Exempt Chemical Preparations Under the Controlled Substances Act, 3335-3340 [2022-01125]

Download as PDF Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices Drug Enforcement Administration 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. [Docket No. DEA–372] SUPPLEMENTARY INFORMATION: Exempt Chemical Preparations Under the Controlled Substances Act Posting of Public Comments 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, Department of Justice. ACTION: Order with opportunity for comment. AGENCY: 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 https://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 jspears on DSK121TN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 Please note that all comments received are considered part of the public record and made available for public inspection online at https:// 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 https:// www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 3335 submission that is not identified as directed above as confidential. An electronic copy of this document is available at https:// 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 1 This 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. E:\FR\FM\21JAN1.SGM 21JAN1 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 Product name Form Aalto Scientific, Ltd ............................ Immunoassay Base (Level A–E) ................................................................ Aalto Scientific, Ltd ............................ Immunoassay Base (Level A–E) ................................................................ Aalto Scientific, Ltd ............................ Immunoassay Base (Level A–E) ................................................................ Aalto Scientific, Ltd ............................ Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. TDM Base (Level A–E) .............................................................................. Aalto Scientific, Ltd ............................ TDM Base (Level A–E) .............................................................................. Aalto Scientific, Ltd ............................ TDM Base (Level A–E) .............................................................................. Aalto Scientific, Ltd ............................ TDM Beckman AU Base (Level A–E) ........................................................ Aalto Scientific, Ltd ............................ TDM Beckman AU Base (Level A–E) ........................................................ Aalto Scientific, Ltd ............................ TDM Beckman AU Base (Level A–E) ........................................................ ARK Diagnostics, Inc ........................ ARK Diagnostics, Inc ........................ Audit MicroControls ........................... Audit MicroControls ........................... Audit MicroControls ........................... Audit MicroControls ........................... Audit MicroControls ........................... Audit MicroControls ........................... Audit MicroControls ........................... Cayman Chemical Company ............ Cayman Chemical Company ............ DRI Fentanyl II Control ............................................................................... DRI Fentanyl II Cutoff Calibrator ................................................................ Linearity FD Fertility Siemens Atellica/Centaur .......................................... Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level A ................. Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level B ................. Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level C ................. Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level D ................. Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level E ................. Linearity FD TDM Siemens Atellica/Centaur ............................................. (S)-5-fluoro ADB (CRM); 100 μg/mL in Acetonitrile ................................... 2′-fluoro ortho-Fluorofentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol. 4-ANPP (CRM); 100 μg/mL in Methanol ................................................... 4-ANPP (CRM); 100 μg/mL in Methanol ................................................... 4-ANPP-13C6 (CRM); 100 μg/mL in Methanol .......................................... 4-ANPP-d5 (CRM); 100 μg/mL in Methanol .............................................. 4-ANPP-d5 (CRM); 100 μg/mL in Methanol .............................................. 4′-chloro-a-Pyrrolidinovalerophenone (hydrochloride) (CRM); 100 μg/mL in Methanol. 4-cyano CUMYL-BUTINACA (CRM); 100 μg/mL in Methanol ................... 4′-methyl Acetyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol 4′-methyl Acetyl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol. 4-methyl-a-Ethylaminopentiophenone (hydrochloride) (CRM); 100 μg/mL in Methanol. 4′-methyl-a-Pyrrolidinohexanophenone (hydrochloride) (CRM); 100 μg/ mL in Methanol. 5-fluoro CUMYL-PINACA; 100 μg/mL in Methanol .................................... Acrylfentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ................... Acrylfentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol .............. Butyryl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ......... Glass or plastic bottle or flask: 500 mL–1 L. Glass or plastic bottle or flask: 100 mL–500 mL. Glass or plastic bottle or flask: 1 mL–100 mL. Glass vial, bottle, or flask: 1 mL ...... Glass vial, bottle, or flask: 500 mL– 1L. Glass vial, bottle, or flask: 100mL– 500 mL. Glass vial, bottle, or flask: 1 mL– 100 mL. Glass vial, bottle, or flask: 500 mL– 1L. Glass vial, bottle, or flask: 100mL– 500 mL. Glass vial, bottle, or flask: 1 mL– 100 mL. Kit: 4 Dropper vials, 10 mL each ..... Kit: 2 Dropper vials, 10 mL each ..... Kit: 5 vials; 3 mL each ..................... Glass vial: 3 mL ............................... Glass vial: 3 mL ............................... Glass vial: 3 mL ............................... Glass vial: 3 mL ............................... Glass vial: 3 mL ............................... Kit: 5 vials; 5 mL each ..................... Glass ampule: 1.0 mL ...................... Glass ampule: 1.0 mL ...................... 4/15/2021 4/15/2021 4/29/2021 4/29/2021 4/29/2021 4/29/2021 4/29/2021 4/29/2021 4/27/2021 4/14/2021 4/14/2021 Glass Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... ...................... 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 Glass ampule: 1.0 mL ...................... Glass ampule: 1.0 mL ...................... Glass ampule: 1.0 mL ...................... 4/14/2021 4/14/2021 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass Glass Glass Glass 4/14/2021 4/14/2021 4/14/2021 4/14/2021 Cayman Cayman Cayman Cayman Cayman Cayman jspears on DSK121TN23PROD with NOTICES1 Application date Supplier Chemical Chemical Chemical Chemical Chemical Chemical Company Company Company Company Company Company ............ ............ ............ ............ ............ ............ Cayman Chemical Company ............ Cayman Chemical Company ............ Cayman Chemical Company ............ Cayman Chemical Company ............ Cayman Chemical Company ............ Cayman Cayman Cayman Cayman Chemical Chemical Chemical Chemical VerDate Sep<11>2014 Company Company Company Company ............ ............ ............ ............ 18:17 Jan 20, 2022 Jkt 256001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: 21JAN1 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 mL mL mL mL mL mL mL mL mL mL ...................... ...................... ...................... ...................... 4/13/2021 4/13/2021 4/13/2021 4/1/2021 4/1/2021 4/1/2021 4/1/2021 4/1/2021 4/1/2021 4/1/2021 3337 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices CHART I—Continued Supplier Product name Cayman Cayman Cayman Cayman Cayman Cayman Chemical Chemical Chemical Chemical Chemical Chemical Company Company Company Company Company Company ............ ............ ............ ............ ............ ............ Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ Cayman Chemical Company ............ Cayman Cayman Cayman Cayman Cayman Cayman Cayman Chemical Chemical Chemical Chemical Chemical Chemical Chemical Company Company Company Company Company Company Company ............ ............ ............ ............ ............ ............ ............ Cayman Chemical Company ............ Cayman Chemical Company ............ Cayman Chemical Company ............ Cayman Chemical Company ............ Cayman Chemical Company ............ Cayman Chemical Company ............ Cayman Chemical Company ............ jspears on DSK121TN23PROD with NOTICES1 Cayman Chemical Company ............ Cayman Cayman Cayman Cayman Cayman Cayman Chemical Chemical Chemical Chemical Chemical Chemical Company Company Company Company Company Company ............ ............ ............ ............ ............ ............ Cayman Chemical Company ............ Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cliniqa Corporation ............................ Cliniqa Corporation ............................ Cliniqa Corporation ............................ VerDate Sep<11>2014 17:39 Jan 20, 2022 Cocaethylene (CRM); 100 μg/mL in Methanol .......................................... Cyclohexyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ........ Cyclohexyl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ... Cyclopentyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ....... Cyclopropyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ....... Cyclopropyl fentanyl-13C6 (hydrochloride) (CRM); 100 μg/mL in Methanol. D8-THCA-A (CRM) 1 mg/ml, 1 mL in acetonitrile ...................................... D8-THCA-A (CRM) 100 μg/ml, 1 mL in acetonitrile ................................... D8-THCH (CRM) 1 mg/ml, 1 mL in acetonitrile ......................................... D8-THCH (CRM) 1 mg/ml, 1 mL in methanol ............................................ D8-THCH (CRM) 100 μg/ml, 1 mL in acetonitrile ...................................... D8-THCH (CRM) 100 μg/ml, 1 mL in methanol ......................................... D9-THCB (CRM) 100 μg/mL, 1 mL acetonitrile ......................................... D9-THCB (CRM) 1 mg/ml, 1 mL in acetonitrile ......................................... D9-THCB (CRM) 1 mg/ml, 1 mL methanol ................................................ D9-THCB (CRM) 100 μg/mL, 1 mL methanol ............................................ D9-THCBA-A (CRM) 1 mg/ml, 1 mL in acetonitrile ................................... D9-THCBA-A (CRM) 100 μg/mL, 1 mL acetonitrile ................................... D9-THCH (CRM) 1 mg/ml, 1 mL in acetonitrile ......................................... D9-THCH (CRM) 1 mg/ml, 1 mL in methanol ............................................ D9-THCH (CRM) 100 μg/ml, 1 mL in acetonitrile ...................................... D9-THCH (CRM) 100 μg/ml, 1 mL in methanol ......................................... D9-THCHA–A (CRM) 1 mg/ml, 1 mL in acetonitrile .................................. D9-THCHA–A (CRM) 100 μg/ml, 1 mL in acetonitrile ............................... D9-THCP (CRM) 1 mg/ml, 1 mL in acetonitrile ......................................... D9-THCP (CRM) 1 mg/ml, 1 mL methanol ................................................ D9-THCP (CRM) 100 μg/mL, 1 mL acetonitrile ......................................... D9-THCP (CRM) 100 μg/mL, 1 mL methanol ............................................ D9-THCPA-A (CRM) 1 mg/ml, 1 mL in acetonitrile ................................... D9-THCPA-A (CRM) 100 μg/mL, 1 mL acetonitrile ................................... FIBF (hydrochloride) (CRM); 100 μg/mL in Methanol ................................ FIBF-d7 (hydrochloride) (CRM); 100 μg/mL in Methanol .......................... Furanyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol .............. Furanyl fentanyl-13C6 (hydrochloride) (CRM); 100 μg/mL in Methanol .... Furanyl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ........ Isobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol .......... Isobutyryl fentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ..... Lorcaserin (hydrochloride) (CRM); 100 μg/mL in Methanol ....................... meta-Fluorobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol. meta-Fluoroisobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol. Methoxyacetyl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol ... MMB-FUBINACA (CRM); 100 μg/mL in Methanol ..................................... MT-45-d11 (hydrochloride) (CRM); 100 μg/mL in Methanol ...................... N-ethyl Pentylone (hydrochloride) (CRM); 100 μg/mL in Methanol ........... Ocfentanil (hydrochloride) (CRM); 100 μg/mL in Methanol ....................... Ocfentanil-d5 (hydrochloride); 100 μg/mL in Methanol (CRM) .................. ortho-Fluorobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol. ortho-Fluoroisobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol. para-Chloroisobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol. para-Fluorobutyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol. para-Fluorobutyryl fentanyl-13C6 (hydrochloride) (CRM); 100 μg/mL in Methanol. para-Fluorobutyryl fentanyl-d7 (hydrochloride) (CRM); 100 μg/mL in Methanol. para-Fluorofentanyl-d5 (hydrochloride) (CRM); 100 μg/mL in Methanol ... para-methoxy-Butyryl fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol. para-methoxy-Butyryl fentanyl-d7 (hydrochloride) (CRM); 100 μg/mL in Methanol. PV8 (hydrochloride) (CRM); 100 μg/mL in Methanol ................................. Tetrahydrofuran fentanyl (hydrochloride) (CRM); 100 μg/mL in Methanol Valeryl fentanyl (CRM); 100 μg/mL in Methanol ........................................ Valeryl fentanyl-13C6 (CRM); 100 μg/mL in Methanol .............................. Valeryl fentanyl-d5 (CRM); 100 μg/mL in Methanol .................................. a-Ethylaminohexanophenone (hydrochloride) (CRM); 100 μg/mL in Methanol. a-Pyrrolidinohexanophenone (hydrochloride) (CRM); 100 μg/mL in Methanol. 6-Acetylcodeine-D3 .................................................................................... Normorphine-D3 ......................................................................................... TDM + MTX Control Level 1, Part: 43746 ................................................. TDM + MTX Control Level 1, Part: 83737 ................................................. TDM + MTX Control Level 2, Part: 43747 ................................................. Jkt 256001 PO 00000 Frm 00060 Fmt 4703 Application date Form Sfmt 4703 Glass Glass Glass Glass Glass Glass ampule: ampule: ampule: ampule: ampule: ampule: 1.0 1.0 1.0 1.0 1.0 1.0 ...................... ...................... ...................... ...................... ...................... ...................... 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1 mL ......................... 1.0 mL ...................... 1.0 mL ...................... 1.0 mL ...................... 1.0 mL ...................... 1.0 mL ...................... 1.0 mL ...................... 1.0 mL ...................... 1.0 mL ...................... 1.0 mL ...................... 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 6/8/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass Glass Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... ...................... ...................... 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass ampule: 1.0 mL ...................... Glass ampule: 1.0 mL ...................... 4/14/2021 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... ...................... 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 4/14/2021 Glass ampule: 1.0 mL ...................... 4/14/2021 Glass ampule: 1.0 mL ...................... Glass ampule: 1.0 mL ...................... Bottle: 500 ml ................................... Vial: 5 ml .......................................... Bottle: 500 ml ................................... 4/15/2021 4/15/2021 4/27/2021 4/27/2021 4/27/2021 E:\FR\FM\21JAN1.SGM ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: 21JAN1 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL 3338 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices jspears on DSK121TN23PROD with NOTICES1 CHART I—Continued Supplier Product name Form Cliniqa Corporation ............................ Cliniqa Corporation ............................ Cliniqa Corporation ............................ College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... TDM + MTX Control Level 2, Part: 83738 ................................................. TDM + MTX Control Level 3, Part: 43747 ................................................. TDM + MTX Control Level 3, Part: 83739 ................................................. 2022 DMPM–01 .......................................................................................... 2022 DMPM–02 .......................................................................................... 2022 DMPM–03 .......................................................................................... 2022 DMPM–05 .......................................................................................... 2022 DMPM–06 .......................................................................................... 2022 DMPM–07 .......................................................................................... 2022 FTC–02 .............................................................................................. 2022 FTC–03 .............................................................................................. 2022 FTC–04 .............................................................................................. 2022 FTC–05 .............................................................................................. 2022 FTC–07 .............................................................................................. 2022 FTC–08 .............................................................................................. 2022 FTC–10 .............................................................................................. 2022 FTC–12 .............................................................................................. 2022 FTC–13 .............................................................................................. 2022 FTC–14 .............................................................................................. 2022 OFD–01 ............................................................................................. 2022 OFD–02 ............................................................................................. 2022 OFD–03 ............................................................................................. 2022 OFD–04 ............................................................................................. 2022 OFD–05 ............................................................................................. 2022 OFD–06 ............................................................................................. 2022 OFD–07 ............................................................................................. 2022 OFD–08 ............................................................................................. 