Exempt Chemical Preparations Under the Controlled Substances Act, 40175-40186 [2013-16010]

Download as PDF Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country, and such merchandise from other countries. (13) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions. Authority: This review is being conducted under authority of Title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.61 of the Commission’s rules. Issued: June 25, 2013. By order of the Commission. William R. Bishop, Supervisory Hearings and Information Officer. [FR Doc. 2013–16103 Filed 7–2–13; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE [OMB Number 1103–NEW] Agency Information Collection Activities; Proposed New Collection; Comments Requested: Police-Led Diversion Programs: National Prevalence and Scope emcdonald on DSK67QTVN1PROD with NOTICES ACTION: 60-Day Notice. The Department of Justice (DOJ) Office of Community Oriented Policing Services (COPS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. The purpose of this notice is to allow for 60 days for public comment until September 3, 2013. This process is conducted in accordance with 5 CFR 1320.10. If you have comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Danielle Ouellette, Department of Justice Office of Community Oriented Policing Services, 145 N Street NE., Washington, DC 20530. Written comments and suggestions from the public and affected agencies VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Enhance the quality, utility, and clarity of the information to be collected; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection (1) Type of Information Collection: Proposed new collection; comments requested (2) Title of the Form/Collection: Police-Led Diversion Programs: National Prevalence and Scope (3) Agency form number, if any, and the applicable component of the Department sponsoring the collection: None. U.S. Department of Justice Office of Community Oriented Policing Services (4) Affected public who will be asked or required to respond, as well as a brief abstract: Law enforcement agencies through a nationally representative sample may be asked to provide information to determine the national prevalence of police-led diversion programs and provide a portrait of their goals, target populations, and policies. Through a cooperative agreement with the COPS Office, the Center for Court Innovation (CCI, Inc.) will create a representative sample of law enforcement agencies based on data available through the FBI Uniform Crime Reporting. CCI will subcontract with a professional survey research firm to administer the survey. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: It is estimated that 3,600 respondents annually will complete the form in approximately 1 hour. (6) An estimate of the total public burden (in hours) associated with the collection: There are an estimated 3,600 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 40175 total annual burden hours associated with this collection. If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 1407B, Washington, DC 20530. June 27, 2013. Jerri Murray, Department Clearance Officer, PRA, U.S. Department of Justice. [FR Doc. 2013–15904 Filed 7–2–13; 8:45 am] BILLING CODE 4410–AT–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–372] Exempt Chemical Preparations Under the Controlled Substances Act Drug Enforcement Administration (DEA), Department of Justice. ACTION: Order with opportunity for comment. AGENCY: The applications for exempt chemical preparations received by DEA between July 1, 2012, and March 31, 2013, as listed below, were accepted for filing and have been approved or denied as indicated. DATES: Electronic comments must be submitted and written comments must be postmarked on or before September 3, 2013. The electronic Federal Docket Management System will not accept comments after midnight 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 electronic and written correspondence. DEA encourages that all comments be submitted electronically through http:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at http:// www.regulations.gov for easy reference. Paper comments that duplicate the electronic submission are not necessary as all comments submitted to www.regulations.gov will be posted for public review and are part of the official docket record. Written comments submitted via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, Virginia 22152. SUMMARY: E:\FR\FM\03JYN1.SGM 03JYN1 40176 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices John W. Partridge, Executive Assistant, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 307–7165. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: 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. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket. Personal identifying information and confidential business information identified and located as set forth above will be redacted, and the comment, in redacted form, will be posted online and placed in DEA’s public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency’s public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph. Legal Authority DEA implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act and the Controlled Substances Import and Export Act (codified at Title 21, Chapter 13 of the U.S.C.), as amended (CSA). DEA drafts and publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. 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 providing for a sufficient supply of controlled substances and listed chemicals for legitimate medical, scientific, research, and industrial purposes. 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 DEA regulations at 21 CFR 1308.23 and 1308.24 further detail the criteria by which the DEA Deputy Assistant Administrator may exempt a chemical preparation or mixture from the application of certain provisions of the CSA. The Deputy Assistant Administrator may, pursuant to 21 CFR 1308.23(f), modify or revoke the criteria by which exemptions are granted and modify the scope of exemptions at any time. Exempt Chemical Preparation Applications Submitted Between July 1, 2012, and March 31, 2013 The Deputy Assistant Administrator received applications between July 1, 2012, and March 31, 2013, requesting exempt chemical preparation status pursuant to 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 Deputy 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 other 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 Deputy Assistant Administrator has determined that each of the chemical preparations or mixtures generally described in Chart I below and specifically described in the application materials received by DEA, are 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 listed below that was provided in the approval letters to the individual requesters. CHART I emcdonald on DSK67QTVN1PROD with NOTICES Supplier AccuStandard, AccuStandard, AccuStandard, AccuStandard, AccuStandard, Inc Inc Inc Inc Inc ................... ................... ................... ................... ................... Product name APP–9–086, a,a-Dimethylphenethylamine .............................. APP–9–086–20X, a,a-Dimethylphenethylamine ...................... AS–E1179, Chloral hydrate ..................................................... CLP–HC–X1, Composite Mix #3A ........................................... M–551.1B, Disinfectant by-products ........................................ 1 This authority has been delegated from the Attorney General to the Administrator of the DEA VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 by 28 CFR 0.100 and subsequently redelegated to PO 00000 Frm 00088 Fmt 4703 Application date Form Sfmt 4703 Amber Amber Amber Amber Amber ampule: ampule: ampule: ampule: ampule: 1 1 1 1 1 mL mL mL mL mL .............. .............. .............. .............. .............. 1/28/2013 1/28/2013 1/28/2013 1/28/2013 1/28/2013 the Deputy Assistant Administrator pursuant to the Appendix to Subpart R of 28 CFR 0.104. E:\FR\FM\03JYN1.SGM 03JYN1 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40177 CHART I—Continued Application date Supplier Product name Form AccuStandard, Inc ................... AccuStandard, Inc ................... AccuStandard, Inc ................... AccuStandard, Inc ................... AccuStandard, Inc ................... AccuStandard, Inc ................... AccuStandard, Inc ................... AccuStandard, Inc ................... Agilent Technologies ............... Agilent Technologies ............... Agilent Technologies ............... Agilent Technologies ............... Agilent Technologies ............... Agilent Technologies ............... Agilent Technologies ............... Alltech Associates, Inc ............ Alltech Associates, Inc ............ Alltech Associates, Inc ............ American Proficiency Institute Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Bio-Rad Laboratories .............. Bio-Rad Laboratories .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Glass ampule: 1 mL ............... Glass ampule: 1 mL ............... Glass ampule: 1 mL ............... Amber bottle: 7 mL ................. Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Box: 3 vials, 2.5 mL each ....... Box: 12 vials, 5 mL each ........ 1/28/2013 1/28/2013 1/28/2013 1/28/2013 1/28/2013 1/28/2013 1/28/2013 1/28/2013 8/3/2012 8/3/2012 8/3/2012 8/3/2012 8/3/2012 8/3/2012 12/6/2012 9/26/2012 9/26/2012 9/26/2012 12/5/2012 8/14/2012 8/14/2012 9/27/2012 10/23/2012 10/23/2012 11/5/2012 1/24/2013 1/24/2013 1/29/2013 3/12/2013 3/12/2013 3/14/2013 11/14/2012 11/21/2012 Box: 6 vials, 5 mL each .......... Box: 3 vials, 5 mL each .......... Glass vial: 25 mL .................... 11/21/2012 11/21/2012 1/11/2013 Bio-Rad Laboratories .............. M–551B, Disinfectant by-products ........................................... M–551B–2, Chloral hydrate ..................................................... M–8015B/5031–21, Paraldehyde ............................................. M–8206B–05, Additional VOC’s by Method 8206B ................. M–8270–02, Semi-Volatile by Capillary Column GC/MS Mix 2 M–8270–04–ASL, Method 8270B—Base/Neutrals Mix ........... M–8270–23–R1, Method 8270 Semi-Volatile Additions .......... M–E–1179–M, Chloral hydrate ................................................ Veterinary Drugs Checkout Mix ............................................... Veterinary Drugs Comprehensive Mix—Submix 6 .................. Forensic Toxicology Comprehensive Mix—Submix 3 ............. Forensic Toxicology Comprehensive Mix—Submix 5 ............. Forensic Toxicology Comprehensive Mix—Submix 2 ............. Forensic Toxicology Checkout Mix .......................................... Forensic Toxicology Comprehensive Mix—Submix 1 ............. 2C–T–2 Quik Check, 1.0 mg/mL ............................................. 5-MeO–DMT Quick Check, 1.0 mg/mL ................................... Carisoprodol Quik Check, 1.0 mg/mL ...................................... American Proficiency Institute SHBG/Testosterone ................ Detectabuse Custom Liquid Control Oral Fluid, OF23 ............ Detectabuse Custom Liquid Control Urine, SD17 ................... Detectabuse Custom Liquid Control Urine, MC176 ................ Detectabuse Custom Liquid Control Urine, MC179 ................ Salivabuse Custom Liquid Control Oral Fluid, OF25 .............. Detectabuse Custom Liquid Control Urine, MC177 ................ Detectabuse Custom Liquid Control Urine, MC178 ................ Detectabuse Custom Liquid Control Oral Fluid, OF24 ............ Detectabuse Custom Liquid Control Urine, MC181 ................ Detectabuse Custom Liquid Control Urine, MC183 ................ Detectabuse Custom Liquid Control Urine, MC184 ................ Detectabuse Custom Liquid Control Urine, MC180 ................ Liquichek Immunoassay Plus Control Trilevel MiniPak ........... Liquichek Immunoassay Plus Control Level 1,2 and 3, Trilevel. Liquid Assayed Multiqual Premium, Levels 1–3 ...................... Liquid Assayed Multiqual Premium, Trilevel Minipak .............. Lyphocheck Urine Toxicology Control MiniPak, Cat. No. 470X. Liquichek Immunoassay Plus Control Level 1 ......................... 2/20/2013 Bio-Rad Laboratories .............. Liquichek Immunoassay Plus Control Level 2 ......................... Bio-Rad Laboratories .............. Liquichek Immunoassay Plus Control Level 3 ......................... Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Benzodiazepine Mix (1 mg/mL) ............................................... Class C Mix Urinalysis Internal Standard Fortified Morphine .. Spice Cannabinoid Mix 2 (0.1 mg/mL) .................................... Spice Cannabinoid Mix 3 (0.1 mg/mL) .................................... Retigabine (1 mg/mL) .............................................................. ±-Norpseudoephedrine-D3 HCl (0.1 mg/mL) ........................... Amobarbital-D5 (0.1 mg/mL) .................................................... 2,5-Dimethoxy-4-(n)-propylthiophenethylamine HCl (2C–T–7 HCl) (1 mg/mL). Class B Mix Urinalysis Internal Standard-8 (0.002–0.2 mg/ mL), Pregabalin-D6 (1.0 mg/mL), Codeine-6-betaglucoronide (1.0 mg/mL), Desomorphine (1.0 mg/mL), Levorphanol-D3 (0.1 mg/mL). Zaleplon-D4 (0.1 mg/mL) ......................................................... Retigabine-D4 (0.1 mg/mL) ...................................................... Tilidine-D6 HCl (0.1 mg/mL) .................................................... TDM Control, Levels 1–3 ......................................................... ELI Oral Fluid Controls, THC (0.5–50 ng/mL) ......................... ELI Oral Fluid Controls, Methamphetamine (2–200 ng/mL) .... ELI Oral Fluid Controls, Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (2–200 ng/mL). ELI Oral Fluid Controls, Multidrug (THC, Benzoylecgonine, Amphetamine, Methamphetamine, Morphine, Codeine, 6Acetylmorphine, & PCP) at 0.5–50 ng/mL. ELI Oral Fluid Calibrators, THC (0.5–50 ng/mL) ..................... ELI Oral Fluid Calibrators, Methamphetamine (2–200 ng/mL) Glass vial: 2.5 mL, Box 12 vials. Glass vial: 2.5 mL, Box 12 vials. Glass vial: 2.5 mL, Box 12 vials. Glass Ampule: 1 mL ............... Glass Ampule: 1 mL ............... Amber ampule: 1 mL .............. Amber ampule: 1 mL .............. Glass Ampule: 1 mL ............... Glass Ampule: 1 mL ............... Glass Ampule: 1 mL ............... Glass Ampule: 1 mL ............... 7/2/2012 7/9/2012 9/26/2012 9/26/2012 11/7/2012 1/7/2013 1/7/2013 1/7/2013 Glass ampule: 1 ml ................. 1/22/2013 Glass Ampule: 1 mL ............... Glass ampule: 1ml .................. Glass ampule: 1ml .................. Dropper bottle: 5 mL ............... Glass vial: 5 ml–4 L ................ Glass vial: 5 ml–4 L ................ Glass vial: 5 ml–4 L ................ 1/31/2013 3/22/2013 3/22/2013 12/4/2012 10/22/2012 10/22/2012 10/22/2012 Glass vial: 5 ml–4 L ................ 10/22/2012 Glass vial: 5 ml–4 L ................ Glass vial: 5 ml–4 L ................ 10/22/2012 10/22/2012 Bio-Rad Laboratories .............. Bio-Rad Laboratories .............. Bio-Rad Laboratories .............. Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation ............... ............... ............... ............... ............... ............... ............... ............... emcdonald on DSK67QTVN1PROD with NOTICES Cerilliant Corporation ............... Cerilliant Corporation ............... Cerilliant Corporation ............... Cerilliant Corporation ............... Cliniqa Corporation .................. ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\03JYN1.SGM 03JYN1 2/20/2013 2/20/2013 40178 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices CHART I—Continued Application date Supplier Product name Form ElSohly Laboratories, Inc ........ ELI Oral Fluid Calibrators, Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (2–200 ng/mL). ELI Oral Fluid Calibrators, Multidrug (THC, Benzoylecgonine, Amphetamine, Methamphetamine, Morphine, Codeine, 6Acetylmorphine, & PCP) at 0.5–200 ng/mL. USGS–BQS LS 4434 Mix 1 ..................................................... Glass vial: 5 ml–4 L ................ 10/22/2012 Glass vial: 5 ml–4 L ................ 10/22/2012 Glass Ampule: 2 mL ............... 8/9/2012 USGS–BQS LS 4434 Mix 2 ..................................................... Glass Ampule: 2 mL ............... 8/9/2012 Tapentadol Calibrator Level 1 (100 ng/mL) ............................. Tapentadol Calibrator Level 2 (200 ng/mL) ............................. Tapentadol Calibrator Level 3 (500 ng/mL) ............................. Tapentadol Calibrator Level 4 (1,000 ng/mL) .......................... Tapentadol Low Control (150 ng/mL) ...................................... Tapentadol High Control (250 ng/mL) ..................................... (S)-(+)-Amphetamine (Dextroamphetamine) 1.0 mg/mL in Methanol. rac-Amphetamine 0.1 mg/mL in Methanol ............................... rac-Amphetamine 1.0 mg/mL in Methanol ............................... rac-Amphetamine-D11 0.1 mg/mL in Methanol ....................... rac-Amphetamine-D11 1.0 mg/mL in Methanol ....................... rac-Amphetamine-D5 (D-label on ring) 0.1 mg/mL in Methanol. Methamphetamine ((S)-(+)-Methamphetamine) 1.0 mg/mL in Methanol. rac-Methamphetamine 0.1 mg/mL in Methanol ....................... rac-Methamphetamine 1.0 mg/mL in Methanol ....................... rac-Methamphetamine-D5 0.1 mg/mL in Methanol ................. rac-Methamphetamine-D5 1.0 mg/mL in Methanol ................. Methcathinone Hydrochloride 1.0 mg/mL in Methanol (as free base). Methylphenidate Hydrochloride 1.0 mg/mL in Methanol (as free base). Amobarbital 1.0 mg/mL in Methanol ........................................ Pentobarbital 1.0 mg/mL in Methanol ...................................... Pentobarbital-D5 1.0 mg/mL in Methanol ................................ Pentobarbital-D5 0.1 mg/mL in Methanol ................................ Secobarbital 1.0 mg/mL in Methanol ....................................... rac-MDA–D5 (rac-3,4-Methylenedioxyamphetamine-D5) 0.1 mg/mL Methanol. rac-MDA–D5 (rac-3,4-Methylenedioxyamphetamine-D5) 1.0 mg/mL Methanol. rac-MBDB HCl (rac-N-Methyl-1-(3,4-Methylenedioxyphenyl)2-butanamine Hydrochloride) 1.0 mg/mL Methanol (as free base). rac-MBDB–D5 (rac-N-Methyl-1-(3,4-Methylenedioxyphenyl)-2butanamine-D5) 0.1 mg/mL Methanol. rac-MDEA–D5 (rac-3,4-Methylenedioxy-N-ethylamphetamineD5) 0.1 mg/mL Methanol. rac-MDEA–D5 (rac-3,4-Methylenedioxy-N-ethylamphetamineD5) 1.0 mg/mL Methanol. rac-MDEA–D6 (rac-3,4-Methylenedioxy-N-ethylamphetamineD6) 0.1 mg/mL Methanol. rac-MDMA–D5 (rac-3,4-MethylenedioxymethamphetamineD5) 0.1 mg/mL Methanol. rac-MDMA–D5 (rac-3,4-MethylenedioxymethamphetamineD5) 1.0 mg/mL Methanol. Phencyclidine (PCP) 1.0 mg/mL Methanol .............................. Phencyclidine-D5 (PCP-D5) 0.1 mg/mL in Methanol .............. Phencyclidine-D5 (PCP-D5) 1.0 mg/mL Methanol .................. Codeine 0.1 mg/mL in Methanol .............................................. Codeine 1.0 mg/mL in Methanol .............................................. Codeine-D3 0.1 mg/mL in Methanol ........................................ Codeine-D3 1.0 mg/mL in Methanol ........................................ Codeine-D6 0.1 mg/mL in Methanol ........................................ Codeine-D6 1.0 mg/mL in Methanol ........................................ Isocodeine 0.1 mg/mL in Methanol .......................................... Norcodeine 0.01 mg/mL in Methanol ....................................... Norcodeine 1.0 mg/mL in Methanol ......................................... Codeine N-Oxide 0.01 mg/mL Methanol ................................. Oxycodone-D3 1.0 mg/mL in Methanol ................................... Glass Glass Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: vial: vial: 10 mL .................... 10 mL .................... 10 mL .................... 10 mL .................... 10 mL .................... 10 mL .................... 1 mL ...................... Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: 1 1 1 1 1 ElSohly Laboratories, Inc ........ Environmental Resource Associates (ERA). Environmental Resource Associates (ERA). Immunalysis Corporation ......... Immunalysis Corporation ......... Immunalysis Corporation ......... Immunalysis Corporation ......... Immunalysis Corporation ......... Immunalysis Corporation ......... LGC Limited ............................ LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ emcdonald on DSK67QTVN1PROD with NOTICES LGC Limited ............................ LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited VerDate Mar<15>2010 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 17:48 Jul 02, 2013 Jkt 229001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 ...................... ...................... ...................... ...................... ...................... 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... ...................... 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 E:\FR\FM\03JYN1.SGM vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 mL mL mL mL mL 12/11/2012 12/11/2012 12/11/2012 12/11/2012 12/11/2012 12/11/2012 9/24/2012 mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL 03JYN1 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40179 CHART I—Continued Supplier LGC LGC LGC LGC Limited Limited Limited Limited ............................ ............................ ............................ ............................ LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ emcdonald on DSK67QTVN1PROD with NOTICES LGC Limited ............................ LGC LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited Limited VerDate Mar<15>2010 ............................ ............................ ............................ ............................ ............................ ............................ ............................ 17:48 Jul 02, 2013 Product name Form Oxycodone-D6 0.1 mg/mL in Methanol ................................... Oxycodone-D6 1.0 mg/mL in Methanol ................................... Hydromorphone 1.0 mg/mL Methanol ..................................... Norhydromorphone Hydrochloride 1.0 mg/mL Methanol (as free base). Pethidine (Meperidine) 1.0 mg/mL in Methanol ....................... Pethidine-D4 (Meperidine-D4) 0.1 mg/mL in Methanol ........... Pethidine-D4 (Meperidine-D4) 1.0 mg/mL in Methanol ........... Morphine 0.1 mg/mL in Methanol ............................................ Morphine 1.0 mg/mL in Methanol ............................................ Morphine 3-beta-D-Glucuronide 0.1 mg/mL in Methanol/ Water (1⁄1). Morphine 3-beta-D-Glucuronide 1.0 mg/mL in Methanol with 0.05 percent Sodium Hydroxide (w/v). Morphine 6-beta-D-Glucuronide 0.1 mg/mL in Methanol/ Water (1⁄1). Morphine 6-beta-D-Glucuronide 1.0 mg/mL Water/Methanol (80/20). Morphine-D3 0.1 mg/mL in Methanol ...................................... Morphine-D3 1.0 mg/mL in Methanol ...................................... Morphine N-Oxide 0.01 mg/mL Methanol ................................ Normorphine 1.0 mg/mL Methanol .......................................... rac-Amphetamine-D10 0.1 mg/mL in Methanol ....................... rac-Amphetamine-D5 (D-label on ring) 0.1 mg/mL in Methanol. rac-Amphetamine-D5 (D-label on side chain) 0.1 mg/mL in Methanol. rac-Amphetamine-D5 (D-label on side chain) 1.0 mg/mL in Methanol. rac-Amphetamine-D6 0.1 mg/mL in Methanol ......................... rac-Amphetamine-D6 1.0 mg/mL in Methanol ......................... rac-Amphetamine-D8 0.1 mg/mL in Methanol ......................... rac-Amphetamine-D8 1.0 mg/mL in Methanol ......................... rac-Methamphetamine-D11 0.1 mg/mL in Methanol ............... rac-Methamphetamine-D11 1.0 mg/mL in Methanol ............... rac-Methamphetamine-D14 0.1 mg/mL in Methanol ............... rac-Methamphetamine-D14 1.0 mg/mL in Methanol ............... rac-Methamphetamine-D8 0.1 mg/mL in Methanol ................. rac-Methamphetamine-D8 1.0 mg/mL in Methanol ................. rac-Methamphetamine-D9 0.1 mg/mL in Methanol ................. rac-Methamphetamine-D9 1.0 mg/mL in Methanol ................. (+)-Norpseudoephedrine Hydrochloride (Cathine Hydrochloride) 0.1 mg/mL in Methanol (as free base). (R)-(+)-Cathinone Hydrochloride 1.0 mg/mL in Methanol (as free base). (S)-(-)-Cathinone Hydrochloride 1.0 mg/mL in Methanol (as free base). (S)-(-)-Methcathinone Hydrochloride 1.0 mg/mL in Methanol (as free base). Phentermine 1.0 mg/mL in Methanol ....................................... Fenfluramine Hydrochloride 1.0 mg/mL in Methanol (as free base). Methylphenidate-D9 Hydrochloride 0.1 mg/mL in Methanol ... Pipradrol Hydrochloride 0.1 mg/mL in Methanol (as free base). Pipradrol Hydrochloride 1.0 mg/mL in Methanol (as free base). GHB Sodium Salt (Sodium Gammahydroxybutyrate) 1.0 mg/ mL in Methanol (as free acid). GHB–D6 Sodium Salt (Sodium Gammahydroxybutyrate-D6) 0.1 mg/mL in Methanol (as free acid). GHB–D6 Sodium Salt (Sodium Gammahydroxybutyrate-D6) 1.0 mg/mL in Methanol (as free acid). Hexobarbital 1.0 mg/mL in Methanol ....................................... Methohexital 1.0 mg/mL in Methanol ....................................... Methohexital-D5 0.1 mg/mL in Methanol ................................. Phenobarbital 1.0 mg/mL in Methanol ..................................... Phenobarbital-D5 (D-label on ring) 0.1 mg/mL in Methanol .... Phenobarbital-D5 (D-label on ring) 1.0 mg/mL in Methanol .... Phenobarbital-D5 (D-label on side chain) 0.1 mg/mL in Methanol. Jkt 229001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 Application date Glass Glass Glass Glass vial: vial: vial: vial: 1 1 1 1 mL mL mL mL ...................... ...................... ...................... ...................... 9/24/2012 9/24/2012 9/24/2012 9/24/2012 Glass Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 mL mL mL mL mL mL ...................... ...................... ...................... ...................... ...................... ...................... 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass vial: 1 mL ...................... 9/24/2012 Glass Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... ...................... 9/24/2012 9/24/2012 9/24/2012 9/24/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass Glass Glass Glass Glass Glass Glass 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 E:\FR\FM\03JYN1.SGM vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL 03JYN1 ...................... ...................... ...................... ...................... ...................... ...................... ...................... 40180 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices CHART I—Continued Application date Supplier Product name Form LGC Limited ............................ Phenobarbital-D5 (D-label on side chain) 1.0 mg/mL in Methanol. Methaqualone 1.0 mg/mL in Methanol .................................... Methaqualone-D7 0.1 mg/mL in Methanol .............................. Clonazepam 1.0 mg/mL in Methanol ....................................... Clonazepam-D4 0.1 mg/mL in Methanol ................................. Chlordiazepoxide 1.0 mg/mL in Methanol ............................... Chlordiazepoxide-D5 0.1 mg/mL in Methanol ......................... Bromazepam 0.1 mg/mL in Methanol ...................................... Bromazepam 1.0 mg/mL in Methanol ...................................... Clobazam 1.0 mg/mL in Methanol ........................................... Delorazepam 0.1 mg/mL in Methanol ...................................... Estazolam 1.0 mg/mL in Methanol .......................................... Estazolam-D5 0.1 mg/mL in Methanol .................................... Flunitrazepam 0.1 mg/mL in Methanol .................................... Flunitrazepam 1.0 mg/mL in Methanol .................................... Flunitrazepam-D7 0.1 mg/mL in Methanol .............................. Prazepam 1.0 mg/mL in Methanol ........................................... Prazepam-D5 0.1 mg/mL in Methanol ..................................... Diazepam 0.1 mg/mL in Methanol ........................................... Diazepam 1.0 mg/mL in Methanol ........................................... Diazepam-D5 0.1 mg/mL in Methanol ..................................... Diazepam-D5 1.0 mg/mL in Methanol ..................................... Flurazepam 0.1 mg/mL in Methanol ........................................ Flurazepam 1.0 mg/mL in Methanol ........................................ Lormetazepam 1.0 mg/mL in Methanol ................................... Zaleplon 1.0 mg/mL in Methanol ............................................. Pregabalin 1.0 mg/mL in Methanol .......................................... Pregabalin-D6 0.1 mg/mL in Methanol .................................... Zolpidem Tartrate 1.0 mg/mL in Methanol (as free base) ....... Zolpidem-D6 0.1 mg/mL in Methanol ...................................... Zopiclone 1.0 mg/mL in Acetonitrile ........................................ Zopiclone Oxide 1.0 mg/mL in Methanol ................................. Zopiclone-D4 0.1 mg/mL in Acetonitrile ................................... Meprobamate 1.0 mg/mL in Methanol ..................................... Nitrazepam 0.1 mg/mL in Acetonitrile ...................................... Nitrazepam 1.0 mg/mL in Acetonitrile ...................................... Nitrazepam-D5 0.1 mg/mL in Acetonitrile ................................ Oxazepam 1.0 mg/mL in Methanol .......................................... Oxazepam-D5 0.1 mg/mL in Methanol .................................... Oxazepam-D5 1.0 mg/mL in Methanol .................................... Nordazepam (Nordiazepam) 0.1 mg/mL in Methanol ............. Nordazepam (Nordiazepam) 1.0 mg/mL in Methanol ............. Nordazepam-D5 (Nordiazepam-D5) 0.1 mg/mL in Methanol .. Nordazepam-D5 (Nordiazepam-D5) 1.0 mg/mL in Methanol .. Alprazolam 1.0 mg/mL in Methanol ......................................... Alprazolam-D5 0.1 mg/mL in Methanol ................................... Alprazolam-D5 1.0 mg/mL in Methanol ................................... Methyltestosterone (17alpha-Methyltestosterone) 1.0 mg/mL in Acetonitrile. Midazolam 1.0 mg/mL in Methanol .......................................... Midazolam-D4 Maleate 0.1 mg/mL in Methanol (as free base). Lorazepam 0.1 mg/mL in Acetonitrile ...................................... Lorazepam 1.0 mg/mL in Acetonitrile ...................................... Lorazepam Acetate ((3RS)-7-Chloro-5-(2-chlorophenyl)-2oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl Acetate) 0.1 mg/mL in Acetonitrile. Lorazepam-D4 0.1 mg/mL in Acetonitrile ................................ Lorazepam-D4 1.0 mg/mL in Acetonitrile ................................ Tetrazepam 0.1 mg/mL in Methanol ........................................ Triazolam 1.0 mg/mL in Methanol ........................................... Triazolam-D4 0.1 mg/mL in Methanol ..................................... Temazepam 0.1 mg/mL in Methanol ....................................... Temazepam 1.0 mg/mL in Methanol ....................................... Temazepam-D5 0.1 mg/mL in Methanol ................................. Temazepam-D5 1.0 mg/mL in Methanol ................................. Androstanolone (5alpha-Dihydrotestosterone, Stanolone) 1.0 mg/mL in Acetonitrile. Androstenedione (Androst-4-ene-3, 17-dione) 1.0 mg/mL in Acetonitrile. Glass vial: 1 mL ...................... 11/30/2012 Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 11/30/2012 Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ emcdonald on DSK67QTVN1PROD with NOTICES LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 E:\FR\FM\03JYN1.SGM vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL 03JYN1 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40181 CHART I—Continued Supplier LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ LGC LGC LGC LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC LGC LGC LGC Limited Limited Limited Limited ............................ ............................ ............................ ............................ emcdonald on DSK67QTVN1PROD with NOTICES LGC Limited ............................ LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ VerDate Mar<15>2010 17:48 Jul 02, 2013 Product name Form Boldenone 1.0 mg/mL in Acetonitrile ....................................... Fluoxymesterone 1.0 mg/mL in Acetonitrile ............................ Mesterolone 1.0 mg/mL in Acetonitrile .................................... Methandienone 1.0 mg/mL in Acetonitrile ............................... Nandrolone 1.0 mg/mL in Acetonitrile ..................................... Norandrostenedione (19-Norandrost-4-ene-3,17-dione) 1.0 mg/mL in Acetonitrile. Norethandrolone 1.0 mg/mL in Acetonitrile ............................. Stanozolol 1.0 mg/mL in Acetonitrile ....................................... Stanozolol-D3 0.1 mg/mL in 1,2-Dimethoxyethane ................. Testosterone 1.0 mg/mL in Acetonitrile ................................... Testosterone Benzoate 1.0 mg/mL in Acetonitrile ................... Testosterone Isocaproate 1.0 mg/mL in Acetonitrile ............... Testosterone Propionate 1.0 mg/mL in Acetonitrile ................ Trenbolone 1.0 mg/mL in Acetonitrile ...................................... RCS–4 (DD–001, (4-Methoxyphenyl)(1-pentylindol-3yl)methanone) 1.0 mg/mL in Acetonitrile. JWH–081 ((4-Methoxynaphthalen-1-yl)(1-pentylindol-3yl)methanone) 1.0 mg/mL in Acetonitrile. JWH–122 ((4-Methylnaphthalen-1-yl)(1-pentylindol-3yl)methanone) 1.0 mg/mL in Acetonitrile. JWH–203 (2-(2-Chlorophenyl)-1-(1-pentylindol-3-yl)ethanone) 1.0 mg/mL in Acetonitrile. Ketamine Hydrochloride 1.0 mg/mL in Methanol (as free base). Ketamine-D4 Hydrochloride 0.1 mg/mL in Methanol (as free base). Iso-LSD (Lysergic Acid Diethylamide) 0.1 mg/mL in Acetonitrile. LAMPA (Lysergic Acid N-Methyl-N-propylamide) 0.025 mg/ mL in Acetonitrile. LSD (Lysergic Acid Diethylamide) 0.025 mg/mL in Acetonitrile. LSD–D3 (Lysergic Acid Diethylamide-D3) 0.025 mg/mL in Acetonitrile. PMA HCl (p-Methoxyamphetamine) 1.0 mg/mL in Methanol (as free base). rac-MDA (rac-3,4-Methylenedioxyamphetamine) 1.0 mg/mL in Methanol. rac-MDEA (rac-3,4-Methylenedioxy-N-ethylamphetamine) 1.0 mg/mL in Methanol. 1-Methylamino-1-(3,4-methylenedioxyphenyl)propane Hydrochloride 1.0 mg/mL in Methanol (as free base). rac-BDB HCl (rac-3,4-Methylenedioxyphenyl-2-butanamine Hydrochloride) 1.0 mg/mL in Methanol (as free base). rac-MDMA (rac-3,4-Methylenedioxymethamphetamine) 1.0 mg/mL in Methanol. Bufotenine 1.0 mg/mL in Acetonitrile ....................................... Methylone Hydrochloride 1.0 mg/mL in Methanol (as free base). Methylone-D3 Hydrochloride 0.1 mg/mL in Methanol (as free base). AM–694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole) 1.0 mg/ mL in Acetonitrile. Cocaine 1.0 mg/mL in Acetonitrile ........................................... Cocaine-D3 0.1 mg/mL in Acetonitrile ..................................... Cocaine-D3 1.0 mg/mL in Acetonitrile ..................................... Norcocaine Hydrochloride 1.0 mg/mL in Acetonitrile (as free base). Norcocaine-D3 Hydrochloride 0.1 mg/mL in Acetonitrile (as free base). O-Methylcodeine 0.1 mg/mL in Acetonitrile ............................. Buprenorphine 0.1 mg/mL in Methanol ................................... Buprenorphine 3-beta-D-Glucuronide 0.1 mg/mL in Methanol Buprenorphine-D4 0.1 mg/mL in Methanol .............................. Dihydrocodeine Hydrochloride 1.0 mg/mL in Methanol (as free base). Dihydrocodeine-D6 Hydrochloride 0.1 mg/mL in Methanol (as free base). Noroxycodone Hydrochloride 1.0 mg/mL in Methanol (as free base). Jkt 229001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 Application date Glass Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 mL mL mL mL mL mL ...................... ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass Glass Glass Glass Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 1 1 1 mL mL mL mL mL mL mL mL mL ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass Glass Glass Glass ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 E:\FR\FM\03JYN1.SGM vial: vial: vial: vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 1 1 1 mL mL mL mL mL mL mL mL mL 03JYN1 40182 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices CHART I—Continued Application date Supplier Product name Form LGC Limited ............................ Noroxycodone-D3 Hydrochloride 0.1 mg/mL in Methanol (as free base). Oxycodone 1.0 mg/mL in Methanol ......................................... Oxycodone-D3 0.1 mg/mL in Methanol ................................... Dihydromorphine 1.0 mg/mL in Methanol ................................ Hydromorphone-D3 0.1 mg/mL in Methanol ........................... Anhydroecgonine Hydrochloride 1.0 mg/mL in Acetonitrile (as free base). Anhydroecgonine Methyl Ester 1.0 mg/mL in Acetonitrile ....... Benzoylecgonine 0.1 mg/mL in Methanol ................................ Benzoylecgonine-D3 0.1 mg/mL in Methanol .......................... Benzoylecgonine-D3 1.0 mg/mL in Methanol .......................... Benzoylecgonine-D8 0.1 mg/mL in Methanol .......................... Benzoylecgonine-D8 1.0 mg/mL in Methanol .......................... Cocaethylene (Benzoylethylecgonine) 1.0 mg/mL in Acetonitrile. Cocaethylene-D3 (Benzoylethylecgonine-D3) 0.1 mg/mL in Acetonitrile. Cocaethylene-D8 (Benzoylethylecgonine-D8) 0.1 mg/mL in Acetonitrile. Ecgonine 1.0 mg/mL in Methanol ............................................ Ecgonine Ethyl Ester 1.0 mg/mL in Acetonitrile ...................... Ecgonine Hydrochloride 1.0 mg/mL in Methanol (as free base). Ecgonine Methyl Ester 0.1 mg/mL in Acetonitrile .................... Ecgonine Methyl Ester 1.0 mg/mL in Acetonitrile .................... Ecgonine-D3 Hydrochloride 0.1 mg/mL in Methanol (as free base). Ecgonine-D3 Methyl Ester 0.1 mg/mL in Acetonitrile .............. Ethylmorphine 1.0 mg/mL in Methanol .................................... Hydrocodone 1.0 mg/mL in Methanol ...................................... Hydrocodone-D3 0.1 mg/mL in Methanol ................................ Hydrocodone-D6 0.1 mg/mL in Methanol ................................ Norhydrocodone Hydrochloride 1.0 mg/mL in Methanol (as free base). Heroin (Diacetylmorphine) 1.0 mg/mL in Acetonitrile .............. Heroin-D9 (Diacetylmorphine-D9) 0.1 mg/mL in Acetonitrile .. Heroin-D9 (Diacetylmorphine-D9) 1.0 mg/mL in Acetonitrile .. rac-Methadone 0.1 mg/mL in Methanol ................................... rac-Methadone 1.0 mg/mL in Methanol ................................... rac-Methadone-D3 0.1 mg/mL in Methanol ............................. rac-Methadone-D3 1.0 mg/mL in Methanol ............................. rac-Methadone-D9 0.1 mg/mL in Methanol ............................. rac-Methadone-D9 1.0 mg/mL in Methanol ............................. Dextropropoxyphene 0.1 mg/mL in Acetonitrile ....................... Dextropropoxyphene 1.0 mg/mL in Acetonitrile ....................... rac-Propoxyphene-D11 0.1 mg/mL in Acetonitrile ................... rac-Propoxyphene-D11 1.0 mg/mL in Acetonitrile ................... rac-Propoxyphene-D5 0.1 mg/mL in Acetonitrile ..................... rac-Propoxyphene-D5 1.0 mg/mL in Acetonitrile ..................... 6-Acetylmorphine 0.1 mg/mL in Acetonitrile ............................ 6-Acetylmorphine 1.0 mg/mL in Acetonitrile ............................ 6-Acetylmorphine-D3 0.1 mg/mL in Acetonitrile ...................... 6-Acetylmorphine-D3 1.0 mg/mL in Acetonitrile ...................... 6-Acetylmorphine-D6 0.1 mg/mL in Acetonitrile ...................... 6-Acetylmorphine-D6 1.0 mg/mL in Acetonitrile ...................... Acetylcodeine 0.1 mg/mL in Acetonitrile .................................. Acetylcodeine 1.0 mg/mL in Acetonitrile .................................. Nordihydromorphine Hydrochloride 1.0 mg/mL in Methanol (as free base). Oxymorphone 1.0 mg/mL in Methanol .................................... Oxymorphone-D3 0.1 mg/mL in Methanol ............................... Oxymorphone-D3 1.0 mg/mL in Methanol ............................... Noroxymorphone Hydrochloride 0.1 mg/mL in Methanol (as free base). Noroxymorphone Hydrochloride 1.0 mg/mL in Methanol (as free base). Butorphanol Tartrate 1.0 mg/mL in Methanol (as free base) .. Sufentanil Citrate 0.1 mg/mL in Methanol (as free base) ....... Glass vial: 1 mL ...................... 11/30/2012 Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: 1 1 1 1 1 mL mL mL mL mL ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass Glass Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 1 mL mL mL mL mL mL mL ...................... ...................... ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 11/30/2012 Glass Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 mL mL mL mL mL mL ...................... ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass Glass Glass Glass vial: vial: vial: vial: 1 1 1 1 mL mL mL mL ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ LGC LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC LGC emcdonald on DSK67QTVN1PROD with NOTICES LGC LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ LGC LGC LGC LGC Limited Limited Limited Limited ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\03JYN1.SGM 03JYN1 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40183 CHART I—Continued Application date Supplier Product name Form LGC Limited ............................ cis-Tilidine (Ethyl (1R,2RS)-2-(Dimethylamino)-1phenylcyclohex-3-enecarboxylate) 0.1 mg/mL in Acetonitrile. Tilidine 0.1 mg/mL in Acetonitrile ............................................. Abbott TDM Multiconstituent Calibrator (CAL 1–6) Catalog Number: 5P04–01. Thermo Scientific DRI Opiate Assay Catalog Number: 100014602. Thermo Scientific DRI Cannabinoid Assay Catalog Number: 10014665. Thermo Scientific Phencyclidine Assay Catalog Number: 10014673. Thermo Scientific Ecstacy Assay Catalog Number: 10014681 Thermo Scientific CEDIA Methamphetamine OFT Calibrator 1: Catalog Number 10016362. Thermo Scientific CEDIA Methamphetamine OFT Calibrator 2: Catalog Number 10063. Thermo Scientific CEDIA Methamphetamine OFT Calibrator 3: Catalog Number 10016364. Thermo Scientific CEDIA Methamphetamine OFT Control 1: Catalog Number 10017686. Thermo Scientific CEDIA Methamphetamine OFT Control 2: Catalog Number 10017687. Thermo Scientific CEDIA Methamphetamine OFT Control 3: Catalog Number 1007688. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 1: Catalog Number 10016882. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 2: Catalog Number 10016883. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 3: Catalog Number 10016884. Thermo Scientific CEDIA Multi-Drug OFT Control 1: Catalog Number 10017711. Thermo Scientific CEDIA Multi-Drug OFT Control 2: Catalog Number 10017712. Thermo Scientific CEDIA Multi-Drug OFT Control 3: Catalog Number 10017713. Thermo Scientific CEDIA THC OFT Calibrator 1: Catalog Number 10016700. Thermo Scientific CEDIA THC OFT Calibrator 2: Catalog Number 10016701. Thermo Scientific CEDIA THC OFT Calibrator 3: Catalog Number 10016702. Thermo Scientific CEDIA THC OFT Control 1: Catalog Number 10017702. Thermo Scientific CEDIA THC OFT Control 2: Catalog Number 10017703. Thermo Scientific CEDIA THC OFT Control 3: Catalog Number 10017704. VITROS Immunodiagnostics Products Testosterone Reagent Pack. VITROS Immunodiagnostics Products Estradiol Reagent Pack. VITROS Immunodiagnostics Products Testosterone Calibrators (1–3). VITROS Immunodiagnostics Products Testosterone Controls (1–3). VITROS Immunodiagnostics Products Testosterone Range Verifiers (Low and High). Custom Revised Appendix IX Mix #1 ...................................... Product and Reactor Samples Standard ................................. 8270 Supplemental Standard #1 ............................................. TTST Stock X (Bulk) ................................................................ Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... Box: 7 vials; 5 mL each .......... 11/30/2012 7/2/2012 Vial: 18 mL, Box: 3 vials ......... 1/30/2013 Vial: 18 mL, Box: 3 vials ......... 1/30/2013 Vial: 18 mL, Box: 3 vials ......... 1/30/2013 Vial: 18 mL, Box: 3 vials ......... Vial: 5 mL; Box: 1 vial ............ 1/30/2013 2/11/2013 Vial: 5 mL; Box: 1 vial ............ 2/11/2013 Vial: 5 mL; Box: 1 vial ............ 2/11/2013 Vial: 10 mL; Box: 1 vial .......... 2/11/2013 Vial: 10 mL; Box: 1 vial .......... 2/11/2013 Vial: 10 mL; Box: 1 vial .......... 2/11/2013 Vial: 10 mL; Box: 1 vial .......... 2/11/2013 Vial: 10 mL; Box: 1 vial .......... 2/11/2013 Vial: 10 mL; Box: 1 vial .......... 2/11/2013 Vial: 15 mL; Box: 1 vial .......... 2/11/2013 Vial: 15 mL; Box: 1 vial .......... 2/11/2013 Vial: 15 mL; Box: 1 vial .......... 2/11/2013 Vial: 5 mL; Box: 1 vial ............ 2/11/2013 Vial: 5 mL; Box: 1 vial ............ 2/11/2013 Vial: 5 mL; Box: 1 vial ............ 2/11/2013 Vial: 10 mL; Box: 1 vial .......... 2/11/2013 Vial: 10 mL; Box: 1 vial .......... 2/11/2013 Vial: 10 mL; Box: 1 vial .......... 2/11/2013 Plastic chamber: 8.4 mL ......... 9/28/2012 Plastic chamber: 13.3 mL ....... 9/28/2012 Box: 3 vials; 2 mL each .......... 10/19/2012 Box: 9 vials; 1 mL each .......... 10/19/2012 Box: 4 vials; 1–1.5 mL each ... 10/19/2012 Glass vial: 1.3 mL ................... Ampule: 2 mL ......................... Ampule: 2 mL ......................... Stock container: 50 mL–1 L ... 2/14/2013 10/12/2012 12/13/2012 7/26/2012 VS TTST Cal Bulk Soln Level 1 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 VS TTST Cal Bulk Soln Level 2 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 VS TTST Cal Bulk Soln Level 3 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 LGC Limited ............................ Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Microgenics Corporation ......... Ortho Clinical Diagnostics, Inc Ortho Clinical Diagnostics, Inc Ortho Clinical Diagnostics, Inc Ortho Clinical Diagnostics, Inc emcdonald on DSK67QTVN1PROD with NOTICES Ortho Clinical Diagnostics, Inc Restek ..................................... Restek Corporation ................. Restek Corporation ................. Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Inc. VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\03JYN1.SGM 03JYN1 40184 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices CHART I—Continued Application date Product name Form 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. 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. 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. Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Inc. Supelco, Inc ............................. emcdonald on DSK67QTVN1PROD with NOTICES Supplier VS TTST Cal Bulk Soln Level 4 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 VS TTST Cal Bulk Soln Level 5 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 VS TTST Cal Bulk Soln Level 6 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 Dimension Vista TTST CAL A ................................................. Vial: 1 mL ................................ 7/26/2012 Dimension Vista TTST CAL B ................................................. Vial: 1 mL ................................ 7/26/2012 Dimension Vista TTST CAL C ................................................. Vial: 1 mL ................................ 7/26/2012 Dimension Vista TTST CAL D ................................................. Vial: 1 mL ................................ 7/26/2012 Dimension Vista TTST CAL E ................................................. Vial: 1 mL ................................ 7/26/2012 Dimension Vista TTST CAL F ................................................. Vial: 1 mL ................................ 7/26/2012 Dimension Vista System TTST CAL ........................................ Box: 12 vials; 1 ml each ......... 7/26/2012 MP TTST Lvl 1 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 MP TTST Lvl 2 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 MP TTST Lvl 3 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 MP TTST Lvl 4 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 MP TTST Lvl 5 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 MP TTST Lvl 6 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 MP TTST CAL Lvl 1 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 MP TTST CAL Lvl 2 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 MP TTST CAL Lvl 3 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 MP TTST CAL Lvl 4 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 MP TTST CAL Lvl 5 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 MP TTST CAL Lvl 6 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 TTST Stock S (Bulk) ................................................................ Stock container: 50 mL–1 L ... 7/26/2012 TTST Stock T (Bulk) ................................................................ Stock container: 50 mL–1 L ... 7/26/2012 Estradiol Diluent ....................................................................... Plastic container: 0.5L–1.0L ... 11/14/2012 Dimension Vista Drug 1 CAL Pilot, Level B ............................ Plastic test tube: 15 mL .......... 12/3/2012 Titan C18 Batch Test 1 Mix ..................................................... Glass ampule: 1 mL ............... 2/28/2013 The Deputy 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 Deputy 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 listed below that was provided in the determination letters to the individual requesters. CHART II Supplier Product name Form Agilent Technologies ............... Forensic Toxicology Comprehensive Mix–Submix 9A ............ Ampule: 1 mL ......................... VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 E:\FR\FM\03JYN1.SGM 03JYN1 Application date 12/6/2012 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40185 CHART II—Continued Application date Supplier Product name Form Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Biochemical Diagnostics, Inc .. Cerilliant Corporation ............... Cerilliant Corporation ............... Cerilliant Corporation ............... Cliniqa Corporation .................. ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ Detectabuse Custom Liquid Control Urine, MC177 ................ Detectabuse Custom Liquid Control Urine, MC178 ................ Salivabuse Custom Liquid Control Oral Fluid, OF24 .............. Detectabuse Custom Liquid Control Urine, MC180 ................ Detectabuse Custom Liquid Control Urine, MC181 ................ Detectabuse Custom Liquid Control Urine, MC182 ................ Detectabuse Custom Liquid Control Urine, MC180 ................ Detectabuse Custom Liquid Control Urine, MC182 ................ (-)-11-nor-9-Carboxy-delta9-THC (1 mg/mL) ........................... Cocaine HCl (10 mg/mL) ......................................................... Lacosamide (10 mg/mL) .......................................................... TDM Control, Levels 1–3 Bulk ................................................. ELI Oral Fluid Controls, THC (0.5–50 ng/mL) ......................... ELI Oral Fluid Controls, Methamphetamine (2–200 ng/mL) .... ELI Oral Fluid Controls, Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (2–200 ng/mL). ELI Oral Fluid Controls, Multidrug (selected from THC, Cocaine/Benzoylecgonine, Amphetamines, Opiates, & PCP at 0.5–50 ng/mL). ELI Oral Fluid Calibrators, THC (0.5–50 ng/mL) ..................... ELI Oral Fluid Calibrators, Methamphetamine (2–200 ng/mL) ELI Oral Fluid Calibrators, Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (2–200 ng/mL). ELI Oral Fluid Calibrators, Multidrug (selected from THC, Cocaine/Benzoylecgonine, Amphetamines, Opiates, & PCP at 0.5–200 ng/mL). LAMPA (Lysergic Acid N-Methyl-N-propylamide) 1.0 mg/mL in Acetonitrile. LSD (Lysergic Acid Diethylamide) 1.0 mg/mL in Acetonitrile .. LSD–D3 (Lysergic Acid Diethylamide-D3) 0.1 mg/mL in Acetonitrile. (-)-Cannabidiol 1.0 mg/mL in Methanol ................................... Cannabinol 1.0 mg/mL in Methanol ......................................... (-)-delta9-THC (Dronabinol) 1.0 mg/mL in Methanol ............... (-)-delta9-THC-D3 (Dronabinol-D3) 0.1 mg/mL in Methanol ... trans-11-Hydroxy-delta9-THC ((6aRS,10aRS)-11-Hydroxydelta9-tetrahydrocannabinol) 0.1 mg/mL in Methanol. trans-11-Hydroxy-delta9-THC ((6aRS,10aRS)-11-Hydroxydelta9-tetrahydrocannabinol) 1.0 mg/mL in Methanol. trans-11-Hydroxy-delta9-THC-D3 (trans-11-Hydroxy-delta9tetrahydrocannabinol-D3) 0.1 mg/mL in Methanol. trans-11-Nor-9-carboxy-delta9-THC 0.1 mg/mL in Methanol .. trans-11-Nor-9-carboxy-delta9-THC-D3 0.1 mg/mL in Methanol. trans-11-Nor-9-carboxy-delta9-THC-D3 1.0 mg/mL in Methanol. Fentanyl 0.1 mg/mL in Methanol ............................................. Fentanyl 1.0 mg/mL in Methanol ............................................. Fentanyl-D5 0.1 mg/mL in Methanol ....................................... Dimension Vista Drug 1 CAL Bulk, Level B ............................ Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–2 L .............. Glass vials: 1 ml–200 mL ....... Glass vials: 1 ml–2 L .............. Glass ampule: 5 mL ............... Glass Ampule: 1 mL ............... Glass Ampule: 1 mL ............... Plastic Container: 500 L ......... Glass vial: 5 ml–4 L ................ Glass vial: 5 ml–4 L ................ Glass vial: 5 ml–4 L ................ 10/11/2012 10/23/2012 10/23/2012 12/14/2012 12/14/2012 1/22/2013 1/29/2013 2/14/2013 7/6/2012 7/6/2012 9/12/2012 12/4/2012 8/9/2012 8/9/2012 8/9/2012 Glass vial: 5 ml–4 L ................ 8/9/2012 Glass vial: 5 ml–4 L ................ Glass vial: 5 ml–4 L ................ Glass vial: 5 ml–4 L ................ 8/9/2012 8/9/2012 8/9/2012 Glass vial: 5 ml–4 L ................ 8/9/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 Glass Glass Glass Glass Glass ...................... ...................... ...................... ...................... ...................... 11/30/2012 11/30/2012 11/30/2012 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... 11/30/2012 11/30/2012 Glass vial: 1 mL ...................... 11/30/2012 Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... Glass vial: 1 mL ...................... Plastic container: 4–100 L ...... 11/30/2012 11/30/2012 11/30/2012 12/3/2012 ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ ElSohly Laboratories, Inc ........ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC LGC LGC LGC LGC Limited Limited Limited Limited Limited ............................ ............................ ............................ ............................ ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ LGC Limited ............................ Siemens Healthcare Diagnostics Inc. emcdonald on DSK67QTVN1PROD with 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. Pursuant to 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. Pursuant to 21 CFR VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 1308.24(g), 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, DEA has determined that each of the exempted bulk products listed in this order may only be used by the manufacturer and may not be distributed by the manufacturer for any purpose or transported to other facilities. Additional exempt chemical preparation requests received between PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 vial: vial: vial: vial: vial: 1 1 1 1 1 mL mL mL mL mL July 1, 2012, and March 31, 2013, and not otherwise referenced in this order may remain under consideration until DEA receives additional information required, pursuant to 21 CFR 1308.23(d), as detailed in separate correspondence to individual requesters. DEA’s order on such requests will be communicated to the public in a future Federal Register publication. DEA also notes that these exemptions are limited to exemption from only those sections of the CSA and the CFR that are specifically identified in 21 CFR E:\FR\FM\03JYN1.SGM 03JYN1 40186 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES 1308.24(a). All other requirements of the CSA and the CFR apply, including, but not limited to, registration as an importer as required by 21 U.S.C. 957. controlled substance will require a new application for exemption pursuant to 21 U.S.C. 811(g)(3)(B) and 21 CFR 1308.23–1308.24. Dated: June 17, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator. Chemical Preparations Containing Newly Controlled Substances The statutory authority for exempt chemical preparations is based on the control status of substances contained within a preparation, the intended administration of a preparation, and the packaged form of a preparation. DEA conducts a case-by-case analysis of each application for exemption to determine whether exemption of a preparation from certain provisions of the CSA is appropriate pursuant to the specified statutory and regulatory requirements. Most exempt chemical preparations have remained effective until the holder of a specific exempt chemical preparation specifically requested that the exemption be terminated. The CSA allows for modifications to the controlled substances schedules to add, remove, or change the schedule of substances thus resulting in periodic modifications to the control status of various substances. 21 U.S.C. 811(a). Since the CSA was enacted in 1970, DEA has on several occasions added to, removed from, or modified the schedules of controlled substances in accordance with the CSA. Such changes may result in the non-compliance of exempt chemical preparations with current statutes or regulations if chemical preparations that have already obtained exempt status contain newly controlled substances. For example, although an exempt chemical preparation may continue to be packaged in the same manner as when it was approved, non-controlled substances in the preparation may become controlled, thus prompting the need for a new application for exemption of the chemical preparation to ensure continued compliance. Other preparations that previously contained no controlled substances may contain newly controlled substances and thus would require an application for exemption. DEA reviews applications for chemical preparation exemptions based on the statutes and regulations that are in place at the time of the application, including the control status of substances included in the preparation. DEA must remain vigilant to ensure that exempt chemical preparations remain consistent with the standards set forth in the CSA and its implementing regulations. As such, DEA reminds the public that any chemical preparation, regardless of whether it was previously exempt, that contains a newly Review of Exemptions Pursuant to 21 U.S.C. 811(g)(3) BILLING CODE 4410–09–P Based on inquiries received from industry, DEA is conducting a comprehensive review of the exempt chemical preparation regulations. DEA’s regulations at 21 CFR 1308.24(a) state that approved chemical preparations are exempt from certain provisions of both Subchapter I and Subchapter II of the CSA: ‘‘The chemical preparations and mixtures approved pursuant to 1308.23 are exempt from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822–823, 825–829, 952–954) and 1301.74 of this chapter, to the extent described in paragraphs (b) to (h) of this section.’’ Pursuant to its regulations, DEA has provided exemptions from the application of section 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 of the Act (21 U.S.C. 822–823, 825–829, 952–954) and 21 CFR 1301.74 since the implementation of the regulations in the early 1970s. Until DEA’s analysis of the exemption regulations is complete, DEA will continue to review and provide exemptions to chemical preparations consistent with the implementing regulations, when warranted. DEA will publish a future notice regarding the outcome of DEA’s review of its regulations with respect to the exemption of chemical preparations. DEPARTMENT OF JUSTICE VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 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 Deputy 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 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. PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 [FR Doc. 2013–16010 Filed 7–2–13; 8:45 am] Drug Enforcement Administration [Docket No. DEA–378] Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Proposed Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2014 Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice with request for comments. AGENCY: This notice proposes initial year 2014 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA) and assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DATES: Electronic comments must be submitted and written comments must be postmarked on or before August 2, 2013. The electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–378’’ on all electronic and written correspondence. DEA encourages that all comments be submitted electronically through http:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at http:// www.regulations.gov for easy reference. Paper comments that duplicate the electronic submission are not necessary as all comments submitted to www.regulations.gov will be posted for public review and are part of the official docket record. Written comments submitted via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive Assistant, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, SUMMARY: E:\FR\FM\03JYN1.SGM 03JYN1

