Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies, 41490-41491 [2021-16385]

Download as PDF 41490 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR section/activity Total annual responses Average burden per response Total hours 610.2, Requests for Samples and Protocols; Official Release ................................................................................. 660.6(b), Protocols ............................................................... 660.36(a)(2) and (b), Samples and Protocols ..................... 660.46(b), Protocols ............................................................. 72 3 1 1 82.972 4 1 1 5,974 12 1 1 3 5 6 5 17,922 60 6 5 Total .............................................................................. 77 ........................ 5,988 ........................ 17,993 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects an overall decrease of 1,463 hours and a corresponding decrease of 491 responses. We attribute this adjustment to a decrease in the number of submissions we received over the last few years. Dated: July 27, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–16384 Filed 7–30–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies Substance Abuse and Mental Health Services Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines). FOR FURTHER INFORMATION CONTACT: Anastasia Donovan, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N06B, Rockville, Maryland 20857; 240–276– 2600 (voice); Anastasia.Donovan@ samhsa.hhs.gov (email). SUPPLEMENTARY INFORMATION: In accordance with Section 9.19 of the Mandatory Guidelines, a notice listing all currently HHS-certified laboratories SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Number of responses per respondent VerDate Sep<11>2014 17:21 Jul 30, 2021 Jkt 253001 and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https://www.samhsa.gov/ workplace/resources/drug-testing/ certified-lab-list. The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and of the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid. The Mandatory Guidelines using Urine were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); April 30, 2010 (75 FR 22809); and on January 23, 2017 (82 FR 7920). The Mandatory Guidelines using Oral Fluid were first published in the Federal Register on October 25, 2019 (84 FR 57554) with an effective date of January 1, 2020. The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Pubic Law 100–71 and allowed urine drug testing only. The Mandatory Guidelines using Urine have since been revised, and new Mandatory Guidelines allowing for oral fluid drug testing have been published. The Mandatory PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Guidelines require strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on specimens for federal agencies. HHS does not allow IITFs to conduct oral fluid testing. To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines using Urine and/ or Oral Fluid. An HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that the test facility has met minimum standards. HHS does not allow IITFs to conduct oral fluid testing. HHS-Certified Laboratories Approved To Conduct Oral Fluid Drug Testing In accordance with the Mandatory Guidelines using Oral Fluid dated October 25, 2019 (84 FR 57554), the following HHS-certified laboratories meet the minimum standards to conduct drug and specimen validity tests on oral fluid specimens: At this time, there are no laboratories certified to conduct drug and specimen validity tests on oral fluid specimens. HHS-Certified Instrumented Initial Testing Facilities Approved To Conduct Urine Drug Testing In accordance with the Mandatory Guidelines using Urine dated January 23, 2017 (82 FR 7920), the following HHS-certified IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens: Dynacare, 6628 50th Street NW, Edmonton, AB Canada T6B 2N7, 780– 784–1190 (Formerly: GammaDynacare Medical Laboratories) E:\FR\FM\02AUN1.SGM 02AUN1 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES HHS-Certified Laboratories Approved To Conduct Urine Drug Testing In accordance with the Mandatory Guidelines using Urine dated January 23, 2017 (82 FR 7920), the following HHS-certified laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens: Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504–361–8989/ 800–433–3823 (Formerly: Kroll Laboratory Specialists, Inc., Laboratory Specialists, Inc.) Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236, 804–378–9130 (Formerly: Kroll Laboratory Specialists, Inc., Scientific Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, Inc.) Clinical Reference Laboratory, Inc., 8433 Quivira Road, Lenexa, KS 66215– 2802, 800–445–6917 Cordant Health Solutions, 2617 East L Street, Tacoma, WA 98421, 800–442– 0438 (Formerly: STERLING Reference Laboratories) Desert Tox, LLC, 5425 E Bell Rd, Suite 125, Scottsdale, AZ 85254, 602–457– 5411/623–748–5045 DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800– 235–4890 Dynacare*, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519– 679–1630 (Formerly: GammaDynacare Medical Laboratories) ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662– 236–2609 Laboratory Corporation of America Holdings, 7207 N. Gessner Road, Houston, TX 77040, 713–856–8288/ 800–800–2387, Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 08869, 908–526–2400/800–437–4986 (Formerly: Roche Biomedical Laboratories, Inc.) Laboratory Corporation of America Holdings, 1904 TW Alexander Drive, Research Triangle Park, NC 27709, 919–572–6900/800–833–3984 (Formerly: LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche Group) Laboratory Corporation of America Holdings, 1120 Main Street, Southaven, MS 38671, 866–827–8042/ 800–233–6339 (Formerly: LabCorp Occupational Testing Services, Inc.; MedExpress/National Laboratory Center) VerDate Sep<11>2014 17:21 Jul 30, 2021 Jkt 253001 LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS 66219, 913–888–3927/800–873–8845 (Formerly: Quest Diagnostics Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division of LabOne, Inc.) Legacy Laboratory Services Toxicology, 1225 NE 2nd Ave., Portland, OR 97232, 503–413–5295/800–950–5295 MedTox Laboratories, Inc., 402 W. County Road D, St. Paul, MN 55112, 651–636–7466/800–832–3244 Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612–725– 2088, Testing for Veterans Affairs (VA) Employees Only Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800–328–6942 (Formerly: Centinela Hospital Airport Toxicology Laboratory) Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888– 635–5840 Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 610–631–4600/877–642–2216 (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline BioScience Laboratories) Redwood Toxicology Laboratory, 3700 Westwind Blvd., Santa Rosa, CA 95403, 800–255–2159 US Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755– 5235, 301–677–7085, Testing for Department of Defense (DoD) Employees Only * The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS’ NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do. Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (Federal PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 41491 Register, July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register on January 23, 2017 (82 FR 7920). After receiving DOT certification, the laboratory will be included in the monthly list of HHS-certified laboratories and participate in the NLCP certification maintenance program. Anastasia Marie Donovan, Policy Analyst, Division of Workplace Programs. [FR Doc. 2021–16385 Filed 7–30–21; 8:45 am] BILLING CODE 4160–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer at (240) 276– 0361. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Government Performance and Results Act (GPRA) Client/Participant Outcomes Measure— (OMB No. 0930–0208)—Revision SAMHSA is requesting approval to modify its existing CSAT Client-level GPRA instrument by removing 40 questions and adding 41 questions to its existing CSAT Client-level GPRA instrument resulting in a net addition of 1 question. Currently, the information collected from this instrument is E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41490-41491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16385]


