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.
US Code:
42 USC 301
Name of Law: Public Health Service Act
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).
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Att 9 all clinical sites Informed Consent_rev. 7.30.2014.pdf
Att 2B_Summary of Public Comments.doc
Att 12_Papers and Presentations.docx
SEARCH Health Questionnaire (Youth )