Notice2025-16913
Proposed Data Collection Submitted for Public Comment and Recommendations
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
September 4, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Distribution of Traceable Opioid Material[supreg] Kits (TOM[supreg] Kits) across U.S. and International Laboratories. The purpose of this information collection request (ICR) is for the CDC to assure that the Traceable Opioid Material[supreg] Kits (TOM[supreg] Kits) are equitably distributed to domestic and international partner laboratories, and to allow CDC to understand the types of laboratories requesting these materials and the analyses that are being conducted.
Full Text
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<title>Federal Register, Volume 90 Issue 169 (Thursday, September 4, 2025)</title>
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[Federal Register Volume 90, Number 169 (Thursday, September 4, 2025)]
[Notices]
[Pages 42766-42767]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16913]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-1313; Docket No. CDC-2025-0387]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Distribution of Traceable Opioid Material[supreg] Kits
(TOM[supreg] Kits) across U.S. and International Laboratories. The
purpose of this information collection request (ICR) is for the CDC to
assure that the Traceable Opioid Material[supreg] Kits (TOM[supreg]
Kits) are equitably distributed to domestic and international partner
laboratories, and to allow CDC to understand the types of laboratories
requesting these materials and the analyses that are being conducted.
DATES: CDC must receive written comments on or before November 3, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0387 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#85eae8e7c5e6e1e6abe2eaf3"><span class="__cf_email__" data-cfemail="9df2f0ffddfef9feb3faf2eb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
submissions of responses; and
5. Assess information collection costs.
Proposed Project
Distribution of Traceable Opioid Material[supreg] Kits (TOM[supreg]
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
The purpose of this information collection request (ICR) is for the
CDC to assure that the Traceable Opioid Material[supreg] Kits
(TOM[supreg] Kits) are equitably distributed to domestic laboratory
sectors (public, private, and non-profit) and to international partner
laboratories. This collection will enable CDC to gather information on
the types of laboratories requesting Traceable Opioid Material[supreg]
Kits and to determine the types of sample analyses that are being
conducted by these laboratories through use of these kits.
CDC requests OMB approval for an estimated 80 annual burden hours.
There is no cost to respondents other than their time.
[[Page 42767]]
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
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U.S. Federal Laboratories....... Test Kit 200 1 6/60 20
Application and
Questions for
U.S. Laboratories
(online).
State, Local, and Tribal Test Kit 200 1 6/60 20
Government Laboratories. Application and
Questions for
U.S. Laboratories
(online).
Private or Not-for-Profit U.S. Test Kit 200 1 6/60 20
Institutions. Application and
Questions for
U.S. Laboratories
(online).
International Laboratories...... Test Kit Questions 300 1 5/60 20
for International
Laboratories.
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Total....................... .................. .............. .............. ............ 80
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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. 2025-16913 Filed 9-3-25; 8:45 am]
BILLING CODE 4163-18-P
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