Exempt Chemical Preparations Under the Controlled Substances Act, 26944-26951 [2017-12110]

Download as PDF asabaliauskas on DSKBBXCHB2PROD with NOTICES 26944 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices a limited exclusion order prohibiting importation of infringing lithium metal oxide cathode materials based upon settlement. FOR FURTHER INFORMATION CONTACT: Panyin A. Hughes, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202– 205–3042. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202–205–2000. General information concerning the Commission may also be obtained by accessing its Internet server (https://www.usitc.gov). The public record for this investigation may be viewed on the Commission’s electronic docket (EDIS) at https:// edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal on 202–205–1810. SUPPLEMENTARY INFORMATION: The Commission instituted the underlying investigation on March 30, 2015, based on a complaint filed by BASF Corporation of Florham Park, New Jersey (‘‘BASF’’) and UChicago Argonne LLC of Lemont, IL (‘‘Argonne’’) (collectively, ‘‘Complainants’’). 80 FR 16696 (Mar. 30, 2015). The complaint alleged violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain lithium metal oxide cathode materials, lithiumion batteries for power tool products containing same, and power tool products with lithium-ion batteries containing same by reason of infringement of one or more of claims 1–4, 7, 13, and 14 of U.S. Patent No. 6,677,082 (‘‘the ’082 patent’’) and claims 1–4, 8, 9, and 17 of U.S. Patent No. 6,680,143 (‘‘the ’143 patent’’). Id. The notice of investigation named the following respondents: Umicore N.V. of Brussels, Belgium; Umicore USA Inc. of Raleigh, North Carolina (collectively, ‘‘Umicore’’); Makita Corporation of Anjo, Japan; Makita Corporation of America of Buford, Georgia; and Makita U.S.A. Inc. of La Mirada, California (collectively, ‘‘Makita’’). Id. The Office of Unfair Import Investigations was a party to the investigation. On November 5, 2015, the ALJ granted a joint motion by Complainants and Makita to terminate the VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 investigation as to Makita based upon settlement. See Order No. 32 (Nov. 5, 2015). The Commission determined not to review this order. See Notice of NonReview (Nov. 23, 2015). On February 29, 2016, the ALJ issued his final initial determination (‘‘ID’’), finding a violation of section 337 by Umicore in connection with claims 1– 4, 7, 13, and 14 of the ’082 patent and claims 1–4, 8, 9, and 17 of the ’143 patent. On May 11, 2016, the Commission determined to review the final ID in part. 81 FR 30548–50 (May 17, 2016). The Commission also granted Umicore’s request for a Commission hearing. Id. On November 17, 2016, the Commission held a hearing on contributory infringement, laches, and the public interest. On review, the Commission determined to affirm the ALJ’s finding of violation of section 337 with respect to the claims identified above. 81 FR 93960–62 (Dec. 22, 2016). Having found a violation of section 337, the Commission determined that the appropriate form of relief was: A limited exclusion order prohibiting the unlicensed entry of lithium metal oxide cathode materials that infringe one or more of claims 1–4, 7, 13, and 14 of the ’082 patent, or claims 1–4, 8, 9, and 17 of the ’143 patent that are manufactured by, or on behalf of, or imported by or on behalf of Umicore N.V. and Umicore USA Inc. or any of their affiliated companies, parents, subsidiaries, agents, or other related business entities, or their successors or assigns. On May 5, 2017, BASF, Argonne, and Umicore filed a joint petition under 19 U.S.C. 1337(k) and Commission Rule 210.76(a) (19 CFR 210.76(a)) to rescind the limited exclusion order based upon settlement. The parties filed both confidential and public versions of the settlement agreements. On May 9, 2017, the Commission investigative attorney filed a response in support of the motion. The Commission has determined to grant the petition. The limited exclusion order issued in this investigation is hereby rescinded. The authority for the Commission’s determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission’s Rules of Practice and Procedure (19 CFR 210). By order of the Commission. Issued: June 6, 2017. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2017–12035 Filed 6–9–17; 8:45 am] BILLING CODE 7020–02–P PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–372] Exempt Chemical Preparations Under the Controlled Substances Act 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 (DEA) between April 1, 2016, and December 31, 2016, 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 August 11, 2017. 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: The Drug Enforcement Administration (DEA) 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: Michael J. Lewis, Diversion Control SUMMARY: E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598–6812. 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. 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 The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and II are referred to as the ‘‘Controlled Substances Act’’ and the ‘‘Controlled Substances Import and Export Act,’’ or the ‘‘CSA’’ for the purpose of this action. 21 U.S.C. 801– 971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Section 201 of the 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 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. 26945 Exempt Chemical Preparation Applications Submitted Between April 1, 2016, and December 31, 2016 The Assistant Administrator received applications between April 1, 2016, and December 31, 2016, 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; if the preparation or mixture contains a narcotic controlled substance, it must be formulated in such a manner that it incorporates methods of denaturing or other means so that the preparation or 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 the 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. CHART I asabaliauskas on DSKBBXCHB2PROD with NOTICES Supplier Product name Form Aalto Scientific, Ltd ..................... Aalto Scientific, Ltd ..................... Aalto Scientific, Ltd ..................... Absolute Standards, Inc .............. Absolute Standards, Inc .............. Absolute Standards, Inc .............. Endocrine Program ......................................................................... Endocrinology .................................................................................. Linearity FD Testosterone, Siemens Centaur ................................. ISO G34 Calibrator Spike High ....................................................... ISO G34 Calibrator Spike Low ........................................................ ISO G34 Calibrator Spike Solution ................................................. Amber vial: 5 mL ............. Amber vial: 5 mL ............. Kit: 5 vials; 3 mL each ..... Glass ampoule: 1 mL ...... Glass ampoule: 1 mL ...... Glass ampoule: 1 mL ...... 1 This authority has been delegated from the Attorney General to the Administrator of the DEA VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 by 28 CFR 0.100, and subsequently redelegated to PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Application date 8/23/2016 8/23/2016 12/7/2016 8/3/2016 8/3/2016 8/3/2016 the Deputy Assistant Administrator pursuant to Section 7 of 28 CFR 0.104, Appendix to Subpart R. E:\FR\FM\12JNN1.SGM 12JNN1 26946 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices CHART I—Continued Application date Supplier Product name Form Absolute Standards, Inc .............. Accriva Diagnostics, Inc .............. ISO G34 Internal Standard ............................................................. Hemochron PT ................................................................................ Arbor Assays ............................... Arbor Assays ............................... Arbor Assays ............................... Arbor Assays ............................... Arbor Assays ............................... Arbor Assays ............................... Biochemical Diagnostics, Inc ...... Biochemical Diagnostics, Inc ...... Biochemical Diagnostics, Inc ...... Biochemical Diagnostics, Inc ...... Biochemical Diagnostics, Inc ...... Biochemical Diagnostics, Inc ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Testosterone 5-pack Enzyme Immunoassay Kit (K032–H5) .......... Testosterone Enzyme Immunoassay Kit (ISWE001) ...................... Testosterone Enzyme Immunoassay Kit (K032–H1) ...................... Testosterone Standard (1,000 ng/mL) ............................................ Testosterone Standard (200,000 pg/mL) ........................................ Testosterone Standard (200,000 pg/mL) ........................................ Detectabuse Custom Liquid Control Urine, MC252 ........................ Detectabuse Custom Liquid Control Urine, MC253 ........................ Detectabuse Custom Liquid Control Urine, MC254 ........................ Detectabuse Custom Liquid Control Urine, MC255 ........................ Detectabuse Custom Liquid Control Urine, MC256 ........................ Detectabuse Custom Liquid Control Urine, MC257 ........................ 11-Keto Testosterone CRM; 1 mg/mL in Acetonitrile ..................... AB-CHMINACA (CRM); 1 mg/mL in Acetonitrile ............................ AB-CHMINACA (CRM); 1 mg/mL in Methanol ............................... AB-CHMINACA (CRM); 100 μg/mL in Acetonitrile ......................... AB-CHMINACA (CRM); 100 μg/mL in Methanol ............................ AB-PINACA CRM; 1 mg/mL in Methanol ....................................... Acetyl Fentanyl CRM; 1 mg/mL in Methanol .................................. Acetyl Fentanyl CRM; 100 μg/mL in Methanol ............................... Cocaine CRM; 1 mg/mL in Acetonitrile ........................................... Cocaine/Heroin/Methamphetamine Mixture CRM; 1 mg/mL each in Acetonitrile. Cocaine/Heroin/Methamphetamine Mixture CRM; 100 μg/mL each in Acetonitrile. Cocaine/Heroin/Methamphetamine Mixture CRM; 250 μg/mL each in Acetonitrile. Cocaine/Heroin/Methamphetamine Mixture CRM; 500 μg/mL each in Acetonitrile. GC-MS Drug Standard Mixture 1 in Acetonitrile ............................. Phytocannabinoid Mixture 1; 1 mg/mL in Acetonitrile .................... Tapentadol (hydrochloride) CRM; 1 mg/mL in Acetonitrile ............. Tapentadol (hydrochloride) CRM; 1 mg/mL in Methanol ................ Tapentadol (hydrochloride) CRM; 100 μg/mL in Acetonitrile .......... Tapentadol (hydrochloride) CRM; 100 μg/mL in Methanol ............. THJ2201 (CRM); 1 mg/mL in Acetonitrile ....................................... THJ2201 (CRM); 1 mg/mL in Methanol .......................................... THJ2201 (CRM); 100 μg/mL in Acetonitrile .................................... THJ2201 (CRM); 100 μg/mL in Methanol ....................................... ToxBox THC/THC Metabolite Plate ................................................ (±)-11-Hydroxy-delta9–THC glucuronide (0.01 mg/mL) .................. (±)-Cannabicyclol (1.0 mg/mL) ........................................................ (±)-cis-3-Methylfentanyl HCl (0.05 mg/mL) ..................................... (±)-cis-3-Methylfentanyl HCl (0.1 mg/mL) ....................................... 5alpha-Dihydrotestosterone-D3 [16, 16, 17–D3]; 10 μg/mL ........... 6beta-Naltrexol (1 mg/mL) .............................................................. AH-7921 HCl (1 mg/mL) ................................................................. AH-7921-D3 HCl (0.1 mg/mL) ......................................................... Brivaracetam-D3 (0.1 mg/mL) ......................................................... Butyryl fentanyl (0.05 mg/mL) ......................................................... Butyryl fentanyl (0.1 mg/mL) ........................................................... Cannabichromenic acid (CBCA) (1.0 mg/mL) ................................ Cannabicyclolic acid (CBLA) (1.0 mg/mL) ...................................... Carfentanil (0.1 mg/mL) .................................................................. Carfentanil oxalate (0.1 mg/mL) ...................................................... Carfentanil-D5 oxalate (0.1 mg/mL) ................................................ Clorazepate dipotassium (1 mg/mL) ............................................... Dihydrotestosterone Calibrator Level 1 (20 pg/mL) ........................ Dihydrotestosterone Calibrator Level 2 (50 pg/mL) ........................ Dihydrotestosterone Calibrator Level 3 (100 pg/mL) ...................... Dihydrotestosterone Calibrator Level 4 (500 pg/mL) ...................... Dihydrotestosterone Calibrator Level 5 (1000 pg/mL) .................... Dihydrotestosterone Calibrator Level 6 (2500 pg/mL) .................... Dihydrotestosterone Calibrator Level 7 (10 ng/mL) ........................ Diphenoxylate HCl (1 mg/mL) ......................................................... Furanyl fentanyl (0.1 mg/mL) .......................................................... Norhydromorphone-D3 HCl (0.1 mg/mL) ........................................ Noroxymorphone-D3 HCl (0.1 mg/mL) ........................................... Glass ampoule: 1 mL ...... Box: 45 cuvettes; 7.5μL each. Kit: 400 μL vial ................. Kit: 1 mL vial .................... Kit: 90 μL vial ................... Plastic vial: 1 mL ............. Plastic vial: 90 μL ............ Plastic vial: 400 μL .......... Glass vial: 1 mL–200 mL Glass vials: 1 ml–200 mL Glass vial: 1 mL–200 mL Glass vial: 1 mL–200 mL Glass vials: 1 ml–200 mL Glass vials: 1 ml–200 mL Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ 10/18/2016 10/18/2016 10/18/2016 10/18/2016 10/18/2016 10/18/2016 7/29/2016 9/30/2016 7/29/2016 7/29/2016 12/19/2016 12/19/2016 6/28/2016 8/26/2016 8/26/2016 8/26/2016 8/26/2016 6/28/2016 6/28/2016 6/28/2016 6/28/2016 8/26/2016 Glass ampule: 1 mL ........ 8/26/2016 Glass ampule: 1 mL ........ 8/26/2016 Glass ampule: 1 mL ........ 8/26/2016 Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ 48-well plate ..................... Glass ampule: 1 mL ........ Glass ampule: 1.0 mL ..... Glass ampule: 1 mL ........ Glass ampule: 0.5 mL ..... Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 0.5 mL ..... Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 0.5 mL ..... Glass ampule: 0.5 mL ..... Glass ampule: 0.5 mL ..... Glass ampule: 1 mL ........ Cryovial: 1 mL .................. Cryovial: 1 mL .................. Cryovial: 1 mL .................. Cryovial: 1 mL .................. Cryovial: 1 mL .................. Cryovial: 1 mL .................. Cryovial: 1 mL .................. Glass ampule: 1 mL ........ Glass ampule: 0.5 mL ..... Glass ampule: 1.0 mL ..... Glass ampule: 1.0 mL ..... 6/28/2016 6/28/2016 8/26/2016 8/26/2016 8/26/2016 8/26/2016 8/26/2016 8/26/2016 8/26/2016 8/26/2016 6/28/2016 11/11/2016 7/18/2016 6/21/2016 7/18/2016 9/28/2016 5/6/2016 5/20/2016 5/20/2016 11/30/2016 6/21/2016 7/18/2016 11/30/2016 11/30/2016 9/28/2016 11/30/2016 11/30/2016 5/6/2016 8/12/2016 8/12/2016 8/12/2016 8/12/2016 8/12/2016 8/12/2016 8/12/2016 5/20/2016 11/30/2016 7/18/2016 7/18/2016 Cayman Chemical Company ...... Cayman Chemical Company ...... asabaliauskas on DSKBBXCHB2PROD with NOTICES Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cayman Chemical Company ...... Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1 8/3/2016 5/17/2016 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices 26947 CHART I—Continued Application date Supplier Product name Form Cerilliant Corporation .................. Cerilliant Corporation .................. Cerilliant Corporation .................. IDEXX Laboratories .................... Pholcodine (1 mg/mL) ..................................................................... Tapentadol-D3 HCl (1 mg/mL) ........................................................ U-47700 (1.0 mg/mL) ...................................................................... Coag Dx PT ..................................................................................... 5/6/2016 11/11/2016 11/30/2016 10/21/2016 IDEXX Laboratories .................... Immunalysis Corporation ............ Coag Dx PT Cartridge ..................................................................... cTHC Urine Calibrator 1 (20 ng/mL) ............................................... Immunalysis Corporation ............ cTHC Urine Calibrator 2 (50 ng/mL) ............................................... Immunalysis Corporation ............ cTHC Urine Calibrator 3 (100 ng/mL) ............................................. Immunalysis Corporation ............ cTHC Urine Calibrator 4 (200 ng/mL) ............................................. Immunalysis Corporation ............ cTHC Urine Control HIGH (62.5 ng/mL) ......................................... Immunalysis Corporation ............ cTHC Urine Control LOW (37.5 ng/mL) .......................................... Immunalysis Immunalysis Immunalysis Immunalysis Immunalysis Immunalysis ............ ............ ............ ............ ............ ............ Fentanyl Urine Calibrator 1 (1 ng/mL) ............................................ Fentanyl Urine Calibrator 2 (2 ng/mL) ............................................ Fentanyl Urine Calibrator 3 (4 ng/mL) ............................................ Fentanyl Urine Control HIGH (1.5 ng/mL) ...................................... Fentanyl Urine Control LOW (0.5 ng/mL) ....................................... MDC Calibrator 1 ............................................................................ Immunalysis Corporation ............ MDC Calibrator 2 ............................................................................ Immunalysis Corporation ............ MDC Calibrator 3 ............................................................................ Immunalysis Corporation ............ MDC Calibrator 4 ............................................................................ Immunalysis Corporation ............ MDC Control HIGH Set 1 ................................................................ Immunalysis Corporation ............ MDC Control HIGH Set 1 ................................................................ Immunalysis Corporation ............ MDC Control LOW Set 1 ................................................................ Immunalysis Corporation ............ MDC Control LOW Set 2 ................................................................ Immunalysis Corporation ............ Opiates Urine Calibrator 2000 1 (1000 ng/mL) .............................. Immunalysis Corporation ............ Opiates Urine Calibrator 2000 2 (2000 ng/mL) .............................. Immunalysis Corporation ............ Opiates Urine Calibrator 2000 3 (4000 ng/mL) .............................. Immunalysis Corporation ............ Opiates Urine Calibrator 2000 4 (6000 ng/mL) .............................. Immunalysis Corporation ............ Oxazepam Urine Control HIGH (125 ng/mL) .................................. Immunalysis Corporation ............ Oxazepam Urine Control LOW (75 ng/mL) .................................... Instrumentation Laboratory ......... Gem Test PT ................................................................................... IsoSciences, LLC ........................ IsoSciences, LLC ........................ Codeine-[13C4, 15N], 1000 μg/mL in methanol ............................. Codeine-6b-Glucuronide-[13C10, 15N], 1000 μg/mL in methanol:water (2:8). Morphine-[13C4, 15N], 1000 μg/mL in methanol ............................ Morphine-6b-Glucuronide-[13C10, 15N], 1000 μg/mL in methanol:water (2:8). Testosterone-[2H8], 100 μg/mL in methanol .................................. Testosterone-[2H8], 1000 μg/mL in methanol ................................ Hemochron Jr .................................................................................. Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Box: 10 cartridges; 7.5μL each. Cartridges: 7.5μL each .... Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL ........ Dropper bottle: 5 mL ........ Dropper bottle: 5 mL ........ Dropper bottle: 5 mL ........ Dropper bottle: 5 mL ........ Dropper bottle: 15 mL, 25 mL. Dropper bottle: 15 mL, 25 mL. Dropper bottle: 15 mL, 25 mL. Dropper bottle: 15 mL, 25 mL. Dropper bottle: 15 mL, 25 mL. Dropper bottle: 15 mL, 25 mL. Dropper bottle: 15 mL, 25 mL. Dropper bottle: 15 mL, 25 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Dropper bottle: 5 mL, 15 mL. Box: 45 cuvettes; 7.5μL each. Amber ampule: 1 mL ....... Amber ampule: 1 mL ....... Amber ampule: 1 mL ....... Amber ampule: 1 mL ....... 10/20/2016 10/20/2016 Amber Ampule: 1 mL ....... Amber Ampule: 1 mL ....... Box: 45 cuvettes; 7.5μL each. Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ 8/10/2016 8/10/2016 7/1/2016 Corporation Corporation Corporation Corporation Corporation Corporation asabaliauskas on DSKBBXCHB2PROD with NOTICES IsoSciences, LLC ........................ IsoSciences, LLC ........................ IsoSciences, LLC ........................ IsoSciences, LLC ........................ ITC ............................................... Lipomed Lipomed Lipomed Lipomed Lipomed Lipomed Lipomed Inc Inc Inc Inc Inc Inc Inc VerDate Sep<11>2014 ................................. ................................. ................................. ................................. ................................. ................................. ................................. 17:28 Jun 09, 2017 25B-NB2OMe (1 mg/mL methanol) ................................................ 25C-NB2OMe (1 mg/mL methanol) ................................................ 25I-NB2OMe (1 mg/mL methanol) .................................................. 25I-NB2OMe-D9 (0.1 mg/mL methanol) ......................................... 25I-NB2OMe-D9 (1 mg/mL methanol) ............................................ 3,4-Methylendioxypyrovalerone (1 mg/mL methanol) ..................... 3,4-Methylenedioxy-a-pyrrolidinopropiophenone (1 mg/mL methanol). Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1 10/21/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 5/27/2016 10/6/2016 10/20/2016 10/20/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 26948 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices CHART I—Continued Application date Product name Form Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Microgenics Corporation ............. 3-Desmethylprodine (1 mg/mL acetonitrile) .................................... 4-Ethylmethcathinone (1 mg/mL methanol) .................................... 4-Methylethcathinone (1 mg/mL methanol) .................................... 4-Methylmethcathinone (1 mg/mL methanol) ................................. 4-Methylmethcathinone-D3 (0.1 mg/mL methanol) ......................... 4-Methylmethcathinone-D3 (1 mg/mL methanol) ............................ Benzodiazepines mixture (.001 mg free base/ml acetonitrile) ........ Benzodiazepines mixture 5 (1 mg free base/mL acetonitrile) ........ Bufotenine.oxalate.monohydrate (1 mg/mL methanol) ................... Butabarbital (1 mg/mL methanol) .................................................... Butalbital (1 mg/mL methanol) ........................................................ Butalbital-D5 (1 mg/mL methanol) .................................................. Butylone (1 mg/mL methanol) ......................................................... Cannabidiol-D3 (0.1 mg/mL methanol) ........................................... Cannabidiol-D3 (1 mg/mL methanol) .............................................. Cannabinol-D3 (0.1 mg/mL methanol) ............................................ Cannabinol-D3 (1 mg/mL methanol) ............................................... Carisoprodol (1 mg/mL methanol) .................................................. Clotiazepam (1 mg/mL methanol) ................................................... Cocaethylene-D3 (1 mg/mL acetonitrile) ........................................ Cocaine mixture 2 (1 mg/mL methanol) ......................................... Desomorphine (1 mg/mL acetonitrile) ............................................. Ethylone (1 mg/mL methanol) ......................................................... JWH-018 (0.1 mg/mL methanol) ..................................................... JWH-018 (1 mg/mL methanol) ........................................................ JWH-018–D11 metabolite (0.1 mg/mL methanol) .......................... JWH-018–D11 metabolite (1 mg/mL methanol) ............................. JWH-019 (0.1 mg/mL methanol) ..................................................... JWH-019 (1 mg/mL methanol) ........................................................ JWH-081 (0.1 mg/mL methanol) ..................................................... JWH-081 (1 mg/mL methanol) ........................................................ JWH-122 (0.1 mg/mL methanol) ..................................................... JWH-122 (1 mg/mL methanol) ........................................................ JWH-200 (0.1 mg/mL methanol) ..................................................... JWH-200 (1 mg/mL methanol) ........................................................ L-Methamphetamine (1 mg/mL methanol) ...................................... Loprazolam (1 mg/mL methanol) .................................................... Mazindol (1 mg/mL Dimethylformamide) ........................................ Meprobamate (1 mg/mL methanol) ................................................. Methandienone (1 mg/mL methanol) .............................................. Methylone (1 mg/mL methanol) ...................................................... Methylone-D3 (0.1 mg/mL methanol) ............................................. Methylone-D3 (1 mg/mL methanol) ................................................ N,N-Dimethylamphetamine (1 mg/mL methanol) ............................ Naphyrone (1 mg/mL methanol) ..................................................... Nimetazepam (1 mg/mL methanol) ................................................. Norbuprenorphine (1 mg/mL methanol) .......................................... Normeperidine (1 mg/mL methanol) ............................................... Pentedrone (1 mg/mL methanol) .................................................... Pentylone (1 mg/mL methanol) ....................................................... Phenobarbital-D5 (side chain) (0.1 mg/mL methanol) .................... Phenobarbital-D5 (side chain) (1 mg/mL methanol) ....................... Pregabalin (1 mg/mL methanol) ...................................................... Propoxyphen-D5 (0.1 mg/mL methanol) ......................................... Propoxyphen-D5 (1 mg/mL methanol) ............................................ Pyrovalerone (1 mg/mL methanol) .................................................. a-Pyrrolidinopropiophenone (1 mg/mL methanol) .......................... a-Pyrrolidinovalerophenone (1 mg/mL methanol) ........................... Cascadion SM Total Testosterone Internal Standard ..................... Cedia Buprenorphine OFT Control Set (Low and High) Catalog Number: 10022377. Cedia Buprenorphine OFT Cutoff Calibrator Catalog Number: 10022376. Cedia Multi-Drug OFT Cutoff Calibrator Set B Catalog Number: 10022355. Cedia Multi-Drug OFT Cutoff Control Set B (Low and High) Catalog Number: 10022356. Intercept i2he Multi-Drug Oral Fluid Cutoff Calibrator Set B Catalog Number: 1001–0419. Intercept i2he Multi-Drug Oral Fluid Cutoff Control Set B (Low and High) Catalog Number: 1001–0420. Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Glass ampule: 1 mL ........ Box: 8 bottles, 29 mL each. Vial: 10 mL; Box: 2 vials .. 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 10/28/2016 12/16/2016 Microgenics Corporation ............. asabaliauskas on DSKBBXCHB2PROD with NOTICES Supplier Vial: 5 mL; Box: 1 vial ..... 11/15/2016 Vial: 10 mL; Box: 1 vial ... 10/20/2016 Vial: 15 mL; Box: 2 vials .. 10/20/2016 Vial: 10 mL; Box: 1 vial ... 10/19/2016 Vial: 15 mL; Box: 2 vials .. 10/19/2016 Microgenics Corporation ............. Microgenics Corporation ............. Microgenics Corporation ............. Microgenics Corporation ............. Microgenics Corporation ............. VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1 11/15/2016 26949 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices CHART I—Continued Application date Supplier Product name Form Microgenics Corporation ............. Vial: 5 mL Box: 1 vial ...... 8/30/2016 Vial: 5 mL Box: 1 vial ...... 8/30/2016 Vial: 5 mL Box: 1 vial ...... 8/30/2016 Vial: 5 mL Box: 1 vial ...... 8/30/2016 Vial: 5 mL Box: 4 vials ..... 