2022 OFD–10 ............................................................................................. 2022 OFD–11 ............................................................................................. 2022 OFD–12 ............................................................................................. 2022 OFD–13 ............................................................................................. 2022 OFD–14 ............................................................................................. 2022 OFD–15 ............................................................................................. 2022 OFD–16 ............................................................................................. 2022 OFD–17 ............................................................................................. 2022 OFD–18 ............................................................................................. 2022 OFD–19 ............................................................................................. 2022 OFD–20 ............................................................................................. 2022 T–03 .................................................................................................. 2022 T–04 .................................................................................................. 2022 T–05 .................................................................................................. 2022 T–07 .................................................................................................. 2022 T–08 .................................................................................................. 2022 T–09 .................................................................................................. 2022 T–12 .................................................................................................. 2022 T–13 .................................................................................................. 2022 THCB–01 ........................................................................................... 2022 THCB–02 ........................................................................................... 2022 THCB–03 ........................................................................................... 2022 THCB–04 ........................................................................................... 2022 THCB–05 ........................................................................................... 2022 THCB–06 ........................................................................................... 2022 UDS–01 ............................................................................................. 2022 UDS–02 ............................................................................................. 2022 UDS–03 ............................................................................................. 2022 UDS–04 ............................................................................................. 2022 UDS–05 ............................................................................................. 2022 UDS–06 ............................................................................................. 2022 UDS–07 ............................................................................................. 2022 UDS–08 ............................................................................................. 2022 UDS–09 ............................................................................................. 2022 UDS–10 ............................................................................................. 2022 UDS–11 ............................................................................................. 2022 UDS–12 ............................................................................................. 2022 UDS–13 ............................................................................................. 2022 UDS–14 ............................................................................................. 2022 UDS–15 ............................................................................................. 2022 UT–01 ................................................................................................ 2022 UT–02 ................................................................................................ 2022 UT–03 ................................................................................................ 2022 UT–04 ................................................................................................ 2022 UT–05 ................................................................................................ 2022 UT–06 ................................................................................................ 2022 UT–07 ................................................................................................ 2022 UT–08 ................................................................................................ 2022 UT–09 ................................................................................................ 2022 UT–10 ................................................................................................ 2022 UT–11 ................................................................................................ 2022 UT–12 ................................................................................................ 2022 UT–13 ................................................................................................ Vial: 5 ml .......................................... Bottle: 500 ml ................................... Vial: 5 ml .......................................... HDPE bottle: 40 mL ......................... HDPE bottle: 40 mL ......................... HDPE bottle: 40 mL ......................... HDPE bottle: 40 mL ......................... HDPE bottle: 40 mL ......................... HDPE bottle: 40 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE vial: 2 mL .............................. HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... HDPE bottle: 20 mL ......................... Glass vial: 10 mL ............................. Glass vial: 10 mL ............................. Glass vial: 10 mL ............................. Glass vial: 10 mL ............................. Glass vial: 10 mL ............................. Glass vial: 10 mL ............................. HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 10 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1 Application date 4/27/2021 4/27/2021 4/27/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 3339 CHART I—Continued Product name Form College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... College of American Pathologists ..... CPI International ................................ LGC—Dr. Ehrenstorfer ...................... 2022 UT–14 ................................................................................................ 2022 UT–15 ................................................................................................ 2022 UTCO–01 .......................................................................................... 2022 ZE–01 ................................................................................................ 2022 ZE–02 ................................................................................................ 2022 ZE–03 ................................................................................................ 2022 ZE–04 ................................................................................................ 2022 ZE–05 ................................................................................................ 2022 ZE–06 ................................................................................................ 2022FTC–01 ............................................................................................... 2022–OFD–09 ............................................................................................ (-)-delta9-tetrahydrocannabinol (d9-THC) 1000 mg/L, 1 mL ..................... Custom (-)-delta9-tetrahydrocannabinol (d9-HC) 1000 μg/mL in acetonitrile. Custom Pharmaceutical Mix 6509 100–10000 μg/mL in methanol ........... Custom Pharmaceutical Mix 6509 100–10000 μg/mL in methanol ........... D11-Tetrahydrocannabinol (D11-THC) 100 μg/mL in Methanol ................. D11-Tetrahydrocannabinol (D11-THC) 100 μg/mL in Methanol ................. D11-Tetrahydrocannabinol (D11-THC) 1000 μg/mL in Methanol ............... D11-Tetrahydrocannabinol (D11-THC) 1000 μg/mL in Methanol ............... D9-Tetrahydrocannabivarinic acid (THCVA) 100 μg/mL in Methanol ........ D9-Tetrahydrocannabivarinic acid (THCVA) 1000 μg/mL in Methanol ...... Boldenone cypionate 100 μg/mL in Acetonitrile ........................................ LZI Norfentanyl (Q) Qualitative Calibrator (5 ng/mL), Ref# C68815 ......... LZI Norfentanyl Level 1 Control (3.75 ng/mL), Ref# C68821 .................... LZI Norfentanyl Level 2 Control (6.25 ng/mL), Ref# C68822 .................... LZI Norfentanyl Qualitative Calibrator (5 ng/mL), Ref# C68810 ................ LZI Norfentanyl Semi-Quantitative Calibrator Set, Ref# C68811 .............. Norbuprenorphine DAU Calibrator, Norbuprcnorphinc, Intermediate Calibrator #2 (40 ng/mL), Ref# A68829. Norbuprenorphine DAU Calibrator, Norbuprenorphine Level 2 Control (13 ng/mL), Ref# A68825. Norbuprenorphine DAU Calibrator, Norbuprenorphine Low Calibrator (5 ng/mL), Ref# A68826. Norbuprenorphine DAU Calibrator, Norbuprenorphine, Cutoff Calibrator (10 ng/mL), Ref# A68827. Norbuprenorphine DAU Calibrator, Norbuprenorphine, High Calibrator (100 ng/mL), Ref# A68830. Norbuprenorphine DAU Calibrator, Norbuprenorphine, Intermediate Calibrator #1 (20 ng/mL), Ref# A68828. Norbuprenorphine DAU Calibrator, Norbuprenorphine, Level 1 Control (7 ng/mL), Ref# A68824. Alinity c Benzodiazepines Qual Calibrator Kit, Catalog Number: 10027281/09P5201. Alinity c Cannabinoids Control 1 Kit, Catalog Number: 10024827/ 09P5410. Alinity c Cannabinoids Control 2 Kit, Catalog Number: 10027212/ 09P5411. Alinity c Cannabinoids Qual Calibrator, Catalog Number: 10024821/ 09P5401. Alinity c Cannabinoids SemiQuant 100 Calibrator Kit, Catalog Number: 10026530/09P5402. Alinity c Cannabinoids SemiQuant 200 Calibrator Kit, Catalog Number: 10026531/09P5403. Alinity c Ecstasy Qual Calibrator Kit, Catalog Number: 10024822/ 09P5801. Alinity c Ecstasy Semiquant Calibrator Kit, Catalog Number: 10026532/ 09P5802. Alinity c Opiates Qual Calibrator Kit, Catalog Number: 10024823/ 09P6501. Alinity c Opiates Semiquant Calibrator Kit, Catalog Number: 10026534/ 09P6502. Codeine monohydrate as codeine Solution, 2,000 mg/L—Parent Stock Solution—Not For Sale. Heroin Solution, 2,000 mg/L—Parent Stock Solution—Not For Sale ........ Hydrocodone (+)-bitartrate salt as hydrocodone Solution, 2,000 mg/L— Parent Stock Solution—Not For Sale. 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). ISO 17034 Custom Toxin/Poison Stock Standard Mix, 10–318, 100 mg/ L, 1 mL. ISO 17034 Custom Toxin/Poison Stock Standard Mix, 10–319, 100 mg/ L, 1 mL. ISO 17034 Custom Toxin/Poison Stock Standard Mix, 34–318, 100 mg/ L, 1 mL. ISO 17034 Custom Toxin/Poison Stock Standard Mix, 34–318, 100 mg/ L, 1 mL. Levorphanol (+)-tartrate salt dehydrate as levorphanol Solution, 2,000 mg/L—Parent Stock Solution—Not For Sale. HDPE bottle: 50 mL ......................... HDPE bottle: 50 mL ......................... HDPE bottle: 40 mL ......................... Glass vial: 5 mL ............................... Glass vial: 5 mL ............................... Glass vial: 5 mL ............................... Glass vial: 5 mL ............................... Glass vial: 5 mL ............................... Glass vial: 5 mL ............................... HDPE bottle: 20 mL ......................... HDPE vial: 2 mL .............................. Amber ampule: 1 mL ....................... Amber ampule: 1 mL ....................... 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/19/2021 4/7/2021 4/12/2021 Amber ampule: 1 mL ....................... 1 kit: 5 ampules × 1 mL each .......... Amber ampule: 1 mL ....................... Amber ampule: 1 mL ....................... Amber ampule: 1 mL ....................... Amber ampule: 1 mL ....................... Amber ampule: 1 mL ....................... Amber ampule: 1 mL ....................... Amber ampule: 1 mL ....................... Dropper bottle: 5 mL ........................ Dropper bottle: 5 mL ........................ Dropper bottle: 5 mL ........................ Dropper bottle: 5 mL ........................ Kit: 4 dropper bottles; 15 mL each .. Dropper bottle: 5 mL ........................ 6/8/2021 4/12/2021 6/14/2021 4/20/2021 6/14/2021 4/20/2021 6/8/2021 6/8/2021 5/4/2021 6/9/2021 6/9/2021 6/9/2021 6/9/2021 6/9/2021 6/9/2021 Dropper bottle: 5 mL ........................ 6/9/2021 Dropper bottle: 5 mL ........................ 6/9/2021 Dropper bottle: 5 mL ........................ 6/9/2021 Dropper bottle: 5 mL ........................ 6/9/2021 Dropper bottle: 5 mL ........................ 6/9/2021 Dropper bottle: 5 mL ........................ 6/9/2021 Kit: 1 vial, 2.9 mL ............................. 4/2/2021 Kit: 2 LDPE, 5 mL each ................... 4/2/2021 Kit: 1 LDPE, 5 mL ............................ 4/2/2021 Kit: 1 vial, 3.0 mL ............................. 4/2/2021 Kit: 3 vials, 3 mL each ..................... 4/2/2021 Kit: 3 vials, 3 mL each ..................... 4/2/2021 Kit: 1 vial, 3.0 mL ............................. 4/2/2021 Kit: 4 vials, 3.0 mL each .................. 4/2/2021 Kit: 1 vial, 3.0 mL ............................. 4/2/2021 Kit: 4 vials, 3 mL each ..................... 4/2/2021 Glass cryule: 2 mL ........................... 5/28/2021 Glass cryule: 2 mL ........................... Glass cryule: 2 mL ........................... 5/28/2021 5/28/2021 Kit: 2 amber ampules, 1 mL each ... 5/28/2021 Amber ampule: 1 mL ....................... 5/28/2021 Amber ampule: 1 mL ....................... 5/28/2021 Amber ampule: 1 mL ....................... 5/27/2021 Amber ampule: 1 mL ....................... 4/26/2021 Glass cryule: 2 mL ........................... 5/28/2021 LGC—Dr. Ehrenstorfer ...................... LGC—Dr. Ehrenstorfer ...................... LGC—Dr. Ehrenstorfer ...................... LGC—Dr. Ehrenstorfer ...................... LGC—Dr. Ehrenstorfer ...................... LGC—Dr. Ehrenstorfer ...................... LGC—Dr. Ehrenstorfer ...................... LGC—Dr. Ehrenstorfer ...................... LGC—Dr. Ehrenstorfer ...................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Lin-Zhi International ........................... Microgenics Corporation ................... Microgenics Corporation ................... Microgenics Corporation ................... Microgenics Corporation ................... Microgenics Corporation ................... Microgenics Corporation ................... Microgenics Corporation ................... Microgenics Corporation ................... Microgenics Corporation ................... Microgenics Corporation ................... o2si Smart Solutions ......................... o2si Smart Solutions ......................... o2si Smart Solutions ......................... o2si smart solutions .......................... jspears on DSK121TN23PROD with NOTICES1 Application date Supplier o2si smart solutions .......................... o2si smart solutions .......................... o2si smart solutions .......................... o2si Smart Solutions ......................... o2si smart solutions .......................... VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1 3340 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices CHART I—Continued Supplier Product name Form o2si Smart Solutions ......................... o2si Smart Solutions ......................... Restek Corporation ........................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... UTAK Laboratories, Inc ..................... Oxycodone Solution, 2,000 mg/L—Parent Stock Solution—Not For Sale Pentazocine Solution, 2,000 mg/L—Parent Stock Solution ....................... Custom D-Methamphetamine Standard ..................................................... DAU High Cutoff 1 Urine Control ............................................................... DAU High Cutoff 2 Urine Control ............................................................... DAU Low Cutoff 1 Urine Control ................................................................ DAU Low Cutoff 2 Urine Control ................................................................ Drugs of Abuse Level 1 Whole Blood Control ........................................... Fentanyl Analogues 2 NG/ML Whole Blood Control ................................. Fentanyl Analogues 5 NG/ML Urine Control ............................................. PM 100 Urine Control ................................................................................. PM 100 Whole Blood Control ..................................................................... PM Plus High Urine Control ....................................................................... PM Plus Low Urine Control ........................................................................ SAMHSA Confirm Level 1 SMX Oral Fluid Control ................................... SAMHSA Confirm Level 2 SMX Oral Fluid Control ................................... Glass cryule: 2 mL ........................... Glass cryule: 2 mL ........................... Glass Ampule: 1.3 mL ..................... Kit: 4 bottles, 10 mL each ................ Kit: 4 bottles, 10 mL each ................ Kit: 4 bottles, 10 mL each ................ Kit: 4 bottles, 10 mL each ................ Kit: 5 bottles, 5 mL each .................. Kit: 5 bottles, 3 mL each .................. Kit: 5 bottles, 3 mL each .................. Kit: 5 bottles, 5 mL each .................. Kit: 5 bottles, 5 mL each .................. Kit: 5 bottles, 5 mL each .................. Kit: 5 bottles, 5 mL each .................. Kit: 5 bottles, 3 mL each .................. Kit: 5 bottles, 3 mL each .................. 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 Application date 5/28/2021 5/28/2021 4/15/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 4/16/2021 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 Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Glass vial, bottle, or flask: 500 mL– 1L. Glass vial, bottle, or flask: 100mL– 500 mL. Glass vial, bottle, or flask: 100 mL .. 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. jspears on DSK121TN23PROD with NOTICES1 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 https:// www.DEAdiversion.usdoj.gov/ schedules/exempt/exempt_chemlist.pdf. The dates of applications of all current VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 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 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Application date 4/1/2021 4/1/2021 4/1/2021 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). E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3335-3340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01125]


