Information Collection

Guidance on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway

IC 6144 under ICR 201609-0910-002 · OMB 0910-0454.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0454 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3538 Guidance on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway	Form and Instruction
0454 GUIDANCE.pdf	Other-Guidance
3538 Electronic Submission System Participant Management Form 0454 FDA Form 3538.pdf	Form and Instruction

IC Title:

Guidance on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway

Agency IC Tracking Number:

CVM

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 11.2

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3538	Electronic Submission System Participant Management Form	0454 FDA Form 3538.pdf		Yes	Yes	Fillable Fileable Signable
Other-Guidance			0454 GUIDANCE.pdf		No		Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 29

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	38	-118	156
Annual IC Time Burden (Hours)	3	-9	12
Annual IC Cost Burden (Dollars)	0	0	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.