OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201303-0920-017 · OMB 0920-0970 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Parent Survey for Parent Groups 1,2,3 & 4 Form and Instruction New Available
Baylor CMV Supporting statement B 3 26 13.doc Supporting Statement B Uploaded 2013-03-27 Available
Attachment 9 IRB approval letter 12 5 2012.pdf Supplementary Document Uploaded 2013-03-27 Available
Attachment 1 Legal authority.doc Supplementary Document Uploaded 2013-03-27 Available
Baylor CMV Supporting statement A_revisions_3 26 13.doc Supporting Statement A Uploaded 2013-03-27 Available
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-0970 201303-0920-017
Historical Active
HHS/CDC 19197
Assessment of the Psychosocial Impact of Newborn Screening for Congenital Cytomegalovirus (CMV) Infection
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 05/22/2013
Retrieve Notice of Action (NOA) 03/29/2013
  Inventory as of this Action Requested Previously Approved
05/31/2014 12 Months From Approved
401 0 0
135 0 0
0 0 0
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.
US Code: 42 USC 241 Name of Law: Research and Investigations Generally
  
None
Not associated with rulemaking
  77 FR 58395 09/20/2012
78 FR 4411 01/22/2013
No
  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
Yes
Miscellaneous Actions
No
This is a new ICR
$14,191
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Petunia Gissendaner 4046390164
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/29/2013