[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23702-23704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09398]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0980]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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

[[Page 23703]]

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, 
Washington, DC 20503 or by fax to (202) 395-5806. Written comments 
should be received within 30 days of this notice.

Proposed Project

    National Environmental Assessment Reporting System (NEARS), 
formerly the National Voluntary Environmental Assessment Information 
System (NVEAIS)--Revision--National Center for Environmental Health 
(NCEH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Since 2014, environmental factor data associated with foodborne 
outbreaks have been reported to the National Voluntary Environmental 
Assessment Information System (NVEAIS; OMB Control No. 0920-0980; 
expiration date 08/31/2016). CDC is requesting a three-year Office of 
Management and Budget (OMB) revision for NVEAIS, hereafter referred to 
as the National Environmental Assessment Reporting System (NEARS). In 
2015, it was recommended that NVEAIS be renamed as NEARS. This name 
change will be an enhancement of the current surveillance system and 
was recommended by CDC leadership, and other food safety partners who 
desired to simplify and improve the name.
    The goal of NEARS remains to collect data on foodborne illness 
outbreaks and environmental assessments routinely conducted by local, 
state, federal, territorial, or tribal food safety programs during 
outbreak investigations. The data reported through this surveillance 
system provides timely data on the causes of outbreaks, including 
environmental factors associated with outbreaks, which are essential to 
environmental public health regulators' efforts to respond more 
effectively to outbreaks and prevent future, similar outbreaks.
    NEARS was developed by the Environmental Health Specialists Network 
(EHS-Net), a collaborative network of CDC, the U.S. Food and Drug 
Administration (FDA), the U.S. Department of Agriculture (USDA), and 
local, state, territorial, and tribal food safety programs. NEARS is 
designed to link to CDC's National Outbreak Reporting System (NORS, 
under the National Disease Surveillance Program II--Disease Summaries; 
OMB Control No. 0920-0004; expiration date 10/31/2017), a disease 
outbreak surveillance system for enteric diseases transmitted by food.
    When linked, NEARS and NORS data provide opportunities to 
strengthen the robustness of outbreak data reported to CDC. The 
foodborne outbreak environmental assessment data reported to NEARS will 
be used to characterize data on food vehicles and monitor trends; 
identify contributing factors and their environmental antecedents; 
generate hypotheses, guide planning, and implementation; evaluate food 
safety programs, and ultimately assist to prevent future outbreaks. 
Collectively, these data play a vital role in improving the food safety 
system, strengthening the robustness of outbreak data reported to CDC.
    The first type of NEARS respondent is food safety program 
officials. Although not a requirement, food safety program personnel 
participating in NEARS will be encouraged to take two trainings: NEARS 
food safety program personnel training and NEARS e-learning. The former 
will train food safety personnel on identifying environmental factors, 
logging in and entering data into the web-based NEARS data entry 
system, and troubleshooting problems. The latter is an e-Learning 
course on how to use a systems approach in foodborne illness outbreak 
environmental assessments. It is suggested that respondents take this 
training one time, for a total of 10 hours.
    Next, for each outbreak, one official from each participating 
program will spend a little over an hour to make establishment 
observations, 30 minutes to record environmental assessment data, and 
40 minutes for data entry for both NEARS's surveys into the web-based 
system. Officials will not report on their programs or personnel.
    Food safety programs are typically located in public health or 
agriculture agencies. There are approximately 3,000 such agencies in 
the United States. It is not possible to determine exactly how many 
outbreaks will occur in the future, nor where they will occur. However, 
based on existing data, we estimate a maximum of 1,400 foodborne 
illness outbreaks will occur annually. Only programs in the 
jurisdictions in which these outbreaks occur would voluntarily report 
to NEARS. Thus, not every program will respond every year. We assume 
each outbreak will occur in a different jurisdiction.
    The second type of NEARS respondents are managers of retail 
establishments. The manager interview will be conducted at each 
establishment associated with an outbreak. Most outbreaks are 
associated with only one establishment. We estimate that a maximum 
average of four managers at each establishment will be interviewed per 
outbreak. Each interview will take about 20 minutes.
    The total estimated annual burden is 20,300 hours, an increase of 
14,233 hours over the previously approved 6,067 burden hours. This 
increase in requested burden hours is due to the addition of the NEARS 
e-learning training opportunity.
    There is no cost to the respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                       Average
                                                                         Number of      Number of     burden per
           Type of  respondents                     Form name           respondents   responses per    response
                                                                                       respondent     (in hours)
----------------------------------------------------------------------------------------------------------------
Food safety program personnel............  NEARS Food Safety Program          1,400               1            2
                                            Training.
                                           NEARS e-Learning (screen           1,400               1           10
                                            shots).
                                           NEARS Data Recording (paper        1,400               1        30/60
                                            form).
                                           NEARS Data Recording and           1,400               1        40/60
                                            Manager Interview Web
                                            Entry.
Retail food personnel....................  NEARS Manager Interview....        5,600               1        20/60
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[[Page 23704]]

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. 2016-09398 Filed 4-21-16; 8:45 am]
 BILLING CODE 4163-18-P