[NCBDDD] Focus Groups Among Adults with or Caring for Individuals with Congenital Heart Defects (CHD), Muscular Dystrophy (MD), and Spina Bifida (SB).

Forms and Documents

Document Name	Status
SP Focus Group Guide Form and Instruction	Unchanged
SB Screening Tool Form and Instruction	Unchanged
MD Focus Group Guide Form and Instruction	Unchanged
MD Screening Tool Form and Instruction	Unchanged
CHD Focus Group Guide Form and Instruction	Modified
CHD Screening Tool Form and Instruction	Modified
ICR Change Request Memo_01212025.docx Justification for No Material/Nonsubstantive Change	2025-01-28
Att35_CHD.MD.SB Focus Groups_PRA_PIA_PrivacySubmission.pdf Supplementary Document	2024-03-28
Att34_Human Subjects Determination.pdf Supplementary Document	2024-03-28
Att32_60day FRN CHD.MD.SB Focus groups.pdf Supplementary Document	2024-03-28
Att31_Auth Legislation.pdf Supplementary Document	2024-03-28
Att30_ALL_Consent Form_03222024.docx Supplementary Document	2024-03-28
Att29_SB11_Thank You Email Individual.docx Supplementary Document	2024-03-28
Att28_SB10_Thank You Email Caregiver.docx Supplementary Document	2024-03-28
Att26_SB8_Calendar Invite Email Individual.docx Supplementary Document	2024-03-28
Att25_SB7_Calendar Invite Email Caregiver.docx Supplementary Document	2024-03-28
Att24_SB6_Participant Selection Email.docx Supplementary Document	2024-03-28
Att22_SB4_FG Mailer Individual.docx Supplementary Document	2024-03-28
Att21_SB3_FG Mailer Caregiver.docx Supplementary Document	2024-03-28
Att20_SB2_FG Email Individual.docx Supplementary Document	2024-03-28
Att19_SB1_FG Email Caregiver.docx Supplementary Document	2024-03-28
Att18_MD11_Thank You Email Individual.docx Supplementary Document	2024-03-28
Att17_MD10_Thank You Email Caregiver.docx Supplementary Document	2024-03-28
Att15_MD8_Calendar Invite Email Individual.docx Supplementary Document	2024-03-28
Att14_MD7_Calendar Invite Email Caregiver.docx Supplementary Document	2024-03-28
Att13_MD6_Participant Selection Email.docx Supplementary Document	2024-03-28
Att11_MD4_FG Mailer Individual.docx Supplementary Document	2024-03-28
Att10_MD3_FG Mailer Caregiver.docx Supplementary Document	2024-03-28
Att9_MD2_FG Email Individual.docx Supplementary Document	2024-03-28
Att8_MD1_FG Email Caregiver.docx Supplementary Document	2024-03-28
Att7_CHD7_ThankYou Email.docx Supplementary Document	2024-03-28
Att5_CHD5_Calendar Invite Email.docx Supplementary Document	2024-03-28
Att4_CHD4_Participant Selection Email.docx Supplementary Document	2024-03-28
Att2_CHD2_FG Mailer.docx Supplementary Document	2024-03-28
Att1_CHD1_FG Email.docx Supplementary Document	2024-03-28
Supporting Statement B_final.docx Supporting Statement B	2024-03-28
Supporting Statement A_final.docx Supporting Statement A	2024-03-28

IC Document Collections

IC ID	Document Title	Status
266384	SP Focus Group Guide Form and Instruction	Unchanged
266383	SB Screening Tool Form and Instruction	Unchanged
266382	MD Focus Group Guide Form and Instruction	Unchanged
266381	MD Screening Tool Form and Instruction	Unchanged
266380	CHD Focus Group Guide Form and Instruction	Modified
266346	CHD Screening Tool Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1433	ICR Reference No: 202501-0920-008
Status: Received in OIRA	Previous ICR Reference No: 202403-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-25-0005
Title: [NCBDDD] Focus Groups Among Adults with or Caring for Individuals with Congenital Heart Defects (CHD), Muscular Dystrophy (MD), and Spina Bifida (SB).
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/28/2025

	Requested	Previously Approved
Expiration Date	05/31/2027	05/31/2027
Responses	330	330
Time Burden (Hours)	203	203
Cost Burden (Dollars)	0	0

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Abstract: The purpose of this project is to conduct focus groups among adults with or caring for individuals with congenital heart defects (CHD), muscular dystrophy (MD), and spina bifida (SB) to obtain firsthand perspectives on the types of care individuals receive with a special focus on: receipt of and access to medical care and barriers and facilitators to accessing, receiving, or reengaging care; the journey to diagnosis; and the transition period from pediatric to adult care (for persons diagnosed during childhood). This change request includes minor modifications to the screener and the discussion guide. The burden is not affected.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

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:
	88 FR 20888	04/07/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 22152	03/29/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
CHD Focus Group Guide	n/a	CHD Focus Group Guide
CHD Screening Tool	n/a	CHD Screening Tool
MD Focus Group Guide	n/a	MD Focus Group Guide
MD Screening Tool	n/a	MC Screening Tool
SB Screening Tool	n/a	SB Screening Tool
SP Focus Group Guide	n/a	SB Focus Group Guide

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ICR Summary 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	330	330	0	0	0	0
Annual Time Burden (Hours)	203	203	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: New Collection

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Annual Cost to Federal Government: $254,330

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 01/28/2025

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