[Federal Register Volume 75, Number 2 (Tuesday, January 5, 2010)]
[Notices]
[Pages 371-373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-31368]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-09-09AY]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Laboratory Response Network (LRN)--Existing Data Collection in use 
without an OMB Control Number--National Center for Preparedness, 
Detection, and Control of Infectious Diseases (NCPDCID), Centers for 
Disease Control and Prevention (CDC).

[[Page 372]]

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 acts of 
biological, chemical, or radiological terrorism and other public health 
emergencies.
    When Federal, State and local public health laboratories 
voluntarily join the 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. Biannually, laboratories are 
required to review, verify and update their testing capability 
information. Complete testing capability information is required in 
order for the LRN Program Office to determine the ability of the 
Network to respond to a biological or chemical terrorism event. The 
sensitivity of all information associated with the LRN requires the LRN 
Program Office to obtain personal information about all individuals 
accessing the LRN Website. In addition, the LRN Program Office must be 
able to contact all laboratory personnel during an event so each 
laboratory staff member that obtains access to the restricted LRN Web 
site must provide his or her contact information to the LRN Program 
Office.
    As a requirement of membership, LRN Laboratories must report all 
biological and chemical testing results to the LRN Program at CDC using 
a CDC developed software tool called the LRN Results Messenger. This 
information is essential for surveillance of anomalies, to support 
response to an event that may involve multiple agencies and to manage 
limited resources. LRN Laboratories must also participate in and report 
results for Proficiency Testing Challenges or Validation Studies. LRN 
Laboratories participate in multiple Proficiency Testing Challenges, 
Exercises and/or Validation Studies every year consisting of five to 
500 simulated samples provided by the LRN Program Office. It is 
necessary to conduct such challenges in order to verify the testing 
capability of the LRN Laboratories. The rarity of biological or 
chemical agents perceived to be of bioterrorism concern prevents some 
LRN Laboratories from maintaining proficiency as a result of day-to-day 
testing. Simulated samples are therefore distributed to ensure 
proficiency across the LRN. The results obtained from testing these 
simulated samples must also be entered into Results Messenger for 
evaluation by the LRN Program Office.
    During a surge event resulting from a bioterrorism or chemical 
terrorism attack, LRN Laboratories are also required to submit all 
testing results using LRN Results Messenger. The LRN Program Office 
requires these results in order to track the progression of a 
bioterrorism event and respond in the most efficient and effective way 
possible and for data sharing with other Federal partners involved in 
the response. The number of samples tested during a response to a 
possible event could range from 10,000 to more than 500,000 samples 
depending on the length and breadth of the event. Since there is 
potentially a large range in the number of samples for a surge event, 
CDC estimates the annualized burden for this event will be 3,000,000 
hours or 625 responses per respondent.
    Semiannually the LRN Program Office may conduct a Special Data Call 
to obtain additional information from LRN Member Laboratories in 
regards to biological or chemical terrorism preparedness. Special Data 
Calls are conducted using the LRN Web site.
    Respondents are public health laboratorians. There are no costs to 
respondents other than their time. The total estimated annualized 
burden for this information collection is 3,176,400 hours.

                                       Estimate of Annualized Burden Hours
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                                                                                      Average         Average
                                                                     Number of       number of      burden per
               Forms                         Respondents            respondents    responses per   response (in
                                                                                    respondent        hours)
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Biennial Requalification...........  Public Health Laboratorians             100               1               2
General Surveillance Testing         Public Health Laboratorians             200              25              24
 Results.
Proficiency Testing/Validation       Public Health Laboratorians             200               5              56
 Testing Results.
Surge Event Testing Results........  Public Health Laboratorians             200             625              24
Special Data Call..................  Public Health Laboratorians             200               2           30/60
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[[Page 373]]

    Dated: December 30, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E9-31368 Filed 1-4-10; 8:45 am]
BILLING CODE 4163-18-P