82 FR 26944 - Exempt Chemical Preparations Under the Controlled Substances Act
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 111 (June 12, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 111 (June 12, 2017)
| Page Range | 26944-26951 | |
| FR Document | 2017-12110 |
[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)] [Notices] [Pages 26944-26951] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12110] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-372] Exempt Chemical Preparations Under the Controlled Substances Act AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Order with opportunity for comment. ----------------------------------------------------------------------- SUMMARY: The applications for exempt chemical preparations received by the Drug Enforcement Administration (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 http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a comment tracking number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments: Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: 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 http://www.regulations.gov and in the DEA's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential. An electronic copy of this document is available at http://www.regulations.gov for easy reference. Legal Authority 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 http://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
![26944 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices
a limited exclusion order prohibiting investigation as to Makita based upon DEPARTMENT OF JUSTICE
importation of infringing lithium metal settlement. See Order No. 32 (Nov. 5,
oxide cathode materials based upon 2015). The Commission determined not Drug Enforcement Administration
settlement. to review this order. See Notice of Non- [Docket No. DEA–372]
FOR FURTHER INFORMATION CONTACT: Review (Nov. 23, 2015).
Panyin A. Hughes, Office of the General On February 29, 2016, the ALJ issued Exempt Chemical Preparations Under
Counsel, U.S. International Trade his final initial determination (‘‘ID’’), the Controlled Substances Act
Commission, 500 E Street SW., finding a violation of section 337 by AGENCY: Drug Enforcement
Washington, DC 20436, telephone 202– Umicore in connection with claims 1– Administration, Department of Justice.
205–3042. Copies of non-confidential 4, 7, 13, and 14 of the ’082 patent and ACTION: Order with opportunity for
documents filed in connection with this claims 1–4, 8, 9, and 17 of the ’143 comment.
investigation are or will be available for patent. On May 11, 2016, the
inspection during official business Commission determined to review the SUMMARY: The applications for exempt
hours (8:45 a.m. to 5:15 p.m.) in the final ID in part. 81 FR 30548–50 (May chemical preparations received by the
Office of the Secretary, U.S. 17, 2016). The Commission also granted Drug Enforcement Administration
International Trade Commission, 500 E Umicore’s request for a Commission (DEA) between April 1, 2016, and
Street SW., Washington, DC 20436, hearing. Id. On November 17, 2016, the December 31, 2016, as listed below,
telephone 202–205–2000. General Commission held a hearing on were accepted for filing and have been
information concerning the Commission contributory infringement, laches, and approved or denied as indicated.
may also be obtained by accessing its the public interest. On review, the DATES: Interested persons may file
Internet server (https://www.usitc.gov). Commission determined to affirm the written comments on this order in
The public record for this investigation ALJ’s finding of violation of section 337 accordance with 21 CFR 1308.23(e).
may be viewed on the Commission’s with respect to the claims identified Electronic comments must be
electronic docket (EDIS) at https:// above. 81 FR 93960–62 (Dec. 22, 2016). submitted, and written comments must
edis.usitc.gov. Hearing-impaired Having found a violation of section be postmarked, on or before August 11,
persons are advised that information on 337, the Commission determined that 2017. Commenters should be aware that
this matter can be obtained by the appropriate form of relief was: A the electronic Federal Docket
contacting the Commission’s TDD limited exclusion order prohibiting the Management System will not accept
terminal on 202–205–1810. unlicensed entry of lithium metal oxide comments after 11:59 p.m. Eastern Time
SUPPLEMENTARY INFORMATION: The cathode materials that infringe one or on the last day of the comment period.
Commission instituted the underlying more of claims 1–4, 7, 13, and 14 of the ADDRESSES: To ensure proper handling
investigation on March 30, 2015, based ’082 patent, or claims 1–4, 8, 9, and 17 of comments, please reference ‘‘Docket
on a complaint filed by BASF of the ’143 patent that are manufactured No. DEA–372’’ on all correspondence,
Corporation of Florham Park, New by, or on behalf of, or imported by or on including any attachments.
