Risk Factors for Community-Associated Clostridium difficile Infection through the Emerging Infections Program

Forms and Documents

Document Name	Status
Form 0920 Pediatrice Control Subjects Telephone Interview Form and Instruction	Modified
Form 0920 Pediatric Control Subjects Screening Process Form and Instruction	Unchanged
Form 0920-1013 Pediatric Case Telephone Interview Form and Instruction	Modified
Form 0929-1013 Pediatric Case Subject Screening Process Form and Instruction	Modified
Form 0920-1013 Adult Control Subjects Telephone Interview Form and Instruction	Modified
Form 0920 Adult Control Subjects Screening Process Form and Instruction	Unchanged
Form 0920 Adult Case Subjects Telephone Interview Form and Instruction	Unchanged
Form 0920-1013 Adult Case Subjects Screening Process Form and Instruction	Modified
Table of Changes.docx Justification for No Material/Nonsubstantive Change	2014-06-30
Mini-ICR_09201013_061214.doc Justification for No Material/Nonsubstantive Change	2014-06-30
Mini-ICR_09201013_061214.doc Supporting Statement A	2014-06-27
Supporting Statement Part B CA_CDI_1_21_14.docx Supporting Statement B	2014-02-13
SPANISH TRANSLATION_Attachment L_Adult Peds Consent CASE and CONTROL with and without HIPPA_1_24_14.doc Supplementary Document	2014-02-17
Rev Attachment H_CA CDI Protocol_IRB_Approved_1_24_14.docx Supplementary Document	2014-02-17
Attachment I_ 6542 Site Restricted New Submission Approval.docx Supplementary Document	2014-02-17
Attachment E_Verbal Consent Case and Control with and without HIPPA_1_24_14.docx Supplementary Document	2014-02-17
Attachment A Sec. 301 42 USC 241[1].pdf Supplementary Document	2014-02-13
SPANISH TRANSLATION_Attachment N_CA CDI Pediatric Patient Interview Form_1_24_14.doc Supplementary Document	2014-02-17
SPANISH TRANSLATION_Attachment K_Pediatric Case and Control Screening Forms_1_24_14.docx Supplementary Document	2014-02-17
SPANISH TRANSLATION_Attachment N_CA CDI Pediatric Patient Interview Form_1_24_14.doc Supplementary Document	2014-02-17
SPANISH TRANSLATION_Attachment K_Pediatric Case and Control Screening Forms_1_24_14.docx Supplementary Document	2014-02-17
SPANISH TRANSLATION_Attachment M_CA CDI Adult_ Patient Interview Form_1_24_14.doc Supplementary Document	2014-02-17
SPANISH TRANSLATION_Attachment J_Adult Case and Control Screening Forms 1_24_14.docx Supplementary Document	2014-02-17
SPANISH TRANSLATION_Attachment M_CA CDI Adult_ Patient Interview Form_1_24_14.doc Supplementary Document	2014-02-17
SPANISH TRANSLATION_Attachment J_Adult Case and Control Screening Forms 1_24_14.docx Supplementary Document	2014-02-14

IC Document Collections

IC ID	Document Title	Status
210434	Pediatrice Control Subjects Telephone Interview Form and Instruction	Modified
210433	Pediatric Control Subjects Screening Process Form and Instruction	Unchanged
210432	Pediatric Case Telephone Interview Form and Instruction	Modified
210431	Pediatric Case Subject Screening Process Form and Instruction	Modified
210430	Adult Control Subjects Telephone Interview Form and Instruction	Modified
210429	Adult Control Subjects Screening Process Form and Instruction	Unchanged
210428	Adult Case Subjects Telephone Interview Form and Instruction	Unchanged
210427	Adult Case Subjects Screening Process Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1013	ICR Reference No: 201406-0920-019
Status: Historical Active	Previous ICR Reference No: 201402-0920-014
Agency/Subagency: HHS/CDC	Agency Tracking No: 21443
Title: Risk Factors for Community-Associated Clostridium difficile Infection through the Emerging Infections Program
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/18/2014
	Date Received in OIRA: 07/02/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	04/30/2017	04/30/2017
Responses	904	0	904
Time Burden (Hours)	201	0	201
Cost Burden (Dollars)	0	0	0

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Abstract: We are requesting a non-substantive change to the study entitled "Risk Factors for Community-Associated Clostridium difficile Infection through the Emerging Infections Program" OMB control number 0920-1013. The proposed changes do not impact methodology of the study or burden. The proposed changes are intended to: improve clarity of a confusing question or script, to clarify the time period in question given we ask participants about various time points in relation to their exposures / disease, to improve the flow of the interview, or to remove questions that were deemed unnecessary / offensive after performing interviews.

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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:
	78 FR 54472	09/04/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 8460	02/12/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Pediatric Control Subjects Screening Process	0920	Attachment D_Pediatric case and control Screening Forms
Adult Case Subjects Screening Process	0920-1013	Attachment C_Adult case and control Screening forms CLEAN VERSION
Adult Case Subjects Telephone Interview	0920	Attachment F_Adult Interview Form
Adult Control Subjects Screening Process	0920	Attachment C_Adult case and control Screening forms
Adult Control Subjects Telephone Interview	0920-1013	Attachment F_Adult Interview Form CLEAN VERSION
Pediatric Case Subject Screening Process	0929-1013	Attachment D_Pediatric case and control Screening Forms CLEAN VERSION
Pediatric Case Telephone Interview	0920-1013	Attachment G_Pediatric Interview Form CLEAN VERSION
Pediatrice Control Subjects Telephone Interview	0920	Attachment G_Pediatric Interview Form

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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	904	904	0	0	0	0
Annual Time Burden (Hours)	201	201	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $230,764

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: 07/02/2014

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