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, 35102-35103 [2021-14044]

Download as PDF 35102 Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices confidentially, and may be made publicly available. Complete license applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: June 25, 2021. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2021–14128 Filed 6–30–21; 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: 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 If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:45 Jun 30, 2021 Jkt 253001 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 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. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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) 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) E:\FR\FM\01JYN1.SGM 01JYN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices 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 BioScience Laboratories) Redwood Toxicology Laboratory, 3700 Westwind Blvd., Santa Rosa, CA 95403, 800–255–2159 VerDate Sep<11>2014 16:45 Jun 30, 2021 Jkt 253001 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. 2021–14044 Filed 6–30–21; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Meeting of the Substance Abuse and Mental Health Services Administration, Center for Mental Health Services National Advisory Council Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: Notice is hereby given of the meeting on August 17, 2021 of the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services National Advisory Council (CMHS NAC). The meeting is open to the public and can be accessed remotely. Agenda with call-in information will be posted on the SAMHSA website prior to the SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 35103 meeting at: https://www.samhsa.gov/ about-us/advisory-councils/meetings. The meeting will include consideration of the minutes from the March 18, 2021, SAMHSA, CMHS NAC meeting; updates from the CMHS Director to include discussions on the Mental Health Block Grant, Certified Community Behavioral Health Clinic, and Children Services; and updates from the Office of the Assitant Secretary for Mental Health and Substance Use. Tuesday, August 17, 2021, 1:00 p.m. to 4:30 p.m., EDT, (OPEN). DATES: The meeting will be held virtually only. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Pamela Foote, Designated Federal Officer, CMHS National Advisory Council, 5600 Fishers Lane, Room 14E57B, Rockville, Maryland 20857, Telephone: (240) 276–1279, Fax: (301) 480–8491, Email: pamela.foote@ samhsa.hhs.gov. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council. Individuals interested in sending written submissions or making public comments, must forward them and notify the contact person on or before July 30, 2021. Up to three minutes will be allotted for each presentation. SUPPLEMENTARY INFORMATION: Registration is required to participate during this meeting. To attend virtually, or to obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register on-line at: http://snacregister.samhsa.gov/ MeetingList.aspx or communicate with the CMHS NAC Designated Federal Officer; Pamela Foote. Meeting information and a roster of Council members may be obtained by accessing the SAMHSA website at: http://www.samhsa.gov/about-us/ advisory-councils/cmhs-nationaladvisory-council or by contacting the CMHS NAC Designated Federal Officer; Pamela Foote. Council Name: Substance Abuse and Mental Health Services Administration, Center for Mental Health Services National Advisory Council. Dated: June 25, 2021. Carlos Castillo, Committee Management Officer, SAMHSA. [FR Doc. 2021–14031 Filed 6–30–21; 8:45 am] BILLING CODE 4162–20–P E:\FR\FM\01JYN1.SGM 01JYN1

Agencies

[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Pages 35102-35103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14044]


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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 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)

[[Page 35103]]

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. 2021-14044 Filed 6-30-21; 8:45 am]
BILLING CODE 4162-20-P