Agencies

[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Notices]
[Pages 40175-40186]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16010]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-372]


Exempt Chemical Preparations Under the Controlled Substances Act

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Order with opportunity for comment.

-----------------------------------------------------------------------

SUMMARY: The applications for exempt chemical preparations received by 
DEA between July 1, 2012, and March 31, 2013, as listed below, were 
accepted for filing and have been approved or denied as indicated.

DATES: Electronic comments must be submitted and written comments must 
be postmarked on or before September 3, 2013. The electronic Federal 
Docket Management System will not accept comments after midnight 
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 electronic and written correspondence. 
DEA encourages that all comments be submitted electronically through 
http://www.regulations.gov using the electronic comment form provided 
on that site. An electronic copy of this document is also available at 
http://www.regulations.gov for easy reference. Paper comments that 
duplicate the electronic submission are not necessary as all comments 
submitted to www.regulations.gov will be posted for public review and 
are part of the official docket record. Written comments submitted via 
regular or express mail should be sent to the Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODL, 
8701 Morrissette Drive, Springfield, Virginia 22152.

[[Page 40176]]


FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (202) 307-7165.

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. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted, 
and the comment, in redacted form, will be posted online and placed in 
DEA's public docket file. Please note that the Freedom of Information 
Act applies to all comments received. If you wish to inspect the 
agency's public docket file in person by appointment, please see the 
FOR FURTHER INFORMATION CONTACT paragraph.

Legal Authority

    DEA implements and enforces Titles II and III of the Comprehensive 
Drug Abuse Prevention and Control Act of 1970, often referred to as the 
Controlled Substances Act and the Controlled Substances Import and 
Export Act (codified at Title 21, Chapter 13 of the U.S.C.), as amended 
(CSA). DEA drafts and publishes the implementing regulations for these 
statutes in Title 21 of the Code of Federal Regulations (CFR), parts 
1300 to 1321. 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 providing for a 
sufficient supply of controlled substances and listed chemicals for 
legitimate medical, scientific, research, and industrial purposes. 
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\ DEA 
regulations at 21 CFR 1308.23 and 1308.24 further detail the criteria 
by which the DEA Deputy Assistant Administrator may exempt a chemical 
preparation or mixture from the application of certain provisions of 
the CSA. The Deputy 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 the 
Appendix to Subpart R of 28 CFR 0.104.
---------------------------------------------------------------------------

Exempt Chemical Preparation Applications Submitted Between July 1, 
2012, and March 31, 2013

    The Deputy Assistant Administrator received applications between 
July 1, 2012, and March 31, 2013, requesting exempt chemical 
preparation status pursuant to 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 Deputy 
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 other 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 Deputy Assistant Administrator has determined 
that each of the chemical preparations or mixtures generally described 
in Chart I below and specifically described in the application 
materials received by DEA, are 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 listed below that was 
provided in the approval letters to the individual requesters.

