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

OMB: 0910-0454

IC ID: 6144

Information Collection (IC) Details

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Guidance- How to Use E-Mail to Submit Information to CVM in Electronic Format Using The FDA Electronic Submission Gateway
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 11.11.2

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

Health Consumer Health and Safety

 

65 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 156 0 0 140 0 16
Annual IC Time Burden (Hours) 12 0 0 11 0 1
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.

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