Exempt Chemical Preparations Under the Controlled Substances Act, 4446-4458 [2013-01133]

Download as PDF 4446 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–361] 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 June 12, 2011, and June 30, 2012, 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 March 25, 2013. Commenters should be aware that 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–361’’ on all electronic and written correspondence. DEA encourages that all comments be submitted electronically through https:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the https:// www.regulations.gov Web site 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. 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: SUMMARY: tkelley on DSK3SPTVN1PROD with Posting of Public Comments Please note that all comments received are considered part of the public record and made available for public inspection online at https:// www.regulations.gov and in the DEA’s public docket. Such information includes personal identifying information (such as your name, VerDate Mar<15>2010 18:11 Jan 18, 2013 Jkt 229001 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. SUPPLEMENTARY INFORMATION: 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 (hereinafter, ‘‘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 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 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 June 12, 2011, and June 30, 2012 The Deputy Assistant Administrator received applications between June 12, 2011, and June 30, 2012, 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 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. E:\FR\FM\22JAN1.SGM 22JAN1 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 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 from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 (21 U.S.C. 822–823, 825–829, and 4447 952–954) of the CSA and from application of 21 CFR 1301.74, to the extent described in 21 CFR 1308.24, as of the date listed below that was provided in the approval letters to the individual requesters. CHART I Supplier Product name Form Exemption date Abbott Laboratories ............................ ARCHITECT 2nd Generation Testosterone Calibrators (B,C,D,E,F). ARCHITECT 2nd Generation Testosterone Controls (L,M,H). ARCHITECT Estradiol Assay Diluent, No. 2K25J Bottle: 4 mL; Box: 6 bottles ............... 12/22/2011 Bottle: 8 mL; Box: 3 bottles ............... 12/22/2011 Bag-in-box: 18–200 L; Flask/Carboy: 1–50 L; Bottle/Vial: 0.5 mL–1 L; Box: 1–50 bottles. Bottle: 5.9 mL ..................................... Bottle: 5.9 mL; Kit: 16 bottles ............ 12/22/2011 12/22/2011 12/22/2011 Bottle: 5.9 mL; Kit: 4 bottles .............. 12/22/2011 Bottle: 5.9 mL; Kit: 16 bottles ............ Bottle: 5.9 mL; Kit: 4 bottles .............. Flask/Carboy: 1–50 L; Bottle/Vial: 0.5 mL–1 L; Box: 1–50 bottles. Bottle: 5.5 mL, Pack: 4 bottles .......... Plastic Vial: 50 discs .......................... 12/22/2011 12/22/2011 12/22/2011 Plastic Vial: 50 discs .......................... 12/22/2011 Plastic Vial: 50 discs .......................... 12/22/2011 Plastic Vial: 50 discs .......................... 12/22/2011 Plastic Vial: 50 discs .......................... 12/22/2011 Plastic Vial: 50 discs .......................... 12/22/2011 Plastic Vial: 50 discs .......................... 12/22/2011 Plastic Vial: 50 discs .......................... 12/22/2011 Glass jar: 100 Chromatograms .......... Glass jar: 100 Chromatograms .......... Plastic vial: 50 discs .......................... Plastic bottle: 2 oz ............................. Plastic bottle: 2 oz. ............................ Plastic bottle: 2 oz ............................. Plastic bottle: 2 oz ............................. Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic vial: 50 discs .......................... Plastic bottle: 2 oz ............................. Vial: 1 mL ........................................... 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 (+)-Pentazocine (1 mg/mL) .................................... Vial: 1 mL ........................................... 12/22/2011 (+)-Pentazocine [ring-1,3-3H] ................................. Vial: 1 mL ........................................... 12/22/2011 (±)-Ketamine [N-methyl-3H] hydrochloride ............. Vial: 1 mL ........................................... 12/22/2011 Abbott Laboratories ............................ Abbott Laboratories ............................ Abbott Laboratories ............................ Abbott Laboratories ............................ Abbott Laboratories ............................ Abbott Laboratories ............................ Abbott Laboratories ............................ Abbott Laboratories ............................ Abbott Laboratories ............................ Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... tkelley on DSK3SPTVN1PROD with Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... Agilent Technologies .......................... American Radiolabeled Chemicals, Inc. American Radiolabeled Chemicals, Inc. American Radiolabeled Chemicals, Inc. American Radiolabeled Chemicals, Inc. VerDate Mar<15>2010 18:11 Jan 18, 2013 ARCHITECT Estradiol Assay Diluent, No. 7K72J ARCHITECT Estradiol Reagent Kit, No. 07K72– 20. ARCHITECT Estradiol Reagent Kit, No. 07K72– 25. ARCHITECT Estradiol Reagent Kit, No. 2K25–20 ARCHITECT Estradiol Reagent Kit, No. 2K25–25 AxSYM Estradiol Buffer ......................................... AxSYM Estradiol Reagent Pack ............................ Special Order Standard TOXI-LAB DISCS; 1, 2, or 3 drugs. Special Procedure Standard TOXI-LAB DISCS: Benzodiazepines: Hydrolysis Procedure. Special Procedure Standard TOXI-LAB DISCS: Benzoylecgonine. Special Procedure Standard TOXI-LAB DISCS: MDMA, MDA, MDEA. Special Procedure Standard TOXI-LAB DISCS: Morphine and Hydromorphone: Differentiation. Special Procedure Standard TOXI-LAB DISCS: Opiate. Special Procedure Standard TOXI-LAB DISCS: Sympathomimetic amines: Differentiation. Special Standard TOXI-LAB DISCS LTD-Opiate: 1, 2, or 3 drugs. TOXI-LAB Chromatograms A ................................ TOXI-LAB Chromatograms B ................................ TOXI-LAB CONTROL LTD FM .............................. TOXI-LAB CONTROL No. 19 ................................ TOXI-LAB CONTROL No. 2 .................................. TOXI-LAB CONTROL No. 3 .................................. TOXI-LAB CONTROL No. 5 .................................. TOXI-LAB CONTROL THC .................................... TOXI-LAB DISCS A–1 ........................................... TOXI-LAB DISCS A–2 ........................................... TOXI-LAB DISCS A–3 ........................................... TOXI-LAB DISCS A–4 ........................................... TOXI-LAB DISCS B–1 ........................................... TOXI-LAB DISCS B–2 ........................................... TOXI-LAB DISCS B–3 ........................................... TOXI-LAB DISCS B–4 ........................................... TOXI-LAB DISCS LTD HD .................................... TOXI-LAB DISCS LTD OP .................................... TOXI-LAB DISCS LTD OPI ................................... TOXI-LAB DISCS THC .......................................... TOXI-LAB Proficiency Sample ............................... (+)-iodo-Lysergic Acid diethylamide [125I] ............. Jkt 229001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM 22JAN1 12/22/2011 12/22/2011 4448 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices CHART I—Continued Product name Form Exemption date Radiolabeled Chemicals, (±)-Ketamine hydrochloride (1 mg/mL) .................. Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, 1,1-Dimethyltryptamine (1 mg/mL) ......................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, 1,1-Dimethyltryptamine [a,b-3H] as TFA salt ......... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Amobarbital (1 mg/mL) .......................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Amphetamine, D-[ring-2,3,5-3H] hydrochloride ..... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Amphetamine, DL-[ring-2,3,5-3H] hydrochloride ... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Amphetamine, L-[ring-2,3,5-3H] hydrochloride ...... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Buprenorphine [ring-3H] hydrochloride .................. Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Buprenorphine hydrochloride (1 mg/mL) ............... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Cocaine (1 mg/mL) ................................................ Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Cocaine [methyl-14C] hydrochloride ...................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Cocaine, levo-[benzoyl-3,4-3H(N)] ......................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Codeine (1 mg/mL) ................................................ Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, D-Amphetamine hydrochloride (1 mg/mL) ............. Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Dextropropoxyphene (1 mg/mL) ............................ Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Diazepam (1 mg/mL) ............................................. Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Dihydrocodeine (1 mg/mL) ..................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Dihydromorphine (1 mg/mL) .................................. Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Diprenorphine (1 mg/mL) ....................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, DL-Amphetamine hydrochloride (1 mg/mL) ........... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, D-Methamphetamine hydrochloride (1 mg/mL) ..... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Ecgonine (1 mg/mL) ............................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Fentanyl (1 mg/mL) ................................................ Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Fentanyl [3H(G)] as TFA salt ................................. Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Fludiazepam (1 mg/mL) ......................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Flunitrazepam (1 mg/mL) ....................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Flunitrazepam [methyl-3H] ..................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Flurazepam (1 mg/mL) ........................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Flurazepam [N-methyl-3H] ..................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Heroin (1 mg/mL) ................................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Heroin [methyl-14C] ............................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Heroin [methyl-3H] ................................................. Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Hydrocodone (1 mg/mL) ........................................ Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Hydromorphone (1 mg/mL) .................................... Vial: 1 mL ........................................... 12/22/2011 Radiolabeled Chemicals, Hydromorphone [N-methyl-14C] hydrochloride ..... Vial: 1 mL ........................................... 12/22/2011 tkelley on DSK3SPTVN1PROD with Supplier American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. American Inc. VerDate Mar<15>2010 18:11 Jan 18, 2013 Jkt 229001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM 22JAN1 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4449 CHART I—Continued Product name Form Exemption date Chemicals, Ibogaine (1 mg/mL) ................................................ Vial: 1 mL ........................................... 12/22/2011 Chemicals, L-Amphetamine hydrochloride (1 mg/mL) ............. Vial: 1 mL ........................................... 12/22/2011 Chemicals, L-Methamphetamine hydrochloride (1 mg/mL) ...... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Lysergic Acid (1 mg/mL) ........................................ Vial: 1 mL ........................................... 12/22/2011 Chemicals, Lysergic acid diethylamide [N-methyl-3H] ............. Vial: 1 mL ........................................... 3/22/2012 Chemicals, Mazindol (1 mg/mL) ............................................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Meperidine Hydrochloride (1 mg/mL) .................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Metazocine (1 mg/mL) ........................................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Metazocine [ring-1,3-3H] ........................................ Vial: 1 mL ........................................... 12/22/2011 Chemicals, Methamphetamine, D-[methyl-14C] hydrochloride Vial: 1 mL ........................................... 12/22/2011 Chemicals, Methamphetamine, L-[methyl-14C] hydrochloride Vial: 1 mL ........................................... 12/22/2011 Chemicals, Midazolam (1 mg/mL) ............................................ Vial: 1 mL ........................................... 12/22/2011 Chemicals, Midazolam [3H(G)] ................................................. Vial: 1 mL ........................................... 12/22/2011 Chemicals, Morphine (1 mg/mL) ............................................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Morphine [N-methyl-14C] ....................................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Normorphine (1 mg/mL) ......................................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Oripavine (1 mg/mL) .............................................. Vial: 1 mL ........................................... 12/22/2011 Chemicals, Oxycodone [N-methyl-14C] hydrochloride ............. Vial: 1 mL ........................................... 12/22/2011 Chemicals, Oxycodone hydrochloride (1 mg/mL) ..................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Oxymorphone (1 mg/mL) ....................................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Phenazocine (1 mg/mL) ......................................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Phencyclidine hydrochloride (1 mg/mL) ................. Vial: 1 mL ........................................... 12/22/2011 Chemicals, Phenylacetone (1 mg/mL) ...................................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Tetrahydrocannabidinol (1 mg/mL) ........................ Vial: 1 mL ........................................... 12/22/2011 Chemicals, Thebaine (1 mg/mL) ............................................... Vial: 1 mL ........................................... 12/22/2011 Chemicals, Thebaine [N-methyl-14C] hydrochloride ................ Vial: 1 mL ........................................... 12/22/2011 Chemicals, Thebaine [N-methyl-3H] hydrochloride .................. Vial: 1 mL ........................................... 12/22/2011 Chemicals, Thebaine [O-methyl-14C] hydrochloride ................ Vial: 1 mL ........................................... 12/22/2011 Chemicals, Thebaine [O-methyl-3H] hydrochloride .................. Vial: 1 mL ........................................... 12/22/2011 Chemicals, g-Hydroxybutyric acid sodium salt (1 mg/mL) ........ Vial: 1 mL ........................................... 12/22/2011 Detectabuse OF10. Detectabuse OF11. Detectabuse OF12. Detectabuse OF13. Detectabuse OF14. Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Supplier American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. American Radiolabeled Inc. Biochemical Diagnostics, Inc ............. tkelley on DSK3SPTVN1PROD with Biochemical Diagnostics, Inc ............. Biochemical Diagnostics, Inc ............. Biochemical Diagnostics, Inc ............. Biochemical Diagnostics, Inc ............. VerDate Mar<15>2010 18:11 Jan 18, 2013 Jkt 229001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM 22JAN1 4450 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices CHART I—Continued Supplier Product name 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 ............. tkelley on DSK3SPTVN1PROD with Biochemical Diagnostics, Inc ............. Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Biochemical Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, Diagnostics, VerDate Mar<15>2010 Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc Inc ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. 18:11 Jan 18, 2013 Detectabuse OF15. Detectabuse OF16. Detectabuse OF17. Detectabuse OF18. Detectabuse OF19. Detectabuse OF20. Detectabuse OF21. Detectabuse OF4. Detectabuse OF5. Detectabuse OF6. Detectabuse OF8. Detectabuse OF9. Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Detectabuse Jkt 229001 PO 00000 Exemption date Form Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/31/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/31/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Liquid Control Oral Fluid, Glass vials: 1 ml–200 mL .................. 7/5/2012 Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom Custom 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 Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Frm 00074 Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Control Fmt 4703 Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Urine, Sfmt 4703 MC134 MC135 MC136 MC137 MC138 MC139 MC140 MC141 MC143 MC144 MC145 MC146 MC147 MC148 MC149 MC150 MC151 MC152 MC153 MC154 MC155 MC156 MC157 MC158 MC159 MC160 MC161 MC162 MC163 MC164 MC165 MC166 MC167 MC168 MC169 MC170 MC171 MC172 MC173 SD10 SD11 SD12 SD13 SD14 SD15 SD16 vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: vials: E:\FR\FM\22JAN1.SGM 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–200 ml–200 ml–100 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 ml–200 22JAN1 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 .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. .................. 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 2/1/2012 3/8/2012 3/8/2012 3/8/2012 3/8/2012 3/8/2012 3/22/2012 7/5/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 8/20/2012 7/5/2012 7/31/2012 7/31/2012 2/1/2012 2/1/2012 2/1/2012 2/1/2012 2/1/2012 7/5/2012 7/5/2012 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4451 CHART I—Continued Supplier Product name Form Exemption date Bio-Rad Laboratories ......................... Liquichek Immunoassay Plus Control Levels 1, 2, and 3. Liquichek Immunoassay Plus Control Trilevel ....... Liquichek Immunoassay Plus Control Trilevel Minipak. Liquichek Urine Toxicology Control S10 ................ Liquichek Urine Toxicology Control S10 Low Opiate. Liquichek Urine Toxicology Control S10 Low Opiate Minipak. Liquichek Urine Toxicology Control S10 Minipak .. Liquichek Urine Toxicology Control S20 ................ Liquichek Urine Toxicology Control S20 Low Opiate. Liquichek Urine Toxicology Control S20 Low Opiate Minipak. Liquichek Urine Toxicology Control S20 Minipak .. Liquid Assayed Multiqual Levels 1–3 .................... Liquid Assayed Multiqual Trilevel MiniPak ............ Liquid Unassayed Multiqual Levels 1–3 ................ Liquid Unassayed Multiqual Trilevel MiniPak ........ Lyphochek Assayed Chemistry Control Bilevel MiniPak. Lyphochek Assayed Chemistry Control Levels 1– 2. Lyphochek Immunoassay Plus Control Levels 1, 2, and 3. Lyphochek Immunoassay Plus Control Trilevel ..... Lyphochek Immunoassay Plus Control Trilevel Minipak. Lyphochek Unassayed Chemistry Control (Human) Bilevel MiniPak. Lyphochek Unassayed Chemistry Control (Human) Levels 1–2. (±) Pentazocine-13C3 (0.1 mg/mL) ........................ (±)-cis-11-Nor-9-carboxy-delta9-THC-D3 glucuronide (0.1 mg/mL). 3,4-Methylenedioxypyrovalerone HCl (1 mg/mL) .. 3,4-Methylenedioxypyrovalerone-D8 HCl (0.1 mg/ mL). 3-Desmethylprodine (1 mg/mL) ............................. 3-Desmethylprodine HCl (1 mg/mL) ...................... 6-alpha/beta-Hydroxyoxymorphone (1 mg/mL) ..... 6-alpha/beta-Hydroxyoxymorphone-D3 (0.1 mg/ mL). Buprenorphine N-oxide (1 mg/mL) ........................ Cannabinol-D3 (0.1 mg/mL) ................................... Carisoprodol (1 mg/mL) ......................................... Carisoprodol-D7 (0.1 mg/mL) ................................ Carisoprodol-D7 (1 mg/mL) ................................... Cocaine N-oxide HCl (1 mg/mL) ............................ Cocaine N-oxide HCl (1 mg/mL) ............................ Cocaine N-oxide-D3 HCl (0.1 mg/mL) ................... Cocaine N-oxide-D3 HCl (0.1 mg/mL) ................... Drug Solution # 15 ................................................. Lacosamide (1 mg/mL) .......................................... Lacosamide-13C, D3 (0.1 mg/mL) ......................... Lacosamide-13C, D3 (1 mg/mL) ............................ Lisdexamfetamine dimesylate (1 mg/mL) .............. Lisdexamfetamine-D4 dimesylate (0.1 mg/mL) ..... Mephedrone HCl (1 mg/mL) .................................. Mephedrone-D3 HCl (0.1 mg/mL) ......................... Methylone HCl (1 mg/mL) ...................................... Methylone-D3 HCl (0.1 mg/mL) ............................. Morphine (8 μg/mL) ................................................ Naloxone N-oxide (0.1 mg/mL) .............................. Norcodeine-D3 (1 mg/mL) ..................................... Normeperidine-D4 (1 mg/mL) ................................ Noroxycodone and Norhydrocodone Mix (0.5 mg/ mL). Opiate Internal Standard Mix-15 ............................ Amber Vial: 10 mL; Box: 12 vials ...... 12/22/2011 Amber Vial: 10 mL; Box: 12 vials ...... Amber Vial: 5 mL; Box: 3 vials .......... 12/22/2011 12/22/2011 Box: 10 vials, 10 mL each ................. Box: 10 vials, 10 mL each ................. 5/31/2012 5/31/2012 Amber vial: 10 mL .............................. 5/31/2012 Amber vial: 10 mL .............................. Box: 10 vials, 10 mL each ................. Box: 10 vials, 10 mL each ................. 5/31/2012 5/31/2012 5/31/2012 Amber vial: 10 mL .............................. 5/31/2012 Amber vial: 10 mL .............................. Amber Vial: 2.5 mL; Box: 12 vials ..... Amber Vial: 2.5 mL; Box: 3 vials ....... Amber Vial: 2.5 mL; Box: 12 vials ..... Amber Vial: 2.5 mL; Box: 3 vials ....... Box 2 vials; 5 mL each ...................... 5/31/2012 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 Amber Vial: 5 mL; Box: 12 vials ........ 12/22/2011 Amber Vial: 10 mL; Box: 12 vials ...... 12/22/2011 Amber Vial: 10 mL; Box: 12 vials ...... Amber Vial: 5 mL; Box: 3 vials .......... 12/22/2011 12/22/2011 Box 2 vials; 5 mL each ...................... 12/22/2011 Amber Vial: 5 mL; Box: 25 vials ........ 12/22/2011 Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... 12/22/2011 12/22/2011 Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... 12/22/2011 12/22/2011 Glass Glass Glass Glass .......................... .......................... .......................... .......................... 7/31/2012 7/31/2012 12/22/2011 12/22/2011 Glass Ampule: 1 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Screw-cap Vial: 50 mL ....................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 1 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 2 mL .......................... Glass Ampule: 1 mL .......................... Glass Ampule: 1 mL .......................... Glass Ampule: 2 mL .......................... 12/22/2011 12/22/2011 12/22/2012 12/22/2012 7/31/2012 12/22/2011 3/8/2012 12/22/2011 3/8/2012 6/5/2012 5/31/2012 12/22/2011 7/31/2012 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 6/5/2012 7/31/2012 7/31/2012 12/22/2011 Glass Ampule: 2 mL .......................... 12/22/2011 Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Bio-Rad Bio-Rad Bio-Rad Bio-Rad Bio-Rad Laboratories Laboratories Laboratories Laboratories Laboratories Laboratories ......................... ......................... ......................... ......................... ......................... ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... tkelley on DSK3SPTVN1PROD with Cerilliant Cerilliant Cerilliant Cerilliant Corporation Corporation Corporation Corporation ......................... ......................... ......................... ......................... Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Cerilliant Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation Corporation ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... Cerilliant Corporation ......................... VerDate Mar<15>2010 18:11 Jan 18, 2013 Jkt 229001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 Ampule: Ampule: Ampule: Ampule: E:\FR\FM\22JAN1.SGM 1 1 2 2 mL mL mL mL 22JAN1 4452 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices CHART I—Continued Supplier Cerilliant Corporation Cerilliant Corporation Cerilliant Corporation Cerilliant Corporation ElSohly Laboratories, Product name ......................... ......................... ......................... ......................... Inc ................... ElSohly Laboratories, Inc ................... Environmental Resource Associates (ERA). Environmental Resource Associates (ERA). Environmental Resource Associates (ERA). Immunalysis Corporation ................... Immunalysis Corporation ................... Immunalysis Corporation ................... Immunalysis Corporation ................... Immunalysis Corporation ................... Immunalysis Corporation ................... Immunalysis Corporation ................... Immunalysis Corporation ................... Immunalysis Corporation ................... Insys Therapeutics, Inc. ..................... 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 .................... tkelley on DSK3SPTVN1PROD with Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... VerDate Mar<15>2010 18:11 Jan 18, 2013 Form Pseudobuprenorphine dihydrochloride (1.0mg/mL) Pyrovalerone HCl (1 mg/mL) ................................. Secobarbital-D5 (1 mg/mL) .................................... Zolpidem-D7 (0.1 mg/mL) ...................................... ELI Drug Standards D9-Tetrahydrocannabinolglucoronide (10 μg/mL in MeOH). ELI Drug Standards D9-Tetrahydrocannabinolglucoronide (100 μg/mL in MeOH). Chloral Hydrate, Proficiency Testing Material, Catalog No. 853. Chloral Hydrate, Reference Material, Catalog No. 676. Waters Steroid Test Mix, Part No. 07364 .............. Glass Glass Glass Glass Glass Methadone Calibrator Levels 1–4 .......................... Methadone High Control ........................................ Methadone Low Control ......................................... Oral Fluid Cutoff Calibrator Pain Management Prediluted in Extraction Buffer. Oral Fluid High Positive Control Pain Management Prediluted in Extration Buffer. Oral Fluid Low Positive Control Pain Management Prediluted in Extraction Buffer. Zolpidem Calibrator ................................................ Zolpidem High Control ........................................... Zolpidem Low Control ............................................ (-)-delta9-Tetrahydrocannabinol (1.0 mg/mL) ........ CEDIA Amphetamine OFT Assay, Catalog Number: 10014947. CEDIA Cannabinoids OFT Assay, Catalog Number: 10014910. CEDIA Cocaine OFT Assay, Catalog Number: 10014764. CEDIA Methamphetamine OFT Assay, Catalog Number: 10014949. CEDIA Methamphetamine OFT Control Set (Low and High) , Catalog #10014953. CEDIA Methamphetamine OFT Cutoff Calibrator, Catalog #10014951. CEDIA Methamphetamine OFT High Calibrator, Catalog #10014952. CEDIA Multi-Drug OFT Control Set (Low and High), Catalog #10014957. CEDIA Multi-Drug OFT Cutoff Calibrator, Catalog #10014955. CEDIA Multi-Drug OFT High Calibrator, Catalog #10014956. CEDIA Opiate OFT Assay, Catalog Number: 10014873. CEDIA PCP OFT Assay, Catalog Number: 10014888. CEDIA THC OFT Control Set (Low and High), Catalog #10014925. CEDIA THC OFT Cutoff Calibrator, Catalog #10014923. CEDIA THC OFT High Calibrator, Catalog #10014924. Thermo Scientific CEDIA Methamphetamine OFT Calibrator 1, Catalog Number: 10016345. Thermo Scientific CEDIA Methamphetamine OFT Calibrator 1, Catalog Number: 10016362. Thermo Scientific CEDIA Methamphetamine OFT Calibrator 2, Catalog Number: 10016346. Thermo Scientific CEDIA Methamphetamine OFT Calibrator 2, Catalog Number: 10016363. Thermo Scientific CEDIA Methamphetamine OFT Calibrator 3, Catalog Number: 10016347. Thermo Scientific CEDIA Methamphetamine OFT Calibrator 3, Catalog Number: 10016364. Thermo Scientific CEDIA Methamphetamine OFT Calibrator 4, Catalog Number: 10016348. Glass Glass Glass Glass Jkt 229001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 Exemption date Ampule: 1 mL .......................... Ampule: 2 mL .......................... Ampule: 1 mL .......................... Ampule: 2 mL .......................... vial: 1 ml .................................. 2/1/2012 12/22/2011 7/31/2012 12/22/2011 5/31/2012 Glass vial: 1 ml .................................. 5/31/2012 Glass Ampule: 2 mL .......................... 3/8/2012 Glass Ampule: 2 mL .......................... 3/8/2012 Glass Ampule: 2 mL .......................... 3/8/2012 vial: vial: vial: vial: ............................... ............................... ............................... ............................... 6/19/2012 6/19/2012 6/19/2012 6/19/2012 Glass vial: 10 mL ............................... 6/19/2012 Glass vial: 10 mL ............................... 6/19/2012 Glass vial: 10 mL ............................... Glass vial: 10 mL ............................... Glass vial: 10 mL ............................... Glass Ampule: 1 mL .......................... Box: 4 bottles; 65 mL each ................ 6/19/2012 6/19/2012 6/19/2012 5/9/2012 12/22/2011 Box: 4 bottles; 65 mL each ................ 12/22/2011 Box: 4 bottles; 65 mL each ................ 12/22/2011 Box: 4 bottles; 65 mL each ................ 12/22/2011 Vial: 10 mL Box: 2 vials ..................... 12/22/2011 Vial: 5 mL Box: 1 vial ......................... 12/22/2011 Vial: 5 mL Box: 1 vial ......................... 12/22/2011 Vial: 15 mL Box: 2 vials ..................... 12/22/2011 Vial: 10 mL Box: 1 vial ....................... 12/22/2011 Vial: 10 mL Box: 1 vial ....................... 12/22/2011 Box: 4 bottles; 65 mL each ................ 12/22/2011 Box: 4 bottles; 65 mL each ................ 12/22/2011 Vial: 10 mL Box: 2 vials ..................... 12/22/2011 Vial: 5 mL Box: 1 vial ......................... 12/22/2011 Vial: 5 mL Box: 1 vial ......................... 12/22/2011 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 E:\FR\FM\22JAN1.SGM 10 10 10 10 mL mL mL mL 22JAN1 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4453 CHART I—Continued Exemption date Supplier Product name Form Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016349. Thermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016365. Thermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016808. Thermo Scientific CEDIA Methamphetamine OFT Cutoff Calibrator, Catalog Number: 10016807. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 1, Catalog Number: 10016865. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 1, Catalog Number: 10016882. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 2, Catalog Number: 10016866. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 2, Catalog Number: 10016883. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 3, Catalog Number: 10016867. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 3, Catalog Number: 10016884. Thermo Scientific CEDIA Multi-Drug OFT Calibrator 4, Catalog Number: 10016868. Thermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016869. Thermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016885. Thermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016895. Thermo Scientific CEDIA Multi-Drug OFT Cutoff Calibrator, Catalog Number: 10016894. Thermo Scientific CEDIA THC OFT Calibrator 1 Catalog Number: 10016644. Thermo Scientific CEDIA THC OFT Calibrator 1 Catalog Number: 10016700. Thermo Scientific CEDIA THC OFT Calibrator 2 Catalog Number: 10016646. Thermo Scientific CEDIA THC OFT Calibrator 2 Catalog Number: 10016701. Thermo Scientific CEDIA THC OFT Calibrator 3 Catalog Number: 10016647. Thermo Scientific CEDIA THC OFT Calibrator 3 Catalog Number: 10016702. Thermo Scientific CEDIA THC OFT Calibrator 4 Catalog Number: 10016648. Thermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016649. Thermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016703. Thermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016731. Thermo Scientific CEDIA THC OFT Cutoff Calibrator Catalog Number: 10016730. Thermo Scientific DRI Fentanyl Assay Catalog Number: 10016005. Thermo Scientific DRI Fentanyl Assay Catalog Number: 10016006. Thermo Scientific DRI Fentanyl Assay Catalog Number: 10016437. Thermo Scientific DRI Fentanyl Calibrator 2 ng/ mL Catalog Number: 10016023. Thermo Scientific DRI Fentanyl High Control 1 ng/ mL Catalog Number: 10016484. Thermo Scientific DRI Fentanyl High Control 2 ng/ mL Catalog Number: 10016485. Vial: 10 mL Box: 2 vials ..................... 