Formative Research to Support the Development of Sickle Cell Disease Educational Messages and Materials

Forms and Documents

Document Name	Status
Focus Group Moderator's Guide Form	New
Participant Screener and Recruitment Form Form	New
Demographic Information Sheet-1.docx Supplementary Document	2012-01-05
SupportingStatementB_SCD (100511).docx Supporting Statement B	2011-11-21
Justification for Renumeration of Respondents 12012.docx Supplementary Document	2012-01-05
SUPPLEMENTAL3_ Informed Consent for Adults (100511) (2).docx Supplementary Document	2011-11-21
SUPPLEMENTAL2_Assent for Adolescents Aged 15-17 (100511) (2).docx Supplementary Document	2011-11-21
SUPPLEMENTAL1_Permission Form for Parents of Adolescents Ages 15-17 (100511 (2).docx Supplementary Document	2011-11-21
Attachment 6_IRB Approval.pdf Supplementary Document	2011-11-21
Attachment 3_Privacy Protection Agreement (062011).pdf Supplementary Document	2011-11-21
Attachment2_60Day_SickleCell.pdf Supplementary Document	2011-11-21
Attachment 1_Public Health Service Act (42 USC 241).docx Supplementary Document	2011-11-21
Demographic Information Sheet.docx Supplementary Document	2011-11-21
Section_A Supporting Statement_SCD_(100511).docx Supporting Statement A	2011-11-21

IC Document Collections

IC ID	Document Title	Status
200325	Focus Group Moderator's Guide Form	New
200324	Participant Screener and Recruitment Form Form	New

ICR Details

OMB Control No: 0920-0915	ICR Reference No: 201112-0920-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Formative Research to Support the Development of Sickle Cell Disease Educational Messages and Materials
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: 01/16/2012
	Date Received in OIRA: 12/05/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	12 Months From Approved
Responses	210	0	0
Time Burden (Hours)	204	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention (CDC) seek to improve the quality of life of people living with sickle cell disease (SCD). To accomplish this goal, CDC aims to address the need for educational messages and materials for adolescents, young adults, adults, and older adults living with SCD. CDC is interested in understanding the informational needs of these audiences related to the adoption of health behaviors and the prevention of complications associated with SCD.

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Authorizing Statute(s): US Code: 42 USC 241 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 42711	07/19/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 74067	11/30/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Participant Screener and Recruitment Form	none	Screener
Focus Group Moderator's Guide	N/A	Focus Group Guide

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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	210	0	0	210	0	0
Annual Time Burden (Hours)	204	0	0	204	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 data collection request.

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Annual Cost to Federal Government: $176,918

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: 12/05/2011

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