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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.

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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 https://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 https://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 https://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 https://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.
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    \1\ This 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.
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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 
non-narcotic 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

[[Page 3336]]

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-by-case 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
----------------------------------------------------------------------------------------------------------------
                                                                                                     Application
                Supplier                           Product name                      Form                date
----------------------------------------------------------------------------------------------------------------
Aalto Scientific, Ltd..................  Immunoassay Base (Level A-E)...  Glass or plastic bottle      4/13/2021
                                                                           or flask: 500 mL-1 L.
Aalto Scientific, Ltd..................  Immunoassay Base (Level A-E)...  Glass or plastic bottle      4/13/2021
                                                                           or flask: 100 mL-500 mL.
Aalto Scientific, Ltd..................  Immunoassay Base (Level A-E)...  Glass or plastic bottle      4/13/2021
                                                                           or flask: 1 mL-100 mL.
Aalto Scientific, Ltd..................  Immunoassy Base (Level A-E)....  Glass vial, bottle, or        4/1/2021
                                                                           flask: 1 mL.
Aalto Scientific, Ltd..................  TDM Base (Level A-E)...........  Glass vial, bottle, or        4/1/2021
                                                                           flask: 500 mL-1L.
Aalto Scientific, Ltd..................  TDM Base (Level A-E)...........  Glass vial, bottle, or        4/1/2021
                                                                           flask: 100mL-500 mL.
Aalto Scientific, Ltd..................  TDM Base (Level A-E)...........  Glass vial, bottle, or        4/1/2021
                                                                           flask: 1 mL-100 mL.
Aalto Scientific, Ltd..................  TDM Beckman AU Base (Level A-E)  Glass vial, bottle, or        4/1/2021
                                                                           flask: 500 mL-1L.
Aalto Scientific, Ltd..................  TDM Beckman AU Base (Level A-E)  Glass vial, bottle, or        4/1/2021
                                                                           flask: 100mL-500 mL.
Aalto Scientific, Ltd..................  TDM Beckman AU Base (Level A-E)  Glass vial, bottle, or        4/1/2021
                                                                           flask: 1 mL-100 mL.
ARK Diagnostics, Inc...................  DRI Fentanyl II Control........  Kit: 4 Dropper vials, 10     4/15/2021
                                                                           mL each.
ARK Diagnostics, Inc...................  DRI Fentanyl II Cutoff           Kit: 2 Dropper vials, 10     4/15/2021
                                          Calibrator.                      mL each.
Audit MicroControls....................  Linearity FD Fertility Siemens   Kit: 5 vials; 3 mL each..    4/29/2021
                                          Atellica/Centaur.
Audit MicroControls....................  Linearity FD Fertility Siemens   Glass vial: 3 mL.........    4/29/2021
                                          Atellica/Centaur, Set 2 Level
                                          A.
Audit MicroControls....................  Linearity FD Fertility Siemens   Glass vial: 3 mL.........    4/29/2021
                                          Atellica/Centaur, Set 2 Level
                                          B.
Audit MicroControls....................  Linearity FD Fertility Siemens   Glass vial: 3 mL.........    4/29/2021
                                          Atellica/Centaur, Set 2 Level
                                          C.
Audit MicroControls....................  Linearity FD Fertility Siemens   Glass vial: 3 mL.........    4/29/2021
                                          Atellica/Centaur, Set 2 Level
                                          D.
Audit MicroControls....................  Linearity FD Fertility Siemens   Glass vial: 3 mL.........    4/29/2021
                                          Atellica/Centaur, Set 2 Level
                                          E.
Audit MicroControls....................  Linearity FD TDM Siemens         Kit: 5 vials; 5 mL each..    4/27/2021
                                          Atellica/Centaur.
Cayman Chemical Company................  (S)-5-fluoro ADB (CRM); 100      Glass ampule: 1.0 mL.....    4/14/2021
                                          [micro]g/mL in Acetonitrile.
Cayman Chemical Company................  2'-fluoro ortho-Fluorofentanyl   Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  4-ANPP (CRM); 100 [micro]g/mL    Glass ampule: 1.0 mL.....    4/14/2021
                                          in Methanol.
Cayman Chemical Company................  4-ANPP (CRM); 100 [micro]g/mL    Glass ampule: 1.0 mL.....    4/14/2021
                                          in Methanol.
Cayman Chemical Company................  4-ANPP-13C6 (CRM); 100 [micro]g/ Glass ampule: 1.0 mL.....    4/14/2021
                                          mL in Methanol.
Cayman Chemical Company................  4-ANPP-d5 (CRM); 100 [micro]g/   Glass ampule: 1.0 mL.....    4/14/2021
                                          mL in Methanol.
Cayman Chemical Company................  4-ANPP-d5 (CRM); 100 [micro]g/   Glass ampule: 1.0 mL.....    4/14/2021
                                          mL in Methanol.
Cayman Chemical Company................  4'-chloro-[alpha]-               Glass ampule: 1.0 mL.....    4/14/2021
                                          Pyrrolidinovalerophenone
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  4-cyano CUMYL-BUTINACA (CRM);    Glass ampule: 1.0 mL.....    4/14/2021
                                          100 [micro]g/mL in Methanol.
Cayman Chemical Company................  4'-methyl Acetyl fentanyl        Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  4'-methyl Acetyl fentanyl-d5     Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  4-methyl-[alpha]-                Glass ampule: 1.0 mL.....    4/14/2021
                                          Ethylaminopentiophenone
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  4'-methyl-[alpha]-               Glass ampule: 1.0 mL.....    4/14/2021
                                          Pyrrolidinohexanophenone
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  5-fluoro CUMYL-PINACA; 100       Glass ampule: 1.0 mL.....    4/14/2021
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Acrylfentanyl (hydrochloride)    Glass ampule: 1.0 mL.....    4/14/2021
                                          (CRM); 100 [micro]g/mL in
                                          Methanol.
Cayman Chemical Company................  Acrylfentanyl-d5                 Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Butyryl fentanyl-d5              Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.

