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, 17170-17171 [2021-06694]
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Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–06690 Filed 3–31–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the National Vaccine Advisory
Committee (NVAC) will hold a virtual
meeting. The meeting will be open to
the public and public comment will be
heard during the meeting.
DATES: The meeting will be held June
16–17, 2021. The confirmed meeting
times and agenda will be posted on the
NVAC website at https://www.hhs.gov/
nvpo/nvac/meetings/ as soon
as they become available.
ADDRESSES: Instructions regarding
attending this meeting will be posted
online at: https://www.hhs.gov/nvpo/
nvac/meetings/ at least one
week prior to the meeting. Preregistration is required for those who
wish to attend the meeting or participate
in public comment. Please register at
https://www.hhs.gov/nvpo/nvac/
meetings/.
FOR FURTHER INFORMATION CONTACT: Ann
Aikin, Acting Designated Federal
Officer, at the Office of Infectious
Disease and HIV/AIDS Policy, U.S.
Department of Health and Human
Services, Mary E. Switzer Building,
Room L618, 330 C Street SW,
Washington, DC 20024. Email: nvac@
hhs.gov. Phone: 202–695–9742.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of HHS was mandated to
establish the National Vaccine Program
to achieve optimal prevention of human
infectious diseases through
immunization and to achieve optimal
prevention against adverse reactions to
vaccines. The NVAC was established to
provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
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SUMMARY:
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19:02 Mar 31, 2021
Jkt 253001
related to the Program’s responsibilities.
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program.
During this NVAC meeting, NVAC
will hear presentations on vaccine
safety, communication activities for
COVID–19 vaccines, and immunization
equity. Please note that agenda items are
subject to change, as priorities dictate.
Information on the final meeting agenda
will be posted prior to the meeting on
the NVAC website: https://www.hhs.gov/
nvpo/nvac/.
Members of the public will have the
opportunity to provide comment at the
NVAC meeting during the public
comment period designated on the
agenda. Public comments made during
the meeting will be limited to three
minutes per person to ensure time is
allotted for all those wishing to speak.
Individuals are also welcome to submit
written comments in advance. Written
comments should not exceed three
pages in length. Individuals submitting
comments should email their written
comments or their request to provide a
comment during the meeting to nvac@
hhs.gov at least five business days prior
to the meeting.
Ann Aikin,
Acting Designated Federal Official, Office of
the Assistant Secretary for Health.
[FR Doc. 2021–06692 Filed 3–31–21; 8:45 am]
BILLING CODE 4150–44–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–
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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
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 Pub. L. 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
E:\FR\FM\01APN1.SGM
01APN1
Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices
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)
jbell on DSKJLSW7X2PROD 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.)
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19:02 Mar 31, 2021
Jkt 253001
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)
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 9990
17171
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
U.S. 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.
[FR Doc. 2021–06694 Filed 3–31–21; 8:45 am]
BILLING CODE 4160–20–P
E:\FR\FM\01APN1.SGM
01APN1
Agencies
[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17170-17171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06694]
-----------------------------------------------------------------------
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: 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 Pub. L. 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
[[Page 17171]]
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)
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
U.S. 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.
[FR Doc. 2021-06694 Filed 3-31-21; 8:45 am]
BILLING CODE 4160-20-P