Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40175 

changes in market demand abroad). 

Demand conditions to consider include 

end uses and applications; the existence 

and availability of substitute products; 

and the level of competition among the 

Domestic Like Product produced in the 

United States, Subject Merchandise 

produced in the Subject Country, and 

such merchandise from other countries. 

(13) (OPTIONAL) A statement of 

whether you agree with the above 

definitions of the Domestic Like Product 

and Domestic Industry; if you disagree 

with either or both of these definitions, 

please explain why and provide 

alternative definitions. 

Authority: This review is being conducted 

under authority of Title VII of the Tariff Act 

of 1930; this notice is published pursuant to 

section 207.61 of the Commission’s rules. 

Issued: June 25, 2013. 

By order of the Commission. 

William R. Bishop, 

Supervisory Hearings and Information 

Officer. 

[FR Doc. 2013–16103 Filed 7–2–13; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

[OMB Number 1103–NEW] 

Agency Information Collection 

Activities; Proposed New Collection; 

Comments Requested: Police-Led 

Diversion Programs: National 

Prevalence and Scope 

ACTION: 60-Day Notice. 

The Department of Justice (DOJ) 

Office of Community Oriented Policing 

Services (COPS) will be submitting the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The proposed 

information collection is published to 

obtain comments from the public and 

affected agencies. The purpose of this 

notice is to allow for 60 days for public 

comment until September 3, 2013. This 

process is conducted in accordance with 

5 CFR 1320.10. 

If you have comments, especially on 

the estimated public burden or 

associated response time, suggestions, 

or need a copy of the proposed 

information collection instrument with 

instructions or additional information, 

please contact Danielle Ouellette, 

Department of Justice Office of 

Community Oriented Policing Services, 

145 N Street NE., Washington, DC 

20530. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address one or more 

of the following four points: 

—Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

—Evaluate the accuracy of the agency’s 

estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

—Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

—Minimize the burden of the collection 

of information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms 

of information technology, e.g., 

permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Proposed new collection; comments 

requested 

(2) Title of the Form/Collection: 

Police-Led Diversion Programs: National 

Prevalence and Scope 

(3) Agency form number, if any, and 

the applicable component of the 

Department sponsoring the collection: 

None. U.S. Department of Justice Office 

of Community Oriented Policing 

Services 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Law enforcement agencies 

through a nationally representative 

sample may be asked to provide 

information to determine the national 

prevalence of police-led diversion 

programs and provide a portrait of their 

goals, target populations, and policies. 

Through a cooperative agreement with 

the COPS Office, the Center for Court 

Innovation (CCI, Inc.) will create a 

representative sample of law 

enforcement agencies based on data 

available through the FBI Uniform 

Crime Reporting. CCI will subcontract 

with a professional survey research firm 

to administer the survey. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond/reply: It is estimated that 3,600 

respondents annually will complete the 

form in approximately 1 hour. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: There are an estimated 3,600 

total annual burden hours associated 

with this collection. 

If additional information is required 

contact: Jerri Murray, Department 

Clearance Officer, United States 

Department of Justice, Justice 

Management Division, Policy and 

Planning Staff, Two Constitution 

Square, 145 N Street NE., Room 1407B, 

Washington, DC 20530. 

June 27, 2013. 

Jerri Murray, 

Department Clearance Officer, PRA, U.S. 

Department of Justice. 

[FR Doc. 2013–15904 Filed 7–2–13; 8:45 am] 

BILLING CODE 4410–AT–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–372] 

Exempt Chemical Preparations Under 

the Controlled Substances Act 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Order with opportunity for 

comment. 

SUMMARY: The applications for exempt 

chemical preparations received by DEA 

between July 1, 2012, and March 31, 

2013, as listed below, were accepted for 

filing and have been approved or denied 

as indicated. 

DATES: Electronic comments must be 

submitted and written comments must 

be postmarked on or before September 

3, 2013. The electronic Federal Docket 

Management System will not accept 

comments after midnight Eastern Time 

on the last day of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–372’’ on all electronic and 

written correspondence. DEA 

encourages that all comments be 

submitted electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at http:// 

www.regulations.gov for easy reference. 

Paper comments that duplicate the 

electronic submission are not necessary 

as all comments submitted to 

www.regulations.gov will be posted for 

public review and are part of the official 

docket record. Written comments 

submitted via regular or express mail 

should be sent to the Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/ODL, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 


emcdonald on DSK67QTVN1PROD with NOTICES
40176 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 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. 

FOR FURTHER INFORMATION CONTACT: John 

W. Partridge, Executive Assistant, Office 

of Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 307–7165. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and made available for 

public inspection online at http:// 

www.regulations.gov and in the DEA’s 

public docket. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want posted online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted online or made 

available in the public docket. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be redacted, and the comment, in 

redacted form, will be posted online and 

placed in DEA’s public docket file. 

Please note that the Freedom of 

Information Act applies to all comments 

received. If you wish to inspect the 

agency’s public docket file in person by 

appointment, please see the FOR

FURTHER INFORMATION CONTACT

paragraph. 

Legal Authority 

DEA implements and enforces Titles 

II and III of the Comprehensive Drug 

Abuse Prevention and Control Act of 

1970, often referred to as the Controlled 

Substances Act and the Controlled 

Substances Import and Export Act 

(codified at Title 21, Chapter 13 of the 

U.S.C.), as amended (CSA). DEA drafts 

and publishes the implementing 

regulations for these statutes in Title 21 

of the Code of Federal Regulations 

(CFR), parts 1300 to 1321. The CSA and 

its implementing regulations are 

designed to prevent, detect, and 

eliminate the diversion of controlled 

substances and listed chemicals into the 

illicit market while providing for a 

sufficient supply of controlled 

substances and listed chemicals for 

legitimate medical, scientific, research, 

and industrial purposes. Controlled 

substances have the potential for abuse 

and dependence and are controlled to 

protect the public health and safety. 

Section 201 of the CSA (21 U.S.C. 

811) authorizes the Attorney General, by 

regulation, to exempt from certain 

provisions of the CSA certain 

compounds, mixtures, or preparations 

containing a controlled substance, if he 

finds that such compounds, mixtures, or 

preparations meet the requirements 

detailed in 21 U.S.C. 811(g)(3)(B).1 DEA 

regulations at 21 CFR 1308.23 and 

1308.24 further detail the criteria by 

which the DEA Deputy Assistant 

Administrator may exempt a chemical 

preparation or mixture from the 

application of certain provisions of the 

CSA. The Deputy Assistant 

Administrator may, pursuant to 21 CFR 

1308.23(f), modify or revoke the criteria 

by which exemptions are granted and 

modify the scope of exemptions at any 

time. 

Exempt Chemical Preparation 

Applications Submitted Between July 1, 

2012, and March 31, 2013 

The Deputy Assistant Administrator 

received applications between July 1, 

2012, and March 31, 2013, requesting 

exempt chemical preparation status 

pursuant to 21 CFR 1308.23. Pursuant to 

the criteria stated in 21 U.S.C. 

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

Deputy Assistant Administrator has 

found that each of the compounds, 

mixtures, and preparations described in 

Chart I below is intended for laboratory, 

industrial, educational, or special 

research purposes and not for general 

administration to a human being or 

other animal and either: (1) Contains no 

narcotic controlled substance and is 

packaged in such a form or 

concentration that the packaged 

quantity does not present any 

significant potential for abuse; or (2) 

contains either a narcotic or nonnarcotic controlled substance and one or 

more adulterating or denaturing agents 

in such a manner, combination, 

quantity, proportion, or concentration 

that the preparation or mixture does not 

present any potential for abuse; if the 

preparation or mixture contains a 

narcotic controlled substance, it must be 

formulated in such a manner that it 

incorporates methods of denaturing or 

other means so that the preparation or 

mixture is not liable to be abused or 

have ill effects if abused, and so that the 

narcotic substance cannot in practice be 

removed. 