Jersey (‘‘BASF’’) and UChicago Argonne behalf of Umicore N.V. and Umicore • Electronic comments: The Drug
LLC of Lemont, IL (‘‘Argonne’’) USA Inc. or any of their affiliated Enforcement Administration (DEA)
(collectively, ‘‘Complainants’’). 80 FR companies, parents, subsidiaries, agents, encourages that all comments be
16696 (Mar. 30, 2015). The complaint or other related business entities, or submitted through the Federal
alleged violations of section 337 of the their successors or assigns. eRulemaking Portal, which provides the
Tariff Act of 1930, as amended (19 ability to type short comments directly
U.S.C. 1337), in the importation into the On May 5, 2017, BASF, Argonne, and into the comment field on the Web page
United States, the sale for importation, Umicore filed a joint petition under 19 or to attach a file for lengthier
and the sale within the United States U.S.C. 1337(k) and Commission Rule comments. Please go to http://
after importation of certain lithium 210.76(a) (19 CFR 210.76(a)) to rescind www.regulations.gov and follow the
metal oxide cathode materials, lithium- the limited exclusion order based upon online instructions at that site for
ion batteries for power tool products settlement. The parties filed both submitting comments. Upon completion
containing same, and power tool confidential and public versions of the of your submission you will receive a
products with lithium-ion batteries settlement agreements. On May 9, 2017, Comment Tracking Number for your
containing same by reason of the Commission investigative attorney comment. Please be aware that
infringement of one or more of claims filed a response in support of the submitted comments are not
1–4, 7, 13, and 14 of U.S. Patent No. motion. instantaneously available for public
6,677,082 (‘‘the ’082 patent’’) and claims The Commission has determined to view on Regulations.gov. If you have
1–4, 8, 9, and 17 of U.S. Patent No. grant the petition. The limited exclusion received a comment tracking number,
6,680,143 (‘‘the ’143 patent’’). Id. The order issued in this investigation is your comment has been successfully
notice of investigation named the hereby rescinded. submitted and there is no need to
following respondents: Umicore N.V. of The authority for the Commission’s resubmit the same comment.
Brussels, Belgium; Umicore USA Inc. of determination is contained in section • Paper comments: Paper comments
Raleigh, North Carolina (collectively, 337 of the Tariff Act of 1930, as that duplicate the electronic submission
‘‘Umicore’’); Makita Corporation of amended (19 U.S.C. 1337), and in Part are not necessary and are discouraged.
Should you wish to mail a comment in
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Anjo, Japan; Makita Corporation of 210 of the Commission’s Rules of
America of Buford, Georgia; and Makita Practice and Procedure (19 CFR 210). lieu of an electronic comment, it should
U.S.A. Inc. of La Mirada, California be sent via regular or express mail to:
By order of the Commission. Drug Enforcement Administration,
(collectively, ‘‘Makita’’). Id. The Office
Issued: June 6, 2017. Attention: DEA Federal Register
of Unfair Import Investigations was a
party to the investigation. Lisa R. Barton, Representative/DRW, 8701 Morrissette
On November 5, 2015, the ALJ Secretary to the Commission. Drive, Springfield, Virginia 22152.
granted a joint motion by Complainants [FR Doc. 2017–12035 Filed 6–9–17; 8:45 am] FOR FURTHER INFORMATION CONTACT:
and Makita to terminate the BILLING CODE 7020–02–P Michael J. Lewis, Diversion Control
VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1](https://thefederalregister.org/doc/82_FR_27055/page/1.svg)
![26946 Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices
CHART I—Continued
Application
Supplier Product name Form date
Absolute Standards, Inc .............. ISO G34 Internal Standard ............................................................. Glass ampoule: 1 mL ...... 8/3/2016
Accriva Diagnostics, Inc .............. Hemochron PT ................................................................................ Box: 45 cuvettes; 7.5μL 5/17/2016
each.
