CDER Export Certificate (FDA 3613f)

Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0498 can be found here:

Documents and Forms

Document Name Document Type
Form Form FDA 3613f CDER Export Certificate (FDA 3613f) Form and Instruction
Form FDA 3613f Supplementary Information Certificate to Foreign Governm CDER use only FDA-3613 f.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	CDER Export Certificate (FDA 3613f)	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:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 3613f	Supplementary Information Certificate to Foreign Government Requests	CDER use only FDA-3613 f.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: 5,251	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	5,251	5,251
Annual IC Time Burden (Hours)	10,502	10,502
Annual IC Cost Burden (Dollars)	695,758	695,758

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.