[Federal Register Volume 90, Number 170 (Friday, September 5, 2025)]
[Notices]
[Pages 42976-42977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-17035]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning the opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer at (240) 276-0361.
Comments are invited on: (a) whether the proposed collections of
information are necessary for the proper performance of the functions
of the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: Mandatory Guidelines for Federal Workplace Drug
Testing Programs (OMB No. 0930-0158)--Extension
SAMHSA will request OMB approval for extension of the Federal Drug
Testing Custody and Control Form (CCF) for federal agency and federally
regulated drug testing programs which must comply with the HHS
Mandatory Guidelines for Federal Workplace Drug Testing Programs using
Urine (UrMG) dated October 12, 2023 (88 FR 70768) and using Oral Fluid
(OFMG) dated October 12, 2023 (88 FR 70814), and OMB approval for
information provided by test facilities (laboratories and Instrumented
Initial Test Facilities, IITFs) for the National Laboratory
Certification Program (NLCP).
The CCF is used by all federal agencies and by employers regulated
by the Department of Transportation (DOT) and the Nuclear Regulatory
Commission (NRC) to document the collection and chain of custody of a
urine or oral fluid specimen at the collection site, for HHS-certified
test facilities to document chain of custody and report results, and
for Medical Review Officers (MROs) to document and report a verified
result. SAMHSA allows the use of the CCF as a paper or electronic form.
The current OMB-approved CCF has an August 31, 2026, expiration
date. In March 2025, SAMHSA was notified of a potential issue with the
current Federal CCF. Most hardcopy paper CCFs are provided as a 5-part
form using carbonless paper. When expiration dates for primary/single
and split specimen oral fluid collection devices were handwritten in
Step 4 on Copy 1, the annotations covered some donor information in
Step 5 on Copies 2-5. SAMHSA notified certified test facilities of the
issue and approved some laboratory requests for modifications.
SAMHSA plans to submit the CCF with the following revisions for OMB
approval:
Copies 2-5
Revised Step 5
1. Shorten the email address line
2. Replace the 2 date fields for ``Daytime Phone No.'' and
``Evening Phone No.'' with a single field ``Phone No.''
3. Move the ``Date of Birth'' field to the left.
Laboratories and IITFs seeking HHS certification under the NLCP
must complete and submit the NLCP application form. The 3 NLCP
Applications (i.e., for urine laboratories, for urine instrumented
initial test facilities [IITFs], and for oral fluid laboratories) have
been updated in accordance with the current UrMG and OFMG. The
revisions enable provision of information for analytes in the
Authorized Testing Panels now published separately from the Mandatory
Guidelines and enable applicant and certified test facilities to submit
information on new technologies/instruments.
Prior to an inspection, an HHS-certified laboratory or IITF is
required to submit specific information regarding its procedures.
Collecting this information prior to an inspection allows the
inspectors to thoroughly review and understand the testing procedures
before arriving for the onsite inspection. The NLCP information
checklist has been updated in accordance with the current UrMG and
OFMG. The changes enable provision of information for analytes in the
Authorized Testing Panels now published separately from the Mandatory
Guidelines and enable applicant and certified test facilities to submit
information on new technologies/instruments.
The annual total burden estimates for the CCF, the NLCP
application, the NLCP information checklist, and the NLCP recordkeeping
requirements are shown in the following table.
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Burden per
Form/respondent Number of Responses per Total number response Annual burden Hourly wage Total cost ($)
respondents respondent of responses (hours) (hours) rate ($) \3\
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Custody and Control Form \1\:
Donor............................... 6,726,610 1 6,726,610 0.08 538,129 25 13,453,225
Collector........................... 6,726,610 1 6,726,610 0.07 470,683 15 7,060,245
Laboratory.......................... 6,726,610 1 6,726,610 0.05 336,331 35 11,771,585
IITF................................ 1 0 0 0.05 0 35 0
Medical Review Officer.............. 6,726,610 1 6,726,610 0.05 336,331 150 50,449,650
[[Page 42977]]
NLCP Application Form \2\:
Laboratory.......................... 20 1 20 3 60 35 2,100
IITF................................ 0 0 0 3 0 35 0
Sections B and C--NLCP Information
Checklist:
Laboratory.......................... 19 1 19 1 19 35 665
IITF................................ 1 1 1 1 1 35 35
Record Keeping:
Laboratory.......................... 19 1 19 250 4,750 35 166,250
IITF................................ 0 0 0 250 0 35 0
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Total........................... 6,726,669 .............. 26,906,499 .............. 1,686,304 .............. 82,903,755
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\1\ Note: The time it takes each respondent (i.e., donor, collector, laboratory, IITF, and MRO) to complete the Federal CCF is based on an average
estimated number of minutes it would take each respondent to complete their designated section of the form or regulated entities (e.g. HHS, DOT, and
NRC).
\1\ Note: The above number of responses is based on an estimate of the total number of specimens collected annually (approximately 150,000 federal
agency specimens; 6,500,000 DOT regulated specimens, and 145,000 NRC regulated specimens).
\2\ Note: The estimate of 20 applications per year is based on requests for a laboratory application (urine or oral fluid) or IITF application in the
past year (i.e., at the time of these calculations).
\2\ Note: The estimate of three burden hours to complete the application has not changed.
\3\ Note: At the time of these calculations, there were 18 certified laboratories and one certified IITF undergoing 2 maintenance inspections each year,
and 1 applicant laboratory.
\3\ Note: The wage rates listed for each respondent are based on estimated average hourly wages for the individuals performing these tasks.
Send comments to SAMHSA Reports Clearance Officer, Room 15-E-57-A,
5600 Fishers Lane, Rockville, MD 20857 OR email a copy to
[email protected]. Written comments should be received by
November 4, 2025.
Alicia Broadus,
Reports Clearance Officer.
[FR Doc. 2025-17035 Filed 9-4-25; 8:45 am]
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