Arbor Assays ............................... Testosterone 5-pack Enzyme Immunoassay Kit (K032–H5) .......... Kit: 400 μL vial ................. 10/18/2016
Arbor Assays ............................... Testosterone Enzyme Immunoassay Kit (ISWE001) ...................... Kit: 1 mL vial .................... 10/18/2016
Arbor Assays ............................... Testosterone Enzyme Immunoassay Kit (K032–H1) ...................... Kit: 90 μL vial ................... 10/18/2016
Arbor Assays ............................... Testosterone Standard (1,000 ng/mL) ............................................ Plastic vial: 1 mL ............. 10/18/2016
Arbor Assays ............................... Testosterone Standard (200,000 pg/mL) ........................................ Plastic vial: 90 μL ............ 10/18/2016
Arbor Assays ............................... Testosterone Standard (200,000 pg/mL) ........................................ Plastic vial: 400 μL .......... 10/18/2016
Biochemical Diagnostics, Inc ...... Detectabuse Custom Liquid Control Urine, MC252 ........................ Glass vial: 1 mL–200 mL 7/29/2016
Biochemical Diagnostics, Inc ...... Detectabuse Custom Liquid Control Urine, MC253 ........................ Glass vials: 1 ml–200 mL 9/30/2016
Biochemical Diagnostics, Inc ...... Detectabuse Custom Liquid Control Urine, MC254 ........................ Glass vial: 1 mL–200 mL 7/29/2016
Biochemical Diagnostics, Inc ...... Detectabuse Custom Liquid Control Urine, MC255 ........................ Glass vial: 1 mL–200 mL 7/29/2016
Biochemical Diagnostics, Inc ...... Detectabuse Custom Liquid Control Urine, MC256 ........................ Glass vials: 1 ml–200 mL 12/19/2016
Biochemical Diagnostics, Inc ...... Detectabuse Custom Liquid Control Urine, MC257 ........................ Glass vials: 1 ml–200 mL 12/19/2016
Cayman Chemical Company ...... 11-Keto Testosterone CRM; 1 mg/mL in Acetonitrile ..................... Glass ampule: 1 mL ........ 6/28/2016
Cayman Chemical Company ...... AB-CHMINACA (CRM); 1 mg/mL in Acetonitrile ............................ Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... AB-CHMINACA (CRM); 1 mg/mL in Methanol ............................... Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... AB-CHMINACA (CRM); 100 μg/mL in Acetonitrile ......................... Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... AB-CHMINACA (CRM); 100 μg/mL in Methanol ............................ Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... AB-PINACA CRM; 1 mg/mL in Methanol ....................................... Glass ampule: 1 mL ........ 6/28/2016
Cayman Chemical Company ...... Acetyl Fentanyl CRM; 1 mg/mL in Methanol .................................. Glass ampule: 1 mL ........ 6/28/2016
Cayman Chemical Company ...... Acetyl Fentanyl CRM; 100 μg/mL in Methanol ............................... Glass ampule: 1 mL ........ 6/28/2016
Cayman Chemical Company ...... Cocaine CRM; 1 mg/mL in Acetonitrile ........................................... Glass ampule: 1 mL ........ 6/28/2016
Cayman Chemical Company ...... Cocaine/Heroin/Methamphetamine Mixture CRM; 1 mg/mL each Glass ampule: 1 mL ........ 8/26/2016
in Acetonitrile.
Cayman Chemical Company ...... Cocaine/Heroin/Methamphetamine Mixture CRM; 100 μg/mL Glass ampule: 1 mL ........ 8/26/2016
each in Acetonitrile.
Cayman Chemical Company ...... Cocaine/Heroin/Methamphetamine Mixture CRM; 250 μg/mL Glass ampule: 1 mL ........ 8/26/2016
each in Acetonitrile.
Cayman Chemical Company ...... Cocaine/Heroin/Methamphetamine Mixture CRM; 500 μg/mL Glass ampule: 1 mL ........ 8/26/2016
each in Acetonitrile.
Cayman Chemical Company ...... GC-MS Drug Standard Mixture 1 in Acetonitrile ............................. Glass ampule: 1 mL ........ 6/28/2016
Cayman Chemical Company ...... Phytocannabinoid Mixture 1; 1 mg/mL in Acetonitrile .................... Glass ampule: 1 mL ........ 6/28/2016
Cayman Chemical Company ...... Tapentadol (hydrochloride) CRM; 1 mg/mL in Acetonitrile ............. Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... Tapentadol (hydrochloride) CRM; 1 mg/mL in Methanol ................ Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... Tapentadol (hydrochloride) CRM; 100 μg/mL in Acetonitrile .......... Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... Tapentadol (hydrochloride) CRM; 100 μg/mL in Methanol ............. Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... THJ2201 (CRM); 1 mg/mL in Acetonitrile ....................................... Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... THJ2201 (CRM); 1 mg/mL in Methanol .......................................... Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... THJ2201 (CRM); 100 μg/mL in Acetonitrile .................................... Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... THJ2201 (CRM); 100 μg/mL in Methanol ....................................... Glass ampule: 1 mL ........ 8/26/2016
Cayman Chemical Company ...... ToxBox THC/THC Metabolite Plate ................................................ 48-well plate ..................... 6/28/2016
Cerilliant Corporation .................. (±)-11-Hydroxy-delta9–THC glucuronide (0.01 mg/mL) .................. Glass ampule: 1 mL ........ 11/11/2016
