[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)
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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