Information Collection

CVM Export Certificate (FDA 3613, 3613a, 3613b)

IC 188597 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 CVM Export Certificate (FDA 3613, 3613a, 3613b)	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 3613 Request for Certificate Supplementary Information FDA-3613_Stat_Sec_Ext_04-25-24.pdf	Form and Instruction
FDA 3613 Request for Certificate Supplementary Information FDA-3613_Stat_Sec_Ext_04-25-24.pdf	Form and Instruction

IC Title:

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_Stat_Sec_Ext_04-25-24.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3613a	SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY REQUESTS	FDA-3613a_Stat_Sec_Ext_04-25-24.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3613b	SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICAL PRODUCT	FDA-3613b_Stat_Sec_Ext_01-24-23 (2).pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3613	Request for Certificate Supplementary Information	FDA-3613_Stat_Sec_Ext_04-25-24.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: 1,618

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,618	-307	1,925
Annual IC Time Burden (Hours)	1,618	-307	1,925
Annual IC Cost Burden (Dollars)	283,150	-53,725	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.