Notice2025-23760
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 23, 2025
Issuing agencies
Health and Human Services DepartmentSubstance Abuse and Mental Health Services Administration
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 244 (Tuesday, December 23, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 244 (Tuesday, December 23, 2025)]
[Notices]
[Pages 60113-60114]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23760]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer at (240) 276-0361.
Project: Mandatory Guidelines for Federal Workplace Drug Testing
Programs Federal Drug Testing Custody and Control Form (CCF) (OMB No.
0930-0158) and National Laboratory Certification Program (NLCP)
Information Collection Tools--Revision
SAMHSA will request OMB approval for revision 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. SAMHSA has resubmitted the CCF with revisions to the form for OMB
approval. During 60-day public comment, 7 commenters submitted comments
on the proposed changes to the CCF. Commenters were comprised of
individuals, organizations, and private sector companies. All comments
were reviewed and taken into consideration in preparation of the
revised CCF. The issues and concerns raised in the public comments are
set out at <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>.
The revisions are listed below:
Copies 1-5
Revised Step 1
1. Removed drug analytes and checkboxes from Item F and changed
``Drug Tests to be Performed'' to ``Other tests to be performed
(specify):''.
Copy 1
Revised Step 4
1. Moved the ``Split Specimen Device Expiration Date'' field to the
right.
Copies 2-5
Revised Step 5
1. Lengthened the email address line and moved it to the right.
2. Replaced the 2 date fields for ``Daytime Phone No.'' and
``Evening Phone No.'' with a single field ``Phone No.'' and moved it to
the left.
3. Moved the ``Date of Birth'' field to the left, reworded as
``Birthdate'' and moved the text under the line.
Laboratories and IITFs seeking HHS certification under the NLCP
must complete and submit the NLCP application form. The NLCP
application form has 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 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 revisions enable provision of information for analytes in the
Authorized Testing Panels now published separately from the Mandatory
Guidelines, and enable 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Responses Total Burden per Annual Hourly
Form/respondent Number of per number of response burden wage rate Total cost
respondents respondent responses (hours) (hours) ($) ($) \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
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
---------------------------------------------------------------------------------------
[[Page 60114]]
Total................................................... 6,726,669 .......... 26,906,499 ........... 1,687,529 .......... 82,946,625
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.
Alicia Broadus,
Public Health Advisor.
[FR Doc. 2025-23760 Filed 12-22-25; 8:45 am]
BILLING CODE 4162-20-P
</pre></body>
</html>Indexed from Federal Register on December 23, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.