[Federal Register Volume 74, Number 54 (Monday, March 23, 2009)]
[Notices]
[Pages 12132-12133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6213]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-09-09AY]


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. 
Alternatively, to obtain a copy of the data collection plans and 
instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar, 
CDC Reports Clearance Officer, 1600 Clifton Road NE., MS-D74, Atlanta, 
Georgia 30333; comments may also be sent by e-mail to [email protected].
    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 information technology. Written comments 
should be received within 60 days of this notice.

Proposed Project

    Laboratory Response Network (LRN)--New--National Center for 
Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), 
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 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 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 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.
    There is no cost to the respondents other than their time.

[[Page 12133]]



                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                      Average         Average
                                                     Number of       number of      burden  per    Total burden
                      Forms                         respondents   responses  per   response  (in       hours
                                                                     respondent       hours)
----------------------------------------------------------------------------------------------------------------
Biannual Requalification........................             200               1               2             400
General Surveillance Testing Results............             200              25              24         120,000
Proficiency Testing/Validation Testing Results..             200               5              56          56,000
Surge Event Testing Results.....................             200             625              24       3,000,000
Special Data Call...............................             200               2           30/60             200
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       3,176,600
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    Dated: March 11, 2009.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
 [FR Doc. E9-6213 Filed 3-20-09; 8:45 am]
BILLING CODE 4163-18-P