8/30/2016 Healthcare Diagnostics, Thermo Scientific CEDIA Buprenorphine II Calibrator 10 ng/mL Catalog Number: 10020799. Thermo Scientific CEDIA Buprenorphine II Calibrator 100 ng/mL Catalog Number: 10020802. Thermo Scientific CEDIA Buprenorphine II Calibrator 20 ng/mL Catalog Number: 10020800. Thermo Scientific CEDIA Buprenorphine II Calibrator 50 ng/mL Catalog Number: 10020801. Thermo Scientific CEDIA Buprenorphine II Controls (Low and High) Catalog Number: 10020804. BK Emit II Plus Oxycodone Negative Control 100 ......................... Bulk Container: 1 L–50 L 8/23/2016 Healthcare Diagnostics, Emit II Plus Oxycodone Negative Control 100 ............................... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, Emit II Plus Oxycodone Negative Control 300 ............................... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, Emit II Plus Oxycodone Positive Control 100 ................................. Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, Emit II Plus Oxycodone Positive Control 300 ................................. Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 .......... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 .......... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 .......... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 .......... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, FC Emit II Plus Oxycodone Negative Control 100 ......................... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, FC Emit II Plus Oxycodone Negative Control 300 ......................... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, FC Emit II Plus Oxycodone Positive Control 100 ........................... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, FC Emit II Plus Oxycodone Positive Control 300 ........................... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, FC Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 .... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, FC Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 .... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, FC Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 .... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, FC Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 .... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, MP FC Emit Oxycodone Negative Control 100 .............................. Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, MP FC Emit Oxycodone Negative Control 300 .............................. Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, MP FC Emit Oxycodone Positive Control 100 ................................ Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, MP FC Emit Oxycodone Positive Control 300 ................................ Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, MP FC Emit Specialty Multi Drug Calibrator/Control LVL 1 ........... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, MP FC Emit Specialty Multi Drug Calibrator/Control LVL 2 ........... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, MP FC Emit Specialty Multi Drug Calibrator/Control LVL 3 ........... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, MP FC Emit Specialty Multi Drug Calibrator/Control LVL 4 ........... Vial: 10 mL ....................... 8/23/2016 Healthcare Diagnostics, Pilot Emit II Plus Oxycodone Negative Control 100 ....................... 4 mL–200 8/23/2016 Healthcare Diagnostics, Pilot Emit II Plus Oxycodone Negative Control 300 ....................... 4 mL–200 8/23/2016 Healthcare Diagnostics, Pilot Emit II Plus Oxycodone Positive Control 100 ......................... 4 mL–200 8/23/2016 Healthcare Diagnostics, Pilot Emit II Plus Oxycodone Positive Control 300 ......................... 4 mL–200 8/23/2016 Healthcare Diagnostics, Pilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 1 .... Pilot container: mL. Pilot container: mL. Pilot container: mL. Pilot container: mL. Pilot container: mL. 4 mL–200 8/23/2016 Microgenics Corporation ............. Microgenics Corporation ............. Microgenics Corporation ............. asabaliauskas on DSKBBXCHB2PROD with NOTICES Microgenics Corporation ............. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. Siemens Inc. VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1 26950 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices CHART I—Continued Supplier Product name Form Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Inc. USP ............................................. UTAK Laboratories, Inc ............... Pilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 2 .... USP Levomethorphan Solution Reference Standard ..................... AED II HR Serum Control, Ref: 72740 ........................................... UTAK Laboratories, Inc ............... AED II MR Serum Control, Ref: 72741 ........................................... UTAK Laboratories, Inc ............... Benzodiazepines 2 Serum Control HR, Ref: 22615 ....................... UTAK Laboratories, Inc ............... Benzodiazepines 2 Serum Control MR, Ref: 22616 ....................... UTAK Laboratories, Inc ............... Benzodiazepines Plus 100 Urine Control, Ref: 12090 ................... UTAK Laboratories, Inc ............... Benzodiazepines Plus 100 Whole Blood Control, Ref: 12092 ....... UTAK Laboratories, Inc ............... Benzodiazepines Plus 400 ng/mL Urine Control, Ref: 12091 ........ UTAK Laboratories, Inc ............... Clonazepam Serum Control HR, Ref: 22610 ................................. UTAK Laboratories, Inc ............... Clonazepam Serum Control MR, Ref: 22611 ................................. UTAK Laboratories, Inc ............... DHEA Plus High Serum Control, Ref: 51411 ................................. UTAK Laboratories, Inc ............... DHEA Plus Low Serum Control, Ref: 51410 .................................. UTAK Laboratories, Inc ............... Pentobarbital Serum Control, Ref: 66319 ....................................... UTAK Laboratories, Inc ............... Steroids Level 1 SMx Serum Control, Ref: 51401 ......................... UTAK Laboratories, Inc ............... Steroids Level 2 SMx Serum Control, Ref: 51402 ......................... UTAK Laboratories, Inc ............... Steroids Level 3 SMx Serum Control, Ref: 51403 ......................... UTAK Laboratories, Inc ............... Steroids Level 4 SMx Serum Control, Ref: 51404 ......................... Pilot container: 4 mL–200 mL. Pilot container: 4 mL–200 mL. Pilot container: 4 mL–200 mL. Box: 3 vials, 1.2 mL each Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 3 mL each. Carton: 5 bottles, 3 mL each. Carton: 5 bottles, 5 mL each. Carton: 5 bottles, 3 mL each. Carton: 5 bottles, 3 mL each. Carton: 5 bottles, 3 mL each. Carton: 5 bottles, 3 mL each. Pilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 3 .... Pilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 4 .... 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 8/23/2016 8/23/2016 8/23/2016 9/13/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 12/27/2016 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 asabaliauskas on DSKBBXCHB2PROD with NOTICES Supplier Product name Form Aalto Scientific, Ltd .................................. Biochemical Diagnostics, Inc ................... Cerilliant Corporation ............................... Cerilliant Corporation ............................... Cerilliant Corporation ............................... Cerilliant Corporation ............................... Lipomed Inc ............................................. Lipomed Inc ............................................. Siemens Healthcare Diagnostics, Inc ..... Siemens Healthcare Diagnostics, Inc ..... Siemens Healthcare Diagnostics, Inc ..... Siemens Healthcare Diagnostics, Inc ..... Siemens Healthcare Diagnostics, Inc ..... Siemens Healthcare Diagnostics, Inc ..... Siemens Healthcare Diagnostics, Inc ..... General Chemistry Serum .......................................................................... Detectabuse Custom Liquid Control Urine, MC253 ................................... (±)-cis-3-Methylfentanyl HCl (0.1 mg/mL) ................................................... (±)-cis-3-Methylfentanyl HCl (1 mg/mL) ...................................................... Butyryl fentanyl (0.1 mg/mL) ...................................................................... Butyryl fentanyl HCl (1 mg/mL) .................................................................. Benzodiazepines mixture 8 (0.25 mg free base/mL acetonitrile) ............... Estazolam (1 mg/mL methanol) ................................................................. BK Emit II Plus Oxycodone Negative Control 300 ..................................... BK Emit II Plus Oxycodone Positive Control 100 ...................................... BK Emit II Plus Oxycodone Positive Control 300 ...................................... BK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 1 .................. BK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 2 .................. BK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 3 .................. BK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 4 .................. Box: 1056 vials; 5 mL each ....... Glass vial: 1 mL–200 mL .......... Glass ampule: 1 mL .................. Glass ampule: 1 mL .................. Glass ampule: 1 mL .................. Glass ampule: 1 mL .................. Glass ampule: 1 mL .................. Glass ampule: 1 mL .................. Bulk Container: 1 L–50 L .......... Bulk Container: 1 L–50 L .......... Bulk Container: 1 L–50 L .......... Bulk Container: 1 L–50 L .......... Bulk Container: 1 L–50 L .......... Bulk Container: 1 L–50 L .......... Bulk Container: 1 L–50 L .......... VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1 Application date 6/20/2016 7/29/2016 6/21/2016 5/6/2016 6/21/2016 5/20/2016 10/28/2016 10/28/2016 8/23/2016 8/23/2016 8/23/2016 8/23/2016 8/23/2016 8/23/2016 8/23/2016 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices 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 sections of the CSA and the CFR that are specifically identified. 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. In accordance with 21 CFR 1308.24(g), the DEA may prescribe requirements other than those set forth in 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, the 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, 2016, and December 31, 2016, and not otherwise referenced in this order may remain under consideration until the DEA receives additional information required, pursuant to 21 CFR 1308.23(d), as detailed in separate correspondence to individual requesters. The DEA’s order on such requests will be communicated to the public in a future Federal Register publication. The 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. asabaliauskas on DSKBBXCHB2PROD with NOTICES Opportunity for Comment Pursuant to 21 CFR 1308.23, 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. VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 Approved Exempt Chemical Preparations Are Posted on DEA’s Web Site A list of all current exemptions, including those listed in this order, is available on the DEA’s Web site at https://www.DEAdiversion.usdoj.gov/ schedules/exempt/exempt_chemlist.pdf. The dates of applications of all current exemptions are posted for easy reference. Dated: May 24, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–12110 Filed 6–9–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Mine Safety and Health Administration [OMB Control No. 1219–0NEW] Proposed Extension of Information Collection; Performance Reports for MSHA Grants Mine Safety and Health Administration, Labor. ACTION: Request for public comments. AGENCY: The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A). This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Performance Reports for MSHA Grants. DATES: All comments must be received on or before August 11, 2017. ADDRESSES: Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. • Federal E-Rulemaking Portal: https://www.regulations.gov. Follow the on-line instructions for submitting comments for docket number MSHA– 2017–0007. • Regular Mail: Send comments to USDOL—MSHA, Office of Standards, Regulations, and Variances, 201 12th SUMMARY: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 26951 Street South, Suite 4E401, Arlington, VA 22202–5452. • Hand Delivery: USDOL—Mine Safety and Health Administration, 201 12th Street South, Suite 4E401, Arlington, VA 22202–5452. Sign in at the receptionist’s desk on the 4th floor via the East elevator. FOR FURTHER INFORMATION CONTACT: Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at MSHA.information.collections@dol.gov (email); 202–693–9440 (voice); or 202– 693–9441 (facsimile). SUPPLEMENTARY INFORMATION: I. Background Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 813(h), authorizes MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, Sec. 101(a) of the Mine Act, 30 U.S.C. 811 authorizes the Secretary of Labor to develop, promulgate, and revise as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal mines. MSHA is requesting approval of a new information collection for narrative reporting of grant requirements. One of MSHA’s strategic goals is to ‘‘improve workplace safety and health’’ through the strategic objective ‘‘secure safe and healthy workplaces, particularly in high-risk industries.’’ MSHA’s goal in accomplishing this objective is to ‘‘prevent death, disease, and injury from mining and promote safe and healthful workplaces for the Nation’s miners.’’ Sec. 115 of the Mine Act, as amended, requires mine operators to have a health and safety training program. Under Sec. 503 of the Mine Act, as amended, the Secretary may award grants to States to assist in developing and enforcing State mining laws and regulations, to improve State workers’ compensation and mining occupational disease laws and programs, and to improve safety and health conditions in the Nation’s mines through Federal-State coordination and cooperation. Therefore, MSHA seeks the Office of Management and Budget’s (OMB) clearance of the information collections the Department of Labor (DOL) requires to carry out its grant program through MSHA. This information collection covers the performance reporting for MSHA for Narrative Reports. MSHA is seeking to transfer its DOL-approved burden on the Narrative Reports under OMB No. 1225–0086 to an MSHA information collection. E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26944-26951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12110]


