, if abused, and so that 

the narcotic substance cannot in 

practice be removed. 

Accordingly, pursuant to 21 U.S.C. 

811(g)(3)(B), 21 CFR 1308.23, and 21 

CFR 1308.24, the Assistant 

Administrator has determined that each 

of the chemical preparations or mixtures 

generally described in Chart I below and 

specifically described in the application 

materials received by DEA is exempt, to 

the extent described in 21 CFR 1308.24, 

from application of sections 302, 303, 

305, 306, 307, 308, 309, 1002, 1003, and 

1004 (21 U.S.C. 822–823, 825–829, and 

952–954) of the CSA, and 21 CFR 

1301.74, as of the date that was 

provided in the approval letters to the 

individual requesters. 

Scope of Approval 

The exemptions are applicable only to 

the precise preparation or mixture 

described in the application submitted 

to DEA in the form(s) listed in this order 

and only for those above mentioned 

sections of the CSA and the CFR. In 

accordance with 21 CFR 1308.24(h), any 

change in the quantitative or qualitative 

composition of the preparation or 

mixture, or change in the trade name or 

other designation of the preparation or 

mixture after the date of application 

requires a new application. The 

requirements set forth in 21 CFR 

1308.24(b)–(e) apply to the exempted 

materials. In accordance with 21 CFR 

1308.24(g), DEA may prescribe 

requirements other than those set forth 

in 21 CFR 1308.24(b)–(e) on a case-bycase basis for materials exempted in 

bulk quantities. Accordingly, in order to 

limit opportunity for diversion from the 

larger bulk quantities, DEA has 

determined that each of the exempted 

bulk products listed in this order may 

only be used in-house by the 

manufacturer, and may not be 

distributed for any purpose, or 

transported to other facilities. 

Additional exempt chemical 

preparation requests received between 

April 1, 2021, and June 30, 2021, and 

not otherwise referenced in this order, 

may remain under consideration until 

DEA receives additional information 

required, pursuant to 21 CFR 

1308.23(d), as detailed in separate 

correspondence to individual 

requesters. DEA’s order on such 

requests will be communicated to the 

public in a future Federal Register 

publication. 

DEA also notes that these exemptions 

are limited to exemption from only 

those sections of the CSA and the CFR 

that are specifically identified in 21 CFR 

1308.24(a). All other requirements of the 

CSA and the CFR apply, including 

registration as an importer as required 

by 21 U.S.C. 957. 

CHART I 

Supplier Product name Form Application 

date 

Aalto Scientific, Ltd ............................ Immunoassay Base (Level A–E) ................................................................ Glass or plastic bottle or flask: 500 

mL–1 L.

4/13/2021 

Aalto Scientific, Ltd ............................ Immunoassay Base (Level A–E) ................................................................ Glass or plastic bottle or flask: 100 

mL–500 mL.

4/13/2021 

Aalto Scientific, Ltd ............................ Immunoassay Base (Level A–E) ................................................................ Glass or plastic bottle or flask: 1 

mL–100 mL.

4/13/2021 

Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Glass vial, bottle, or flask: 1 mL ...... 4/1/2021 

Aalto Scientific, Ltd ............................ TDM Base (Level A–E) .............................................................................. Glass vial, bottle, or flask: 500 mL– 

1L.

4/1/2021 

Aalto Scientific, Ltd ............................ TDM Base (Level A–E) .............................................................................. Glass vial, bottle, or flask: 100mL– 

500 mL.

4/1/2021 

Aalto Scientific, Ltd ............................ TDM Base (Level A–E) .............................................................................. Glass vial, bottle, or flask: 1 mL– 

100 mL.

4/1/2021 

Aalto Scientific, Ltd ............................ TDM Beckman AU Base (Level A–E) ........................................................ Glass vial, bottle, or flask: 500 mL– 

1L.

4/1/2021 

Aalto Scientific, Ltd ............................ TDM Beckman AU Base (Level A–E) ........................................................ Glass vial, bottle, or flask: 100mL– 

500 mL.

