## 4446 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

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. 

### 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 http:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http:// 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 http:// www.regulations.gov and in the DEA’s public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase ‘‘PERSONAL IDENTIFYING INFORMATION’’ in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase ‘‘CONFIDENTIAL BUSINESS INFORMATION’’ in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.

Personal identifying information and confidential business information identified and located as set forth above will be redacted, and the comment, in redacted form, will be posted online and placed in DEA’s public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency’s public docket file in person by appointment, please see the **FOR FURTHER INFORMATION CONTACT**  

### paragraph.
**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. 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


## 4447 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 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.



### C HART 

### I

Supplier Product name Form Exemption date

Abbott Laboratories ............................ ARCHITECT 2nd Generation Testosterone Calibrators (B,C,D,E,F). Bottle: 4 mL; Box: 6 bottles ............... 12/22/2011

Abbott Laboratories ............................ ARCHITECT 2nd Generation Testosterone Controls (L,M,H). Bottle: 8 mL; Box: 3 bottles ............... 12/22/2011

Abbott Laboratories ............................ ARCHITECT Estradiol Assay Diluent, No. 2K25J Bag-in-box: 18–200 L; Flask/Carboy: 1–50 L; Bottle/Vial: 0.5 mL–1 L; Box: 1–50 bottles. 12/22/2011

Abbott Laboratories ............................ ARCHITECT Estradiol Assay Diluent, No. 7K72J Bottle: 5.9 mL ...................... ............... 12/22/2011 Abbott Laboratories ............................ ARCHITECT Estradiol Reagent Kit, No. 07K72– 20. Bottle: 5.9 mL; Kit: 16 bottles ............ 12/22/2011

Abbott Laboratories ............................ ARCHITECT Estradiol Reagent Kit, No. 07K72– 25. Bottle: 5.9 mL; Kit: 4 bottles .............. 12/22/2011

Abbott Laboratories ............................ ARCHITECT Estradiol Reagent Kit, No. 2K25–20 Bottle: 5.9 mL; Kit: 16 bottles .... ........ 12/22/2011 Abbott Laboratories ............................ ARCHITECT Estradiol Reagent Kit, No. 2K25–25 Bottle: 5.9 mL; Kit: 4 bottles ..... ......... 12/22/2011 Abbott Laboratories ............................ AxSYM Estradiol Buffer ......................................... Flask/Carboy: 1–50 L; Bottle/Vial: 0.5 mL–1 L; Box: 1–50 bottles. 12/22/2011

Abbott Laboratories ............................ AxSYM Estradiol Reagent Pack ............................ Bottle: 5.5 mL, Pack: 4 bottles .......... 12/22/2011 Agilent Technologies .......................... Special Order Standard TOXI-LAB DISCS; 1, 2, or 3 drugs. Plastic Vial: 50 discs .......................... 12/22/2011

Agilent Technologies .......................... Special Procedure Standard TOXI-LAB DISCS: Benzodiazepines: Hydrolysis Procedure. Plastic Vial: 50 discs .......................... 12/22/2011

Agilent Technologies .......................... Special Procedure Standard TOXI-LAB DISCS: Benzoylecgonine. Plastic Vial: 50 discs .......................... 12/22/2011

Agilent Technologies .......................... Special Procedure Standard TOXI-LAB DISCS: MDMA, MDA, MDEA. Plastic Vial: 50 discs .......................... 12/22/2011

Agilent Technologies .......................... Special Procedure Standard TOXI-LAB DISCS: Morphine and Hydromorphone: Differentiation. Plastic Vial: 50 discs .......................... 12/22/2011

Agilent Technologies .......................... Special Procedure Standard TOXI-LAB DISCS: Opiate. Plastic Vial: 50 discs .......................... 12/22/2011

Agilent Technologies .......................... Special Procedure Standard TOXI-LAB DISCS: Sympathomimetic amines: Differentiation. Plastic Vial: 50 discs .......................... 12/22/2011

Agilent Technologies .......................... Special Standard TOXI-LAB DISCS LTD-Opiate: 1, 2, or 3 drugs. Plastic Vial: 50 discs .......................... 12/22/2011

Agilent Technologies .......................... TOXI-LAB Chromatograms A ................................ Glass jar: 100 Chromatograms .......... 12/22/2011 Agilent Technologies .......................... TOXI-LAB Chromatograms B ................................ Glass jar: 100 Chromatograms .......... 12/22/2011 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 diethylamide [125I] ............. Vial: 1 mL ........................................... 12/22/2011

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-methyl-3H] hydrochloride ............. Vial: 1 mL ........................................... 12/22/2011


## 4448 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### I—Continued

Supplier Product name Form Exemption date

American Radiolabeled Chemicals,

Inc. (±)-Ketamine hydrochloride (1 mg/mL) .................. Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. 1,1-Dimethyltryptamine (1 mg/mL) ......................... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. 1,1-Dimethyltryptamine [a, b-3H] as TFA salt ......... Vial: 1 mL ........................................... 12/22/2011

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] hydrochloride ..... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Amphetamine, DL-[ring-2,3,5-3H] hydrochloride ... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Amphetamine, L-[ring-2,3,5-3H] hydrochloride ...... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Buprenorphine [ring-3H] hydrochloride .................. Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Buprenorphine hydrochloride (1 mg/mL) ............... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Cocaine (1 mg/mL) ................................................ Vial: 1 mL ........................................... 12/22/201 1

