CBER - Information Packages

Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products

OMB: 0910-0429

IC ID: 189764

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CBER - Information Packages
 
No Modified
 
Voluntary
 
21 CFR 301

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

Health Public Health Monitoring

 

112 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 203 0 0 5 0 198
Annual IC Time Burden (Hours) 3,654 0 0 90 0 3,564
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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