SEARCH for Diabetes in Youth Study

Forms and Documents

Document Name	Status
Att 11_published article describing SEARCH methods.pdf Supplementary Document	2011-11-04
SEARCH Phase 3_SS Part B_11 02 2011.docx Supporting Statement B	2011-11-04
Att 9. Example Consent Forms.pdf Supplementary Document	2011-09-23
Att 10_Data Use Agreements September 2011.pdf Supplementary Document	2011-09-23
Att 8_Certificate of Confidentiality September 2011.pdf Supplementary Document	2011-09-21
Att 7_IRB Approved September 2011.pdf Supplementary Document	2011-09-21
Att 6_List of Expert Consultants April 2011 Final.pdf Supplementary Document	2011-09-21
Att 5_References.doc Supplementary Document	2011-09-21
Att 3_SEARCH 3 Sites.docx Supplementary Document	2011-09-21
Att 2_60-day FRN 02 11 2011.pdf Supplementary Document	2011-09-21
Att 1_Authorizing Legislation.doc Supplementary Document	2011-09-21
SEARCH Phase 3_SS Part A_11 02 2011.docx Supporting Statement A	2011-11-04

IC Document Collections

IC ID	Document Title	Status
197885	SEARCH Unanticipated Occurrence/Condition Reporting Form Other-WORD	Removed
197884	SEARCH Specimen Collection Form Other-WORD	Modified
197883	SEARCH Physical Examination Form Other-WORD	Modified
197882	Peds QL Diabetes Module Other-WORD	Modified
197881	SEARCH Diabetes Related Family Conflict Survey Other-WORD	Modified
197880	SEARCH Pathology Notificaiton (Retinal Photo) Other-WORD	Modified
197879	SEARCH Tanner Stage Other-WORD	Modified
197878	SEARCH Supplemental Questionnaire Other-WORD	Modified
197877	SEARCH Low Blood Surgar Survey Other-WORD	Modified
197876	SEARCH Diabetes Eating Problem Survey (DEPS-R) Other-WORD	Modified
197875	SEARCH MNSI Other-WORD	Modified
197874	SEARCH PedsQL Other-WORD	Modified
197873	SEARCH Quality of Care Survey Other-WORD	Modified
197872	SEARCH Medical Record Validation of Self-Report Other-WORD	Removed
197871	SEARCH CES-Depression Other-WORD	Modified
197870	SEARCH Health Questionnaire - Parent Version Other-WORD	Removed
197869	SEARCH Health Questionnaire - Youth/ & Parent Versions Other-WORD	Modified
197868	SEARCH Physical Examination Form Other-WORD	Modified
197867	SEARCH Specimen Collection Form Other-WORD	Modified
197866	SEARCH Inpatient Survey (Initial Participant Survey - Parent/Guardian) Other-WORD	Removed
197865	SEARCH Medical Inventory Other-WORD	Modified
197864	SEARCH - Initial Participant Survey - Parent/Gardian (Inpatient) Other-4a2	Modified

ICR Details

OMB Control No: 0920-0904	ICR Reference No: 201109-0920-007
Status: Historical Active	Previous ICR Reference No: 201105-0920-013
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: SEARCH for Diabetes in Youth Study
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/06/2011
	Date Received in OIRA: 09/28/2011
Terms of Clearance:

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

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Abstract: CDC requests OMB approval to collect de-identified, case-level information from five SEARCH sites that are participating in Phase 3 of a longitudinal study of diabetes in youth, and a case registry.

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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:
	76 FR 7859	02/11/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 29245	05/20/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

IC Title	Form No.	Form Name
SEARCH Medical Inventory
SEARCH - Initial Participant Survey - Parent/Gardian (Inpatient)
SEARCH Specimen Collection Form
SEARCH Physical Examination Form
SEARCH Health Questionnaire - Youth/ & Parent Versions
SEARCH CES-Depression
SEARCH PedsQL
SEARCH Quality of Care Survey
SEARCH MNSI
SEARCH Diabetes Eating Problem Survey (DEPS-R)
SEARCH Low Blood Surgar Survey
SEARCH Supplemental Questionnaire
SEARCH Tanner Stage
SEARCH Pathology Notificaiton (Retinal Photo)
SEARCH Diabetes Related Family Conflict Survey
Peds QL Diabetes Module
SEARCH Physical Examination Form
SEARCH Specimen Collection Form
SEARCH Inpatient Survey (Initial Participant Survey - Parent/Guardian)
SEARCH Health Questionnaire - Parent Version
SEARCH Medical Record Validation of Self-Report
SEARCH Unanticipated Occurrence/Condition Reporting Form

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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	15,750	0	0	15,750	0	0
Annual Time Burden (Hours)	6,135	0	0	6,135	0	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: No

Burden Reduction Due to:

Short Statement: This is a new ICR request. OMB previously reviewed and issued an NOA on 9/02/2011; OMB Action: Improperly Submitted; Comment: May be resubmitted withou a new FR notice.

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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

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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: 09/28/2011

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