Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies, 9229-9230 [2010-3973]
Download as PDF
Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices
Submit electronic comments to https://
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electronic access to the draft guidance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:
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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a draft guidance for industry entitled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draft guidance includes four parts.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This draft guidance is being issued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The draft guidance, when finalized, will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
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16:46 Feb 26, 2010
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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
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
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.
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
9229
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 https://
www.workplace.samhsa.gov and https://
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
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01MRN1
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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
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16:46 Feb 26, 2010
Jkt 220001
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.
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\01MRN1.SGM
01MRN1
Agencies
[Federal Register Volume 75, Number 39 (Monday, March 1, 2010)]
[Notices]
[Pages 9229-9230]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3973]
-----------------------------------------------------------------------
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 https://www.workplace.samhsa.gov and https://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
[[Page 9230]]
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 Bio-Science Laboratories)
Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403,
610-631-4600/877-642-2216. (Formerly: SmithKline Beecham Clinical
Laboratories; SmithKline Bio-Science 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 HHS-certified 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