[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)
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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