Accordingly, pursuant to 21 U.S.C. 

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

CFR 1308.24, the Deputy Assistant 

Administrator has determined that each 

of the chemical preparations or mixtures 

generally described in Chart I below and 

specifically described in the application 

materials received by DEA, are exempt, 

to the extent described in 21 CFR 

1308.24, from application of sections 

302, 303, 305, 306, 307, 308, 309, 1002, 

1003, and 1004 (21 U.S.C. 822–823, 

825–829, and 952–954) of the CSA, and 

21 CFR 1301.74, as of the date listed 

below that was provided in the approval 

letters to the individual requesters. 

CHART I 

Supplier Product name Form Application 

date 

AccuStandard, Inc ................... APP–9–086, a,a-Dimethylphenethylamine .............................. Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... APP–9–086–20X, a,a-Dimethylphenethylamine ...................... Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... AS–E1179, Chloral hydrate ..................................................... Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... CLP–HC–X1, Composite Mix #3A ........................................... Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... M–551.1B, Disinfectant by-products ........................................ Amber ampule: 1 mL .............. 1/28/2013 


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CHART I—Continued 

Supplier Product name Form Application 

date 

AccuStandard, Inc ................... M–551B, Disinfectant by-products ........................................... Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... M–551B–2, Chloral hydrate ..................................................... Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... M–8015B/5031–21, Paraldehyde ............................................. Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... M–8206B–05, Additional VOC’s by Method 8206B ................. Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... M–8270–02, Semi-Volatile by Capillary Column GC/MS Mix 2 Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... M–8270–04–ASL, Method 8270B—Base/Neutrals Mix ........... Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... M–8270–23–R1, Method 8270 Semi-Volatile Additions .......... Amber ampule: 1 mL .............. 1/28/2013 

AccuStandard, Inc ................... M–E–1179–M, Chloral hydrate ................................................ Amber ampule: 1 mL .............. 1/28/2013 

Agilent Technologies ............... Veterinary Drugs Checkout Mix ............................................... Amber ampule: 1 mL .............. 8/3/2012 

Agilent Technologies ............... Veterinary Drugs Comprehensive Mix—Submix 6 .................. Amber ampule: 1 mL .............. 8/3/2012 

Agilent Technologies ............... Forensic Toxicology Comprehensive Mix—Submix 3 ............. Amber ampule: 1 mL .............. 8/3/2012 

Agilent Technologies ............... Forensic Toxicology Comprehensive Mix—Submix 5 ............. Amber ampule: 1 mL .............. 8/3/2012 

Agilent Technologies ............... Forensic Toxicology Comprehensive Mix—Submix 2 ............. Amber ampule: 1 mL .............. 8/3/2012 

Agilent Technologies ............... Forensic Toxicology Checkout Mix .......................................... Amber ampule: 1 mL .............. 8/3/2012 

Agilent Technologies ............... Forensic Toxicology Comprehensive Mix—Submix 1 ............. Amber ampule: 1 mL .............. 12/6/2012 

Alltech Associates, Inc ............ 2C–T–2 Quik Check, 1.0 mg/mL ............................................. Glass ampule: 1 mL ............... 9/26/2012 

Alltech Associates, Inc ............ 5-MeO–DMT Quick Check, 1.0 mg/mL ................................... Glass ampule: 1 mL ............... 9/26/2012 

Alltech Associates, Inc ............ Carisoprodol Quik Check, 1.0 mg/mL ...................................... Glass ampule: 1 mL ............... 9/26/2012 

American Proficiency Institute American Proficiency Institute SHBG/Testosterone ................ Amber bottle: 7 mL ................. 12/5/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Oral Fluid, OF23 ............ Glass vials: 1 ml–200 mL ....... 8/14/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, SD17 ................... Glass vials: 1 ml–200 mL ....... 8/14/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC176 ................ Glass vials: 1 ml–200 mL ....... 9/27/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC179 ................ Glass vials: 1 ml–200 mL ....... 10/23/2012 

Biochemical Diagnostics, Inc .. Salivabuse Custom Liquid Control Oral Fluid, OF25 .............. Glass vials: 1 ml–200 mL ....... 10/23/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC177 ................ Glass vials: 1 ml–200 mL ....... 11/5/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC178 ................ Glass vials: 1 ml–200 mL ....... 1/24/2013 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Oral Fluid, OF24 ............ Glass vials: 1 ml–200 mL ....... 1/24/2013 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC181 ................ Glass vials: 1 ml–200 mL ....... 1/29/2013 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC183 ................ Glass vials: 1 ml–200 mL ....... 3/12/2013 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC184 ................ Glass vials: 1 ml–200 mL ....... 3/12/2013 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC180 ................ Glass vials: 1 ml–200 mL ....... 3/14/2013 

Bio-Rad Laboratories .............. Liquichek Immunoassay Plus Control Trilevel MiniPak ........... Box: 3 vials, 2.5 mL each ....... 11/14/2012 

Bio-Rad Laboratories .............. Liquichek Immunoassay Plus Control Level 1,2 and 3, 

Trilevel.

Box: 12 vials, 5 mL each ........ 11/21/2012 

Bio-Rad Laboratories .............. Liquid Assayed Multiqual Premium, Levels 1–3 ...................... Box: 6 vials, 5 mL each .......... 11/21/2012 

Bio-Rad Laboratories .............. Liquid Assayed Multiqual Premium, Trilevel Minipak .............. Box: 3 vials, 5 mL each .......... 11/21/2012 

Bio-Rad Laboratories .............. Lyphocheck Urine Toxicology Control MiniPak, Cat. No. 

470X.

Glass vial: 25 mL .................... 1/11/2013 

Bio-Rad Laboratories .............. Liquichek Immunoassay Plus Control Level 1 ......................... Glass vial: 2.5 mL, Box 12

vials.

2/20/2013 

Bio-Rad Laboratories .............. Liquichek Immunoassay Plus Control Level 2 ......................... Glass vial: 2.5 mL, Box 12

vials.

2/20/2013 

Bio-Rad Laboratories .............. Liquichek Immunoassay Plus Control Level 3 ......................... Glass vial: 2.5 mL, Box 12

vials.

2/20/2013 

Cerilliant Corporation ............... Benzodiazepine Mix (1 mg/mL) ............................................... Glass Ampule: 1 mL ............... 7/2/2012 

Cerilliant Corporation ............... Class C Mix Urinalysis Internal Standard Fortified Morphine .. Glass Ampule: 1 mL ............... 7/9/2012 

Cerilliant Corporation ............... Spice Cannabinoid Mix 2 (0.1 mg/mL) .................................... Amber ampule: 1 mL .............. 9/26/2012 

Cerilliant Corporation ............... Spice Cannabinoid Mix 3 (0.1 mg/mL) .................................... Amber ampule: 1 mL .............. 9/26/2012 

Cerilliant Corporation ............... Retigabine (1 mg/mL) .............................................................. Glass Ampule: 1 mL ............... 11/7/2012 

Cerilliant Corporation ............... ±-Norpseudoephedrine-D3 HCl (0.1 mg/mL) ........................... Glass Ampule: 1 mL ............... 1/7/2013 

Cerilliant Corporation ............... Amobarbital-D5 (0.1 mg/mL) .................................................... Glass Ampule: 1 mL ............... 1/7/2013 

Cerilliant Corporation ............... 2,5-Dimethoxy-4-(n)-propylthiophenethylamine HCl (2C–T–7 

HCl) (1 mg/mL).

