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Notifications Required Under Sections 310.306 (unapproved drugs); 314.81(b)(3)(iii) (products approved under an NDA or ANDA); and 600.82 (products approved under a BLA)

IC 209641 under ICR 201807-0910-002 · OMB 0910-0759.

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Notifications Required Under Sections 310.306 (unapproved drugs); 314.81(b)(3)(iii) (products approved under an NDA or ANDA); and 600.82 (products approved under a BLA) CDER
 
No Modified
 
Mandatory
 
21 CFR 314.81(b)(3)(iii) 21 CFR 600.82 21 CFR 310.306

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

Health Consumer Health and Safety

 

75 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 353 0 0 128 0 225
Annual IC Time Burden (Hours) 705 0 0 255 0 450
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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