7/5/2012 Vial: 10 mL Box: 2 vials ..................... 7/5/2012 Vial: 10 mL Box: 2 vials ..................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 10 mL Box: 1 vial ....................... 7/5/2012 Vial: 10 mL Box: 1 vial ....................... 7/5/2012 Vial: 10 mL Box: 1 vial ....................... 7/5/2012 Vial: 10 mL Box: 1 vial ....................... 7/5/2012 Vial: 10 mL Box: 1 vial ....................... 7/5/2012 Vial: 10 mL Box: 1 vial ....................... 7/5/2012 Vial: 10 mL Box: 1 vial ....................... 7/5/2012 Vial: 15 mL Box: 2 vials ..................... 7/5/2012 Vial: 15 mL Box: 2 vials ..................... 7/5/2012 Vial: 15 mL Box: 2 vials ..................... 7/5/2012 Vial: 10 mL Box: 1 vial ....................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vial: 10 mL Box: 2 vials ..................... 7/5/2012 Vial: 10 mL Box: 2 vials ..................... 7/5/2012 Vial: 10 mL Box: 2 vials ..................... 7/5/2012 Vial: 5 mL Box: 1 vial ......................... 7/5/2012 Vials: 500 mL ..................................... 5/31/2012 3 vials, 18 mL each ........................... 5/31/2012 3 vials, 18 mL each ........................... 5/31/2012 Vials: 10 mL ....................................... 5/31/2012 Box: 1 vial; 25 mL .............................. 5/31/2012 Box: 1 vial; 10 mL .............................. 5/31/2012 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 .................... Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... tkelley on DSK3SPTVN1PROD with Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... VerDate Mar<15>2010 18:11 Jan 18, 2013 Jkt 229001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM 22JAN1 4454 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices CHART I—Continued Exemption date Supplier Product name Form Microgenics Corporation .................... Thermo Scientific DRI Fentanyl High Control 3 ng/ mL Catalog Number: 10016024. Thermo Scientific DRI Fentanyl High Control 3 ng/ mL Catalog Number: 10016486. Thermo Scientific DRI Fentanyl Low Control 1 ng/ mL Catalog Number: 10016022. Thermo Scientific MAS Omni•CORE Liquid Assayed Integrated Chemistry Control Levels 1–3. Thermo Scientific MAS Omni•CORE Liquid Assayed Integrated Chemistry Control Sample Pack. Thermo Scientific MAS Omni•IMMUNE Liquid Assayed Integrated Chemistry Control Levels 1–3. Thermo Scientific MAS Omni•IMMUNE Liquid Assayed Integrated Chemistry Control Sample Pack. Thermo Scientific MAS Omni•IMMUNE PRO Liquid Assayed Integrated Chemistry Control Levels 1–3. Thermo Scientific MAS Omni•IMMUNE PRO Liquid Assayed Integrated Chemistry Control Sample Pack. Appendix IX Mix #1, Revised ................................. Custom a,a-Dimethylphenethylamine Standard .... Custom Chloral Hydrate Standard ......................... Custom LS4434 Standard 1 .................................. Metabolomic Standard Mix #1 ............................... UCMR3 Method 539 Calibration Standard ............ UCMR3 Method Calibration Standard ................... Oral Fluid DAT Cal A Levels 1–5 .......................... Oral Fluid DAT Cal B Levels 1–5 .......................... Oral Fluid DAT Control Set A Material No. 05473390190. Oral Fluid DAT Control Set B Material No. 05473411190. Oral Fluid DAT Qual Cal Material No. 05475929190. Oral Fluid DAT SQ Cal A Material No. 05475872190. Oral Fluid DAT SQ Cal B Material No. 05475899190. HH–4 Cell Culture Medium .................................... HH–4 Cell Culture Medium .................................... ADVIA Chemistry Drug CAL 1 ............................... ADVIA Chemistry Drug CAL 1, Level 2 ................. ADVIA Chemistry Drug CAL 1, Level 3 ................. ADVIA Chemistry Drug CAL 1, Level 4 ................. ADVIA Chemistry Drug CAL 1, Level 5 ................. Bulk EII Plus THC CAL 2 ML ................................ Bulk EII Plus THC CAL 3 ML ................................ Bulk EII Plus THC CAL 4 ML ................................ Bulk EII Plus THC CAL 5 ML ................................ Bulk EII Plus THC Control 1 ML ............................ Bulk EII Plus THC Control 2 ML ............................ Bulk EII Plus THC Control 3 ML ............................ Bulk EII Plus THC Control 4 ML ............................ Bulk EII Plus THC Control 5 ML ............................ Bulk EII Plus THC Control 6 ML ............................ Dimension Drug Calibrator, Level 2 ....................... Dimension Drug Calibrator, Level 3 ....................... Dimension Drug Calibrator, Level 4 ....................... Dimension Drug Calibrator, Level 5 ....................... Dimension Clinical Chemistry System DRUG Calibrator. Dimension Vista DRUG 1 CAL, B ......................... Dimension Vista Drug 4 CAL, Level B .................. Dimension Vista Drug 4 CAL, Level C .................. Dimension Vista Drug 4 CAL, Level D .................. Dimension Vista Drug 4 CAL, Level E .................. Dimension Vista LOCI 8 CAL ................................ Dimension Vista LOCI 9 CAL Levels A–E ............. Vials: 25 mL ....................................... 5/31/2012 Box: 1 vial; 25 mL .............................. 5/31/2012 Vials: 25 mL ....................................... 5/31/2012 Vial 5 mL; Box: 6 vials ....................... 12/22/2011 Box: 6 vials; 5 mL each ..................... 12/22/2011 Vial 5 mL; Box: 6 vials ....................... 12/22/2011 Box: 6 vials; 5 mL each ..................... 12/22/2011 Vial 5 mL; Box: 6 vials ....................... 12/22/2011 Box: 6 vials; 5 mL each ..................... 12/22/2011 Ampule: 2 mL ..................................... Ampule: 2 mL ..................................... Ampule: 2 mL ..................................... Ampule: 2 mL ..................................... Ampule: 2 mL ..................................... Ampule: 2 mL ..................................... Ampule: 2 mL ..................................... Glass vial: 5 mL ................................. Glass vial: 5 mL ................................. Box of 6 vials, 10 mL each ................ 12/22/2011 12/22/2011 12/22/2011 7/5/2012 2/1/2012 12/22/2011 5/31/2012 7/31/2012 7/31/2012 7/31/2012 Box of 6 vials, 10 mL each ................ 7/31/2012 Box of 4 vials, 5 mL each .................. 7/31/2012 Box of 6 vials, 5 mL each .................. 7/31/2012 Box of 6 vials, 5 mL each .................. 7/31/2012 Bag: 1L, 200L, 500L; Bottle: 1L, 2L .. Bag: 20 L, 100L, 1,000 L ................... Carton: 10 vials; 3 ml each ................ Vial: 3 mL ........................................... Vial: 3 mL ........................................... Vial: 3 mL ........................................... Vial: 3 mL ........................................... Bulk Container: 4 mL–100 L .............. Bulk Container: 4 mL–100 L .............. Bulk Container: 4 mL–100 L .............. Bulk Container: 4 mL–100 L .............. Bulk Container: 4 mL–100 L .............. Bulk Container: 4 mL–100 L .............. Bulk Container: 4 mL–100 L .............. Bulk Container: 4 mL–100 L .............. Bulk Container: 4 mL–100 L .............. Bulk Container: 4 mL–100 L .............. Vial: 2.5 mL ........................................ Vial: 2.5 mL ........................................ Vial: 2.5 mL ........................................ Vial: 2.5 mL ........................................ Carton: 10 vials; 2.5 ml each ............. 2/3/2012 3/22/2012 11/5/2012 11/5/2012 11/5/2012 11/5/2012 11/5/2012 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 11/5/2012 11/5/2012 11/5/2012 11/5/2012 11/5/2012 Vial: 2.5 mL ........................................ Vial: 3 mL ........................................... Vial: 3 mL ........................................... Vial: 3 mL ........................................... Vial: 3 mL ........................................... Box of 10 vials; Vial: 2.5 mL .............. Vial: 1.5 mL ........................................ 7/31/2012 11/5/2012 11/5/2012 11/5/2012 11/5/2012 3/22/2012 12/22/2011 Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... Microgenics Corporation .................... Restek Corporation ............................ Restek Corporation ............................ Restek Corporation ............................ Restek Corporation ............................ Restek Corporation ............................ Restek Corporation ............................ Restek Corporation ............................ Roche Diagnostics Operations, Inc ... Roche Diagnostics Operations, Inc ... Roche Diagnostics Operations, Inc ... Roche Diagnostics Operations, Inc ... Roche Diagnostics Operations, Inc ... Roche Diagnostics Operations, Inc ... Roche Diagnostics Operations, Inc ... tkelley on DSK3SPTVN1PROD with SAFC Biosciences ............................. SAFC Biosciences ............................. 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 Siemens Siemens Siemens Siemens Siemens Siemens Healthcare Healthcare Healthcare Healthcare Healthcare Healthcare Healthcare VerDate Mar<15>2010 Diagnostics Diagnostics Diagnostics Diagnostics Diagnostics Diagnostics Diagnostics 18:11 Jan 18, 2013 Inc Inc Inc Inc Inc Inc Inc Jkt 229001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM 22JAN1 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4455 CHART I—Continued Supplier Product name Form Exemption date 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 Siemens Healthcare Diagnostics Inc Siemens Healthcare Diagnostics Inc Siemens Healthcare Diagnostics Inc Supelco, Inc ....................................... Ultra Scientific, Inc ............................. Ultra Scientific, Inc ............................. Dimension Vista System DRUG 1 CAL ................. Dimension Vista System Drug 4 CAL .................... Dimension Vista System LOCI 9 Calibrator .......... Dimension Vista UDAT CAL .................................. Dimension Vista UDAT CAL Bulk, Level B ........... Dimension Vista UDAT CAL Pilot, Level B ........... Dimension Vista UDAT CAL, Level B .................... FC EII Plus THC CAL 2 ML ................................... FC EII Plus THC CAL 3 ML ................................... FC EII Plus THC CAL 4 ML ................................... FC EII Plus THC CAL 5 ML ................................... FC EII Plus THC Control 1 ML .............................. FC EII Plus THC Control 2 ML .............................. FC EII Plus THC Control 3 ML .............................. FC EII Plus THC Control 4 ML .............................. FC EII Plus THC Control 5 ML .............................. FC EII Plus THC Control 6 ML .............................. MP LOCI 9 TTST Cal Lvl 1–7 FC ......................... MP LOCI 9 TTST Lvl 1–7 Bulk .............................. VS Drug 1 Cal Bulk Soln, Level B ......................... VS LOCI 9 CAL BULK SOLN Levels 1–5 ............. VS LOCI CAL 8 BULK SOLN Level 2 ................... VS LOCI CAL 8 BULK SOLN Level 3 ................... VS LOCI CAL 8 BULK SOLN Level 4 ................... VS LOCI CAL 8 BULK SOLN Level 5 ................... VS LOCI CAL 8 Vial Level E ................................. VS LOCI CAL 8 Vial Level B ................................. VS LOCI CAL 8 Vial Level C ................................. VS LOCI CAL 8 Vial Level D ................................. Custom Mix, 0.2–163.2 μg/mL in methanol ........... DSA Detection Cocaine HCl Standard .................. DSA Detection Cocaine HCl StandardPhenobarbital (625 μg/mL). DSA Detection Cocaine HCl StandardPhenobarbital (6400 μg/mL). GE-Ion Track 100 ng/μL TNT/Cocaine HCl Standard Rev. 1. GE-Ion Track 100 ng/μL TNT/Cocaine HCl Standard Rev. 1. Phenobarbital (625 μg/mL) .................................... Phenobarbital (6400 μg/mL) .................................. Ultracheck WS Chloral Hydrate Sample ................ Carton: 6 vials; 2.5 mL each ............. Carton: 10 vials; 3 ml each ................ Box of 10 vials; Vial: 1.5 mL .............. Glass vial: 3 mL; Carton: 6 vials ....... Bulk Container: 20 L–25 L ................. Pilot Container: 2 mL–125 mL ........... Glass vial: 3 mL ................................. Plastic vial: 15 mL .............................. Plastic vial: 15 mL .............................. Plastic vial: 15 mL .............................. Plastic vial: 15 mL .............................. Plastic vial: 15 mL .............................. Plastic vial: 15 mL .............................. Plastic vial: 15 mL .............................. Plastic vial: 15 mL .............................. Plastic vial: 15 mL .............................. Plastic vial: 15 mL .............................. Vial: 1–5 mL ....................................... Bulk container: 4 mL–100 L ............... Bulk container: 2 mL–1 L ................... Bulk container: 4 mL–100 L ............... Bulk container: 4 mL–100 L ............... Bulk container: 4 mL–100 L ............... Bulk container: 4 mL–100 L ............... Bulk container: 4 mL–100 L ............... Vial: 2.5 mL ........................................ Vial: 2.5 mL ........................................ Vial: 2.5 mL ........................................ Vial: 2.5 mL ........................................ Glass ampule: 1 mL ........................... Amber ampule: 1 mL ......................... Amber ampule: 1 mL ......................... 7/31/2012 11/5/2012 12/22/2011 12/22/2011 5/31/2012 5/31/2012 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 7/31/2012 12/22/2011 3/22/2012 3/22/2012 3/22/2012 3/22/2012 3/22/2012 3/22/2012 3/22/2012 3/22/2012 7/31/2012 12/22/2011 12/22/2011 Amber ampule: 1 mL ......................... 12/22/2011 Amber ampule: 10 mL ....................... 12/22/2011 Glass bottle: 100 mL .......................... 12/22/2011 Amber ampule: 1 mL ......................... Amber ampule: 1 mL ......................... Glass ampule: 2 mL ........................... 5/31/2012 5/31/2012 12/22/2011 Ultra Scientific, Inc ............................. Ultra Scientific, Inc ............................. Ultra Scientific, Inc ............................. Ultra Scientific, Inc ............................. Ultra Scientific, Inc ............................. Ultra Scientific, Inc ............................. 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 the CSA or from application 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 Product name Form Denial date Abbott Laboratories ............................ Abbott Laboratories ............................ tkelley on DSK3SPTVN1PROD with Supplier ARCHITECT Estradiol Assay Diluent, No. 2K25J AxSYM Estradiol Buffer ......................................... 12/22/2011 12/22/2011 American Radiolabeled Inc.. Biochemical Diagnostics, Biochemical Diagnostics, Biochemical Diagnostics, Biochemical Diagnostics, Biochemical Diagnostics, Biochemical Diagnostics, Biochemical Diagnostics, Biochemical Diagnostics, Lysergic acid diethylamide ..................................... Tank: 50–500 L .................................. Bulk Tank: 50–500 L; Bag-in-box: 18–200 L. Vial: 1 mL ........................................... 12/22/2011 Benzoylecgonine Bulk Solution (5 mg/mL) ............ Cocaine Bulk Solution(5 mg/mL) ........................... Codeine Bulk Solution(5 mg/mL) ........................... d-Amphetamine Bulk Solution (5 mg/mL) .............. Detectabuse Custom Liquid Control Urine, MC134 Detectabuse Custom Liquid Control Urine, MC135 Detectabuse Custom Liquid Control Urine, MC136 Detectabuse Custom Liquid Control Urine, MC137 Bottle: 1 ml–1 L Bottle: 1 ml–1 L Bottle: 1 ml–1 L Bottle: 1 ml–1 L Glass vials: 500 Glass vials: 500 Glass vials: 200 Glass vials: 500 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 VerDate Mar<15>2010 Chemicals, Inc. Inc. Inc. Inc. Inc. Inc. Inc. Inc. ............ ............ ............ ............ ............ ............ ............ ............ 18:11 Jan 18, 2013 Jkt 229001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM .................................. .................................. .................................. .................................. ml–2 L ..................... ml–2 L ..................... ml–2 L ..................... ml–2 L ..................... 22JAN1 4456 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices CHART II—Continued Supplier Product name Form Denial date 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. ............ Biochemical Diagnostics, Inc. ............ Biochemical Diagnostics, Inc. ............ Biochemical Diagnostics, Inc. ............ Biochemical Diagnostics, Inc. ............ Biochemical Diagnostics, Inc. ............ Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Detectabuse Custom Liquid Control Urine, MC138 Detectabuse Custom Liquid Control Urine, MC139 Detectabuse Custom Liquid Control Urine, MC140 Detectabuse Custom Liquid Control Urine, MC141 Detectabuse Custom Liquid Control Urine, MC142 d-Methamphetamine Bulk Solution(5 mg/mL) ....... d-Propoxyphene Bulk Solution (5 mg/mL) ............. Hydrocodone Bulk Solution(5 mg/mL) ................... Hydromorphone Bulk Solution(5 mg/mL) ............... MDA Bulk Solution(5 mg/mL) ................................ MDEA Bulk Solution(5 mg/mL) .............................. MDMA Bulk Solution(5 mg/mL) ............................. Methadone Bulk Solution(5 mg/mL) ...................... Methaqualone Bulk Solution(5 mg/mL) .................. Morphine Bulk Solution (5 mg/mL) ........................ Oxazepam Bulk Solution (5 mg/mL) ...................... Secobarbital Bulk Solution (5 mg/mL) ................... Liquichek Urine Toxicology Control C1 Minipak .... Liquichek Urine Toxicology Control C2 Minipak .... Liquichek Urine Toxicology Control C3 Minipak .... Liquichek Urine Toxicology Control C4 Minipak .... Liquichek Urine Toxicology Control Low Opiate Level C2 Minipak. Liquichek Urine Toxicology Control Low Opiate Level C3 Minipak. Liquichek Urine Toxicology Control S1 Minipak .... Liquichek Urine Toxicology Control S1E Low Opiate Minipak. Liquichek Urine Toxicology Control S1E Minipak .. Liquichek Urine Toxicology Control S1S Minipak .. Liquichek Urine Toxicology Control S2 Minipak .... Liquichek Urine Toxicology Control S2E Low Opiate Minipak. Liquichek Urine Toxicology Control S2E Minipak .. Liquichek Urine Toxicology Control S2SMinipak ... Liquichek Urine Toxicology Control S3 Minipak .... 4-Methylmethcathinone (hydrochloride), 10 mg in 1 mL Methanol. 4-Methylmethcathinone (hydrochloride), 25 mg in 2.5 mL Methanol. 4-Methylmethcathinone (hydrochloride), 5 mg in 500 μL Methanol. 5-methoxy DMT, 10 mg in 1 mL Methanol ............ 5-methoxy DMT, 25 mg in 2.5 mL Methanol ......... 5-methoxy DMT, 5 mg in 500 μL Methanol ........... Methylenedioxy Pyrovalerone (hydrochloride), 10 mg in 1 mL Methanol. Methylenedioxy Pyrovalerone (hydrochloride), 25 mg in 2.5 mL Methanol. Methylenedioxy Pyrovalerone (hydrochloride), 5 mg in 500 μL Methanol. Methylenedioxy Pyrovalerone, 10 mg in 1 mL Methanol. Methylenedioxy Pyrovalerone, 25 mg in 2.5 mL Methanol. Methylenedioxy Pyrovalerone, 5 mg in 500 μL Methanol. Methylenedioxy Pyrovalerone-d8 (hydrochloride), 10 mg in 1 mL Methanol. Methylenedioxy Pyrovalerone-d8 (hydrochloride), 25 mg in 2.5 mL Methanol. Methylenedioxy Pyrovalerone-d8 (hydrochloride), 5 mg in 500 μL Methanol. Methylone (hydrochloride), 10 mg in 1 mL Methanol. Methylone (hydrochloride), 25 mg in 2.5 mL Methanol. Methylone (hydrochloride), 5 mg in 500 μL Methanol. Codeine (1 mg/mL) ................................................ Codeine-D3 (1 mg/mL) .......................................... Drug Solution # 16 ................................................. Glass vials: 500 ml–2 L ..................... Glass vials: 500 ml–2 L ..................... Glass vials: 500 ml–2 L ..................... Glass vials: 500 ml–2 L ..................... Glass vials: 1 ml–200 mL .................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Bottle: 1 ml–1 L .................................. Amber Vial: 20mL .............................. Amber Vial: 20mL .............................. Amber Vial: 20mL .............................. Amber Vial: 20mL .............................. Amber Vial: 20mL .............................. 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 11/15/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 12/22/2011 Amber Vial: 20mL .............................. 12/22/2011 Amber Vial: 10mL .............................. Amber Vial: 10mL .............................. 12/22/2011 12/22/2011 Amber Amber Amber Amber .............................. .............................. .............................. .............................. 12/22/2011 12/22/2011 12/22/2011 12/22/2011 Amber Vial: 10mL .............................. Amber Vial: 10mL .............................. Amber Vial: 10mL .............................. Glass vial: 1 mL ................................. 12/22/2011 12/22/2011 12/22/2011 7/31/2012 Glass vial: 2.5 mL .............................. 7/31/2012 Glass vial: 500 μL .............................. 7/31/2012 Glass Glass Glass Glass 1 mL ................................. 2.5 mL .............................. 500 μL .............................. 1 mL ................................. 7/31/2012 7/31/2012 7/31/2012 7/31/2012 Glass vial: 2.5 mL .............................. 7/31/2012 Glass vial: 500 μL .............................. 7/31/2012 Glass vial: 1 mL ................................. 7/31/2012 Glass vial: 2.5 mL .............................. 7/31/2012 Glass vial: 500 μL .............................. 7/31/2012 Glass vial: 1 mL ................................. 7/31/2012 Glass vial: 2.5 mL .............................. 7/31/2012 Glass vial: 500 μL .............................. 7/31/2012 Glass vial: 1 mL ................................. 7/31/2012 Glass vial: 2.5 mL .............................. 7/31/2012 Glass vial: 500 μL .............................. 7/31/2012 Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Screw-cap Vial: 50 mL ....................... 7/31/2012 7/31/2012 6/5/2012 Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Bio-Rad Bio-Rad Bio-Rad Laboratories Laboratories Laboratories Laboratories ......................... ......................... ......................... ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Bio-Rad Laboratories ......................... Cayman Chemical Company ............. Cayman Chemical Company ............. Cayman Chemical Company ............. Cayman Cayman Cayman Cayman Chemical Chemical Chemical Chemical Company Company Company Company ............. ............. ............. ............. Cayman Chemical Company ............. Cayman Chemical Company ............. Cayman Chemical Company ............. Cayman Chemical Company ............. Cayman Chemical Company ............. Cayman Chemical Company ............. Cayman Chemical Company ............. Cayman Chemical Company ............. Cayman Chemical Company ............. tkelley on DSK3SPTVN1PROD with Cayman Chemical Company ............. Cayman Chemical Company ............. Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... VerDate Mar<15>2010 18:11 Jan 18, 2013 Jkt 229001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 Vial: Vial: Vial: Vial: vial: vial: vial: vial: E:\FR\FM\22JAN1.SGM 10mL 10mL 10mL 10mL 22JAN1 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4457 CHART II—Continued Product name Form Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Cerilliant Corporation ......................... Environmental Resource Associates (ERA). Environmental Resource Associates (ERA). Immunalysis Corporation ................... Immunalysis Corporation ................... Immunalysis Corporation ................... Restek Corporation ............................ Restek Corporation ............................ 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. tkelley on DSK3SPTVN1PROD with Supplier Drug Solution # 17 ................................................. Drug Solution # 18 ................................................. Drug Solution # 19 ................................................. Drug Solution # 20 ................................................. Hydrocodone (1 mg/mL) ........................................ Hydrocodone-D6 (1 mg/mL) .................................. Hydromorphone (1 mg/mL) .................................... Hydromorphone-D3 (1 mg/mL) .............................. Morphine (1 mg/mL) ............................................... Morphine-D3 (1 mg/mL) ......................................... Noroxycodone HCl (1 mg/mL) ............................... Noroxycodone-D3 HCl (1 mg/mL) ......................... Oxycodone (1 mg/mL) ........................................... Oxycodone-D3 (1 mg/mL) ...................................... Oxymorphone (1 mg/mL) ....................................... Oxymorphone-D3 (1 mg/mL) ................................. USGS BQS LS4434 Mix 1 ..................................... Screw-cap Vial: 50 mL ....................... Screw-cap Vial: 50 mL ....................... Screw-cap Vial: 50 mL ....................... Screw-cap Vial: 50 mL ....................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass ampule: 5 mL ........................... Glass Ampule: 1–2 mL ...................... 6/5/2012 6/5/2012 6/5/2012 6/5/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 7/31/2012 USGS BQS LS4434 Mix 2 ..................................... Glass Ampule: 1–2 mL ...................... 7/31/2012 Tapentadol Calibrator Levels 1–4 .......................... Tapentadol High Control ........................................ Tapentadol Low Control ......................................... Custom Cannabinoids Standard ............................ Custom Paraldehyde Standard (10 mg/mL) .......... Dimension Vista UDAT CAL Bulk, Level B ........... Dimension Vista UDAT CAL Bulk, Level B ........... Drug CAL BULK SOLN, Level 2 ............................ Drug CAL BULK SOLN, Level 3 ............................ Drug CAL BULK SOLN, Level 4 ............................ Drug CAL BULK SOLN, Level 5 ............................ VS Drug 1 Cal Bulk Soln, Level B ......................... Glass vial: 10 mL ............................... Glass vial: 10 mL ............................... Glass vial: 10 mL ............................... Ampule: 2 mL ..................................... Ampule: 2 mL ..................................... Bulk Container: 4mL–100L ................ Bulk Container: 26 L–50L .................. Bulk container: 2 L–100 L .................. Bulk container: 2 mL–100 L ............... Bulk container: 2 mL–100 L ............... Bulk container: 2m L–100 L ............... Bulk container: 2 mL–100 L ............... 6/19/2012 6/19/2012 6/19/2012 5/31/2012 7/5/2012 12/22/2011 5/31/2012 11/5/2012 11/5/2012 11/5/2012 11/5/2012 7/31/2012 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. 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 in-house and may not be transported to other facilities. Additional exempt chemical preparation requests received between June 12, 2011, and June 30, 2012, and not otherwise referenced in this order may remain pending 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 VerDate Mar<15>2010 18:11 Jan 18, 2013 Jkt 229001 such requests will be published in a future Federal Register. 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 indefinitely unless 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. PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 Denial date Such changes may result in the noncompliance 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 E:\FR\FM\22JAN1.SGM 22JAN1 4458 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 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. Request 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. tkelley on DSK3SPTVN1PROD with 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 https:// www.deadiversion.usdoj.gov/schedules/ exempt/exempt_chemlist.pdf. The dates of applications of all current exemptions are posted for easy reference. VerDate Mar<15>2010 18:11 Jan 18, 2013 Jkt 229001 Dated: January 14, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2013–01133 Filed 1–18–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Employee Benefits Security Administration Proposed Information Collection Request Submitted for Public Comment; Survey Regarding Pension Benefit Statements Employee Benefits Security Administration, Department of Labor. ACTION: Notice. AGENCY: The Department of Labor (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public’s reporting burden. It also helps the public understand the Department’s information collection requirements and provide the requested data in the desired format. The Employee Benefits Security Administration (EBSA) is soliciting comments on the proposed information collection request (ICR) described below. A copy of the ICRs may be obtained by contacting the office listed in the ADDRESSES section of this notice. ICRs also are available at reginfo.gov (https://www.reginfo.gov/public/do/ PRAMain). DATES: Written comments must be submitted to the office shown in the Addresses section on or before March 25, 2013. ADDRESSES: G. Christopher Cosby, Department of Labor, Employee Benefits Security Administration, 200 Constitution Avenue NW., N–5718, Washington, DC 20210, (202) 693–8410, FAX (202) 693–4745 (these are not tollfree numbers). SUMMARY: I. Supplementary Information This notice requests public comment on the Department’s proposed collection of information regarding a survey and focus groups that will ask respondents to answer questions related to information presented in benefit statements received from their retirement plans. A summary of the ICR and the current burden estimates follows: PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 Agency: Employee Benefits Security Administration, Department of Labor. Title: Household survey questions and experiments related to pension benefit statements. Type of Review: New collection of information. OMB Number: 1210–NEW. Respondents: 2,950. Number of Annual Responses: 2,950. Total Burden Hours: 945 hours. Total Annualized Capital/Startup Costs: $0. Total Annual Costs: $244,800. Description: The Department is planning to survey participants in an existing household Internet panel called the American Life Panel (ALP) and conduct four focus groups consisting of non-panel members to explore whether information presented in retirement plan benefit statements can be presented in a manner that is understandable for participants and beneficiaries and makes them better prepared for retirement. Topics probed in the survey include participants’ current allocations to their retirement accounts, their expectations for how long they will need to keep working, their financial goals for retirement, the basis for calculating those goals, how frequently they view their current benefits statement, whether they receive benefit statements in paper or electronic format, and what information from the statements do they primarily focus on. Survey participants will then be provided with two different benefits statements that provide slightly different information and will be asked to answer several questions based on those statements to better assess what they understand about the statements. The study results will be used to support the Department’s rulemaking pursuant to section 105(a) of the Employee Retirement Income Security Act of 1974 as amended by the Pension Protection Act of 2006, which requires administrators of ERISA-covered individual account plans to furnish periodic benefit statements to participants and beneficiaries and the Department to develop model benefits statements. II. Focus of Comments The Department is particularly interested in comments that: • Evaluate whether the collections of information are 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 collections of information, including the validity of the methodology and assumptions used; E:\FR\FM\22JAN1.SGM 22JAN1

