Congenital Heart Survey to Recognize Outcomes, Needs, and Well-Being

Forms and Documents

Document Name	Status
Contact information - Spanish Form	Unchanged
Contact information - English Form	Unchanged
Survey questionnaire Form	Modified
Non-Sub Change Request_CH STRONG.docx Justification for No Material/Nonsubstantive Change	2016-07-20
Att. 11 - References.pdf Supplementary Document	2016-07-01
Att. 13 - Spanish Intro.pdf Supplementary Document	2016-07-01
Att. 7 - Intro Letter.pdf Supplementary Document	2016-07-01
Att. 16 - Spanish Letter to Mother.pdf Supplementary Document	2016-07-01
Att. 15 - Letter to Mother.pdf Supplementary Document	2016-07-01
Att. 14 - Spanish Consent.pdf Supplementary Document	2016-07-01
Att. 5 - Consent.pdf Supplementary Document	2016-07-01
CH STRONG_Supporting Statement Part A_20160609_clean.docx Supporting Statement A	2016-07-01
Att. 16 - Spanish Letter to Mother.pdf Supplementary Document	2016-02-04
Att. 15 - Letter to Mother.pdf Supplementary Document	2016-02-04
Att. 13 - Spanish Consent.pdf Supplementary Document	2016-02-04
Att. 12 - Spanish Intro.pdf Supplementary Document	2016-02-04
Att. 10 - References.pdf Supplementary Document	2016-02-04
Att. 9 - Reminder Phone Call Script.pdf Supplementary Document	2016-02-04
Att. 8 - Postcards.pdf Supplementary Document	2016-02-04
Att. 7 - Intro Letter.pdf Supplementary Document	2016-02-04
Att. 6 - Consent.pdf Supplementary Document	2016-02-04
Att. 5 - IRB Approval Letter.pdf Supplementary Document	2016-02-04
Att. 4 - External Reviewers.pdf Supplementary Document	2016-02-04
Att. 2 - 60-Day FRN.pdf Supplementary Document	2016-02-04
Att. 1 - Authorizing Legislation.pdf Supplementary Document	2016-02-04
CH STRONG_Supporting Statement Part B_20160609_clean.docx Supporting Statement B	2016-07-01

IC Document Collections

IC ID	Document Title	Status
220012	Contact information - Spanish Form	Unchanged
220011	Contact information - English Form	Unchanged
220010	Survey questionnaire Form	Modified

ICR Details

OMB Control No: 0920-1122	ICR Reference No: 201607-0920-007
Status: Historical Active	Previous ICR Reference No: 201601-0920-013
Agency/Subagency: HHS/CDC	Agency Tracking No: 15BHD
Title: Congenital Heart Survey to Recognize Outcomes, Needs, and Well-Being
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/21/2016
	Date Received in OIRA: 07/21/2016
Terms of Clearance: Approved consistent with the understanding that incentives will be provided as follows: $5 prepaid incentive sent with the survey, and a $10 incentive contingent upon completion of the survey.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	07/31/2017	07/31/2017
Responses	7,565	0	7,565
Time Burden (Hours)	2,254	0	2,254
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request to add one question to the survey instrument, in English and Spanish, without a change in burden. The purpose of this survey is to collect information on barriers to health care, quality of life, social and educational outcomes, and transition of care from childhood to adulthood among adults born with congenital heart defects.

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Authorizing Statute(s): US Code: 42 USC 241 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:
	80 FR 195	10/08/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 7344	02/11/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Survey questionnaire	none, none, none	CH STRONG survey - screenshots ,   English Survey ,   Spanish Survey
Contact information - English	none	Contact Information - English
Contact information - Spanish	none	Contact information - Spanish

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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	7,565	7,565	0	0	0	0
Annual Time Burden (Hours)	2,254	2,254	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $882,000

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? 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? 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: 07/21/2016

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