CDER Export Certificate (FDA 3613b)

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⚠️ Notice: This information collection may be referencing outdated material.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 FDA 3613b CDER Export Certificate (FDA 3613b) Form and Instruction
FDA 3613b Supplementary Information Certificate of a Pharmaceutica FDA-3613b.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	CDER Export Certificate (FDA 3613b)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

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	FDA 3613b	Supplementary Information Certificate of a Pharmaceutical Product	FDA-3613b.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	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	5,251	-1,795	7,046
Annual IC Time Burden (Hours)	10,502	3,456	7,046
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.