Information Collection

CDRH Export Certificate (FDA 3613, 3613a, 3613c)

IC 188596 under ICR 202101-0910-012 · 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⚠️ Notice: This information collection may be referencing outdated material.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 3613c CDRH Export Certificate (FDA 3613, 3613a, 3613c)	Form and Instruction
FDA 3613 Supplementary Information Certificate to Foreign Governm FDA-3613.pdf	Form and Instruction
FDA 3613 Supplementary Information Certificate to Foreign Governm FDA-3613.pdf	Form and Instruction
FDA 3613a Supplementary Information Certificate of Exportability R FDA-3613a.pdf	Form and Instruction
FDA 3613a Supplementary Information Certificate of Exportability R FDA-3613a.pdf	Form and Instruction
FDA 3613c Supplementary Information Non-Clinical Research Use Only FDA-3613c.pdf	Form and Instruction
FDA 3613c Supplementary Information Non-Clinical Research Use Only FDA-3613c.pdf	Form and Instruction
FDA 3613g Request for Certificate for Device not Exported from the FDA 3613g Export Cert for Device not from US.pdf	Form and Instruction
FDA 3613g Request for Certificate for Device not Exported from the FDA 3613g Export Cert for Device not from US.pdf	Form and Instruction

IC Title:

CDRH Export Certificate (FDA 3613, 3613a, 3613c)

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 1.101

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3613	Supplementary Information Certificate to Foreign Government Requests	FDA-3613.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613a	Supplementary Information Certificate of Exportability Requests	FDA-3613a.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613c	Supplementary Information Non-Clinical Research Use Only Certificate	FDA-3613c.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613g	Request for Certificate for Device not Exported from the United States	FDA 3613g Export Cert for Device not from US.pdf	Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 11,175

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	11,175	11,175
Annual IC Time Burden (Hours)	22,350	22,350
Annual IC Cost Burden (Dollars)	1,955,625	1,955,625

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.