SEARCH for Diabetes in Youth Study

Forms and Documents

Document Name	Status
SEARCH_Phase 3_SS Part B_0511.docx Supporting Statement B	2011-05-18
Att 8_Confidentiality Certificate.pdf Supplementary Document	2011-05-20
Att 7_IRB approvals_April 2011.pdf Supplementary Document	2011-05-20
Att 6_List of Expert Consultants April 2011 Final.pdf Supplementary Document	2011-05-20
Att 5_References.doc Supplementary Document	2011-05-20
Att 4d_Tracking Database Manual.docx Supplementary Document	2011-05-20
Att 3_SEARCH 3 Sites.docx Supplementary Document	2011-05-18
Att 2_Federal Register Notice.pdf Supplementary Document	2011-05-18
Att 1_Authorizing Legislation.doc Supplementary Document	2011-05-18
SEARCH_Phase 3_SS Part A_0511.docx Supporting Statement A	2011-05-18

IC Document Collections

IC ID	Document Title	Status
197885	SEARCH Unanticipated Occurrence/Condition Reporting Form Other-WORD	New
197884	SEARCH Specimen Collection Form Other-WORD	New
197883	SEARCH Physical Examination Form Other-WORD	New
197882	SEARCH Peds QL Diabetes Module -- Parent Report for Children (ages 8-12) Other-WORD	New
197881	SEARCH Diabetes Related Family Conflict Survey - Parent Version for those who have a 10-17 year old child Other-WORD	New
197880	SEARCH Pathology Notification (Retinal Photo) Other-WORD	New
197879	SEARCH Tanner Stage -- Female -- for age 8-17 Other-WORD	New
197878	SEARCH Supplemental Questionnaire for Age 10 or Older Other-WORD	New
197877	SEARCH Low Blood Sugar Survey - Parent version Other-WORD	New
197876	SEARCH Diabetes Eating Problem Survey (DEPS_R) for age 10 and older Other-WORD	New
197875	SEARCH Michigan Neuropathy Screening Instrument (MNSI) Other-WORD	New
197874	SEARCH PedsQL (Pediatric Quality of Life Inventory) Other-WORD	New
197873	SEARCH Study Quality of Care Survey- Young Adult Version Other-WORD	New
197872	SEARCH Medical Record Validation of Self-Report Other-WORD	New
197871	SEARCH CES-Depression Other-WORD	New
197870	SEARCH Health Questionnaire - Parent Version Other-WORD	New
197869	SEARCH Health Questionnaire - Young Adult Version (age 18 and older) Other-WORD	New
197868	SEARCH Physical Examination Form Other-WORD	New
197867	SEARCH Specimen Collection Form Other-WORD	New
197866	SEARCH Inpatient Survey (Initial Participant Survey - Parent/Guardian) Other-WORD	New
197865	SEARCH Medication Inventory Other-WORD	New
197864	SEARCH 3 Extended Core Information Form (Registry Study) Other-WORD	New

ICR Details

OMB Control No: 0920-0904	ICR Reference No: 201105-0920-013
Status: Historical Inactive	Previous ICR Reference No:
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: Improperly submitted	Conclusion Date: 09/02/2011
	Date Received in OIRA: 05/26/2011
Terms of Clearance: May be resubmitted withou a new FR notice.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	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: 22

IC Title	Form No.	Form Name
SEARCH Supplemental Questionnaire for Age 10 or Older
SEARCH Tanner Stage -- Female -- for age 8-17
SEARCH Pathology Notification (Retinal Photo)
SEARCH Diabetes Related Family Conflict Survey - Parent Version for those who have a 10-17 year old child
SEARCH Peds QL Diabetes Module -- Parent Report for Children (ages 8-12)
SEARCH Physical Examination Form
SEARCH Specimen Collection Form
SEARCH Medical Record Validation of Self-Report
SEARCH Study Quality of Care Survey- Young Adult Version
SEARCH PedsQL (Pediatric Quality of Life Inventory)
SEARCH Michigan Neuropathy Screening Instrument (MNSI)
SEARCH Diabetes Eating Problem Survey (DEPS_R) for age 10 and older
SEARCH Low Blood Sugar Survey - Parent version
SEARCH Unanticipated Occurrence/Condition Reporting Form
SEARCH 3 Extended Core Information Form (Registry Study)
SEARCH Medication Inventory
SEARCH Inpatient Survey (Initial Participant Survey - Parent/Guardian)
SEARCH Specimen Collection Form
SEARCH Physical Examination Form
SEARCH Health Questionnaire - Young Adult Version (age 18 and older)
SEARCH Health Questionnaire - Parent Version
SEARCH CES-Depression

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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 information collection request (ICR).

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Annual Cost to Federal Government: $2,198,945

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: 05/26/2011

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