View Information Collection Request (ICR) Package

OMB Control No: 0920-0904	ICR Reference No: 201405-0920-004
Status: Historical Active	Previous ICR Reference No: 201109-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: SEARCH for Diabetes in Youth Study
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/13/2014
	Date Received in OIRA: 05/27/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	11/30/2014
Responses	13,910	0	15,750
Time Burden (Hours)	4,248	0	6,135
Cost Burden (Dollars)	0	0	0

Abstract: CDC requests OMB approval to continue collecting information in Phase 3 of a registry study and longitudinal research study known as SEARCH for Diabetes in Youth. OMB first approved this study in 2011 (OMB # 0920-0904, exp. 11/30/2014). OMB approval is requested for the final two years of the five year project. Phase 3 is built upon activities initiated in 2000 through a multi-center collaborative research project that involved six clinical sites and a data coordinating center, all funded through cooperative agreements. Information collected in previous phases of SEARCH was not provided directly to the CDC. A number of changes have been implemented and will continue during Phase 3. Respondents will be youth < 20 years of age who have been diagnosed with diabetes. Information will be collected from the study participants by five clinical sites, each funded through a cooperative agreement, and transmitted to CDC via a data collection contractor, which will serve as the Coordinating Center for the study. Information collection will support 1) a case registry that can be used to estimate the incidence of diabetes in youth in the U.S., and 2) a cohort study of youth with diabetes to estimate the prevalence and incidence of risk factors and complications, including chronic microvascular (retinopathy, nephropathy, and autonomic neuropathy) and selected markers of macrovascular complications (hypertension, arterial stiffness) of diabetes. The registry study will continue to collect information from participants related to diabetes diagnosis but will no longer be asking participants to complete an in-person study examination. Two forms will be discontinued from the registry study and one new form will be added to the cohort study to assess whether youth with diabetes re following recommended dietary advice. There is a net reduction in total estimated annualized burden. To date, SEARCH Phase 3 has identified an average of 1,361 incident cases of diabetes among youth under 20 years each year of the study and has completed an average of 1,088 participant surveys each year (80% participation rate among registry study participants). As of November 14, 2013, SEARCH Phase 3 has completed visits for 1,839 cohort study participants.

Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 13056	03/07/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 26760	05/09/2014
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	13,910	15,750	-1,840
Annual Time Burden (Hours)	4,248	6,135	-1,887
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Forms

Short Statement: The SEARCH for Diabetes in Youth Study was initially approved with 6,135 annualized burden hours. In this Revision, we request approval for 4,248 annualized burden hours (a net reduction of 1,887 annualized burden hours). The changes that affect the total estimated annualized burden are: Reduction due to discontinuation of the Physical Examination Form for Registry Participants (former Attachment 4a_3) and the Specimen Collection Form for Registry Participants (former Attachment 4a_4); Increase due to addition of the Food Frequency Questionnaire (new Attachment 4b_16) and for rounding: Specimen Collection for Cohort Study Participants (Attachment 4b_15).

Annual Cost to Federal Government: $5,614,169

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Thelma Sims 4046394771

View ICR - OIRA Conclusion