Information Collection

CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)

IC 6208 under ICR 202308-0910-003 · OMB 0910-0498.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3613 CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction
Form FDA 3613 Supplementary Information Certificate to Foreign Government Requests CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction
Form FDA 3613a Supplementary Information Certificate of Exportability Requests CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction
Form FDA 3613c Supplementary Information Non-Clinical Research Use Only Certificate CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction
Form FDA 3613g Certificate To Foreign Government For Device Not Exported From the United States Requests CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction
FDA 3613 Supplementary Information Certificate to Foreign Governm FDA-3613_Stat_Sec_Ext_04-25-24.pdf	Form and Instruction
FDA 3613 Supplementary Information Certificate to Foreign Governm FDA-3613_Stat_Sec_Ext_04-25-24.pdf	Form and Instruction
FDA 3613a Supplementary Information Certificate of Exportability R FDA-3613a_Stat_Sec_Ext_04-25-24.pdf	Form and Instruction
FDA 3613a Supplementary Information Certificate of Exportability R FDA-3613a_Stat_Sec_Ext_04-25-24.pdf	Form and Instruction
FDA 3613b Supplementary Information Certificate of a Pharmaceutica FDA-3613b_Stat_Sec_Ext_01-24-23 (2).pdf	Form and Instruction
FDA 3613b Supplementary Information Certificate of a Pharmaceutica FDA-3613b_Stat_Sec_Ext_01-24-23 (2).pdf	Form and Instruction
FDA 3613c Supplementary Information Non-Clinical Research Use Only FDA-3613c_Stat_Sec_Ext_04-25-24.pdf	Form and Instruction
FDA 3613c Supplementary Information Non-Clinical Research Use Only FDA-3613c_Stat_Sec_Ext_04-25-24.pdf	Form and Instruction
FDA 3613g Certificate To Foreign Government For Device Not Exporte FDA-3613g_Stat_Sec_Ext_04-25-2024.pdf	Form and Instruction
FDA 3613g Certificate To Foreign Government For Device Not Exporte FDA-3613g_Stat_Sec_Ext_04-25-2024.pdf	Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)

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.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3613	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3613a	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3613b	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3613c	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3613g	Yes	Yes	Fillable Fileable Signable

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 2,344

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 90 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,344	-307	2,651
Annual IC Time Burden (Hours)	2,344	-307	2,651
Annual IC Cost Burden (Dollars)	410,200	-53,725	463,925

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.

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