Supporting Statement Part B 121112

Supporting Statement Part B 121112.doc

Laboratory Response Network

OMB: 0920-0850

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Laboratory Response Network

(OMB Control No. 0920-0850)

Request for Extension

January 3, 2013



B. Collections of Information Employing Statistical Methods



Contents


B. Collections of Information Employing Statistical Methods


No statistical methods are used in this data collection.


1. Respondent Universe and Sampling Methods


When federal, state and local public health laboratories voluntarily join the Laboratory Response Network (LRN), they assume specific responsibilities and are required to provide information to the LRN Program Office at CDC. Each laboratory must submit and maintain complete information regarding the testing capabilities of the laboratory. Biennially, laboratories are required to review, verify and update their testing capability information. Complete testing capability information is required in order for CDC to determine the ability of the Network to respond to a biological or chemical terrorism event.

2. Procedures for the Collection of Information


As a requirement of membership, LRN laboratories must report all biological and chemical testing results to the LRN Program using a CDC developed software tool called the LRN Results Messenger. CDC supplies this software to LRN laboratories at no charge. This information obtained from LRN laboratories is essential for surveillance of anomalies, to support response to an event that may involve multiple agencies, and to manage limited resources.


LRN laboratories are also required to participate in Proficiency Testing Challenges or Validation Studies and report their results to CDC. LRN laboratories participate in multiple Proficiency Testing Challenges, Exercises and/or Validation Studies every year. These activities consist of 5-500 simulated samples provided by CDC. These challenges are necessary to verify the testing capability of the LRN laboratories. Because biological or chemical agents perceived to be of bioterrorism concern can occur rarely, some LRN laboratories may not maintaining proficiency in certain testing methods as a result of day-to-day testing. Thus, simulated samples are distributed to ensure proficiency across LRN member laboratories. LRN laboratories also enter the results of these simulated samples into the LRN Results Messenger for evaluation by CDC.


During a surge event resulting from a bioterrorism or chemical terrorism attack, LRN Laboratories must submit all testing results using LRN Results Messenger. CDC uses these results in order to track the progression of a bioterrorism event, respond in the most efficient and effective way possible, and shares this data with other Federal partners involved in the response.



3. Methods to Maximize Response Rates and Deal with No Response


Response to data collection is required as part of LRN membership. To improve response rate and compliance the LRN program office will contact member laboratories to offer assistance with submitting data.


4. Tests of Procedures or Methods to be Undertaken


CDC currently collects this data under a previously approved data collection. The protocols and electronic systems used for this data collection are continually updated and improved for quality of data collection and ease of use for both the public, industry and CDC program administrators.


5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data


Not Applicable







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