Information Collection

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

IC 6208 under ICR 201502-0910-003 · 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⚠️ Notice: This information collection may be referencing outdated material.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 3613 Supplementary Information Certificate to Foreign Government Requests CBER Export Certificate (FDA 3613, 3613b, 3613c)	Form and Instruction
Form FDA 3613a Supplementary Information Certificate of Exportability Requests CBER Export Certificate (FDA 3613, 3613b, 3613c)	Form and Instruction
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product CBER Export Certificate (FDA 3613, 3613b, 3613c)	Form and Instruction
Form FDA 3613c Supplementary Information Non-Clinical Research Use Only Certificate CBER Export Certificate (FDA 3613, 3613b, 3613c)	Form and Instruction
FDA 3613 Supplementary Information Certificate to Foreign Governm FDA-3613 2-27-2015.pdf	Form and Instruction
FDA 3613a Supplementary Information Certificate of Exportability R FDA-3613a 2-27-2015.pdf	Form and Instruction
FDA 3613b Supplementary Information Certificate of a Pharmaceutica FDA-3613b 2-27-2015.pdf	Form and Instruction
FDA 3613c Supplementary Information Non-Clinical Research Use Only FDA-3613c 2-27-2015.pdf	Form and Instruction

IC Title:

CBER Export Certificate (FDA 3613, 3613b, 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:

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
Form and Instruction	FDA 3613a	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613b	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613c	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Immunization Management

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 2,114

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	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	2,114	0	2,114
Annual IC Time Burden (Hours)	2,114	0	2,114
Annual IC Cost Burden (Dollars)	369,950	369,950	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.

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