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Published Document: 2024-02640 (89 FR 9166)
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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 March 5, 2024, from 10 a.m. EST to 12:45 p.m. EST.
The board will meet in open-session March 5, 2024, from 10 a.m. EST to 12:45 p.m. EST to hear presentations regarding proposed changes to the analyte table including fentanyl prevalence, fentanyl immunoassay updates, cost and benefits analysis and a summary of public comments received regarding the proposed changes to the HHS Drug Testing Panels.
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 is involved in 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, not in conjunction with heroin and other substances. According to the National Forensic Laboratory Information System (NFLIS) 2022 report, fentanyl was the 3rd most frequently identified drug and accounted for 13.81% of all drugs reported by forensic laboratories.[1]
Norfentanyl is an important component of identifying people who use fentanyl when urine is the specimen matrix. Fentanyl has been detected in oral fluid in patients receiving pain management
( printed page 9167)
services, 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.
Proposed addition to HHS Drug Testing Panels as listed below:
Urine analyte
Initial test
cutoff
Confirmation cutoff
Fentanyl
1 ng/mL
1.0 ng/mL.
Norfentanyl
1.0 ng/mL.
Oral fluid analyte
Initial test
cutoff
Confirmation cutoff
Fentanyl
1 ng/mL
1.0 ng/mL.
The Department plans to remove MDA and methylenedioxy- methamphetamine (MDMA) 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).
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:
March 5, 2024, from 10:00 a.m. EST to 12:45 p.m. EST: OPEN.
Place:
Virtual.
To Submit Comments:
Requests to make public comment during the public comment period of the March DTAB meeting must be made in writing at least 7 days prior to the meeting to the following email:
DFWP@samhsa.hhs.gov.
Contact:
Lisa S. Davis, M.S, Social Science Analyst, Center for Substance Abuse Prevention, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone: (240) 276-1440, Email:
Lisa.Davis@samhsa.hhs.gov.
Anastasia Flanagan,
Public Health Advisor, Division of Workplace Programs.
Footnotes
1.
National Forensic Laboratory Information System (NFLIS). (2022).
NFLIS-Drug 2022 Annual Report.
U.S. Department of Justice, Drug Enforcement Agency, Diversion Control Division.
2022 NFLIS-Drug Annual Report.pdf.