SEARCH for Diabetes in Youth Study

Forms and Documents

Document Name	Status
SEARCH Initial Participant Survey - Prevalence Form	New
SEARCH Specimen Collection Form Form	Modified
SEARCH Physical Examination Form	Modified
SEARCH Medication Inventory (Incident Case) Form	Modified
SEARCH - Initial Participant Survey - Incident Form	Modified
30dy170904 Published.pdf Supplementary Document	2017-07-21
Att 11_published article describing SEARCH methods.pdf Supplementary Document	2017-07-19
Attachment 12_Capture_Recapture Technical Report.pdf Supplementary Document	2017-07-19
Attachment 9_All Sites IRB Approved Consent Assent.pdf Supplementary Document	2017-07-19
Attachment 7 IRB Approvals.pdf Supplementary Document	2017-07-19
Attachment 6 List of Experts Consulted.pdf Supplementary Document	2017-07-19
Att 3_SEARCH_StudySites and CoordinatingCenter.docx Supplementary Document	2017-07-19
Attachment 2a_60 day Federal Registry Notice.pdf Supplementary Document	2017-07-19
SEARCH for Diabetes (Youth) SupSta B.docx Supporting Statement B	2017-07-21
Att 10_Data Use Agreements.pdf Supplementary Document	2017-07-19
Attachment 8_SEARCH 4 Certificate of Confidentiality 3_25_2016.pdf Supplementary Document	2017-07-21
Attachment 5 Uses of SEARCH data and publications.doc Supplementary Document	2017-07-19
Att 1_Authorizing Legislation.doc Supplementary Document	2017-07-19
SEARCH for Diabetes (Youth) SupSta A clean 10172017.docx Supporting Statement A	2017-10-18

IC Document Collections

IC ID	Document Title	Status
227648	SEARCH Initial Participant Survey - Prevalence Form	New
211580	SEARCH Health Questionnaire (Youth ) Other-WORD	Removed
211579	SEARCH Food Frequency Questionnaire Other-PDF	Removed
197884	SEARCH Specimen Collection Form Form	Modified
197883	SEARCH Physical Examination Form	Modified
197882	Peds QL Diabetes Module Other-WORD	Removed
197881	SEARCH Diabetes Related Family Conflict Survey Other-WORD	Removed
197880	SEARCH Pathology Notificaiton (Retinal Photo) Other-WORD	Removed
197879	SEARCH Tanner Stage Other-WORD	Removed
197878	SEARCH Supplemental Questionnaire Other-WORD	Removed
197877	SEARCH Low Blood Surgar Survey Other-WORD	Removed
197876	SEARCH Diabetes Eating Problem Survey (DEPS-R) Other-PDF	Removed
197875	SEARCH Michigan Neuropathy Screening Instrument (MNSI) Other-PDF	Removed
197874	SEARCH PedsQL Other-PDF	Removed
197873	SEARCH Quality of Care Survey (Feb 2014) Other-PDF	Removed
197871	SEARCH CES-Depression Other-PDF	Removed
197869	SEARCH Health Questionnaire (Parent_Feb 2014) Cohort Study Other-PDF	Removed
197865	SEARCH Medication Inventory (Incident Case) Form	Modified
197864	SEARCH - Initial Participant Survey - Incident Form	Modified

ICR Details

OMB Control No: 0920-0904	ICR Reference No: 201705-0920-019
Status: Historical Active	Previous ICR Reference No: 201405-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0904
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: 10/27/2017
	Date Received in OIRA: 07/21/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	36 Months From Approved	10/31/2017
Responses	5,444	0	13,910
Time Burden (Hours)	2,016	0	4,248
Cost Burden (Dollars)	0	0	0

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Abstract: CDC requests OMB approval to continue collecting information in Phase 4 of a registry study known as SEARCH for Diabetes in Youth. OMB first approved this study in 2011 (OMB # 0920-0904, exp. 11/30/2014), and a revision was approved in 2014 (exp. 8/31/2017). OMB approval is requested for the final three years of the five year project. Phase 4 is built upon activities a multi-center initiated in 2000 through collaborative research project that involved six clinical sites and a data coordinating center, all funded through cooperative agreements. Phase 3 and 4 only included 5 clinical sites and a data coordinating center. A number of changes have been implemented and will continue during Phase 4. Respondents will continue to be youth < 20 years of age who have been diagnosed with diabetes or their parents. Information will support a case registry that can be used to estimate the incidence and prevalence of diabetes in youth in the U.S. IN Phase 3, CDC also funded a cohort component to this study. For Phase 4, CDC is no longer funding this component. The registry study will continue to collect information from participants who were initially diagnosed with diabetes in 2016 to complete an in-person study examination.

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

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 88685	12/08/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 32702	07/17/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
SEARCH Pathology Notificaiton (Retinal Photo)
SEARCH Diabetes Related Family Conflict Survey
SEARCH Initial Participant Survey - Prevalence	n/a, n/a	Initial Participant Survey - Adult Prevalent Case ,   Initial Participant Survey - Child Prevalent Case
SEARCH Tanner Stage
Peds QL Diabetes Module
SEARCH Specimen Collection Form	n/a	Specimen Collection Form
SEARCH Medication Inventory (Incident Case)	n/a	Medications Inventory
SEARCH - Initial Participant Survey - Incident	n/a, n/a, n/a, n/a	Initial Participant Survey - Incident Case Child Version (screen shots) ,   Initial Participant Survey - Incident Case Child Version (Paper) ,   Initial Participant Survey - Incident Case Young Adult Version (screen shots) ,   Initial Participant Survey - Incident Case Young Adult version (paper)
SEARCH Health Questionnaire (Youth )
SEARCH CES-Depression
SEARCH Quality of Care Survey (Feb 2014)
SEARCH Michigan Neuropathy Screening Instrument (MNSI)
SEARCH Diabetes Eating Problem Survey (DEPS-R)
SEARCH Low Blood Surgar Survey
SEARCH Supplemental Questionnaire
SEARCH Food Frequency Questionnaire
SEARCH Physical Examination	n/a	Physical Examination Form
SEARCH Health Questionnaire (Parent_Feb 2014) Cohort Study
SEARCH PedsQL

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	5,444	13,910	0	1,474	-9,940	0
Annual Time Burden (Hours)	2,016	4,248	0	-670	-1,562	0
Annual Cost Burden (Dollars)	0	0	0	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: Miscellaneous Actions

Short Statement: The SEARCH for Diabetes in Youth Study was initially approved with 4,248 annualized burden hours. In this Revision, we request approval for 1,879 annualized burden hours (a net reduction of 2,369 annualized burden hours).

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Annual Cost to Federal Government: $2,502,626

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 07/21/2017

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