[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Pages 68542-68543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0850; Docket No. CDC-2015-0093]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
extension of the Laboratory Response Network information collection.

DATES: Written comments must be received on or before January 4, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0093 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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 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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Laboratory Response Network--Extension--(OMB Control No. 0920-0850, 
expires April 30, 2016), 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. Biennually, 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

[[Page 68543]]

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.
    There is no cost to the respondents other than their time. The 
total estimated annualized burden is 2,382,300 hours.

                                        Estimated Annualized Burden Hours
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                                                                  Average number
                                                     Number of     of responses   Average burden   Total burden
          Respondents                 Forms         respondents         per        per  response       hours
                                                                    respondent        (hours)
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Public Health Laboratories....  Biennial                     150               1               2             300
                                 Requalification.
Public Health Laboratories....  General                      150              25              24          90,000
                                 Surveillance
                                 Testing Results.
Public Health Laboratories....  Proficiency                  150               5              56          42,000
                                 Testing/
                                 Validation
                                 Testing Results.
Public Health Laboratories....  Surge Event                  150             625              24       2,250,000
                                 Testing Results.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............       2,382,300
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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. 2015-28154 Filed 11-4-15; 8:45 am]
 BILLING CODE 4163-18-P