Information Collection Request

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

ICR 201406-0920-019 · OMB 0920-1013 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form 0920 Pediatrice Control Subjects Telephone Interview Form and Instruction Modified Available
Form 0920 Pediatric Control Subjects Screening Process Form and Instruction Unchanged Available
Form 0920-1013 Pediatric Case Telephone Interview Form and Instruction Modified Available
Form 0929-1013 Pediatric Case Subject Screening Process Form and Instruction Modified Available
Form 0920-1013 Adult Control Subjects Telephone Interview Form and Instruction Modified Available
Form 0920 Adult Control Subjects Screening Process Form and Instruction Unchanged Available
Form 0920 Adult Case Subjects Telephone Interview Form and Instruction Unchanged Available
Form 0920-1013 Adult Case Subjects Screening Process Form and Instruction Modified Available
Table of Changes.docx Justification for No Material/Nonsubstantive Change Uploaded 2014-06-30 Available
Mini-ICR_09201013_061214.doc Justification for No Material/Nonsubstantive Change Uploaded 2014-06-30 Available
Mini-ICR_09201013_061214.doc Supporting Statement A Uploaded 2014-06-27 Available
Supporting Statement Part B CA_CDI_1_21_14.docx Supporting Statement B Uploaded 2014-02-13 Available
SPANISH TRANSLATION_Attachment L_Adult Peds Consent CASE and CONTROL with and without HIPPA_1_24_14.doc Supplementary Document Uploaded 2014-02-17 Available
Rev Attachment H_CA CDI Protocol_IRB_Approved_1_24_14.docx Supplementary Document Uploaded 2014-02-17 Available
Attachment I_ 6542 Site Restricted New Submission Approval.docx Supplementary Document Uploaded 2014-02-17 Available
Attachment E_Verbal Consent Case and Control with and without HIPPA_1_24_14.docx Supplementary Document Uploaded 2014-02-17 Available
Attachment A Sec. 301 42 USC 241[1].pdf Supplementary Document Uploaded 2014-02-13 Available
SPANISH TRANSLATION_Attachment N_CA CDI Pediatric Patient Interview Form_1_24_14.doc Supplementary Document Uploaded 2014-02-17 Available
SPANISH TRANSLATION_Attachment K_Pediatric Case and Control Screening Forms_1_24_14.docx Supplementary Document Uploaded 2014-02-17 Available
SPANISH TRANSLATION_Attachment N_CA CDI Pediatric Patient Interview Form_1_24_14.doc Supplementary Document Uploaded 2014-02-17 Repair queued
SPANISH TRANSLATION_Attachment K_Pediatric Case and Control Screening Forms_1_24_14.docx Supplementary Document Uploaded 2014-02-17 Available
SPANISH TRANSLATION_Attachment M_CA CDI Adult_ Patient Interview Form_1_24_14.doc Supplementary Document Uploaded 2014-02-17 Available
SPANISH TRANSLATION_Attachment J_Adult Case and Control Screening Forms 1_24_14.docx Supplementary Document Uploaded 2014-02-17 Repair queued
SPANISH TRANSLATION_Attachment M_CA CDI Adult_ Patient Interview Form_1_24_14.doc Supplementary Document Uploaded 2014-02-17 Available
SPANISH TRANSLATION_Attachment J_Adult Case and Control Screening Forms 1_24_14.docx Supplementary Document Uploaded 2014-02-14 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-1013 201406-0920-019
Historical Active 201402-0920-014
HHS/CDC 21443
Risk Factors for Community-Associated Clostridium difficile Infection through the Emerging Infections Program
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 07/18/2014
Retrieve Notice of Action (NOA) 07/02/2014
  Inventory as of this Action Requested Previously Approved
04/30/2017 04/30/2017 04/30/2017
904 0 904
201 0 201
0 0 0

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.

US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  78 FR 54472 09/04/2013
79 FR 8460 02/12/2014
No

  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
No
No

$230,764
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Catina Conner 4046394775

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/02/2014