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

Forms and Documents

Document Name	Status
Form 0920-1122 Spanish Contact Information Form Form	Modified
Form 0920-1122 English Contact information Form Form	Modified
Form 0920-1122 Congential Heart Survey To Recognize Outcomes, Needs, and well-beinG (CH STRONG) Form	Modified
Att. 19 - Spanish Contact Info.pdf Supplementary Document	2018-03-13
Att. 18 - Contact Info.pdf Supplementary Document	2018-03-13
Att. 17 - Spanish Letter to Mother.pdf Supplementary Document	2018-03-13
Att. 16 - Letter to Mother.pdf Supplementary Document	2018-03-13
CH STRONG_SupSta Part A_031318.docx Supporting Statement A	2018-03-14
Att. 15 - Spanish Consent.pdf Supplementary Document	2018-03-13
Att. 14 - Spanish Intro.pdf Supplementary Document	2018-03-13
Att. 12 - References.pdf Supplementary Document	2018-03-13
Att. 10 - Reminder Phone Call Script.pdf Supplementary Document	2018-03-13
Att. 9 - Postcards.pdf Supplementary Document	2018-03-13
Att. 4 - Intro Letter.pdf Supplementary Document	2018-03-13
Att. 5 - Consent.pdf Supplementary Document	2018-03-13
Att. 8 - IRB Approval (Renewal).pdf Supplementary Document	2018-03-13
Att. 7 - External Reviewers.pdf Supplementary Document	2018-03-13
Att. 2 - 60dy Published FRN.pdf Supplementary Document	2018-03-13
Att. 1 - Authorizing Legislation.pdf Supplementary Document	2018-03-13
CH STRONG_Supporting Statement Part B_2018 jan9 clean.docx Supporting Statement B	2018-03-13

IC Document Collections

IC ID	Document Title	Status
220012	Spanish Contact Information Form Form	Modified
220011	English Contact information Form Form	Modified
220010	Congential Heart Survey To Recognize Outcomes, Needs, and well-beinG (CH STRONG) Form	Modified

ICR Details

OMB Control No: 0920-1122	ICR Reference No: 201803-0920-008
Status: Active	Previous ICR Reference No: 201607-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1122
Title: Congenital Heart Survey to Recognize Outcomes, Needs, and Well-Being
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/01/2018
	Date Received in OIRA: 03/14/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	36 Months From Approved
Responses	1,940	0	0
Time Burden (Hours)	564	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of CH STRONG is to assess barriers to care, quality of life, social and educational outcomes, and transition of care among adults born with congenital heart defects (CHD).

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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:
	82 FR 43991	09/20/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 4055	01/29/2018
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
Congential Heart Survey To Recognize Outcomes, Needs, and well-beinG (CH STRONG)	0920-1122, 0920-1122	CHSTRONG Cogenital Heart Survey To Recognize Outcomes, Needs, and well-beinG ,   CHSTRONG Encuesta Cardiaca Congenita para Reconocer los Resultados, las Necesidades y el Bienestar
English Contact information Form	0920-1122	English Contact Information Form
Spanish Contact Information Form	0920-1122	Spanish Contact information Form (CH STRONG)

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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	1,940	0	0	1,940	0	0
Annual Time Burden (Hours)	564	0	0	564	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: There were delays in recruitment due to challenges with tracking and tracing individuals for correct addresses.

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Annual Cost to Federal Government: $78,000

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: 03/14/2018

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