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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 (DEA) between April 1, 2016, and 
December 31, 2016, 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 August 
11, 2017. 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: The Drug Enforcement Administration 
(DEA) 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: Michael J. Lewis, Diversion Control

[[Page 26945]]

Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

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.
    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

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. Titles II and II are referred to as 
the ``Controlled Substances Act'' and the ``Controlled Substances 
Import and Export Act,'' or the ``CSA'' for the purpose of this action. 
21 U.S.C. 801-971. The DEA publishes the implementing regulations for 
these statutes in title 21 of the Code of Federal Regulations (CFR), 
chapter II.
    The CSA and its implementing regulations are designed to prevent, 
detect, and eliminate the diversion of controlled substances and listed 
chemicals into the illicit market while ensuring an adequate supply is 
available for the legitimate medical, scientific, research, and 
industrial needs of the United States. Controlled substances have the 
potential for abuse and dependence and are controlled to protect the 
public health and safety.
    Section 201 of the 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 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.
---------------------------------------------------------------------------

    \1\ This authority has been delegated from the Attorney General 
to the Administrator of the DEA by 28 CFR 0.100, and subsequently 
redelegated to the Deputy Assistant Administrator pursuant to 
Section 7 of 28 CFR 0.104, Appendix to Subpart R.
---------------------------------------------------------------------------

Exempt Chemical Preparation Applications Submitted Between April 1, 
2016, and December 31, 2016

    The Assistant Administrator received applications between April 1, 
2016, and December 31, 2016, 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; if the preparation or mixture contains a narcotic 
controlled substance, it must be formulated in such a manner that it 
incorporates methods of denaturing or other means so that the 
preparation or 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 the 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.

