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 

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); 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withdrawn from the HHS National 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 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: 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) 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices 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 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. 2021–14044 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 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: 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 

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. 

DATES: Tuesday, August 17, 2021, 1:00 

p.m. to 4:30 p.m., EDT, (OPEN). 

ADDRESSES: The meeting will be held 

virtually only. 

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. 

SUPPLEMENTARY INFORMATION: 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. 

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 


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