Orphan Drug Requirements

Orphan Drugs

OMB: 0910-0167

IC ID: 5770

Information Collection (IC) Details

View Information Collection (IC)

Orphan Drug Requirements
 
No Modified
 
Mandatory
 
21 CFR 316

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance 0167 Guidance-Meetings with OPD.pdf Yes Yes Fillable Fileable
Form and Instruction FDA 4035 FDA Orphan Drug Designation Request Form 0167 FDA-4035.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

2,039 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 5,613 0 0 1,036 0 4,577
Annual IC Time Burden (Hours) 174,289 0 0 50,616 0 123,673
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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