[[Page 3337]]

 
Cayman Chemical Company................  Cocaethylene (CRM); 100          Glass ampule: 1.0 mL.....    4/14/2021
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Cyclohexyl fentanyl              Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Cyclohexyl fentanyl-d5           Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Cyclopentyl fentanyl             Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Cyclopropyl fentanyl             Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Cyclopropyl fentanyl-13C6        Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  D8-THCA-A (CRM) 1 mg/ml, 1 mL    Glass ampule: 1 mL.......     6/8/2021
                                          in acetonitrile.
Cayman Chemical Company................  D8-THCA-A (CRM) 100 [micro]g/    Glass ampule: 1 mL.......     6/8/2021
                                          ml, 1 mL in acetonitrile.
Cayman Chemical Company................  D8-THCH (CRM) 1 mg/ml, 1 mL in   Glass ampule: 1 mL.......     6/8/2021
                                          acetonitrile.
Cayman Chemical Company................  D8-THCH (CRM) 1 mg/ml, 1 mL in   Glass ampule: 1 mL.......     6/8/2021
                                          methanol.
Cayman Chemical Company................  D8-THCH (CRM) 100 [micro]g/ml,   Glass ampule: 1 mL.......     6/8/2021
                                          1 mL in acetonitrile.
Cayman Chemical Company................  D8-THCH (CRM) 100 [micro]g/ml,   Glass ampule: 1 mL.......     6/8/2021
                                          1 mL in methanol.
Cayman Chemical Company................  D9-THCB (CRM) 100 [micro]g/mL,   Glass ampule: 1 mL.......     6/8/2021
                                          1 mL acetonitrile.
Cayman Chemical Company................  D9-THCB (CRM) 1 mg/ml, 1 mL in   Glass ampule: 1 mL.......     6/8/2021
                                          acetonitrile.
Cayman Chemical Company................  D9-THCB (CRM) 1 mg/ml, 1 mL      Glass ampule: 1 mL.......     6/8/2021
                                          methanol.
Cayman Chemical Company................  D9-THCB (CRM) 100 [micro]g/mL,   Glass ampule: 1 mL.......     6/8/2021
                                          1 mL methanol.
Cayman Chemical Company................  D9-THCBA-A (CRM) 1 mg/ml, 1 mL   Glass ampule: 1 mL.......     6/8/2021
                                          in acetonitrile.
Cayman Chemical Company................  D9-THCBA-A (CRM) 100 [micro]g/   Glass ampule: 1 mL.......     6/8/2021
                                          mL, 1 mL acetonitrile.
Cayman Chemical Company................  D9-THCH (CRM) 1 mg/ml, 1 mL in   Glass ampule: 1 mL.......     6/8/2021
                                          acetonitrile.
Cayman Chemical Company................  D9-THCH (CRM) 1 mg/ml, 1 mL in   Glass ampule: 1 mL.......     6/8/2021
                                          methanol.
Cayman Chemical Company................  D9-THCH (CRM) 100 [micro]g/ml,   Glass ampule: 1 mL.......     6/8/2021
                                          1 mL in acetonitrile.
Cayman Chemical Company................  D9-THCH (CRM) 100 [micro]g/ml,   Glass ampule: 1 mL.......     6/8/2021
                                          1 mL in methanol.
Cayman Chemical Company................  D9-THCHA-A (CRM) 1 mg/ml, 1 mL   Glass ampule: 1 mL.......     6/8/2021
                                          in acetonitrile.
Cayman Chemical Company................  D9-THCHA-A (CRM) 100 [micro]g/   Glass ampule: 1 mL.......     6/8/2021
                                          ml, 1 mL in acetonitrile.
Cayman Chemical Company................  D9-THCP (CRM) 1 mg/ml, 1 mL in   Glass ampule: 1 mL.......     6/8/2021
                                          acetonitrile.
Cayman Chemical Company................  D9-THCP (CRM) 1 mg/ml, 1 mL      Glass ampule: 1 mL.......     6/8/2021
                                          methanol.
Cayman Chemical Company................  D9-THCP (CRM) 100 [micro]g/mL,   Glass ampule: 1 mL.......     6/8/2021
                                          1 mL acetonitrile.
Cayman Chemical Company................  D9-THCP (CRM) 100 [micro]g/mL,   Glass ampule: 1 mL.......     6/8/2021
                                          1 mL methanol.
Cayman Chemical Company................  D9-THCPA-A (CRM) 1 mg/ml, 1 mL   Glass ampule: 1 mL.......     6/8/2021
                                          in acetonitrile.
Cayman Chemical Company................  D9-THCPA-A (CRM) 100 [micro]g/   Glass ampule: 1 mL.......     6/8/2021
                                          mL, 1 mL acetonitrile.
Cayman Chemical Company................  FIBF (hydrochloride) (CRM); 100  Glass ampule: 1.0 mL.....    4/14/2021
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  FIBF-d7 (hydrochloride) (CRM);   Glass ampule: 1.0 mL.....    4/14/2021
                                          100 [micro]g/mL in Methanol.
Cayman Chemical Company................  Furanyl fentanyl                 Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Furanyl fentanyl-13C6            Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Furanyl fentanyl-d5              Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Isobutyryl fentanyl              Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Isobutyryl fentanyl-d5           Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Lorcaserin (hydrochloride)       Glass ampule: 1.0 mL.....    4/14/2021
                                          (CRM); 100 [micro]g/mL in
                                          Methanol.
Cayman Chemical Company................  meta-Fluorobutyryl fentanyl      Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  meta-Fluoroisobutyryl fentanyl   Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Methoxyacetyl fentanyl           Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  MMB-FUBINACA (CRM); 100          Glass ampule: 1.0 mL.....    4/14/2021
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  MT-45-d11 (hydrochloride)        Glass ampule: 1.0 mL.....    4/14/2021
                                          (CRM); 100 [micro]g/mL in
                                          Methanol.
Cayman Chemical Company................  N-ethyl Pentylone                Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Ocfentanil (hydrochloride)       Glass ampule: 1.0 mL.....    4/14/2021
                                          (CRM); 100 [micro]g/mL in
                                          Methanol.
Cayman Chemical Company................  Ocfentanil-d5 (hydrochloride);   Glass ampule: 1.0 mL.....    4/14/2021
                                          100 [micro]g/mL in Methanol
                                          (CRM).
Cayman Chemical Company................  ortho-Fluorobutyryl fentanyl     Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  ortho-Fluoroisobutyryl fentanyl  Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  para-Chloroisobutyryl fentanyl   Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  para-Fluorobutyryl fentanyl      Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  para-Fluorobutyryl fentanyl-     Glass ampule: 1.0 mL.....    4/14/2021
                                          13C6 (hydrochloride) (CRM);
                                          100 [micro]g/mL in Methanol.
Cayman Chemical Company................  para-Fluorobutyryl fentanyl-d7   Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  para-Fluorofentanyl-d5           Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  para-methoxy-Butyryl fentanyl    Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  para-methoxy-Butyryl fentanyl-   Glass ampule: 1.0 mL.....    4/14/2021
                                          d7 (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  PV8 (hydrochloride) (CRM); 100   Glass ampule: 1.0 mL.....    4/14/2021
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Tetrahydrofuran fentanyl         Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Valeryl fentanyl (CRM); 100      Glass ampule: 1.0 mL.....    4/14/2021
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Valeryl fentanyl-13C6 (CRM);     Glass ampule: 1.0 mL.....    4/14/2021
                                          100 [micro]g/mL in Methanol.
Cayman Chemical Company................  Valeryl fentanyl-d5 (CRM); 100   Glass ampule: 1.0 mL.....    4/14/2021
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  [alpha]-Ethylaminohexanophenone  Glass ampule: 1.0 mL.....    4/14/2021
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  [alpha]-                         Glass ampule: 1.0 mL.....    4/14/2021
                                          Pyrrolidinohexanophenone
                                          (hydrochloride) (CRM); 100
                                          [micro]g/mL in Methanol.
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,       Bottle: 500 ml...........    4/27/2021
                                          Part: 43746.
Cliniqa Corporation....................  TDM + MTX Control Level 1,       Vial: 5 ml...............    4/27/2021
                                          Part: 83737.
Cliniqa Corporation....................  TDM + MTX Control Level 2,       Bottle: 500 ml...........    4/27/2021
                                          Part: 43747.