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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, 
Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Department of Health and Human Services (HHS) notifies 
Federal agencies of the laboratories and Instrumented Initial Testing 
Facilities (IITFs) currently certified to meet the standards of the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs using 
Urine or Oral Fluid (Mandatory Guidelines).

FOR FURTHER INFORMATION CONTACT: Anastasia Donovan, Division of 
Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N06B, 
Rockville, Maryland 20857; 240-276-2600 (voice); 
[email protected] (email).

SUPPLEMENTARY INFORMATION: In accordance with Section 9.19 of the 
Mandatory Guidelines, a notice listing all currently HHS-certified 
laboratories and IITFs is published in the Federal Register during the 
first week of each month. If any laboratory or IITF certification is 
suspended or revoked, the laboratory or IITF will be omitted from 
subsequent lists until such time as it is restored to full 
certification under the Mandatory Guidelines.
    If any laboratory or IITF has withdrawn from the HHS National 
Laboratory Certification Program (NLCP) during the past month, it will 
be listed at the end and will be omitted from the monthly listing 
thereafter.
    This notice is also available on the internet at https://www.samhsa.gov/workplace/resources/drug-testing/certified-lab-list.
    The Department of Health and Human Services (HHS) notifies federal 
agencies of the laboratories and Instrumented Initial Testing 
Facilities (IITFs) currently certified to meet the standards of the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs 
(Mandatory Guidelines) using Urine and of the laboratories currently 
certified to meet the standards of the Mandatory Guidelines using Oral 
Fluid.
    The Mandatory Guidelines using Urine were first published in the 
Federal Register on April 11, 1988 (53 FR 11970), and subsequently 
revised in the Federal Register on June 9, 1994 (59 FR 29908); 
September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); 
November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); April 
30, 2010 (75 FR 22809); and on January 23, 2017 (82 FR 7920).
    The Mandatory Guidelines using Oral Fluid were first published in 
the Federal Register on October 25, 2019 (84 FR 57554) with an 
effective date of January 1, 2020.
    The Mandatory Guidelines were initially developed in accordance 
with Executive Order 12564 and section 503 of Pubic Law 100-71 and 
allowed urine drug testing only. The Mandatory Guidelines using Urine 
have since been revised, and new Mandatory Guidelines allowing for oral 
fluid drug testing have been published. The Mandatory Guidelines 
require strict standards that laboratories and IITFs must meet in order 
to conduct drug and specimen validity tests on specimens for federal 
agencies. HHS does not allow IITFs to conduct oral fluid testing.
    To become certified, an applicant laboratory or IITF must undergo 
three rounds of performance testing plus an on-site inspection. To 
maintain that certification, a laboratory or IITF must participate in a 
quarterly performance testing program plus undergo periodic, on-site 
inspections.
    Laboratories and IITFs in the applicant stage of certification are 
not to be considered as meeting the minimum requirements described in 
the HHS Mandatory Guidelines using Urine and/or Oral Fluid. An HHS-
certified laboratory or IITF must have its letter of certification from 
HHS/SAMHSA (formerly: HHS/NIDA), which attests that the test facility 
has met minimum standards. HHS does not allow IITFs to conduct oral 
fluid testing.

HHS-Certified Laboratories Approved To Conduct Oral Fluid Drug Testing

    In accordance with the Mandatory Guidelines using Oral Fluid dated 
October 25, 2019 (84 FR 57554), the following HHS-certified 
laboratories meet the minimum standards to conduct drug and specimen 
validity tests on oral fluid specimens: At this time, there are no 
laboratories certified to conduct drug and specimen validity tests on 
oral fluid specimens.

