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Biologics; Licensing; General Biological Products Standards; and Additional Standards

IC 5935 under ICR 202407-0910-010 · OMB 0910-0338.

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Biologics; Licensing; General Biological Products Standards; and Additional Standards
 
No Unchanged
 
Mandatory
 
21 CFR Subchapter F: Biologics 21 CFR 601 - Licensing 21 CFR 600; 610-680 (Product Stds.)  (To search for a specific CFR, visit the Code of Federal Regulations.)

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

Health Consumer Health and Safety

 

371 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 67,117 0 0 0 0 67,117
Annual IC Time Burden (Hours) 813,017 0 0 0 0 813,017
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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