American Radiolabeled Chemicals,

Inc. Cocaine [methyl-14C] hydrochloride ...................... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Cocaine, levo-[benzoyl-3,4-3H(N)] ......................... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Codeine (1 mg/mL) ................................................ Vial: 1 mL ........................................... 12/22/201 1

American Radiolabeled Chemicals,

Inc. D-Amphetamine hydrochloride (1 mg/mL) ............. Vial: 1 mL ........................................... 12/22/2011

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 mg/mL) ........... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. D-Methamphetamine hydrochloride (1 mg/mL) ..... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Ecgonine (1 mg/mL) ............................................... Vial: 1 mL ........................................... 12/22/201 1

American Radiolabeled Chemicals,

Inc. Fentanyl (1 mg/mL) ................................................ Vial: 1 mL ........................................... 12/22/20 11

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 ........................................... 12/22/2 011

American Radiolabeled Chemicals,

Inc. Heroin [methyl-14C] ............................................... Vial: 1 mL ........................................... 12/22/20 11

American Radiolabeled Chemicals,

Inc. Heroin [methyl-3H] ................................................. Vial: 1 mL ........................................... 12/22/2 011

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] hydrochloride ..... Vial: 1 mL ........................................... 12/22/2011


## 4449 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### I—Continued

Supplier Product name Form Exemption date

American Radiolabeled Chemicals,

Inc. Ibogaine (1 mg/mL) ................................................ Vial: 1 mL ........................................... 12/22/20 11

American Radiolabeled Chemicals,

Inc. L-Amphetamine hydrochloride (1 mg/mL) ............. Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. L-Methamphetamine hydrochloride (1 mg/mL) ...... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Lysergic Acid (1 mg/mL) ........................................ Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Lysergic acid diethylamide [N-methyl-3H] ............. Vial: 1 mL ........................................... 3/22/2012

American Radiolabeled Chemicals,

Inc. Mazindol (1 mg/mL) ............................................... Vial: 1 mL ........................................... 12/22/201 1

American Radiolabeled Chemicals,

Inc. Meperidine Hydrochloride (1 mg/mL) .................... Vial: 1 mL ........................................... 12/22/2011

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] hydrochloride Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Methamphetamine, L-[methyl-14C] hydrochloride Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Midazolam (1 mg/mL) ............................................ Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Midazolam [3H(G)] ................................................. Vial: 1 mL ........................................... 12/22/20 11

American Radiolabeled Chemicals,

Inc. Morphine (1 mg/mL) ............................................... Vial: 1 mL ........................................... 12/22/201 1

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 ........................................... 12/22/201 1

American Radiolabeled Chemicals,

Inc. Oxycodone [N-methyl-14C] hydrochloride ............. Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Oxycodone hydrochloride (1 mg/mL) ..................... Vial: 1 mL ........................................... 12/22/2011

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 mg/mL) ................. Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Phenylacetone (1 mg/mL) ...................................... Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Tetrahydrocannabidinol (1 mg/mL) ........................ Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Thebaine (1 mg/mL) ............................................... Vial: 1 mL ........................................... 12/22/201 1

American Radiolabeled Chemicals,

Inc. Thebaine [N-methyl-14C] hydrochloride ................ Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Thebaine [N-methyl-3H] hydrochloride .................. Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Thebaine [O-methyl-14C] hydrochloride ................ Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. Thebaine [O-methyl-3H] hydrochloride .................. Vial: 1 mL ........................................... 12/22/2011

American Radiolabeled Chemicals,

Inc. g -Hydroxybutyric acid sodium salt (1 mg/mL) ........ Vial: 1 mL ........................................... 12/22/2011

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF10. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF11. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF12. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF13. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF14. Glass vials: 1 ml–200 mL .................. 7/5/2012


## 4450 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### I—Continued

Supplier Product name Form Exemption date

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF15. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF16. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF17. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF18. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF19. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF20. Glass vials: 1 ml–200 mL .................. 7/31/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF21. Glass vials: 1 ml–200 mL .................. 7/31/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF4. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF5. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF6. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF8. Glass vials: 1 ml–200 mL .................. 7/5/2012

Biochemical Diagnostics, Inc ............. Detectabuse Custom Liquid Control Oral Fluid, OF9. Glass vials: 1 ml–200 mL .................. 7/5/2012

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


## 4451 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### I—Continued

Supplier Product name Form Exemption date

Bio-Rad Laboratories ......................... Liquichek Immunoassay Plus Control Levels 1, 2, and 3. Amber Vial: 10 mL; Box: 12 vials ...... 12/22/2011

Bio-Rad Laboratories ......................... Liquichek Immunoassay Plus Control Trilevel ....... Amber Vial: 10 mL; Box: 12 vials ...... 12/22/2011 Bio-Rad Laboratories ......................... Liquichek Immunoassay Plus Control Trilevel Minipak. Amber Vial: 5 mL; Box: 3 vials .......... 12/22/2011

Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S10 ................ Box: 10 vials, 10 mL each ... .............. 5/31/2012Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S10 Low Opiate. Box: 10 vials, 10 mL each ................. 5/31/2012

Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S10 Low Opiate Minipak. Amber vial: 10 mL .............................. 5/31/2012

Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S10 Minipak .. Amber vial: 10 mL ................. ............. 5/31/2012 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S20 ................ Box: 10 vials, 10 mL each ... .............. 5/31/2012Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S20 Low Opiate. Box: 10 vials, 10 mL each ................. 5/31/2012

Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S20 Low Opiate Minipak. Amber vial: 10 mL .............................. 5/31/2012

Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S20 Minipak .. Amber vial: 10 mL ................. ............. 5/31/2012 Bio-Rad Laboratories ......................... Liquid Assayed Multiqual Levels 1–3 .................... Amber Vial: 2.5 mL; Box: 12 vials ..... 12/22/2011 Bio-Rad Laboratories ......................... Liquid Assayed Multiqual Trilevel MiniPak ............ Amber Vial: 2.5 mL; Box: 3 vi als ....... 12/22/2011 Bio-Rad Laboratories ......................... Liquid Unassayed Multiqual Levels 1–3 ................ Amber Vial: 2.5 mL; Box: 12 vials ..... 12/22/2011 Bio-Rad Laboratories ......................... Liquid Unassayed Multiqual Trilevel MiniPak ........ Amber Vial: 2.5 mL; Box: 3 vial s ....... 12/22/2011 Bio-Rad Laboratories ......................... Lyphochek Assayed Chemistry Control Bilevel MiniPak. Box 2 vials; 5 mL each ...................... 12/22/2011

Bio-Rad Laboratories ......................... Lyphochek Assayed Chemistry Control Levels 1– 2. Amber Vial: 5 mL; Box: 12 vials ........ 12/22/2011

Bio-Rad Laboratories ......................... Lyphochek Immunoassay Plus Control Levels 1, 2, and 3. Amber Vial: 10 mL; Box: 12 vials ...... 12/22/2011

Bio-Rad Laboratories ......................... Lyphochek Immunoassay Plus Control Trilevel ..... Amber Vial: 10 mL; Box: 12 vials .. .... 12/22/2011 Bio-Rad Laboratories ......................... Lyphochek Immunoassay Plus Control Trilevel Minipak. Amber Vial: 5 mL; Box: 3 vials .......... 12/22/2011

Bio-Rad Laboratories ......................... Lyphochek Unassayed Chemistry Control (Human) Bilevel MiniPak. Box 2 vials; 5 mL each ...................... 12/22/2011

Bio-Rad Laboratories ......................... Lyphochek Unassayed Chemistry Control (Human) Levels 1–2. Amber Vial: 5 mL; Box: 25 vials ........ 12/22/2011

Cerilliant Corporation ......................... (±) Pentazocine-13C3 (0.1 mg/mL) ........................ Glass Ampule: 2 mL .......................... 12/22/2011 Cerilliant Corporation ......................... (±)-cis-11-Nor-9-carboxy-delta9-THC-D3 glucuronide (0.1 mg/mL). Glass Ampule: 2 mL .......................... 12/22/2011

Cerilliant Corporation ......................... 3,4-Methylenedioxypyrovalerone HCl (1 mg/mL) .. Glass Ampule: 2 mL ................ .......... 12/22/2011 Cerilliant Corporation ......................... 3,4-Methylenedioxypyrovalerone-D8 HCl (0.1 mg/ mL). Glass Ampule: 2 mL .......................... 12/22/2011

Cerilliant Corporation ......................... 3-Desmethylprodine (1 mg/mL) ............................. Glass Ampule: 1 mL ..... ..................... 7/31/2012 Cerilliant Corporation ......................... 3-Desmethylprodine HCl (1 mg/mL) ...................... Glass Ampule: 1 mL ........ .................. 7/31/2012 Cerilliant Corporation ......................... 6-alpha/beta-Hydroxyoxymorphone (1 mg/mL) ..... Glass Ampule: 2 mL ................ .......... 12/22/2011 Cerilliant Corporation ......................... 6-alpha/beta-Hydroxyoxymorphone-D3 (0.1 mg/ mL). Glass Ampule: 2 mL .......................... 12/22/2011

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 m L .......................... 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/mL) ................... Glass Ampule: 2 mL ......... ................. 12/22/2011 Cerilliant Corporation ......................... Cocaine N-oxide-D3 HCl (0.1 mg/mL) ................... Glass Ampule: 2 mL ......... ................. 3/8/2012 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 mg/mL) .............. Glass Ampule: 2 mL ........... ............... 12/22/2011 Cerilliant Corporation ......................... Lisdexamfetamine-D4 dimesylate (0.1 mg/mL) ..... Glass Ampule: 2 mL ............... ........... 12/22/2011 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 μg/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 Mix (0.5 mg/ mL). Glass Ampule: 2 mL .......................... 12/22/2011

Cerilliant Corporation ......................... Opiate Internal Standard Mix-15 ............................ Glass Ampule: 2 mL ... ....................... 12/22/2011


## 4452 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### I—Continued

Supplier Product name Form Exemption date

Cerilliant Corporation ......................... Pseudobuprenorphine dihydrochloride (1.0mg/mL) Glass Ampule: 1 mL ............... ........... 2/1/2012 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 D9-Tetrahydrocannabinolglucoronide (10 μg/mL in MeOH). Glass vial: 1 ml .................................. 5/31/2012

ElSohly Laboratories, Inc ................... ELI Drug Standards D9-Tetrahydrocannabinolglucoronide (100 μg/mL in MeOH). Glass vial: 1 ml .................................. 5/31/2012

Environmental Resource Associates

(ERA). Chloral Hydrate, Proficiency Testing Material, Catalog No. 853. Glass Ampule: 2 mL .......................... 3/8/2012

Environmental Resource Associates

(ERA). Chloral Hydrate, Reference Material, Catalog No. 676. Glass Ampule: 2 mL .......................... 3/8/2012

Environmental Resource Associates

(ERA). Waters Steroid Test Mix, Part No. 07364 .............. Glass Ampule: 2 mL .......................... 3/8/2012

