CDER - Meeting Requests

Formal Meetings with Sponsors and Applicants for PDUFA Products

OMB: 0910-0429

IC ID: 6097

Documents and Forms
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Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

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CDER - Meeting Requests
 
No Modified
 
Voluntary
 
21 CFR 314.102 21 CFR 312.47

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

1,319 0
   
Private Sector Businesses or other for-profits
 
   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 3,058 0 0 3,058 0 0
Annual IC Time Burden (Hours) 30,580 0 0 30,580 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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