Communications Research for the Development of Messages and Materials about Cytomegalovirus (CMV)

Forms and Documents

Document Name	Status
Informed Consent form Form and Instruction	New
Web Survey: Fact Sheet, Factsheet Testing Screenshots, Video Testing, and Testing Screenshots Form and Instruction	New
Web Survey Screener and Web Survey Screener Screenshots Form and Instruction	New
Focus Group Demographic Profile Questionnaire and Focus Group Informed Consent Form	New
CMV Focus Group Screener Form	New
CMV_IncentiveJustification Rev 9 5.docx Supplementary Document	2012-09-07
CMV_Supporting Statement B Rev 5 17 12.docx Supporting Statement B	2012-06-26
Supplemental 1_ Draft CDC Material_CMV Factsheet.docx Supplementary Document	2012-06-26
Attachment 5_IRB Findings and Approval.pdf Supplementary Document	2012-06-26
Attachment 1 Applicable Laws or Regulations.docx Supplementary Document	2012-06-26
Attachment 3I Web Survey Video Testing Screenshots.docx Supplementary Document	2012-06-26
Attachment 3G Web Survey Factsheet Testing Screenshots.docx Supplementary Document	2012-06-26
Attachment 3E Web Survey Screener Screenshots.docx Supplementary Document	2012-06-26
CMV Supporting Statement A Rev 5 17 12.docx Supporting Statement A	2012-06-26

IC Document Collections

IC ID	Document Title	Status
202909	Informed Consent form Form and Instruction	New
202908	Web Survey: Fact Sheet, Factsheet Testing Screenshots, Video Testing, and Testing Screenshots Form and Instruction	New
202907	Web Survey Screener and Web Survey Screener Screenshots Form and Instruction	New
202906	Focus Group Demographic Profile Questionnaire and Focus Group Informed Consent Form	New
202905	Focus Group Discussion Guide Other-Discussion Guide	New
202904	CMV Focus Group Screener Form	New

ICR Details

OMB Control No: 0920-0947	ICR Reference No: 201206-0920-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Communications Research for the Development of Messages and Materials about Cytomegalovirus (CMV)
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 with change	Conclusion Date: 09/10/2012
	Date Received in OIRA: 06/27/2012
Terms of Clearance: Approved consistent with the understanding that any changes made to the Phase II ICs will need to be reviewed and approved prior to use (this can be done through a non-substantive change).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2014	24 Months From Approved
Responses	5,960	0	0
Time Burden (Hours)	543	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: NCBDDD will conduct a multiphase communication research study to determine effective CMV communication strategies to reach the target audiences. The first phase will be largely exploratory and will include focus groups with Caucasian and African-American pregnant or expecting mothers ages 18-40 who also have a child age 5 years or younger. The focus groups will assess understanding of audience members' knowledge, attitudes, and beliefs about CMV, their perceptions about personal risk and prevention behaviors, their communication preferences, and initial reactions to CDC CMV messages and materials. The second phase will consist of a web survey to assess baseline awareness and knowledge regarding congenital CMV, measure current CMV prevention behaviors prior to viewing any CMV communication interventions (factsheet, video) and CDC's CMV prevention guidelines, and test refined CDC CMV messages and materials with a larger sample of the target audience.

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Authorizing Statute(s): PL: Pub.L. 42 - 241 301 Name of Law: The Public Health and Welfare
  

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 11125	02/24/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 38065	06/26/2012
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
CMV Focus Group Screener	none	CMV Focus Group Screener
Focus Group Discussion Guide
Focus Group Demographic Profile Questionnaire and Focus Group Informed Consent	none	Focus Group Demographic Profile Questionnaire
Web Survey Screener and Web Survey Screener Screenshots	none	Web Survey
Web Survey: Fact Sheet, Factsheet Testing Screenshots, Video Testing, and Testing Screenshots	none, none, none	Web Survey Factsheet ,   Web Survey Video ,   Web Survey
Informed Consent form	none	Informed Consent

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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	5,960	0	0	5,960	0	0
Annual Time Burden (Hours)	543	0	0	543	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: $189,336

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: 06/27/2012

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