Glass Ampule: 1 mL ............... 1/7/2013 

Cerilliant Corporation ............... Class B Mix Urinalysis Internal Standard-8 (0.002–0.2 mg/ 

mL), Pregabalin-D6 (1.0 mg/mL), Codeine-6-betaglucoronide (1.0 mg/mL), Desomorphine (1.0 mg/mL), 

Levorphanol-D3 (0.1 mg/mL).

Glass ampule: 1 ml ................. 1/22/2013 

Cerilliant Corporation ............... Zaleplon-D4 (0.1 mg/mL) ......................................................... Glass Ampule: 1 mL ............... 1/31/2013 

Cerilliant Corporation ............... Retigabine-D4 (0.1 mg/mL) ...................................................... Glass ampule: 1ml .................. 3/22/2013 

Cerilliant Corporation ............... Tilidine-D6 HCl (0.1 mg/mL) .................................................... Glass ampule: 1ml .................. 3/22/2013 

Cliniqa Corporation .................. TDM Control, Levels 1–3 ......................................................... Dropper bottle: 5 mL ............... 12/4/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Controls, THC (0.5–50 ng/mL) ......................... Glass vial: 5 ml–4 L ................ 10/22/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Controls, Methamphetamine (2–200 ng/mL) .... Glass vial: 5 ml–4 L ................ 10/22/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Controls, Amphetamine, Benzoylecgonine, 

Morphine, Phencyclidine (2–200 ng/mL).

Glass vial: 5 ml–4 L ................ 10/22/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Controls, Multidrug (THC, Benzoylecgonine, 

Amphetamine, Methamphetamine, Morphine, Codeine, 6- 

Acetylmorphine, & PCP) at 0.5–50 ng/mL.

Glass vial: 5 ml–4 L ................ 10/22/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Calibrators, THC (0.5–50 ng/mL) ..................... Glass vial: 5 ml–4 L ................ 10/22/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Calibrators, Methamphetamine (2–200 ng/mL) Glass vial: 5 ml–4 L ................ 10/22/2012 


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CHART I—Continued 

Supplier Product name Form Application 

date 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Calibrators, Amphetamine, Benzoylecgonine, 

Morphine, Phencyclidine (2–200 ng/mL).

Glass vial: 5 ml–4 L ................ 10/22/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Calibrators, Multidrug (THC, Benzoylecgonine, 

Amphetamine, Methamphetamine, Morphine, Codeine, 6- 

Acetylmorphine, & PCP) at 0.5–200 ng/mL.

Glass vial: 5 ml–4 L ................ 10/22/2012 

Environmental Resource Associates (ERA).USGS–BQS LS 4434 Mix 1 ..................................................... Glass Ampule: 2 mL ............... 8/9/2012 

Environmental Resource Associates (ERA).USGS–BQS LS 4434 Mix 2 ..................................................... Glass Ampule: 2 mL ............... 8/9/2012 

Immunalysis Corporation ......... Tapentadol Calibrator Level 1 (100 ng/mL) ............................. Glass vial: 10 mL .................... 12/11/2012 

Immunalysis Corporation ......... Tapentadol Calibrator Level 2 (200 ng/mL) ............................. Glass vial: 10 mL .................... 12/11/2012 

Immunalysis Corporation ......... Tapentadol Calibrator Level 3 (500 ng/mL) ............................. Glass vial: 10 mL .................... 12/11/2012 

Immunalysis Corporation ......... Tapentadol Calibrator Level 4 (1,000 ng/mL) .......................... Glass vial: 10 mL .................... 12/11/2012 

Immunalysis Corporation ......... Tapentadol Low Control (150 ng/mL) ...................................... Glass vial: 10 mL .................... 12/11/2012 

Immunalysis Corporation ......... Tapentadol High Control (250 ng/mL) ..................................... Glass vial: 10 mL .................... 12/11/2012 

LGC Limited ............................ (S)-(+)-Amphetamine (Dextroamphetamine) 1.0 mg/mL in 

Methanol.

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Amphetamine 0.1 mg/mL in Methanol ............................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Amphetamine 1.0 mg/mL in Methanol ............................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Amphetamine-D11 0.1 mg/mL in Methanol ....................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Amphetamine-D11 1.0 mg/mL in Methanol ....................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Amphetamine-D5 (D-label on ring) 0.1 mg/mL in Methanol.Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Methamphetamine ((S)-(+)-Methamphetamine) 1.0 mg/mL in 

Methanol.

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Methamphetamine 0.1 mg/mL in Methanol ....................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Methamphetamine 1.0 mg/mL in Methanol ....................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Methamphetamine-D5 0.1 mg/mL in Methanol ................. Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Methamphetamine-D5 1.0 mg/mL in Methanol ................. Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Methcathinone Hydrochloride 1.0 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Methylphenidate Hydrochloride 1.0 mg/mL in Methanol (as 

free base).

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Amobarbital 1.0 mg/mL in Methanol ........................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Pentobarbital 1.0 mg/mL in Methanol ...................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Pentobarbital-D5 1.0 mg/mL in Methanol ................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Pentobarbital-D5 0.1 mg/mL in Methanol ................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Secobarbital 1.0 mg/mL in Methanol ....................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-MDA–D5 (rac-3,4-Methylenedioxyamphetamine-D5) 0.1 

mg/mL Methanol.

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-MDA–D5 (rac-3,4-Methylenedioxyamphetamine-D5) 1.0 

mg/mL Methanol.

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-MBDB HCl (rac-N-Methyl-1-(3,4-Methylenedioxyphenyl)- 

2-butanamine Hydrochloride) 1.0 mg/mL Methanol (as free 

base).

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-MBDB–D5 (rac-N-Methyl-1-(3,4-Methylenedioxyphenyl)-2- 

butanamine-D5) 0.1 mg/mL Methanol.

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-MDEA–D5 (rac-3,4-Methylenedioxy-N-ethylamphetamineD5) 0.1 mg/mL Methanol.Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-MDEA–D5 (rac-3,4-Methylenedioxy-N-ethylamphetamineD5) 1.0 mg/mL Methanol.Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-MDEA–D6 (rac-3,4-Methylenedioxy-N-ethylamphetamineD6) 0.1 mg/mL Methanol.Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-MDMA–D5 (rac-3,4-MethylenedioxymethamphetamineD5) 0.1 mg/mL Methanol.Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-MDMA–D5 (rac-3,4-MethylenedioxymethamphetamineD5) 1.0 mg/mL Methanol.Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Phencyclidine (PCP) 1.0 mg/mL Methanol .............................. Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Phencyclidine-D5 (PCP-D5) 0.1 mg/mL in Methanol .............. Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Phencyclidine-D5 (PCP-D5) 1.0 mg/mL Methanol .................. Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Codeine 0.1 mg/mL in Methanol .............................................. Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Codeine 1.0 mg/mL in Methanol .............................................. Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Codeine-D3 0.1 mg/mL in Methanol ........................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Codeine-D3 1.0 mg/mL in Methanol ........................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Codeine-D6 0.1 mg/mL in Methanol ........................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Codeine-D6 1.0 mg/mL in Methanol ........................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Isocodeine 0.1 mg/mL in Methanol .......................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Norcodeine 0.01 mg/mL in Methanol ....................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Norcodeine 1.0 mg/mL in Methanol ......................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Codeine N-Oxide 0.01 mg/mL Methanol ................................. Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Oxycodone-D3 1.0 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 9/24/2012 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40179 

CHART I—Continued 

Supplier Product name Form Application 

date 

LGC Limited ............................ Oxycodone-D6 0.1 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Oxycodone-D6 1.0 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Hydromorphone 1.0 mg/mL Methanol ..................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Norhydromorphone Hydrochloride 1.0 mg/mL Methanol (as 

free base).