Cerilliant Corporation .................. (±)-Cannabicyclol (1.0 mg/mL) ........................................................ Glass ampule: 1.0 mL ..... 7/18/2016
Cerilliant Corporation .................. (±)-cis-3-Methylfentanyl HCl (0.05 mg/mL) ..................................... Glass ampule: 1 mL ........ 6/21/2016
Cerilliant Corporation .................. (±)-cis-3-Methylfentanyl HCl (0.1 mg/mL) ....................................... Glass ampule: 0.5 mL ..... 7/18/2016
Cerilliant Corporation .................. 5alpha-Dihydrotestosterone-D3 [16, 16, 17–D3]; 10 μg/mL ........... Glass ampule: 1 mL ........ 9/28/2016
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) (1.0 mg/mL) ................................ Glass ampule: 1 mL ........ 11/30/2016
Cerilliant Corporation .................. Cannabicyclolic acid (CBLA) (1.0 mg/mL) ...................................... Glass ampule: 1 mL ........ 11/30/2016
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/mL) ................................................ Glass ampule: 0.5 mL ..... 11/30/2016
Cerilliant Corporation .................. Clorazepate dipotassium (1 mg/mL) ............................................... Glass ampule: 1 mL ........ 5/6/2016
Cerilliant Corporation .................. Dihydrotestosterone Calibrator Level 1 (20 pg/mL) ........................ Cryovial: 1 mL .................. 8/12/2016
Cerilliant Corporation .................. Dihydrotestosterone Calibrator Level 2 (50 pg/mL) ........................ Cryovial: 1 mL .................. 8/12/2016
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Cerilliant Corporation .................. Dihydrotestosterone Calibrator Level 3 (100 pg/mL) ...................... Cryovial: 1 mL .................. 8/12/2016
Cerilliant Corporation .................. Dihydrotestosterone Calibrator Level 4 (500 pg/mL) ...................... Cryovial: 1 mL .................. 8/12/2016
Cerilliant Corporation .................. Dihydrotestosterone Calibrator Level 5 (1000 pg/mL) .................... Cryovial: 1 mL .................. 8/12/2016
Cerilliant Corporation .................. Dihydrotestosterone Calibrator Level 6 (2500 pg/mL) .................... Cryovial: 1 mL .................. 8/12/2016
Cerilliant Corporation .................. Dihydrotestosterone Calibrator Level 7 (10 ng/mL) ........................ Cryovial: 1 mL .................. 8/12/2016
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/mL) ........................................ Glass ampule: 1.0 mL ..... 7/18/2016
Cerilliant Corporation .................. Noroxymorphone-D3 HCl (0.1 mg/mL) ........................................... Glass ampule: 1.0 mL ..... 7/18/2016
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![Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices 26947
CHART I—Continued
Application
Supplier Product name Form date
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; 7.5μL 10/21/2016
each.
IDEXX Laboratories .................... Coag Dx PT Cartridge ..................................................................... Cartridges: 7.5μL each .... 10/21/2016
Immunalysis Corporation ............ cTHC Urine Calibrator 1 (20 ng/mL) ............................................... Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ cTHC Urine Calibrator 2 (50 ng/mL) ............................................... Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ cTHC Urine Calibrator 3 (100 ng/mL) ............................................. Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ cTHC Urine Calibrator 4 (200 ng/mL) ............................................. Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ cTHC Urine Control HIGH (62.5 ng/mL) ......................................... Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ cTHC Urine Control LOW (37.5 ng/mL) .......................................... Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ Fentanyl Urine Calibrator 1 (1 ng/mL) ............................................ Dropper bottle: 5 mL ........ 5/27/2016
Immunalysis Corporation ............ Fentanyl Urine Calibrator 2 (2 ng/mL) ............................................ Dropper bottle: 5 mL ........ 5/27/2016
Immunalysis Corporation ............ Fentanyl Urine Calibrator 3 (4 ng/mL) ............................................ Dropper bottle: 5 mL ........ 5/27/2016
Immunalysis Corporation ............ Fentanyl Urine Control HIGH (1.5 ng/mL) ...................................... Dropper bottle: 5 mL ........ 5/27/2016
Immunalysis Corporation ............ Fentanyl Urine Control LOW (0.5 ng/mL) ....................................... Dropper bottle: 5 mL ........ 5/27/2016
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 (1000 ng/mL) .............................. Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ Opiates Urine Calibrator 2000 2 (2000 ng/mL) .............................. Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ Opiates Urine Calibrator 2000 3 (4000 ng/mL) .............................. Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ Opiates Urine Calibrator 2000 4 (6000 ng/mL) .............................. Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ Oxazepam Urine Control HIGH (125 ng/mL) .................................. Dropper bottle: 5 mL, 15 5/27/2016
mL.
