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CBER Export Certificate (FDA 3613, 3613b, 3613c)
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802
OMB: 0910-0498
IC ID: 6208
OMB.report
HHS/FDA
OMB 0910-0498
ICR 202009-0910-006
IC 6208
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0498 can be found here:
2024-04-29 - Revision of a currently approved collection
2023-03-27 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
Form FDA 3613c
CBER Export Certificate (FDA 3613, 3613b, 3613c)
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 3613b Supplementary Information Certificate of a Pharmaceutica
FDA-3613b.pdf
Form and Instruction
FDA 3613c Supplementary Information Non-Clinical Research Use Only
FDA-3613c.pdf
Form and Instruction
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
CBER Export Certificate (FDA 3613, 3613b, 3613c)
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Required to Obtain or Retain Benefits
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
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
No
Fillable Fileable
Form and Instruction
FDA 3613b
Supplementary Information Certificate of a Pharmaceutical Product
FDA-3613b.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3613c
Supplementary Information Non-Clinical Research Use Only Certificate
FDA-3613c.pdf
Yes
No
Fillable Fileable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Immunization Management
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
2,651
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
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
2,651
0
0
0
0
2,651
Annual IC Time Burden (Hours)
2,651
0
0
0
0
2,651
Annual IC Cost Burden (Dollars)
463,925
0
0
0
0
463,925
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.