                                                     Chart I
----------------------------------------------------------------------------------------------------------------
                                                                                                    Application
               Supplier                          Product name                     Form                 date
----------------------------------------------------------------------------------------------------------------
AccuStandard, Inc.....................  APP-9-086, a,a-                 Amber ampule: 1 mL......       1/28/2013
                                         Dimethylphenethylamine.
AccuStandard, Inc.....................  APP-9-086-20X, a,a-             Amber ampule: 1 mL......       1/28/2013
                                         Dimethylphenethylamine.
AccuStandard, Inc.....................  AS-E1179, Chloral hydrate.....  Amber ampule: 1 mL......       1/28/2013
AccuStandard, Inc.....................  CLP-HC-X1, Composite Mix        Amber ampule: 1 mL......       1/28/2013
                                         3A.
AccuStandard, Inc.....................  M-551.1B, Disinfectant by-      Amber ampule: 1 mL......       1/28/2013
                                         products.

[[Page 40177]]

 
AccuStandard, Inc.....................  M-551B, Disinfectant by-        Amber ampule: 1 mL......       1/28/2013
                                         products.
AccuStandard, Inc.....................  M-551B-2, Chloral hydrate.....  Amber ampule: 1 mL......       1/28/2013
AccuStandard, Inc.....................  M-8015B/5031-21, Paraldehyde..  Amber ampule: 1 mL......       1/28/2013
AccuStandard, Inc.....................  M-8206B-05, Additional VOC's    Amber ampule: 1 mL......       1/28/2013
                                         by Method 8206B.
AccuStandard, Inc.....................  M-8270-02, Semi-Volatile by     Amber ampule: 1 mL......       1/28/2013
                                         Capillary Column GC/MS Mix 2.
AccuStandard, Inc.....................  M-8270-04-ASL, Method 8270B--   Amber ampule: 1 mL......       1/28/2013
                                         Base/Neutrals Mix.
AccuStandard, Inc.....................  M-8270-23-R1, Method 8270 Semi- Amber ampule: 1 mL......       1/28/2013
                                         Volatile Additions.
AccuStandard, Inc.....................  M-E-1179-M, Chloral hydrate...  Amber ampule: 1 mL......       1/28/2013
Agilent Technologies..................  Veterinary Drugs Checkout Mix.  Amber ampule: 1 mL......        8/3/2012
Agilent Technologies..................  Veterinary Drugs Comprehensive  Amber ampule: 1 mL......        8/3/2012
                                         Mix--Submix 6.
Agilent Technologies..................  Forensic Toxicology             Amber ampule: 1 mL......        8/3/2012
                                         Comprehensive Mix--Submix 3.
Agilent Technologies..................  Forensic Toxicology             Amber ampule: 1 mL......        8/3/2012
                                         Comprehensive Mix--Submix 5.
Agilent Technologies..................  Forensic Toxicology             Amber ampule: 1 mL......        8/3/2012
                                         Comprehensive Mix--Submix 2.
Agilent Technologies..................  Forensic Toxicology Checkout    Amber ampule: 1 mL......        8/3/2012
                                         Mix.
Agilent Technologies..................  Forensic Toxicology             Amber ampule: 1 mL......       12/6/2012
                                         Comprehensive Mix--Submix 1.
Alltech Associates, Inc...............  2C-T-2 Quik Check, 1.0 mg/mL..  Glass ampule: 1 mL......       9/26/2012
Alltech Associates, Inc...............  5-MeO-DMT Quick Check, 1.0 mg/  Glass ampule: 1 mL......       9/26/2012
                                         mL.
Alltech Associates, Inc...............  Carisoprodol Quik Check, 1.0    Glass ampule: 1 mL......       9/26/2012
                                         mg/mL.
American Proficiency Institute........  American Proficiency Institute  Amber bottle: 7 mL......       12/5/2012
                                         SHBG/Testosterone.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       8/14/2012
                                         Control Oral Fluid, OF23.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       8/14/2012
                                         Control Urine, SD17.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       9/27/2012
                                         Control Urine, MC176.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL      10/23/2012
                                         Control Urine, MC179.
Biochemical Diagnostics, Inc..........  Salivabuse Custom Liquid        Glass vials: 1 ml-200 mL      10/23/2012
                                         Control Oral Fluid, OF25.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       11/5/2012
                                         Control Urine, MC177.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       1/24/2013
                                         Control Urine, MC178.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       1/24/2013
                                         Control Oral Fluid, OF24.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       1/29/2013
                                         Control Urine, MC181.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       3/12/2013
                                         Control Urine, MC183.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       3/12/2013
                                         Control Urine, MC184.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       3/14/2013
                                         Control Urine, MC180.
Bio-Rad Laboratories..................  Liquichek Immunoassay Plus      Box: 3 vials, 2.5 mL          11/14/2012
                                         Control Trilevel MiniPak.       each.
Bio-Rad Laboratories..................  Liquichek Immunoassay Plus      Box: 12 vials, 5 mL each      11/21/2012
                                         Control Level 1,2 and 3,
                                         Trilevel.
Bio-Rad Laboratories..................  Liquid Assayed Multiqual        Box: 6 vials, 5 mL each.      11/21/2012
                                         Premium, Levels 1-3.
Bio-Rad Laboratories..................  Liquid Assayed Multiqual        Box: 3 vials, 5 mL each.      11/21/2012
                                         Premium, Trilevel Minipak.
Bio-Rad Laboratories..................  Lyphocheck Urine Toxicology     Glass vial: 25 mL.......       1/11/2013
                                         Control MiniPak, Cat. No.
                                         470X.
Bio-Rad Laboratories..................  Liquichek Immunoassay Plus      Glass vial: 2.5 mL, Box        2/20/2013
                                         Control Level 1.                12 vials.
Bio-Rad Laboratories..................  Liquichek Immunoassay Plus      Glass vial: 2.5 mL, Box        2/20/2013
                                         Control Level 2.                12 vials.
Bio-Rad Laboratories..................  Liquichek Immunoassay Plus      Glass vial: 2.5 mL, Box        2/20/2013
                                         Control Level 3.                12 vials.
Cerilliant Corporation................  Benzodiazepine Mix (1 mg/mL)..  Glass Ampule: 1 mL......        7/2/2012
Cerilliant Corporation................  Class C Mix Urinalysis          Glass Ampule: 1 mL......        7/9/2012
                                         Internal Standard Fortified
                                         Morphine.
Cerilliant Corporation................  Spice Cannabinoid Mix 2 (0.1    Amber ampule: 1 mL......       9/26/2012
                                         mg/mL).
Cerilliant Corporation................  Spice Cannabinoid Mix 3 (0.1    Amber ampule: 1 mL......       9/26/2012
                                         mg/mL).
Cerilliant Corporation................  Retigabine (1 mg/mL)..........  Glass Ampule: 1 mL......       11/7/2012
Cerilliant Corporation................  -                   Glass Ampule: 1 mL......        1/7/2013
                                         Norpseudoephedrine-D3 HCl
                                         (0.1 mg/mL).
Cerilliant Corporation................  Amobarbital-D5 (0.1 mg/mL)....  Glass Ampule: 1 mL......        1/7/2013
Cerilliant Corporation................  2,5-Dimethoxy-4-(n)-            Glass Ampule: 1 mL......        1/7/2013
                                         propylthiophenethylamine HCl
                                         (2C-T-7 HCl) (1 mg/mL).
Cerilliant Corporation................  Class B Mix Urinalysis          Glass ampule: 1 ml......       1/22/2013
                                         Internal Standard-8 (0.002-
                                         0.2 mg/mL), Pregabalin-D6
                                         (1.0 mg/mL), Codeine-6-beta-
                                         glucoronide (1.0 mg/mL),
                                         Desomorphine (1.0 mg/mL),
                                         Levorphanol-D3 (0.1 mg/mL).
Cerilliant Corporation................  Zaleplon-D4 (0.1 mg/mL).......  Glass Ampule: 1 mL......       1/31/2013
Cerilliant Corporation................  Retigabine-D4 (0.1 mg/mL).....  Glass ampule: 1ml.......       3/22/2013
Cerilliant Corporation................  Tilidine-D6 HCl (0.1 mg/mL)...  Glass ampule: 1ml.......       3/22/2013
Cliniqa Corporation...................  TDM Control, Levels 1-3.......  Dropper bottle: 5 mL....       12/4/2012
ElSohly Laboratories, Inc.............  ELI Oral Fluid Controls, THC    Glass vial: 5 ml-4 L....      10/22/2012
                                         (0.5-50 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Controls,        Glass vial: 5 ml-4 L....      10/22/2012
                                         Methamphetamine (2-200 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Controls,        Glass vial: 5 ml-4 L....      10/22/2012
                                         Amphetamine, Benzoylecgonine,
                                         Morphine, Phencyclidine (2-
                                         200 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Controls,        Glass vial: 5 ml-4 L....      10/22/2012
                                         Multidrug (THC,
                                         Benzoylecgonine, Amphetamine,
                                         Methamphetamine, Morphine,
                                         Codeine, 6-Acetylmorphine, &
                                         PCP) at 0.5-50 ng/mL.
ElSohly Laboratories, Inc.............  ELI Oral Fluid Calibrators,     Glass vial: 5 ml-4 L....      10/22/2012
                                         THC (0.5-50 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Calibrators,     Glass vial: 5 ml-4 L....      10/22/2012
                                         Methamphetamine (2-200 ng/mL).

[[Page 40178]]

 
ElSohly Laboratories, Inc.............  ELI Oral Fluid Calibrators,     Glass vial: 5 ml-4 L....      10/22/2012
                                         Amphetamine, Benzoylecgonine,
                                         Morphine, Phencyclidine (2-
                                         200 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Calibrators,     Glass vial: 5 ml-4 L....      10/22/2012
                                         Multidrug (THC,
                                         Benzoylecgonine, Amphetamine,
                                         Methamphetamine, Morphine,
                                         Codeine, 6-Acetylmorphine, &
                                         PCP) at 0.5-200 ng/mL.
Environmental Resource Associates       USGS-BQS LS 4434 Mix 1........  Glass Ampule: 2 mL......        8/9/2012
 (ERA).
Environmental Resource Associates       USGS-BQS LS 4434 Mix 2........  Glass Ampule: 2 mL......        8/9/2012
 (ERA).
Immunalysis Corporation...............  Tapentadol Calibrator Level 1   Glass vial: 10 mL.......      12/11/2012
                                         (100 ng/mL).
Immunalysis Corporation...............  Tapentadol Calibrator Level 2   Glass vial: 10 mL.......      12/11/2012
                                         (200 ng/mL).
Immunalysis Corporation...............  Tapentadol Calibrator Level 3   Glass vial: 10 mL.......      12/11/2012
                                         (500 ng/mL).
Immunalysis Corporation...............  Tapentadol Calibrator Level 4   Glass vial: 10 mL.......      12/11/2012
                                         (1,000 ng/mL).
Immunalysis Corporation...............  Tapentadol Low Control (150 ng/ Glass vial: 10 mL.......      12/11/2012
                                         mL).
Immunalysis Corporation...............  Tapentadol High Control (250    Glass vial: 10 mL.......      12/11/2012
                                         ng/mL).
LGC Limited...........................  (S)-(+)-Amphetamine             Glass vial: 1 mL........       9/24/2012
                                         (Dextroamphetamine) 1.0 mg/mL
                                         in Methanol.
LGC Limited...........................  rac-Amphetamine 0.1 mg/mL in    Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  rac-Amphetamine 1.0 mg/mL in    Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  rac-Amphetamine-D11 0.1 mg/mL   Glass vial: 1 mL........       9/24/2012
                                         in Methanol.
LGC Limited...........................  rac-Amphetamine-D11 1.0 mg/mL   Glass vial: 1 mL........       9/24/2012
                                         in Methanol.
LGC Limited...........................  rac-Amphetamine-D5 (D-label on  Glass vial: 1 mL........       9/24/2012
                                         ring) 0.1 mg/mL in Methanol.
LGC Limited...........................  Methamphetamine ((S)-(+)-       Glass vial: 1 mL........       9/24/2012
                                         Methamphetamine) 1.0 mg/mL in
                                         Methanol.
LGC Limited...........................  rac-Methamphetamine 0.1 mg/mL   Glass vial: 1 mL........       9/24/2012
                                         in Methanol.
LGC Limited...........................  rac-Methamphetamine 1.0 mg/mL   Glass vial: 1 mL........       9/24/2012
                                         in Methanol.
LGC Limited...........................  rac-Methamphetamine-D5 0.1 mg/  Glass vial: 1 mL........       9/24/2012
                                         mL in Methanol.
LGC Limited...........................  rac-Methamphetamine-D5 1.0 mg/  Glass vial: 1 mL........       9/24/2012
                                         mL in Methanol.
LGC Limited...........................  Methcathinone Hydrochloride     Glass vial: 1 mL........       9/24/2012
                                         1.0 mg/mL in Methanol (as
                                         free base).
LGC Limited...........................  Methylphenidate Hydrochloride   Glass vial: 1 mL........       9/24/2012
                                         1.0 mg/mL in Methanol (as
                                         free base).
LGC Limited...........................  Amobarbital 1.0 mg/mL in        Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Pentobarbital 1.0 mg/mL in      Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Pentobarbital-D5 1.0 mg/mL in   Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Pentobarbital-D5 0.1 mg/mL in   Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Secobarbital 1.0 mg/mL in       Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  rac-MDA-D5 (rac-3,4-            Glass vial: 1 mL........       9/24/2012
                                         Methylenedioxyamphetamine-D5)
                                         0.1 mg/mL Methanol.
LGC Limited...........................  rac-MDA-D5 (rac-3,4-            Glass vial: 1 mL........       9/24/2012
                                         Methylenedioxyamphetamine-D5)
                                         1.0 mg/mL Methanol.
LGC Limited...........................  rac-MBDB HCl (rac-N-Methyl-1-   Glass vial: 1 mL........       9/24/2012
                                         (3,4-Methylenedioxyphenyl)-2-
                                         butanamine Hydrochloride) 1.0
                                         mg/mL Methanol (as free base).
LGC Limited...........................  rac-MBDB-D5 (rac-N-Methyl-1-    Glass vial: 1 mL........       9/24/2012
                                         (3,4-Methylenedioxyphenyl)-2-
                                         butanamine-D5) 0.1 mg/mL
                                         Methanol.
LGC Limited...........................  rac-MDEA-D5 (rac-3,4-           Glass vial: 1 mL........       9/24/2012
                                         Methylenedioxy-N-
                                         ethylamphetamine-D5) 0.1 mg/
                                         mL Methanol.
LGC Limited...........................  rac-MDEA-D5 (rac-3,4-           Glass vial: 1 mL........       9/24/2012
                                         Methylenedioxy-N-
                                         ethylamphetamine-D5) 1.0 mg/
                                         mL Methanol.
LGC Limited...........................  rac-MDEA-D6 (rac-3,4-           Glass vial: 1 mL........       9/24/2012
                                         Methylenedioxy-N-
                                         ethylamphetamine-D6) 0.1 mg/
                                         mL Methanol.
LGC Limited...........................  rac-MDMA-D5 (rac-3,4-           Glass vial: 1 mL........       9/24/2012
                                         Methylenedioxymethamphetamine-
                                         D5) 0.1 mg/mL Methanol.
LGC Limited...........................  rac-MDMA-D5 (rac-3,4-           Glass vial: 1 mL........       9/24/2012
                                         Methylenedioxymethamphetamine-
                                         D5) 1.0 mg/mL Methanol.
LGC Limited...........................  Phencyclidine (PCP) 1.0 mg/mL   Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Phencyclidine-D5 (PCP-D5) 0.1   Glass vial: 1 mL........       9/24/2012
                                         mg/mL in Methanol.
LGC Limited...........................  Phencyclidine-D5 (PCP-D5) 1.0   Glass vial: 1 mL........       9/24/2012
                                         mg/mL Methanol.
LGC Limited...........................  Codeine 0.1 mg/mL in Methanol.  Glass vial: 1 mL........       9/24/2012
LGC Limited...........................  Codeine 1.0 mg/mL in Methanol.  Glass vial: 1 mL........       9/24/2012
LGC Limited...........................  Codeine-D3 0.1 mg/mL in         Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Codeine-D3 1.0 mg/mL in         Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Codeine-D6 0.1 mg/mL in         Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Codeine-D6 1.0 mg/mL in         Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Isocodeine 0.1 mg/mL in         Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Norcodeine 0.01 mg/mL in        Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Norcodeine 1.0 mg/mL in         Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Codeine N-Oxide 0.01 mg/mL      Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Oxycodone-D3 1.0 mg/mL in       Glass vial: 1 mL........       9/24/2012
                                         Methanol.