Immunalysis Corporation ............ Oxazepam Urine Control LOW (75 ng/mL) .................................... Dropper bottle: 5 mL, 15 5/27/2016
mL.
Instrumentation Laboratory ......... Gem Test PT ................................................................................... Box: 45 cuvettes; 7.5μL 10/6/2016
each.
IsoSciences, LLC ........................ Codeine-[13C4, 15N], 1000 μg/mL in methanol ............................. Amber ampule: 1 mL ....... 10/20/2016
IsoSciences, LLC ........................ Codeine-6b-Glucuronide-[13C10, 15N], 1000 μg/mL in meth- Amber ampule: 1 mL ....... 10/20/2016
anol:water (2:8).
IsoSciences, LLC ........................ Morphine-[13C4, 15N], 1000 μg/mL in methanol ............................ Amber ampule: 1 mL ....... 10/20/2016
IsoSciences, LLC ........................ Morphine-6b-Glucuronide-[13C10, 15N], 1000 μg/mL in meth- Amber ampule: 1 mL ....... 10/20/2016
anol:water (2:8).
IsoSciences, LLC ........................ Testosterone-[2H8], 100 μg/mL in methanol .................................. Amber Ampule: 1 mL ....... 8/10/2016
IsoSciences, LLC ........................ Testosterone-[2H8], 1000 μg/mL in methanol ................................ Amber Ampule: 1 mL ....... 8/10/2016
ITC ............................................... Hemochron Jr .................................................................................. Box: 45 cuvettes; 7.5μL 7/1/2016
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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 methanol) ......................................... Glass ampule: 1 mL ........ 10/28/2016
Lipomed Inc ................................. 25I-NB2OMe-D9 (1 mg/mL methanol) ............................................ Glass ampule: 1 mL ........ 10/28/2016
Lipomed Inc ................................. 3,4-Methylendioxypyrovalerone (1 mg/mL methanol) ..................... Glass ampule: 1 mL ........ 10/28/2016
Lipomed Inc ................................. 3,4-Methylenedioxy-a-pyrrolidinopropiophenone (1 mg/mL meth- Glass ampule: 1 mL ........ 10/28/2016
anol).
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![Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices 26951
Scope of Approval Approved Exempt Chemical Street South, Suite 4E401, Arlington,
Preparations Are Posted on DEA’s Web VA 22202–5452.
The exemptions are applicable only to Site • Hand Delivery: USDOL—Mine
the precise preparation or mixture Safety and Health Administration, 201
described in the application submitted A list of all current exemptions,
12th Street South, Suite 4E401,
to DEA in the form(s) listed in this order including those listed in this order, is
Arlington, VA 22202–5452. Sign in at
available on the DEA’s Web site at
and only for those sections of the CSA the receptionist’s desk on the 4th floor
http://www.DEAdiversion.usdoj.gov/
and the CFR that are specifically via the East elevator.
schedules/exempt/exempt_chemlist.pdf.
identified. In accordance with 21 CFR FOR FURTHER INFORMATION CONTACT:
The dates of applications of all current
1308.24(h), any change in the Sheila McConnell, Director, Office of
exemptions are posted for easy
quantitative or qualitative composition reference. Standards, Regulations, and Variances,
of the preparation or mixture, or change MSHA, at
in the trade name or other designation Dated: May 24, 2017. MSHA.information.collections@dol.gov
of the preparation or mixture after the Louis J. Milione, (email); 202–693–9440 (voice); or 202–
date of application requires a new Assistant Administrator. 693–9441 (facsimile).
application. In accordance with 21 CFR [FR Doc. 2017–12110 Filed 6–9–17; 8:45 am] SUPPLEMENTARY INFORMATION:
1308.24(g), the DEA may prescribe BILLING CODE 4410–09–P
I. Background
requirements other than those set forth
in 1308.24(b)–(e) on a case-by-case basis Section 103(h) of the Federal Mine
for materials exempted in bulk DEPARTMENT OF LABOR Safety and Health Act of 1977 (Mine
quantities. Accordingly, in order to limit Act), 30 U.S.C. 813(h), authorizes
Mine Safety and Health Administration MSHA to collect information necessary
opportunity for diversion from the
to carry out its duty in protecting the
larger bulk quantities, the DEA has [OMB Control No. 1219–0NEW] safety and health of miners. Further,
determined that each of the exempted Sec. 101(a) of the Mine Act, 30 U.S.C.
