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

Forms and Documents

Document Name	Status
SupSta_B_0915.docx Supporting Statement B	2013-05-10
Att 3_Priv Prot Agreement.pdf Supplementary Document	2013-05-10
Att 6_IRB Approval.pdf Supplementary Document	2013-05-10
Att 2_60dy_SCD_0915.pdf Supplementary Document	2013-05-10
Att 1_PHSA (42 USC 241).docx Supplementary Document	2013-05-10
Demographic Information Sheet-1.docx Supplementary Document	2012-01-05
SUPPLEMENTAL3_ Informed Consent for Adults (100511) (2).docx Supplementary Document	2013-05-10
SUPPLEMENTAL2_Assent for Adolescents Aged 15-17 (100511) (2).docx Supplementary Document	2013-05-10
SUPPLEMENTAL1_Permission Form for Parents of Adolescents Ages 15-17 (100511 (2).docx Supplementary Document	2013-05-10
SupSta_A_0915.docx Supporting Statement A	2013-05-10

IC Document Collections

IC ID	Document Title	Status
200325	Focus Group Moderator's Guide Other-WORD	Modified
200324	Participant Screener and Recruitment Form Other-WORD	Modified

ICR Details

OMB Control No: 0920-0915	ICR Reference No: 201305-0920-007
Status: Historical Active	Previous ICR Reference No: 201112-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 19578
Title: Formative Research to Support the Development of Sickle Cell Disease Educational Messages and Materials
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/12/2013
	Date Received in OIRA: 05/14/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	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: CDC seeks 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 healthy behaviors and the prevention of complications associated with SCD. To develop these messages and materials, CDC will conduct formative focus groups with people with SCD across the country.

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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:
	78 FR 3429	01/16/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 27391	05/10/2013
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
Focus Group Moderator's 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 Reinstatement without change of a previously approved collection.

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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? Yes

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: 05/14/2013

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