2011-5460. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to 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

FoodNet Non-O157 Shiga toxin-Producing E. coli Study: Assessment of Risk Factors for Laboratory-Confirmed Infections and Characterization of Illnesses by Microbiological Characteristics—New—National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Each year many Shiga toxin-producing E. coli (STEC) infections occur in the United States, ranging in severity from mild diarrhea, to hemorrhagic colitis and in some cases, life-threatening hemolytic uremic syndrome (HUS). HUS occurs most frequently following infection with serogroup O157; 6% of patients with this type of STEC infection develop HUS, with highest occurrence in children aged < 5 years. HUS has a fatality rate of approximately 5%; up to 25% of HUS survivors are left with chronic kidney damage. STEC are broadly categorized into two groups by their O antigens, STEC O157 and non-O157 STEC. The serogroup O157 is most frequently isolated and most strongly associated with HUS. Risk factors for STEC O157 infections in the United States and internationally have been intensely studied. Non-O157 STEC are a diverse group that includes all Shiga toxin-producing E. coli of serogroups other than O157. Over 50 STEC serogroups are known to have caused human illness. Numerous non-O157 outbreaks have been reported from throughout the world and clinical outcomes in some patients can be as severe as those seen with STEC O157 infections, however, little is known about the specific risk factors for infections due to non-O157 STEC serogroups. More comprehensive understanding of risk factors for sporadic non-O157 STEC infections is needed to inform prevention and control efforts. The FoodNet case-control study will be the first multistate investigation of non-outbreak-associated non-O157 STEC infections in the United States. It will investigate risk factors for non-O157 STEC infections, both as a group and individually for the most common non-O157 STEC serogroups. In addition, the study will characterize the major known virulence factors of non-O157 STEC to assess how risk factors and clinical features vary by virulence factor profiles. As the largest, most comprehensive, and most powerful study of its kind, it could make an important contribution towards better understanding of non-O157 STEC infections and to providing science-based recommendations for interventions to prevent these infections.

Persons with non-O157 STEC infections who are identified as part of routine public health surveillance and randomly selected healthy persons in the patients' communities (to serve as controls) will be contacted and offered enrollment into this study. Participation is completely voluntary and there is no cost for enrollment. The total estimated annualized burden is 268 hours.

Estimated Annualized Burden Hours

Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Patients	161	1	25/60
Controls	483	1	25/60

Catina Conner,

Acting Reports Clearance Officer, Centers for Disease Control and Prevent.