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, 61961-61963 [2020-21692]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Amy F. Petrik, Ph.D., 240–627–3721;
amy.petrik@nih.gov. Licensing
information and copies of the U.S.
patent application listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD, 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
SUMMARY:
Structure-Based Design of SARS2-CoV–
2 Spike Immunogens Stabilized in the
RBD-All Down Conformation
jbell on DSKJLSW7X2PROD with NOTICES
Description of Technology:
SARS-CoV–2 has emerged as a global
pathogen, sparking urgent vaccine
development efforts. The trimeric
SARS-CoV–2 spike appears to be a
leading vaccine antigen. However, the
inability of antibodies such as CR3022,
which binds tightly to a cryptic spike
epitope, to neutralize SARS-CoV–2
suggests a spike-based means of
neutralization escape.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases (NIAID)
sought to understand how antibodies
with high affinity fail to neutralize the
SARS-CoV–2. To that end, the
researchers characterized the SARSCoV–2 spike protein conformational
changes as a function of pH and
observed that at endosomal pH the spike
protein has a conformation in which all
of the receptor binding domains (RBD)
are in a down conformation which
VerDate Sep<11>2014
22:13 Sep 30, 2020
Jkt 253001
could explain the virus’ ability to escape
neutralization in the endosome.
Hypothesizing that SARS-CoV–2
escapes neutralization through pHdependent conformational masking, the
researchers designed spike proteins
with mutations to stabilize the spike in
the RBD-all down conformation. Such
designs include cavity-filling mutations,
disulfides, aspartic acid to asparagine
mutations, proline mutations, and other
sequence modifications to fix the spike
protein in its RBD-all down
conformation so that immunization at a
physiological pH will elicit antibodies
that can recognize the low pH-stabilized
all RBD-down conformation of the spike
protein and no longer be susceptible to
pH-induced neutralization escape.
Immunogenicity studies are underway
to determine which of the designs will
yield a neutralizing immune response in
mice. Pending results in mice, a lead
candidate will be selected for studies in
nonhuman primates.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications
• An improved stabilized spike
immunogen for the development of
protective SARS-CoV–2 vaccine.
Competitive Advantages
• Stabilized SARS-CoV–2 spike
variants with potential to elicit higher
levels of neutralizing antibodies than
current related vaccine development.
• Identification of a methodology to
screen for improved spike variants (by
assessing binding by neutralizing versus
non-neutralizing antibodies).
Development Stage: Preclinical
Research.
Inventors: Peter Dak-Pin Kwong
(NIAID); Tongqing Zhou (NIAID);
Yaroslav Tsybovsky (NCI); Adam
Shabbir Olia (NIAID); John R. Mascola
(NIAID).
Publications: Zhou, T et al., (2020).
Cryo-EM Structures Delineate a pHDependent Switch that Mediates
Endosomal Positioning of SARS-CoV–2
Spike Receptor-Binding Domains.
BioRxiv.
Intellectual Property: HHS Reference
Number E–187–2020 includes U.S.
Provisional Patent Application Number
63/046,603, filed 06/30/2020.
Licensing Contact: To license this
technology, please contact Amy F.
Petrik, Ph.D., 240–627–3721;
amy.petrik@nih.gov.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
61961
Dated: September 17, 2020.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2020–21708 Filed 9–30–20; 8:45 am]
BILLING CODE 4140–01–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, 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: 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
SUMMARY:
E:\FR\FM\01OCN1.SGM
01OCN1
61962
Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
(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 Public 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.
jbell on DSKJLSW7X2PROD with NOTICES
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.
VerDate Sep<11>2014
22:13 Sep 30, 2020
Jkt 253001
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)
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–
* 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 LAPSAaccredited 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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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)
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, 1777
Montreal Circle, Tucker, GA 30084,
800–729–6432 (Formerly: SmithKline
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.
E:\FR\FM\01OCN1.SGM
01OCN1
Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
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)
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
Anastasia Marie Donovan,
Policy Analyst.
[FR Doc. 2020–21692 Filed 9–30–20; 8:45 am]
BILLING CODE 4160–20–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2020–0047]
Towing Safety Advisory Committee;
October 2020 Teleconference
Coast Guard, Department of
Homeland Security.
ACTION: Notice of Federal Advisory
Committee teleconference meeting.
AGENCY:
The Towing Safety Advisory
Committee (Committee) will meet via
teleconference to discuss Task 16–01,
Subchapter M Implementation. The
Committee is expected to receive the
final report from the subcommittee
tasked with identifying the parameters
Coast Guard officials should use to
determine whether a vessel inspected
under subchapters other than
Subchapter M performs occasional
towing. Additional items to be
discussed are also included as agenda
items in the SUPPLEMENTARY
INFORMATION section below.
DATES: Meeting: The full Committee will
meet by teleconference on Thursday,
October 29, 2020, from 1 p.m. until 3
p.m. Eastern Standard Time. Please note
that this meeting may close early if the
Committee has completed its business.