HHS-Certified Instrumented Initial Testing Facilities Approved To 
Conduct Urine Drug Testing

    In accordance with the Mandatory Guidelines using Urine dated 
January 23, 2017 (82 FR 7920), the following HHS-certified IITFs meet 
the minimum standards to conduct drug and specimen validity tests on 
urine specimens:

Dynacare, 6628 50th Street NW, Edmonton, AB Canada T6B 2N7, 780-784-
1190 (Formerly: Gamma-Dynacare Medical Laboratories)

[[Page 41491]]

HHS-Certified Laboratories Approved To Conduct Urine Drug Testing

    In accordance with the Mandatory Guidelines using Urine dated 
January 23, 2017 (82 FR 7920), the following HHS-certified laboratories 
meet the minimum standards to conduct drug and specimen validity tests 
on urine specimens:

Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504-361-
8989/800-433-3823 (Formerly: Kroll Laboratory Specialists, Inc., 
Laboratory Specialists, Inc.)
Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236, 
804-378-9130 (Formerly: Kroll Laboratory Specialists, Inc., Scientific 
Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, 
Inc.)
Clinical Reference Laboratory, Inc., 8433 Quivira Road, Lenexa, KS 
66215-2802, 800-445-6917
Cordant Health Solutions, 2617 East L Street, Tacoma, WA 98421, 800-
442-0438 (Formerly: STERLING Reference Laboratories)
Desert Tox, LLC, 5425 E Bell Rd, Suite 125, Scottsdale, AZ 85254, 602-
457-5411/623-748-5045
DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800-
235-4890
Dynacare*, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519-679-
1630 (Formerly: Gamma-Dynacare Medical Laboratories)
ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 
662-236-2609
Laboratory Corporation of America Holdings, 7207 N. Gessner Road, 
Houston, TX 77040, 713-856-8288/800-800-2387,
Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 
08869, 908-526-2400/800-437-4986 (Formerly: Roche Biomedical 
Laboratories, Inc.)
Laboratory Corporation of America Holdings, 1904 TW Alexander Drive, 
Research Triangle Park, NC 27709, 919-572-6900/800-833-3984 (Formerly: 
LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, 
Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical 
Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche 
Group)
Laboratory Corporation of America Holdings, 1120 Main Street, 
Southaven, MS 38671, 866-827-8042/800-233-6339 (Formerly: LabCorp 
Occupational Testing Services, Inc.; MedExpress/National Laboratory 
Center)
LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS 
66219, 913-888-3927/800-873-8845 (Formerly: Quest Diagnostics 
Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division 
of LabOne, Inc.)
Legacy Laboratory Services Toxicology, 1225 NE 2nd Ave., Portland, OR 
97232, 503-413-5295/800-950-5295
MedTox Laboratories, Inc., 402 W. County Road D, St. Paul, MN 55112, 
651-636-7466/800-832-3244
Minneapolis Veterans Affairs Medical Center, Forensic Toxicology 
Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612-725-2088, 
Testing for Veterans Affairs (VA) Employees Only
Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 
91311, 800-328-6942 (Formerly: Centinela Hospital Airport Toxicology 
Laboratory)
Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888-635-
5840
Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 
610-631-4600/877-642-2216 (Formerly: SmithKline Beecham Clinical 
Laboratories; SmithKline Bio-Science Laboratories)
Redwood Toxicology Laboratory, 3700 Westwind Blvd., Santa Rosa, CA 
95403, 800-255-2159
US Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., 
Fort George G. Meade, MD 20755-5235, 301-677-7085, Testing for 
Department of Defense (DoD) Employees Only

    * The Standards Council of Canada (SCC) voted to end its Laboratory 
Accreditation Program for Substance Abuse (LAPSA) effective May 12, 
1998. Laboratories certified through that program were accredited to 
conduct forensic urine drug testing as required by U.S. Department of 
Transportation (DOT) regulations. As of that date, the certification of 
those accredited Canadian laboratories will continue under DOT 
authority. The responsibility for conducting quarterly performance 
testing plus periodic on-site inspections of those LAPSA-accredited 
laboratories was transferred to the U.S. HHS, with the HHS' NLCP 
contractor continuing to have an active role in the performance testing 
and laboratory inspection processes. Other Canadian laboratories 
wishing to be considered for the NLCP may apply directly to the NLCP 
contractor just as U.S. laboratories do.
    Upon finding a Canadian laboratory to be qualified, HHS will 
recommend that DOT certify the laboratory (Federal Register, July 16, 
1996) as meeting the minimum standards of the Mandatory Guidelines 
published in the Federal Register on January 23, 2017 (82 FR 7920). 
After receiving DOT certification, the laboratory will be included in 
the monthly list of HHS-certified laboratories and participate in the 
NLCP certification maintenance program.

Anastasia Marie Donovan,
Policy Analyst, Division of Workplace Programs.
[FR Doc. 2021-16385 Filed 7-30-21; 8:45 am]
BILLING CODE 4160-20-P