Agencies

[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Pages 4446-4458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01133]



[[Page 4446]]

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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-361]


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 June 12, 2011, and June 30, 2012, 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 March 25, 2013. Commenters should be aware 
that 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-361'' on all electronic and written correspondence. 
DEA encourages that all comments be submitted electronically through 
https://www.regulations.gov using the electronic comment form provided 
on that site. An electronic copy of this document is also available at 
the https://www.regulations.gov Web site 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.

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 https://www.regulations.gov and in the DEA's public docket. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. 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.

SUPPLEMENTARY INFORMATION: 

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 
(hereinafter, ``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 June 12, 
2011, and June 30, 2012

    The Deputy Assistant Administrator received applications between 
June 12, 2011, and June 30, 2012, 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

[[Page 4447]]

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 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 from application of 21 CFR 
1301.74, to the extent described in 21 CFR 1308.24, as of the date 
listed below that was provided in the approval letters to the 
individual requesters.

                                                     Chart I
----------------------------------------------------------------------------------------------------------------
                                                                                                      Exemption
                Supplier                           Product name                      Form                date
----------------------------------------------------------------------------------------------------------------
Abbott Laboratories....................  ARCHITECT 2nd Generation         Bottle: 4 mL; Box: 6        12/22/2011
                                          Testosterone Calibrators         bottles.
                                          (B,C,D,E,F).
Abbott Laboratories....................  ARCHITECT 2nd Generation         Bottle: 8 mL; Box: 3        12/22/2011
                                          Testosterone Controls (L,M,H).   bottles.
Abbott Laboratories....................  ARCHITECT Estradiol Assay        Bag-in-box: 18-200 L;       12/22/2011
                                          Diluent, No. 2K25J.              Flask/Carboy: 1-50 L;
                                                                           Bottle/Vial: 0.5 mL-1 L;
                                                                           Box: 1-50 bottles.
Abbott Laboratories....................  ARCHITECT Estradiol Assay        Bottle: 5.9 mL...........   12/22/2011
                                          Diluent, No. 7K72J.
Abbott Laboratories....................  ARCHITECT Estradiol Reagent      Bottle: 5.9 mL; Kit: 16     12/22/2011
                                          Kit, No. 07K72-20.               bottles.
Abbott Laboratories....................  ARCHITECT Estradiol Reagent      Bottle: 5.9 mL; Kit: 4      12/22/2011
                                          Kit, No. 07K72-25.               bottles.
Abbott Laboratories....................  ARCHITECT Estradiol Reagent      Bottle: 5.9 mL; Kit: 16     12/22/2011
                                          Kit, No. 2K25-20.                bottles.
Abbott Laboratories....................  ARCHITECT Estradiol Reagent      Bottle: 5.9 mL; Kit: 4      12/22/2011
                                          Kit, No. 2K25-25.                bottles.
Abbott Laboratories....................  AxSYM Estradiol Buffer.........  Flask/Carboy: 1-50 L;       12/22/2011
                                                                           Bottle/Vial: 0.5 mL-1 L;
                                                                           Box: 1-50 bottles.
Abbott Laboratories....................  AxSYM Estradiol Reagent Pack...  Bottle: 5.5 mL, Pack: 4     12/22/2011
                                                                           bottles.
Agilent Technologies...................  Special Order Standard TOXI-LAB  Plastic Vial: 50 discs...   12/22/2011
                                          DISCS; 1, 2, or 3 drugs.
Agilent Technologies...................  Special Procedure Standard TOXI- Plastic Vial: 50 discs...   12/22/2011
                                          LAB DISCS: Benzodiazepines:
                                          Hydrolysis Procedure.
Agilent Technologies...................  Special Procedure Standard TOXI- Plastic Vial: 50 discs...   12/22/2011
                                          LAB DISCS: Benzoylecgonine.
Agilent Technologies...................  Special Procedure Standard TOXI- Plastic Vial: 50 discs...   12/22/2011
                                          LAB DISCS: MDMA, MDA, MDEA.
Agilent Technologies...................  Special Procedure Standard TOXI- Plastic Vial: 50 discs...   12/22/2011
                                          LAB DISCS: Morphine and
                                          Hydromorphone: Differentiation.
Agilent Technologies...................  Special Procedure Standard TOXI- Plastic Vial: 50 discs...   12/22/2011
                                          LAB DISCS: Opiate.
Agilent Technologies...................  Special Procedure Standard TOXI- Plastic Vial: 50 discs...   12/22/2011
                                          LAB DISCS: Sympathomimetic
                                          amines: Differentiation.
Agilent Technologies...................  Special Standard TOXI-LAB DISCS  Plastic Vial: 50 discs...   12/22/2011
                                          LTD-Opiate: 1, 2, or 3 drugs.
Agilent Technologies...................  TOXI-LAB Chromatograms A.......  Glass jar: 100              12/22/2011
                                                                           Chromatograms.
Agilent Technologies...................  TOXI-LAB Chromatograms B.......  Glass jar: 100              12/22/2011
                                                                           Chromatograms.
Agilent Technologies...................  TOXI-LAB CONTROL LTD FM........  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB CONTROL No. 19........  Plastic bottle: 2 oz.....   12/22/2011
Agilent Technologies...................  TOXI-LAB CONTROL No. 2.........  Plastic bottle: 2 oz.....   12/22/2011
Agilent Technologies...................  TOXI-LAB CONTROL No. 3.........  Plastic bottle: 2 oz.....   12/22/2011
Agilent Technologies...................  TOXI-LAB CONTROL No. 5.........  Plastic bottle: 2 oz.....   12/22/2011
Agilent Technologies...................  TOXI-LAB CONTROL THC...........  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS A-1.............  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS A-2.............  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS A-3.............  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS A-4.............  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS B-1.............  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS B-2.............  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS B-3.............  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS B-4.............  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS LTD HD..........  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS LTD OP..........  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS LTD OPI.........  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB DISCS THC.............  Plastic vial: 50 discs...   12/22/2011
Agilent Technologies...................  TOXI-LAB Proficiency Sample....  Plastic bottle: 2 oz.....   12/22/2011
American Radiolabeled Chemicals, Inc...  (+)-iodo-Lysergic Acid           Vial: 1 mL...............   12/22/2011
                                          diethylamide [125I].
American Radiolabeled Chemicals, Inc...  (+)-Pentazocine (1 mg/mL)......  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  (+)-Pentazocine [ring-1,3-3H]..  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  ()-Ketamine [N-      Vial: 1 mL...............   12/22/2011
                                          methyl-3H] hydrochloride.

[[Page 4448]]

 
American Radiolabeled Chemicals, Inc...  ()-Ketamine          Vial: 1 mL...............   12/22/2011
                                          hydrochloride (1 mg/mL).
American Radiolabeled Chemicals, Inc...  1,1-Dimethyltryptamine (1 mg/    Vial: 1 mL...............   12/22/2011
                                          mL).
American Radiolabeled Chemicals, Inc...  1,1-Dimethyltryptamine           Vial: 1 mL...............   12/22/2011
                                          [a,[beta]-3H] as TFA salt.
American Radiolabeled Chemicals, Inc...  Amobarbital (1 mg/mL)..........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Amphetamine, D-[ring-2,3,5-3H]   Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Amphetamine, DL-[ring-2,3,5-3H]  Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Amphetamine, L-[ring-2,3,5-3H]   Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Buprenorphine [ring-3H]          Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Buprenorphine hydrochloride (1   Vial: 1 mL...............   12/22/2011
                                          mg/mL).
American Radiolabeled Chemicals, Inc...  Cocaine (1 mg/mL)..............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Cocaine [methyl-14C]             Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Cocaine, levo-[benzoyl-3,4-      Vial: 1 mL...............   12/22/2011
                                          3H(N)].
American Radiolabeled Chemicals, Inc...  Codeine (1 mg/mL)..............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  D-Amphetamine hydrochloride (1   Vial: 1 mL...............   12/22/2011
                                          mg/mL).
American Radiolabeled Chemicals, Inc...  Dextropropoxyphene (1 mg/mL)...  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Diazepam (1 mg/mL).............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Dihydrocodeine (1 mg/mL).......  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Dihydromorphine (1 mg/mL)......  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Diprenorphine (1 mg/mL)........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  DL-Amphetamine hydrochloride (1  Vial: 1 mL...............   12/22/2011
                                          mg/mL).
American Radiolabeled Chemicals, Inc...  D-Methamphetamine hydrochloride  Vial: 1 mL...............   12/22/2011
                                          (1 mg/mL).
American Radiolabeled Chemicals, Inc...  Ecgonine (1 mg/mL).............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Fentanyl (1 mg/mL).............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Fentanyl [3H(G)] as TFA salt...  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Fludiazepam (1 mg/mL)..........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Flunitrazepam (1 mg/mL)........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Flunitrazepam [methyl-3H]......  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Flurazepam (1 mg/mL)...........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Flurazepam [N-methyl-3H].......  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Heroin (1 mg/mL)...............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Heroin [methyl-14C]............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Heroin [methyl-3H].............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Hydrocodone (1 mg/mL)..........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Hydromorphone (1 mg/mL)........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Hydromorphone [N-methyl-14C]     Vial: 1 mL...............   12/22/2011
                                          hydrochloride.

[[Page 4449]]

 
American Radiolabeled Chemicals, Inc...  Ibogaine (1 mg/mL).............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  L-Amphetamine hydrochloride (1   Vial: 1 mL...............   12/22/2011
                                          mg/mL).
American Radiolabeled Chemicals, Inc...  L-Methamphetamine hydrochloride  Vial: 1 mL...............   12/22/2011
                                          (1 mg/mL).
American Radiolabeled Chemicals, Inc...  Lysergic Acid (1 mg/mL)........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Lysergic acid diethylamide [N-   Vial: 1 mL...............    3/22/2012
                                          methyl-3H].
American Radiolabeled Chemicals, Inc...  Mazindol (1 mg/mL).............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Meperidine Hydrochloride (1 mg/  Vial: 1 mL...............   12/22/2011
                                          mL).
American Radiolabeled Chemicals, Inc...  Metazocine (1 mg/mL)...........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Metazocine [ring-1,3-3H].......  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Methamphetamine, D-[methyl-14C]  Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Methamphetamine, L-[methyl-14C]  Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Midazolam (1 mg/mL)............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Midazolam [3H(G)]..............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Morphine (1 mg/mL).............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Morphine [N-methyl-14C]........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Normorphine (1 mg/mL)..........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Oripavine (1 mg/mL)............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Oxycodone [N-methyl-14C]         Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Oxycodone hydrochloride (1 mg/   Vial: 1 mL...............   12/22/2011
                                          mL).
American Radiolabeled Chemicals, Inc...  Oxymorphone (1 mg/mL)..........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Phenazocine (1 mg/mL)..........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Phencyclidine hydrochloride (1   Vial: 1 mL...............   12/22/2011
                                          mg/mL).
American Radiolabeled Chemicals, Inc...  Phenylacetone (1 mg/mL)........  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Tetrahydrocannabidinol (1 mg/    Vial: 1 mL...............   12/22/2011
                                          mL).
American Radiolabeled Chemicals, Inc...  Thebaine (1 mg/mL).............  Vial: 1 mL...............   12/22/2011
American Radiolabeled Chemicals, Inc...  Thebaine [N-methyl-14C]          Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Thebaine [N-methyl-3H]           Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Thebaine [O-methyl-14C]          Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  Thebaine [O-methyl-3H]           Vial: 1 mL...............   12/22/2011
                                          hydrochloride.
American Radiolabeled Chemicals, Inc...  [gamma]-Hydroxybutyric acid      Vial: 1 mL...............   12/22/2011
                                          sodium salt (1 mg/mL).
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF10.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF11.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF12.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF13.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF14.

[[Page 4450]]

 
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF15.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF16.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF17.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF18.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF19.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    7/31/2012
                                          Control Oral Fluid, OF20.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    7/31/2012
                                          Control Oral Fluid, OF21.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF4.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF5.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF6.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF8.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Oral Fluid, OF9.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   11/15/2011
                                          Control Urine, MC134.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   11/15/2011
                                          Control Urine, MC135.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-100 mL.   11/15/2011
                                          Control Urine, MC136.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   11/15/2011
                                          Control Urine, MC137.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   11/15/2011
                                          Control Urine, MC138.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   11/15/2011
                                          Control Urine, MC139.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   11/15/2011
                                          Control Urine, MC140.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   11/15/2011
                                          Control Urine, MC141.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     2/1/2012
                                          Control Urine, MC143.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     3/8/2012
                                          Control Urine, MC144.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     3/8/2012
                                          Control Urine, MC145.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     3/8/2012
                                          Control Urine, MC146.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     3/8/2012
                                          Control Urine, MC147.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     3/8/2012
                                          Control Urine, MC148.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    3/22/2012
                                          Control Urine, MC149.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Urine, MC150.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC151.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC152.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC153.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC154.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC155.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC156.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC157.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC158.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC159.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC160.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC161.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC162.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC163.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC164.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC165.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC166.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC167.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC168.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC169.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    8/20/2012
                                          Control Urine, MC170.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Urine, MC171.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    7/31/2012
                                          Control Urine, MC172.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.    7/31/2012
                                          Control Urine, MC173.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     2/1/2012
                                          Control Urine, SD10.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     2/1/2012
                                          Control Urine, SD11.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     2/1/2012
                                          Control Urine, SD12.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     2/1/2012
                                          Control Urine, SD13.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     2/1/2012
                                          Control Urine, SD14.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Urine, SD15.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.     7/5/2012
                                          Control Urine, SD16.

