Information Collection

FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch

IC 259086 under ICR 202303-0910-006 · OMB 0910-0046.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0046 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 5054 FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch	Form and Instruction
FDA 5054 New Inquiry Form CDER Import Compliance Branch FDA 5054 New Import Inquiry - CDER.pdf	Form and Instruction
FDA 5054 New Inquiry Form CDER Import Compliance Branch FDA 5054 New Import Inquiry - CDER.pdf	Form and Instruction

IC Title:

FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 5054	New Inquiry Form CDER Import Compliance Branch	FDA 5054 New Import Inquiry - CDER.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: 1,000

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1,000	1,000
Annual IC Time Burden (Hours)	83	83
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.