[Federal Register Volume 81, Number 24 (Friday, February 5, 2016)]
[Notices]
[Pages 6272-6274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02175]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0980; Docket No. CDC-2016-0018]


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 
revision of the information collection project entitled National 
Environmental Assessment Reporting System (NEARS), formerly known as 
the National Voluntary Environmental Assessment Information System 
(NVEAIS). The NEARS collects data on foodborne illness outbreaks and 
environmental assessments routinely conducted by food safety programs 
during outbreak investigations.

DATES: Written comments must be received on or before April 5, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0018 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#711e1c13311215125f161e07"><span class="__cf_email__" data-cfemail="b0dfddd2f0d3d4d39ed7dfc6">[email protected]</span></a>.

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

[[Page 6273]]

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

    National Environmental Assessment Reporting System (NEARS), 
formerly the National Voluntary Environmental Assessment Information 
System (NVEAIS; OMB Control No. 0920-0980; expiration date 08/31/
2016)--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). CDC intends to seek a three-
year Office of Management and Budget (OMB) approval to revise the 
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 about one hour to make establishment observations, 
30 minutes to record environmental assessment data and 30 minutes to 
report environmental assessment data into the NEARS 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 respondent is 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 20,067 hours, an increase of 
14,000 hours over the previously approved 6,067. 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   Total  burden
       Type of respondents              Form name       respondents   responses per    response        hours
                                                                       respondent     (in hours)
----------------------------------------------------------------------------------------------------------------
Food safety program personnel....  NEARS Food Safety          1,400               1            2           2,800
                                    Program Training.
                                   NEARS e-Learning           1,400               1           10          14,000
                                    (screenshots).

[[Page 6274]]

 
                                   NEARS Data                 1,400               1        30/60             700
                                    Recording (paper
                                    form).
                                   NEARS Data                 1,400               1        30/60             700
                                    Reporting (web
                                    entry).
Retail food personnel............  NEARS Manager              5,600               1        20/60           1,867
                                    Interview.
                                                       ---------------------------------------------------------
    Total........................  ...................  ...........  ..............  ...........          20,067
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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. 2016-02175 Filed 2-4-16; 8:45 am]
BILLING CODE 4163-18-P


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