The Laboratory Response Network is an
integrated national and international network of laboratories that
can respond to suspected acts of biological, chemical, or
radiological terrorism and other public health emergencies. Member
laboratories submit information regarding the testing capabilities
of the laboratory; report all biological and chemical testing
results; and participate in Proficiency Testing Challenges or
Validation. The goal of the study is to identify gaps in
preparedness for biological threats and emerging infectious
diseases. The data will be used to develop strategies, policies,
and operating procedures for responding to biological threat
emergencies. The LRN website, Results Messenger data exchange
application, and Special Data Calls Questionnaires are methods used
to collect data from member laboratories. There is a reduction in
Burden Hours from the previously approved collection due to a
decrease in participating laboratories. In this revision, the
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 (i.e. Ct values) or a sample conclusion are
no longer collected. As part of laboratory qualification data
collection, the ability to add program feedback was added. Burden
was further reduced by re-evaluating 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.
US Code:
42
USC 241 Name of Law: Public Health Service Act
EO: EO 39 Name/Subject of EO: Presidential Decision
Directive 39
This is a revision of a
previous collection seeking approval of 59,024 annual burden hours
and 3 years of approval.
$3,001,147
No
Yes
No
No
No
No
No
Odion Clunis 770 488-0045
lta2@cdc.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
02/12/2026
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