Information Collection

CVM Export Certificate (FDA 3613, 3613b)

IC 188597 under ICR 202208-0910-015 · 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⚠️ Notice: This information collection may be referencing outdated material.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 CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction
Form FDA 3613 SUPPLEMENTARY INFORMATION CERTIFICATE TO FOREIGN GOVERNMENT REQUESTS CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction
Form FDA 3613a SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY REQUESTS CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction
Form FDA 3613b SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICAL PRODUCT CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction
Form FDA 3613 Request for Certificate Supplementary Information CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction
FDA 3613 SUPPLEMENTARY INFORMATION CERTIFICATE TO FOREIGN GOVERNM Mock up to 3613_02_06_20 (1).pdf	Form and Instruction
FDA 3613 SUPPLEMENTARY INFORMATION CERTIFICATE TO FOREIGN GOVERNM Mock up to 3613_02_06_20 (1).pdf	Form and Instruction
FDA 3613a SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY R Mock up to 3613a_02_06_20 _2.pdf	Form and Instruction
FDA 3613a SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY R Mock up to 3613a_02_06_20 _2.pdf	Form and Instruction
FDA 3613b SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICA Mock up to 3613b_02_06_20.pdf	Form and Instruction
FDA 3613b SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICA Mock up to 3613b_02_06_20.pdf	Form and Instruction
FDA 3613 Request for Certificate Supplementary Information FDA 3613 Export Certs Supplementary Information.pdf	Form and Instruction
FDA 3613 Request for Certificate Supplementary Information FDA 3613 Export Certs Supplementary Information.pdf	Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

CVM Export Certificate (FDA 3613, 3613b)

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

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	Mock up to 3613_02_06_20 (1).pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613a	SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY REQUESTS	Mock up to 3613a_02_06_20 _2.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613b	SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICAL PRODUCT	Mock up to 3613b_02_06_20.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613	Request for Certificate Supplementary Information	FDA 3613 Export Certs Supplementary Information.pdf	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: 1,925

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	1,925	1,925
Annual IC Time Burden (Hours)	1,925	1,925
Annual IC Cost Burden (Dollars)	336,875	336,875

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.