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.

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:

• Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.
• 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: omb@cdc.gov.

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 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.