                                                     Chart I
----------------------------------------------------------------------------------------------------------------
                                                                                                     Application
                Supplier                           Product name                      Form                date
----------------------------------------------------------------------------------------------------------------
Aalto Scientific, Ltd..................  Endocrine Program..............  Amber vial: 5 mL.........    8/23/2016
Aalto Scientific, Ltd..................  Endocrinology..................  Amber vial: 5 mL.........    8/23/2016
Aalto Scientific, Ltd..................  Linearity FD Testosterone,       Kit: 5 vials; 3 mL each..    12/7/2016
                                          Siemens Centaur.
Absolute Standards, Inc................  ISO G34 Calibrator Spike High..  Glass ampoule: 1 mL......     8/3/2016
Absolute Standards, Inc................  ISO G34 Calibrator Spike Low...  Glass ampoule: 1 mL......     8/3/2016
Absolute Standards, Inc................  ISO G34 Calibrator Spike         Glass ampoule: 1 mL......     8/3/2016
                                          Solution.

[[Page 26946]]

 
Absolute Standards, Inc................  ISO G34 Internal Standard......  Glass ampoule: 1 mL......     8/3/2016
Accriva Diagnostics, Inc...............  Hemochron PT...................  Box: 45 cuvettes;            5/17/2016
                                                                           7.5[mu]L each.
Arbor Assays...........................  Testosterone 5-pack Enzyme       Kit: 400 [mu]L vial......   10/18/2016
                                          Immunoassay Kit (K032-H5).
Arbor Assays...........................  Testosterone Enzyme Immunoassay  Kit: 1 mL vial...........   10/18/2016
                                          Kit (ISWE001).
Arbor Assays...........................  Testosterone Enzyme Immunoassay  Kit: 90 [mu]L vial.......   10/18/2016
                                          Kit (K032-H1).
Arbor Assays...........................  Testosterone Standard (1,000 ng/ Plastic vial: 1 mL.......   10/18/2016
                                          mL).
Arbor Assays...........................  Testosterone Standard (200,000   Plastic vial: 90 [mu]L...   10/18/2016
                                          pg/mL).
Arbor Assays...........................  Testosterone Standard (200,000   Plastic vial: 400 [mu]L..   10/18/2016
                                          pg/mL).
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vial: 1 mL-200 mL..    7/29/2016
                                          Control Urine, MC252.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    9/30/2016
                                          Control Urine, MC253.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vial: 1 mL-200 mL..    7/29/2016
                                          Control Urine, MC254.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vial: 1 mL-200 mL..    7/29/2016
                                          Control Urine, MC255.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   12/19/2016
                                          Control Urine, MC256.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   12/19/2016
                                          Control Urine, MC257.
Cayman Chemical Company................  11-Keto Testosterone CRM; 1 mg/  Glass ampule: 1 mL.......    6/28/2016
                                          mL in Acetonitrile.
Cayman Chemical Company................  AB-CHMINACA (CRM); 1 mg/mL in    Glass ampule: 1 mL.......    8/26/2016
                                          Acetonitrile.
Cayman Chemical Company................  AB-CHMINACA (CRM); 1 mg/mL in    Glass ampule: 1 mL.......    8/26/2016
                                          Methanol.
Cayman Chemical Company................  AB-CHMINACA (CRM); 100 [micro]g/ Glass ampule: 1 mL.......    8/26/2016
                                          mL in Acetonitrile.
Cayman Chemical Company................  AB-CHMINACA (CRM); 100 [micro]g/ Glass ampule: 1 mL.......    8/26/2016
                                          mL in Methanol.
Cayman Chemical Company................  AB-PINACA CRM; 1 mg/mL in        Glass ampule: 1 mL.......    6/28/2016
                                          Methanol.
Cayman Chemical Company................  Acetyl Fentanyl CRM; 1 mg/mL in  Glass ampule: 1 mL.......    6/28/2016
                                          Methanol.
Cayman Chemical Company................  Acetyl Fentanyl CRM; 100         Glass ampule: 1 mL.......    6/28/2016
                                          [micro]g/mL in Methanol.
Cayman Chemical Company................  Cocaine CRM; 1 mg/mL in          Glass ampule: 1 mL.......    6/28/2016
                                          Acetonitrile.
Cayman Chemical Company................  Cocaine/Heroin/Methamphetamine   Glass ampule: 1 mL.......    8/26/2016
                                          Mixture CRM; 1 mg/mL each in
                                          Acetonitrile.
Cayman Chemical Company................  Cocaine/Heroin/Methamphetamine   Glass ampule: 1 mL.......    8/26/2016
                                          Mixture CRM; 100 [micro]g/mL
                                          each in Acetonitrile.
Cayman Chemical Company................  Cocaine/Heroin/Methamphetamine   Glass ampule: 1 mL.......    8/26/2016
                                          Mixture CRM; 250 [micro]g/mL
                                          each in Acetonitrile.
Cayman Chemical Company................  Cocaine/Heroin/Methamphetamine   Glass ampule: 1 mL.......    8/26/2016
                                          Mixture CRM; 500 [micro]g/mL
                                          each in Acetonitrile.
Cayman Chemical Company................  GC-MS Drug Standard Mixture 1    Glass ampule: 1 mL.......    6/28/2016
                                          in Acetonitrile.
Cayman Chemical Company................  Phytocannabinoid Mixture 1; 1    Glass ampule: 1 mL.......    6/28/2016
                                          mg/mL in Acetonitrile.
Cayman Chemical Company................  Tapentadol (hydrochloride) CRM;  Glass ampule: 1 mL.......    8/26/2016
                                          1 mg/mL in Acetonitrile.
Cayman Chemical Company................  Tapentadol (hydrochloride) CRM;  Glass ampule: 1 mL.......    8/26/2016
                                          1 mg/mL in Methanol.
Cayman Chemical Company................  Tapentadol (hydrochloride) CRM;  Glass ampule: 1 mL.......    8/26/2016
                                          100 [micro]g/mL in
                                          Acetonitrile.
Cayman Chemical Company................  Tapentadol (hydrochloride) CRM;  Glass ampule: 1 mL.......    8/26/2016
                                          100 [micro]g/mL in Methanol.
Cayman Chemical Company................  THJ2201 (CRM); 1 mg/mL in        Glass ampule: 1 mL.......    8/26/2016
                                          Acetonitrile.
Cayman Chemical Company................  THJ2201 (CRM); 1 mg/mL in        Glass ampule: 1 mL.......    8/26/2016
                                          Methanol.
Cayman Chemical Company................  THJ2201 (CRM); 100 [micro]g/mL   Glass ampule: 1 mL.......    8/26/2016
                                          in Acetonitrile.
Cayman Chemical Company................  THJ2201 (CRM); 100 [micro]g/mL   Glass ampule: 1 mL.......    8/26/2016
                                          in Methanol.
Cayman Chemical Company................  ToxBox THC/THC Metabolite Plate  48-well plate............    6/28/2016
Cerilliant Corporation.................  ()-11-Hydroxy-       Glass ampule: 1 mL.......   11/11/2016
                                          delta9-THC glucuronide (0.01
                                          mg/mL).
Cerilliant Corporation.................  ()-Cannabicyclol     Glass ampule: 1.0 mL.....    7/18/2016
                                          (1.0 mg/mL).
Cerilliant Corporation.................  ()-cis-3-            Glass ampule: 1 mL.......    6/21/2016
                                          Methylfentanyl HCl (0.05 mg/
                                          mL).
Cerilliant Corporation.................  ()-cis-3-            Glass ampule: 0.5 mL.....    7/18/2016
                                          Methylfentanyl HCl (0.1 mg/mL).
Cerilliant Corporation.................  5alpha-Dihydrotestosterone-D3    Glass ampule: 1 mL.......    9/28/2016
                                          [16, 16, 17-D3]; 10 [micro]g/
                                          mL.
Cerilliant Corporation.................  6beta-Naltrexol (1 mg/mL)......  Glass ampule: 1 mL.......     5/6/2016
Cerilliant Corporation.................  AH-7921 HCl (1 mg/mL)..........  Glass ampule: 1 mL.......    5/20/2016
Cerilliant Corporation.................  AH-7921-D3 HCl (0.1 mg/mL).....  Glass ampule: 1 mL.......    5/20/2016
Cerilliant Corporation.................  Brivaracetam-D3 (0.1 mg/mL)....  Glass ampule: 1 mL.......   11/30/2016
Cerilliant Corporation.................  Butyryl fentanyl (0.05 mg/mL)..  Glass ampule: 1 mL.......    6/21/2016
Cerilliant Corporation.................  Butyryl fentanyl (0.1 mg/mL)...  Glass ampule: 0.5 mL.....    7/18/2016
Cerilliant Corporation.................  Cannabichromenic acid (CBCA)     Glass ampule: 1 mL.......   11/30/2016
                                          (1.0 mg/mL).
Cerilliant Corporation.................  Cannabicyclolic acid (CBLA)      Glass ampule: 1 mL.......   11/30/2016
                                          (1.0 mg/mL).
Cerilliant Corporation.................  Carfentanil (0.1 mg/mL)........  Glass ampule: 0.5 mL.....    9/28/2016
Cerilliant Corporation.................  Carfentanil oxalate (0.1 mg/mL)  Glass ampule: 0.5 mL.....   11/30/2016
Cerilliant Corporation.................  Carfentanil-D5 oxalate (0.1 mg/  Glass ampule: 0.5 mL.....   11/30/2016
                                          mL).
Cerilliant Corporation.................  Clorazepate dipotassium (1 mg/   Glass ampule: 1 mL.......     5/6/2016
                                          mL).
Cerilliant Corporation.................  Dihydrotestosterone Calibrator   Cryovial: 1 mL...........    8/12/2016
                                          Level 1 (20 pg/mL).
Cerilliant Corporation.................  Dihydrotestosterone Calibrator   Cryovial: 1 mL...........    8/12/2016
                                          Level 2 (50 pg/mL).
Cerilliant Corporation.................  Dihydrotestosterone Calibrator   Cryovial: 1 mL...........    8/12/2016
                                          Level 3 (100 pg/mL).
Cerilliant Corporation.................  Dihydrotestosterone Calibrator   Cryovial: 1 mL...........    8/12/2016
                                          Level 4 (500 pg/mL).
Cerilliant Corporation.................  Dihydrotestosterone Calibrator   Cryovial: 1 mL...........    8/12/2016
                                          Level 5 (1000 pg/mL).
Cerilliant Corporation.................  Dihydrotestosterone Calibrator   Cryovial: 1 mL...........    8/12/2016
                                          Level 6 (2500 pg/mL).
Cerilliant Corporation.................  Dihydrotestosterone Calibrator   Cryovial: 1 mL...........    8/12/2016
                                          Level 7 (10 ng/mL).
Cerilliant Corporation.................  Diphenoxylate HCl (1 mg/mL)....  Glass ampule: 1 mL.......    5/20/2016
Cerilliant Corporation.................  Furanyl fentanyl (0.1 mg/mL)...  Glass ampule: 0.5 mL.....   11/30/2016
Cerilliant Corporation.................  Norhydromorphone-D3 HCl (0.1 mg/ Glass ampule: 1.0 mL.....    7/18/2016
                                          mL).
Cerilliant Corporation.................  Noroxymorphone-D3 HCl (0.1 mg/   Glass ampule: 1.0 mL.....    7/18/2016
                                          mL).