4/1/2021 

Aalto Scientific, Ltd ............................ TDM Beckman AU Base (Level A–E) ........................................................ Glass vial, bottle, or flask: 1 mL– 

100 mL.

4/1/2021 

ARK Diagnostics, Inc ........................ DRI Fentanyl II Control ............................................................................... Kit: 4 Dropper vials, 10 mL each ..... 4/15/2021 

ARK Diagnostics, Inc ........................ DRI Fentanyl II Cutoff Calibrator ................................................................ Kit: 2 Dropper vials, 10 mL each ..... 4/15/2021 

Audit MicroControls ........................... Linearity FD Fertility Siemens Atellica/Centaur .......................................... Kit: 5 vials; 3 mL each ..................... 4/29/2021 

Audit MicroControls ........................... Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level A ................. Glass vial: 3 mL ............................... 4/29/2021 

Audit MicroControls ........................... Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level B ................. Glass vial: 3 mL ............................... 4/29/2021 

Audit MicroControls ........................... Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level C ................. Glass vial: 3 mL ............................... 4/29/2021 

Audit MicroControls ........................... Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level D ................. Glass vial: 3 mL ............................... 4/29/2021 

Audit MicroControls ........................... Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level E ................. Glass vial: 3 mL ............................... 4/29/2021 

Audit MicroControls ........................... Linearity FD TDM Siemens Atellica/Centaur ............................................. Kit: 5 vials; 5 mL each ..................... 4/27/2021 

Cayman Chemical Company ............ (S)-5-fluoro ADB (CRM); 100 μg/mL in Acetonitrile ................................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 2′-fluoro ortho-Fluorofentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol.Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4-ANPP (CRM); 100 μg/mL in Methanol ................................................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4-ANPP (CRM); 100 μg/mL in Methanol ................................................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4-ANPP-13C6 (CRM); 100 μg/mL in Methanol .......................................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4-ANPP-d5 (CRM); 100 μg/mL in Methanol .............................................. Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4-ANPP-d5 (CRM); 100 μg/mL in Methanol .............................................. Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4′-chloro-a-Pyrrolidinovalerophenone (hydrochloride) (CRM); 100 μg/mL 

in Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4-cyano CUMYL-BUTINACA (CRM); 100 μg/mL in Methanol ................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4′-methyl Acetyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4′-methyl Acetyl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol.Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4-methyl-a-Ethylaminopentiophenone (hydrochloride) (CRM); 100 μg/mL 

in Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 4′-methyl-a-Pyrrolidinohexanophenone (hydrochloride) (CRM); 100 μg/ 

mL in Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ 5-fluoro CUMYL-PINACA; 100 μg/mL in Methanol .................................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Acrylfentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Acrylfentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol .............. Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Butyryl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ......... Glass ampule: 1.0 mL ...................... 4/14/2021 


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Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 3337 

