2011-12468. 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 or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

SEARCH for Diabetes in Youth Study—New—Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Diabetes is one of the most common chronic diseases among children in the United States. When diabetes strikes during childhood, it is routinely assumed to be type 1, or juvenile-onset, diabetes. Type 1 diabetes (T1D) develops when the body's immune system destroys pancreatic cells that make the hormone insulin. Type 2 diabetes begins when the body develops a resistance to insulin and no longer uses it properly. As the need for insulin rises, the pancreas gradually loses its ability to produce sufficient amounts of insulin to regulate blood sugar.

Reports of increasing frequency of both type 1 and type 2 diabetes in youth have been among the most concerning aspects of the evolving diabetes epidemic. In response to this growing public health concern, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) funded the SEARCH for Diabetes in Youth Study.

The SEARCH for Diabetes in Youth Study began in 2000 as a multi-center, epidemiological study, conducted in six geographically dispersed Study Centers that reflected the racial and ethnic diversity of the U.S. Phases 1 (2000-2005) and 2 (2005-2010) produced estimates of the prevalence and incidence of diabetes among youth age < 20 years, according to diabetes type, age, sex, and race/ethnicity, and characterized selected acute and chronic complications of diabetes and their risk factors, as well as the quality of life and quality of health care.

CDC proposes to collect de-identified, case-level information from five SEARCH sites during Phase 3 of the SEARCH for Diabetes in Youth Study. Phase 3 brings together major and timely facets of childhood diabetes research: An epidemiologic component that assesses temporal trends in the incidence of diabetes in youth; a pathophysiologic component addressing the natural history of diabetes in youth; a health services research component to evaluate the processes and quality of care for youth with diabetes; and a public health perspective on case classification of diabetes in youth.

Information will be collected for three years through a data collection contractor, which will serve as the SEARCH Study Coordinating Center. Data will be transmitted electronically to the Coordinating Center through a secure, dedicated Web site. Information can be entered and transmitted at any time. The information collection has three components.

The Registry Study will collect information on newly diagnosed incident diabetes cases in youth age < 20 years. CDC estimates that each clinical site will identify and register an average of 255 cases per year. The items collected for each case include an inpatient survey, core information, medications, and physical exam data. The total estimated annualized burden for this information collection is 744 hours.

The Cohort Study is a longitudinal research study about SEARCH cases whose diabetes was incident in 2002 or later. CDC estimates that each clinical site will conduct follow-up on an average of 142 cases per year. The items collected for each case include health questionnaires for youth and parents, physical exam information, and surveys about eating behavior, blood sugar, neuropathy, family relationships, and quality of life. Information will also be collected to monitor unanticipated occurrences and conditions. CDC estimates that each site will report an average of 13 unanticipated occurrences per year.

Respondents will be the five study sites funded for SEARCH Phase 3. Participation in the data collection is required for the study sites, but participation in the SEARCH study is voluntary for individuals who are followed at those sites.

The total estimated annualized burden is 2,132 hours. There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Number of respondents	Number of responses per respondent	Form name	Average burden per response
SEARCH Clinical Sites: Registry Study	5	255	Extended Core Medication Inventory	10/60 5/60
			Inpatient Survey	10/60
			Specimen Collection (Registry)	5/60
			Physical Exam (Registry)	5/60
SEARCH Clinical Sites: Cohort Study	5	142	Health Questionnaire-Youth Health Questionnaire-Parent	15/60 15/60
			CES-Depression	4/60
			Medical Record Validation	10/60
			Quality of Care	13/60
			Peds QL	5/60
			SEARCH MNSI Neuropathy	5/60
			Diabetes Eating Survey	5/60
			Low Blood Sugar Survey	5/60
			Supplemental	10/60
			Tanner Stage	5/60
			Retinal Photo	5/60
			Family Conflict	5/60
			Pediatric Diabetes QOL Scale	5/60
			Physical Exam	5/60
			Specimen Collection	5/60
SEARCH Clinical Sites: Monitoring	5	13	Unanticipated Occurrence/Condition Reporting Form	5/60

Dated: May 16, 2011.

Daniel Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.