Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Notices 31739 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of Laboratories Which 

Meet Minimum Standards To Engage in 

Urine Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories currently 

certified to meet the standards of 

Subpart C of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). The 

Mandatory Guidelines were first 

published in the Federal Register on 

April 11, 1988 (53 FR 11970), and 

subsequently revised in the Federal 

Register on June 9, 1994 (59 FR 29908), 

on September 30, 1997 (62 FR 51118), 

and on April 13, 2004 (69 FR 19644). 

A notice listing all currently certified 

laboratories is published in the Federal 

Register during the first week of each 

month. If any laboratory’s certification 

is suspended or revoked, the laboratory 

will be omitted from subsequent lists 

until such time as it is restored to full 

certification under the Mandatory 

Guidelines. 

If any laboratory has withdrawn from 

the HHS National Laboratory 

Certification Program (NLCP) during the 

past month, it will be listed at the end, 

and will be omitted from the monthly 

listing thereafter. 

This notice is also available on the 

Internet at http:// 

www.workplace.samhsa.gov and http:// 

www.drugfreeworkplace.gov. 

FOR FURTHER INFORMATION CONTACT: Mrs. 

Giselle Hersh, Division of Workplace 

Programs, SAMHSA/CSAP, Room 2– 

1042, One Choke Cherry Road, 

Rockville, Maryland 20857; 240–276– 

2600 (voice), 240–276–2610 (fax). 

SUPPLEMENTARY INFORMATION: The 

Mandatory Guidelines were developed 

in accordance with Executive Order 

12564 and section 503 of Public Law 

100–71. Subpart C of the Mandatory 

Guidelines, ‘‘Certification of 

Laboratories Engaged in Urine Drug 

Testing for Federal Agencies,’’ sets strict 

standards that laboratories must meet in 

order to conduct drug and specimen 

validity tests on urine specimens for 

Federal agencies. To become certified, 

an applicant laboratory must undergo 

three rounds of performance testing plus 

an on-site inspection. To maintain that 

certification, a laboratory must 

participate in a quarterly performance 

testing program plus undergo periodic, 

on-site inspections. 

Laboratories which claim to be in the 

applicant stage of certification are not to 

be considered as meeting the minimum 

requirements described in the HHS 

Mandatory Guidelines. A laboratory 

must have its letter of certification from 

HHS/SAMHSA (formerly: HHS/NIDA) 

which attests that it has met minimum 

standards. 

In accordance with Subpart C of the 

Mandatory Guidelines dated April 13, 

2004 (69 FR 19644), the following 

laboratories meet the minimum 

standards to conduct drug and specimen 

validity tests on urine specimens: 

ACL Laboratories, 8901 W. Lincoln 

Ave., West Allis, WI 53227. 414–328– 

7840/800–877–7016 (Formerly: 

Bayshore Clinical Laboratory). 

ACM Medical Laboratory, Inc., 160 

Elmgrove Park, Rochester, NY 14624. 

585–429–2264. 

Advanced Toxicology Network, 3560 

Air Center Cove, Suite 101, Memphis, 

TN 38118. 901–794–5770/888–290– 

1150. 

Aegis Analytical Laboratories, 345 Hill 

Ave., Nashville, TN 37210. 615–255– 

2400 (Formerly: Aegis Sciences 

Corporation, Aegis Analytical 

Laboratories, Inc.). 

Baptist Medical Center-Toxicology 

Laboratory, 9601 I–630, Exit 7, Little 

Rock, AR 72205–7299. 501–202–2783 

(Formerly: Forensic Toxicology 

Laboratory Baptist Medical Center). 

Clendo Reference Laboratory, Avenue 

Santa Cruz #58, Bayamon, Puerto Rico 

00959. 787–620–9095. 

Clinical Reference Lab, 8433 Quivira 

Road, Lenexa, KS 66215–2802. 800– 

445–6917. 

Doctors Laboratory, Inc., 2906 Julia 

Drive, Valdosta, GA 31602. 229–671– 

2281. 

DrugScan, Inc., P.O. Box 2969, 1119 

Mearns Road, Warminster, PA 18974. 

215–674–9310. 

DynaLIFE Dx*, 10150–102 St., Suite 

200, Edmonton, Alberta, Canada T5J 

5E2. 780–451–3702/800–661–9876 

(Formerly: Dynacare Kasper Medical 

Laboratories). 

ElSohly Laboratories, Inc., 5 Industrial 

Park Drive, Oxford, MS 38655. 662– 

236–2609. 

Gamma-Dynacare Medical 

Laboratories*, A Division of the 

Gamma-Dynacare Laboratory 

Partnership, 245 Pall Mall Street, 

London, ONT, Canada N6A 1P4. 519– 

679–1630. 

