Clostridium difficile Infection (CDI) Surveillance

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Attachment H - IRB approval for portocol 5558_Cont.doc	Supplementary Document	Uploaded 2011-03-17	Repair queued
Attachment G - CDI Case Report Form.pdf	Supplementary Document	Uploaded 2011-03-17	Repair queued
Attachment C _ADULT VERBAL CONSENT Assent 16_17 for CDI.doc	Supplementary Document	Uploaded 2011-03-17	Repair queued
Attachment D _ CDI ASSENT for 13-15 .doc	Supplementary Document	Uploaded 2011-03-17	Repair queued
Supporting Statement A Final.doc	Supporting Statement A	Uploaded 2011-03-17	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
197248	Telephone Interview	Instruction	New
197247	Screening Form	Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 201104-0920-006
Status: Historical Inactive	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: Improperly submitted	Conclusion Date: 05/31/2011
	Date Received in OIRA: 04/12/2011
Terms of Clearance: This collection requires a supporting statement Part B.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	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. C. difficile is an anaerobic, spore-forming, gram positive bacillus that produces two pathogenic toxins. A and B. CDI ranges in severity from mild diarrhea to fulminant colitis and death.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: USC
  

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	03/15/2011
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Screening Form
Telephone Interview

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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, there are no changes existing for the information collection.

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Annual Cost to Federal Government: $214,588

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? 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: 04/12/2011

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