Focus Group Study for Raising Public Awareness of Deep Vein Thrombosis/Pulmonary Embolism

Forms and Documents

Document Name	Status
Participant Re-screener Form	New
Participant Screener Form	New
Focus Group PSA List.docx Supplementary Document	2011-07-28
DVT-Factsheet_Final.pdf Supplementary Document	2011-07-28
Supporting Statement Part B_DVTPE.docx Supporting Statement B	2011-06-22
Informed Consent form.docx Supplementary Document	2011-06-15
Attachment 10 IRB Findings and Approval.pdf Supplementary Document	2011-06-15
60 Day FRN_DVTPE (03162011).pdf Supplementary Document	2011-06-15
Attachment 1 Legal authority.doc Supplementary Document	2011-06-15
Section_A_Supporting_Statement_RDVT_Revised.doc Supporting Statement A	2011-07-28

IC Document Collections

IC ID	Document Title	Status
198207	Moderator's Guide: Formative Research Focus Groups Instruction	New
198206	Participant Re-screener Form	New
198205	Participant Screener Form	New

ICR Details

OMB Control No: 0920-0899	ICR Reference No: 201106-0920-014
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Focus Group Study for Raising Public Awareness of Deep Vein Thrombosis/Pulmonary Embolism
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: 09/02/2011
	Date Received in OIRA: 06/23/2011
Terms of Clearance: This collection is approved for one year, for the first phase of formative research only. Before conducting the second round of message testing, CDC will be required to submit a revised ICR with copies of the testing stimuli that will be used in the message testing focus groups.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	24 Months From Approved
Responses	252	0	0
Time Burden (Hours)	125	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The National Center for Birth Defects and Developmental Disabilities, Division of Blood Disorders, will conduct focus groups to develop messaging concepts to be used in a public awareness campaign to build knowledge and awareness of deep vein thrombosis/pulmonary embolism, increase recognition of symptoms and risk factors, and empower people to take action. We will conduct focus groups to explore consumer knowledge, attitudes, and behaviors and use these insights to develop message concepts. Second stage focus groups will test the message concepts and identify ways to present the messages.

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Authorizing Statute(s): US Code: 42 USC 301 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:
	76 FR 14400	03/16/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 34705	06/14/2011
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
Participant Screener	none, none	Participant Screener - Seniors 65-80 ,   Participant Screener - Adults 25-64 Recently Hospitalized
Participant Re-screener	none, none	Participant Re-Screener - Adults 25-64 Recently Hospitalized ,   Participant Re-screener - Seniors 65-80
Moderator's Guide: Formative Research Focus 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	252	0	0	252	0	0
Annual Time Burden (Hours)	125	0	0	125	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: $177,783

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: 06/23/2011

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