FoodNet Non-0157 Shiga Toxin-Producing E.coli Study: Assessment of Risk Factors for Laboratory-Confirmed Infections and Characterization of Illnesses by Microbiological Characteristics

Forms and Documents

Document Name	Status
Form Control Questionna Control Questionnaire Form	Modified
Form Case Questionnaire Case Questionnaire Form	Modified
Supporting Statement B_11-2-11.doc Supporting Statement B	2011-11-02
Consent and assent forms for cases and controls_11-2-11.doc Supplementary Document	2011-11-02
(5) 5975 CDC IRB Approval 09072010.docx Supplementary Document	2011-05-04
60 day ecoli.pdf Supplementary Document	2011-05-04
(1) Attachment A Sec. 301 42 USC 241[1].pdf Supplementary Document	2011-05-04
OMB_NonO157 CaCo Supporting Statement_11-2-11.doc Supporting Statement A	2011-11-02

IC Document Collections

IC ID	Document Title	Status
197043	Control Questionnaire Form	Modified
197042	Case Questionnaire Form	Modified

ICR Details

OMB Control No: 0920-0905	ICR Reference No: 201105-0920-003
Status: Historical Active	Previous ICR Reference No: 201103-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: FoodNet Non-0157 Shiga Toxin-Producing E.coli Study: Assessment of Risk Factors for Laboratory-Confirmed Infections and Characterization of Illnesses by Microbiological Characteristics
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: 11/06/2011
	Date Received in OIRA: 05/05/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2014	36 Months From Approved
Responses	644	0	0
Time Burden (Hours)	268	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Each year many Shiga toxin-producing E. coli (STEC) infections occur in the USm ranging from mild diarrhea to life-threatening hemolytic uremic syndrome (HUS). HUS occurs most frequently following infection with serogroup 0157 and has a fatality rate of 5%. Although studied less than 0157 STEC, non-0157 STEC are of public health importance. The FoodNet case-control study will be the first multistate study of non-outbreak-associated non-0157 STEC infections in the US. It will investigate risk factors as a group and individually for the most common non-0157 STEC serogroups. It will characterize the major known virulence factors to assess how risk factors and clinical features vary by virulence factor profiles. It would contribute to better understanding of non-0157 STEC infections and to provide science-based recommendations for preventive interventions.

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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:
	75 FR 81613	12/28/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 13191	03/10/2011
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
Case Questionnaire	Case Questionnaire	case Questionnaire
Control Questionnaire	Control Questionnaire	Control Questionnaire

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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	644	0	0	644	0	0
Annual Time Burden (Hours)	268	0	0	268	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 resubmission of a new ICR - a supporting statement part B has been added.

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Annual Cost to Federal Government: $24,278

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: 05/05/2011

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