Designation Requests

Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review

OMB: 0910-0389

IC ID: 6040

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

View Information Collection (IC)

Designation Requests
 
No Modified
 
Voluntary
 
21 CFR 356(C)  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance GUIDANCE 0389 12-29-2014.pdf Yes No Paper Only

Health Public Health Monitoring

 

81 0
   
Private Sector Businesses or other for-profits
 
   80 %

  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 115 0 0 38 0 77
Annual IC Time Burden (Hours) 6,900 0 0 -800 0 7,700
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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