Kroll Laboratory Specialists, Inc., 1111 

Newton St., Gretna, LA 70053. 504– 

361–8989/800–433–3823 (Formerly: 

Laboratory Specialists, Inc.). 

Kroll Laboratory Specialists, Inc., 450 

Southlake Blvd., Richmond, VA 

23236, 804–378–9130, (Formerly: 

Scientific Testing Laboratories, Inc.; 

Kroll Scientific Testing Laboratories, 

Inc.). 

Laboratory Corporation of America 

Holdings, 7207 N. Gessner Road, 

Houston, TX 77040. 713–856–8288/ 

800–800–2387. 

Laboratory Corporation of America 

Holdings, 69 First Ave., Raritan, NJ 

08869. 908–526–2400/800–437–4986 

(Formerly: Roche Biomedical 

Laboratories, Inc.). 

Laboratory Corporation of America 

Holdings, 1904 Alexander Drive, 

Research Triangle Park, NC 27709. 

919–572–6900/800–833–3984 

(Formerly: LabCorp Occupational 

Testing Services, Inc., CompuChem 

Laboratories, Inc.; CompuChem 

Laboratories, Inc., A Subsidiary of 

Roche Biomedical Laboratory; Roche 

CompuChem Laboratories, Inc., A 

Member of the Roche Group). 

Laboratory Corporation of America 

Holdings, 1120 Main Street, 

Southaven, MS 38671. 866–827–8042/ 

800–233–6339 (Formerly: LabCorp 

Occupational Testing Services, Inc.; 

MedExpress/National Laboratory 

Center). 

LabOne, Inc. d/b/a Quest Diagnostics, 

10101 Renner Blvd., Lenexa, KS 

66219. 913–888–3927/800–873–8845 

(Formerly: Quest Diagnostics 

Incorporated; LabOne, Inc.; Center for 

Laboratory Services, a Division of 

LabOne, Inc.). 

Maxxam Analytics*, 6740 Campobello 

Road, Mississauga, ON, Canada L5N 

2L8. 905–817–5700 (Formerly: 

Maxxam Analytics Inc., NOVAMANN 

(Ontario), Inc.). 

MedTox Laboratories, Inc., 402 W. 

County Road D, St. Paul, MN 55112. 

651–636–7466/800–832–3244. 

MetroLab-Legacy Laboratory Services, 

1225 NE 2nd Ave., Portland, OR 

97232. 503–413–5295/800–950–5295. 

Minneapolis Veterans Affairs Medical 

Center, Forensic Toxicology 

Laboratory, 1 Veterans Drive, 

Minneapolis, MN 55417. 612–725– 

2088. 

National Toxicology Laboratories, Inc., 

1100 California Ave., Bakersfield, CA 

93304. 661–322–4250/800–350–3515. 

One Source Toxicology Laboratory, Inc., 

1213 Genoa-Red Bluff, Pasadena, TX 

77504. 888–747–3774 (Formerly: 

University of Texas Medical Branch, 

Clinical Chemistry Division; UTMB 

Pathology-Toxicology Laboratory). 

Pacific Toxicology Laboratories, 9348 

DeSoto Ave., Chatsworth, CA 91311. 

31740 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Notices 

800–328–6942 (Formerly: Centinela 

Hospital Airport Toxicology 

Laboratory). 

Pathology Associates Medical 

Laboratories, 110 West Cliff Dr., 

Spokane, WA 99204. 509–755–8991/ 

800–541–7891x7. 

Phamatech, Inc., 10151 Barnes Canyon 

Road, San Diego, CA 92121. 858–643– 

5555. 

Quest Diagnostics Incorporated, 3175 

Presidential Dr., Atlanta, GA 30340. 

770–452–1590/800–729–6432 

(Formerly: SmithKline Beecham 

Clinical Laboratories; SmithKline BioScience Laboratories). 

Quest Diagnostics Incorporated, 400 

Egypt Road, Norristown, PA 19403. 

610–631–4600/877–642–2216 

(Formerly: SmithKline Beecham 

Clinical Laboratories; SmithKline BioScience Laboratories). 

Quest Diagnostics Incorporated, 7600 

Tyrone Ave., Van Nuys, CA 91405. 

866–370–6699/818–989–2521 

(Formerly: SmithKline Beecham 

Clinical Laboratories). 

S.E.D. Medical Laboratories, 5601 Office 

Blvd., Albuquerque, NM 87109. 505– 

727–6300/800–999–5227. 

