[Federal Register Volume 78, Number 2 (Thursday, January 3, 2013)]
[Notices]
[Pages 306-307]
From the Federal Register Online via the Government Publishing 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 [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 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
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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]
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