Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies, 126-128 [2011-33406]
Download as PDF
<![CDATA[
126
Federal Register / Vol. 77, No. 1 / Tuesday, January 3, 2012 / Notices
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Medical Device Classification
Product Codes.’’ The purpose of the
guidance document is to educate
regulated industry and FDA Staff on
how, when, and why to use
classification product codes for medical
devices regulated by the Center for
Devices and Radiological Health (CDRH)
and the Center for Biologics Evaluation
and Research (CBER). This document
describes how classification product
codes are used in a variety of FDA
program areas to regulate and track
medical devices. This draft guidance is
not final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 2, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Medical Device
Classification Product Codes’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 4613, Silver Spring, MD 20993–
0002 or Office of Communication,
Outreach and Development (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. Send one self-addressed
adhesive label to assist that office in
processing your request, or fax your
request to CDRH at (301) 847–8149. The
draft guidance may also be obtained by
mail by calling CBER at (800) 835–4709
or (301) 827–1800. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Diane Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:13 Dec 30, 2011
Jkt 226001
Hampshire Ave., Bldg. 66, Rm. 1644,
Silver Spring, MD 20993–0002, (301)
796–6559; and
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852, (301) 827–6210.
on medical device classification product
codes. 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 statute
and regulations.
I. Background
Since the May 28, 1976, Medical
Device Amendments were passed, the
Classification Regulation Panels (parts
862 through 892 (21 CFR parts 862
through 892)) have been the basis for the
CDRH’s Classification Product Code
structure and organization. These 16
Panels have largely been the driving
force for CDRH’s internal organizational
structure as well. Relying on the
Classification Regulation Panels
structure, CDRH created classification
product codes to assist in accurate
identification and tracking of current
medical devices and to allow for
tracking and easy reference of predicate
device types.
Classification product codes are a
method of classifying medical devices.
Medical device product codes consist of
a three-letter combination, which
associates a device’s type with a product
classification. Classification product
codes and information associated with
these devices, such as names and
attributes, are assigned by CDRH to
support their regulation.
The purpose of the guidance
document is to educate regulated
industry and FDA Staff on how, when,
and why to use classification product
codes for medical devices in a variety of
FDA program areas to regulate and track
medical devices. This document is
limited to medical devices as defined in
section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
321(h)) and does not discuss
classification products codes used to
regulate non-medical electronic
radiation emitting products.
The scope of the guidance document
includes devices described in the
existing classification under parts 862
through 892. It also describes how
classification product codes are used for
CBER regulated devices, which
currently do not fall within this existing
classification. This guidance may also
be applicable to future devices. It also
covers unclassified devices and devices
not yet classified.
III. Electronic Access
II. Significance of Guidance
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
the CBER Internet site at https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm. To receive
‘‘Medical Device Classification Product
Codes,’’ you may either send an email
request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to (301)
847–8149 to receive a hard copy. Please
use the document number 1774 to
identify the guidance you are
requesting.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments 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.
Dated: December 28, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–33686 Filed 12–30–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of Laboratories and
Instrumented Initial Testing Facilities
Which Meet Minimum Standards To
Engage in Urine Drug Testing for
Federal Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
E:\FR\FM\03JAN1.SGM
03JAN1
Federal Register / Vol. 77, No. 1 / Tuesday, January 3, 2012 / Notices
The Department of Health and
Human Services (HHS) notifies Federal
agencies of the Laboratories and
Instrumented Initial Testing Facilities
(IITF) currently certified to meet the
standards 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);
September 30, 1997 (62 FR 51118);
April 13, 2004 (69 FR 19644); November
25, 2008 (73 FR 71858); December 10,
2008 (73 FR 75122); and on April 30,
2010 (75 FR 22809).
A notice listing all currently certified
Laboratories and Instrumented Initial
Testing Facilities (IITF) is published in
the Federal Register during the first
week of each month. If any Laboratory/
IITF’s certification is suspended or
revoked, the Laboratory/IITF will be
omitted from subsequent lists until such
time as it is restored to full certification
under the Mandatory Guidelines.