[[Page 26947]]

 
Cerilliant Corporation.................  Pholcodine (1 mg/mL)...........  Glass ampule: 1 mL.......     5/6/2016
Cerilliant Corporation.................  Tapentadol-D3 HCl (1 mg/mL)....  Glass ampule: 1 mL.......   11/11/2016
Cerilliant Corporation.................  U-47700 (1.0 mg/mL)............  Glass ampule: 1 mL.......   11/30/2016
IDEXX Laboratories.....................  Coag Dx PT.....................  Box: 10 cartridges;         10/21/2016
                                                                           7.5[mu]L each.
IDEXX Laboratories.....................  Coag Dx PT Cartridge...........  Cartridges: 7.5[mu]L each   10/21/2016
Immunalysis Corporation................  cTHC Urine Calibrator 1 (20 ng/  Dropper bottle: 5 mL, 15     5/27/2016
                                          mL).                             mL.
Immunalysis Corporation................  cTHC Urine Calibrator 2 (50 ng/  Dropper bottle: 5 mL, 15     5/27/2016
                                          mL).                             mL.
Immunalysis Corporation................  cTHC Urine Calibrator 3 (100 ng/ Dropper bottle: 5 mL, 15     5/27/2016
                                          mL).                             mL.
Immunalysis Corporation................  cTHC Urine Calibrator 4 (200 ng/ Dropper bottle: 5 mL, 15     5/27/2016
                                          mL).                             mL.
Immunalysis Corporation................  cTHC Urine Control HIGH (62.5    Dropper bottle: 5 mL, 15     5/27/2016
                                          ng/mL).                          mL.
Immunalysis Corporation................  cTHC Urine Control LOW (37.5 ng/ Dropper bottle: 5 mL, 15     5/27/2016
                                          mL).                             mL.
Immunalysis Corporation................  Fentanyl Urine Calibrator 1 (1   Dropper bottle: 5 mL.....    5/27/2016
                                          ng/mL).
Immunalysis Corporation................  Fentanyl Urine Calibrator 2 (2   Dropper bottle: 5 mL.....    5/27/2016
                                          ng/mL).
Immunalysis Corporation................  Fentanyl Urine Calibrator 3 (4   Dropper bottle: 5 mL.....    5/27/2016
                                          ng/mL).
Immunalysis Corporation................  Fentanyl Urine Control HIGH      Dropper bottle: 5 mL.....    5/27/2016
                                          (1.5 ng/mL).
Immunalysis Corporation................  Fentanyl Urine Control LOW (0.5  Dropper bottle: 5 mL.....    5/27/2016
                                          ng/mL).
Immunalysis Corporation................  MDC Calibrator 1...............  Dropper bottle: 15 mL, 25    5/27/2016
                                                                           mL.
Immunalysis Corporation................  MDC Calibrator 2...............  Dropper bottle: 15 mL, 25    5/27/2016
                                                                           mL.
Immunalysis Corporation................  MDC Calibrator 3...............  Dropper bottle: 15 mL, 25    5/27/2016
                                                                           mL.
Immunalysis Corporation................  MDC Calibrator 4...............  Dropper bottle: 15 mL, 25    5/27/2016
                                                                           mL.
Immunalysis Corporation................  MDC Control HIGH Set 1.........  Dropper bottle: 15 mL, 25    5/27/2016
                                                                           mL.
Immunalysis Corporation................  MDC Control HIGH Set 1.........  Dropper bottle: 15 mL, 25    5/27/2016
                                                                           mL.
Immunalysis Corporation................  MDC Control LOW Set 1..........  Dropper bottle: 15 mL, 25    5/27/2016
                                                                           mL.
Immunalysis Corporation................  MDC Control LOW Set 2..........  Dropper bottle: 15 mL, 25    5/27/2016
                                                                           mL.
Immunalysis Corporation................  Opiates Urine Calibrator 2000 1  Dropper bottle: 5 mL, 15     5/27/2016
                                          (1000 ng/mL).                    mL.
Immunalysis Corporation................  Opiates Urine Calibrator 2000 2  Dropper bottle: 5 mL, 15     5/27/2016
                                          (2000 ng/mL).                    mL.
Immunalysis Corporation................  Opiates Urine Calibrator 2000 3  Dropper bottle: 5 mL, 15     5/27/2016
                                          (4000 ng/mL).                    mL.
Immunalysis Corporation................  Opiates Urine Calibrator 2000 4  Dropper bottle: 5 mL, 15     5/27/2016
                                          (6000 ng/mL).                    mL.
Immunalysis Corporation................  Oxazepam Urine Control HIGH      Dropper bottle: 5 mL, 15     5/27/2016
                                          (125 ng/mL).                     mL.
Immunalysis Corporation................  Oxazepam Urine Control LOW (75   Dropper bottle: 5 mL, 15     5/27/2016
                                          ng/mL).                          mL.
Instrumentation Laboratory.............  Gem Test PT....................  Box: 45 cuvettes;            10/6/2016
                                                                           7.5[mu]L each.
IsoSciences, LLC.......................  Codeine-[13C4, 15N], 1000 [mu]g/ Amber ampule: 1 mL.......   10/20/2016
                                          mL in methanol.
IsoSciences, LLC.......................  Codeine-6[beta]-Glucuronide-     Amber ampule: 1 mL.......   10/20/2016
                                          [13C10, 15N], 1000 [mu]g/mL in
                                          methanol:water (2:8).
IsoSciences, LLC.......................  Morphine-[13C4, 15N], 1000       Amber ampule: 1 mL.......   10/20/2016
                                          [mu]g/mL in methanol.
IsoSciences, LLC.......................  Morphine-6[beta]-Glucuronide-    Amber ampule: 1 mL.......   10/20/2016
                                          [13C10, 15N], 1000 [mu]g/mL in
                                          methanol:water (2:8).
IsoSciences, LLC.......................  Testosterone-[2H8], 100          Amber Ampule: 1 mL.......    8/10/2016
                                          [micro]g/mL in methanol.
IsoSciences, LLC.......................  Testosterone-[2H8], 1000         Amber Ampule: 1 mL.......    8/10/2016
                                          [micro]g/mL in methanol.
ITC....................................  Hemochron Jr...................  Box: 45 cuvettes;             7/1/2016
                                                                           7.5[mu]L each.
Lipomed Inc............................  25B-NB2OMe (1 mg/mL methanol)..  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  25C-NB2OMe (1 mg/mL methanol)..  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  25I-NB2OMe (1 mg/mL methanol)..  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  25I-NB2OMe-D9 (0.1 mg/mL         Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  25I-NB2OMe-D9 (1 mg/mL           Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  3,4-Methylendioxypyrovalerone    Glass ampule: 1 mL.......   10/28/2016
                                          (1 mg/mL methanol).
Lipomed Inc............................  3,4-Methylenedioxy-[alpha]-      Glass ampule: 1 mL.......   10/28/2016
                                          pyrrolidinopropiophenone (1 mg/
                                          mL methanol).

