Requests for Designations: Combination Products reporting and records

Product Jurisdiction and Combination Products

OMB: 0910-0523

IC ID: 6241

Information Collection (IC) Details

View Information Collection (IC)

Requests for Designations: Combination Products reporting and records
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 3 and 4

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 5003 REQUEST FOR DESIGNATION Form FDA 5003 RFD 2020.pdf Yes Yes Fillable Fileable
Form and Instruction FDA 5004 Pre-REQUEST FOR DESIGNATION-INFORMAL SUBMISSION Form FDA 5004 Pre RFD 2020.pdf Yes Yes Fillable Fileable
Form and Instruction FDA 5005 Pre RFD - Supplemental Form FDA 5005 Pre RFD Supplement 2020.pdf Yes Yes Fillable Fileable
Other-Agency Guidance GFI How to Write an RFD - April 2011.pdf Yes Yes Fillable Fileable
Other-Agency Guidance GFI How-to-Prepare-a-PreRFD - February 2018.pdf Yes Yes Fillable Fileable
Other-Agency Guidance GFI Requesting Feedback Combo Products - December 2020pdf.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

135 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 135 0 0 -4 0 139
Annual IC Time Burden (Hours) 3,243 0 0 -96 0 3,339
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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