CHART I—Continued 

Supplier Product name Form Application 

date 

Cayman Chemical Company ............ Cocaethylene (CRM); 100 μg/mL in Methanol .......................................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Cyclohexyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ........ Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Cyclohexyl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Cyclopentyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ....... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Cyclopropyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ....... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Cyclopropyl fentanyl-13C6 (hydrochloride) (CRM); 100 μg/mL in Methanol.Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ D8-THCA-A (CRM) 1 mg/ml, 1 mL in acetonitrile ...................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D8-THCA-A (CRM) 100 μg/ml, 1 mL in acetonitrile ................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D8-THCH (CRM) 1 mg/ml, 1 mL in acetonitrile ......................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D8-THCH (CRM) 1 mg/ml, 1 mL in methanol ............................................ Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D8-THCH (CRM) 100 μg/ml, 1 mL in acetonitrile ...................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D8-THCH (CRM) 100 μg/ml, 1 mL in methanol ......................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCB (CRM) 100 μg/mL, 1 mL acetonitrile ......................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCB (CRM) 1 mg/ml, 1 mL in acetonitrile ......................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCB (CRM) 1 mg/ml, 1 mL methanol ................................................ Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCB (CRM) 100 μg/mL, 1 mL methanol ............................................ Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCBA-A (CRM) 1 mg/ml, 1 mL in acetonitrile ................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCBA-A (CRM) 100 μg/mL, 1 mL acetonitrile ................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCH (CRM) 1 mg/ml, 1 mL in acetonitrile ......................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCH (CRM) 1 mg/ml, 1 mL in methanol ............................................ Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCH (CRM) 100 μg/ml, 1 mL in acetonitrile ...................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCH (CRM) 100 μg/ml, 1 mL in methanol ......................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCHA–A (CRM) 1 mg/ml, 1 mL in acetonitrile .................................. Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCHA–A (CRM) 100 μg/ml, 1 mL in acetonitrile ............................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCP (CRM) 1 mg/ml, 1 mL in acetonitrile ......................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCP (CRM) 1 mg/ml, 1 mL methanol ................................................ Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCP (CRM) 100 μg/mL, 1 mL acetonitrile ......................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCP (CRM) 100 μg/mL, 1 mL methanol ............................................ Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCPA-A (CRM) 1 mg/ml, 1 mL in acetonitrile ................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ D9-THCPA-A (CRM) 100 μg/mL, 1 mL acetonitrile ................................... Glass ampule: 1 mL ......................... 6/8/2021 

Cayman Chemical Company ............ FIBF (hydrochloride) (CRM); 100 μg/mL in Methanol ................................ Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ FIBF-d7 (hydrochloride) (CRM); 100 μg/mL in Methanol .......................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Furanyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol .............. Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Furanyl fentanyl-13C6 (hydrochloride) (CRM); 100 μg/mL in Methanol .... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Furanyl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ........ Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Isobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol .......... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Isobutyryl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ..... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Lorcaserin (hydrochloride) (CRM); 100 μg/mL in Methanol ....................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ meta-Fluorobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol.Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ meta-Fluoroisobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in 

Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Methoxyacetyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ MMB-FUBINACA (CRM); 100 μg/mL in Methanol ..................................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ MT-45-d11 (hydrochloride) (CRM); 100 μg/mL in Methanol ...................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ N-ethyl Pentylone (hydrochloride) (CRM); 100 μg/mL in Methanol ........... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Ocfentanil (hydrochloride) (CRM); 100 μg/mL in Methanol ....................... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Ocfentanil-d5 (hydrochloride); 100 μg/mL in Methanol (CRM) .................. Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ ortho-Fluorobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol.Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ ortho-Fluoroisobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in 

Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ para-Chloroisobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in 

Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ para-Fluorobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol.Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ para-Fluorobutyryl fentanyl-13C6 (hydrochloride) (CRM); 100 μg/mL in 

Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ para-Fluorobutyryl fentanyl-d7 (hydrochloride) (CRM); 100 μg/mL in 

Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ para-Fluorofentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ... Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ para-methoxy-Butyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in 

Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ para-methoxy-Butyryl fentanyl-d7 (hydrochloride) (CRM); 100 μg/mL in 

Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ PV8 (hydrochloride) (CRM); 100 μg/mL in Methanol ................................. Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Tetrahydrofuran fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Valeryl fentanyl (CRM); 100 μg/mL in Methanol ........................................ Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Valeryl fentanyl-13C6 (CRM); 100 μg/mL in Methanol .............................. Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ Valeryl fentanyl-d5 (CRM); 100 μg/mL in Methanol .................................. Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ a-Ethylaminohexanophenone (hydrochloride) (CRM); 100 μg/mL in 

Methanol.

