2023-25463. Notice of Meeting; Correction

AGENCY:

Substance Abuse and Mental Health Services Administration, HHS.

ACTION:

Notice; correction.

SUMMARY:

The Substance Abuse and Mental Health Services Administration (SAMHSA) published a document in the Federal Register of October 17, 2023, in FR Doc. 2023–22797 announcing the meeting of the SAMHSA Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB) on December 5, 2023, and to request comments on editing the Authorized Drug Testing Panels for federally regulated testing. The document was revised to reflect new information under the Supplementary Section.

FOR FURTHER INFORMATION CONTACT:

Lisa Davis, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Rockville, MD 20857, (240) 276–1440 (voice), [e-mail] (email).

SUPPLEMENTARY INFORMATION:

Notice of Meeting

Pursuant to Public Law 92–463, notice is hereby given that the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Prevention's (CSAP) Drug Testing Advisory Board (DTAB) will convene via web conference on December 5, 2023, from 10:00 a.m. EST to 4:30 p.m.

The board will meet in open-session December 5, 2023, from 10:00 a.m. EST to 4:30 p.m. EST to hear Federal Partner updates and presentations regarding National Laboratory Certification Program (NLCP) activities, updates to the Medical Review Officer (MRO) Guidance Manual, laboratory-created cannabinoids and other contaminants in commercially available products, and the process for adding or removing analytes from the Authorized Drug Testing Panels for federally regulated testing. The Board will discuss the Mandatory Guidelines for Federal Workplace Drug Testing Programs and revisions to the Authorized Drug Testing Panels for Urine and Oral Fluid to add fentanyl and (for urine) nor-fentanyl, and to remove methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine (MDA). Additionally, the Department is asking for public comments on these recommended changes to the drug testing panel.

Section 8105 of the Fighting Opioid Abuse in Transportation Act, included in the SUPPORT for Patients and Communities Act, required the Secretary to determine whether it is justified, based on the reliability and cost-effectiveness of testing, to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs to include fentanyl. Section 8105 additionally required the Secretary to consider whether to include any other drugs or other substances listed in Schedule I and II of Controlled Substances Act (CSA). Norfentanyl is a metabolite of fentanyl. Because it is also an immediate precursor used in the illicit manufacture of fentanyl, it is a Schedule II substance under the CSA.

Fentanyl accounts for a large proportion of overdose deaths in the United States and is therefore an important public safety concern. Furthermore, fentanyl is increasingly used as a stand-alone substance of abuse, not in conjunction with heroin and other substances. According to the National Forensic Laboratory Information System (NFLIS) 2021 report, fentanyl was the 4th most frequently identified drug and accounted for 11.61% of all drugs reported by forensic laboratories.¹ Norfentanyl is an important component of identifying fentanyl users when urine is the specimen matrix. Fentanyl has been detected in oral fluid in pain management patients, overdose cases, and driving under the influence of drugs (DUID) cases. Information provided by HHS-certified laboratories in 2023 indicated that a majority (84%) of the laboratories analyzed non-regulated workplace specimens for fentanyl and/or norfentanyl, and that all had the ability to analyze urine specimens for fentanyl with sufficiently sensitive detection limits using commercially available immunoassay kits and confirmatory test instrumentation commonly used in HHS-certified laboratories.

The Division of Workplace Programs welcomes public comment prior to the DTAB meeting regarding the possible addition of fentanyl to the Authorized Drug Testing Panels for Urine and Oral Fluid. Please see below for the process to submit comments.

Addition to HHS Drug Testing Panels as listed below:

Urine analyte	Initial test cutoff	Confirmation cutoff
Fentanyl	1 ng/mL	0.5 ng/mL.
Norfentanyl	1 ng/mL	0.5 ng/mL.

Oral fluid analyte	Initial test cutoff	Confirmation cutoff
Fentanyl	1 ng/mL	0.5 ng/mL.

Remove Methylenedioxyamphetamine (MDA) and Methylenedioxymethamphetamine (MDMA) from the Authorized Drug Testing Panel:

The Department plans to remove MDA and methylenedioxymethamphetamine from the drug testing panel, because the number of positive specimens reported by HHS-certified laboratories does not support testing all specimens for MDA and MDMA in Federal workplace drug testing programs. Information provided to the Department through the NLCP in 2021 and 2022 shows the positivity rate for MDMA ranges from 0.001 to 0.003%, and a review of the results indicate that >25% of the positive specimens are likely agency blind samples. MDA has a lower positivity rate than MDMA and both have lower positivity rates than phencyclidine (PCP). SAMHSA also considered removing PCP but decided against this change. While PCP has an overall positivity rate nearly as low as MDMA, there are regional differences in positivity, with some areas of the country having much higher rates, so PCP remains a regulated test analyte. Because MDA and MDMA are Schedule I drugs, a Federal agency may test specimens for these analytes in accordance with Section 3.2 of the UrMG and OFMG ( i.e., on a case-by-case basis for reasonable suspicion or post-accident testing, or routinely with a waiver from the Secretary). The Division of Workplace Programs welcomes public comment prior to the DTAB meeting regarding the removal of MDA and MDMA from the Urine and Oral Fluid Analyte Table. Please see below for the process to submit comments.

Meeting registration information can be completed at https://snacregister.samhsa.gov/​. Web conference and call information will be sent after completing registration. Meeting information and a roster of DTAB members may be obtained by accessing the SAMHSA Advisory Committees website, https://www.samhsa.gov/​about-us/​advisory-councils/​meetings, or by contacting the Designated Federal Officer, Lisa Davis.

Committee Name: Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention, Drug Testing Advisory Board.

Dates/Time/Type: December 5, 2023, from 10:00 a.m. EST to 4:30 p.m. EST: OPEN

Place: Virtual.

To Submit Comments: Requests to make public comment during the public comment period of the December DTAB meeting must be made in writing at least 7 days prior to the meeting to the following email: [e-mail].

Please submit written comments regarding the addition of Fentanyl and the removal of MDA and MDMA to the analyte table to the following email: [e-mail].

Comments regarding the addition of Fentanyl and the removal of MDA and MDMA to the analyte table will be accepted for review for an additional 30 days following this meeting, or no later than January 4th, 2024.

Contact: Lisa S. Davis, M.S., Social Science Analyst, Center for Substance Abuse Prevention, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone: [phone], email: [e-mail].

Endnote:

¹  National Forensic Laboratory Information System (NFLIS). (2021). NFLIS-Drug 2021 Annual Report. U.S. Department of Justice, Drug Enforcement Agency, Diversion Control Division. https://www.nflis.deadiversion.usdoj.gov/​.

Dated: November 13, 2023.

Anastasia Flanagan,

Public Health Advisor, Division of Workplace Programs.