Assessment of the Psychosocial Impact of Newborn Screening for Congenital Cytomegalovirus (CMV) Infection

Forms and Documents

Document Name	Status
Parent Survey for Parent Groups 1,2,3 & 4 Form and Instruction	New
Baylor CMV Supporting statement B 3 26 13.doc Supporting Statement B	2013-03-27
Attachment 9 IRB approval letter 12 5 2012.pdf Supplementary Document	2013-03-27
Attachment 1 Legal authority.doc Supplementary Document	2013-03-27
Baylor CMV Supporting statement A_revisions_3 26 13.doc Supporting Statement A	2013-03-27

IC Document Collections

IC ID	Document Title	Status
206299	Parent Survey for Parent Groups 1,2,3 & 4 Form and Instruction	New
206298	Interview Recruitment Letter Instruction	New
206297	Parent Interview Other-Interview Guide	New
206296	Focus Group Recruitment Letter Instruction	New
206295	Parent Focus Group Guide Other-Focus Group Guide	New

ICR Details

OMB Control No: 0920-0970	ICR Reference No: 201303-0920-017
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 19197
Title: Assessment of the Psychosocial Impact of Newborn Screening for Congenital Cytomegalovirus (CMV) Infection
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: Approved without change	Conclusion Date: 05/22/2013
	Date Received in OIRA: 03/29/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2014	12 Months From Approved
Responses	401	0	0
Time Burden (Hours)	135	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC is requesting OMB approval for one year to collect information about newborn congenital cytomegalovirus (CMV) screening. The purpose of this information collection is to understand the psychosocial impact of newborn screening on parents whose infants underwent CMV screening as part of a routine infant CMV screening program in Houston, Texas. The potential study population includes approximately 70 CMV-infected children who were symptomatic at birth, 100 CMV-infected children who were asymptomatic at birth (20 of whom developed sequelae), and 50 controls that were CMV-uninfected. The goals of this information collection are to: 1) document the positive and negative psychosocial impacts of newborn CMV screening on parents and their children; 2) identify modifiable factors that might increase positive psychosocial impacts and decrease negative psychosocial impacts of newborn CMV screening; 3) use what is learned about psychosocial impacts to identify key messages that parents need relative to newborn CMV screening and follow-up; and 4) to learn what challenges are associated with obtaining a congenital CMV diagnosis in the absence of CMV newborn screening.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Research and Investigations Generally
  

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:
	77 FR 58395	09/20/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 4411	01/22/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Parent Focus Group Guide
Focus Group Recruitment Letter
Parent Interview
Interview Recruitment Letter
Parent Survey for Parent Groups 1,2,3 & 4	None	CMV Parent Survey for All Parent Groups

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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	401	0	0	401	0	0
Annual Time Burden (Hours)	135	0	0	135	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: This is a new ICR

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Annual Cost to Federal Government: $14,191

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: 03/29/2013

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