382 Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 

FDA’s GGP regulation provides that the 

public may comment on any guidance at 

any time, including Level 1 guidance 

documents for immediate 

implementation and Level 2 guidance 

documents, and FDA may delay 

implementation of any guidance 

document. 

a. In light of the above, we seek input 

on whether there are any additional 

circumstances, categories of guidance 

documents, or topics for guidance for 

which it may be appropriate and 

consistent with the FD&C Act and 

FDA’s GGP regulation for FDA to 

consider issuance as a Level 1 guidance 

document for immediate 

implementation without prior public 

comment. 

b. We also seek comment on whether 

there are additional categories or types 

of guidance documents that FDA should 

consider issuing as Level 2 guidance 

documents to streamline the guidance 

process and allow the Agency to better 

leverage its resources for the timely 

development of more guidance 

documents. 

3. FDA requests comment on any 

novel guidance document formats that 

would be of particular utility, such as 

use of templates to accompany a 

guidance document, Q&A formats, 

flowcharts, etc., that are used in FDA 

guidance documents or that were used 

in guidance documents issued in 

response to the COVID–19 PHE. 

4. FDA makes robust use of guidance 

documents to assist industry in making 

regulatory submissions. As described in 

the report, examples of such guidances 

include device-specific guidance 

documents, disease or indication 

specific guidance documents that 

include recommendations on 

developing drugs intended to treat a 

specific disease or for a specific 

indication to support submissions of 

New Drug Applications (NDAs) or 

Supplemental NDAs, product specific 

guidances for generic drug development 

to support submission of Abbreviated 

New Drug Applications (ANDAs), Data 

Technical Conformance Guides to 

accompany guidance documents, and 

guidance documents that provide 

assistance with registration and listing 

requirements. FDA requests comment 

on the utility of guidances in 

streamlining regulatory submissions and 

whether there are additional categories 

or types of guidance that would be 

helpful to streamline processes for 

regulatory submissions to the Agency. 

5. Currently, FDA’s GGP regulation 

(§ 10.115) provides that interested 

persons can suggest areas for guidance 

document development and that such 

suggestions should address why a 

guidance document is necessary. 

(§ 10.115(f)(2)). In addition, proposed 

guidance documents can be submitted 

to a specified docket for FDA 

consideration. (§ 10.115(f)(3)). FDA 

requests comments on whether the 

currently available mechanisms for 

submitting suggested areas for guidance 

development and proposed guidance 

documents are useful and sufficient or 

whether additional mechanisms, for 

example, a Center-specific or Officespecific mailbox for such suggestions 

would ease the process for such 

submissions. 

6. FDA Centers publish guidance 

agendas on their web pages to give 

interested parties and the public notice 

of the areas in which FDA is 

considering upcoming guidance. We 

request comment on the utility of these 

guidance agendas and what, if any, 

modifications to these agendas would be 

helpful for the Agency to consider. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft report and plan at 

https://www.fda.gov/about-fda/reports/ 

reports-agency-policies-and-initiatives 

or https://www.regulations.gov. 

Dated: December 22, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28872 Filed 1–2–24; 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, 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 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: 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 


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Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 383 

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 

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 

Quest Diagnostics Incorporated, 400 

Egypt Road, Norristown, PA 19403, 

610–631–4600/877–642–2216, 

(Formerly: SmithKline Beecham 

Clinical Laboratories; SmithKline BioScience Laboratories) 

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 (61 FR 

37015) 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 D. Flanagan, 

Public Health Advisor, Division of Workplace 

Programs. 

[FR Doc. 2023–28882 Filed 1–2–24; 8:45 am] 

BILLING CODE 4160–20–P 


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