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

1This 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 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4447 

narcotic substance cannot in practice be 

removed. 

Accordingly, pursuant to 21 U.S.C. 

811(g)(3)(B), 21 CFR 1308.23, and 21 

CFR 1308.24, the Deputy Assistant 

Administrator has determined that each 

of the chemical preparations or mixtures 

generally described in Chart I below and 

specifically described in the application 

materials received by DEA, are exempt 

from application of sections 302, 303, 

305, 306, 307, 308, 309, 1002, 1003, and 

1004 (21 U.S.C. 822–823, 825–829, and 

952–954) of the CSA and from 

application of 21 CFR 1301.74, to the 

extent described in 21 CFR 1308.24, as 

of the date listed below that was 

provided in the approval letters to the 

individual requesters. 

CHART I 

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 


tkelley on DSK3SPTVN1PROD with 
4448 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 

CHART 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 ........................................... 12/22/2011 

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 ........................................... 12/22/2011 

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 ........................................... 12/22/2011 

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

Fentanyl [3H(G)] as TFA salt ................................. Vial: 1 mL ........................................... 12/22/2011 

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

Heroin [methyl-14C] ............................................... Vial: 1 mL ........................................... 12/22/2011 

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4449 

CHART I—Continued 

Supplier Product name Form Exemption 

date 

American Radiolabeled Chemicals, 

Inc.

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

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 ........................................... 12/22/2011 

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 ........................................... 12/22/2011 

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

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

American Radiolabeled Chemicals, 

Inc.

Oxycodone [N-methyl-14C] 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 ........................................... 12/22/2011 

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 


tkelley on DSK3SPTVN1PROD with 
4450 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 

CHART 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 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4451 

CHART I—Continued 

Supplier Product name Form Exemption 

date 

Bio-Rad Laboratories ......................... Liquichek Immunoassay Plus Control Levels 1, 2, 

and 3.

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 ................. 5/31/2012 

Bio-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 ................. 5/31/2012 

Bio-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 vials ....... 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 vials ....... 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 mL .......................... 12/22/2012 

Cerilliant Corporation ......................... Carisoprodol-D7 (0.1 mg/mL) ................................ Glass Ampule: 2 mL .......................... 12/22/2012 

Cerilliant Corporation ......................... Carisoprodol-D7 (1 mg/mL) ................................... Glass Ampule: 2 mL .......................... 7/31/2012 

Cerilliant Corporation ......................... Cocaine N-oxide HCl (1 mg/mL) ............................ Glass Ampule: 2 mL .......................... 12/22/2011 

Cerilliant Corporation ......................... Cocaine N-oxide HCl (1 mg/mL) ............................ Glass Ampule: 2 mL .......................... 3/8/2012 

Cerilliant Corporation ......................... Cocaine N-oxide-D3 HCl (0.1 mg/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 


tkelley on DSK3SPTVN1PROD with 
4452 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 

CHART 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 .......................... 5/9/2012 

Microgenics 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 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4453 

CHART 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 


tkelley on DSK3SPTVN1PROD with 
4454 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 

CHART 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 ........................................ 11/5/2012 

Siemens 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 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4455 

CHART I—Continued 

Supplier Product name Form Exemption 

date 

Siemens Healthcare Diagnostics Inc 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. 

CHART 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: 50–500 L; 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 


tkelley on DSK3SPTVN1PROD with 
4456 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 

CHART 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 .............................. 12/22/2011 

Bio-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 .............................. 12/22/2011 

Bio-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 μL 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 μL 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 μL 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 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4457 

CHART 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 


tkelley on DSK3SPTVN1PROD with 
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; 


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