Notice2025-15215
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
August 11, 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 to take this 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 Laboratory Response Network. This collection will allow CDC to continue to track laboratory testing capacity, capability, and distribution to ensure all areas of the nation are protected during a public health emergency response.
Full Text
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<title>Federal Register, Volume 90 Issue 152 (Monday, August 11, 2025)</title>
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[Federal Register Volume 90, Number 152 (Monday, August 11, 2025)]
[Notices]
[Pages 38652-38654]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15215]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-0850; Docket No. CDC-2025-0255]
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 to take this 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 Laboratory Response Network. This collection will allow
CDC to continue to track laboratory testing capacity, capability, and
distribution to ensure all areas of the nation are protected during a
public health emergency response.
DATES: CDC must receive written comments on or before October 10, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0255 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.
[[Page 38653]]
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#254a4847654641460b424a53"><span class="__cf_email__" data-cfemail="2f40424d6f4c4b4c01484059">[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
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 as described below. 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
upload 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 some improvements to the LRN SIH: The LRN SIH
migrated to CDC Secure Access Management Services (SAMS) servers to
provide a more secured login and user authentication. 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 place 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
[[Page 38654]]
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.
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 with greater
depth and detail for more efficient and effective decision making.
There is no cost to respondents other than their time to participate.
Estimated Annualized Burden Hours
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Average number Average burden
Respondent type Form Number of of responses per response Total burden
responders per responder (hours) hours
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Public Health Laboratories.... Laboratory 136 1 2 272
Qualification.
Routine Testing 136 25 0.5 1,700
Results.
Challenge Panel/ 136 2 12 3,264
Validation
Testing Results.
Public Health 136 625 0.5 42,500
Surge Response
Testing Results.
Proficiency 44 35 2 3,080
Testing/
Characterizatio
n Results (LRN-
C).
Surge Event 57 6 24 8,208
Testing Results/
Exercises (LRN-
C: SPaSE,
Surge, ERE).
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Total..................... ................ .............. .............. .............. 59,024
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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. 2025-15215 Filed 8-8-25; 8:45 am]
BILLING CODE 4163-18-P
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