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⚠️ Notice: This information collection may be referencing outdated material.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 3613f CDER Export Certificate (FDA 3613f) Form and Instruction
CDER eCATS API Drug FlowFINAL03072016.pdf Other-Screenshots of electronic subm
CDER eCATS- Approved Drug FlowFINAL03072016.pdf Other-Screenshots of electronic subm
CDER eCATS- OTC Drug FlowFINAL03072016.pdf Other-Screenshots of electronic subm
CDER eCATS -Unapproved Drug FlowFINAL03072016.pdf Other-Screenshots of electronic subm
3613f Request for Certificates of a Pharmaceutical Product for FDA FORM 3613(f) CDER 0498 6-25-2015.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: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3613f	Request for Certificates of a Pharmaceutical Product for CDER Products	FDA FORM 3613(f) CDER 0498 6-25-2015.pdf	Yes	Yes	Fillable Fileable
Other-Screenshots of electronic submission of API Drug			CDER eCATS API Drug FlowFINAL03072016.pdf	Yes	Yes	Fillable Fileable
Other-Screenshots of electronic submission of Approved Drug			CDER eCATS- Approved Drug FlowFINAL03072016.pdf	Yes	Yes	Fillable Fileable
Other-Screenshots of electronic submission for CDER OTC Drug			CDER eCATS- OTC Drug FlowFINAL03072016.pdf	Yes	Yes	Fillable Fileable
Other-Screenshots of electronic submission of Unapproved Drug			CDER eCATS -Unapproved Drug FlowFINAL03072016.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	Previously Approved
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.