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 Pain Management Prediluted in Extraction Buffer. Glass vial: 10 mL ............................... 6/19/2012

Immunalysis Corporation ................... Oral Fluid High Positive Control Pain Management Prediluted in Extration Buffer. Glass vial: 10 mL ............................... 6/19/2012

Immunalysis Corporation ................... Oral Fluid Low Positive Control Pain Management Prediluted in Extraction Buffer. Glass vial: 10 mL ............................... 6/19/2012

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 (1.0 mg/mL) ........ Glass Ampule: 1 mL ............. ............. 5/9/2012Microgenics Corporation .................... CEDIA Amphetamine OFT Assay, Catalog Number: 10014947. Box: 4 bottles; 65 mL each ................ 12/22/2011

Microgenics Corporation .................... CEDIA Cannabinoids OFT Assay, Catalog Number: 10014910. Box: 4 bottles; 65 mL each ................ 12/22/2011

Microgenics Corporation .................... CEDIA Cocaine OFT Assay, Catalog Number: 10014764. Box: 4 bottles; 65 mL each ................ 12/22/2011

Microgenics Corporation .................... CEDIA Methamphetamine OFT Assay, Catalog Number: 10014949. Box: 4 bottles; 65 mL each ................ 12/22/2011

Microgenics Corporation .................... CEDIA Methamphetamine OFT Control Set (Low and High) , Catalog #10014953. Vial: 10 mL Box: 2 vials ..................... 12/22/2011

Microgenics Corporation .................... CEDIA Methamphetamine OFT Cutoff Calibrator, Catalog #10014951. Vial: 5 mL Box: 1 vial ......................... 12/22/2011

Microgenics Corporation .................... CEDIA Methamphetamine OFT High Calibrator, Catalog #10014952. Vial: 5 mL Box: 1 vial ......................... 12/22/2011

Microgenics Corporation .................... CEDIA Multi-Drug OFT Control Set (Low and High), Catalog #10014957. Vial: 15 mL Box: 2 vials ..................... 12/22/2011

Microgenics Corporation .................... CEDIA Multi-Drug OFT Cutoff Calibrator, Catalog #10014955. Vial: 10 mL Box: 1 vial ....................... 12/22/2011

Microgenics Corporation .................... CEDIA Multi-Drug OFT High Calibrator, Catalog #10014956. Vial: 10 mL Box: 1 vial ....................... 12/22/2011

Microgenics Corporation .................... CEDIA Opiate OFT Assay, Catalog Number: 10014873. Box: 4 bottles; 65 mL each ................ 12/22/2011

Microgenics Corporation .................... CEDIA PCP OFT Assay, Catalog Number: 10014888. Box: 4 bottles; 65 mL each ................ 12/22/2011

Microgenics Corporation .................... CEDIA THC OFT Control Set (Low and High), Catalog #10014925. Vial: 10 mL Box: 2 vials ..................... 12/22/2011

Microgenics Corporation .................... CEDIA THC OFT Cutoff Calibrator, Catalog #10014923. Vial: 5 mL Box: 1 vial ......................... 12/22/2011

Microgenics Corporation .................... CEDIA THC OFT High Calibrator, Catalog #10014924. Vial: 5 mL Box: 1 vial ......................... 12/22/2011

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 1, Catalog Number: 10016345. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 1, Catalog Number: 10016362. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 2, Catalog Number: 10016346. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 2, Catalog Number: 10016363. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 3, Catalog Number: 10016347. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 3, Catalog Number: 10016364. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 4, Catalog Number: 10016348. Vial: 5 mL Box: 1 vial ......................... 7/5/2012


## 4453 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### I—Continued

Supplier Product name Form Exemption date

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016349. Vial: 10 mL Box: 2 vials ..................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016365. Vial: 10 mL Box: 2 vials ..................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016808. Vial: 10 mL Box: 2 vials ..................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Methamphetamine OFT Cutoff Calibrator, Catalog Number: 10016807. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 1, Catalog Number: 10016865. Vial: 10 mL Box: 1 vial ....................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 1, Catalog Number: 10016882. Vial: 10 mL Box: 1 vial ....................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 2, Catalog Number: 10016866. Vial: 10 mL Box: 1 vial ....................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 2, Catalog Number: 10016883. Vial: 10 mL Box: 1 vial ....................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 3, Catalog Number: 10016867. Vial: 10 mL Box: 1 vial ....................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 3, Catalog Number: 10016884. Vial: 10 mL Box: 1 vial ....................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 4, Catalog Number: 10016868. Vial: 10 mL Box: 1 vial ....................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016869. Vial: 15 mL Box: 2 vials ..................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016885. Vial: 15 mL Box: 2 vials ..................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016895. Vial: 15 mL Box: 2 vials ..................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA Multi-Drug OFT Cutoff Calibrator, Catalog Number: 10016894. Vial: 10 mL Box: 1 vial ....................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Calibrator 1 Catalog Number: 10016644. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Calibrator 1 Catalog Number: 10016700. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Calibrator 2 Catalog Number: 10016646. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Calibrator 2 Catalog Number: 10016701. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Calibrator 3 Catalog Number: 10016647. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Calibrator 3 Catalog Number: 10016702. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Calibrator 4 Catalog Number: 10016648. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016649. Vial: 10 mL Box: 2 vials ..................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016703. Vial: 10 mL Box: 2 vials ..................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016731. Vial: 10 mL Box: 2 vials ..................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific CEDIA THC OFT Cutoff Calibrator Catalog Number: 10016730. Vial: 5 mL Box: 1 vial ......................... 7/5/2012

