Developing a Self-Management Tool for Individuals with Systemic Lupus Erythematosus (SLE)

Forms and Documents

Document Name	Status
Att. 9_684 Form.pdf Supplementary Document	2016-02-04
Att. 7-ORAU IRB Determination.pdf Supplementary Document	2016-02-04
Att. 5-Participant Information Sheet.docx Supplementary Document	2016-02-04
SS Part B_1.20.16.docx Supporting Statement B	2016-02-04
SS Part A_1.20.16_4 19 2016.docx Supporting Statement A	2016-04-19

IC Document Collections

IC ID	Document Title	Status
219993	Att 8_Prototype CDC SLE Self-management Tool (Women) Other-WORD	New
219992	Att 8_Prototype CDC SLE Self-management Tool (Men) Other-WORD	New
219990	Att 6_ Discussion Guide (Focus Groups with Women) Other-WORD	New
219989	Att 6_Discussion Guide (Interviews with Men) Other-WORD	New
219988	Att 4b_Screener for Men Other-null	New
219987	Att 4a_Screener for Women Other-WORD	New

ICR Details

OMB Control No: 0920-1113	ICR Reference No: 201602-0920-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 16CO
Title: Developing a Self-Management Tool for Individuals with Systemic Lupus Erythematosus (SLE)
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: 04/20/2016
	Date Received in OIRA: 02/08/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	12 Months From Approved
Responses	528	0	0
Time Burden (Hours)	606	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC proposes to conduct a qualitative information collection involving individuals with SLE. CDC has developed a draft tool that consists of resources designed to help SLE patients manage their condition more effectively. Feedback on the prototype will be obtained before the final version of the tool is released.

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Authorizing Statute(s): US Code: 42 USC 241 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:
	80 FR 69679	11/10/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 5124	02/01/2016
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
Att 8_Prototype CDC SLE Self-management Tool (Women)
Att 6_ Discussion Guide (Focus Groups with Women)
Att 6_Discussion Guide (Interviews with Men)
Att 8_Prototype CDC SLE Self-management Tool (Men)
Att 4a_Screener for Women
Att 4b_Screener for Men

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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	528	0	0	528	0	0
Annual Time Burden (Hours)	606	0	0	606	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, one-time information collection.

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Annual Cost to Federal Government: $1,206,168

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 02/08/2016

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