[[Page 4451]]

 
Bio-Rad Laboratories...................  Liquichek Immunoassay Plus       Amber Vial: 10 mL; Box:     12/22/2011
                                          Control Levels 1, 2, and 3.      12 vials.
Bio-Rad Laboratories...................  Liquichek Immunoassay Plus       Amber Vial: 10 mL; Box:     12/22/2011
                                          Control Trilevel.                12 vials.
Bio-Rad Laboratories...................  Liquichek Immunoassay Plus       Amber Vial: 5 mL; Box: 3    12/22/2011
                                          Control Trilevel Minipak.        vials.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Box: 10 vials, 10 mL each    5/31/2012
                                          Control S10.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Box: 10 vials, 10 mL each    5/31/2012
                                          Control S10 Low Opiate.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber vial: 10 mL........    5/31/2012
                                          Control S10 Low Opiate Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber vial: 10 mL........    5/31/2012
                                          Control S10 Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Box: 10 vials, 10 mL each    5/31/2012
                                          Control S20.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Box: 10 vials, 10 mL each    5/31/2012
                                          Control S20 Low Opiate.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber vial: 10 mL........    5/31/2012
                                          Control S20 Low Opiate Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber vial: 10 mL........    5/31/2012
                                          Control S20 Minipak.
Bio-Rad Laboratories...................  Liquid Assayed Multiqual Levels  Amber Vial: 2.5 mL; Box:    12/22/2011
                                          1-3.                             12 vials.
Bio-Rad Laboratories...................  Liquid Assayed Multiqual         Amber Vial: 2.5 mL; Box:    12/22/2011
                                          Trilevel MiniPak.                3 vials.
Bio-Rad Laboratories...................  Liquid Unassayed Multiqual       Amber Vial: 2.5 mL; Box:    12/22/2011
                                          Levels 1-3.                      12 vials.
Bio-Rad Laboratories...................  Liquid Unassayed Multiqual       Amber Vial: 2.5 mL; Box:    12/22/2011
                                          Trilevel MiniPak.                3 vials.
Bio-Rad Laboratories...................  Lyphochek Assayed Chemistry      Box 2 vials; 5 mL each...   12/22/2011
                                          Control Bilevel MiniPak.
Bio-Rad Laboratories...................  Lyphochek Assayed Chemistry      Amber Vial: 5 mL; Box: 12   12/22/2011
                                          Control Levels 1-2.              vials.
Bio-Rad Laboratories...................  Lyphochek Immunoassay Plus       Amber Vial: 10 mL; Box:     12/22/2011
                                          Control Levels 1, 2, and 3.      12 vials.
Bio-Rad Laboratories...................  Lyphochek Immunoassay Plus       Amber Vial: 10 mL; Box:     12/22/2011
                                          Control Trilevel.                12 vials.
Bio-Rad Laboratories...................  Lyphochek Immunoassay Plus       Amber Vial: 5 mL; Box: 3    12/22/2011
                                          Control Trilevel Minipak.        vials.
Bio-Rad Laboratories...................  Lyphochek Unassayed Chemistry    Box 2 vials; 5 mL each...   12/22/2011
                                          Control (Human) Bilevel
                                          MiniPak.
Bio-Rad Laboratories...................  Lyphochek Unassayed Chemistry    Amber Vial: 5 mL; Box: 25   12/22/2011
                                          Control (Human) Levels 1-2.      vials.
Cerilliant Corporation.................  () Pentazocine-13C3  Glass Ampule: 2 mL.......   12/22/2011
                                          (0.1 mg/mL).
Cerilliant Corporation.................  ()-cis-11-Nor-9-     Glass Ampule: 2 mL.......   12/22/2011
                                          carboxy-delta9-THC-D3
                                          glucuronide (0.1 mg/mL).
Cerilliant Corporation.................  3,4-Methylenedioxypyrovalerone   Glass Ampule: 2 mL.......   12/22/2011
                                          HCl (1 mg/mL).
Cerilliant Corporation.................  3,4-Methylenedioxypyrovalerone-  Glass Ampule: 2 mL.......   12/22/2011
                                          D8 HCl (0.1 mg/mL).
Cerilliant Corporation.................  3-Desmethylprodine (1 mg/mL)...  Glass Ampule: 1 mL.......    7/31/2012
Cerilliant Corporation.................  3-Desmethylprodine HCl (1 mg/    Glass Ampule: 1 mL.......    7/31/2012
                                          mL).
Cerilliant Corporation.................  6-alpha/beta-Hydroxyoxymorphone  Glass Ampule: 2 mL.......   12/22/2011
                                          (1 mg/mL).
Cerilliant Corporation.................  6-alpha/beta-Hydroxyoxymorphone- Glass Ampule: 2 mL.......   12/22/2011
                                          D3 (0.1 mg/mL).
Cerilliant Corporation.................  Buprenorphine N-oxide (1 mg/mL)  Glass Ampule: 1 mL.......   12/22/2011
Cerilliant Corporation.................  Cannabinol-D3 (0.1 mg/mL)......  Glass Ampule: 2 mL.......   12/22/2011
Cerilliant Corporation.................  Carisoprodol (1 mg/mL).........  Glass Ampule: 2 mL.......   12/22/2012
Cerilliant Corporation.................  Carisoprodol-D7 (0.1 mg/mL)....  Glass Ampule: 2 mL.......   12/22/2012
Cerilliant Corporation.................  Carisoprodol-D7 (1 mg/mL)......  Glass Ampule: 2 mL.......    7/31/2012
Cerilliant Corporation.................  Cocaine N-oxide HCl (1 mg/mL)..  Glass Ampule: 2 mL.......   12/22/2011
Cerilliant Corporation.................  Cocaine N-oxide HCl (1 mg/mL)..  Glass Ampule: 2 mL.......     3/8/2012
Cerilliant Corporation.................  Cocaine N-oxide-D3 HCl (0.1 mg/  Glass Ampule: 2 mL.......   12/22/2011
                                          mL).
Cerilliant Corporation.................  Cocaine N-oxide-D3 HCl (0.1 mg/  Glass Ampule: 2 mL.......     3/8/2012
                                          mL).
Cerilliant Corporation.................  Drug Solution  15.....  Screw-cap Vial: 50 mL....     6/5/2012
Cerilliant Corporation.................  Lacosamide (1 mg/mL)...........  Glass Ampule: 2 mL.......    5/31/2012
Cerilliant Corporation.................  Lacosamide-13C, D3 (0.1 mg/mL).  Glass Ampule: 2 mL.......   12/22/2011
Cerilliant Corporation.................  Lacosamide-13C, D3 (1 mg/mL)...  Glass Ampule: 1 mL.......    7/31/2012
Cerilliant Corporation.................  Lisdexamfetamine dimesylate (1   Glass Ampule: 2 mL.......   12/22/2011
                                          mg/mL).
Cerilliant Corporation.................  Lisdexamfetamine-D4 dimesylate   Glass Ampule: 2 mL.......   12/22/2011
                                          (0.1 mg/mL).
Cerilliant Corporation.................  Mephedrone HCl (1 mg/mL).......  Glass Ampule: 2 mL.......   12/22/2011
Cerilliant Corporation.................  Mephedrone-D3 HCl (0.1 mg/mL)..  Glass Ampule: 2 mL.......   12/22/2011
Cerilliant Corporation.................  Methylone HCl (1 mg/mL)........  Glass Ampule: 2 mL.......   12/22/2011
Cerilliant Corporation.................  Methylone-D3 HCl (0.1 mg/mL)...  Glass Ampule: 2 mL.......   12/22/2011
Cerilliant Corporation.................  Morphine (8 [mu]g/mL)..........  Glass Ampule: 2 mL.......   12/22/2011
Cerilliant Corporation.................  Naloxone N-oxide (0.1 mg/mL)...  Glass Ampule: 2 mL.......     6/5/2012
Cerilliant Corporation.................  Norcodeine-D3 (1 mg/mL)........  Glass Ampule: 1 mL.......    7/31/2012
Cerilliant Corporation.................  Normeperidine-D4 (1 mg/mL).....  Glass Ampule: 1 mL.......    7/31/2012
Cerilliant Corporation.................  Noroxycodone and Norhydrocodone  Glass Ampule: 2 mL.......   12/22/2011
                                          Mix (0.5 mg/mL).
Cerilliant Corporation.................  Opiate Internal Standard Mix-15  Glass Ampule: 2 mL.......   12/22/2011

[[Page 4452]]

 
Cerilliant Corporation.................  Pseudobuprenorphine              Glass Ampule: 1 mL.......     2/1/2012
                                          dihydrochloride (1.0mg/mL).
Cerilliant Corporation.................  Pyrovalerone HCl (1 mg/mL).....  Glass Ampule: 2 mL.......   12/22/2011
Cerilliant Corporation.................  Secobarbital-D5 (1 mg/mL)......  Glass Ampule: 1 mL.......    7/31/2012
Cerilliant Corporation.................  Zolpidem-D7 (0.1 mg/mL)........  Glass Ampule: 2 mL.......   12/22/2011
ElSohly Laboratories, Inc..............  ELI Drug Standards [Delta]9-     Glass vial: 1 ml.........    5/31/2012
                                          Tetrahydrocannabinol-
                                          glucoronide (10 [mu]g/mL in
                                          MeOH).
ElSohly Laboratories, Inc..............  ELI Drug Standards [Delta]9-     Glass vial: 1 ml.........    5/31/2012
                                          Tetrahydrocannabinol-
                                          glucoronide (100 [mu]g/mL in
                                          MeOH).
Environmental Resource Associates (ERA)  Chloral Hydrate, Proficiency     Glass Ampule: 2 mL.......     3/8/2012
                                          Testing Material, Catalog No.
                                          853.
Environmental Resource Associates (ERA)  Chloral Hydrate, Reference       Glass Ampule: 2 mL.......     3/8/2012
                                          Material, Catalog No. 676.
Environmental Resource Associates (ERA)  Waters Steroid Test Mix, Part    Glass Ampule: 2 mL.......     3/8/2012
                                          No. 07364.
Immunalysis Corporation................  Methadone Calibrator Levels 1-4  Glass vial: 10 mL........    6/19/2012
Immunalysis Corporation................  Methadone High Control.........  Glass vial: 10 mL........    6/19/2012
Immunalysis Corporation................  Methadone Low Control..........  Glass vial: 10 mL........    6/19/2012
Immunalysis Corporation................  Oral Fluid Cutoff Calibrator     Glass vial: 10 mL........    6/19/2012
                                          Pain Management Prediluted in
                                          Extraction Buffer.
Immunalysis Corporation................  Oral Fluid High Positive         Glass vial: 10 mL........    6/19/2012
                                          Control Pain Management
                                          Prediluted in Extration Buffer.
Immunalysis Corporation................  Oral Fluid Low Positive Control  Glass vial: 10 mL........    6/19/2012
                                          Pain Management Prediluted in
                                          Extraction Buffer.
Immunalysis Corporation................  Zolpidem Calibrator............  Glass vial: 10 mL........    6/19/2012
Immunalysis Corporation................  Zolpidem High Control..........  Glass vial: 10 mL........    6/19/2012
Immunalysis Corporation................  Zolpidem Low Control...........  Glass vial: 10 mL........    6/19/2012
Insys Therapeutics, Inc................  (-)-delta9-Tetrahydrocannabinol  Glass Ampule: 1 mL.......     5/9/2012
                                          (1.0 mg/mL).
Microgenics Corporation................  CEDIA Amphetamine OFT Assay,     Box: 4 bottles; 65 mL       12/22/2011
                                          Catalog Number: 10014947.        each.
Microgenics Corporation................  CEDIA Cannabinoids OFT Assay,    Box: 4 bottles; 65 mL       12/22/2011
                                          Catalog Number: 10014910.        each.
Microgenics Corporation................  CEDIA Cocaine OFT Assay,         Box: 4 bottles; 65 mL       12/22/2011
                                          Catalog Number: 10014764.        each.
Microgenics Corporation................  CEDIA Methamphetamine OFT        Box: 4 bottles; 65 mL       12/22/2011
                                          Assay, Catalog Number:           each.
                                          10014949.
Microgenics Corporation................  CEDIA Methamphetamine OFT        Vial: 10 mL Box: 2 vials.   12/22/2011
                                          Control Set (Low and High) ,
                                          Catalog 10014953.
Microgenics Corporation................  CEDIA Methamphetamine OFT        Vial: 5 mL Box: 1 vial...   12/22/2011
                                          Cutoff Calibrator, Catalog
                                          10014951.
Microgenics Corporation................  CEDIA Methamphetamine OFT High   Vial: 5 mL Box: 1 vial...   12/22/2011
                                          Calibrator, Catalog 10014952.
Microgenics Corporation................  CEDIA Multi-Drug OFT Control     Vial: 15 mL Box: 2 vials.   12/22/2011
                                          Set (Low and High), Catalog
                                          10014957.
Microgenics Corporation................  CEDIA Multi-Drug OFT Cutoff      Vial: 10 mL Box: 1 vial..   12/22/2011
                                          Calibrator, Catalog 10014955.
Microgenics Corporation................  CEDIA Multi-Drug OFT High        Vial: 10 mL Box: 1 vial..   12/22/2011
                                          Calibrator, Catalog 10014956.
Microgenics Corporation................  CEDIA Opiate OFT Assay, Catalog  Box: 4 bottles; 65 mL       12/22/2011
                                          Number: 10014873.                each.
Microgenics Corporation................  CEDIA PCP OFT Assay, Catalog     Box: 4 bottles; 65 mL       12/22/2011
                                          Number: 10014888.                each.
Microgenics Corporation................  CEDIA THC OFT Control Set (Low   Vial: 10 mL Box: 2 vials.   12/22/2011
                                          and High), Catalog 10014925.
Microgenics Corporation................  CEDIA THC OFT Cutoff             Vial: 5 mL Box: 1 vial...   12/22/2011
                                          Calibrator, Catalog 10014923.
Microgenics Corporation................  CEDIA THC OFT High Calibrator,   Vial: 5 mL Box: 1 vial...   12/22/2011
                                          Catalog 10014924.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Methamphetamine OFT Calibrator
                                          1, Catalog Number: 10016345.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Methamphetamine OFT Calibrator
                                          1, Catalog Number: 10016362.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Methamphetamine OFT Calibrator
                                          2, Catalog Number: 10016346.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Methamphetamine OFT Calibrator
                                          2, Catalog Number: 10016363.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Methamphetamine OFT Calibrator
                                          3, Catalog Number: 10016347.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Methamphetamine OFT Calibrator
                                          3, Catalog Number: 10016364.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Methamphetamine OFT Calibrator
                                          4, Catalog Number: 10016348.

