Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 9229 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Robert Temple, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4212, 

Silver Spring, MD 20993–0002, 

301–796–2270; or 

Robert T. O’Neill, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 3554, 

Silver Spring, MD 20993–0002, 

301–796–1700; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 1401 

Rockville Pike, suite 200N, 

Rockville, MD 20852–1448, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Non-Inferiority Clinical Trials.’’ The 

draft guidance includes four parts. The 

first part is a discussion of regulatory, 

study design, scientific, and statistical 

issues associated with the use of noninferiority studies when these are used 

to establish the effectiveness of a new 

drug or therapeutic biologic product. 

The second part focuses on some of 

these issues in more detail, notably the 

quantitative analytical and statistical 

approaches used to determine the noninferiority margin for use in NI studies, 

as well as the advantages and 

disadvantages of available methods. The 

third part addresses commonly asked 

questions about NI studies and provides 

practical advice about various 

approaches. The fourth part includes 

five examples of successful and 

unsuccessful efforts to define noninferiority margins and conduct NI 

studies. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on non-inferiority clinical trials. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances, http://www.fda.gov/ 

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/ 

default.htm, or http:// 

www.regulations.gov. 

Dated: February 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4109 Filed 2–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

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 

mstockstill on DSKH9S0YB1PROD with NOTICES

9230 Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 

Rock, AR 72205–7299, 501–202–2783. 

(Formerly: Forensic Toxicology 

Laboratory Baptist Medical Center) 

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, 

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 x1276. 

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. 

Dated: February 22, 2010. 

Elaine Parry, 

Director, Office of Program Services, 

SAMHSA. 

[FR Doc. 2010–3973 Filed 2–26–10; 8:45 am] 

BILLING CODE 4160–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

mstockstill on DSKH9S0YB1PROD with NOTICES