Clostridium difficile Infection (CDI) Surveillance

Forms and Documents

Document Name	Status
Form New form Telephone Interview Form and Instruction	New
Form New form Screening Form Form and Instruction	New
Supporting Statement B .doc Supporting Statement B	2011-06-16
Attachment H - IRB approval for portocol 5558_Cont.doc Supplementary Document	2011-06-16
Attachment G - CDI Case Report Form.pdf Supplementary Document	2011-06-16
Attachment C _ADULT VERBAL CONSENTrevised.doc Supplementary Document	2011-06-16
Attachment D _ CDI ASSENT for 13-15 .doc Supplementary Document	2011-06-16
Supporting Statement A .doc Supporting Statement A	2011-06-16

IC Document Collections

IC ID	Document Title	Status
198154	Telephone Interview Form and Instruction	New
198153	Screening Form Form and Instruction	New

ICR Details

OMB Control No: 0920-0892	ICR Reference No: 201106-0920-012
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Clostridium difficile Infection (CDI) Surveillance
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 without change	Conclusion Date: 07/25/2011
	Date Received in OIRA: 06/16/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2014	36 Months From Approved
Responses	1,100	0	0
Time Burden (Hours)	383	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC is requesting OMB approval for a new data collection. Steady increases in the rate and severity of Clostridium difficile infection (CDI) indicate a clear need to conduct longitudinal assessment of the impact of CDI in the United States. The proposed surveillance for CDI through the EIP will expand CDC capacity to monitor incidence of C. difficile in community and healthcare settings as well as to monitor and detect antimicrobial resistance.

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Authorizing Statute(s): None

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:
	75 FR 53310	08/31/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 14021	03/09/2011
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
Screening Form	New form	Attachment E Screening Questions for CDI
Telephone Interview	New form	Attachment F CDI Health Interview

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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	1,100	0	0	1,100	0	0
Annual Time Burden (Hours)	383	0	0	383	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 request, there are no changes to report.

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Annual Cost to Federal Government: $214,588

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: 06/16/2011

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