[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Notices]
[Pages 14094-14095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-0850]


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 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 
20503 or by fax to (202) 395-5806. Written comments should be received 
within 30 days of this notice.

Proposed Project

    Laboratory Response Network (LRN)--0920-0850-Extension (expiration 
5/31/13)--National Center for Emerging and Zoonotic Infections 
(NCEZID), 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 acts of 
biological, chemical, or radiological threats 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. Biennually, 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 threat 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 Web site. 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

[[Page 14095]]

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 
2,250,000 hours or 625 responses per respondent.
    There is no cost to the respondents other than their time. The 
total estimated annualized burden is 2,382,300 hours.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of      Avg. burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs)
----------------------------------------------------------------------------------------------------------------
Public Health Laboratories............  Biennial Requalification             150               1               2
Public Health Laboratories............  General Surveillance                 150              25              24
                                         Testing Results.
Public Health Laboratories............  Proficiency Testing/                 150               5              56
                                         Validation Testing
                                         Results.
Public Health Laboratories............  Surge Event Testing                  150             625              24
                                         Results.
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    Dated: February 26, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2013-04900 Filed 3-1-13; 8:45 am]
BILLING CODE 4163-18-P