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CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports

IC 189313 under ICR 202509-0910-004 · OMB 0910-0014.

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CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
 
No Unchanged
 
Mandatory
 
21 CFR 312.23(a)(1) Cover sheet 21 CFR 312.20-312.38

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

Health Consumer Health and Safety

 

2,075 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 22,510 0 0 0 0 22,510
Annual IC Time Burden (Hours) 5,440,784 0 0 0 0 5,440,784
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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