2012-17982. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-7570 and send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [e-mail].

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; and (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. Written comments should be received within 60 days of this notice.

Proposed Project

Using the Standardized National Hypothesis Generating Questionnaire during Multistate Investigations of Foodborne Disease Clusters and Outbreaks—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Each year, it is estimated that roughly 1 in 6 Americans become ill with a foodborne disease. Unfortunately, of these Americans, approximately 128,000 are hospitalized and 3,000 die as a result of foodborne diseases. CDC and partners ensure rapid and coordinated surveillance, detection, and response to multistate foodborne disease outbreaks to limit the number of illnesses and to learn how to prevent similar outbreaks from happening in the future.

Conducting interviews during the initial hypothesis-generating phase of multistate foodborne disease outbreaks presents numerous challenges. In the U.S., there is not a standard, national form or data collection system for illnesses caused by many enteric pathogens. Data elements for hypothesis generation must be developed and agreed upon for each investigation. This process can take several days to weeks, and may cause interviews to occur long after a person's illness.

CDC requests OMB approval to collect standardized information from individuals who have become ill during a multistate foodborne disease event. The questionnaire is designed to be administered by public health officials as part of multistate hypothesis-generating interview activities and is not expected to entail significant burden to respondents.

The Standardized National Hypothesis-Generating Core Elements Project was established with the goal to define a core set of data elements to be used for hypothesis generation during multistate foodborne investigations. These elements represent the minimum set of information that should be available for all outbreak-associated cases identified during hypothesis generation. The Standardized National Hypothesis Generating Questionnaire (SNHGQ) is a data collection tool for the core elements.

The core elements and use of the SNHGQ would ensure that exposures of importance for investigating multistate outbreaks of various enteric disease pathogens would be ascertained similarly across many jurisdictions. This will allow for rapid pooling of data to improve the timeliness of hypothesis-generating analyses and reducing the time it takes to pinpoint how and where contamination events occur.

Both the content of the questionnaire (the core elements) and the format were developed through a series of working groups comprised of local, state, and federal public health partners. The questionnaire is designed to be administered over the phone by public health officials to collect core elements data from case-patients or their proxies. It is designed to be used when a multistate cluster of enteric disease infections is identified. Data collected during a multistate investigation of an enteric disease cluster will be pooled and analyzed at the CDC in order to develop hypotheses about potential sources of infection.

The total estimated annualized burden for the Standardized National Generating Questionnaire is 3,000 hours (approximately 4,000 individuals identified during the hypothesis-generating phase of outbreak investigations x 45 minutes/response). There are no costs to 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)	Total burden (in hours)
Individuals	Standardized National Hypothesis Generating Questionnaire (Core Elements)	4,000	1	45/60	3,000
Total					3,000

Kimberly S. Lane,

Deputy Director, Office of Science Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.