Information Collection

CDER Export Certificate (FDA 3613f)

IC 217014 under ICR 202308-0910-003 · OMB 0910-0498.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
CDER eCATS API Drug FlowFINAL03072016.pdf	Other-Screenshots of electronic subm
CDER eCATS API Drug FlowFINAL03072016.pdf	Other-Screenshots of electronic subm
CDER eCATS- Approved Drug FlowFINAL03072016.pdf	Other-Screenshots of electronic subm
CDER eCATS- Approved Drug FlowFINAL03072016.pdf	Other-Screenshots of electronic subm
CDER eCATS- OTC Drug FlowFINAL03072016.pdf	Other-Screenshots of electronic subm
CDER eCATS- OTC Drug FlowFINAL03072016.pdf	Other-Screenshots of electronic subm
CDER eCATS -Unapproved Drug FlowFINAL03072016.pdf	Other-Screenshots of electronic subm
CDER eCATS -Unapproved Drug FlowFINAL03072016.pdf	Other-Screenshots of electronic subm
FDA 3613f REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR FDA-3613f_Stat_Sec_Ext_02-24-23_0.pdf	Form and Instruction
FDA 3613f REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR FDA-3613f_Stat_Sec_Ext_02-24-23_0.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
Other-Screenshots of electronic submission of API Drug			CDER eCATS API Drug FlowFINAL03072016.pdf	Yes	Yes	Fillable Fileable
Other-Screenshots of electronic submission of Approved Drug			CDER eCATS- Approved Drug FlowFINAL03072016.pdf	Yes	Yes	Fillable Fileable
Other-Screenshots of electronic submission for CDER OTC Drug			CDER eCATS- OTC Drug FlowFINAL03072016.pdf	Yes	Yes	Fillable Fileable
Other-Screenshots of electronic submission of Unapproved Drug			CDER eCATS -Unapproved Drug FlowFINAL03072016.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613f	REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR CDER PRODUCTS	FDA-3613f_Stat_Sec_Ext_02-24-23_0.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: 9,396

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	9,396	5,716	3,680
Annual IC Time Burden (Hours)	9,396	5,716	3,680
Annual IC Cost Burden (Dollars)	1,644,300	1,000,300	644,000

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.