(CDER) Focus Groups Examining Consumer Reporting of Adverse Events

FDA Focus Groups and Interviews

OMB: 0910-0497

IC ID: 267658

Documents and Forms
Document Name
Document Type
Other-Screener
Other-Recruitment Flyer
Other-Confirmation Letter
Other-Reminder Letter
Other- Informed Consent
Other- Moderator Guide
IC Document
IC Document
Information Collection (IC) Details

View Information Collection (IC)

(CDER) Focus Groups Examining Consumer Reporting of Adverse Events CDER
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Screener Attachment A. Screener.docx Yes Yes Fillable Fileable
Other-Recruitment Flyer Attachment B. Recruitment Flyer.docx No   Printable Only
Other-Confirmation Letter Attachment C. Confirmation Letter.docx Yes No Printable Only
Other-Reminder Letter Attachment D. Reminder Letter.docx Yes No Printable Only
Other- Informed Consent Attachment E. Informed Consent.docx Yes No Fillable Fileable
Other- Moderator Guide Attachment F. Moderator Guide.docx No   Printable Only

Health Consumer Health and Safety

 

150 0
   
Individuals or Households
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 150 0 150 0 0 0
Annual IC Time Burden (Hours) 114 0 114 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
Gen IC Memo 0497 OMB Memo_Examining Consumer Reporting of AE 2024.docx 05/14/2024
IRB Letter IRB Letter.pdf 05/14/2024
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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