[[Page 40179]]

 
LGC Limited...........................  Oxycodone-D6 0.1 mg/mL in       Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Oxycodone-D6 1.0 mg/mL in       Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Hydromorphone 1.0 mg/mL         Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Norhydromorphone Hydrochloride  Glass vial: 1 mL........       9/24/2012
                                         1.0 mg/mL Methanol (as free
                                         base).
LGC Limited...........................  Pethidine (Meperidine) 1.0 mg/  Glass vial: 1 mL........       9/24/2012
                                         mL in Methanol.
LGC Limited...........................  Pethidine-D4 (Meperidine-D4)    Glass vial: 1 mL........       9/24/2012
                                         0.1 mg/mL in Methanol.
LGC Limited...........................  Pethidine-D4 (Meperidine-D4)    Glass vial: 1 mL........       9/24/2012
                                         1.0 mg/mL in Methanol.
LGC Limited...........................  Morphine 0.1 mg/mL in Methanol  Glass vial: 1 mL........       9/24/2012
LGC Limited...........................  Morphine 1.0 mg/mL in Methanol  Glass vial: 1 mL........       9/24/2012
LGC Limited...........................  Morphine 3-beta-D-Glucuronide   Glass vial: 1 mL........       9/24/2012
                                         0.1 mg/mL in Methanol/Water
                                         (\1/1\).
LGC Limited...........................  Morphine 3-beta-D-Glucuronide   Glass vial: 1 mL........       9/24/2012
                                         1.0 mg/mL in Methanol with
                                         0.05 percent Sodium Hydroxide
                                         (w/v).
LGC Limited...........................  Morphine 6-beta-D-Glucuronide   Glass vial: 1 mL........       9/24/2012
                                         0.1 mg/mL in Methanol/Water
                                         (\1/1\).
LGC Limited...........................  Morphine 6-beta-D-Glucuronide   Glass vial: 1 mL........       9/24/2012
                                         1.0 mg/mL Water/Methanol (80/
                                         20).
LGC Limited...........................  Morphine-D3 0.1 mg/mL in        Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Morphine-D3 1.0 mg/mL in        Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Morphine N-Oxide 0.01 mg/mL     Glass vial: 1 mL........       9/24/2012
                                         Methanol.
LGC Limited...........................  Normorphine 1.0 mg/mL Methanol  Glass vial: 1 mL........       9/24/2012
LGC Limited...........................  rac-Amphetamine-D10 0.1 mg/mL   Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  rac-Amphetamine-D5 (D-label on  Glass vial: 1 mL........      11/30/2012
                                         ring) 0.1 mg/mL in Methanol.
LGC Limited...........................  rac-Amphetamine-D5 (D-label on  Glass vial: 1 mL........      11/30/2012
                                         side chain) 0.1 mg/mL in
                                         Methanol.
LGC Limited...........................  rac-Amphetamine-D5 (D-label on  Glass vial: 1 mL........      11/30/2012
                                         side chain) 1.0 mg/mL in
                                         Methanol.
LGC Limited...........................  rac-Amphetamine-D6 0.1 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  rac-Amphetamine-D6 1.0 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  rac-Amphetamine-D8 0.1 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  rac-Amphetamine-D8 1.0 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  rac-Methamphetamine-D11 0.1 mg/ Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol.
LGC Limited...........................  rac-Methamphetamine-D11 1.0 mg/ Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol.
LGC Limited...........................  rac-Methamphetamine-D14 0.1 mg/ Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol.
LGC Limited...........................  rac-Methamphetamine-D14 1.0 mg/ Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol.
LGC Limited...........................  rac-Methamphetamine-D8 0.1 mg/  Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol.
LGC Limited...........................  rac-Methamphetamine-D8 1.0 mg/  Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol.
LGC Limited...........................  rac-Methamphetamine-D9 0.1 mg/  Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol.
LGC Limited...........................  rac-Methamphetamine-D9 1.0 mg/  Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol.
LGC Limited...........................  (+)-Norpseudoephedrine          Glass vial: 1 mL........      11/30/2012
                                         Hydrochloride (Cathine
                                         Hydrochloride) 0.1 mg/mL in
                                         Methanol (as free base).
LGC Limited...........................  (R)-(+)-Cathinone               Glass vial: 1 mL........      11/30/2012
                                         Hydrochloride 1.0 mg/mL in
                                         Methanol (as free base).
LGC Limited...........................  (S)-(-)-Cathinone               Glass vial: 1 mL........      11/30/2012
                                         Hydrochloride 1.0 mg/mL in
                                         Methanol (as free base).
LGC Limited...........................  (S)-(-)-Methcathinone           Glass vial: 1 mL........      11/30/2012
                                         Hydrochloride 1.0 mg/mL in
                                         Methanol (as free base).
LGC Limited...........................  Phentermine 1.0 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Fenfluramine Hydrochloride 1.0  Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Methanol (as free
                                         base).
LGC Limited...........................  Methylphenidate-D9              Glass vial: 1 mL........      11/30/2012
                                         Hydrochloride 0.1 mg/mL in
                                         Methanol.
LGC Limited...........................  Pipradrol Hydrochloride 0.1 mg/ Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol (as free base).
LGC Limited...........................  Pipradrol Hydrochloride 1.0 mg/ Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol (as free base).
LGC Limited...........................  GHB Sodium Salt (Sodium         Glass vial: 1 mL........      11/30/2012
                                         Gammahydroxybutyrate) 1.0 mg/
                                         mL in Methanol (as free acid).
LGC Limited...........................  GHB-D6 Sodium Salt (Sodium      Glass vial: 1 mL........      11/30/2012
                                         Gammahydroxybutyrate-D6) 0.1
                                         mg/mL in Methanol (as free
                                         acid).
LGC Limited...........................  GHB-D6 Sodium Salt (Sodium      Glass vial: 1 mL........      11/30/2012
                                         Gammahydroxybutyrate-D6) 1.0
                                         mg/mL in Methanol (as free
                                         acid).
LGC Limited...........................  Hexobarbital 1.0 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Methohexital 1.0 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Methohexital-D5 0.1 mg/mL in    Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Phenobarbital 1.0 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Phenobarbital-D5 (D-label on    Glass vial: 1 mL........      11/30/2012
                                         ring) 0.1 mg/mL in Methanol.
LGC Limited...........................  Phenobarbital-D5 (D-label on    Glass vial: 1 mL........      11/30/2012
                                         ring) 1.0 mg/mL in Methanol.
LGC Limited...........................  Phenobarbital-D5 (D-label on    Glass vial: 1 mL........      11/30/2012
                                         side chain) 0.1 mg/mL in
                                         Methanol.

[[Page 40180]]

 
LGC Limited...........................  Phenobarbital-D5 (D-label on    Glass vial: 1 mL........      11/30/2012
                                         side chain) 1.0 mg/mL in
                                         Methanol.
LGC Limited...........................  Methaqualone 1.0 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Methaqualone-D7 0.1 mg/mL in    Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Clonazepam 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Clonazepam-D4 0.1 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Chlordiazepoxide 1.0 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Chlordiazepoxide-D5 0.1 mg/mL   Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  Bromazepam 0.1 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Bromazepam 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Clobazam 1.0 mg/mL in Methanol  Glass vial: 1 mL........      11/30/2012
LGC Limited...........................  Delorazepam 0.1 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Estazolam 1.0 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Estazolam-D5 0.1 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Flunitrazepam 0.1 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Flunitrazepam 1.0 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Flunitrazepam-D7 0.1 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Prazepam 1.0 mg/mL in Methanol  Glass vial: 1 mL........      11/30/2012
LGC Limited...........................  Prazepam-D5 0.1 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Diazepam 0.1 mg/mL in Methanol  Glass vial: 1 mL........      11/30/2012
LGC Limited...........................  Diazepam 1.0 mg/mL in Methanol  Glass vial: 1 mL........      11/30/2012
LGC Limited...........................  Diazepam-D5 0.1 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Diazepam-D5 1.0 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Flurazepam 0.1 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Flurazepam 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Lormetazepam 1.0 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Zaleplon 1.0 mg/mL in Methanol  Glass vial: 1 mL........      11/30/2012
LGC Limited...........................  Pregabalin 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Pregabalin-D6 0.1 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Zolpidem Tartrate 1.0 mg/mL in  Glass vial: 1 mL........      11/30/2012
                                         Methanol (as free base).
LGC Limited...........................  Zolpidem-D6 0.1 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Zopiclone 1.0 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Zopiclone Oxide 1.0 mg/mL in    Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Zopiclone-D4 0.1 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Meprobamate 1.0 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Nitrazepam 0.1 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Nitrazepam 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Nitrazepam-D5 0.1 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Oxazepam 1.0 mg/mL in Methanol  Glass vial: 1 mL........      11/30/2012
LGC Limited...........................  Oxazepam-D5 0.1 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Oxazepam-D5 1.0 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Nordazepam (Nordiazepam) 0.1    Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Methanol.
LGC Limited...........................  Nordazepam (Nordiazepam) 1.0    Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Methanol.
LGC Limited...........................  Nordazepam-D5 (Nordiazepam-D5)  Glass vial: 1 mL........      11/30/2012
                                         0.1 mg/mL in Methanol.
LGC Limited...........................  Nordazepam-D5 (Nordiazepam-D5)  Glass vial: 1 mL........      11/30/2012
                                         1.0 mg/mL in Methanol.
LGC Limited...........................  Alprazolam 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Alprazolam-D5 0.1 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Alprazolam-D5 1.0 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Methyltestosterone (17alpha-    Glass vial: 1 mL........      11/30/2012
                                         Methyltestosterone) 1.0 mg/mL
                                         in Acetonitrile.
LGC Limited...........................  Midazolam 1.0 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Midazolam-D4 Maleate 0.1 mg/mL  Glass vial: 1 mL........      11/30/2012
                                         in Methanol (as free base).
LGC Limited...........................  Lorazepam 0.1 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Lorazepam 1.0 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Lorazepam Acetate ((3RS)-7-     Glass vial: 1 mL........      11/30/2012
                                         Chloro-5-(2-chlorophenyl)-2-
                                         oxo-2,3-dihydro-1H-1,4-
                                         benzodiazepin-3-yl Acetate)
                                         0.1 mg/mL in Acetonitrile.
LGC Limited...........................  Lorazepam-D4 0.1 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Lorazepam-D4 1.0 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Tetrazepam 0.1 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Triazolam 1.0 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Triazolam-D4 0.1 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Temazepam 0.1 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Temazepam 1.0 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Temazepam-D5 0.1 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Temazepam-D5 1.0 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Androstanolone (5alpha-         Glass vial: 1 mL........      11/30/2012
                                         Dihydrotestosterone,
                                         Stanolone) 1.0 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  Androstenedione (Androst-4-ene- Glass vial: 1 mL........      11/30/2012
                                         3, 17-dione) 1.0 mg/mL in
                                         Acetonitrile.