Comments and supporting
documents: To ensure your comments
are received by Committee members
before the teleconference, submit your
written comments no later than October
20, 2020.
ADDRESSES: To join the teleconference
or to request special accommodations,
contact the individual listed in the FOR
FURTHER INFORMATION CONTACT section
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:13 Sep 30, 2020
Jkt 253001
no later than 1 p.m. on October 20,
2020, to obtain the needed information.
The number of teleconference lines are
limited and will be available on a firstcome, first-served basis.
Instructions: You are free to submit
comments at any time, including orally
at the teleconference, but if you want
Committee members to review your
comments before the teleconference,
please submit your comments no later
than October 20, 2020. We encourage
you to submit comments through the
Federal eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov call or email the
individual in the FOR FURTHER
INFORMATION CONTACT section of this
document for alternate instructions. You
must include the docket number
[USCG–2020–0047]. Comments received
will be posted without alteration at
https://www.regulations.gov, including
any personal information provided. For
more about privacy and submissions in
response to this document, see DHS’s
eRulemaking System of Records notice
(85FR 14226, March 11, 2020). If you
encounter technical difficulties with
comment submission, contact the
individual listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice.
Docket Search: Documents mentioned
in this notice as being available in the
docket, and all public comments, will
be in our online docket at https://
www.regulations.gov and can be viewed
by following that website’s instructions.
Additionally, if you go to the online
docket and sign-up for email alerts, you
will be notified when comments are
posted.
Mr.
Matthew D. Layman, Alternate
Designated Federal Officer of the
Towing Safety Advisory Committee,
2703 Martin Luther King Jr Ave. SE,
Stop 7509, Washington, DC 20593–
7509, telephone 202–372–1421, fax
202–372–8382 or Matthew.D.Layman@
uscg.mil.
FOR FURTHER INFORMATION CONTACT:
The
Towing Safety Advisory Committee
provides advice and recommendations
to the Department of Homeland Security
on matters related to shallow-draft
inland and coastal waterway navigation
and towing safety. It was established by
Public Law 96–380 in 1980 and was an
active committee on December 3, 2018,
the day before the Frank LoBiondo
Coast Guard Authorization Act of 2018
(Pub. L. 115–282) was enacted, and
operates under provisions of Sec. 601
(d) of that Act.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
61963
Agenda
The agenda for the October 29, 2020,
teleconference meeting is as follows:
(1) Final report from the
Subcommittee on ‘‘Recommendations
on the Implementation of 46 Code of
Federal Regulations Subchapter M—
Inspection of Towing Vessels (Task 16–
01).
(2) Update on the National Towing
Safety Advisory Committee and the
December 4, 2020 termination date for
the Towing Safety Advisory Committee.
(3) Update from the Office of
Commercial Vessel Compliance on the
status of Subchapter M Implementation.
(4) Awards and recognition.
(5) Public Comment period.
A copy of all pre-meeting
documentation will be available at
https://www.dco.uscg.mil/OurOrganization/Assistant-Commandantfor-Prevention-Policy-CG-5P/
Commercial-Regulations-standards-CG5PS/Office-of-Operating-andEnvironmental-Standards/vfos/TSAC/.
Alternatively, you may contact Mr.
Matthew Layman as noted in the FOR
FURTHER INFORMATION CONTACT section
above.
During the October 29, 2020
teleconference, a public comment
period will be held from approximately
2:45 p.m. to 3 p.m. Eastern Standard
Time. Speakers are requested to limit
their comments to 3 minutes. Please
note that this public comment period
may start before 2:45 p.m. if all other
agenda items have been covered and
may end before 3 p.m. if all of those
wishing to comment have done so.
Please contact Mr. Matthew D. Layman,
listed in the FOR FURTHER INFORMATION
CONTACT section to register as a speaker.
Dated: September 18, 2020.
Jeffrey G. Lantz,
Director of Commercial Regulations and
Standards.
[FR Doc. 2020–21742 Filed 9–30–20; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–R5–ES–2020–N128;
FXES11130500000–201–FF05E00000]
Endangered Species; Receipt of
Recovery Permit Applications
Fish and Wildlife Service,
Interior.
ACTION: Notice of receipt of permit
applications; request for comments.
AGENCY:
We, the U.S. Fish and
Wildlife Service, have received
SUMMARY:
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Notices]
[Pages 61961-61963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21692]
-----------------------------------------------------------------------
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, 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: 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
[[Page 61962]]
(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 Public 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)
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)
---------------------------------------------------------------------------
* 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.
---------------------------------------------------------------------------
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, 1777 Montreal Circle, Tucker, GA 30084,
800-729-6432 (Formerly: SmithKline
[[Page 61963]]
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)
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
Anastasia Marie Donovan,
Policy Analyst.
[FR Doc. 2020-21692 Filed 9-30-20; 8:45 am]
BILLING CODE 4160-20-P
