Notice2023-25463
Notice of Meeting; Correction
Primary source
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Published
November 17, 2023
Issuing agencies
Health and Human Services DepartmentSubstance Abuse and Mental Health Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 221 (Friday, November 17, 2023)</title>
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[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80323-80324]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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), <a href="/cdn-cgi/l/email-protection#5814312b39761c392e312b182b3935302b397630302b763f372e"><span class="__cf_email__" data-cfemail="430f2a30226d0722352a300330222e2b30226d2b2b306d242c35">[email protected]</span></a> (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:
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Initial test Confirmation
Urine analyte cutoff cutoff
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Fentanyl........................ 1 ng/mL........... 0.5 ng/mL.
Norfentanyl..................... 1 ng/mL........... 0.5 ng/mL.
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Initial test Confirmation
Oral fluid analyte cutoff cutoff
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Fentanyl........................ 1 ng/mL........... 0.5 ng/mL.
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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 <a href="https://snacregister.samhsa.gov/">https://snacregister.samhsa.gov/</a>. 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, <a href="https://www.samhsa.gov/about-us/advisory-councils/meetings">https://www.samhsa.gov/about-us/advisory-councils/meetings</a>, 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:
<a href="/cdn-cgi/l/email-protection#0f4b49585f4f7c6e62677c6e2167677c21686079"><span class="__cf_email__" data-cfemail="2c686a7b7c6c5f4d41445f4d0244445f024b435a">[email protected]</span></a>.
Please submit written comments regarding the addition of Fentanyl
and the removal of MDA and MDMA to the analyte table to the following
email: <a href="/cdn-cgi/l/email-protection#67232130372714060a0f1406490f0f1449000811"><span class="__cf_email__" data-cfemail="bffbf9e8efffccded2d7ccde91d7d7cc91d8d0c9">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#93dffae0f2bdd7f2e5fae0d3e0f2fefbe0f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="662a0f1507482207100f152615070b0e1507480e0e1548010910">[email protected]</span></a>.
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. <a href="https://www.nflis.deadiversion.usdoj.gov/">https://www.nflis.deadiversion.usdoj.gov/</a>.
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
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