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Pethidine (Meperidine) 1.0 mg/mL in Methanol ....................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Pethidine-D4 (Meperidine-D4) 0.1 mg/mL in Methanol ........... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Pethidine-D4 (Meperidine-D4) 1.0 mg/mL in Methanol ........... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Morphine 0.1 mg/mL in Methanol ............................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Morphine 1.0 mg/mL in Methanol ............................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Morphine 3-beta-D-Glucuronide 0.1 mg/mL in Methanol/ 

Water (1⁄1).

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Morphine 3-beta-D-Glucuronide 1.0 mg/mL in Methanol with 

0.05 percent Sodium Hydroxide (w/v).

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Morphine 6-beta-D-Glucuronide 0.1 mg/mL in Methanol/ 

Water (1⁄1).

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Morphine 6-beta-D-Glucuronide 1.0 mg/mL Water/Methanol 

(80/20).

Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Morphine-D3 0.1 mg/mL in Methanol ...................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Morphine-D3 1.0 mg/mL in Methanol ...................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Morphine N-Oxide 0.01 mg/mL Methanol ................................ Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ Normorphine 1.0 mg/mL Methanol .......................................... Glass vial: 1 mL ...................... 9/24/2012 

LGC Limited ............................ rac-Amphetamine-D10 0.1 mg/mL in Methanol ....................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Amphetamine-D5 (D-label on ring) 0.1 mg/mL in Methanol.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Amphetamine-D5 (D-label on side chain) 0.1 mg/mL in 

Methanol.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Amphetamine-D5 (D-label on side chain) 1.0 mg/mL in 

Methanol.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Amphetamine-D6 0.1 mg/mL in Methanol ......................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Amphetamine-D6 1.0 mg/mL in Methanol ......................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Amphetamine-D8 0.1 mg/mL in Methanol ......................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Amphetamine-D8 1.0 mg/mL in Methanol ......................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methamphetamine-D11 0.1 mg/mL in Methanol ............... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methamphetamine-D11 1.0 mg/mL in Methanol ............... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methamphetamine-D14 0.1 mg/mL in Methanol ............... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methamphetamine-D14 1.0 mg/mL in Methanol ............... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methamphetamine-D8 0.1 mg/mL in Methanol ................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methamphetamine-D8 1.0 mg/mL in Methanol ................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methamphetamine-D9 0.1 mg/mL in Methanol ................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methamphetamine-D9 1.0 mg/mL in Methanol ................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ (+)-Norpseudoephedrine Hydrochloride (Cathine Hydrochloride) 0.1 mg/mL in Methanol (as free base).Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ (R)-(+)-Cathinone Hydrochloride 1.0 mg/mL in Methanol (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ (S)-(-)-Cathinone Hydrochloride 1.0 mg/mL in Methanol (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ (S)-(-)-Methcathinone Hydrochloride 1.0 mg/mL in Methanol 

(as free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Phentermine 1.0 mg/mL in Methanol ....................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Fenfluramine Hydrochloride 1.0 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Methylphenidate-D9 Hydrochloride 0.1 mg/mL in Methanol ... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Pipradrol Hydrochloride 0.1 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Pipradrol Hydrochloride 1.0 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ GHB Sodium Salt (Sodium Gammahydroxybutyrate) 1.0 mg/ 

mL in Methanol (as free acid).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ GHB–D6 Sodium Salt (Sodium Gammahydroxybutyrate-D6) 

0.1 mg/mL in Methanol (as free acid).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ GHB–D6 Sodium Salt (Sodium Gammahydroxybutyrate-D6) 

1.0 mg/mL in Methanol (as free acid).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Hexobarbital 1.0 mg/mL in Methanol ....................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Methohexital 1.0 mg/mL in Methanol ....................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Methohexital-D5 0.1 mg/mL in Methanol ................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Phenobarbital 1.0 mg/mL in Methanol ..................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Phenobarbital-D5 (D-label on ring) 0.1 mg/mL in Methanol .... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Phenobarbital-D5 (D-label on ring) 1.0 mg/mL in Methanol .... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Phenobarbital-D5 (D-label on side chain) 0.1 mg/mL in Methanol.Glass vial: 1 mL ...................... 11/30/2012 


emcdonald on DSK67QTVN1PROD with NOTICES
40180 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 

CHART I—Continued 

Supplier Product name Form Application 

date 

LGC Limited ............................ Phenobarbital-D5 (D-label on side chain) 1.0 mg/mL in Methanol.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Methaqualone 1.0 mg/mL in Methanol .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Methaqualone-D7 0.1 mg/mL in Methanol .............................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Clonazepam 1.0 mg/mL in Methanol ....................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Clonazepam-D4 0.1 mg/mL in Methanol ................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Chlordiazepoxide 1.0 mg/mL in Methanol ............................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Chlordiazepoxide-D5 0.1 mg/mL in Methanol ......................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Bromazepam 0.1 mg/mL in Methanol ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Bromazepam 1.0 mg/mL in Methanol ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Clobazam 1.0 mg/mL in Methanol ........................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Delorazepam 0.1 mg/mL in Methanol ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Estazolam 1.0 mg/mL in Methanol .......................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Estazolam-D5 0.1 mg/mL in Methanol .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Flunitrazepam 0.1 mg/mL in Methanol .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Flunitrazepam 1.0 mg/mL in Methanol .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Flunitrazepam-D7 0.1 mg/mL in Methanol .............................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Prazepam 1.0 mg/mL in Methanol ........................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Prazepam-D5 0.1 mg/mL in Methanol ..................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Diazepam 0.1 mg/mL in Methanol ........................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Diazepam 1.0 mg/mL in Methanol ........................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Diazepam-D5 0.1 mg/mL in Methanol ..................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Diazepam-D5 1.0 mg/mL in Methanol ..................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Flurazepam 0.1 mg/mL in Methanol ........................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Flurazepam 1.0 mg/mL in Methanol ........................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Lormetazepam 1.0 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Zaleplon 1.0 mg/mL in Methanol ............................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Pregabalin 1.0 mg/mL in Methanol .......................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Pregabalin-D6 0.1 mg/mL in Methanol .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Zolpidem Tartrate 1.0 mg/mL in Methanol (as free base) ....... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Zolpidem-D6 0.1 mg/mL in Methanol ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Zopiclone 1.0 mg/mL in Acetonitrile ........................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Zopiclone Oxide 1.0 mg/mL in Methanol ................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Zopiclone-D4 0.1 mg/mL in Acetonitrile ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Meprobamate 1.0 mg/mL in Methanol ..................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Nitrazepam 0.1 mg/mL in Acetonitrile ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Nitrazepam 1.0 mg/mL in Acetonitrile ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Nitrazepam-D5 0.1 mg/mL in Acetonitrile ................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Oxazepam 1.0 mg/mL in Methanol .......................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Oxazepam-D5 0.1 mg/mL in Methanol .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Oxazepam-D5 1.0 mg/mL in Methanol .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Nordazepam (Nordiazepam) 0.1 mg/mL in Methanol ............. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Nordazepam (Nordiazepam) 1.0 mg/mL in Methanol ............. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Nordazepam-D5 (Nordiazepam-D5) 0.1 mg/mL in Methanol .. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Nordazepam-D5 (Nordiazepam-D5) 1.0 mg/mL in Methanol .. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Alprazolam 1.0 mg/mL in Methanol ......................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Alprazolam-D5 0.1 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Alprazolam-D5 1.0 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Methyltestosterone (17alpha-Methyltestosterone) 1.0 mg/mL 