[[Page 4453]]

 
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 10 mL Box: 2 vials.     7/5/2012
                                          Methamphetamine OFT Control
                                          Set (Low and High), Catalog
                                          Number: 10016349.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 10 mL Box: 2 vials.     7/5/2012
                                          Methamphetamine OFT Control
                                          Set (Low and High), Catalog
                                          Number: 10016365.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 10 mL Box: 2 vials.     7/5/2012
                                          Methamphetamine OFT Control
                                          Set (Low and High), Catalog
                                          Number: 10016808.
Microgenics Corporation................  Thermo Scientific CEDIA          Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Methamphetamine OFT Cutoff
                                          Calibrator, Catalog Number:
                                          10016807.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 10 mL Box: 1 vial..     7/5/2012
                                          Drug OFT Calibrator 1, Catalog
                                          Number: 10016865.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 10 mL Box: 1 vial..     7/5/2012
                                          Drug OFT Calibrator 1, Catalog
                                          Number: 10016882.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 10 mL Box: 1 vial..     7/5/2012
                                          Drug OFT Calibrator 2, Catalog
                                          Number: 10016866.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 10 mL Box: 1 vial..     7/5/2012
                                          Drug OFT Calibrator 2, Catalog
                                          Number: 10016883.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 10 mL Box: 1 vial..     7/5/2012
                                          Drug OFT Calibrator 3, Catalog
                                          Number: 10016867.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 10 mL Box: 1 vial..     7/5/2012
                                          Drug OFT Calibrator 3, Catalog
                                          Number: 10016884.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 10 mL Box: 1 vial..     7/5/2012
                                          Drug OFT Calibrator 4, Catalog
                                          Number: 10016868.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 15 mL Box: 2 vials.     7/5/2012
                                          Drug OFT Control Set (Low and
                                          High), Catalog Number:
                                          10016869.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 15 mL Box: 2 vials.     7/5/2012
                                          Drug OFT Control Set (Low and
                                          High), Catalog Number:
                                          10016885.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 15 mL Box: 2 vials.     7/5/2012
                                          Drug OFT Control Set (Low and
                                          High), Catalog Number:
                                          10016895.
Microgenics Corporation................  Thermo Scientific CEDIA Multi-   Vial: 10 mL Box: 1 vial..     7/5/2012
                                          Drug OFT Cutoff Calibrator,
                                          Catalog Number: 10016894.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Calibrator 1 Catalog Number:
                                          10016644.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Calibrator 1 Catalog Number:
                                          10016700.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Calibrator 2 Catalog Number:
                                          10016646.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Calibrator 2 Catalog Number:
                                          10016701.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Calibrator 3 Catalog Number:
                                          10016647.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Calibrator 3 Catalog Number:
                                          10016702.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Calibrator 4 Catalog Number:
                                          10016648.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 10 mL Box: 2 vials.     7/5/2012
                                          Control Set (Low and High),
                                          Catalog Number: 10016649.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 10 mL Box: 2 vials.     7/5/2012
                                          Control Set (Low and High),
                                          Catalog Number: 10016703.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 10 mL Box: 2 vials.     7/5/2012
                                          Control Set (Low and High),
                                          Catalog Number: 10016731.
Microgenics Corporation................  Thermo Scientific CEDIA THC OFT  Vial: 5 mL Box: 1 vial...     7/5/2012
                                          Cutoff Calibrator Catalog
                                          Number: 10016730.
Microgenics Corporation................  Thermo Scientific DRI Fentanyl   Vials: 500 mL............    5/31/2012
                                          Assay Catalog Number: 10016005.
Microgenics Corporation................  Thermo Scientific DRI Fentanyl   3 vials, 18 mL each......    5/31/2012
                                          Assay Catalog Number: 10016006.
Microgenics Corporation................  Thermo Scientific DRI Fentanyl   3 vials, 18 mL each......    5/31/2012
                                          Assay Catalog Number: 10016437.
Microgenics Corporation................  Thermo Scientific DRI Fentanyl   Vials: 10 mL.............    5/31/2012
                                          Calibrator 2 ng/mL Catalog
                                          Number: 10016023.
Microgenics Corporation................  Thermo Scientific DRI Fentanyl   Box: 1 vial; 25 mL.......    5/31/2012
                                          High Control 1 ng/mL Catalog
                                          Number: 10016484.
Microgenics Corporation................  Thermo Scientific DRI Fentanyl   Box: 1 vial; 10 mL.......    5/31/2012
                                          High Control 2 ng/mL Catalog
                                          Number: 10016485.

[[Page 4454]]

 
Microgenics Corporation................  Thermo Scientific DRI Fentanyl   Vials: 25 mL.............    5/31/2012
                                          High Control 3 ng/mL Catalog
                                          Number: 10016024.
Microgenics Corporation................  Thermo Scientific DRI Fentanyl   Box: 1 vial; 25 mL.......    5/31/2012
                                          High Control 3 ng/mL Catalog
                                          Number: 10016486.
Microgenics Corporation................  Thermo Scientific DRI Fentanyl   Vials: 25 mL.............    5/31/2012
                                          Low Control 1 ng/mL Catalog
                                          Number: 10016022.
Microgenics Corporation................  Thermo Scientific MAS            Vial 5 mL; Box: 6 vials..   12/22/2011
                                          OmniCORE Liquid
                                          Assayed Integrated Chemistry
                                          Control Levels 1-3.
Microgenics Corporation................  Thermo Scientific MAS            Box: 6 vials; 5 mL each..   12/22/2011
                                          OmniCORE Liquid
                                          Assayed Integrated Chemistry
                                          Control Sample Pack.
Microgenics Corporation................  Thermo Scientific MAS            Vial 5 mL; Box: 6 vials..   12/22/2011
                                          OmniIMMUNE Liquid
                                          Assayed Integrated Chemistry
                                          Control Levels 1-3.
Microgenics Corporation................  Thermo Scientific MAS            Box: 6 vials; 5 mL each..   12/22/2011
                                          OmniIMMUNE Liquid
                                          Assayed Integrated Chemistry
                                          Control Sample Pack.
Microgenics Corporation................  Thermo Scientific MAS            Vial 5 mL; Box: 6 vials..   12/22/2011
                                          OmniIMMUNE PRO Liquid
                                          Assayed Integrated Chemistry
                                          Control Levels 1-3.
Microgenics Corporation................  Thermo Scientific MAS            Box: 6 vials; 5 mL each..   12/22/2011
                                          OmniIMMUNE PRO Liquid
                                          Assayed Integrated Chemistry
                                          Control Sample Pack.
Restek Corporation.....................  Appendix IX Mix 1,      Ampule: 2 mL.............   12/22/2011
                                          Revised.
Restek Corporation.....................  Custom a,a-                      Ampule: 2 mL.............   12/22/2011
                                          Dimethylphenethylamine
                                          Standard.
Restek Corporation.....................  Custom Chloral Hydrate Standard  Ampule: 2 mL.............   12/22/2011
Restek Corporation.....................  Custom LS4434 Standard 1.......  Ampule: 2 mL.............     7/5/2012
Restek Corporation.....................  Metabolomic Standard Mix 1.
Restek Corporation.....................  UCMR3 Method 539 Calibration     Ampule: 2 mL.............   12/22/2011
                                          Standard.
Restek Corporation.....................  UCMR3 Method Calibration         Ampule: 2 mL.............    5/31/2012
                                          Standard.
Roche Diagnostics Operations, Inc......  Oral Fluid DAT Cal A Levels 1-5  Glass vial: 5 mL.........    7/31/2012
Roche Diagnostics Operations, Inc......  Oral Fluid DAT Cal B Levels 1-5  Glass vial: 5 mL.........    7/31/2012
Roche Diagnostics Operations, Inc......  Oral Fluid DAT Control Set A     Box of 6 vials, 10 mL        7/31/2012
                                          Material No. 05473390190.        each.
Roche Diagnostics Operations, Inc......  Oral Fluid DAT Control Set B     Box of 6 vials, 10 mL        7/31/2012
                                          Material No. 05473411190.        each.
Roche Diagnostics Operations, Inc......  Oral Fluid DAT Qual Cal          Box of 4 vials, 5 mL each    7/31/2012
                                          Material No. 05475929190.
Roche Diagnostics Operations, Inc......  Oral Fluid DAT SQ Cal A          Box of 6 vials, 5 mL each    7/31/2012
                                          Material No. 05475872190.
Roche Diagnostics Operations, Inc......  Oral Fluid DAT SQ Cal B          Box of 6 vials, 5 mL each    7/31/2012
                                          Material No. 05475899190.
SAFC Biosciences.......................  HH-4 Cell Culture Medium.......  Bag: 1L, 200L, 500L;          2/3/2012
                                                                           Bottle: 1L, 2L.
SAFC Biosciences.......................  HH-4 Cell Culture Medium.......  Bag: 20 L, 100L, 1,000 L.    3/22/2012
Siemens Healthcare Diagnostics Inc.....  ADVIA Chemistry Drug CAL 1.....  Carton: 10 vials; 3 ml       11/5/2012
                                                                           each.
Siemens Healthcare Diagnostics Inc.....  ADVIA Chemistry Drug CAL 1,      Vial: 3 mL...............    11/5/2012
                                          Level 2.
Siemens Healthcare Diagnostics Inc.....  ADVIA Chemistry Drug CAL 1,      Vial: 3 mL...............    11/5/2012
                                          Level 3.
Siemens Healthcare Diagnostics Inc.....  ADVIA Chemistry Drug CAL 1,      Vial: 3 mL...............    11/5/2012
                                          Level 4.
Siemens Healthcare Diagnostics Inc.....  ADVIA Chemistry Drug CAL 1,      Vial: 3 mL...............    11/5/2012
                                          Level 5.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC CAL 2 ML.....  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC CAL 3 ML.....  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC CAL 4 ML.....  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC CAL 5 ML.....  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC Control 1 ML.  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC Control 2 ML.  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC Control 3 ML.  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC Control 4 ML.  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC Control 5 ML.  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Bulk EII Plus THC Control 6 ML.  Bulk Container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Dimension Drug Calibrator,       Vial: 2.5 mL.............    11/5/2012
                                          Level 2.
Siemens Healthcare Diagnostics Inc.....  Dimension Drug Calibrator,       Vial: 2.5 mL.............    11/5/2012
                                          Level 3.
Siemens Healthcare Diagnostics Inc.....  Dimension Drug Calibrator,       Vial: 2.5 mL.............    11/5/2012
                                          Level 4.
Siemens Healthcare Diagnostics Inc.....  Dimension Drug Calibrator,       Vial: 2.5 mL.............    11/5/2012
                                          Level 5.
Siemens Healthcare Diagnostics Inc.....  Dimension Clinical Chemistry     Carton: 10 vials; 2.5 ml     11/5/2012
                                          System DRUG Calibrator.          each.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista DRUG 1 CAL, B..  Vial: 2.5 mL.............    7/31/2012
Siemens Healthcare Diagnostics Inc.....  Dimension Vista Drug 4 CAL,      Vial: 3 mL...............    11/5/2012
                                          Level B.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista Drug 4 CAL,      Vial: 3 mL...............    11/5/2012
                                          Level C.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista Drug 4 CAL,      Vial: 3 mL...............    11/5/2012
                                          Level D.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista Drug 4 CAL,      Vial: 3 mL...............    11/5/2012
                                          Level E.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista LOCI 8 CAL.....  Box of 10 vials; Vial:       3/22/2012
                                                                           2.5 mL.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista LOCI 9 CAL       Vial: 1.5 mL.............   12/22/2011
                                          Levels A-E.

[[Page 4455]]

 
Siemens Healthcare Diagnostics Inc.....  Dimension Vista System DRUG 1    Carton: 6 vials; 2.5 mL      7/31/2012
                                          CAL.                             each.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista System Drug 4    Carton: 10 vials; 3 ml       11/5/2012
                                          CAL.                             each.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista System LOCI 9    Box of 10 vials; Vial:      12/22/2011
                                          Calibrator.                      1.5 mL.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista UDAT CAL.......  Glass vial: 3 mL; Carton:   12/22/2011
                                                                           6 vials.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista UDAT CAL Bulk,   Bulk Container: 20 L-25 L    5/31/2012
                                          Level B.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista UDAT CAL Pilot,  Pilot Container: 2 mL-125    5/31/2012
                                          Level B.                         mL.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista UDAT CAL, Level  Glass vial: 3 mL.........   12/22/2011
                                          B.
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC CAL 2 ML.......  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC CAL 3 ML.......  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC CAL 4 ML.......  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC CAL 5 ML.......  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC Control 1 ML...  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC Control 2 ML...  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC Control 3 ML...  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC Control 4 ML...  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC Control 5 ML...  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  FC EII Plus THC Control 6 ML...  Plastic vial: 15 mL......   12/22/2011
Siemens Healthcare Diagnostics Inc.....  MP LOCI 9 TTST Cal Lvl 1-7 FC..  Vial: 1-5 mL.............   12/22/2011
Siemens Healthcare Diagnostics Inc.....  MP LOCI 9 TTST Lvl 1-7 Bulk....  Bulk container: 4 mL-100    12/22/2011
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  VS Drug 1 Cal Bulk Soln, Level   Bulk container: 2 mL-1 L.    7/31/2012
                                          B.
Siemens Healthcare Diagnostics Inc.....  VS LOCI 9 CAL BULK SOLN Levels   Bulk container: 4 mL-100    12/22/2011
                                          1-5.                             L.
Siemens Healthcare Diagnostics Inc.....  VS LOCI CAL 8 BULK SOLN Level 2  Bulk container: 4 mL-100     3/22/2012
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  VS LOCI CAL 8 BULK SOLN Level 3  Bulk container: 4 mL-100     3/22/2012
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  VS LOCI CAL 8 BULK SOLN Level 4  Bulk container: 4 mL-100     3/22/2012
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  VS LOCI CAL 8 BULK SOLN Level 5  Bulk container: 4 mL-100     3/22/2012
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  VS LOCI CAL 8 Vial Level E.....  Vial: 2.5 mL.............    3/22/2012
Siemens Healthcare Diagnostics Inc.....  VS LOCI CAL 8 Vial Level B.....  Vial: 2.5 mL.............    3/22/2012
Siemens Healthcare Diagnostics Inc.....  VS LOCI CAL 8 Vial Level C.....  Vial: 2.5 mL.............    3/22/2012
Siemens Healthcare Diagnostics Inc.....  VS LOCI CAL 8 Vial Level D.....  Vial: 2.5 mL.............    3/22/2012
Supelco, Inc...........................  Custom Mix, 0.2-163.2 [mu]g/mL   Glass ampule: 1 mL.......    7/31/2012
                                          in methanol.
Ultra Scientific, Inc..................  DSA Detection Cocaine HCl        Amber ampule: 1 mL.......   12/22/2011
                                          Standard.
Ultra Scientific, Inc..................  DSA Detection Cocaine HCl        Amber ampule: 1 mL.......   12/22/2011
                                          StandardPhenobarbital (625
                                          [mu]g/mL).
Ultra Scientific, Inc..................  DSA Detection Cocaine HCl        Amber ampule: 1 mL.......   12/22/2011
                                          StandardPhenobarbital (6400
                                          [mu]g/mL).
Ultra Scientific, Inc..................  GE-Ion Track 100 ng/[mu]L TNT/   Amber ampule: 10 mL......   12/22/2011
                                          Cocaine HCl Standard Rev. 1.
Ultra Scientific, Inc..................  GE-Ion Track 100 ng/[mu]L TNT/   Glass bottle: 100 mL.....   12/22/2011
                                          Cocaine HCl Standard Rev. 1.
Ultra Scientific, Inc..................  Phenobarbital (625 [mu]g/mL)...  Amber ampule: 1 mL.......    5/31/2012
Ultra Scientific, Inc..................  Phenobarbital (6400 [mu]g/mL)..  Amber ampule: 1 mL.......    5/31/2012
Ultra Scientific, Inc..................  Ultracheck WS Chloral Hydrate    Glass ampule: 2 mL.......   12/22/2011
                                          Sample.
----------------------------------------------------------------------------------------------------------------

