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, 324-326 [2024-31499]
Download as PDF
324
Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices
115–52) was signed into law, which
outlined additional requirements to be
included in the report.
lotter on DSK11XQN23PROD with NOTICES1
II. Topics for Discussion at the Public
Meeting
Some of the issues to be discussed at
the meeting will include, but not be
limited to:
• Hearing from patients/parents/
caregivers and patient/parent/caregiver
groups, consumer groups, industry,
academia, and other interested parties
about the public health impact that the
pediatric legislation may have had on
them or their communities, including
treatment advances for children
resulting from the legislation, as well as
areas of continued unmet medical need.
• Understanding the effects of the
requirement of pediatric studies under
PREA or the incentives under BPCA on
drug/biologic development plans,
including issues related to the balance
of incentives and requirements and
progress toward international alignment
on pediatric drug development to the
extent practicable.
• Understanding if there are any
barriers or resource issues preventing
undertaking or completing studies
under PREA and BPCA, including
issues related to clinical trial
infrastructure and enrollment and
ensuring pediatric clinical trial
populations reflect the diversity of
children most likely to use and benefit
from the therapeutic treatments.
• Understanding successes and
challenges with leveraging scientific
advances in product development,
including, but not limited to, use of
pediatric extrapolation, adaptive trial
designs, biomarkers as surrogates, and
real-world data to facilitate more timely
evidence-generation for pediatric
populations.
III. Participating in the Public Meeting
Registration: For more information
and to register for the public meeting,
please visit: https://www.fda.gov/newsevents/fda-meetings-conferences-andworkshops/interested-parties-meetingimplementation-best-pharmaceuticalschildren-act-and-pediatric-research.
Please provide complete contact
information for each attendee, including
name, email address, and affiliation.
Registration is free and based on space
availability for in-person attendance,
with priority given to early registrants.
Persons interested in attending this
public meeting in-person must register
by May 1, 2025, 11:59 p.m. Eastern
Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
VerDate Sep<11>2014
18:01 Jan 02, 2025
Jkt 265001
organization. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 8 a.m. We will post a
notice on the meeting web page if
registration for in-person attendance
closes before the day of the public
meeting.
If you need special accommodations
due to a disability, please contact OPT@
fda.hhs.gov no later than May 8, 2025,
11:59 p.m. Eastern Time.
Requests for Oral Comment: During
online registration you may indicate if
you wish to present an oral comment
during a public comment session, and
which topic(s) you wish to address. We
will do our best to accommodate
requests to make oral comments.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
comments. All requests to make oral
comments, for both virtual and inperson attendees, must be received by
the close of in-person registration on
May 1, 2025, 11:59 p.m. Eastern Time.
Following the close of registration, we
will determine the amount of time
allotted to each presenter and the
approximate time that the oral comment
session is to begin, and will notify
participants making an oral comment by
May 5, 2025, 11:59 p.m. Eastern Time.
If making an oral comment, any
presentation materials must be emailed
to OPT@fda.hhs.gov (see FOR FURTHER
INFORMATION CONTACT) no later than May
9, 2025, 11:59 p.m. Eastern Time. No
commercial or promotional material
will be permitted to be presented or
distributed at the public meeting.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. The link to view the virtual
Zoom webinar will be sent to registered
participants prior to the meeting. The
meeting web page link is: https://
www.fda.gov/news-events/fda-meetingsconferences-and-workshops/interestedparties-meeting-implementation-bestpharmaceuticals-children-act-andpediatric-research.
Although FDA verified the website
addresses in this document, please note
that websites are subject to change over
time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov, https://
www.fda.gov/news-events/fda-meetingsconferences-and-workshops/interestedparties-meeting-implementation-bestpharmaceuticals-children-act-andpediatric-research, or the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, between 9
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
Notice of this meeting is given
pursuant to 21 CFR 10.65.
Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31312 Filed 1–2–25; 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, 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 (Mandatory Guidelines) using
Urine and the laboratories currently
certified to meet the standards of the
Mandatory Guidelines using Oral Fluid.
FOR FURTHER INFORMATION CONTACT:
Anastasia Flanagan, Division of
Workplace Programs, SAMHSA/CSAP,
5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240–276–
2600 (voice); Anastasia.Flanagan@
samhsa.hhs.gov (email).