[[Page 40181]]

 
LGC Limited...........................  Boldenone 1.0 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Fluoxymesterone 1.0 mg/mL in    Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Mesterolone 1.0 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Methandienone 1.0 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Nandrolone 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Norandrostenedione (19-         Glass vial: 1 mL........      11/30/2012
                                         Norandrost-4-ene-3,17-dione)
                                         1.0 mg/mL in Acetonitrile.
LGC Limited...........................  Norethandrolone 1.0 mg/mL in    Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Stanozolol 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Stanozolol-D3 0.1 mg/mL in 1,2- Glass vial: 1 mL........      11/30/2012
                                         Dimethoxyethane.
LGC Limited...........................  Testosterone 1.0 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Testosterone Benzoate 1.0 mg/   Glass vial: 1 mL........      11/30/2012
                                         mL in Acetonitrile.
LGC Limited...........................  Testosterone Isocaproate 1.0    Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Acetonitrile.
LGC Limited...........................  Testosterone Propionate 1.0 mg/ Glass vial: 1 mL........      11/30/2012
                                         mL in Acetonitrile.
LGC Limited...........................  Trenbolone 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  RCS-4 (DD-001, (4-              Glass vial: 1 mL........      11/30/2012
                                         Methoxyphenyl)(1-pentylindol-
                                         3-yl)methanone) 1.0 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  JWH-081 ((4-Methoxynaphthalen-  Glass vial: 1 mL........      11/30/2012
                                         1-yl)(1-pentylindol-3-
                                         yl)methanone) 1.0 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  JWH-122 ((4-Methylnaphthalen-1- Glass vial: 1 mL........      11/30/2012
                                         yl)(1-pentylindol-3-
                                         yl)methanone) 1.0 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  JWH-203 (2-(2-Chlorophenyl)-1-  Glass vial: 1 mL........      11/30/2012
                                         (1-pentylindol-3-yl)ethanone)
                                         1.0 mg/mL in Acetonitrile.
LGC Limited...........................  Ketamine Hydrochloride 1.0 mg/  Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol (as free base).
LGC Limited...........................  Ketamine-D4 Hydrochloride 0.1   Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Methanol (as free
                                         base).
LGC Limited...........................  Iso-LSD (Lysergic Acid          Glass vial: 1 mL........      11/30/2012
                                         Diethylamide) 0.1 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  LAMPA (Lysergic Acid N-Methyl-  Glass vial: 1 mL........      11/30/2012
                                         N-propylamide) 0.025 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  LSD (Lysergic Acid              Glass vial: 1 mL........      11/30/2012
                                         Diethylamide) 0.025 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  LSD-D3 (Lysergic Acid           Glass vial: 1 mL........      11/30/2012
                                         Diethylamide-D3) 0.025 mg/mL
                                         in Acetonitrile.
LGC Limited...........................  PMA HCl (p-Methoxyamphetamine)  Glass vial: 1 mL........      11/30/2012
                                         1.0 mg/mL in Methanol (as
                                         free base).
LGC Limited...........................  rac-MDA (rac-3,4-               Glass vial: 1 mL........      11/30/2012
                                         Methylenedioxyamphetamine)
                                         1.0 mg/mL in Methanol.
LGC Limited...........................  rac-MDEA (rac-3,4-              Glass vial: 1 mL........      11/30/2012
                                         Methylenedioxy-N-
                                         ethylamphetamine) 1.0 mg/mL
                                         in Methanol.
LGC Limited...........................  1-Methylamino-1-(3,4-           Glass vial: 1 mL........      11/30/2012
                                         methylenedioxyphenyl)propane
                                         Hydrochloride 1.0 mg/mL in
                                         Methanol (as free base).
LGC Limited...........................  rac-BDB HCl (rac-3,4-           Glass vial: 1 mL........      11/30/2012
                                         Methylenedioxyphenyl-2-
                                         butanamine Hydrochloride) 1.0
                                         mg/mL in Methanol (as free
                                         base).
LGC Limited...........................  rac-MDMA (rac-3,4-              Glass vial: 1 mL........      11/30/2012
                                         Methylenedioxymethamphetamine
                                         ) 1.0 mg/mL in Methanol.
LGC Limited...........................  Bufotenine 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Methylone Hydrochloride 1.0 mg/ Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol (as free base).
LGC Limited...........................  Methylone-D3 Hydrochloride 0.1  Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Methanol (as free
                                         base).
LGC Limited...........................  AM-694 (1-(5-Fluoropentyl)-3-   Glass vial: 1 mL........      11/30/2012
                                         (2-iodobenzoyl)indole) 1.0 mg/
                                         mL in Acetonitrile.
LGC Limited...........................  Cocaine 1.0 mg/mL in            Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Cocaine-D3 0.1 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Cocaine-D3 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Norcocaine Hydrochloride 1.0    Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Acetonitrile (as
                                         free base).
LGC Limited...........................  Norcocaine-D3 Hydrochloride     Glass vial: 1 mL........      11/30/2012
                                         0.1 mg/mL in Acetonitrile (as
                                         free base).
LGC Limited...........................  O-Methylcodeine 0.1 mg/mL in    Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Buprenorphine 0.1 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Buprenorphine 3-beta-D-         Glass vial: 1 mL........      11/30/2012
                                         Glucuronide 0.1 mg/mL in
                                         Methanol.
LGC Limited...........................  Buprenorphine-D4 0.1 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Dihydrocodeine Hydrochloride    Glass vial: 1 mL........      11/30/2012
                                         1.0 mg/mL in Methanol (as
                                         free base).
LGC Limited...........................  Dihydrocodeine-D6               Glass vial: 1 mL........      11/30/2012
                                         Hydrochloride 0.1 mg/mL in
                                         Methanol (as free base).
LGC Limited...........................  Noroxycodone Hydrochloride 1.0  Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Methanol (as free
                                         base).

[[Page 40182]]

 
LGC Limited...........................  Noroxycodone-D3 Hydrochloride   Glass vial: 1 mL........      11/30/2012
                                         0.1 mg/mL in Methanol (as
                                         free base).
LGC Limited...........................  Oxycodone 1.0 mg/mL in          Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Oxycodone-D3 0.1 mg/mL in       Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Dihydromorphine 1.0 mg/mL in    Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Hydromorphone-D3 0.1 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Anhydroecgonine Hydrochloride   Glass vial: 1 mL........      11/30/2012
                                         1.0 mg/mL in Acetonitrile (as
                                         free base).
LGC Limited...........................  Anhydroecgonine Methyl Ester    Glass vial: 1 mL........      11/30/2012
                                         1.0 mg/mL in Acetonitrile.
LGC Limited...........................  Benzoylecgonine 0.1 mg/mL in    Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Benzoylecgonine-D3 0.1 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  Benzoylecgonine-D3 1.0 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  Benzoylecgonine-D8 0.1 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  Benzoylecgonine-D8 1.0 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Methanol.
LGC Limited...........................  Cocaethylene                    Glass vial: 1 mL........      11/30/2012
                                         (Benzoylethylecgonine) 1.0 mg/
                                         mL in Acetonitrile.
LGC Limited...........................  Cocaethylene-D3                 Glass vial: 1 mL........      11/30/2012
                                         (Benzoylethylecgonine-D3) 0.1
                                         mg/mL in Acetonitrile.
LGC Limited...........................  Cocaethylene-D8                 Glass vial: 1 mL........      11/30/2012
                                         (Benzoylethylecgonine-D8) 0.1
                                         mg/mL in Acetonitrile.
LGC Limited...........................  Ecgonine 1.0 mg/mL in Methanol  Glass vial: 1 mL........      11/30/2012
LGC Limited...........................  Ecgonine Ethyl Ester 1.0 mg/mL  Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  Ecgonine Hydrochloride 1.0 mg/  Glass vial: 1 mL........      11/30/2012
                                         mL in Methanol (as free base).
LGC Limited...........................  Ecgonine Methyl Ester 0.1 mg/   Glass vial: 1 mL........      11/30/2012
                                         mL in Acetonitrile.
LGC Limited...........................  Ecgonine Methyl Ester 1.0 mg/   Glass vial: 1 mL........      11/30/2012
                                         mL in Acetonitrile.
LGC Limited...........................  Ecgonine-D3 Hydrochloride 0.1   Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Methanol (as free
                                         base).
LGC Limited...........................  Ecgonine-D3 Methyl Ester 0.1    Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Acetonitrile.
LGC Limited...........................  Ethylmorphine 1.0 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Hydrocodone 1.0 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Hydrocodone-D3 0.1 mg/mL in     Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Hydrocodone-D6 0.1 mg/mL in     Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Norhydrocodone Hydrochloride    Glass vial: 1 mL........      11/30/2012
                                         1.0 mg/mL in Methanol (as
                                         free base).
LGC Limited...........................  Heroin (Diacetylmorphine) 1.0   Glass vial: 1 mL........      11/30/2012
                                         mg/mL in Acetonitrile.
LGC Limited...........................  Heroin-D9 (Diacetylmorphine-    Glass vial: 1 mL........      11/30/2012
                                         D9) 0.1 mg/mL in Acetonitrile.
LGC Limited...........................  Heroin-D9 (Diacetylmorphine-    Glass vial: 1 mL........      11/30/2012
                                         D9) 1.0 mg/mL in Acetonitrile.
LGC Limited...........................  rac-Methadone 0.1 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  rac-Methadone 1.0 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  rac-Methadone-D3 0.1 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  rac-Methadone-D3 1.0 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  rac-Methadone-D9 0.1 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  rac-Methadone-D9 1.0 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Dextropropoxyphene 0.1 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  Dextropropoxyphene 1.0 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  rac-Propoxyphene-D11 0.1 mg/mL  Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  rac-Propoxyphene-D11 1.0 mg/mL  Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  rac-Propoxyphene-D5 0.1 mg/mL   Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  rac-Propoxyphene-D5 1.0 mg/mL   Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  6-Acetylmorphine 0.1 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  6-Acetylmorphine 1.0 mg/mL in   Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  6-Acetylmorphine-D3 0.1 mg/mL   Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  6-Acetylmorphine-D3 1.0 mg/mL   Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  6-Acetylmorphine-D6 0.1 mg/mL   Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  6-Acetylmorphine-D6 1.0 mg/mL   Glass vial: 1 mL........      11/30/2012
                                         in Acetonitrile.
LGC Limited...........................  Acetylcodeine 0.1 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Acetylcodeine 1.0 mg/mL in      Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
LGC Limited...........................  Nordihydromorphine              Glass vial: 1 mL........      11/30/2012
                                         Hydrochloride 1.0 mg/mL in
                                         Methanol (as free base).
LGC Limited...........................  Oxymorphone 1.0 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Oxymorphone-D3 0.1 mg/mL in     Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Oxymorphone-D3 1.0 mg/mL in     Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Noroxymorphone Hydrochloride    Glass vial: 1 mL........      11/30/2012
                                         0.1 mg/mL in Methanol (as
                                         free base).
LGC Limited...........................  Noroxymorphone Hydrochloride    Glass vial: 1 mL........      11/30/2012
                                         1.0 mg/mL in Methanol (as
                                         free base).
LGC Limited...........................  Butorphanol Tartrate 1.0 mg/mL  Glass vial: 1 mL........      11/30/2012
                                         in Methanol (as free base).
LGC Limited...........................  Sufentanil Citrate 0.1 mg/mL    Glass vial: 1 mL........      11/30/2012
                                         in Methanol (as free base).

[[Page 40183]]

 
LGC Limited...........................  cis-Tilidine (Ethyl (1R,2RS)-2- Glass vial: 1 mL........      11/30/2012
                                         (Dimethylamino)-1-
                                         phenylcyclohex-3-
                                         enecarboxylate) 0.1 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  Tilidine 0.1 mg/mL in           Glass vial: 1 mL........      11/30/2012
                                         Acetonitrile.
Microgenics Corporation...............  Abbott TDM Multiconstituent     Box: 7 vials; 5 mL each.        7/2/2012
                                         Calibrator (CAL 1-6) Catalog
                                         Number: 5P04-01.
Microgenics Corporation...............  Thermo Scientific DRI Opiate    Vial: 18 mL, Box: 3            1/30/2013
                                         Assay Catalog Number:           vials.
                                         100014602.
Microgenics Corporation...............  Thermo Scientific DRI           Vial: 18 mL, Box: 3            1/30/2013
                                         Cannabinoid Assay Catalog       vials.
                                         Number: 10014665.
Microgenics Corporation...............  Thermo Scientific               Vial: 18 mL, Box: 3            1/30/2013
                                         Phencyclidine Assay Catalog     vials.
                                         Number: 10014673.
Microgenics Corporation...............  Thermo Scientific Ecstacy       Vial: 18 mL, Box: 3            1/30/2013
                                         Assay Catalog Number:           vials.
                                         10014681.
Microgenics Corporation...............  Thermo Scientific CEDIA         Vial: 5 mL; Box: 1 vial.       2/11/2013
                                         Methamphetamine OFT
                                         Calibrator 1: Catalog Number
                                         10016362.
Microgenics Corporation...............  Thermo Scientific CEDIA         Vial: 5 mL; Box: 1 vial.       2/11/2013
                                         Methamphetamine OFT
                                         Calibrator 2: Catalog Number
                                         10063.
Microgenics Corporation...............  Thermo Scientific CEDIA         Vial: 5 mL; Box: 1 vial.       2/11/2013
                                         Methamphetamine OFT
                                         Calibrator 3: Catalog Number
                                         10016364.
Microgenics Corporation...............  Thermo Scientific CEDIA         Vial: 10 mL; Box: 1 vial       2/11/2013
                                         Methamphetamine OFT Control
                                         1: Catalog Number 10017686.
Microgenics Corporation...............  Thermo Scientific CEDIA         Vial: 10 mL; Box: 1 vial       2/11/2013
                                         Methamphetamine OFT Control
                                         2: Catalog Number 10017687.
Microgenics Corporation...............  Thermo Scientific CEDIA         Vial: 10 mL; Box: 1 vial       2/11/2013
                                         Methamphetamine OFT Control
                                         3: Catalog Number 1007688.
Microgenics Corporation...............  Thermo Scientific CEDIA Multi-  Vial: 10 mL; Box: 1 vial       2/11/2013
                                         Drug OFT Calibrator 1:
                                         Catalog Number 10016882.
Microgenics Corporation...............  Thermo Scientific CEDIA Multi-  Vial: 10 mL; Box: 1 vial       2/11/2013
                                         Drug OFT Calibrator 2:
                                         Catalog Number 10016883.
Microgenics Corporation...............  Thermo Scientific CEDIA Multi-  Vial: 10 mL; Box: 1 vial       2/11/2013
                                         Drug OFT Calibrator 3:
                                         Catalog Number 10016884.
Microgenics Corporation...............  Thermo Scientific CEDIA Multi-  Vial: 15 mL; Box: 1 vial       2/11/2013
                                         Drug OFT Control 1: Catalog
                                         Number 10017711.
Microgenics Corporation...............  Thermo Scientific CEDIA Multi-  Vial: 15 mL; Box: 1 vial       2/11/2013
                                         Drug OFT Control 2: Catalog
                                         Number 10017712.
Microgenics Corporation...............  Thermo Scientific CEDIA Multi-  Vial: 15 mL; Box: 1 vial       2/11/2013
                                         Drug OFT Control 3: Catalog
                                         Number 10017713.
Microgenics Corporation...............  Thermo Scientific CEDIA THC     Vial: 5 mL; Box: 1 vial.       2/11/2013
                                         OFT Calibrator 1: Catalog
                                         Number 10016700.
Microgenics Corporation...............  Thermo Scientific CEDIA THC     Vial: 5 mL; Box: 1 vial.       2/11/2013
                                         OFT Calibrator 2: Catalog
                                         Number 10016701.
Microgenics Corporation...............  Thermo Scientific CEDIA THC     Vial: 5 mL; Box: 1 vial.       2/11/2013
                                         OFT Calibrator 3: Catalog
                                         Number 10016702.
Microgenics Corporation...............  Thermo Scientific CEDIA THC     Vial: 10 mL; Box: 1 vial       2/11/2013
                                         OFT Control 1: Catalog Number
                                         10017702.
Microgenics Corporation...............  Thermo Scientific CEDIA THC     Vial: 10 mL; Box: 1 vial       2/11/2013
                                         OFT Control 2: Catalog Number
                                         10017703.
Microgenics Corporation...............  Thermo Scientific CEDIA THC     Vial: 10 mL; Box: 1 vial       2/11/2013
                                         OFT Control 3: Catalog Number
                                         10017704.
Ortho Clinical Diagnostics, Inc.......  VITROS Immunodiagnostics        Plastic chamber: 8.4 mL.       9/28/2012
                                         Products Testosterone Reagent
                                         Pack.
Ortho Clinical Diagnostics, Inc.......  VITROS Immunodiagnostics        Plastic chamber: 13.3 mL       9/28/2012
                                         Products Estradiol Reagent
                                         Pack.
Ortho Clinical Diagnostics, Inc.......  VITROS Immunodiagnostics        Box: 3 vials; 2 mL each.      10/19/2012
                                         Products Testosterone
                                         Calibrators (1-3).
Ortho Clinical Diagnostics, Inc.......  VITROS Immunodiagnostics        Box: 9 vials; 1 mL each.      10/19/2012
                                         Products Testosterone
                                         Controls (1-3).
Ortho Clinical Diagnostics, Inc.......  VITROS Immunodiagnostics        Box: 4 vials; 1-1.5 mL        10/19/2012
                                         Products Testosterone Range     each.
                                         Verifiers (Low and High).
Restek................................  Custom Revised Appendix IX Mix  Glass vial: 1.3 mL......       2/14/2013
                                         1.
Restek Corporation....................  Product and Reactor Samples     Ampule: 2 mL............      10/12/2012
                                         Standard.
Restek Corporation....................  8270 Supplemental Standard      Ampule: 2 mL............      12/13/2012
                                         1.
Siemens Healthcare Diagnostics Inc....  TTST Stock X (Bulk)...........  Stock container: 50 mL-1       7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  VS TTST Cal Bulk Soln Level 1.  Bulk container: 4 mL-100       7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  VS TTST Cal Bulk Soln Level 2.  Bulk container: 4 mL-100       7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  VS TTST Cal Bulk Soln Level 3.  Bulk container: 4 mL-100       7/26/2012
                                                                         L.

