Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Notices 95225 

covers a portion of the possible 

applications of E–046–2022. 

This Notice is made in accordance 

with 35 U.S.C. 209 and 37 CFR part 404. 

The prospective exclusive license will 

be royalty bearing, and the prospective 

exclusive license may be granted unless 

within fifteen (15) days from the date of 

this published Notice, the National 

Cancer Institute receives written 

evidence and argument that establishes 

that the grant of the license would not 

be consistent with the requirements of 

35 U.S.C. 209 and 37 CFR part 404. 

In response to this Notice, the public 

may file comments or objections. 

Comments and objections, other than 

those in the form of a license 

application, will not be treated 

confidentially and may be made 

publicly available. 

License applications submitted in 

response to this Notice will be 

presumed to contain business 

confidential information and any release 

of information from 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: November 25, 2024. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2024–28081 Filed 11–29–24; 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 (Mandatory Guidelines) using 

Urine and the laboratories currently 

certified to meet the standards of the 

Mandatory Guidelines using Oral Fluid. 

FOR FURTHER INFORMATION CONTACT: 

Anastasia Flanagan, Division of 

Workplace Programs, SAMHSA/CSAP, 

5600 Fishers Lane, Room 16N06B, 

Rockville, Maryland 20857; 240–276– 

2600 (voice); Anastasia.Flanagan@

samhsa.hhs.gov (email). 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) publishes a notice 

listing all HHS-certified laboratories and 

Instrumented Initial Testing Facilities 

(IITFs) in the Federal Register during 

the first week of each month, in 

accordance with section 9.19 of the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Mandatory Guidelines) using Urine and 

section 9.17 of the Mandatory 

Guidelines using Oral Fluid. 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/drug-testing-resources/ 

certified-lab-list. 

HHS separately notifies Federal 

agencies of the laboratories and IITFs 

currently certified to meet the standards 

of the 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); January 23, 

2017 (82 FR 7920); and on October 12, 

2023 (88 FR 70768). 

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, and subsequently 

revised in the Federal Register on 

October 12, 2023 (88 FR 70814). 

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 effective 

October 10, 2023 (88 FR 70814), 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 effective 

February 1, 2024 (88 FR 70768), 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 effective 

February 1, 2024 (88 FR 70768), 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.) 


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95226 Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Notices 

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. 

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. 

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.) 

Laboratory Corporation of America, 

1225 NE 2nd Ave., Portland, OR 

97232, 503–413–5295/800–950–5295. 

(Formerly: Legacy Laboratory Services 

Toxicology MetroLab) 

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) 

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. 

Omega Laboratories, Inc.*, 2150 

Dunwin Drive, Unit 1 & 2, 

Mississauga, ON, Canada L5L 5M8, 

289–919–3188. 

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. 

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 continued 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 as meeting 

the minimum standards of the current 

Mandatory Guidelines published in the 

Federal Register. After receiving DOT 

certification, the laboratory will be 

included in the monthly list of HHScertified laboratories and participate in 

the NLCP certification maintenance 

program. DOT established this process 

in July 1996 (61 FR 37015) to allow 

foreign laboratories to participate in the 

DOT drug testing program. 

Anastasia D. Flanagan, 

Public Health Advisor, Division of Workplace 

Programs. 

[FR Doc. 2024–28147 Filed 11–29–24; 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: Submission for OMB 

Review; 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 on (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: 988 Suicide & Crisis 

Lifeline and Crisis Services Program 

Evaluation—New Package 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA) 988 & Behavioral Health 

Crisis Coordinating Office (BHCCO)) is 

requesting clearance for the new data 

collection associated with the 

evaluation of the SAMHSA 988 Suicide 

and Crisis Lifeline and Crisis Services 

Program Evaluation (988 Suicide and 

Crisis Lifeline Evaluation). The 

collection of this information is critical 

to successfully oversee operational 

response and quality of service through 

the 988 Suicide and Crisis Lifeline to 

ensure connections to care for 

individuals in suicidal crisis or 

emotional distress contacting in for 988 

phone, chat, and text support for 

connecting local, state/territory, and 

national outcomes and monitoring 

contractual obligations for current and 

future 988 Suicide and Crisis Lifeline 

grant programs. Much of the 

information is already embedded in the 

current 988 Suicide and Crisis Lifeline 


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