SUPPLEMENTARY INFORMATION: The
Department of Health and Human
Services (HHS) publishes a notice
listing all HHS-certified laboratories and
Instrumented Initial Testing Facilities
(IITFs) in the Federal Register during
the first week of each month, in
accordance with Section 9.19 of the
Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Mandatory Guidelines) using Urine and
Section 9.17 of the Mandatory
Guidelines using Oral Fluid. 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
SUMMARY:
E:\FR\FM\03JAN1.SGM
03JAN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices
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/drug-testing-resources/
certified-lab-list.
HHS separately notifies Federal
agencies of the laboratories and IITFs
currently certified to meet the standards
of the 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); January 23,
2017 (82 FR 7920); and on October 12,
2023 (88 FR 70768).
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, and subsequently
revised in the Federal Register on
October 12, 2023 (88 FR 70814).
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.
VerDate Sep<11>2014
18:01 Jan 02, 2025
Jkt 265001
HHS-Certified Laboratories Approved
To Conduct Oral Fluid Drug Testing
In accordance with the Mandatory
Guidelines using Oral Fluid effective
October 10, 2023 (88 FR 70814), 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 effective
February 1, 2024 (88 FR 70768), 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 effective
February 1, 2024 (88 FR 70768), 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
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
LabOne, Inc. d/b/a Quest Diagnostics,
10101 Renner Blvd., Lenexa, KS
66219, 913–888–3927/800–873–8845,
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
325
(Formerly: Quest Diagnostics
Incorporated; LabOne, Inc.; Center for
Laboratory Services, a Division of
LabOne, 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 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)
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
Omega Laboratories, Inc.*, 2150
Dunwin Drive, Unit 1 & 2,
Mississauga, ON, Canada L5L 5M8,
289–919–3188
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
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 following laboratory is
voluntarily withdrawing from the
National Laboratory Certification
Program effective January 10, 2025:
Laboratory Corporation of America,
1225 NE 2nd Ave., Portland, OR
97323, 503–413–5295/800–950–5295,
(Formerly: Legacy Laboratory Services
Toxicology MetroLab)
*The Standards Council of Canada
(SCC) voted to end its Laboratory
E:\FR\FM\03JAN1.SGM
03JAN1
326
Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices
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 continued 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 as meeting
the minimum standards of the current
Mandatory Guidelines published in the
Federal Register. After receiving DOT
certification, the laboratory will be
included in the monthly list of HHScertified laboratories and participate in
the NLCP certification maintenance
program. DOT established this process
in July 1996 (61 FR 37015) to allow
foreign laboratories to participate in the
DOT drug testing program.
Anastasia D. Flanagan,
Public Health Advisor, Division of Workplace
Programs.
[FR Doc. 2024–31499 Filed 1–2–25; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. CISA–2024–0037]
Request for Comment on the National
Cyber Incident Response Plan Update
Cybersecurity and
Infrastructure Security Agency (CISA),
Department of Homeland Security
(DHS).
ACTION: Notice of availability; extension
of comment period.
AGENCY:
On December 16, 2024, the
Cybersecurity and Infrastructure
Security Agency (CISA) published a
request for comment in the Federal
Register on a draft National Cyber
Incident Response Plan (NCIRP) Update,
which requests feedback on the draft
update. CISA is extending the public
comment period for the draft update for
an additional thirty days through
February 14, 2025.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:01 Jan 02, 2025
Jkt 265001
The comment period for the draft
update published on December 16,
2024, at 89 FR 101614 is extended.
Comments and related materials must
be submitted on or before February 14,
2025.
ADDRESSES: You may submit comments,
identified by docket number CISA–
2024–0037, by clicking on the ‘‘Submit
a Public Comment’’ button above or by
following the instructions below for
submitting comments directly via the
Federal public document portal, at
https://www.regulations.gov.
Instructions: All comments received
must include the agency name and
docket number CISA–2024–0037. All
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided. CISA
reserves the right to publicly republish
relevant and unedited comments in
their entirety that are submitted to the
docket. Do not include personal
information such as account numbers,
social security numbers, or names of
other individuals. Do not submit
confidential business information or
otherwise sensitive or protected
information.
Docket: For access to the docket to
read the draft National Cyber Incident
Response Plan (NCIRP) Update or
comments received, go to https://
www.regulations.gov. For convenience,
CISA has also posted the draft NCIRP
Update on https://www.cisa.gov/
national-cyber-incident-response-planncirp.
FOR FURTHER INFORMATION CONTACT:
Technical Content information: Mark
Peters, 771–212–7125, mark.peters@
cisa.dhs.gov.
Program information: Michael
Fogarty, 202–412–8385,
michael.fogarty@cisa.dhs.gov.