If any Laboratory/IITF 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 initially
developed in accordance with Executive
Order 12564 and section 503 of Public
Law 100–71. The ‘‘Mandatory
Guidelines for Federal Workplace Drug
Testing Programs’’, as amended in the
revisions listed above, requires {or set}
strict standards that Laboratories and
Instrumented Initial Testing Facilities
(IITF) must meet in order to conduct
drug and specimen validity tests on
urine specimens for Federal agencies.
To become certified, an applicant
Laboratory/IITF must undergo three
rounds of performance testing plus an
on-site inspection. To maintain that
certification, a Laboratory/IITF must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories and Instrumented Initial
Testing Facilities (IITF) in the applicant
stage of certification are not to be
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:13 Dec 30, 2011
Jkt 226001
considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines. A Laboratory/
IITF must have its letter of certification
from HHS/SAMHSA (formerly: HHS/
NIDA) which attests that it has met
minimum standards.
In accordance with the Mandatory
Guidelines dated November 25, 2008
(73 FR 71858), the following
Laboratories and Instrumented Initial
Testing Facilities (IITF) meet the
minimum standards to conduct drug
and specimen validity tests on urine
specimens:
Instrumented Initial Testing Facilities
(IITF)
None.
Laboratories
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.).
Alere Toxicology Services, 1111 Newton
St., Gretna, LA 70053, (504) 361–
8989/(800) 433–3823, (Formerly: Kroll
Laboratory Specialists, Inc.,
Laboratory Specialists, Inc.).
Alere Toxicology Services, 450
Southlake Blvd., Richmond, VA
23236, (804) 378–9130, (Formerly:
Kroll Laboratory Specialists, Inc.,
Scientific Testing Laboratories, Inc.;
Kroll Scientific Testing Laboratories,
Inc.).
Baptist Medical Center-Toxicology
Laboratory, 11401 I–30, Little Rock,
AR 72209–7056, (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.
ElSohly Laboratories, Inc., 5 Industrial
Park Drive, Oxford, MS 38655, (662)
236–2609.
Gamma-Dynacare Medical
Laboratories,* A Division of the
Gamma-Dynacare Laboratory
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
127
Partnership, 245 Pall Mall Street,
London, ONT, Canada N6A 1P4, (519)
679–1630.
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).
E:\FR\FM\03JAN1.SGM
03JAN1
pmangrum on DSK3VPTVN1PROD with NOTICES
128
Federal Register / Vol. 77, No. 1 / Tuesday, January 3, 2012 / Notices
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, 1777
Montreal Circle, Tucker, GA 30084,
(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 BioScience Laboratories).
Quest Diagnostics Incorporated, 8401
Fallbrook Ave., West Hills, CA 91304,
(800) 877–2520, (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
VerDate Mar<15>2010
15:13 Dec 30, 2011
Jkt 226001
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 30, 2010 (75 FR
22809). 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: December 22, 2011.
Janine Denis Cook,
Chemist, Division of Workplace Programs,
Center for Substance Abuse Prevention,
SAMHSA.
[FR Doc. 2011–33406 Filed 12–30–11; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form N–600, Revision of a
Currently Approved Information
Collection; Comment Request
30-Day Notice of Information
Collection Under Review: Form N–600,
Application for Certificate of
Citizenship.
ACTION:
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on September 27, 2011, at 76
FR 59710, allowing for a 60-day public
comment period. USCIS received
comments for this information
collection.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until February 2,
2012. This process is conducted in
accordance with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Management
and Budget (OMB) USCIS Desk Officer.