Glass ampule: 1.0 mL ...................... 4/14/2021 

Cayman Chemical Company ............ a-Pyrrolidinohexanophenone (hydrochloride) (CRM); 100 μg/mL in Methanol.Glass ampule: 1.0 mL ...................... 4/14/2021 

Cerilliant Corporation ......................... 6-Acetylcodeine-D3 .................................................................................... Glass ampule: 1.0 mL ...................... 4/15/2021 

Cerilliant Corporation ......................... Normorphine-D3 ......................................................................................... Glass ampule: 1.0 mL ...................... 4/15/2021 

Cliniqa Corporation ............................ TDM + MTX Control Level 1, Part: 43746 ................................................. Bottle: 500 ml ................................... 4/27/2021 

Cliniqa Corporation ............................ TDM + MTX Control Level 1, Part: 83737 ................................................. Vial: 5 ml .......................................... 4/27/2021 

Cliniqa Corporation ............................ TDM + MTX Control Level 2, Part: 43747 ................................................. Bottle: 500 ml ................................... 4/27/2021 


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3338 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 

CHART I—Continued 

Supplier Product name Form Application 

date 

Cliniqa Corporation ............................ TDM + MTX Control Level 2, Part: 83738 ................................................. Vial: 5 ml .......................................... 4/27/2021 

Cliniqa Corporation ............................ TDM + MTX Control Level 3, Part: 43747 ................................................. Bottle: 500 ml ................................... 4/27/2021 

Cliniqa Corporation ............................ TDM + MTX Control Level 3, Part: 83739 ................................................. Vial: 5 ml .......................................... 4/27/2021 

College of American Pathologists ..... 2022 DMPM–01 .......................................................................................... HDPE bottle: 40 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 DMPM–02 .......................................................................................... HDPE bottle: 40 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 DMPM–03 .......................................................................................... HDPE bottle: 40 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 DMPM–05 .......................................................................................... HDPE bottle: 40 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 DMPM–06 .......................................................................................... HDPE bottle: 40 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 DMPM–07 .......................................................................................... HDPE bottle: 40 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–02 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–03 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–04 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–05 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–07 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–08 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–10 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–12 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–13 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 FTC–14 .............................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 OFD–01 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–02 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–03 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–04 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–05 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–06 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–07 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–08 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–10 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–11 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–12 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–13 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–14 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–15 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–16 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–17 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–18 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–19 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 OFD–20 ............................................................................................. HDPE vial: 2 mL .............................. 4/19/2021 

College of American Pathologists ..... 2022 T–03 .................................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 T–04 .................................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 T–05 .................................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 T–07 .................................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 T–08 .................................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 T–09 .................................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 T–12 .................................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 T–13 .................................................................................................. HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 THCB–01 ........................................................................................... Glass vial: 10 mL ............................. 4/19/2021 

College of American Pathologists ..... 2022 THCB–02 ........................................................................................... Glass vial: 10 mL ............................. 4/19/2021 

College of American Pathologists ..... 2022 THCB–03 ........................................................................................... Glass vial: 10 mL ............................. 4/19/2021 

College of American Pathologists ..... 2022 THCB–04 ........................................................................................... Glass vial: 10 mL ............................. 4/19/2021 

College of American Pathologists ..... 2022 THCB–05 ........................................................................................... Glass vial: 10 mL ............................. 4/19/2021 

College of American Pathologists ..... 2022 THCB–06 ........................................................................................... Glass vial: 10 mL ............................. 4/19/2021 

College of American Pathologists ..... 2022 UDS–01 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–02 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–03 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–04 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–05 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–06 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–07 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–08 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–09 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–10 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–11 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–12 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–13 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–14 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UDS–15 ............................................................................................. HDPE bottle: 10 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–01 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–02 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–03 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–04 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–05 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–06 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–07 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–08 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–09 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–10 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–11 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–12 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–13 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 3339 

CHART I—Continued 

Supplier Product name Form Application 

date 

College of American Pathologists ..... 2022 UT–14 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UT–15 ................................................................................................ HDPE bottle: 50 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 UTCO–01 .......................................................................................... HDPE bottle: 40 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022 ZE–01 ................................................................................................ Glass vial: 5 mL ............................... 4/19/2021 

