Written recommendations; content and format of a request, the providing of; refusal to provide

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: 5770

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
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Written recommendations; content and format of a request, the providing of; refusal to provide
 
No Modified
 
Mandatory
 
21 CFR 316.14 21 CFR 316.10 21 CFR 316.12

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

Health Immunization Management

 

2 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 2 0 0 -3 0 5
Annual IC Time Burden (Hours) 200 0 0 -450 0 650
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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