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

IC 189329 under ICR 202509-0910-004 · OMB 0910-0014.

Documents and Forms
Document Name
Document Type
Other-Agency Guidance Document
Other-Agency Guidance Document
Other-Agency Guidance
Other-Agency Guidance
Information Collection (IC) Details

View Information Collection (IC)

CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
 
No Unchanged
 
Mandatory
 
21 CFR 312.20-312.38

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance Document GFI Pharmacogenomic Data Submissions.pdf Yes Yes Paper Only
Other-Agency Guidance 0470 GFI Special Protocol Assessment April 2018.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

31,025 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 101,751 0 0 0 0 101,751
Annual IC Time Burden (Hours) 20,220,727 0 0 0 0 20,220,727
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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