[Federal Register Volume 78, Number 2 (Thursday, January 3, 2013)]
[Notices]
[Pages 306-307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-13-0850]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 
and send comments to Ron Otten, 1600 Clifton Road MS-D74, Atlanta, GA 
30333 or send an email to omb@cdc.gov.
    Comments are invited on (a) whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have a practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Laboratory Response Network (LRN) (OMB No. 0920-0850, Exp. 5/31/
2013)--Extension--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. Biennially, laboratories are 
required to review, verify and update their testing capability 
information. Complete testing capability information is required in

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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 prevent 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 2,250,000 
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. There is no cost to the 
respondents other than their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
             Type of respondents                               Form name                    respondents    responses per   response (in      (in hrs)
                                                                                                            respondent         hrs)
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Public Health Laboratories...................  Biennial Requalification.................             150               1               2             300
Public Health Laboratories...................  General Surveillance Testing Results.....             150              25              24          90,000
Public Health Laboratories...................  Proficiency Testing/Validation Testing                150               5              56          42,000
                                                Results.
Public Health Laboratories...................  Surge Event Testing Results..............             150             625              24       2,250,000
Public Health Laboratories...................  Special Data Call........................             150              10               2           3,000
                                                                                         ---------------------------------------------------------------
    Total....................................  .........................................  ..............  ..............  ..............       2,385,300
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    Dated: December 20, 2012.
Ron Otten,
Director, Office of Science Integrity, Office of the Associate Director 
for Science, Office of the Director, Centers for Disease Control and 
Prevention.
[FR Doc. 2012-31182 Filed 1-2-13; 8:45 am]
BILLING CODE 4163-18-P