[[Page 3338]]

 
Cliniqa Corporation....................  TDM + MTX Control Level 2,       Vial: 5 ml...............    4/27/2021
                                          Part: 83738.
Cliniqa Corporation....................  TDM + MTX Control Level 3,       Bottle: 500 ml...........    4/27/2021
                                          Part: 43747.
Cliniqa Corporation....................  TDM + MTX Control Level 3,       Vial: 5 ml...............    4/27/2021
                                          Part: 83739.
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

[[Page 3339]]

 
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  Amber ampule: 1 mL.......     4/7/2021
                                          (d9-THC) 1000 mg/L, 1 mL.
LGC--Dr. Ehrenstorfer..................  Custom (-)-delta9-               Amber ampule: 1 mL.......    4/12/2021
                                          tetrahydrocannabinol (d9-HC)
                                          1000 [micro]g/mL in
                                          acetonitrile.
LGC--Dr. Ehrenstorfer..................  Custom Pharmaceutical Mix 6509   Amber ampule: 1 mL.......     6/8/2021
                                          100-10000 [micro]g/mL in
                                          methanol.
LGC--Dr. Ehrenstorfer..................  Custom Pharmaceutical Mix 6509   1 kit: 5 ampules x 1 mL      4/12/2021
                                          100-10000 [micro]g/mL in         each.
                                          methanol.
LGC--Dr. Ehrenstorfer..................  [Delta]11-Tetrahydrocannabinol   Amber ampule: 1 mL.......    6/14/2021
                                          ([Delta]11-THC) 100 [mu]g/mL
                                          in Methanol.
LGC--Dr. Ehrenstorfer..................  [Delta]11-Tetrahydrocannabinol   Amber ampule: 1 mL.......    4/20/2021
                                          ([Delta]11-THC) 100 [mu]g/mL
                                          in Methanol.
LGC--Dr. Ehrenstorfer..................  [Delta]11-Tetrahydrocannabinol   Amber ampule: 1 mL.......    6/14/2021
                                          ([Delta]11-THC) 1000 [mu]g/mL
                                          in Methanol.
LGC--Dr. Ehrenstorfer..................  [Delta]11-Tetrahydrocannabinol   Amber ampule: 1 mL.......    4/20/2021
                                          ([Delta]11-THC) 1000 [mu]g/mL
                                          in Methanol.
LGC--Dr. Ehrenstorfer..................  [Delta]9-                        Amber ampule: 1 mL.......     6/8/2021
                                          Tetrahydrocannabivarinic acid
                                          (THCVA) 100 [mu]g/mL in
                                          Methanol.
LGC--Dr. Ehrenstorfer..................  [Delta]9-                        Amber ampule: 1 mL.......     6/8/2021
                                          Tetrahydrocannabivarinic acid
                                          (THCVA) 1000 [mu]g/mL in
                                          Methanol.
LGC--Dr. Ehrenstorfer..................  Boldenone cypionate 100 [mu]g/   Amber ampule: 1 mL.......     5/4/2021
                                          mL in Acetonitrile.
Lin-Zhi International..................  LZI Norfentanyl (Q) Qualitative  Dropper bottle: 5 mL.....     6/9/2021
                                          Calibrator (5 ng/mL), Ref#
                                          C68815.
Lin-Zhi International..................  LZI Norfentanyl Level 1 Control  Dropper bottle: 5 mL.....     6/9/2021
                                          (3.75 ng/mL), Ref# C68821.
Lin-Zhi International..................  LZI Norfentanyl Level 2 Control  Dropper bottle: 5 mL.....     6/9/2021
                                          (6.25 ng/mL), Ref# C68822.
Lin-Zhi International..................  LZI Norfentanyl Qualitative      Dropper bottle: 5 mL.....     6/9/2021
                                          Calibrator (5 ng/mL), Ref#
                                          C68810.
Lin-Zhi International..................  LZI Norfentanyl Semi-            Kit: 4 dropper bottles;       6/9/2021
                                          Quantitative Calibrator Set,     15 mL each.
                                          Ref# C68811.
Lin-Zhi International..................  Norbuprenorphine DAU             Dropper bottle: 5 mL.....     6/9/2021
                                          Calibrator, Norbuprcnorphinc,
                                          Intermediate Calibrator #2 (40
                                          ng/mL), Ref# A68829.
Lin-Zhi International..................  Norbuprenorphine DAU             Dropper bottle: 5 mL.....     6/9/2021
                                          Calibrator, Norbuprenorphine
                                          Level 2 Control (13 ng/mL),
                                          Ref# A68825.
Lin-Zhi International..................  Norbuprenorphine DAU             Dropper bottle: 5 mL.....     6/9/2021
                                          Calibrator, Norbuprenorphine
                                          Low Calibrator (5 ng/mL), Ref#
                                          A68826.
Lin-Zhi International..................  Norbuprenorphine DAU             Dropper bottle: 5 mL.....     6/9/2021
                                          Calibrator, Norbuprenorphine,
                                          Cutoff Calibrator (10 ng/mL),
                                          Ref# A68827.
Lin-Zhi International..................  Norbuprenorphine DAU             Dropper bottle: 5 mL.....     6/9/2021
                                          Calibrator, Norbuprenorphine,
                                          High Calibrator (100 ng/mL),
                                          Ref# A68830.
Lin-Zhi International..................  Norbuprenorphine DAU             Dropper bottle: 5 mL.....     6/9/2021
                                          Calibrator, Norbuprenorphine,
                                          Intermediate Calibrator #1 (20
                                          ng/mL), Ref# A68828.
Lin-Zhi International..................  Norbuprenorphine DAU             Dropper bottle: 5 mL.....     6/9/2021
                                          Calibrator, Norbuprenorphine,
                                          Level 1 Control (7 ng/mL),
                                          Ref# A68824.
Microgenics Corporation................  Alinity c Benzodiazepines Qual   Kit: 1 vial, 2.9 mL......     4/2/2021
                                          Calibrator Kit, Catalog
                                          Number: 10027281/09P5201.
Microgenics Corporation................  Alinity c Cannabinoids Control   Kit: 2 LDPE, 5 mL each...     4/2/2021
                                          1 Kit, Catalog Number:
                                          10024827/09P5410.
Microgenics Corporation................  Alinity c Cannabinoids Control   Kit: 1 LDPE, 5 mL........     4/2/2021
                                          2 Kit, Catalog Number:
                                          10027212/09P5411.
Microgenics Corporation................  Alinity c Cannabinoids Qual      Kit: 1 vial, 3.0 mL......     4/2/2021
                                          Calibrator, Catalog Number:
                                          10024821/09P5401.
Microgenics Corporation................  Alinity c Cannabinoids           Kit: 3 vials, 3 mL each..     4/2/2021
                                          SemiQuant 100 Calibrator Kit,
                                          Catalog Number: 10026530/
                                          09P5402.
Microgenics Corporation................  Alinity c Cannabinoids           Kit: 3 vials, 3 mL each..     4/2/2021
                                          SemiQuant 200 Calibrator Kit,
                                          Catalog Number: 10026531/
                                          09P5403.
Microgenics Corporation................  Alinity c Ecstasy Qual           Kit: 1 vial, 3.0 mL......     4/2/2021
                                          Calibrator Kit, Catalog
                                          Number: 10024822/09P5801.
Microgenics Corporation................  Alinity c Ecstasy Semiquant      Kit: 4 vials, 3.0 mL each     4/2/2021
                                          Calibrator Kit, Catalog
                                          Number: 10026532/09P5802.
Microgenics Corporation................  Alinity c Opiates Qual           Kit: 1 vial, 3.0 mL......     4/2/2021
                                          Calibrator Kit, Catalog
                                          Number: 10024823/09P6501.
Microgenics Corporation................  Alinity c Opiates Semiquant      Kit: 4 vials, 3 mL each..     4/2/2021
                                          Calibrator Kit, Catalog
                                          Number: 10026534/09P6502.
o2si Smart Solutions...................  Codeine monohydrate as codeine   Glass cryule: 2 mL.......    5/28/2021
                                          Solution, 2,000 mg/L--Parent
                                          Stock Solution--Not For Sale.
o2si Smart Solutions...................  Heroin Solution, 2,000 mg/L--    Glass cryule: 2 mL.......    5/28/2021
                                          Parent Stock Solution--Not For
                                          Sale.
o2si Smart Solutions...................  Hydrocodone (+)-bitartrate salt  Glass cryule: 2 mL.......    5/28/2021
                                          as hydrocodone Solution, 2,000
                                          mg/L--Parent Stock Solution--
                                          Not For Sale.
o2si smart solutions...................  ISO 17034--Custom Toxin/Poison   Kit: 2 amber ampules, 1      5/28/2021
                                          Standard Kit, 45-46, 100 mg/L,   mL each.
                                          1 x 1 ml of Each Level (G34-
                                          140319-01, G34-140339-01, G34-
                                          140340-01).
o2si smart solutions...................  ISO 17034 Custom Toxin/Poison    Amber ampule: 1 mL.......    5/28/2021
                                          Stock Standard Mix, 10-318,
                                          100 mg/L, 1 mL.
o2si smart solutions...................  ISO 17034 Custom Toxin/Poison    Amber ampule: 1 mL.......    5/28/2021
                                          Stock Standard Mix, 10-319,
                                          100 mg/L, 1 mL.
o2si smart solutions...................  ISO 17034 Custom Toxin/Poison    Amber ampule: 1 mL.......    5/27/2021
                                          Stock Standard Mix, 34-318,
                                          100 mg/L, 1 mL.
o2si Smart Solutions...................  ISO 17034 Custom Toxin/Poison    Amber ampule: 1 mL.......    4/26/2021
                                          Stock Standard Mix, 34-318,
                                          100 mg/L, 1 mL.
o2si smart solutions...................  Levorphanol (+)-tartrate salt    Glass cryule: 2 mL.......    5/28/2021
                                          dehydrate as levorphanol
                                          Solution, 2,000 mg/L--Parent
                                          Stock Solution--Not For Sale.

