Notice2026-02651
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 6222-6224]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02651]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-26-0850]
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 titled ``Laboratory Response Network (LRN)'' 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 August 11, 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,
[[Page 6223]]
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.
Proposed Project
Laboratory Response Network (OMB Control No. 0920-0850, Exp. 4/30/
2026)--Revision--Office of Laboratory Systems and Response (OLSR),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Laboratory Response Network (LRN) was established by the
Department of Health and Human Services (HHS), Centers for Disease
Control and Prevention (CDC) in accordance with Presidential Decision
Directive 39, which outlined national anti-terrorism policies and
assigned specific missions to federal departments and agencies. The
LRN's mission is to maintain an integrated national and international
network of laboratories that can respond to suspected biological,
chemical, or radiological threats and other public health emergencies.
To ensure fulfillment of that mission, CDC collects data from the LRN
member laboratories related to laboratory capability, capacity, and
distribution as well as laboratory test results.
Upon volunteering to join the LRN, laboratories are required to
submit qualification information to the LRN Program Office at CDC, to
include first and last names, work addresses, work email addresses,
work phone numbers, and alternative phone numbers of personnel trained
in LRN procedures. This information is needed to contact laboratory
personnel in the case of a public health emergency, to ship reagents,
test kits, or supplies, and determine laboratory testing capacity.
Laboratories are also required to provide additional qualification
information related to testing capability and capacity including
available testing equipment, safety equipment, facilities, reagents,
test kits, and validated tests. This information is used by CDC to
ensure that laboratory testing capability is distributed across the
country, and the network has adequate testing capacity to provide
adequate public health emergency response. Qualification information is
collected in the LRN Secure Information Hub (SIH) accessed through the
CDC Secure Access Management System (SAMS). Laboratories are required
to update their capability and capacity information whenever changes
occur such as personnel changes, the addition of new tests, or the
addition of new equipment. For laboratories that hold United States
Department of Agriculture (USDA) or Select Agent permits, copies of the
permits are also collected. This information is used to inform CDC of
additional laboratory capability. These permits are not required for
LRN membership.
LRN laboratories are also required to report certain laboratory
test results to CDC. The test results include details about the type
and source of samples as well as the tests performed, results obtained,
and conclusions. CDC collects test results related to validation
studies and proficiency testing to verify that laboratories continue to
properly perform the tests they have validated. CDC collects test data
related to emergency response exercises to verify laboratory
performance in a simulated emergency response situation. CDC collects
test results related to routine testing of known biological and
chemical threat agents. These results are used to monitor emerging
threat situations. CDC also collects test results for samples analyzed
during a public health threat response to monitor threat levels and
determine procurement, allocation, and distribution of response
resources.
Laboratory test results are reported to CDC using either a CSV file
uploaded into a cloud-based web page (DataLink) or using their
laboratory information management system (LIMS) to send an electronic
Health Level Seven (HL7) message. DataLink is accessed by the LRN
laboratories through SAMS and can be rapidly modified for a new or
emerging threat, with the burden of maintenance removed from the member
laboratory.
There have been a number of improvements to the LRN SIH: (1) the
LRN SIH migrated to SAMS servers to provide a more secure login and
user authentication; and (2) a new CDC template was implemented to
support 508 compliance and responsive designs. Additionally, there is a
decrease in the estimated burden from 422,716 to 59,024 annual hours.
This decrease in burden is due to several factors. Burden has been
reduced by the continued expansion of LRN laboratories implementing HL7
reporting and decreasing the need for manual entry to Results
Messenger. The number of data elements collected for the LRN Data
Exchange has also been reduced. Numerical test results (e.g., Ct
values) or a sample conclusion are no longer collected. Burden was
further reduced by reevaluating the burden calculation based upon
requirements LRN places upon the member laboratories versus the
requirements of the Clinical Laboratory Improvement Amendments (CLIA)
regulations and other quality management programs placed upon the
laboratories. In the instance of proficiency tests and challenge
panels, the analysis of these samples is required by CLIA and/or other
quality management systems implemented locally. Therefore, the only
burden the LRN is placing on the laboratory is the time required to
accession the samples and report the results to LRN. In the cases of
routine and emergency response testing, these samples are part of the
workflow that each LRN laboratory already has in place. The only burden
LRN is placing upon the laboratories is the time to report the results
to LRN. These changes in how burden hours were determined per activity
are reflected in the burden table. Per CDC Notice of Funding
Opportunity (NOFO) PHEP Cooperative Agreement CDC-RFA-TU24-0137: Public
Health Emergency Preparedness (PHEP) Cooperative Agreement, LRN-C
laboratories are required to participate in Surge Capacity Exercises
and proficiency testing to ensure laboratory readiness to support CDC
laboratory capacity during a national emergency involving chemical
threats. There is no cost for respondents other than their time to
participate.
This data collection is vital to the continued support of the
national public health system in its efforts to respond to chemical and
biological threats. The state, local, and federal public health
laboratories participating in this program generate the data in this
collection as part of their individual emergency response duties. By
merging this data into a single collection, a local perspective of an
emerging threat becomes a broader national perspective
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with greater depth and detail for more efficient and effective decision
making.
Estimated Annualized Burden Hours
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Average number Average burden
Respondent type Forms Number of of responses per response
responders per responder (hours)
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PHLs *................................ Laboratory Qualification 136 1 2
PHLs.................................. Routine Testing Results. 136 25 0.5
PHLs.................................. Challenge Panel/ 136 2 12
Validation Testing
Results.
PHLs.................................. Public Health Surge 136 625 0.5
Response Testing
Results.
PHLs.................................. Proficiency Testing/ 44 35 2
Characterization
Results (LRN-C).
PHLs.................................. Surge Event Testing 57 6 24
Results/Exercises (LRN-
C: SPaSE, Surge, ERE).
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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. 2026-02651 Filed 2-10-26; 8:45 am]
BILLING CODE 4163-18-P
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