Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies, 41490-41491 [2021-16385]
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41490
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/activity
Total annual
responses
Average
burden per
response
Total hours
610.2, Requests for Samples and Protocols; Official Release .................................................................................
660.6(b), Protocols ...............................................................
660.36(a)(2) and (b), Samples and Protocols .....................
660.46(b), Protocols .............................................................
72
3
1
1
82.972
4
1
1
5,974
12
1
1
3
5
6
5
17,922
60
6
5
Total ..............................................................................
77
........................
5,988
........................
17,993
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall decrease of 1,463 hours and a
corresponding decrease of 491
responses. We attribute this adjustment
to a decrease in the number of
submissions we received over the last
few years.
Dated: July 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16384 Filed 7–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine and Oral
Fluid Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITFs) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs using Urine or Oral Fluid
(Mandatory Guidelines).
FOR FURTHER INFORMATION CONTACT:
Anastasia Donovan, Division of
Workplace Programs, SAMHSA/CSAP,
5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240–276–
2600 (voice); Anastasia.Donovan@
samhsa.hhs.gov (email).
SUPPLEMENTARY INFORMATION: In
accordance with Section 9.19 of the
Mandatory Guidelines, a notice listing
all currently HHS-certified laboratories
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
VerDate Sep<11>2014
17:21 Jul 30, 2021
Jkt 253001
and IITFs is published in the Federal
Register during the first week of each
month. If any laboratory or IITF
certification is suspended or revoked,
the laboratory or IITF will be omitted
from subsequent lists until such time as
it is restored to full certification under
the Mandatory Guidelines.
If any laboratory or 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.samhsa.gov/
workplace/resources/drug-testing/
certified-lab-list.
The Department of Health and Human
Services (HHS) notifies federal agencies
of the laboratories and Instrumented
Initial Testing Facilities (IITFs)
currently certified to meet the standards
of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Mandatory Guidelines) using Urine and
of the laboratories currently certified to
meet the standards of the Mandatory
Guidelines using Oral Fluid.
The Mandatory Guidelines using
Urine 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); April
30, 2010 (75 FR 22809); and on January
23, 2017 (82 FR 7920).
The Mandatory Guidelines using Oral
Fluid were first published in the
Federal Register on October 25, 2019
(84 FR 57554) with an effective date of
January 1, 2020.
The Mandatory Guidelines were
initially developed in accordance with
Executive Order 12564 and section 503
of Pubic Law 100–71 and allowed urine
drug testing only. The Mandatory
Guidelines using Urine have since been
revised, and new Mandatory Guidelines
allowing for oral fluid drug testing have
been published. The Mandatory
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Guidelines require strict standards that
laboratories and IITFs must meet in
order to conduct drug and specimen
validity tests on specimens for federal
agencies. HHS does not allow IITFs to
conduct oral fluid testing.
To become certified, an applicant
laboratory or IITF must undergo three
rounds of performance testing plus an
on-site inspection. To maintain that
certification, a laboratory or IITF must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories and IITFs in the
applicant stage of certification are not to
be considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines using Urine and/
or Oral Fluid. An HHS-certified
laboratory or IITF must have its letter of
certification from HHS/SAMHSA
(formerly: HHS/NIDA), which attests
that the test facility has met minimum
standards. HHS does not allow IITFs to
conduct oral fluid testing.
HHS-Certified Laboratories Approved
To Conduct Oral Fluid Drug Testing
In accordance with the Mandatory
Guidelines using Oral Fluid dated
October 25, 2019 (84 FR 57554), the
following HHS-certified laboratories
meet the minimum standards to conduct
drug and specimen validity tests on oral
fluid specimens: At this time, there are
no laboratories certified to conduct drug
and specimen validity tests on oral fluid
specimens.
HHS-Certified Instrumented Initial
Testing Facilities Approved To Conduct
Urine Drug Testing
In accordance with the Mandatory
Guidelines using Urine dated January
23, 2017 (82 FR 7920), the following
HHS-certified IITFs meet the minimum
standards to conduct drug and specimen
validity tests on urine specimens:
Dynacare, 6628 50th Street NW,
Edmonton, AB Canada T6B 2N7, 780–
784–1190 (Formerly: GammaDynacare Medical Laboratories)
E:\FR\FM\02AUN1.SGM
02AUN1
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
HHS-Certified Laboratories Approved
To Conduct Urine Drug Testing
In accordance with the Mandatory
Guidelines using Urine dated January
23, 2017 (82 FR 7920), the following
HHS-certified laboratories meet the
minimum standards to conduct drug
and specimen validity tests on urine
specimens:
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.)
