Information Collection

CDER Export Certificate (FDA 3613b)

IC 188595 under ICR 201305-0910-001 · OMB 0910-0498.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

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 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 %

table that charts list of burden
	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)	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.