SUPPLEMENTARY INFORMATION: On
December 16, 2024, CISA published a
request for comment on the NCIRP
Update (89 FR 101614). In the draft
update, CISA addresses changes in the
cyber threat and operations landscape
by incorporating feedback and lessons
learned from stakeholders to make the
updated NCIRP more fully inclusive
across non-federal stakeholders—further
establishing a foundation for continued
improvement of the nation’s response to
significant cyber incidents. The request
for comment provided for a 30-day
comment period, set to close January 15,
2025. CISA received multiple requests
to extend the deadline given the
holidays occurring during the public
comment period. Therefore, the
comment period is now open through
February 14, 2025.
DATES:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
This notice is issued under the
authority of 6 U.S.C. 652, 659, 660, and
665b.
Jeffrey E. Greene,
Executive Assistant Director for
Cybersecurity, Cybersecurity and
Infrastructure Security Agency, Department
of Homeland Security.
[FR Doc. 2024–31514 Filed 1–2–25; 8:45 am]
BILLING CODE 9111–LF–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0068]
Agency Information Collection
Activities; Extension, Without Change,
of a Currently Approved Collection:
Registration for Classification as a
Refugee
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 60-Day notice.
AGENCY:
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) invites
the general public and other Federal
agencies to comment upon this
proposed extension of a currently
approved collection of information. In
accordance with the Paperwork
Reduction Act (PRA) of 1995, the
information collection notice is
published in the Federal Register to
obtain comments regarding the nature of
the information collection, the
categories of respondents, the estimated
burden (i.e., the time, effort, and
resources used by the respondents to
respond), the estimated cost to the
respondent, and the actual information
collection instruments.
DATES: Comments are encouraged and
will be accepted for 60 days until March
4, 2025.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0068 in the body of the letter, the
agency name and Docket ID USCIS–
2007–0036. Submit comments via the
Federal eRulemaking Portal website at
https://www.regulations.gov under eDocket ID number USCIS–2007–0036.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief, telephone
number (240) 721–3000 (This is not a
toll-free number. Comments are not
accepted via telephone message). Please
note contact information provided here
SUMMARY:
E:\FR\FM\03JAN1.SGM
03JAN1
Agencies
[Federal Register Volume 90, Number 2 (Friday, January 3, 2025)]
[Notices]
[Pages 324-326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31499]
-----------------------------------------------------------------------
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
(Mandatory Guidelines) using Urine and the laboratories currently
certified to meet the standards of the Mandatory Guidelines using Oral
Fluid.
FOR FURTHER INFORMATION CONTACT: Anastasia Flanagan, Division of
Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240-276-2600 (voice);
[email protected] (email).
SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) publishes a notice listing all HHS-certified laboratories and
Instrumented Initial Testing Facilities (IITFs) in the Federal Register
during the first week of each month, in accordance with Section 9.19 of
the Mandatory Guidelines for Federal Workplace Drug Testing Programs
(Mandatory Guidelines) using Urine and Section 9.17 of the Mandatory
Guidelines using Oral Fluid. 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
[[Page 325]]
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/drug-testing-resources/certified-lab-list.
HHS separately notifies Federal agencies of the laboratories and
IITFs currently certified to meet the standards of the 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); January 23, 2017 (82 FR 7920); and on October
12, 2023 (88 FR 70768).
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, and subsequently revised in the
Federal Register on October 12, 2023 (88 FR 70814).
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
effective October 10, 2023 (88 FR 70814), 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 effective
February 1, 2024 (88 FR 70768), 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 effective
February 1, 2024 (88 FR 70768), 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
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
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.)
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)
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
Omega Laboratories, Inc.*, 2150 Dunwin Drive, Unit 1 & 2, Mississauga,
ON, Canada L5L 5M8, 289-919-3188
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
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 following laboratory is voluntarily withdrawing from the
National Laboratory Certification Program effective January 10, 2025:
Laboratory Corporation of America, 1225 NE 2nd Ave., Portland, OR
97323, 503-413-5295/800-950-5295, (Formerly: Legacy Laboratory Services
Toxicology MetroLab)
*The Standards Council of Canada (SCC) voted to end its Laboratory
[[Page 326]]
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 continued 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 as meeting the minimum
standards of the current Mandatory Guidelines published in the Federal
Register. 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. DOT
established this process in July 1996 (61 FR 37015) to allow foreign
laboratories to participate in the DOT drug testing program.
Anastasia D. Flanagan,
Public Health Advisor, Division of Workplace Programs.
[FR Doc. 2024-31499 Filed 1-2-25; 8:45 am]
BILLING CODE 4162-20-P