[[Page 26948]]

 
Lipomed Inc............................  3-Desmethylprodine (1 mg/mL      Glass ampule: 1 mL.......   10/28/2016
                                          acetonitrile).
Lipomed Inc............................  4-Ethylmethcathinone (1 mg/mL    Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  4-Methylethcathinone (1 mg/mL    Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  4-Methylmethcathinone (1 mg/mL   Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  4-Methylmethcathinone-D3 (0.1    Glass ampule: 1 mL.......   10/28/2016
                                          mg/mL methanol).
Lipomed Inc............................  4-Methylmethcathinone-D3 (1 mg/  Glass ampule: 1 mL.......   10/28/2016
                                          mL methanol).
Lipomed Inc............................  Benzodiazepines mixture (.001    Glass ampule: 1 mL.......   10/28/2016
                                          mg free base/ml acetonitrile).
Lipomed Inc............................  Benzodiazepines mixture 5 (1 mg  Glass ampule: 1 mL.......   10/28/2016
                                          free base/mL acetonitrile).
Lipomed Inc............................  Bufotenine.oxalate.monohydrate   Glass ampule: 1 mL.......   10/28/2016
                                          (1 mg/mL methanol).
Lipomed Inc............................  Butabarbital (1 mg/mL methanol)  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Butalbital (1 mg/mL methanol)..  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Butalbital-D5 (1 mg/mL           Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Butylone (1 mg/mL methanol)....  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Cannabidiol-D3 (0.1 mg/mL        Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Cannabidiol-D3 (1 mg/mL          Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Cannabinol-D3 (0.1 mg/mL         Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Cannabinol-D3 (1 mg/mL           Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Carisoprodol (1 mg/mL methanol)  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Clotiazepam (1 mg/mL methanol).  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Cocaethylene-D3 (1 mg/mL         Glass ampule: 1 mL.......   10/28/2016
                                          acetonitrile).
Lipomed Inc............................  Cocaine mixture 2 (1 mg/mL       Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Desomorphine (1 mg/mL            Glass ampule: 1 mL.......   10/28/2016
                                          acetonitrile).
Lipomed Inc............................  Ethylone (1 mg/mL methanol)....  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-018 (0.1 mg/mL methanol)...  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-018 (1 mg/mL methanol).....  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-018-D11 metabolite (0.1 mg/  Glass ampule: 1 mL.......   10/28/2016
                                          mL methanol).
Lipomed Inc............................  JWH-018-D11 metabolite (1 mg/mL  Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  JWH-019 (0.1 mg/mL methanol)...  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-019 (1 mg/mL methanol).....  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-081 (0.1 mg/mL methanol)...  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-081 (1 mg/mL methanol).....  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-122 (0.1 mg/mL methanol)...  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-122 (1 mg/mL methanol).....  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-200 (0.1 mg/mL methanol)...  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  JWH-200 (1 mg/mL methanol).....  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  L-Methamphetamine (1 mg/mL       Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Loprazolam (1 mg/mL methanol)..  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Mazindol (1 mg/mL                Glass ampule: 1 mL.......   10/28/2016
                                          Dimethylformamide).
Lipomed Inc............................  Meprobamate (1 mg/mL methanol).  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Methandienone (1 mg/mL           Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Methylone (1 mg/mL methanol)...  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Methylone-D3 (0.1 mg/mL          Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Methylone-D3 (1 mg/mL methanol)  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  N,N-Dimethylamphetamine (1 mg/   Glass ampule: 1 mL.......   10/28/2016
                                          mL methanol).
Lipomed Inc............................  Naphyrone (1 mg/mL methanol)...  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Nimetazepam (1 mg/mL methanol).  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Norbuprenorphine (1 mg/mL        Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Normeperidine (1 mg/mL           Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Pentedrone (1 mg/mL methanol)..  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Pentylone (1 mg/mL methanol)...  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Phenobarbital-D5 (side chain)    Glass ampule: 1 mL.......   10/28/2016
                                          (0.1 mg/mL methanol).
Lipomed Inc............................  Phenobarbital-D5 (side chain)    Glass ampule: 1 mL.......   10/28/2016
                                          (1 mg/mL methanol).
Lipomed Inc............................  Pregabalin (1 mg/mL methanol)..  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  Propoxyphen-D5 (0.1 mg/mL        Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Propoxyphen-D5 (1 mg/mL          Glass ampule: 1 mL.......   10/28/2016
                                          methanol).
Lipomed Inc............................  Pyrovalerone (1 mg/mL methanol)  Glass ampule: 1 mL.......   10/28/2016
Lipomed Inc............................  [alpha]-                         Glass ampule: 1 mL.......   10/28/2016
                                          Pyrrolidinopropiophenone (1 mg/
                                          mL methanol).
Lipomed Inc............................  [alpha]-                         Glass ampule: 1 mL.......   10/28/2016
                                          Pyrrolidinovalerophenone (1 mg/
                                          mL methanol).
Microgenics Corporation................  Cascadion SM Total Testosterone  Box: 8 bottles, 29 mL       12/16/2016
                                          Internal Standard.               each.
Microgenics Corporation................  Cedia Buprenorphine OFT Control  Vial: 10 mL; Box: 2 vials   11/15/2016
                                          Set (Low and High) Catalog
                                          Number: 10022377.
Microgenics Corporation................  Cedia Buprenorphine OFT Cutoff   Vial: 5 mL; Box: 1 vial..   11/15/2016
                                          Calibrator Catalog Number:
                                          10022376.
Microgenics Corporation................  Cedia Multi-Drug OFT Cutoff      Vial: 10 mL; Box: 1 vial.   10/20/2016
                                          Calibrator Set B Catalog
                                          Number: 10022355.
Microgenics Corporation................  Cedia Multi-Drug OFT Cutoff      Vial: 15 mL; Box: 2 vials   10/20/2016
                                          Control Set B (Low and High)
                                          Catalog Number: 10022356.
Microgenics Corporation................  Intercept i2he Multi-Drug Oral   Vial: 10 mL; Box: 1 vial.   10/19/2016
                                          Fluid Cutoff Calibrator Set B
                                          Catalog Number: 1001-0419.
Microgenics Corporation................  Intercept i2he Multi-Drug Oral   Vial: 15 mL; Box: 2 vials   10/19/2016
                                          Fluid Cutoff Control Set B
                                          (Low and High) Catalog Number:
                                          1001-0420.

[[Page 26949]]

 
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...    8/30/2016
                                          Buprenorphine II Calibrator 10
                                          ng/mL Catalog Number: 10020799.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...    8/30/2016
                                          Buprenorphine II Calibrator
                                          100 ng/mL Catalog Number:
                                          10020802.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...    8/30/2016
                                          Buprenorphine II Calibrator 20
                                          ng/mL Catalog Number: 10020800.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...    8/30/2016
                                          Buprenorphine II Calibrator 50
                                          ng/mL Catalog Number: 10020801.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 4 vials..    8/30/2016
                                          Buprenorphine II Controls (Low
                                          and High) Catalog Number:
                                          10020804.
Siemens Healthcare Diagnostics, Inc....  BK Emit II Plus Oxycodone        Bulk Container: 1 L-50 L.    8/23/2016
                                          Negative Control 100.
Siemens Healthcare Diagnostics, Inc....  Emit II Plus Oxycodone Negative  Vial: 10 mL..............    8/23/2016
                                          Control 100.
Siemens Healthcare Diagnostics, Inc....  Emit II Plus Oxycodone Negative  Vial: 10 mL..............    8/23/2016
                                          Control 300.
Siemens Healthcare Diagnostics, Inc....  Emit II Plus Oxycodone Positive  Vial: 10 mL..............    8/23/2016
                                          Control 100.
Siemens Healthcare Diagnostics, Inc....  Emit II Plus Oxycodone Positive  Vial: 10 mL..............    8/23/2016
                                          Control 300.
Siemens Healthcare Diagnostics, Inc....  Emit II Plus Specialty Multi     Vial: 10 mL..............    8/23/2016
                                          Drug Calibrator/Control Level
                                          1.
Siemens Healthcare Diagnostics, Inc....  Emit II Plus Specialty Multi     Vial: 10 mL..............    8/23/2016
                                          Drug Calibrator/Control Level
                                          2.
Siemens Healthcare Diagnostics, Inc....  Emit II Plus Specialty Multi     Vial: 10 mL..............    8/23/2016
                                          Drug Calibrator/Control Level
                                          3.
Siemens Healthcare Diagnostics, Inc....  Emit II Plus Specialty Multi     Vial: 10 mL..............    8/23/2016
                                          Drug Calibrator/Control Level
                                          4.
Siemens Healthcare Diagnostics, Inc....  FC Emit II Plus Oxycodone        Vial: 10 mL..............    8/23/2016
                                          Negative Control 100.
Siemens Healthcare Diagnostics, Inc....  FC Emit II Plus Oxycodone        Vial: 10 mL..............    8/23/2016
                                          Negative Control 300.
Siemens Healthcare Diagnostics, Inc....  FC Emit II Plus Oxycodone        Vial: 10 mL..............    8/23/2016
                                          Positive Control 100.
Siemens Healthcare Diagnostics, Inc....  FC Emit II Plus Oxycodone        Vial: 10 mL..............    8/23/2016
                                          Positive Control 300.
Siemens Healthcare Diagnostics, Inc....  FC Emit II Plus Specialty Multi  Vial: 10 mL..............    8/23/2016
                                          Drug Calibrator/Control Level
                                          1.
Siemens Healthcare Diagnostics, Inc....  FC Emit II Plus Specialty Multi  Vial: 10 mL..............    8/23/2016
                                          Drug Calibrator/Control Level
                                          2.
Siemens Healthcare Diagnostics, Inc....  FC Emit II Plus Specialty Multi  Vial: 10 mL..............    8/23/2016
                                          Drug Calibrator/Control Level
                                          3.
Siemens Healthcare Diagnostics, Inc....  FC Emit II Plus Specialty Multi  Vial: 10 mL..............    8/23/2016
                                          Drug Calibrator/Control Level
                                          4.
Siemens Healthcare Diagnostics, Inc....  MP FC Emit Oxycodone Negative    Vial: 10 mL..............    8/23/2016
                                          Control 100.
Siemens Healthcare Diagnostics, Inc....  MP FC Emit Oxycodone Negative    Vial: 10 mL..............    8/23/2016
                                          Control 300.
Siemens Healthcare Diagnostics, Inc....  MP FC Emit Oxycodone Positive    Vial: 10 mL..............    8/23/2016
                                          Control 100.
Siemens Healthcare Diagnostics, Inc....  MP FC Emit Oxycodone Positive    Vial: 10 mL..............    8/23/2016
                                          Control 300.
Siemens Healthcare Diagnostics, Inc....  MP FC Emit Specialty Multi Drug  Vial: 10 mL..............    8/23/2016
                                          Calibrator/Control LVL 1.
Siemens Healthcare Diagnostics, Inc....  MP FC Emit Specialty Multi Drug  Vial: 10 mL..............    8/23/2016
                                          Calibrator/Control LVL 2.
Siemens Healthcare Diagnostics, Inc....  MP FC Emit Specialty Multi Drug  Vial: 10 mL..............    8/23/2016
                                          Calibrator/Control LVL 3.
Siemens Healthcare Diagnostics, Inc....  MP FC Emit Specialty Multi Drug  Vial: 10 mL..............    8/23/2016
                                          Calibrator/Control LVL 4.
Siemens Healthcare Diagnostics, Inc....  Pilot Emit II Plus Oxycodone     Pilot container: 4 mL-200    8/23/2016
                                          Negative Control 100.            mL.
Siemens Healthcare Diagnostics, Inc....  Pilot Emit II Plus Oxycodone     Pilot container: 4 mL-200    8/23/2016
                                          Negative Control 300.            mL.
Siemens Healthcare Diagnostics, Inc....  Pilot Emit II Plus Oxycodone     Pilot container: 4 mL-200    8/23/2016
                                          Positive Control 100.            mL.
Siemens Healthcare Diagnostics, Inc....  Pilot Emit II Plus Oxycodone     Pilot container: 4 mL-200    8/23/2016
                                          Positive Control 300.            mL.
Siemens Healthcare Diagnostics, Inc....  Pilot Emit II Plus Specialty     Pilot container: 4 mL-200    8/23/2016
                                          Multi Drug Calibrator/Control    mL.
                                          LVL 1.

