Requests for designation and associated communications

Product Jurisdiction and Combination Products

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0523 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 5003 Requests for designation and associated communications 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 5005 Pre RFD - Supplemental Form FDA 5005 Pre RFD Supplement 2020.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Requests for designation and associated communications	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

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 139	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	139	-53	192
Annual IC Time Burden (Hours)	3,339	227	3,112
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.