83 FR 50096 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 193 (October 4, 2018)

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Laboratory Response Network 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 Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50096-50098]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0850; Docket No. CDC-2018-0088]


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 effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Laboratory Response Network 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.

DATES: CDC must receive written comments on or before December 3, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0088 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments 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 Jeffrey M. Zirger, 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 the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Laboratory Response Network Information Collection (OMB Control No. 
0920-0850, Exp. Date: 4/30/2019)--Extension--National Center for 
Emerging and Zoonotic Infectious

[[Page 50097]]

Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC is requesting a 3-year extension without change to the data 
collection plan or tools for Laboratory Response Network (OMB Control 
No. 0920-0850, Exp. Date: April 30, 2019). The only change is a 
decrease in the estimated burden from 2,382,300 to 2,064,660 annual 
hours. 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 
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 through the Laboratory Information Management System 
Integration (LIMSi) 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 October 
24, 2014 and November 7, 2016 and December 12, 2016. We had 130 
domestic LRN labs tasked with completing the requalification. We 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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                                                                      Average         Average
                                                     Number of       number of      burden per     Total burden
          Respondents                 Forms         respondents    responses per     response          hours
                                                                    respondent        (hours)
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Public Health Laboratories....  Biennial                     130               1               2             260
                                 Requalification.
                                General                      130              25              24          78,000
                                 Surveillance
                                 Testing Results.
                                Proficiency                  130               5              56          36,400
                                 Testing/
                                 Validation
                                 Testing Results.

[[Page 50098]]

 
                                Surge Event                  130             625              24       1,950,000
                                 Testing Results.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............       2,064,660
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Jeffrey M. Zirger,
Acting 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. 2018-21570 Filed 10-3-18; 8:45 am]
BILLING CODE 4163-18-P