South Bend Medical Foundation, Inc., 

530 N. Lafayette Blvd., South Bend, 

IN 46601. 574–234–4176 x276. 

Southwest Laboratories, 4625 E. Cotton 

Center Boulevard, Suite 177, Phoenix, 

AZ 85040. 602–438–8507/800–279– 

0027. 

St. Anthony Hospital Toxicology 

Laboratory, 1000 N. Lee St., 

Oklahoma City, OK 73101. 405–272– 

7052. 

STERLING Reference Laboratories, 2617 

East L Street, Tacoma, Washington 

98421. 800–442–0438. 

Toxicology & Drug Monitoring 

Laboratory, University of Missouri 

Hospital & Clinics, 301 Business Loop 

70 West, Suite 208, Columbia, MO 

65203. 573–882–1273. 

Toxicology Testing Service, Inc., 5426 

NW. 79th Ave., Miami, FL 33166. 

305–593–2260. 

U.S. Army Forensic Toxicology Drug 

Testing Laboratory, 2490 Wilson St., 

Fort George G. Meade, MD 20755– 

5235. 301–677–7085. 

*The Standards Council of Canada 

(SCC) voted to end its Laboratory 

Accreditation Program for Substance 

Abuse (LAPSA) effective May 12, 1998. 

Laboratories certified through that 

program were accredited to conduct 

forensic urine drug testing as required 

by U.S. Department of Transportation 

(DOT) regulations. As of that date, the 

certification of those accredited 

Canadian laboratories will continue 

under DOT authority. The responsibility 

for conducting quarterly performance 

testing plus periodic on-site inspections 

of those LAPSA-accredited laboratories 

was transferred to the U.S. HHS, with 

the HHS’ NLCP contractor continuing to 

have an active role in the performance 

testing and laboratory inspection 

processes. Other Canadian laboratories 

wishing to be considered for the NLCP 

may apply directly to the NLCP 

contractor just as U.S. laboratories do. 

Upon finding a Canadian laboratory to 

be qualified, HHS will recommend that 

DOT certify the laboratory (Federal 

Register, July 16, 1996) as meeting the 

minimum standards of the Mandatory 

Guidelines published in the Federal 

Register on April 13, 2004 (69 FR 

19644). After receiving DOT 

certification, the laboratory will be 

included in the monthly list of HHScertified laboratories and participate in 

the NLCP certification maintenance 

program. 

Elaine Parry, 

Director, Office of Program Services, 

SAMHSA. 

[FR Doc. E9–15648 Filed 7–1–09; 8:45 am] 

BILLING CODE 4160–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0339] 

Guidance for Industry on Updating 

Labeling for Susceptibility Test 

Information in Systemic Antibacterial 

Drug Products and Antimicrobial 

Susceptibility Testing Devices; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Updating Labeling for 

Susceptibility Test Information in 

Systemic Antibacterial Drug Products 

and Antimicrobial Susceptibility 

Testing Devices.’’ The Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) includes a requirement 

that FDA identify and periodically 

update susceptibility test interpretive 

criteria for antibacterial drug products 

and make those findings publicly 

available. This guidance describes how 

FDA will comply with the FDAAA 

requirement and procedures for 

application holders to update the 

labeling of antibacterial drug products 

and antimicrobial susceptibility testing 

(AST) devices. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002 or the 

Division of Small Manufacturers 

Assistance (HFZ–220), Center for 

Devices and Radiological Health, Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850–4307. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding antibacterial drug 

products: Edward Cox, Center for 

Drug Evaluation and Research, 

Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 

22, rm. 6212, Silver Spring, MD 

20993–0002, 301–796–1300; or 

Regarding AST devices: Freddie 

Poole, Center for Devices and 

Radiological Health (HFZ–440), 

Food and Drug Administration, 

2098 Gaither Rd., Rockville, MD 

20850, 240–276–0712. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Updating Labeling for Susceptibility 

Test Information in Systemic 

Antibacterial Drug Products and 

Antimicrobial Susceptibility Testing 

Devices.’’ Antibacterial susceptibility 

testing is used to determine if bacteria 

that are isolated from a patient with an 

infection are likely to be killed or 

inhibited by a particular antibacterial 

drug product at the concentrations of 

the drug that are attainable at the site of 

infection using the dosing regimen(s) 

indicated in the drug product’s labeling. 

The results from antibacterial 

susceptibility testing generally 

categorize bacteria as ‘‘susceptible,’’ 

‘‘intermediate,’’ or ‘‘resistant’’ to each 

antibacterial drug tested. When 

available, culture and susceptibility 

testing results are one of the factors that 

physicians consider when selecting an 

antimicrobial drug product for treating a