in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Midazolam 1.0 mg/mL in Methanol .......................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Midazolam-D4 Maleate 0.1 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Lorazepam 0.1 mg/mL in Acetonitrile ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Lorazepam 1.0 mg/mL in Acetonitrile ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Lorazepam Acetate ((3RS)-7-Chloro-5-(2-chlorophenyl)-2- 

oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl Acetate) 0.1 

mg/mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Lorazepam-D4 0.1 mg/mL in Acetonitrile ................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Lorazepam-D4 1.0 mg/mL in Acetonitrile ................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Tetrazepam 0.1 mg/mL in Methanol ........................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Triazolam 1.0 mg/mL in Methanol ........................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Triazolam-D4 0.1 mg/mL in Methanol ..................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Temazepam 0.1 mg/mL in Methanol ....................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Temazepam 1.0 mg/mL in Methanol ....................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Temazepam-D5 0.1 mg/mL in Methanol ................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Temazepam-D5 1.0 mg/mL in Methanol ................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Androstanolone (5alpha-Dihydrotestosterone, Stanolone) 1.0 

mg/mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Androstenedione (Androst-4-ene-3, 17-dione) 1.0 mg/mL in 

Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40181 

CHART I—Continued 

Supplier Product name Form Application 

date 

LGC Limited ............................ Boldenone 1.0 mg/mL in Acetonitrile ....................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Fluoxymesterone 1.0 mg/mL in Acetonitrile ............................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Mesterolone 1.0 mg/mL in Acetonitrile .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Methandienone 1.0 mg/mL in Acetonitrile ............................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Nandrolone 1.0 mg/mL in Acetonitrile ..................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Norandrostenedione (19-Norandrost-4-ene-3,17-dione) 1.0 

mg/mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Norethandrolone 1.0 mg/mL in Acetonitrile ............................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Stanozolol 1.0 mg/mL in Acetonitrile ....................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Stanozolol-D3 0.1 mg/mL in 1,2-Dimethoxyethane ................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Testosterone 1.0 mg/mL in Acetonitrile ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Testosterone Benzoate 1.0 mg/mL in Acetonitrile ................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Testosterone Isocaproate 1.0 mg/mL in Acetonitrile ............... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Testosterone Propionate 1.0 mg/mL in Acetonitrile ................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Trenbolone 1.0 mg/mL in Acetonitrile ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ RCS–4 (DD–001, (4-Methoxyphenyl)(1-pentylindol-3- 

yl)methanone) 1.0 mg/mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ JWH–081 ((4-Methoxynaphthalen-1-yl)(1-pentylindol-3- 

yl)methanone) 1.0 mg/mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ JWH–122 ((4-Methylnaphthalen-1-yl)(1-pentylindol-3- 

yl)methanone) 1.0 mg/mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ JWH–203 (2-(2-Chlorophenyl)-1-(1-pentylindol-3-yl)ethanone) 

1.0 mg/mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ketamine Hydrochloride 1.0 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ketamine-D4 Hydrochloride 0.1 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Iso-LSD (Lysergic Acid Diethylamide) 0.1 mg/mL in Acetonitrile.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ LAMPA (Lysergic Acid N-Methyl-N-propylamide) 0.025 mg/ 

mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ LSD (Lysergic Acid Diethylamide) 0.025 mg/mL in Acetonitrile.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ LSD–D3 (Lysergic Acid Diethylamide-D3) 0.025 mg/mL in 

Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ PMA HCl (p-Methoxyamphetamine) 1.0 mg/mL in Methanol 

(as free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-MDA (rac-3,4-Methylenedioxyamphetamine) 1.0 mg/mL 

in Methanol.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-MDEA (rac-3,4-Methylenedioxy-N-ethylamphetamine) 1.0 

mg/mL in Methanol.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ 1-Methylamino-1-(3,4-methylenedioxyphenyl)propane Hydrochloride 1.0 mg/mL in Methanol (as free base).Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-BDB HCl (rac-3,4-Methylenedioxyphenyl-2-butanamine 

Hydrochloride) 1.0 mg/mL in Methanol (as free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-MDMA (rac-3,4-Methylenedioxymethamphetamine) 1.0 

mg/mL in Methanol.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Bufotenine 1.0 mg/mL in Acetonitrile ....................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Methylone Hydrochloride 1.0 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Methylone-D3 Hydrochloride 0.1 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ AM–694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole) 1.0 mg/ 

mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Cocaine 1.0 mg/mL in Acetonitrile ........................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Cocaine-D3 0.1 mg/mL in Acetonitrile ..................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Cocaine-D3 1.0 mg/mL in Acetonitrile ..................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Norcocaine Hydrochloride 1.0 mg/mL in Acetonitrile (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Norcocaine-D3 Hydrochloride 0.1 mg/mL in Acetonitrile (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ O-Methylcodeine 0.1 mg/mL in Acetonitrile ............................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Buprenorphine 0.1 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Buprenorphine 3-beta-D-Glucuronide 0.1 mg/mL in Methanol Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Buprenorphine-D4 0.1 mg/mL in Methanol .............................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Dihydrocodeine Hydrochloride 1.0 mg/mL in Methanol (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Dihydrocodeine-D6 Hydrochloride 0.1 mg/mL in Methanol (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Noroxycodone Hydrochloride 1.0 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 


emcdonald on DSK67QTVN1PROD with NOTICES
40182 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 

CHART I—Continued 

Supplier Product name Form Application 

date 

LGC Limited ............................ Noroxycodone-D3 Hydrochloride 0.1 mg/mL in Methanol (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Oxycodone 1.0 mg/mL in Methanol ......................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Oxycodone-D3 0.1 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Dihydromorphine 1.0 mg/mL in Methanol ................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Hydromorphone-D3 0.1 mg/mL in Methanol ........................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Anhydroecgonine Hydrochloride 1.0 mg/mL in Acetonitrile (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Anhydroecgonine Methyl Ester 1.0 mg/mL in Acetonitrile ....... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Benzoylecgonine 0.1 mg/mL in Methanol ................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Benzoylecgonine-D3 0.1 mg/mL in Methanol .......................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Benzoylecgonine-D3 1.0 mg/mL in Methanol .......................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Benzoylecgonine-D8 0.1 mg/mL in Methanol .......................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Benzoylecgonine-D8 1.0 mg/mL in Methanol .......................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Cocaethylene (Benzoylethylecgonine) 1.0 mg/mL in Acetonitrile.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Cocaethylene-D3 (Benzoylethylecgonine-D3) 0.1 mg/mL in 

Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Cocaethylene-D8 (Benzoylethylecgonine-D8) 0.1 mg/mL in 

Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ecgonine 1.0 mg/mL in Methanol ............................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ecgonine Ethyl Ester 1.0 mg/mL in Acetonitrile ...................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ecgonine Hydrochloride 1.0 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ecgonine Methyl Ester 0.1 mg/mL in Acetonitrile .................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ecgonine Methyl Ester 1.0 mg/mL in Acetonitrile .................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ecgonine-D3 Hydrochloride 0.1 mg/mL in Methanol (as free 

base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ecgonine-D3 Methyl Ester 0.1 mg/mL in Acetonitrile .............. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Ethylmorphine 1.0 mg/mL in Methanol .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Hydrocodone 1.0 mg/mL in Methanol ...................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Hydrocodone-D3 0.1 mg/mL in Methanol ................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Hydrocodone-D6 0.1 mg/mL in Methanol ................................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Norhydrocodone Hydrochloride 1.0 mg/mL in Methanol (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Heroin (Diacetylmorphine) 1.0 mg/mL in Acetonitrile .............. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Heroin-D9 (Diacetylmorphine-D9) 0.1 mg/mL in Acetonitrile .. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Heroin-D9 (Diacetylmorphine-D9) 1.0 mg/mL in Acetonitrile .. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methadone 0.1 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methadone 1.0 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methadone-D3 0.1 mg/mL in Methanol ............................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methadone-D3 1.0 mg/mL in Methanol ............................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methadone-D9 0.1 mg/mL in Methanol ............................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Methadone-D9 1.0 mg/mL in Methanol ............................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Dextropropoxyphene 0.1 mg/mL in Acetonitrile ....................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Dextropropoxyphene 1.0 mg/mL in Acetonitrile ....................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Propoxyphene-D11 0.1 mg/mL in Acetonitrile ................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Propoxyphene-D11 1.0 mg/mL in Acetonitrile ................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Propoxyphene-D5 0.1 mg/mL in Acetonitrile ..................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ rac-Propoxyphene-D5 1.0 mg/mL in Acetonitrile ..................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ 6-Acetylmorphine 0.1 mg/mL in Acetonitrile ............................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ 6-Acetylmorphine 1.0 mg/mL in Acetonitrile ............................ Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ 6-Acetylmorphine-D3 0.1 mg/mL in Acetonitrile ...................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ 6-Acetylmorphine-D3 1.0 mg/mL in Acetonitrile ...................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ 6-Acetylmorphine-D6 0.1 mg/mL in Acetonitrile ...................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ 6-Acetylmorphine-D6 1.0 mg/mL in Acetonitrile ...................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Acetylcodeine 0.1 mg/mL in Acetonitrile .................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Acetylcodeine 1.0 mg/mL in Acetonitrile .................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Nordihydromorphine Hydrochloride 1.0 mg/mL in Methanol 

(as free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Oxymorphone 1.0 mg/mL in Methanol .................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Oxymorphone-D3 0.1 mg/mL in Methanol ............................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Oxymorphone-D3 1.0 mg/mL in Methanol ............................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Noroxymorphone Hydrochloride 0.1 mg/mL in Methanol (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Noroxymorphone Hydrochloride 1.0 mg/mL in Methanol (as 

free base).

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Butorphanol Tartrate 1.0 mg/mL in Methanol (as free base) .. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Sufentanil Citrate 0.1 mg/mL in Methanol (as free base) ....... Glass vial: 1 mL ...................... 11/30/2012 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40183 

CHART I—Continued 

Supplier Product name Form Application 

date 

LGC Limited ............................ cis-Tilidine (Ethyl (1R,2RS)-2-(Dimethylamino)-1- 

phenylcyclohex-3-enecarboxylate) 0.1 mg/mL in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Tilidine 0.1 mg/mL in Acetonitrile ............................................. Glass vial: 1 mL ...................... 11/30/2012 

Microgenics Corporation ......... Abbott TDM Multiconstituent Calibrator (CAL 1–6) Catalog 

Number: 5P04–01.

Box: 7 vials; 5 mL each .......... 7/2/2012 

Microgenics Corporation ......... Thermo Scientific DRI Opiate Assay Catalog Number: 

100014602.

Vial: 18 mL, Box: 3 vials ......... 1/30/2013 

Microgenics Corporation ......... Thermo Scientific DRI Cannabinoid Assay Catalog Number: 

10014665.

Vial: 18 mL, Box: 3 vials ......... 1/30/2013 

Microgenics Corporation ......... Thermo Scientific Phencyclidine Assay Catalog Number: 

10014673.

Vial: 18 mL, Box: 3 vials ......... 1/30/2013 

Microgenics Corporation ......... Thermo Scientific Ecstacy Assay Catalog Number: 10014681 Vial: 18 mL, Box: 3 vials ......... 1/30/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 

1: Catalog Number 10016362.

Vial: 5 mL; Box: 1 vial ............ 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 

2: Catalog Number 10063.

Vial: 5 mL; Box: 1 vial ............ 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Methamphetamine OFT Calibrator 

3: Catalog Number 10016364.

Vial: 5 mL; Box: 1 vial ............ 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Methamphetamine OFT Control 1: 

Catalog Number 10017686.

Vial: 10 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Methamphetamine OFT Control 2: 

Catalog Number 10017687.

Vial: 10 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Methamphetamine OFT Control 3: 

Catalog Number 1007688.

Vial: 10 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 1: Catalog Number 10016882.Vial: 10 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 2: Catalog Number 10016883.Vial: 10 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Multi-Drug OFT Calibrator 3: Catalog Number 10016884.Vial: 10 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Multi-Drug OFT Control 1: Catalog 

Number 10017711.

Vial: 15 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Multi-Drug OFT Control 2: Catalog 

Number 10017712.

Vial: 15 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA Multi-Drug OFT Control 3: Catalog 

Number 10017713.

Vial: 15 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA THC OFT Calibrator 1: Catalog 

Number 10016700.

Vial: 5 mL; Box: 1 vial ............ 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA THC OFT Calibrator 2: Catalog 

Number 10016701.

Vial: 5 mL; Box: 1 vial ............ 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA THC OFT Calibrator 3: Catalog 

Number 10016702.

Vial: 5 mL; Box: 1 vial ............ 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA THC OFT Control 1: Catalog Number 10017702.Vial: 10 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA THC OFT Control 2: Catalog Number 10017703.Vial: 10 mL; Box: 1 vial .......... 2/11/2013 

Microgenics Corporation ......... Thermo Scientific CEDIA THC OFT Control 3: Catalog Number 10017704.Vial: 10 mL; Box: 1 vial .......... 2/11/2013 

Ortho Clinical Diagnostics, Inc VITROS Immunodiagnostics Products Testosterone Reagent 

Pack.

Plastic chamber: 8.4 mL ......... 9/28/2012 

Ortho Clinical Diagnostics, Inc VITROS Immunodiagnostics Products Estradiol Reagent 

Pack.

Plastic chamber: 13.3 mL ....... 9/28/2012 

Ortho Clinical Diagnostics, Inc VITROS Immunodiagnostics Products Testosterone Calibrators (1–3).Box: 3 vials; 2 mL each .......... 10/19/2012 

Ortho Clinical Diagnostics, Inc VITROS Immunodiagnostics Products Testosterone Controls 

(1–3).

Box: 9 vials; 1 mL each .......... 10/19/2012 

Ortho Clinical Diagnostics, Inc VITROS Immunodiagnostics Products Testosterone Range 

Verifiers (Low and High).

Box: 4 vials; 1–1.5 mL each ... 10/19/2012 

Restek ..................................... Custom Revised Appendix IX Mix #1 ...................................... Glass vial: 1.3 mL ................... 2/14/2013 

Restek Corporation ................. Product and Reactor Samples Standard ................................. Ampule: 2 mL ......................... 10/12/2012 

Restek Corporation ................. 8270 Supplemental Standard #1 ............................................. Ampule: 2 mL ......................... 12/13/2012 

Siemens Healthcare 

Diagnostics Inc.

TTST Stock X (Bulk) ................................................................ Stock container: 50 mL–1 L ... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

VS TTST Cal Bulk Soln Level 1 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

VS TTST Cal Bulk Soln Level 2 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

VS TTST Cal Bulk Soln Level 3 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 


emcdonald on DSK67QTVN1PROD with NOTICES
40184 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 

CHART I—Continued 

Supplier Product name Form Application 

date 

Siemens Healthcare 

Diagnostics Inc.