Clinical Reference Laboratory, Inc., 8433
Quivira Road, Lenexa, KS 66215–
2802, 800–445–6917
Cordant Health Solutions, 2617 East L
Street, Tacoma, WA 98421, 800–442–
0438 (Formerly: STERLING Reference
Laboratories)
Desert Tox, LLC, 5425 E Bell Rd, Suite
125, Scottsdale, AZ 85254, 602–457–
5411/623–748–5045
DrugScan, Inc., 200 Precision Road,
Suite 200, Horsham, PA 19044, 800–
235–4890
Dynacare*, 245 Pall Mall Street,
London, ONT, Canada N6A 1P4, 519–
679–1630 (Formerly: GammaDynacare Medical Laboratories)
ElSohly Laboratories, Inc., 5 Industrial
Park Drive, Oxford, MS 38655, 662–
236–2609
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 TW 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)
VerDate Sep<11>2014
17:21 Jul 30, 2021
Jkt 253001
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.)
Legacy Laboratory Services Toxicology,
1225 NE 2nd Ave., Portland, OR
97232, 503–413–5295/800–950–5295
MedTox Laboratories, Inc., 402 W.
County Road D, St. Paul, MN 55112,
651–636–7466/800–832–3244
Minneapolis Veterans Affairs Medical
Center, Forensic Toxicology
Laboratory, 1 Veterans Drive,
Minneapolis, MN 55417, 612–725–
2088, Testing for Veterans Affairs
(VA) Employees Only
Pacific Toxicology Laboratories, 9348
DeSoto Ave., Chatsworth, CA 91311,
800–328–6942 (Formerly: Centinela
Hospital Airport Toxicology
Laboratory)
Phamatech, Inc., 15175 Innovation
Drive, San Diego, CA 92128, 888–
635–5840
Quest Diagnostics Incorporated, 400
Egypt Road, Norristown, PA 19403,
610–631–4600/877–642–2216
(Formerly: SmithKline Beecham
Clinical Laboratories; SmithKline BioScience Laboratories)
Redwood Toxicology Laboratory, 3700
Westwind Blvd., Santa Rosa, CA
95403, 800–255–2159
US Army Forensic Toxicology Drug
Testing Laboratory, 2490 Wilson St.,
Fort George G. Meade, MD 20755–
5235, 301–677–7085, Testing for
Department of Defense (DoD)
Employees Only
* 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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
41491
Register, July 16, 1996) as meeting the
minimum standards of the Mandatory
Guidelines published in the Federal
Register on January 23, 2017 (82 FR
7920). 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.
Anastasia Marie Donovan,
Policy Analyst, Division of Workplace
Programs.
[FR Doc. 2021–16385 Filed 7–30–21; 8:45 am]
BILLING CODE 4160–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer at (240) 276–
0361.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Government
Performance and Results Act (GPRA)
Client/Participant Outcomes Measure—
(OMB No. 0930–0208)—Revision
SAMHSA is requesting approval to
modify its existing CSAT Client-level
GPRA instrument by removing 40
questions and adding 41 questions to its
existing CSAT Client-level GPRA
instrument resulting in a net addition of
1 question. Currently, the information
collected from this instrument is
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41490-41491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16385]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Current List of HHS-Certified Laboratories and Instrumented
Initial Testing Facilities Which Meet Minimum Standards To Engage in
Urine and Oral Fluid Drug Testing for Federal Agencies
AGENCY: Substance Abuse and Mental Health Services Administration,
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) notifies
Federal agencies of the laboratories and Instrumented Initial Testing
Facilities (IITFs) currently certified to meet the standards of the
Mandatory Guidelines for Federal Workplace Drug Testing Programs using
Urine or Oral Fluid (Mandatory Guidelines).
FOR FURTHER INFORMATION CONTACT: Anastasia Donovan, Division of
Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240-276-2600 (voice);
[email protected] (email).
SUPPLEMENTARY INFORMATION: In accordance with Section 9.19 of the
Mandatory Guidelines, a notice listing all currently HHS-certified
laboratories and IITFs is published in the Federal Register during the
first week of each month. If any laboratory or IITF certification is
suspended or revoked, the laboratory or IITF will be omitted from
subsequent lists until such time as it is restored to full
certification under the Mandatory Guidelines.
If any laboratory or 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.samhsa.gov/workplace/resources/drug-testing/certified-lab-list.
The Department of Health and Human Services (HHS) notifies federal
agencies of the laboratories and Instrumented Initial Testing
Facilities (IITFs) currently certified to meet the standards of the
Mandatory Guidelines for Federal Workplace Drug Testing Programs
(Mandatory Guidelines) using Urine and of the laboratories currently
certified to meet the standards of the Mandatory Guidelines using Oral
Fluid.
