OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

Small Group Discussions with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework (BRF)

IC 251530 under ICR 202206-0910-016 · OMB 0910-0697.

Documents and Forms
Document Name
Document Type
Other-External Discussion Informed C
Other-External Discussion Informed C
Other-External Small Group Discussio
Other-External Small Group Discussio
Other-Small Group Discussion Moderat
Other-Small Group Discussion Moderat
Other-Small Group Discussion Questio
Other-Small Group Discussion Questio
IC Document
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Small Group Discussions with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework (BRF) CDER
 
Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-External Discussion Informed Consent BRF_External Discussion Informed Consent.docx Yes Yes Fillable Printable
Other-External Small Group Discussion Email Invitation BRF_External Small Group Discussion Email Invitation.docx Yes Yes Fillable Printable
Other-Small Group Discussion Moderator Script_Applicant and External Stakeholder BRF_Small Group Discussion Moderator Script_Applicant and External Stakeholder.docx No   Printable Only
Other-Small Group Discussion Questions BRF_Small Group Discussion Questions.docx Yes No Printable Only

Health Consumer Health and Safety

 

325 0
   
Individuals or Households
 
   100 %

  Requested 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 325 0 0 0 0 325
Annual IC Time Burden (Hours) 488 0 0 0 0 488
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
Memo Benefit-Risk Framework Small Group Discussions 0697 OMB Memo Benefit-Risk Framework Small Group Discussions.docx 02/11/2022
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.