Microgenics Corporation .................... Thermo Scientific DRI Fentanyl Assay Catalog Number: 10016005. Vials: 500 mL ..................................... 5/31/2012

Microgenics Corporation .................... Thermo Scientific DRI Fentanyl Assay Catalog Number: 10016006. 3 vials, 18 mL each ........................... 5/31/2012

Microgenics Corporation .................... Thermo Scientific DRI Fentanyl Assay Catalog Number: 10016437. 3 vials, 18 mL each ........................... 5/31/2012

Microgenics Corporation .................... Thermo Scientific DRI Fentanyl Calibrator 2 ng/ mL Catalog Number: 10016023. Vials: 10 mL ....................................... 5/31/2012

Microgenics Corporation .................... Thermo Scientific DRI Fentanyl High Control 1 ng/ mL Catalog Number: 10016484. Box: 1 vial; 25 mL .............................. 5/31/2012

Microgenics Corporation .................... Thermo Scientific DRI Fentanyl High Control 2 ng/ mL Catalog Number: 10016485. Box: 1 vial; 10 mL .............................. 5/31/2012


## 4454 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### I—Continued

Supplier Product name Form Exemption date

Microgenics Corporation .................... Thermo Scientific DRI Fentanyl High Control 3 ng/ mL Catalog Number: 10016024. Vials: 25 mL ....................................... 5/31/2012

Microgenics Corporation .................... Thermo Scientific DRI Fentanyl High Control 3 ng/ mL Catalog Number: 10016486. Box: 1 vial; 25 mL .............................. 5/31/2012

Microgenics Corporation .................... Thermo Scientific DRI Fentanyl Low Control 1 ng/ mL Catalog Number: 10016022. Vials: 25 mL ....................................... 5/31/2012

Microgenics Corporation .................... Thermo Scientific MAS Omni • CORE Liquid Assayed Integrated Chemistry Control Levels 1–3. Vial 5 mL; Box: 6 vials ....................... 12/22/2011

Microgenics Corporation .................... Thermo Scientific MAS Omni • CORE Liquid Assayed Integrated Chemistry Control Sample Pack. Box: 6 vials; 5 mL each ..................... 12/22/2011

Microgenics Corporation .................... Thermo Scientific MAS Omni • IMMUNE Liquid Assayed Integrated Chemistry Control Levels 1–3. Vial 5 mL; Box: 6 vials ....................... 12/22/2011

Microgenics Corporation .................... Thermo Scientific MAS Omni • IMMUNE Liquid Assayed Integrated Chemistry Control Sample Pack. Box: 6 vials; 5 mL each ..................... 12/22/2011

Microgenics Corporation .................... Thermo Scientific MAS Omni • IMMUNE PRO Liquid Assayed Integrated Chemistry Control Levels 1–3. Vial 5 mL; Box: 6 vials ....................... 12/22/2011

Microgenics Corporation .................... Thermo Scientific MAS Omni • IMMUNE PRO Liquid Assayed Integrated Chemistry Control Sample Pack. Box: 6 vials; 5 mL each ..................... 12/22/2011

Restek Corporation ............................ Appendix IX Mix #1, Revised ................................. Ampule: 2 mL ......... ............................ 12/22/2011 Restek Corporation ............................ Custom a,a-Dimethylphenethylamine Standard .... Ampule: 2 mL ....................... .............. 12/22/2011 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 ............................... Ampule: 2 mL ........... .......................... 2/1/2012 Restek Corporation ............................ UCMR3 Method 539 Calibration Standard ............ Ampule: 2 mL .................... ................. 12/22/2011 Restek Corporation ............................ UCMR3 Method Calibration Standard ................... Ampule: 2 mL ................. .................... 5/31/2012 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 Material No. 05473390190. Box of 6 vials, 10 mL each ................ 7/31/2012

Roche Diagnostics Operations, Inc ... Oral Fluid DAT Control Set B Material No. 05473411190. Box of 6 vials, 10 mL each ................ 7/31/2012

Roche Diagnostics Operations, Inc ... Oral Fluid DAT Qual Cal Material No. 05475929190. Box of 4 vials, 5 mL each .................. 7/31/2012

Roche Diagnostics Operations, Inc ... Oral Fluid DAT SQ Cal A Material No. 05475872190. Box of 6 vials, 5 mL each .................. 7/31/2012

Roche Diagnostics Operations, Inc ... Oral Fluid DAT SQ Cal B Material No. 05475899190. Box of 6 vials, 5 mL each .................. 7/31/2012