[[Page 40184]]

 
Siemens Healthcare Diagnostics Inc....  VS TTST Cal Bulk Soln Level 4.  Bulk container: 4 mL-100       7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  VS TTST Cal Bulk Soln Level 5.  Bulk container: 4 mL-100       7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  VS TTST Cal Bulk Soln Level 6.  Bulk container: 4 mL-100       7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  Dimension Vista TTST CAL A....  Vial: 1 mL..............       7/26/2012
Siemens Healthcare Diagnostics Inc....  Dimension Vista TTST CAL B....  Vial: 1 mL..............       7/26/2012
Siemens Healthcare Diagnostics Inc....  Dimension Vista TTST CAL C....  Vial: 1 mL..............       7/26/2012
Siemens Healthcare Diagnostics Inc....  Dimension Vista TTST CAL D....  Vial: 1 mL..............       7/26/2012
Siemens Healthcare Diagnostics Inc....  Dimension Vista TTST CAL E....  Vial: 1 mL..............       7/26/2012
Siemens Healthcare Diagnostics Inc....  Dimension Vista TTST CAL F....  Vial: 1 mL..............       7/26/2012
Siemens Healthcare Diagnostics Inc....  Dimension Vista System TTST     Box: 12 vials; 1 ml each       7/26/2012
                                         CAL.
Siemens Healthcare Diagnostics Inc....  MP TTST Lvl 1 Bulk............  Bulk container: 4 mL-20        7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  MP TTST Lvl 2 Bulk............  Bulk container: 4 mL-20        7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  MP TTST Lvl 3 Bulk............  Bulk container: 4 mL-20        7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  MP TTST Lvl 4 Bulk............  Bulk container: 4 mL-20        7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  MP TTST Lvl 5 Bulk............  Bulk container: 4 mL-20        7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  MP TTST Lvl 6 Bulk............  Bulk container: 4 mL-20        7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  MP TTST CAL Lvl 1 FC..........  Vial: 1-5 mL............       7/26/2012
Siemens Healthcare Diagnostics Inc....  MP TTST CAL Lvl 2 FC..........  Vial: 1-5 mL............       7/26/2012
Siemens Healthcare Diagnostics Inc....  MP TTST CAL Lvl 3 FC..........  Vial: 1-5 mL............       7/26/2012
Siemens Healthcare Diagnostics Inc....  MP TTST CAL Lvl 4 FC..........  Vial: 1-5 mL............       7/26/2012
Siemens Healthcare Diagnostics Inc....  MP TTST CAL Lvl 5 FC..........  Vial: 1-5 mL............       7/26/2012
Siemens Healthcare Diagnostics Inc....  MP TTST CAL Lvl 6 FC..........  Vial: 1-5 mL............       7/26/2012
Siemens Healthcare Diagnostics Inc....  TTST Stock S (Bulk)...........  Stock container: 50 mL-1       7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  TTST Stock T (Bulk)...........  Stock container: 50 mL-1       7/26/2012
                                                                         L.
Siemens Healthcare Diagnostics Inc....  Estradiol Diluent.............  Plastic container: 0.5L-      11/14/2012
                                                                         1.0L.
Siemens Healthcare Diagnostics Inc....  Dimension Vista Drug 1 CAL      Plastic test tube: 15 mL       12/3/2012
                                         Pilot, Level B.
Supelco, Inc..........................  Titan C18 Batch Test 1 Mix....  Glass ampule: 1 mL......       2/28/2013
----------------------------------------------------------------------------------------------------------------

    The Deputy 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 Deputy 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 listed below that was provided in the determination letters to the 
individual requesters.

                                                    Chart II
----------------------------------------------------------------------------------------------------------------
                                                                                                    Application
               Supplier                          Product name                     Form                 date
----------------------------------------------------------------------------------------------------------------
Agilent Technologies..................  Forensic Toxicology             Ampule: 1 mL............       12/6/2012
                                         Comprehensive Mix-Submix 9A.

[[Page 40185]]

 
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL      10/11/2012
                                         Control Urine, MC177.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL      10/23/2012
                                         Control Urine, MC178.
Biochemical Diagnostics, Inc..........  Salivabuse Custom Liquid        Glass vials: 1 ml-200 mL      10/23/2012
                                         Control Oral Fluid, OF24.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL      12/14/2012
                                         Control Urine, MC180.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL      12/14/2012
                                         Control Urine, MC181.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-2 L...       1/22/2013
                                         Control Urine, MC182.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-200 mL       1/29/2013
                                         Control Urine, MC180.
Biochemical Diagnostics, Inc..........  Detectabuse Custom Liquid       Glass vials: 1 ml-2 L...       2/14/2013
                                         Control Urine, MC182.
Cerilliant Corporation................  (-)-11-nor-9-Carboxy-delta9-    Glass ampule: 5 mL......        7/6/2012
                                         THC (1 mg/mL).
Cerilliant Corporation................  Cocaine HCl (10 mg/mL)........  Glass Ampule: 1 mL......        7/6/2012
Cerilliant Corporation................  Lacosamide (10 mg/mL).........  Glass Ampule: 1 mL......       9/12/2012
Cliniqa Corporation...................  TDM Control, Levels 1-3 Bulk..  Plastic Container: 500 L       12/4/2012
ElSohly Laboratories, Inc.............  ELI Oral Fluid Controls, THC    Glass vial: 5 ml-4 L....        8/9/2012
                                         (0.5-50 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Controls,        Glass vial: 5 ml-4 L....        8/9/2012
                                         Methamphetamine (2-200 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Controls,        Glass vial: 5 ml-4 L....        8/9/2012
                                         Amphetamine, Benzoylecgonine,
                                         Morphine, Phencyclidine (2-
                                         200 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Controls,        Glass vial: 5 ml-4 L....        8/9/2012
                                         Multidrug (selected from THC,
                                         Cocaine/Benzoylecgonine,
                                         Amphetamines, Opiates, & PCP
                                         at 0.5-50 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Calibrators,     Glass vial: 5 ml-4 L....        8/9/2012
                                         THC (0.5-50 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Calibrators,     Glass vial: 5 ml-4 L....        8/9/2012
                                         Methamphetamine (2-200 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Calibrators,     Glass vial: 5 ml-4 L....        8/9/2012
                                         Amphetamine, Benzoylecgonine,
                                         Morphine, Phencyclidine (2-
                                         200 ng/mL).
ElSohly Laboratories, Inc.............  ELI Oral Fluid Calibrators,     Glass vial: 5 ml-4 L....        8/9/2012
                                         Multidrug (selected from THC,
                                         Cocaine/Benzoylecgonine,
                                         Amphetamines, Opiates, & PCP
                                         at 0.5-200 ng/mL).
LGC Limited...........................  LAMPA (Lysergic Acid N-Methyl-  Glass vial: 1 mL........      11/30/2012
                                         N-propylamide) 1.0 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  LSD (Lysergic Acid              Glass vial: 1 mL........      11/30/2012
                                         Diethylamide) 1.0 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  LSD-D3 (Lysergic Acid           Glass vial: 1 mL........      11/30/2012
                                         Diethylamide-D3) 0.1 mg/mL in
                                         Acetonitrile.
LGC Limited...........................  (-)-Cannabidiol 1.0 mg/mL in    Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  Cannabinol 1.0 mg/mL in         Glass vial: 1 mL........      11/30/2012
                                         Methanol.
LGC Limited...........................  (-)-delta9-THC (Dronabinol)     Glass vial: 1 mL........      11/30/2012
                                         1.0 mg/mL in Methanol.
LGC Limited...........................  (-)-delta9-THC-D3 (Dronabinol-  Glass vial: 1 mL........      11/30/2012
                                         D3) 0.1 mg/mL in Methanol.
LGC Limited...........................  trans-11-Hydroxy-delta9-THC     Glass vial: 1 mL........      11/30/2012
                                         ((6aRS,10aRS)-11-Hydroxy-
                                         delta9-tetrahydrocannabinol)
                                         0.1 mg/mL in Methanol.
LGC Limited...........................  trans-11-Hydroxy-delta9-THC     Glass vial: 1 mL........      11/30/2012
                                         ((6aRS,10aRS)-11-Hydroxy-
                                         delta9-tetrahydrocannabinol)
                                         1.0 mg/mL in Methanol.
LGC Limited...........................  trans-11-Hydroxy-delta9-THC-D3  Glass vial: 1 mL........      11/30/2012
                                         (trans-11-Hydroxy-delta9-
                                         tetrahydrocannabinol-D3) 0.1
                                         mg/mL in Methanol.
LGC Limited...........................  trans-11-Nor-9-carboxy-delta9-  Glass vial: 1 mL........      11/30/2012
                                         THC 0.1 mg/mL in Methanol.
LGC Limited...........................  trans-11-Nor-9-carboxy-delta9-  Glass vial: 1 mL........      11/30/2012
                                         THC-D3 0.1 mg/mL in Methanol.
LGC Limited...........................  trans-11-Nor-9-carboxy-delta9-  Glass vial: 1 mL........      11/30/2012
                                         THC-D3 1.0 mg/mL in Methanol.
LGC Limited...........................  Fentanyl 0.1 mg/mL in Methanol  Glass vial: 1 mL........      11/30/2012
LGC Limited...........................  Fentanyl 1.0 mg/mL in Methanol  Glass vial: 1 mL........      11/30/2012
LGC Limited...........................  Fentanyl-D5 0.1 mg/mL in        Glass vial: 1 mL........      11/30/2012
                                         Methanol.
Siemens Healthcare Diagnostics Inc....  Dimension Vista Drug 1 CAL      Plastic container: 4-100       12/3/2012
                                         Bulk, Level B.                  L.
----------------------------------------------------------------------------------------------------------------

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. Pursuant to 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. Pursuant to 21 CFR 1308.24(g), 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, DEA has determined that each of the exempted bulk products 
listed in this order may only be used by the manufacturer and may not 
be distributed by the manufacturer for any purpose or transported to 
other facilities.
    Additional exempt chemical preparation requests received between 
July 1, 2012, and March 31, 2013, and not otherwise referenced in this 
order may remain under consideration until DEA receives additional 
information required, pursuant to 21 CFR 1308.23(d), as detailed in 
separate correspondence to individual requesters. DEA's order on such 
requests will be communicated to the public in a future Federal 
Register publication.
    DEA also notes that these exemptions are limited to exemption from 
only those sections of the CSA and the CFR that are specifically 
identified in 21 CFR

[[Page 40186]]

1308.24(a). All other requirements of the CSA and the CFR apply, 
including, but not limited to, registration as an importer as required 
by 21 U.S.C. 957.

Chemical Preparations Containing Newly Controlled Substances

    The statutory authority for exempt chemical preparations is based 
on the control status of substances contained within a preparation, the 
intended administration of a preparation, and the packaged form of a 
preparation. DEA conducts a case-by-case analysis of each application 
for exemption to determine whether exemption of a preparation from 
certain provisions of the CSA is appropriate pursuant to the specified 
statutory and regulatory requirements.
    Most exempt chemical preparations have remained effective until the 
holder of a specific exempt chemical preparation specifically requested 
that the exemption be terminated. The CSA allows for modifications to 
the controlled substances schedules to add, remove, or change the 
schedule of substances thus resulting in periodic modifications to the 
control status of various substances. 21 U.S.C. 811(a). Since the CSA 
was enacted in 1970, DEA has on several occasions added to, removed 
from, or modified the schedules of controlled substances in accordance 
with the CSA. Such changes may result in the non-compliance of exempt 
chemical preparations with current statutes or regulations if chemical 
preparations that have already obtained exempt status contain newly 
controlled substances. For example, although an exempt chemical 
preparation may continue to be packaged in the same manner as when it 
was approved, non-controlled substances in the preparation may become 
controlled, thus prompting the need for a new application for exemption 
of the chemical preparation to ensure continued compliance. Other 
preparations that previously contained no controlled substances may 
contain newly controlled substances and thus would require an 
application for exemption.
    DEA reviews applications for chemical preparation exemptions based 
on the statutes and regulations that are in place at the time of the 
application, including the control status of substances included in the 
preparation. DEA must remain vigilant to ensure that exempt chemical 
preparations remain consistent with the standards set forth in the CSA 
and its implementing regulations. As such, DEA reminds the public that 
any chemical preparation, regardless of whether it was previously 
exempt, that contains a newly controlled substance will require a new 
application for exemption pursuant to 21 U.S.C. 811(g)(3)(B) and 21 CFR 
1308.23-1308.24.

Review of Exemptions Pursuant to 21 U.S.C. 811(g)(3)

    Based on inquiries received from industry, DEA is conducting a 
comprehensive review of the exempt chemical preparation regulations. 
DEA's regulations at 21 CFR 1308.24(a) state that approved chemical 
preparations are exempt from certain provisions of both Subchapter I 
and Subchapter II of the CSA: ``The chemical preparations and mixtures 
approved pursuant to 1308.23 are exempt from application of sections 
302, 303, 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 
U.S.C. 822-823, 825-829, 952-954) and 1301.74 of this chapter, to the 
extent described in paragraphs (b) to (h) of this section.'' Pursuant 
to its regulations, DEA has provided exemptions from the application of 
section 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 of the 
Act (21 U.S.C. 822-823, 825-829, 952-954) and 21 CFR 1301.74 since the 
implementation of the regulations in the early 1970s. Until DEA's 
analysis of the exemption regulations is complete, DEA will continue to 
review and provide exemptions to chemical preparations consistent with 
the implementing regulations, when warranted. DEA will publish a future 
notice regarding the outcome of DEA's review of its regulations with 
respect to the exemption of chemical preparations.

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 Deputy 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 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: June 17, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2013-16010 Filed 7-2-13; 8:45 am]
BILLING CODE 4410-09-P