41490 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section/activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

610.2, Requests for Samples and Protocols; Official Release ................................................................................. 72 82.972 5,974 3 17,922 

660.6(b), Protocols ............................................................... 3 4 12 5 60 

660.36(a)(2) and (b), Samples and Protocols ..................... 1 1 1 6 6 

660.46(b), Protocols ............................................................. 1 1 1 5 5 

Total .............................................................................. 77 ........................ 5,988 ........................ 17,993 

1There 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 

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); 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 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: GammaDynacare Medical Laboratories) 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 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: 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 

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 

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 


khammond on DSKJM1Z7X2PROD with NOTICES