Requests for Designations: Combination Products reporting and records

Product Jurisdiction and Combination Products

Documents and Forms

Document Name Document Type
Form FDA 5003 Requests for Designations: Combination Products reporting and records Form and Instruction
GFI How to Write an RFD - April 2011.pdf Other-Agency Guidance
GFI How to Write an RFD - April 2011.pdf Other-Agency Guidance
GFI How-to-Prepare-a-PreRFD - February 2018.pdf Other-Agency Guidance
GFI How-to-Prepare-a-PreRFD - February 2018.pdf Other-Agency Guidance
GFI Requesting Feedback Combo Products - December 2020pdf.pdf Other-Agency Guidance
GFI Requesting Feedback Combo Products - December 2020pdf.pdf Other-Agency Guidance
FDA 5003 REQUEST FOR DESIGNATION Form FDA 5003 RFD 2020.pdf Form and Instruction
FDA 5003 REQUEST FOR DESIGNATION Form FDA 5003 RFD 2020.pdf Form and Instruction
FDA 5004 Pre-REQUEST FOR DESIGNATION-INFORMAL SUBMISSION Form FDA 5004 Pre RFD 2020.pdf Form and Instruction
FDA 5004 Pre-REQUEST FOR DESIGNATION-INFORMAL SUBMISSION Form FDA 5004 Pre RFD 2020.pdf Form and Instruction
FDA 5005 Pre RFD - Supplemental Form FDA 5005 Pre RFD Supplement 2020.pdf Form and Instruction
FDA 5005 Pre RFD - Supplemental Form FDA 5005 Pre RFD Supplement 2020.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Requests for Designations: Combination Products reporting and records	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 3 and 4

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 135	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	135	-4	139
Annual IC Time Burden (Hours)	3,243	-96	3,339
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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.