Notice2026-02652
Agency Forms Undergoing Paperwork Reduction Act Review
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
February 11, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 91 Issue 28 (Wednesday, February 11, 2026)</title>
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[Federal Register Volume 91, Number 28 (Wednesday, February 11, 2026)]
[Notices]
[Pages 6218-6219]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02652]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-26-1313]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request (ICR) titled ``Distribution of Traceable Opioid
Material Kits (TOM Kits) across U.S. and International Laboratories''
to the Office of Management and Budget (OMB) for review and approval.
CDC previously published a ``Proposed Data Collection Submitted for
Public Comment and Recommendations'' notice on September 4, 2025 to
obtain comments from the public and affected agencies. CDC received one
comment related to the previous notice. This notice serves to allow an
additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. 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. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
[[Page 6219]]
Proposed Project
Distribution of Traceable Opioid Material Kits (TOM Kits) across
U.S. and International Laboratories (OMB Control No. 0920-1313, Exp. 3/
31/2026)--Extension--National Center for Environmental Health (NCEH),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
In response to the Health and Human Services (HHS) Acting
Secretary's 2017 and ongoing public health emergency declaration on
opioids, the Centers for Disease Control and Prevention (CDC) has led
the development of Traceable Opioid Material Kits (TOM Kits) to support
detection of emerging opioids. CDC maintains the contents of the TOM
Kits based on new needs identified, in part, through the U.S. Drug
Enforcement Agency (DEA) Emerging Threat Reports. For example, the DEA
2018 data indicated that fentanyl and fentanyl-related compounds
accounted for approximately 76% of their opioid identifications. The
CDC is requesting a three-year Paperwork Reduction Act (PRA) clearance
for an Extension ICR titled ``Distribution of Traceable Opioid Material
Kits (TOM Kits) across U.S. and International Laboratories'' (OMB
Control No. 0920-1313; Expiration 03/31/2026).
CDC will continue to distribute TOM Kits through a single vendor,
which will manufacture the test kits. The CDC vendor will distribute
these kits to domestic laboratories, as previously approved under CDC
contract. The CDC vendor will distribute these test kits to
international laboratories in partnership with the United Nations and
under a separate contract with the International Narcotics Control
Board (INCB) (hereafter, collectively coined the ``UN''). The UN, and
not the CDC, is paying the vendor to ship the kits to international
requesters and kits will only be shipped internationally if excess kits
are identified that are not required domestically.
TOM Kits are not intended for diagnostic use and are free to
domestic and international laboratories in the public, private,
clinical, law enforcement, research, and public health domains. The CDC
vendor collects both application and laboratory information on domestic
laboratories when they apply for test kits. International laboratories
that apply for test kits through the UN will be directed to complete
and share their laboratory information with the vendor, but not with
the CDC. This information is used to prioritize which laboratories will
receive kits when quantities are limited. The brief web-based surveys
will allow the CDC to: (1) determine what service the recipient
laboratory performs; and (2) equitably distribute test kits based on
the analysis techniques and matrices used by the recipient laboratory.
Since project inception, over 4,000 TOM Kits have been distributed
to laboratories to improve their drug testing capabilities. Based on
this experience, we anticipate that up to 600 domestic laboratories
will request test kits per year. Given that each application will take
six minutes, the annual time burden for 600 domestic laboratories will
be 60 hours. CDC estimates an additional 20 annual burden hours for the
international distribution of test kits. We estimate that 300
international partner laboratories will apply for test kits per year
with the UN, which in turn will direct these laboratories to complete
the brief four-minute survey on laboratory information on the CDC
vendor website.
CDC estimates a total time burden of 80 hours per year and a total
number of 900 responses per year which is the same as previously
approved. There is no cost to the respondents other than their time to
participate.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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US Federal Laboratories............... Test Kit Application and 200 1 6/60
Questions for US
Laboratories (online).
State, Local, and Tribal Government Test Kit Application and 200 1 6/60
Laboratories. Questions for US
Laboratories (online).
Private or Not-for-Profit US Test Kit Application and 200 1 6/60
Institutions. Questions for US
Laboratories (online).
International Laboratories............ Test Kit Questions for 300 1 4/60
International
Laboratories.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2026-02652 Filed 2-10-26; 8:45 am]
BILLING CODE 4163-18-P
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