The Mandatory Guidelines using Urine 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); April
30, 2010 (75 FR 22809); and on January 23, 2017 (82 FR 7920).
The Mandatory Guidelines using Oral Fluid were first published in
the Federal Register on October 25, 2019 (84 FR 57554) with an
effective date of January 1, 2020.
The Mandatory Guidelines were initially developed in accordance
with Executive Order 12564 and section 503 of Pubic Law 100-71 and
allowed urine drug testing only. The Mandatory Guidelines using Urine
have since been revised, and new Mandatory Guidelines allowing for oral
fluid drug testing have been published. The Mandatory Guidelines
require strict standards that laboratories and IITFs must meet in order
to conduct drug and specimen validity tests on specimens for federal
agencies. HHS does not allow IITFs to conduct oral fluid testing.
To become certified, an applicant laboratory or IITF must undergo
three rounds of performance testing plus an on-site inspection. To
maintain that certification, a laboratory or IITF must participate in a
quarterly performance testing program plus undergo periodic, on-site
inspections.
Laboratories and IITFs in the applicant stage of certification are
not to be considered as meeting the minimum requirements described in
the HHS Mandatory Guidelines using Urine and/or Oral Fluid. An HHS-
certified laboratory or IITF must have its letter of certification from
HHS/SAMHSA (formerly: HHS/NIDA), which attests that the test facility
has met minimum standards. HHS does not allow IITFs to conduct oral
fluid testing.
HHS-Certified Laboratories Approved To Conduct Oral Fluid Drug Testing
In accordance with the Mandatory Guidelines using Oral Fluid dated
October 25, 2019 (84 FR 57554), the following HHS-certified
laboratories meet the minimum standards to conduct drug and specimen
validity tests on oral fluid specimens: At this time, there are no
laboratories certified to conduct drug and specimen validity tests on
oral fluid specimens.
HHS-Certified Instrumented Initial Testing Facilities Approved To
Conduct Urine Drug Testing
In accordance with the Mandatory Guidelines using Urine dated
January 23, 2017 (82 FR 7920), the following HHS-certified IITFs meet
the minimum standards to conduct drug and specimen validity tests on
urine specimens:
Dynacare, 6628 50th Street NW, Edmonton, AB Canada T6B 2N7, 780-784-
1190 (Formerly: Gamma-Dynacare Medical Laboratories)
[[Page 41491]]
HHS-Certified Laboratories Approved To Conduct Urine Drug Testing
In accordance with the Mandatory Guidelines using Urine dated
January 23, 2017 (82 FR 7920), the following HHS-certified laboratories
meet the minimum standards to conduct drug and specimen validity tests
on urine specimens:
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.)
Clinical Reference Laboratory, Inc., 8433 Quivira Road, Lenexa, KS
66215-2802, 800-445-6917
Cordant Health Solutions, 2617 East L Street, Tacoma, WA 98421, 800-
442-0438 (Formerly: STERLING Reference Laboratories)
Desert Tox, LLC, 5425 E Bell Rd, Suite 125, Scottsdale, AZ 85254, 602-
457-5411/623-748-5045
DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800-
235-4890
Dynacare*, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519-679-
1630 (Formerly: Gamma-Dynacare Medical Laboratories)
ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655,
662-236-2609
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 TW 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.)
Legacy Laboratory Services Toxicology, 1225 NE 2nd Ave., Portland, OR
97232, 503-413-5295/800-950-5295
MedTox Laboratories, Inc., 402 W. County Road D, St. Paul, MN 55112,
651-636-7466/800-832-3244
Minneapolis Veterans Affairs Medical Center, Forensic Toxicology
Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612-725-2088,
Testing for Veterans Affairs (VA) Employees Only
Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA
91311, 800-328-6942 (Formerly: Centinela Hospital Airport Toxicology
Laboratory)
Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888-635-
5840
Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403,
610-631-4600/877-642-2216 (Formerly: SmithKline Beecham Clinical
Laboratories; SmithKline Bio-Science Laboratories)
Redwood Toxicology Laboratory, 3700 Westwind Blvd., Santa Rosa, CA
95403, 800-255-2159
US Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St.,
Fort George G. Meade, MD 20755-5235, 301-677-7085, Testing for
Department of Defense (DoD) Employees Only
* 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 January 23, 2017 (82 FR 7920).
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.
Anastasia Marie Donovan,
Policy Analyst, Division of Workplace Programs.
[FR Doc. 2021-16385 Filed 7-30-21; 8:45 am]
BILLING CODE 4160-20-P
