Voluntary Consensus Standards

Biologics License Applications; Procedures & Requirements

OMB: 0910-0338

IC ID: 261932

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

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Voluntary Consensus Standards
 
No Unchanged
 
Voluntary
 
21 CFR 601.29; Guidance documents

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

Health Consumer Health and Safety

 

9 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 9 0 0 0 0 9
Annual IC Time Burden (Hours) 27 0 0 0 0 27
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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