[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10090-10091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-19-0850]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Laboratory Response Network to the Office of 
Management and Budget (OMB) for review and approval. CDC previously 
published a ``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on October 4, 2018 to obtain comments from the 
public and affected agencies. CDC received one comment related to the 
previous notice. This notice serves to allow an additional 30 days for 
public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Laboratory Response Network (0920-0850, Exp. Date 4/30/2019--
Extension--National Center for Emerging and Zoonotic Infectious 
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC is requesting a three year extension without change to the data 
collection plan or tools. The only change is a decrease in annual 
burden hours from 2,382,300 to 2,064,660. The decrease is due to a 
decrease in the number of LRN member laboratories from 150 to 130 
laboratories.
    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.
    Federal, state and local public health laboratories join the LRN 
voluntarily. When laboratories join, 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. This information is needed 
so that the LRN Program Office can 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 that CDC obtain

[[Page 10091]]

personal information about all individuals accessing the LRN website. 
Since CDC must be able to contact all laboratory personnel during an 
event, each laboratory staff member who obtains access to the 
restricted LRN website 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 using a CDC 
developed software tool called the LRN Results Messenger, or through 
the laboratory information management system (LIMS) which CDC refers to 
as Data Integration. CDC supplies this software to LRN laboratories at 
no charge. This information obtained from LRN laboratories is essential 
for surveillance of anomalies, to support response to an event that may 
involve multiple agencies, and to manage limited resources.
    LRN laboratories are also required to participate in Proficiency 
Testing Challenges or Validation Studies and report their results to 
CDC. LRN laboratories participate in multiple Proficiency Testing 
Challenges, Exercises and/or Validation Studies every year. These 
activities consist of 5-500 simulated samples provided by CDC. These 
challenges are necessary to verify the testing capability of the LRN 
laboratories. Because biological or chemical agents perceived to be of 
bioterrorism concern can occur rarely, some LRN laboratories may not be 
maintaining proficiency in certain testing methods as a result of day-
to-day testing. Thus, simulated samples are distributed to ensure 
proficiency across LRN member laboratories. LRN laboratories also enter 
the results of these simulated samples into the LRN Results Messenger 
or through Data Integration for evaluation by CDC.
    During a surge event resulting from a bioterrorism or chemical 
terrorism attack, or during an emerging infectious disease outbreak, 
LRN Laboratories must submit all testing results using LRN Results 
Messenger or through Data Integration. CDC uses these results in order 
to track the progression of a bioterrorism event, responds in the most 
efficient and effective way possible, and shares this data with other 
Federal partners involved in the response.
    Data is collected via two primary avenues, the program LRN Results 
Messenger or through Data Integration and the LRN website. Laboratories 
belonging to the Laboratory Response Network utilize the CDC developed 
software tool LRN Results Messenger to submit testing results to CDC. 
Data Integration is an effort parallel to the LRN Results Messenger 
which will ultimately allow laboratories to submit data to CDC using 
their own data collection systems. Results include details about the 
type and source of samples as well as the tests performed and the 
numerical and empirical results of those tests. The LRN website is used 
by laboratories to provide their complete testing capabilities to CDC. 
All individuals who use the LRN website must provide their contact 
information to the LRN Program Office during registration.
    An LRN laboratory must provide its testing capabilities, physical 
and shipping addresses, United States Department of Agriculture (USDA) 
and Select Agent Permits, and specified responsible individuals' names, 
phone numbers and email addresses. After registering with the LRN 
website, a user must provide his/her first and last name, work phone 
number, alternate phone number, email address, and month and day of 
birth.
    During reporting of results, sample details, tests performed, 
results obtained, and conclusions of tests are required. 
Accomplishments during the last three years include the requalification 
of labs. The requalification occurred between November 7, 2016 and 
December 12, 2016. We had 130 domestic LRN labs tasked with completing 
the requalification, and had a 96% response rate. The LRN website has 
remained the same, and has only undergone routine maintenance since 
2015 to keep it in working order.
    This data collection is authorized under the Public Health Service 
Act, (42 U.S.C. 241) Section 301. CDC has estimated the annualized 
burden for this project to be 2,064,660 hours, a decrease of 317,640 
hours per year. There is no cost to respondents other than the time to 
participate.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Public health laboratories............  Biennial Requalification             130               1               2
                                        General Surveillance                 130              25              24
                                         Testing Results.
                                        Proficiency Testing/                 130               5              56
                                         Validation Testing
                                         Results.
                                        Surge Event Testing                  130             625              24
                                         Results.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-05152 Filed 3-18-19; 8:45 am]
BILLING CODE 4163-18-P