Guidance- How to Use E-Mail to Submit Information to CVM in Electronic Format Using The FDA Electronic Submission Gateway

Guidance for Industry on How to Use E-Mail Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
Form FDA 3538 Guidance- How to Use E-Mail to Submit Information to CVM in Electronic Format Using The FDA Electronic Submission Gateway Form and Instruction
FDA 3538 Electronic Submission System Participant Management Form Form FDA 3538.pdf Form and Instruction
Guidance- 0910-0454.pdf Guidance: How to Submit Information in Electronic Format to CVM Using The FDA Electronic Submission Gateway IC Document

Information Collection (IC) Details

IC Title:	Guidance- How to Use E-Mail to Submit Information to CVM in Electronic Format Using The FDA Electronic Submission Gateway	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 11.11.2

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3538	Electronic Submission System Participant Management Form	Form FDA 3538.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: 65	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	156	140	16
Annual IC Time Burden (Hours)	12	11	1
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
Guidance: How to Submit Information in Electronic Format to CVM Using The FDA Electronic Submission Gateway	Guidance- 0910-0454.pdf	05/17/2010

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.