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CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers

IC 189328 under ICR 202509-0910-004 · OMB 0910-0014.

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CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
 
No Unchanged
 
Mandatory
 
21 CFR 312.1-312.10

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

Health Consumer Health and Safety

 

512 0
   
Private Sector Businesses or other for-profits
 
   99 %

  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 553 0 0 0 0 553
Annual IC Time Burden (Hours) 14,040 0 0 0 0 14,040
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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