College of American Pathologists ..... 2022 ZE–02 ................................................................................................ Glass vial: 5 mL ............................... 4/19/2021 

College of American Pathologists ..... 2022 ZE–03 ................................................................................................ Glass vial: 5 mL ............................... 4/19/2021 

College of American Pathologists ..... 2022 ZE–04 ................................................................................................ Glass vial: 5 mL ............................... 4/19/2021 

College of American Pathologists ..... 2022 ZE–05 ................................................................................................ Glass vial: 5 mL ............................... 4/19/2021 

College of American Pathologists ..... 2022 ZE–06 ................................................................................................ Glass vial: 5 mL ............................... 4/19/2021 

College of American Pathologists ..... 2022FTC–01 ............................................................................................... HDPE bottle: 20 mL ......................... 4/19/2021 

College of American Pathologists ..... 2022–OFD–09 ............................................................................................ HDPE vial: 2 mL .............................. 4/19/2021 

CPI International ................................ (-)-delta9-tetrahydrocannabinol (d9-THC) 1000 mg/L, 1 mL ..................... Amber ampule: 1 mL ....................... 4/7/2021 

LGC—Dr. Ehrenstorfer ...................... Custom (-)-delta9-tetrahydrocannabinol (d9-HC) 1000 μg/mL in acetonitrile.Amber ampule: 1 mL ....................... 4/12/2021 

LGC—Dr. Ehrenstorfer ...................... Custom Pharmaceutical Mix 6509 100–10000 μg/mL in methanol ........... Amber ampule: 1 mL ....................... 6/8/2021 

LGC—Dr. Ehrenstorfer ...................... Custom Pharmaceutical Mix 6509 100–10000 μg/mL in methanol ........... 1 kit: 5 ampules × 1 mL each .......... 4/12/2021 

LGC—Dr. Ehrenstorfer ...................... D11-Tetrahydrocannabinol (D11-THC) 100 μg/mL in Methanol ................. Amber ampule: 1 mL ....................... 6/14/2021 

LGC—Dr. Ehrenstorfer ...................... D11-Tetrahydrocannabinol (D11-THC) 100 μg/mL in Methanol ................. Amber ampule: 1 mL ....................... 4/20/2021 

LGC—Dr. Ehrenstorfer ...................... D11-Tetrahydrocannabinol (D11-THC) 1000 μg/mL in Methanol ............... Amber ampule: 1 mL ....................... 6/14/2021 

LGC—Dr. Ehrenstorfer ...................... D11-Tetrahydrocannabinol (D11-THC) 1000 μg/mL in Methanol ............... Amber ampule: 1 mL ....................... 4/20/2021 

LGC—Dr. Ehrenstorfer ...................... D9-Tetrahydrocannabivarinic acid (THCVA) 100 μg/mL in Methanol ........ Amber ampule: 1 mL ....................... 6/8/2021 

LGC—Dr. Ehrenstorfer ...................... D9-Tetrahydrocannabivarinic acid (THCVA) 1000 μg/mL in Methanol ...... Amber ampule: 1 mL ....................... 6/8/2021 

LGC—Dr. Ehrenstorfer ...................... Boldenone cypionate 100 μg/mL in Acetonitrile ........................................ Amber ampule: 1 mL ....................... 5/4/2021 

Lin-Zhi International ........................... LZI Norfentanyl (Q) Qualitative Calibrator (5 ng/mL), Ref# C68815 ......... Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... LZI Norfentanyl Level 1 Control (3.75 ng/mL), Ref# C68821 .................... Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... LZI Norfentanyl Level 2 Control (6.25 ng/mL), Ref# C68822 .................... Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... LZI Norfentanyl Qualitative Calibrator (5 ng/mL), Ref# C68810 ................ Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... LZI Norfentanyl Semi-Quantitative Calibrator Set, Ref# C68811 .............. Kit: 4 dropper bottles; 15 mL each .. 6/9/2021 

Lin-Zhi International ........................... Norbuprenorphine DAU Calibrator, Norbuprcnorphinc, Intermediate Calibrator #2 (40 ng/mL), Ref# A68829.Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... Norbuprenorphine DAU Calibrator, Norbuprenorphine Level 2 Control 

(13 ng/mL), Ref# A68825.

Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... Norbuprenorphine DAU Calibrator, Norbuprenorphine Low Calibrator (5 

ng/mL), Ref# A68826.

Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... Norbuprenorphine DAU Calibrator, Norbuprenorphine, Cutoff Calibrator 

(10 ng/mL), Ref# A68827.

Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... Norbuprenorphine DAU Calibrator, Norbuprenorphine, High Calibrator 

(100 ng/mL), Ref# A68830.

Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... Norbuprenorphine DAU Calibrator, Norbuprenorphine, Intermediate Calibrator #1 (20 ng/mL), Ref# A68828.Dropper bottle: 5 mL ........................ 6/9/2021 

Lin-Zhi International ........................... Norbuprenorphine DAU Calibrator, Norbuprenorphine, Level 1 Control (7 

ng/mL), Ref# A68824.

Dropper bottle: 5 mL ........................ 6/9/2021 

Microgenics Corporation ................... Alinity c Benzodiazepines Qual Calibrator Kit, Catalog Number: 

10027281/09P5201.

Kit: 1 vial, 2.9 mL ............................. 4/2/2021 

Microgenics Corporation ................... Alinity c Cannabinoids Control 1 Kit, Catalog Number: 10024827/ 

09P5410.

Kit: 2 LDPE, 5 mL each ................... 4/2/2021 

Microgenics Corporation ................... Alinity c Cannabinoids Control 2 Kit, Catalog Number: 10027212/ 

09P5411.

Kit: 1 LDPE, 5 mL ............................ 4/2/2021 

Microgenics Corporation ................... Alinity c Cannabinoids Qual Calibrator, Catalog Number: 10024821/ 

09P5401.

Kit: 1 vial, 3.0 mL ............................. 4/2/2021 

Microgenics Corporation ................... Alinity c Cannabinoids SemiQuant 100 Calibrator Kit, Catalog Number: 

10026530/09P5402.

Kit: 3 vials, 3 mL each ..................... 4/2/2021 

Microgenics Corporation ................... Alinity c Cannabinoids SemiQuant 200 Calibrator Kit, Catalog Number: 

10026531/09P5403.

Kit: 3 vials, 3 mL each ..................... 4/2/2021 

Microgenics Corporation ................... Alinity c Ecstasy Qual Calibrator Kit, Catalog Number: 10024822/ 

09P5801.

Kit: 1 vial, 3.0 mL ............................. 4/2/2021 

Microgenics Corporation ................... Alinity c Ecstasy Semiquant Calibrator Kit, Catalog Number: 10026532/ 

09P5802.

Kit: 4 vials, 3.0 mL each .................. 4/2/2021 

Microgenics Corporation ................... Alinity c Opiates Qual Calibrator Kit, Catalog Number: 10024823/ 

09P6501.

Kit: 1 vial, 3.0 mL ............................. 4/2/2021 

Microgenics Corporation ................... Alinity c Opiates Semiquant Calibrator Kit, Catalog Number: 10026534/ 

09P6502.

Kit: 4 vials, 3 mL each ..................... 4/2/2021 

o2si Smart Solutions ......................... Codeine monohydrate as codeine Solution, 2,000 mg/L—Parent Stock 

Solution—Not For Sale.

Glass cryule: 2 mL ........................... 5/28/2021 

o2si Smart Solutions ......................... Heroin Solution, 2,000 mg/L—Parent Stock Solution—Not For Sale ........ Glass cryule: 2 mL ........................... 5/28/2021 

o2si Smart Solutions ......................... Hydrocodone (+)-bitartrate salt as hydrocodone Solution, 2,000 mg/L— 

Parent Stock Solution—Not For Sale.

