Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation

Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)

OMB: 0910-0167

IC ID: 181014

Information Collection (IC) Details

View Information Collection (IC)

Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation
 
No Modified
 
Mandatory
 
21 CFR 316.20 21 CFR 316.21 21 CFR 316.26

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA3671 Common EMEA/FDA Application for Orphan Medicinal Product Designation FDA 3671.pdf Yes Yes Fillable Fileable Signable

Health Immunization Management

 

214 0
   
Private Sector Businesses or other for-profits
 
   40 %

  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 428 0 0 86 0 342
Annual IC Time Burden (Hours) 64,200 0 0 19,740 0 44,460
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

© 2024 OMB.report | Privacy Policy