    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 the CSA or from application 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            Denial date
----------------------------------------------------------------------------------------------------------------
Abbott Laboratories....................  ARCHITECT Estradiol Assay        Tank: 50-500 L...........   12/22/2011
                                          Diluent, No. 2K25J.
Abbott Laboratories....................  AxSYM Estradiol Buffer.........  Bulk Tank: 50-500 L; Bag-   12/22/2011
                                                                           in-box: 18-200 L.
American Radiolabeled Chemicals, Inc...  Lysergic acid diethylamide.....  Vial: 1 mL...............   12/22/2011
Biochemical Diagnostics, Inc...........  Benzoylecgonine Bulk Solution    Bottle: 1 ml-1 L.........   11/15/2011
                                          (5 mg/mL).
Biochemical Diagnostics, Inc...........  Cocaine Bulk Solution(5 mg/mL).  Bottle: 1 ml-1 L.........   11/15/2011
Biochemical Diagnostics, Inc...........  Codeine Bulk Solution(5 mg/mL).  Bottle: 1 ml-1 L.........   11/15/2011
Biochemical Diagnostics, Inc...........  d-Amphetamine Bulk Solution (5   Bottle: 1 ml-1 L.........   11/15/2011
                                          mg/mL).
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 500 ml-2 L..   11/15/2011
                                          Control Urine, MC134.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 500 ml-2 L..   11/15/2011
                                          Control Urine, MC135.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 200 ml-2 L..   11/15/2011
                                          Control Urine, MC136.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 500 ml-2 L..   11/15/2011
                                          Control Urine, MC137.

[[Page 4456]]

 
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 500 ml-2 L..   11/15/2011
                                          Control Urine, MC138.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 500 ml-2 L..   11/15/2011
                                          Control Urine, MC139.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 500 ml-2 L..   11/15/2011
                                          Control Urine, MC140.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 500 ml-2 L..   11/15/2011
                                          Control Urine, MC141.
Biochemical Diagnostics, Inc...........  Detectabuse Custom Liquid        Glass vials: 1 ml-200 mL.   11/15/2011
                                          Control Urine, MC142.
Biochemical Diagnostics, Inc...........  d-Methamphetamine Bulk           Bottle: 1 ml-1 L.........   11/15/2011
                                          Solution(5 mg/mL).
Biochemical Diagnostics, Inc...........  d-Propoxyphene Bulk Solution (5  Bottle: 1 ml-1 L.........   11/15/2011
                                          mg/mL).
Biochemical Diagnostics, Inc...........  Hydrocodone Bulk Solution(5 mg/  Bottle: 1 ml-1 L.........   11/15/2011
                                          mL).
Biochemical Diagnostics, Inc...........  Hydromorphone Bulk Solution(5    Bottle: 1 ml-1 L.........   11/15/2011
                                          mg/mL).
Biochemical Diagnostics, Inc...........  MDA Bulk Solution(5 mg/mL).....  Bottle: 1 ml-1 L.........   11/15/2011
Biochemical Diagnostics, Inc...........  MDEA Bulk Solution(5 mg/mL)....  Bottle: 1 ml-1 L.........   11/15/2011
Biochemical Diagnostics, Inc...........  MDMA Bulk Solution(5 mg/mL)....  Bottle: 1 ml-1 L.........   11/15/2011
Biochemical Diagnostics, Inc...........  Methadone Bulk Solution(5 mg/    Bottle: 1 ml-1 L.........   11/15/2011
                                          mL).
Biochemical Diagnostics, Inc...........  Methaqualone Bulk Solution(5 mg/ Bottle: 1 ml-1 L.........   11/15/2011
                                          mL).
Biochemical Diagnostics, Inc...........  Morphine Bulk Solution (5 mg/    Bottle: 1 ml-1 L.........   11/15/2011
                                          mL).
Biochemical Diagnostics, Inc...........  Oxazepam Bulk Solution (5 mg/    Bottle: 1 ml-1 L.........   11/15/2011
                                          mL).
Biochemical Diagnostics, Inc...........  Secobarbital Bulk Solution (5    Bottle: 1 ml-1 L.........   11/15/2011
                                          mg/mL).
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 20mL.........   12/22/2011
                                          Control C1 Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 20mL.........   12/22/2011
                                          Control C2 Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 20mL.........   12/22/2011
                                          Control C3 Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 20mL.........   12/22/2011
                                          Control C4 Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 20mL.........   12/22/2011
                                          Control Low Opiate Level C2
                                          Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 20mL.........   12/22/2011
                                          Control Low Opiate Level C3
                                          Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 10mL.........   12/22/2011
                                          Control S1 Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 10mL.........   12/22/2011
                                          Control S1E Low Opiate Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 10mL.........   12/22/2011
                                          Control S1E Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 10mL.........   12/22/2011
                                          Control S1S Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 10mL.........   12/22/2011
                                          Control S2 Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 10mL.........   12/22/2011
                                          Control S2E Low Opiate Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 10mL.........   12/22/2011
                                          Control S2E Minipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 10mL.........   12/22/2011
                                          Control S2SMinipak.
Bio-Rad Laboratories...................  Liquichek Urine Toxicology       Amber Vial: 10mL.........   12/22/2011
                                          Control S3 Minipak.
Cayman Chemical Company................  4-Methylmethcathinone            Glass vial: 1 mL.........    7/31/2012
                                          (hydrochloride), 10 mg in 1 mL
                                          Methanol.
Cayman Chemical Company................  4-Methylmethcathinone            Glass vial: 2.5 mL.......    7/31/2012
                                          (hydrochloride), 25 mg in 2.5
                                          mL Methanol.
Cayman Chemical Company................  4-Methylmethcathinone            Glass vial: 500 [micro]L.    7/31/2012
                                          (hydrochloride), 5 mg in 500
                                          [micro]L Methanol.
Cayman Chemical Company................  5-methoxy DMT, 10 mg in 1 mL     Glass vial: 1 mL.........    7/31/2012
                                          Methanol.
Cayman Chemical Company................  5-methoxy DMT, 25 mg in 2.5 mL   Glass vial: 2.5 mL.......    7/31/2012
                                          Methanol.
Cayman Chemical Company................  5-methoxy DMT, 5 mg in 500       Glass vial: 500 [micro]L.    7/31/2012
                                          [micro]L Methanol.
Cayman Chemical Company................  Methylenedioxy Pyrovalerone      Glass vial: 1 mL.........    7/31/2012
                                          (hydrochloride), 10 mg in 1 mL
                                          Methanol.
Cayman Chemical Company................  Methylenedioxy Pyrovalerone      Glass vial: 2.5 mL.......    7/31/2012
                                          (hydrochloride), 25 mg in 2.5
                                          mL Methanol.
Cayman Chemical Company................  Methylenedioxy Pyrovalerone      Glass vial: 500 [micro]L.    7/31/2012
                                          (hydrochloride), 5 mg in 500
                                          [micro]L Methanol.
Cayman Chemical Company................  Methylenedioxy Pyrovalerone, 10  Glass vial: 1 mL.........    7/31/2012
                                          mg in 1 mL Methanol.
Cayman Chemical Company................  Methylenedioxy Pyrovalerone, 25  Glass vial: 2.5 mL.......    7/31/2012
                                          mg in 2.5 mL Methanol.
Cayman Chemical Company................  Methylenedioxy Pyrovalerone, 5   Glass vial: 500 [micro]L.    7/31/2012
                                          mg in 500 [micro]L Methanol.
Cayman Chemical Company................  Methylenedioxy Pyrovalerone-d8   Glass vial: 1 mL.........    7/31/2012
                                          (hydrochloride), 10 mg in 1 mL
                                          Methanol.
Cayman Chemical Company................  Methylenedioxy Pyrovalerone-d8   Glass vial: 2.5 mL.......    7/31/2012
                                          (hydrochloride), 25 mg in 2.5
                                          mL Methanol.
Cayman Chemical Company................  Methylenedioxy Pyrovalerone-d8   Glass vial: 500 [micro]L.    7/31/2012
                                          (hydrochloride), 5 mg in 500
                                          [micro]L Methanol.
Cayman Chemical Company................  Methylone (hydrochloride), 10    Glass vial: 1 mL.........    7/31/2012
                                          mg in 1 mL Methanol.
Cayman Chemical Company................  Methylone (hydrochloride), 25    Glass vial: 2.5 mL.......    7/31/2012
                                          mg in 2.5 mL Methanol.
Cayman Chemical Company................  Methylone (hydrochloride), 5 mg  Glass vial: 500 [micro]L.    7/31/2012
                                          in 500 [micro]L Methanol.
Cerilliant Corporation.................  Codeine (1 mg/mL)..............  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Codeine-D3 (1 mg/mL)...........  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Drug Solution  16.....  Screw-cap Vial: 50 mL....     6/5/2012

[[Page 4457]]

 
Cerilliant Corporation.................  Drug Solution  17.....  Screw-cap Vial: 50 mL....     6/5/2012
Cerilliant Corporation.................  Drug Solution  18.....  Screw-cap Vial: 50 mL....     6/5/2012
Cerilliant Corporation.................  Drug Solution  19.....  Screw-cap Vial: 50 mL....     6/5/2012
Cerilliant Corporation.................  Drug Solution  20.....  Screw-cap Vial: 50 mL....     6/5/2012
Cerilliant Corporation.................  Hydrocodone (1 mg/mL)..........  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Hydrocodone-D6 (1 mg/mL).......  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Hydromorphone (1 mg/mL)........  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Hydromorphone-D3 (1 mg/mL).....  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Morphine (1 mg/mL).............  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Morphine-D3 (1 mg/mL)..........  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Noroxycodone HCl (1 mg/mL).....  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Noroxycodone-D3 HCl (1 mg/mL)..  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Oxycodone (1 mg/mL)............  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Oxycodone-D3 (1 mg/mL).........  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Oxymorphone (1 mg/mL)..........  Glass ampule: 5 mL.......    7/31/2012
Cerilliant Corporation.................  Oxymorphone-D3 (1 mg/mL).......  Glass ampule: 5 mL.......    7/31/2012
Environmental Resource Associates (ERA)  USGS BQS LS4434 Mix 1..........  Glass Ampule: 1-2 mL.....    7/31/2012
Environmental Resource Associates (ERA)  USGS BQS LS4434 Mix 2..........  Glass Ampule: 1-2 mL.....    7/31/2012
Immunalysis Corporation................  Tapentadol Calibrator Levels 1-  Glass vial: 10 mL........    6/19/2012
                                          4.
Immunalysis Corporation................  Tapentadol High Control........  Glass vial: 10 mL........    6/19/2012
Immunalysis Corporation................  Tapentadol Low Control.........  Glass vial: 10 mL........    6/19/2012
Restek Corporation.....................  Custom Cannabinoids Standard...  Ampule: 2 mL.............    5/31/2012
Restek Corporation.....................  Custom Paraldehyde Standard (10  Ampule: 2 mL.............     7/5/2012
                                          mg/mL).
Siemens Healthcare Diagnostics Inc.....  Dimension Vista UDAT CAL Bulk,   Bulk Container: 4mL-100L.   12/22/2011
                                          Level B.
Siemens Healthcare Diagnostics Inc.....  Dimension Vista UDAT CAL Bulk,   Bulk Container: 26 L-50L.    5/31/2012
                                          Level B.
Siemens Healthcare Diagnostics Inc.....  Drug CAL BULK SOLN, Level 2....  Bulk container: 2 L-100 L    11/5/2012
Siemens Healthcare Diagnostics Inc.....  Drug CAL BULK SOLN, Level 3....  Bulk container: 2 mL-100     11/5/2012
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Drug CAL BULK SOLN, Level 4....  Bulk container: 2 mL-100     11/5/2012
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  Drug CAL BULK SOLN, Level 5....  Bulk container: 2m L-100     11/5/2012
                                                                           L.
Siemens Healthcare Diagnostics Inc.....  VS Drug 1 Cal Bulk Soln, Level   Bulk container: 2 mL-100     7/31/2012
                                          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. 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 in-house and may not be transported to other 
facilities.
    Additional exempt chemical preparation requests received between 
June 12, 2011, and June 30, 2012, and not otherwise referenced in this 
order may remain pending 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 published in a future Federal Register.

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 
indefinitely unless 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

[[Page 4458]]

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.

Request 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 https://www.deadiversion.usdoj.gov/schedules/exempt/exempt_chemlist.pdf. The 
dates of applications of all current exemptions are posted for easy 
reference.

    Dated: January 14, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2013-01133 Filed 1-18-13; 8:45 am]
BILLING CODE 4410-09-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.