2016-09398. 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 [phone] or send an email to [e-mail]. 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 [phone]. 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

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

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.