[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80323-80324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Notice of Meeting; Correction

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice; correction.

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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), [email protected] (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:

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


------------------------------------------------------------------------
                                     Initial test        Confirmation
       Oral fluid analyte               cutoff              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

[[Page 80324]]

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: 
[email protected].
    Please submit written comments regarding the addition of Fentanyl 
and the removal of MDA and MDMA to the analyte table to the following 
email: [email protected].
    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: (240) 276-1440, email: [email protected].

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.
[FR Doc. 2023-25463 Filed 11-16-23; 8:45 am]
BILLING CODE 4162-20-P