VS TTST Cal Bulk Soln Level 4 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

VS TTST Cal Bulk Soln Level 5 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

VS TTST Cal Bulk Soln Level 6 .............................................. Bulk container: 4 mL–100 L ... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

Dimension Vista TTST CAL A ................................................. Vial: 1 mL ................................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

Dimension Vista TTST CAL B ................................................. Vial: 1 mL ................................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

Dimension Vista TTST CAL C ................................................. Vial: 1 mL ................................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

Dimension Vista TTST CAL D ................................................. Vial: 1 mL ................................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

Dimension Vista TTST CAL E ................................................. Vial: 1 mL ................................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

Dimension Vista TTST CAL F ................................................. Vial: 1 mL ................................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

Dimension Vista System TTST CAL ........................................ Box: 12 vials; 1 ml each ......... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST Lvl 1 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST Lvl 2 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST Lvl 3 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST Lvl 4 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST Lvl 5 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST Lvl 6 Bulk ................................................................. Bulk container: 4 mL–20 L ..... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST CAL Lvl 1 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST CAL Lvl 2 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST CAL Lvl 3 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST CAL Lvl 4 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST CAL Lvl 5 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

MP TTST CAL Lvl 6 FC ........................................................... Vial: 1–5 mL ............................ 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

TTST Stock S (Bulk) ................................................................ Stock container: 50 mL–1 L ... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

TTST Stock T (Bulk) ................................................................ Stock container: 50 mL–1 L ... 7/26/2012 

Siemens Healthcare 

Diagnostics Inc.

Estradiol Diluent ....................................................................... Plastic container: 0.5L–1.0L ... 11/14/2012 

Siemens Healthcare 

Diagnostics Inc.

Dimension Vista Drug 1 CAL Pilot, Level B ............................ Plastic test tube: 15 mL .......... 12/3/2012 

Supelco, Inc ............................. Titan C18 Batch Test 1 Mix ..................................................... Glass ampule: 1 mL ............... 2/28/2013 

The Deputy Assistant Administrator 

has found that each of the compounds, 

mixtures, and preparations described in 

Chart II below is not consistent with the 

criteria stated in 21 U.S.C. 811(g)(3)(B) 

and in 21 CFR 1308.23. Accordingly, the 

Deputy Assistant Administrator has 

determined that the chemical 

preparations or mixtures generally 

described in Chart II below and 

specifically described in the application 

materials received by DEA, are not 

exempt from application of any part of 

the CSA or from application of any part 

of the CFR, with regard to the requested 

exemption pursuant to 21 CFR 1308.23, 

as of the date listed below that was 

provided in the determination letters to 

the individual requesters. 

CHART II 

Supplier Product name Form Application 

date 

Agilent Technologies ............... Forensic Toxicology Comprehensive Mix–Submix 9A ............ Ampule: 1 mL ......................... 12/6/2012 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40185 

CHART II—Continued 

Supplier Product name Form Application 

date 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC177 ................ Glass vials: 1 ml–200 mL ....... 10/11/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC178 ................ Glass vials: 1 ml–200 mL ....... 10/23/2012 

Biochemical Diagnostics, Inc .. Salivabuse Custom Liquid Control Oral Fluid, OF24 .............. Glass vials: 1 ml–200 mL ....... 10/23/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC180 ................ Glass vials: 1 ml–200 mL ....... 12/14/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC181 ................ Glass vials: 1 ml–200 mL ....... 12/14/2012 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC182 ................ Glass vials: 1 ml–2 L .............. 1/22/2013 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC180 ................ Glass vials: 1 ml–200 mL ....... 1/29/2013 

Biochemical Diagnostics, Inc .. Detectabuse Custom Liquid Control Urine, MC182 ................ Glass vials: 1 ml–2 L .............. 2/14/2013 

Cerilliant Corporation ............... (-)-11-nor-9-Carboxy-delta9-THC (1 mg/mL) ........................... Glass ampule: 5 mL ............... 7/6/2012 

Cerilliant Corporation ............... Cocaine HCl (10 mg/mL) ......................................................... Glass Ampule: 1 mL ............... 7/6/2012 

Cerilliant Corporation ............... Lacosamide (10 mg/mL) .......................................................... Glass Ampule: 1 mL ............... 9/12/2012 

Cliniqa Corporation .................. TDM Control, Levels 1–3 Bulk ................................................. Plastic Container: 500 L ......... 12/4/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Controls, THC (0.5–50 ng/mL) ......................... Glass vial: 5 ml–4 L ................ 8/9/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Controls, Methamphetamine (2–200 ng/mL) .... Glass vial: 5 ml–4 L ................ 8/9/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Controls, Amphetamine, Benzoylecgonine, 

Morphine, Phencyclidine (2–200 ng/mL).

Glass vial: 5 ml–4 L ................ 8/9/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Controls, Multidrug (selected from THC, Cocaine/Benzoylecgonine, Amphetamines, Opiates, & PCP at 

0.5–50 ng/mL).

Glass vial: 5 ml–4 L ................ 8/9/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Calibrators, THC (0.5–50 ng/mL) ..................... Glass vial: 5 ml–4 L ................ 8/9/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Calibrators, Methamphetamine (2–200 ng/mL) Glass vial: 5 ml–4 L ................ 8/9/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Calibrators, Amphetamine, Benzoylecgonine, 

Morphine, Phencyclidine (2–200 ng/mL).

Glass vial: 5 ml–4 L ................ 8/9/2012 

ElSohly Laboratories, Inc ........ ELI Oral Fluid Calibrators, Multidrug (selected from THC, Cocaine/Benzoylecgonine, Amphetamines, Opiates, & PCP at 

0.5–200 ng/mL).

Glass vial: 5 ml–4 L ................ 8/9/2012 

LGC Limited ............................ LAMPA (Lysergic Acid N-Methyl-N-propylamide) 1.0 mg/mL 

in Acetonitrile.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ LSD (Lysergic Acid Diethylamide) 1.0 mg/mL in Acetonitrile .. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ LSD–D3 (Lysergic Acid Diethylamide-D3) 0.1 mg/mL in Acetonitrile.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ (-)-Cannabidiol 1.0 mg/mL in Methanol ................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Cannabinol 1.0 mg/mL in Methanol ......................................... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ (-)-delta9-THC (Dronabinol) 1.0 mg/mL in Methanol ............... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ (-)-delta9-THC-D3 (Dronabinol-D3) 0.1 mg/mL in Methanol ... Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ trans-11-Hydroxy-delta9-THC ((6aRS,10aRS)-11-Hydroxydelta9-tetrahydrocannabinol) 0.1 mg/mL in Methanol.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ trans-11-Hydroxy-delta9-THC ((6aRS,10aRS)-11-Hydroxydelta9-tetrahydrocannabinol) 1.0 mg/mL in Methanol.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ trans-11-Hydroxy-delta9-THC-D3 (trans-11-Hydroxy-delta9- 

tetrahydrocannabinol-D3) 0.1 mg/mL in Methanol.

Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ trans-11-Nor-9-carboxy-delta9-THC 0.1 mg/mL in Methanol .. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ trans-11-Nor-9-carboxy-delta9-THC-D3 0.1 mg/mL in Methanol.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ trans-11-Nor-9-carboxy-delta9-THC-D3 1.0 mg/mL in Methanol.Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Fentanyl 0.1 mg/mL in Methanol ............................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Fentanyl 1.0 mg/mL in Methanol ............................................. Glass vial: 1 mL ...................... 11/30/2012 

LGC Limited ............................ Fentanyl-D5 0.1 mg/mL in Methanol ....................................... Glass vial: 1 mL ...................... 11/30/2012 

Siemens Healthcare 

Diagnostics Inc.