[[Page 26950]]

 
Siemens Healthcare Diagnostics, Inc....  Pilot Emit II Plus Specialty     Pilot container: 4 mL-200    8/23/2016
                                          Multi Drug Calibrator/Control    mL.
                                          LVL 2.
Siemens Healthcare Diagnostics, Inc....  Pilot Emit II Plus Specialty     Pilot container: 4 mL-200    8/23/2016
                                          Multi Drug Calibrator/Control    mL.
                                          LVL 3.
Siemens Healthcare Diagnostics, Inc....  Pilot Emit II Plus Specialty     Pilot container: 4 mL-200    8/23/2016
                                          Multi Drug Calibrator/Control    mL.
                                          LVL 4.
USP....................................  USP Levomethorphan Solution      Box: 3 vials, 1.2 mL each    9/13/2016
                                          Reference Standard.
UTAK Laboratories, Inc.................  AED II HR Serum Control, Ref:    Carton: 5 bottles, 5 mL     12/27/2016
                                          72740.                           each.
UTAK Laboratories, Inc.................  AED II MR Serum Control, Ref:    Carton: 5 bottles, 5 mL     12/27/2016
                                          72741.                           each.
UTAK Laboratories, Inc.................  Benzodiazepines 2 Serum Control  Carton: 5 bottles, 5 mL     12/27/2016
                                          HR, Ref: 22615.                  each.
UTAK Laboratories, Inc.................  Benzodiazepines 2 Serum Control  Carton: 5 bottles, 5 mL     12/27/2016
                                          MR, Ref: 22616.                  each.
UTAK Laboratories, Inc.................  Benzodiazepines Plus 100 Urine   Carton: 5 bottles, 5 mL     12/27/2016
                                          Control, Ref: 12090.             each.
UTAK Laboratories, Inc.................  Benzodiazepines Plus 100 Whole   Carton: 5 bottles, 5 mL     12/27/2016
                                          Blood Control, Ref: 12092.       each.
UTAK Laboratories, Inc.................  Benzodiazepines Plus 400 ng/mL   Carton: 5 bottles, 5 mL     12/27/2016
                                          Urine Control, Ref: 12091.       each.
UTAK Laboratories, Inc.................  Clonazepam Serum Control HR,     Carton: 5 bottles, 5 mL     12/27/2016
                                          Ref: 22610.                      each.
UTAK Laboratories, Inc.................  Clonazepam Serum Control MR,     Carton: 5 bottles, 5 mL     12/27/2016
                                          Ref: 22611.                      each.
UTAK Laboratories, Inc.................  DHEA Plus High Serum Control,    Carton: 5 bottles, 3 mL     12/27/2016
                                          Ref: 51411.                      each.
UTAK Laboratories, Inc.................  DHEA Plus Low Serum Control,     Carton: 5 bottles, 3 mL     12/27/2016
                                          Ref: 51410.                      each.
UTAK Laboratories, Inc.................  Pentobarbital Serum Control,     Carton: 5 bottles, 5 mL     12/27/2016
                                          Ref: 66319.                      each.
UTAK Laboratories, Inc.................  Steroids Level 1 SMx Serum       Carton: 5 bottles, 3 mL     12/27/2016
                                          Control, Ref: 51401.             each.
UTAK Laboratories, Inc.................  Steroids Level 2 SMx Serum       Carton: 5 bottles, 3 mL     12/27/2016
                                          Control, Ref: 51402.             each.
UTAK Laboratories, Inc.................  Steroids Level 3 SMx Serum       Carton: 5 bottles, 3 mL     12/27/2016
                                          Control, Ref: 51403.             each.
UTAK Laboratories, Inc.................  Steroids Level 4 SMx Serum       Carton: 5 bottles, 3 mL     12/27/2016
                                          Control, Ref: 51404.             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 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...................  General Chemistry Serum......  Box: 1056 vials; 5 mL each    6/20/2016
Biochemical Diagnostics, Inc............  Detectabuse Custom Liquid      Glass vial: 1 mL-200 mL...    7/29/2016
                                           Control Urine, MC253.
Cerilliant Corporation..................  ()-cis-3-          Glass ampule: 1 mL........    6/21/2016
                                           Methylfentanyl HCl (0.1 mg/
                                           mL).
Cerilliant Corporation..................  ()-cis-3-          Glass ampule: 1 mL........     5/6/2016
                                           Methylfentanyl HCl (1 mg/mL).
Cerilliant Corporation..................  Butyryl fentanyl (0.1 mg/mL).  Glass ampule: 1 mL........    6/21/2016
Cerilliant Corporation..................  Butyryl fentanyl HCl (1 mg/    Glass ampule: 1 mL........    5/20/2016
                                           mL).
Lipomed Inc.............................  Benzodiazepines mixture 8      Glass ampule: 1 mL........   10/28/2016
                                           (0.25 mg free base/mL
                                           acetonitrile).
Lipomed Inc.............................  Estazolam (1 mg/mL methanol).  Glass ampule: 1 mL........   10/28/2016
Siemens Healthcare Diagnostics, Inc.....  BK Emit II Plus Oxycodone      Bulk Container: 1 L-50 L..    8/23/2016
                                           Negative Control 300.
Siemens Healthcare Diagnostics, Inc.....  BK Emit II Plus Oxycodone      Bulk Container: 1 L-50 L..    8/23/2016
                                           Positive Control 100.
Siemens Healthcare Diagnostics, Inc.....  BK Emit II Plus Oxycodone      Bulk Container: 1 L-50 L..    8/23/2016
                                           Positive Control 300.
Siemens Healthcare Diagnostics, Inc.....  BK Emit II Plus Specialty      Bulk Container: 1 L-50 L..    8/23/2016
                                           Multi Drug Calibrator/
                                           Control LVL 1.
Siemens Healthcare Diagnostics, Inc.....  BK Emit II Plus Specialty      Bulk Container: 1 L-50 L..    8/23/2016
                                           Multi Drug Calibrator/
                                           Control LVL 2.
Siemens Healthcare Diagnostics, Inc.....  BK Emit II Plus Specialty      Bulk Container: 1 L-50 L..    8/23/2016
                                           Multi Drug Calibrator/
                                           Control LVL 3.
Siemens Healthcare Diagnostics, Inc.....  BK Emit II Plus Specialty      Bulk Container: 1 L-50 L..    8/23/2016
                                           Multi Drug Calibrator/
                                           Control LVL 4.
----------------------------------------------------------------------------------------------------------------


[[Page 26951]]

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 sections of the CSA and the CFR 
that are specifically identified. 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. In accordance with 21 CFR 1308.24(g), the 
DEA may prescribe requirements other than those set forth in 
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, the 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, 2016, and December 31, 2016, and not otherwise referenced in 
this order may remain under consideration until the DEA receives 
additional information required, pursuant to 21 CFR 1308.23(d), as 
detailed in separate correspondence to individual requesters. The DEA's 
order on such requests will be communicated to the public in a future 
Federal Register publication.
    The 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.

Opportunity for Comment

    Pursuant to 21 CFR 1308.23, 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.

Approved Exempt Chemical Preparations Are Posted on DEA's Web Site

    A list of all current exemptions, including those listed in this 
order, is available on the DEA's Web site at https://www.DEAdiversion.usdoj.gov/schedules/exempt/exempt_chemlist.pdf. The 
dates of applications of all current exemptions are posted for easy 
reference.

    Dated: May 24, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-12110 Filed 6-9-17; 8:45 am]
 BILLING CODE 4410-09-P

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