Glass cryule: 2 mL ........................... 5/28/2021 

o2si smart solutions .......................... ISO 17034—Custom Toxin/Poison Standard Kit, 45–46, 100 mg/L, 1 × 1 

ml of Each Level (G34–140319–01, G34–140339–01, G34–140340– 

01).

Kit: 2 amber ampules, 1 mL each ... 5/28/2021 

o2si smart solutions .......................... ISO 17034 Custom Toxin/Poison Stock Standard Mix, 10–318, 100 mg/ 

L, 1 mL.

Amber ampule: 1 mL ....................... 5/28/2021 

o2si smart solutions .......................... ISO 17034 Custom Toxin/Poison Stock Standard Mix, 10–319, 100 mg/ 

L, 1 mL.

Amber ampule: 1 mL ....................... 5/28/2021 

o2si smart solutions .......................... ISO 17034 Custom Toxin/Poison Stock Standard Mix, 34–318, 100 mg/ 

L, 1 mL.

Amber ampule: 1 mL ....................... 5/27/2021 

o2si Smart Solutions ......................... ISO 17034 Custom Toxin/Poison Stock Standard Mix, 34–318, 100 mg/ 

L, 1 mL.

Amber ampule: 1 mL ....................... 4/26/2021 

o2si smart solutions .......................... Levorphanol (+)-tartrate salt dehydrate as levorphanol Solution, 2,000 

mg/L—Parent Stock Solution—Not For Sale.

Glass cryule: 2 mL ........................... 5/28/2021 


jspears on DSK121TN23PROD with NOTICES1
3340 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 

CHART I—Continued 

Supplier Product name Form Application 

date 

o2si Smart Solutions ......................... Oxycodone Solution, 2,000 mg/L—Parent Stock Solution—Not For Sale Glass cryule: 2 mL ........................... 5/28/2021 

o2si Smart Solutions ......................... Pentazocine Solution, 2,000 mg/L—Parent Stock Solution ....................... Glass cryule: 2 mL ........................... 5/28/2021 

Restek Corporation ........................... Custom D-Methamphetamine Standard ..................................................... Glass Ampule: 1.3 mL ..................... 4/15/2021 

UTAK Laboratories, Inc ..................... DAU High Cutoff 1 Urine Control ............................................................... Kit: 4 bottles, 10 mL each ................ 4/16/2021 

UTAK Laboratories, Inc ..................... DAU High Cutoff 2 Urine Control ............................................................... Kit: 4 bottles, 10 mL each ................ 4/16/2021 

UTAK Laboratories, Inc ..................... DAU Low Cutoff 1 Urine Control ................................................................ Kit: 4 bottles, 10 mL each ................ 4/16/2021 

UTAK Laboratories, Inc ..................... DAU Low Cutoff 2 Urine Control ................................................................ Kit: 4 bottles, 10 mL each ................ 4/16/2021 

UTAK Laboratories, Inc ..................... Drugs of Abuse Level 1 Whole Blood Control ........................................... Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... Fentanyl Analogues 2 NG/ML Whole Blood Control ................................. Kit: 5 bottles, 3 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... Fentanyl Analogues 5 NG/ML Urine Control ............................................. Kit: 5 bottles, 3 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... PM 100 Urine Control ................................................................................. Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... PM 100 Whole Blood Control ..................................................................... Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... PM Plus High Urine Control ....................................................................... Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... PM Plus Low Urine Control ........................................................................ Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... SAMHSA Confirm Level 1 SMX Oral Fluid Control ................................... Kit: 5 bottles, 3 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... SAMHSA Confirm Level 2 SMX Oral Fluid Control ................................... Kit: 5 bottles, 3 mL each .................. 4/16/2021 

The Assistant Administrator has 

found that each of the compounds, 

mixtures, and preparations described in 

Chart II below is not consistent with the 

criteria stated in 21 U.S.C. 811(g)(3)(B) 

and in 21 CFR 1308.23. Accordingly, the 

Assistant Administrator has determined 

that the chemical preparations or 

mixtures generally described in Chart II 

below and specifically described in the 

application materials received by DEA, 

are not exempt from application of any 

part of the CSA or from application of 

any part of the CFR, with regard to the 

requested exemption pursuant to 21 

CFR 1308.23, as of the date that was 

provided in the determination letters to 

the individual requesters. 