Dimension Vista Drug 1 CAL Bulk, Level B ............................ Plastic container: 4–100 L ...... 12/3/2012 

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 

and only for those sections of the CSA 

and the CFR that are specifically 

identified. Pursuant to 21 CFR 

1308.24(h), any change in the 

quantitative or qualitative composition 

of the preparation or mixture or change 

in the trade name or other designation 

of the preparation or mixture after the 

date of application requires a new 

application. Pursuant to 21 CFR 

1308.24(g), DEA may prescribe 

requirements other than those set forth 

in 1308.24(b)–(e) on a case-by-case basis 

for materials exempted in bulk 

quantities. Accordingly, in order to limit 

opportunity for diversion from the 

larger bulk quantities, DEA has 

determined that each of the exempted 

bulk products listed in this order may 

only be used by the manufacturer and 

may not be distributed by the 

manufacturer for any purpose or 

transported to other facilities. 

Additional exempt chemical 

preparation requests received between 

July 1, 2012, and March 31, 2013, and 

not otherwise referenced in this order 

may remain under consideration until 

DEA receives additional information 

required, pursuant to 21 CFR 

1308.23(d), as detailed in separate 

correspondence to individual 

requesters. DEA’s order on such 

requests will be communicated to the 

public in a future Federal Register 

publication. 

DEA also notes that these exemptions 

are limited to exemption from only 

those sections of the CSA and the CFR 

that are specifically identified in 21 CFR 


emcdonald on DSK67QTVN1PROD with NOTICES
40186 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 

1308.24(a). All other requirements of the 

CSA and the CFR apply, including, but 

not limited to, registration as an 

importer as required by 21 U.S.C. 957. 

Chemical Preparations Containing 

Newly Controlled Substances 

The statutory authority for exempt 

chemical preparations is based on the 

control status of substances contained 

within a preparation, the intended 

administration of a preparation, and the 

packaged form of a preparation. DEA 

conducts a case-by-case analysis of each 

application for exemption to determine 

whether exemption of a preparation 

from certain provisions of the CSA is 

appropriate pursuant to the specified 

statutory and regulatory requirements. 

Most exempt chemical preparations 

have remained effective until the holder 

of a specific exempt chemical 

preparation specifically requested that 

the exemption be terminated. The CSA 

allows for modifications to the 

controlled substances schedules to add, 

remove, or change the schedule of 

substances thus resulting in periodic 

modifications to the control status of 

various substances. 21 U.S.C. 811(a). 

Since the CSA was enacted in 1970, 

DEA has on several occasions added to, 

removed from, or modified the 

schedules of controlled substances in 

accordance with the CSA. Such changes 

may result in the non-compliance of 

exempt chemical preparations with 

current statutes or regulations if 

chemical preparations that have already 

obtained exempt status contain newly 

controlled substances. For example, 

although an exempt chemical 

preparation may continue to be 

packaged in the same manner as when 

it was approved, non-controlled 

substances in the preparation may 

become controlled, thus prompting the 

need for a new application for 

exemption of the chemical preparation 

to ensure continued compliance. Other 

preparations that previously contained 

no controlled substances may contain 

newly controlled substances and thus 

would require an application for 

exemption. 

DEA reviews applications for 

chemical preparation exemptions based 

on the statutes and regulations that are 

in place at the time of the application, 

including the control status of 

substances included in the preparation. 

DEA must remain vigilant to ensure that 

exempt chemical preparations remain 

consistent with the standards set forth 

in the CSA and its implementing 

regulations. As such, DEA reminds the 

public that any chemical preparation, 

regardless of whether it was previously 

exempt, that contains a newly 

controlled substance will require a new 

application for exemption pursuant to 

21 U.S.C. 811(g)(3)(B) and 21 CFR 

1308.23–1308.24. 

Review of Exemptions Pursuant to 21 

U.S.C. 811(g)(3) 

Based on inquiries received from 

industry, DEA is conducting a 

comprehensive review of the exempt 

chemical preparation regulations. DEA’s 

regulations at 21 CFR 1308.24(a) state 

that approved chemical preparations are 

exempt from certain provisions of both 

Subchapter I and Subchapter II of the 

CSA: ‘‘The chemical preparations and 

mixtures approved pursuant to 1308.23 

are exempt from application of sections 

302, 303, 305, 306, 307, 308, 309, 1002, 

1003 and 1004 of the Act (21 U.S.C. 

822–823, 825–829, 952–954) and 

1301.74 of this chapter, to the extent 

described in paragraphs (b) to (h) of this 

section.’’ Pursuant to its regulations, 

DEA has provided exemptions from the 

application of section 302, 303, 305, 

306, 307, 308, 309, 1002, 1003, and 1004 

of the Act (21 U.S.C. 822–823, 825–829, 

952–954) and 21 CFR 1301.74 since the 

implementation of the regulations in the 

early 1970s. Until DEA’s analysis of the 

exemption regulations is complete, DEA 

will continue to review and provide 

exemptions to chemical preparations 

consistent with the implementing 

regulations, when warranted. DEA will 

publish a future notice regarding the 

outcome of DEA’s review of its 

regulations with respect to the 

exemption of chemical preparations. 

Opportunity for Comment 

Pursuant to 21 CFR 1308.23, any 

interested person may submit written 

comments on or objections to any 

chemical preparation in this order that 

has been approved or denied as exempt. 

If any comments or objections raise 

significant issues regarding any finding 

of fact or conclusion of law upon which 

this order is based, the Deputy Assistant 

Administrator will immediately 

suspend the effectiveness of any 

applicable part of this order until he 

may reconsider the application in light 

of the comments and objections filed. 

Approved Exempt Chemical 

Preparations Are Posted on DEA’s Web 

Site 

A list of all current exemptions, 

including those listed in this order, is 

available on DEA’s Web site at http:// 

www.DEAdiversion.usdoj.gov/ 

schedules/exempt/exempt_chemlist.pdf. 

The dates of applications of all current 

exemptions are posted for easy 

reference. 

Dated: June 17, 2013. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2013–16010 Filed 7–2–13; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–378] 

Proposed Aggregate Production 

Quotas for Schedule I and II Controlled 

Substances and Proposed 

Assessment of Annual Needs for the 

List I Chemicals Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine for 2014 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Notice with request for 

comments. 

SUMMARY: This notice proposes initial 

year 2014 aggregate production quotas 

for controlled substances in Schedules I 

and II of the Controlled Substances Act 

(CSA) and assessment of annual needs 

for the List I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. 

DATES: Electronic comments must be 

submitted and written comments must 

be postmarked on or before August 2, 

2013. The electronic Federal Docket 

Management System will not accept 

comments after midnight Eastern Time 

on the last day of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–378’’ on all electronic and 

written correspondence. DEA 

encourages that all comments be 

submitted electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at http:// 

www.regulations.gov for easy reference. 

Paper comments that duplicate the 

electronic submission are not necessary 

as all comments submitted to 

www.regulations.gov will be posted for 

public review and are part of the official 

docket record. Written comments 

submitted via regular or express mail 

should be sent to the Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/ODL, 8701 

Morrissette Drive, Springfield, VA 

22152. 

FOR FURTHER INFORMATION CONTACT: John 

W. Partridge, Executive Assistant, Office 

of Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 


emcdonald on DSK67QTVN1PROD with NOTICES