SAFC Biosciences ............................. HH–4 Cell Culture Medium .................................... Bag: 1L, 200L, 500L; Bottle: 1L, 2L .. 2/3/2012 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 each ......... ....... 11/5/2012 Siemens Healthcare Diagnostics Inc ADVIA Chemistry Drug CAL 1, Level 2 ................. Vial: 3 mL ............................... ............ 11/5/2012 Siemens Healthcare Diagnostics Inc ADVIA Chemistry Drug CAL 1, Level 3 ................. Vial: 3 mL ............................... ............ 11/5/2012 Siemens Healthcare Diagnostics Inc ADVIA Chemistry Drug CAL 1, Level 4 ................. Vial: 3 mL ............................... ............ 11/5/2012 Siemens Healthcare Diagnostics Inc ADVIA Chemistry Drug CAL 1, Level 5 ................. Vial: 3 mL ............................... ............ 11/5/2012 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC CAL 2 ML ................................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC CAL 3 ML ................................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC CAL 4 ML ................................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC CAL 5 ML ................................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC Control 1 ML ............................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC Control 2 ML ............................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC Control 3 ML ............................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC Control 4 ML ............................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC Control 5 ML ............................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Bulk EII Plus THC Control 6 ML ............................ Bulk Container: 4 mL–100 L ......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Dimension Drug Calibrator, Level 2 ....................... Vial: 2.5 mL ........................ ................ 11/5/2012 Siemens Healthcare Diagnostics Inc Dimension Drug Calibrator, Level 3 ....................... Vial: 2.5 mL ........................ ................ 11/5/2012 Siemens Healthcare Diagnostics Inc Dimension Drug Calibrator, Level 4 ....................... Vial: 2.5 mL ........................ ................ 11/5/2012 Siemens Healthcare Diagnostics Inc Dimension Drug Calibrator, Level 5 ....................... Vial: 2.5 mL ........................ ................ 11/5/2012Siemens Healthcare Diagnostics Inc Dimension Clinical Chemistry System DRUG Calibrator. Carton: 10 vials; 2.5 ml each ............. 11/5/2012

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, Level B .................. Vial: 3 mL .............................. ............. 11/5/2012 Siemens Healthcare Diagnostics Inc Dimension Vista Drug 4 CAL, Level C .................. Vial: 3 mL .............................. ............. 11/5/2012 Siemens Healthcare Diagnostics Inc Dimension Vista Drug 4 CAL, Level D .................. Vial: 3 mL .............................. ............. 11/5/2012 Siemens Healthcare Diagnostics Inc Dimension Vista Drug 4 CAL, Level E .................. Vial: 3 mL .............................. ............. 11/5/2012 Siemens Healthcare Diagnostics Inc Dimension Vista LOCI 8 CAL ................................ Box of 10 vials; Vial: 2.5 mL ...... ........ 3/22/2012 Siemens Healthcare Diagnostics Inc Dimension Vista LOCI 9 CAL Levels A–E ............. Vial: 1.5 mL ............................... ......... 12/22/2011


## 4455 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### I—Continued

Supplier Product name Form Exemption date

Siemens Healthcare Diagnostics Inc Dimension Vista System DRUG 1 CAL ................. Carton: 6 vials; 2.5 mL each ............. 7/31/2012 Siemens Healthcare Diagnostics Inc Dimension Vista System Drug 4 CAL .................... Carton: 10 vials; 3 ml each ............. ... 11/5/2012 Siemens Healthcare Diagnostics Inc Dimension Vista System LOCI 9 Calibrator .......... Box of 10 vials; Vial: 1.5 mL .............. 12/22/2011 Siemens Healthcare Diagnostics Inc Dimension Vista UDAT CAL .................................. Glass vial: 3 mL; Carton: 6 vials .. ..... 12/22/2011 Siemens Healthcare Diagnostics Inc Dimension Vista UDAT CAL Bulk, Level B ........... Bulk Container: 20 L–25 L ................. 5/31/2012 Siemens Healthcare Diagnostics Inc Dimension Vista UDAT CAL Pilot, Level B ........... Pilot Container: 2 mL–125 mL ........... 5/31 /2012 Siemens Healthcare Diagnostics Inc Dimension Vista UDAT CAL, Level B .................... Glass vial: 3 mL ........................ ......... 12/22/2011 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 L .......... ..... 12/22/2011 Siemens Healthcare Diagnostics Inc VS Drug 1 Cal Bulk Soln, Level B ......................... Bulk container: 2 mL–1 L ............ ....... 7/31/2012 Siemens Healthcare Diagnostics Inc VS LOCI 9 CAL BULK SOLN Levels 1–5 ............. Bulk container: 4 mL–100 L ............... 12/22/2011 Siemens Healthcare Diagnostics Inc VS LOCI CAL 8 BULK SOLN Level 2 ................... Bulk container: 4 mL–100 L ............... 3/22/2012 Siemens Healthcare Diagnostics Inc VS LOCI CAL 8 BULK SOLN Level 3 ................... Bulk container: 4 mL–100 L ............... 3/22/2012 Siemens Healthcare Diagnostics Inc VS LOCI CAL 8 BULK SOLN Level 4 ................... Bulk container: 4 mL–100 L ............... 3/22/2012 Siemens Healthcare Diagnostics Inc VS LOCI CAL 8 BULK SOLN Level 5 ................... Bulk container: 4 mL–100 L ............... 3/22/2012 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 μg/mL in methanol ........... Glass ampule: 1 mL ........................... 7/31/2012 Ultra Scientific, Inc ............................. DSA Detection Cocaine HCl Standard .................. Amber ampule: 1 mL ....... .................. 12/22/2011 Ultra Scientific, Inc ............................. DSA Detection Cocaine HCl StandardPhenobarbital (625 μg/mL). Amber ampule: 1 mL ......................... 12/22/2011

Ultra Scientific, Inc ............................. DSA Detection Cocaine HCl StandardPhenobarbital (6400 μg/mL). Amber ampule: 1 mL ......................... 12/22/2011

Ultra Scientific, Inc ............................. GE-Ion Track 100 ng/μL TNT/Cocaine HCl Standard Rev. 1. Amber ampule: 10 mL ....................... 12/22/2011

Ultra Scientific, Inc ............................. GE-Ion Track 100 ng/μL TNT/Cocaine HCl Standard Rev. 1. Glass bottle: 100 mL .......................... 12/22/2011