bulk products listed in this order may Proposed Extension of Information
811 authorizes the Secretary of Labor to
only be used in-house by the Collection; Performance Reports for
develop, promulgate, and revise as may
manufacturer, and may not be MSHA Grants
be appropriate, improved mandatory
distributed for any purpose, or AGENCY: Mine Safety and Health health or safety standards for the
transported to other facilities. Administration, Labor. protection of life and prevention of
Additional exempt chemical ACTION: Request for public comments. injuries in coal and metal and nonmetal
preparation requests received between mines.
April 1, 2016, and December 31, 2016, SUMMARY: The Department of Labor, as MSHA is requesting approval of a
and not otherwise referenced in this part of its continuing effort to reduce new information collection for narrative
order may remain under consideration paperwork and respondent burden, reporting of grant requirements. One of
until the DEA receives additional conducts a pre-clearance consultation MSHA’s strategic goals is to ‘‘improve
information required, pursuant to 21 program to provide the general public workplace safety and health’’ through
CFR 1308.23(d), as detailed in separate and Federal agencies with an the strategic objective ‘‘secure safe and
opportunity to comment on proposed healthy workplaces, particularly in
correspondence to individual
collections of information in accordance high-risk industries.’’ MSHA’s goal in
requesters. The DEA’s order on such
with the Paperwork Reduction Act of accomplishing this objective is to
requests will be communicated to the ‘‘prevent death, disease, and injury from
public in a future Federal Register 1995, 44 U.S.C. 3506(c)(2)(A). This
program helps to assure that requested mining and promote safe and healthful
publication. workplaces for the Nation’s miners.’’
data can be provided in the desired
The DEA also notes that these format, reporting burden (time and Sec. 115 of the Mine Act, as amended,
exemptions are limited to exemption financial resources) is minimized, requires mine operators to have a health
from only those sections of the CSA and collection instruments are clearly and safety training program. Under Sec.
the CFR that are specifically identified understood, and the impact of collection 503 of the Mine Act, as amended, the
in 21 CFR 1308.24(a). All other requirements on respondents can be Secretary may award grants to States to
requirements of the CSA and the CFR properly assessed. Currently, the Mine assist in developing and enforcing State
apply, including registration as an Safety and Health Administration mining laws and regulations, to improve
importer as required by 21 U.S.C. 957. (MSHA) is soliciting comments on the State workers’ compensation and
information collection for Performance mining occupational disease laws and
Opportunity for Comment programs, and to improve safety and
Reports for MSHA Grants.
health conditions in the Nation’s mines
Pursuant to 21 CFR 1308.23, any DATES: All comments must be received
through Federal-State coordination and
interested person may submit written on or before August 11, 2017. cooperation.
comments on or objections to any ADDRESSES: Comments concerning the Therefore, MSHA seeks the Office of
chemical preparation in this order that information collection requirements of Management and Budget’s (OMB)
has been approved or denied as exempt. this notice may be sent by any of the clearance of the information collections
If any comments or objections raise
asabaliauskas on DSKBBXCHB2PROD with NOTICES
methods listed below. the Department of Labor (DOL) requires
significant issues regarding any finding • Federal E-Rulemaking Portal: to carry out its grant program through
of fact or conclusion of law upon which http://www.regulations.gov. Follow the MSHA. This information collection
this order is based, the Assistant on-line instructions for submitting covers the performance reporting for
Administrator will immediately comments for docket number MSHA– MSHA for Narrative Reports. MSHA is
suspend the effectiveness of any 2017–0007. seeking to transfer its DOL-approved
applicable part of this order until he • Regular Mail: Send comments to burden on the Narrative Reports under
may reconsider the application in light USDOL—MSHA, Office of Standards, OMB No. 1225–0086 to an MSHA
of the comments and objections filed. Regulations, and Variances, 201 12th information collection.
VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1](https://thefederalregister.org/doc/82_FR_27055/page/8.svg)
Document Created: 2017-06-10 01:40:29
Document Modified: 2017-06-10 01:40:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Order with opportunity for comment. | |
| 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. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 82 FR 26944 |
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