2018-08007. 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 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, Environmental Health Specialists Network (EHS-NET) Program Generic Package. The goal of this food safety research program is to collect data in retail food establishments that will identify and help to understand environmental factors (e.g., manager food safety certification, implementation of food safety practices, etc.) associated with retail-related foodborne illness and outbreaks.

DATES:

CDC must receive written comments on or before June 18, 2018.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2018-0031 by any of the following methods:

• Federal eRulemaking Portal: Regulations.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. 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 Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

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

Environmental Health Specialists Network (EHS-NET) Program Generic Package (OMB Control Number 0920-0792; expiration date 9/30/2018)—Revision—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC), is requesting a three-year Office of Management and Budget approval for the revision Generic Information Collection plan titled the Environmental Health Specialists (EHS-Net).

The EHS-Net program focuses on identifying the environmental causes of foodborne illness. In October 2008, OMB approved the EHS-Net program generic information collection plan. OMB approved renewal collections in both 2012 and 2015. To date, EHS-Net has conducted five individual data collections under this plan.

CDC seeks a revision to conduct information collections through 2021. The CDC plans to revise the plan in the following ways:

(1) The burden hours have increased to allow for additional statistical designs. The number of restaurants per site (8 EHS-Net sites, which has remained the same) has increased from 47 to 50 restaurants (totaling 400 restaurants); the sample size was increased to detect a greater odds ratio and establish a stronger power.

(2) The number of respondents has increased to gather additional food worker responses per establishment. Collecting data from additional food workers (increased to 10 food workers per restaurant from 1 food worker per restaurant, totaling 4,000 food workers) will help minimize the potential bias of only having one worker represent all of food workers in a given establishment. Additionally, going forward the restaurant observation data collection by the health department (HD) staff will also be included in the burden table.

(3) We expect to conduct up to three studies in a 5-year cooperative period; based on a more accurate study schedule in a 5-year EHS-Net cooperative agreement. Therefore, due to an increase in the number of restaurants, food workers interviews and addition of restaurant observation activity the estimated annual burden hours expected to increase from 295 to 1,777 annual hours.

The goal of this information collection is to improve food safety and reduce foodborne illness, which supports the U.S. Department of Health and Human Services' Healthy People 2020 Goal. Reducing foodborne illness first requires identification and understanding of the environmental factors that cause these illnesses. We need to know how and why food becomes contaminated with foodborne illness pathogens. This information can then be used to determine effective food safety prevention methods. Ultimately, these actions can lead to increased regulatory program effectiveness and decreased foodborne illness. The purpose of the information collection is to gather data that will help us identify and understand environmental factors associated with foodborne illness. Specifically, the information will be used to:

(a) Describe retail food establishment food handling and food safety practices and manager/worker and establishment characteristics,

(b) Determine how retail food establishment and worker characteristics are related to food handling and food safety practices.

The program Environmental Health Specialists Network (EHS-Net), conducted by a collaborative project of CDC, Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and local and state sites.

Environmental factors associated with foodborne illness include both food safety practices (e.g., inadequate cleaning practices) and the factors in the environment associated with those practices (e.g., worker and retail food establishment characteristics). To understand these factors, we need to continue to collect data from those who prepare food (i.e., food workers) and on the environments in which the food is prepared (i.e., retail food establishment kitchens). Thus, data collection methods for this generic information collection plane include: (1) Screener; (2) manager and food worker interviews/surveys; and (3) observation of kitchen/restaurant environments. These methods allow data collection on food safety practices and environmental factors associated with those practices.

For each data collection, CDC will collect data in approximately 50 retail food establishments per site. Thus, there will be approximately 400 establishments per data collection (an estimated 8 sites with 50 establishments).

The total estimated annual burden for each data collection will be 1,777 hours.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Managers	EHS-Net Manager Recruiting Script	889	1	3/60	44
Managers	EHS-Net Manager Informed Consent and Interview	400	1	30/60	200
Food Workers	EHS-Net Food Worker Recruiting Screener, Informed Consent and Interview	4,000	1	20/60	1,333
HD staff	EHS-Net Restaurant Observation	400	1	30/60	200
Total					1,777

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.