CHART II 

Supplier Product name Form Application 

date 

Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Glass vial, bottle, or flask: 500 mL– 

1L.

4/1/2021 

Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Glass vial, bottle, or flask: 100mL– 

500 mL.

4/1/2021 

Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Glass vial, bottle, or flask: 100 mL .. 4/1/2021 

Opportunity for Comment 

Pursuant to 21 CFR 1308.23(e), any 

interested person may submit written 

comments on or objections to any 

chemical preparation in this order that 

has been approved or denied as exempt. 

If any comments or objections raise 

significant issues regarding any finding 

of fact or conclusion of law upon which 

this order is based, the Assistant 

Administrator will immediately 

suspend the effectiveness of any 

applicable part of this order until he 

may reconsider the application in light 

of the comments and objections filed. 

Thereafter, the Assistant Administrator 

shall reinstate, revoke, or amend his 

original order as he determines 

appropriate. 

Approved Exempt Chemical 

Preparations Are Posted on the DEA’s 

Website 

A list of all current exemptions, 

including those listed in this order, is 

available on the DEA’s website at http:// 

www.DEAdiversion.usdoj.gov/ 

schedules/exempt/exempt_chemlist.pdf. 

The dates of applications of all current 

exemptions are posted for easy 

reference. 

* * * * * 

Brian S. Besser, 

Acting Assistant Administrator. 

[FR Doc. 2022–01125 Filed 1–20–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Daniel R. Nevarre, M.D.; Decision and 

Order 

On June 7, 2021, a former Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause to Daniel R. Nevarre, M.D., 

(hereinafter, Applicant), of South 

Jordan, Utah. Order to Show Cause 

(hereinafter, OSC), at 1. The OSC 

proposed the denial of Applicant’s 

application No. H21079595C for a DEA 

Certificate of Registration, because the 

United States Department of Health and 

Human Services, Office of Inspector 

General (hereinafter, HHS/OIG) 

mandatorily excluded Applicant from 

participation in Medicare, Medicaid, 

and all Federal health care programs for 

a minimum period of 10 years pursuant 

to 42 U.S.C. 1320a–7(a); and such 

exclusion ‘‘warrants denial of 

[Applicant’s] application for DEA 

registration pursuant to 21 U.S.C. 

824(a)(5).’’ Id. at 2. The OSC also alleged 

that Applicant’s application ‘‘contains 

material false statements’’ and thus 

forms an independent ground for denial. 

Id. at 2 (citing 21 U.S.C. 824(a)(1)). 

The OSC alleged that on May 25, 

2018, Applicant ‘‘pled guilty to one 

count of medical assistance fraud in 

violation of 62 P.S. § 1407(a)(1), and to 

one count of insurance fraud, in 

violation of 18 Pa.C.S. § 4117(a)(2).’’ Id. 

at 1–2 (citing Commonwealth of Pa. v. 

Daniel Raymond Nevarre, No. CP–11– 

CR–0000717–2018 (Pa. Ct. Comm. Pl. 

May 25, 2018)). The OSC further alleged 

that, based on such conviction, HHS/ 

OIG ‘‘mandatorily excluded [Applicant] 

from participation in Medicare, 

Medicaid, and all Federal health care 

programs’’ for a minimum period of 10 

years pursuant to 42 U.S.C. 1320a–7(a), 

effective November 20, 2018. Id. The 

OSC therefore proposed denial of 

Applicant’s application based on 21 

U.S.C. 824(a)(5). 


jspears on DSK121TN23PROD with NOTICES1