Population-based Surveillance of Outcomes, Needs, and Well-being of Children and Adolescents with Congenital Heart Defects

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Congenital Heart Survey To Recognize Outcomes, Needs, and wellbeinG of KIDS	Form and Instruction	New	Repair queued
Att 22_References.docx	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 21_Postcards.docx	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 20_Initial Letter.docx	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 19_ Survey Question Crosswalk.xlsx	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 18_Spanish Intro.docx	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 17_English Intro.docx	Supplementary Document	Uploaded 2022-07-21	Available
Att 16_Spanish Participant Info Sheet.docx	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 15_English Participant Info Sheet.docx	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 14_PIA.pdf	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 13_Research Determination.pdf	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 12_ThankYouLetter Spanish.docx	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 11_ThankYouLetter English.docx	Supplementary Document	Uploaded 2022-07-21	Available
Att 3_List of Sites.docx	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 2_60 Day OMB.pdf	Supplementary Document	Uploaded 2022-07-21	Repair queued
Att 1_Auth Legislation.pdf	Supplementary Document	Uploaded 2022-07-21	Repair queued
SupportingStatementPartB full.docx	Supporting Statement B	Uploaded 2022-07-21	Repair queued
SSA_07132022.docx	Supporting Statement A	Uploaded 2022-07-21	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
254790	Congenital Heart Survey To Recognize Outcomes, Needs, and wellbeinG of KIDS	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202206-0920-002
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-22CL
Title: Population-based Surveillance of Outcomes, Needs, and Well-being of Children and Adolescents with Congenital Heart Defects
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/22/2022

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	2,556	0
Time Burden (Hours)	852	0
Cost Burden (Dollars)	17,184	0

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Abstract: Data from U.S. state birth defect surveillance systems, or population-based studies derived from them, will be used to identify a population-based sample of children and adolescents 2 to 17 years of age born with congenital heart defects (CHD). Surveys will be mailed to their caregivers inquiring about the child’s cardiac and other healthcare utilization, barriers to health care, quality of life, social and educational outcomes, and transition of care from childhood to adulthood as well as the needs and experiences of caregivers. Collected information will be used to inform current knowledge, allocate resources, develop services, and, ultimately, improve long-term health of children and adolescents born with CHD.

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Authorizing Statute(s): US Code: 42 USC 241, 247b-4 and 280g-13 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:
	87 FR 8252	02/14/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 43858	07/22/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Congenital Heart Survey To Recognize Outcomes, Needs, and wellbeinG of KIDS	None, None	Congenital Heart Survey To Recognize Outcomes, Needs, and wellbeinG of KIDS (English) ,   Congenital Heart Survey To Recognize Outcomes, Needs, and wellbeinG of KIDS (Spanish)

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ICR Summary of Burden

table that charts list of burden

	Total Request	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	2,556	0	0	2,556	0	0
Annual Time Burden (Hours)	852	0	0	852	0	0
Annual Cost Burden (Dollars)	17,184	0	0	17,184	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 information collection.

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Annual Cost to Federal Government: $773,031

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.     No

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? No

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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: 07/22/2022

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