Ultra Scientific, Inc ............................. Phenobarbital (625 μg/mL) .................................... Amber ampule: 1 mL ......................... 5/31/2012 Ultra Scientific, Inc ............................. Phenobarbital (6400 μg/mL) .................................. Amber ampule: 1 mL ......................... 5/31/2012 Ultra Scientific, Inc ............................. Ultracheck WS Chloral Hydrate Sample ................ Glass ampule: 2 mL ....... .................... 12/22/2011



### 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.



### C HART 

### II

Supplier Product name Form Denial date

Abbott Laboratories ............................ ARCHITECT Estradiol Assay Diluent, No. 2K25J Tank: 50–500 L ...................... ............ 12/22/2011 Abbott Laboratories ............................ AxSYM Estradiol Buffer ......................................... Bulk Tank: 50–500L; Bag-in-box: 18–200 L. 12/22/2011

American Radiolabeled Chemicals,

Inc.. Lysergic acid diethylamide ..................................... Vial: 1 mL ........................................... 12/22/2011

Biochemical Diagnostics, Inc. ............ Benzoylecgonine Bulk Solution (5 mg/mL) ............ Bottle: 1 ml–1 L ................... ............... 11/15/2011 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 mg/mL) .............. Bottle: 1 ml–1 L ................... ............... 11/15/2011 Biochemical Diagnostics, Inc. ............ Detectabuse Custom Liquid Control Urine, MC134 Glass vials: 500 ml–2 L ................ ..... 11/15/2011 Biochemical Diagnostics, Inc. ............ Detectabuse Custom Liquid Control Urine, MC135 Glass vials: 500 ml–2 L ................ ..... 11/15/2011 Biochemical Diagnostics, Inc. ............ Detectabuse Custom Liquid Control Urine, MC136 Glass vials: 200 ml–2 L ................ ..... 11/15/2011 Biochemical Diagnostics, Inc. ............ Detectabuse Custom Liquid Control Urine, MC137 Glass vials: 500 ml–2 L ................ ..... 11/15/2011


## 4456 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### II—Continued

Supplier Product name Form Denial date

Biochemical Diagnostics, Inc. ............ Detectabuse Custom Liquid Control Urine, MC138 Glass vials: 500 ml–2 L ................ ..... 11/15/2011 Biochemical Diagnostics, Inc. ............ Detectabuse Custom Liquid Control Urine, MC139 Glass vials: 500 ml–2 L ................ ..... 11/15/2011 Biochemical Diagnostics, Inc. ............ Detectabuse Custom Liquid Control Urine, MC140 Glass vials: 500 ml–2 L ................ ..... 11/15/2011 Biochemical Diagnostics, Inc. ............ Detectabuse Custom Liquid Control Urine, MC141 Glass vials: 500 ml–2 L ................ ..... 11/15/2011 Biochemical Diagnostics, Inc. ............ Detectabuse Custom Liquid Control Urine, MC142 Glass vials: 1 ml–200 mL ............... ... 11/15/2011 Biochemical Diagnostics, Inc. ............ d-Methamphetamine Bulk Solution(5 mg/mL) ....... Bottle: 1 ml–1 L ....................... ........... 11/15/2011 Biochemical Diagnostics, Inc. ............ d-Propoxyphene Bulk Solution (5 mg/mL) ............. Bottle: 1 ml–1 L ................... ............... 11/15/2011 Biochemical Diagnostics, Inc. ............ Hydrocodone Bulk Solution(5 mg/mL) ................... Bottle: 1 ml–1 L ................. ................. 11/15/2011 Biochemical Diagnostics, Inc. ............ Hydromorphone Bulk Solution(5 mg/mL) ............... Bottle: 1 ml–1 L ................... ............... 11/15/2011 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/mL) ...................... Bottle: 1 ml–1 L ................ .................. 11/15/2011 Biochemical Diagnostics, Inc. ............ Methaqualone Bulk Solution(5 mg/mL) .................. Bottle: 1 ml–1 L ................. ................. 11/15/2011 Biochemical Diagnostics, Inc. ............ Morphine Bulk Solution (5 mg/mL) ........................ Bottle: 1 ml–1 L .............. .................... 11/15/2011 Biochemical Diagnostics, Inc. ............ Oxazepam Bulk Solution (5 mg/mL) ...................... Bottle: 1 ml–1 L ................ .................. 11/15/2011 Biochemical Diagnostics, Inc. ............ Secobarbital Bulk Solution (5 mg/mL) ................... Bottle: 1 ml–1 L ............... ................... 11/15/2011 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control C1 Minipak .... Amber Vial: 20mL ................. ............. 12/22/2011 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control C2 Minipak .... Amber Vial: 20mL ................. ............. 12/22/2011 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control C3 Minipak .... Amber Vial: 20mL ................. ............. 12/22/2011 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control C4 Minipak .... Amber Vial: 20mL ................. ............. 12/22/2011 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control Low Opiate Level C2 Minipak. Amber Vial: 20mL .............................. 12/22/2011

Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control Low Opiate Level C3 Minipak. Amber Vial: 20mL .............................. 12/22/2011

Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S1 Minipak .... Amber Vial: 10mL ................. ............. 12/22/2011Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S1E Low Opiate Minipak. Amber Vial: 10mL .............................. 12/22/2011

Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S1E Minipak .. Amber Vial: 10mL .................. ............ 12/22/2011 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S1S Minipak .. Amber Vial: 10mL .................. ............ 12/22/2011 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S2 Minipak .... Amber Vial: 10mL ................. ............. 12/22/2011Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S2E Low Opiate Minipak. Amber Vial: 10mL .............................. 12/22/2011

Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S2E Minipak .. Amber Vial: 10mL .................. ............ 12/22/2011 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S2SMinipak ... Amber Vial: 10mL .................. ............ 12/22/2011 Bio-Rad Laboratories ......................... Liquichek Urine Toxicology Control S3 Minipak .... Amber Vial: 10mL ................. ............. 12/22/2011 Cayman Chemical Company ............. 4-Methylmethcathinone (hydrochloride), 10 mg in 1 mL Methanol. Glass vial: 1 mL ................................. 7/31/2012

Cayman Chemical Company ............. 4-Methylmethcathinone (hydrochloride), 25 mg in 2.5 mL Methanol. Glass vial: 2.5 mL .............................. 7/31/2012

Cayman Chemical Company ............. 4-Methylmethcathinone (hydrochloride), 5 mg in 500 μ L Methanol. Glass vial: 500 μL .............................. 7/31/2012

Cayman Chemical Company ............. 5-methoxy DMT, 10 mg in 1 mL Methanol ............ Glass vial: 1 mL .......................... ....... 7/31/2012 Cayman Chemical Company ............. 5-methoxy DMT, 25 mg in 2.5 mL Methanol ......... Glass vial: 2.5 mL ......................... ..... 7/31/2012 Cayman Chemical Company ............. 5-methoxy DMT, 5 mg in 500 μL Methanol ........... Glass vial: 500 μL .............................. 7/31/2012 Cayman Chemical Company ............. Methylenedioxy Pyrovalerone (hydrochloride), 10 mg in 1 mL Methanol. Glass vial: 1 mL ................................. 7/31/2012

Cayman Chemical Company ............. Methylenedioxy Pyrovalerone (hydrochloride), 25 mg in 2.5 mL Methanol. Glass vial: 2.5 mL .............................. 7/31/2012

Cayman Chemical Company ............. Methylenedioxy Pyrovalerone (hydrochloride), 5 mg in 500 μ L Methanol. Glass vial: 500 μL .............................. 7/31/2012

Cayman Chemical Company ............. Methylenedioxy Pyrovalerone, 10 mg in 1 mL Methanol. Glass vial: 1 mL ................................. 7/31/2012

Cayman Chemical Company ............. Methylenedioxy Pyrovalerone, 25 mg in 2.5 mL Methanol. Glass vial: 2.5 mL .............................. 7/31/2012

Cayman Chemical Company ............. Methylenedioxy Pyrovalerone, 5 mg in 500 μL Methanol. Glass vial: 500 μL .............................. 7/31/2012

Cayman Chemical Company ............. Methylenedioxy Pyrovalerone-d8 (hydrochloride), 10 mg in 1 mL Methanol. Glass vial: 1 mL ................................. 7/31/2012

Cayman Chemical Company ............. Methylenedioxy Pyrovalerone-d8 (hydrochloride), 25 mg in 2.5 mL Methanol. Glass vial: 2.5 mL .............................. 7/31/2012

Cayman Chemical Company ............. Methylenedioxy Pyrovalerone-d8 (hydrochloride), 5 mg in 500 μ L Methanol. Glass vial: 500 μL .............................. 7/31/2012

Cayman Chemical Company ............. Methylone (hydrochloride), 10 mg in 1 mL Methanol. Glass vial: 1 mL ................................. 7/31/2012

Cayman Chemical Company ............. Methylone (hydrochloride), 25 mg in 2.5 mL Methanol. Glass vial: 2.5 mL .............................. 7/31/2012

Cayman Chemical Company ............. Methylone (hydrochloride), 5 mg in 500 μL Methanol. Glass vial: 500 μL .............................. 7/31/2012

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


## 4457 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices

C HART 

### II—Continued

Supplier Product name Form Denial date

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 1–4 .......................... Glass vial: 10 mL .......... ..................... 6/19/2012 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 mg/mL) .......... Ampule: 2 mL ..................... ................ 7/5/2012 Siemens Healthcare Diagnostics Inc. Dimension Vista UDAT CAL Bulk, Level B ........... Bulk Container: 4mL–100L ................ 12/22/2011 Siemens Healthcare Diagnostics Inc. Dimension Vista UDAT CAL Bulk, Level B ........... Bulk Container: 26 L–50L .................. 5/31/2012 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 L .......... ..... 11/5/2012 Siemens Healthcare Diagnostics Inc. Drug CAL BULK SOLN, Level 4 ............................ Bulk container: 2 mL–100 L .......... ..... 11/5/2012 Siemens Healthcare Diagnostics Inc. Drug CAL BULK SOLN, Level 5 ............................ Bulk container: 2m L–100 L .......... ..... 11/5/2012 Siemens Healthcare Diagnostics Inc. VS Drug 1 Cal Bulk Soln, Level B ......................... Bulk container: 2 mL–100 L ........ ....... 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 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 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


## 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. Approved Exempt Chemical Preparations Are Posted on DEA’s Web site

A list of all current exemptions, including those listed in this order, is available on DEA’s Web site at http:// www.deadiversion.usdoj.gov/schedules/ exempt/exempt

_chemlist.pdf. The dates of applications of all current exemptions are posted for easy reference. Dated: 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** 

**AGENCY** 

### : Employee Benefits Security Administration, Department of Labor.
**ACTION** 

### : Notice.

**SUMMARY** 

### : 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 (http://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). 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: 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;