Comments may be submitted to: USCIS,
Chief, Regulatory Products Division, 20
Massachusetts Avenue, Washington, DC
20529–2020. Comments may also be
submitted to DHS via facsimile to (202)
272–0997 or via email at
uscisfrcomment@dhs.gov, and to the
OMB USCIS Desk Officer via facsimile
at (202) 395–5806 or via email at
oira_submission@omb.eop.gov. When
submitting comments by email please
make sure to add OMB Control Number
1615–0057 in the subject box. Written
comments and suggestions from the
public and affected agencies should
address one or more of the following
four points:
(1) 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;
(2) 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;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) 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:
Revision of a currently approved
information collection.
(2) Title of the Form/Collection:
Application for Certificate of
Citizenship.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form N–600;
U.S. Citizenship and Immigration
Services (USCIS).
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
Households. USCIS uses the
information on Form N–600 to make a
determination that the citizenship
eligibility requirements and conditions
are met by the applicant.
E:\FR\FM\03JAN1.SGM
03JAN1
]]>Agencies
[Federal Register Volume 77, Number 1 (Tuesday, January 3, 2012)]
[Notices]
[Pages 126-128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33406]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Current List of Laboratories and Instrumented Initial Testing
Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing
for Federal Agencies
AGENCY: Substance Abuse and Mental Health Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 127]]
SUMMARY: The Department of Health and Human Services (HHS) notifies
Federal agencies of the Laboratories and Instrumented Initial Testing
Facilities (IITF) currently certified to meet the standards 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); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644);
November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and
on April 30, 2010 (75 FR 22809).
A notice listing all currently certified Laboratories and
Instrumented Initial Testing Facilities (IITF) is published in the
Federal Register during the first week of each month. If any
Laboratory/IITF's certification is suspended or revoked, the
Laboratory/IITF will be omitted from subsequent lists until such time
as it is restored to full certification under the Mandatory Guidelines.
If any Laboratory/IITF 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 initially
developed in accordance with Executive Order 12564 and section 503 of
Public Law 100-71. The ``Mandatory Guidelines for Federal Workplace
Drug Testing Programs'', as amended in the revisions listed above,
requires {or set{time} strict standards that Laboratories and
Instrumented Initial Testing Facilities (IITF) must meet in order to
conduct drug and specimen validity tests on urine specimens for Federal
agencies.
To become certified, an applicant Laboratory/IITF must undergo
three rounds of performance testing plus an on-site inspection. To
maintain that certification, a Laboratory/IITF must participate in a
quarterly performance testing program plus undergo periodic, on-site
inspections.
Laboratories and Instrumented Initial Testing Facilities (IITF) in
the applicant stage of certification are not to be considered as
meeting the minimum requirements described in the HHS Mandatory
Guidelines. A Laboratory/IITF must have its letter of certification
from HHS/SAMHSA (formerly: HHS/NIDA) which attests that it has met
minimum standards.
In accordance with the Mandatory Guidelines dated November 25, 2008
(73 FR 71858), the following Laboratories and Instrumented Initial
Testing Facilities (IITF) meet the minimum standards to conduct drug
and specimen validity tests on urine specimens:
Instrumented Initial Testing Facilities (IITF)
None.
Laboratories
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.).
Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, (504)
361-8989/(800) 433-3823, (Formerly: Kroll Laboratory Specialists, Inc.,
Laboratory Specialists, Inc.).
Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236,
(804) 378-9130, (Formerly: Kroll Laboratory Specialists, Inc.,
Scientific Testing Laboratories, Inc.; Kroll Scientific Testing
Laboratories, Inc.).
Baptist Medical Center-Toxicology Laboratory, 11401 I-30, Little Rock,
AR 72209-7056, (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.
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.
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).
[[Page 128]]
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, 1777 Montreal Circle, Tucker, GA 30084,
(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, 8401 Fallbrook Ave., West Hills, CA
91304, (800) 877-2520, (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 30, 2010 (75 FR 22809).
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: December 22, 2011.
Janine Denis Cook,
Chemist, Division of Workplace Programs, Center for Substance Abuse
Prevention, SAMHSA.
[FR Doc. 2011-33406 Filed 12-30-11; 8:45 am]
BILLING CODE 4162-20-P
