[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Notices]
[Pages 3138-3139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00955]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0850]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: 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

Background and Brief Description

    Laboratory Response Network, (OMB Control Number 0920-0850, expires 
April 30, 2016)--Extension--National Center for Emerging and Zoonotic 
Infectious Diseases (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 
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 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.
    The requalification occurred between October 24, 2014 and November 
7, 2014. We had 122 domestic LRN labs tasked with completing the 
requalification. We had a 90% response rate.
    We conducted LRN proficiency testing (PT). The purpose of PT is to 
simulate real samples for labs that would not have regularly performed 
some of the LRN procedures. Having the ability to conduct LRN PTs under 
OMB approval has led to improved laboratory performance and better 
preparedness. In FY13, the PT passing rate was 89%, which improved to 
96% in FY14 and 97% in FY15.
    There is no cost to the respondents other than their time. The 
total estimated annualized burden is 2,382,300 hours.

[[Page 3139]]



                                        Estimated Annualized Burden Hours
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                                                                            Average number of    Average burden
       Type of respondents               Form name           Number of        responses per       per response
                                                            respondents         respondent          (hours)
----------------------------------------------------------------------------------------------------------------
Public Health Laboratories.......  Biennial                            150                  1                  2
                                    Requalification.
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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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-00955 Filed 1-19-16; 8:45 am]
BILLING CODE 4163-18-P