[[Page 3340]]

 
o2si Smart Solutions...................  Oxycodone Solution, 2,000 mg/L-- Glass cryule: 2 mL.......    5/28/2021
                                          Parent Stock Solution--Not For
                                          Sale.
o2si Smart Solutions...................  Pentazocine Solution, 2,000 mg/  Glass cryule: 2 mL.......    5/28/2021
                                          L--Parent Stock Solution.
Restek Corporation.....................  Custom D-Methamphetamine         Glass Ampule: 1.3 mL.....    4/15/2021
                                          Standard.
UTAK Laboratories, Inc.................  DAU High Cutoff 1 Urine Control  Kit: 4 bottles, 10 mL        4/16/2021
                                                                           each.
UTAK Laboratories, Inc.................  DAU High Cutoff 2 Urine Control  Kit: 4 bottles, 10 mL        4/16/2021
                                                                           each.
UTAK Laboratories, Inc.................  DAU Low Cutoff 1 Urine Control.  Kit: 4 bottles, 10 mL        4/16/2021
                                                                           each.
UTAK Laboratories, Inc.................  DAU Low Cutoff 2 Urine Control.  Kit: 4 bottles, 10 mL        4/16/2021
                                                                           each.
UTAK Laboratories, Inc.................  Drugs of Abuse Level 1 Whole     Kit: 5 bottles, 5 mL each    4/16/2021
                                          Blood Control.
UTAK Laboratories, Inc.................  Fentanyl Analogues 2 NG/ML       Kit: 5 bottles, 3 mL each    4/16/2021
                                          Whole Blood Control.
UTAK Laboratories, Inc.................  Fentanyl Analogues 5 NG/ML       Kit: 5 bottles, 3 mL each    4/16/2021
                                          Urine Control.
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  Kit: 5 bottles, 3 mL each    4/16/2021
                                          Fluid Control.
UTAK Laboratories, Inc.................  SAMHSA Confirm Level 2 SMX Oral  Kit: 5 bottles, 3 mL each    4/16/2021
                                          Fluid Control.
----------------------------------------------------------------------------------------------------------------

    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
----------------------------------------------------------------------------------------------------------------
                                                                                                     Application
                Supplier                           Product name                      Form                date
----------------------------------------------------------------------------------------------------------------
Aalto Scientific, Ltd..................  Immunoassy Base (Level A-E)....  Glass vial, bottle, or        4/1/2021
                                                                           flask: 500 mL-1L.
Aalto Scientific, Ltd..................  Immunoassy Base (Level A-E)....  Glass vial, bottle, or        4/1/2021
                                                                           flask: 100mL-500 mL.
Aalto Scientific, Ltd..................  Immunoassy Base (Level A-E)....  Glass vial, bottle, or        4/1/2021
                                                                           flask: 100 mL.
----------------------------------------------------------------------------------------------------------------

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 https://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

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