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 In this section:

                About ESG

About ESG

                        User Guide
          ESG Account Management Portal User Guide
          Submission Statistics
          Impact of the Gateway
          Center Submission Types
          Submission Acknowledgements
          ESG Submission Process
          Planned Maintenance and Status History
          Submission Times Home
          For Industry
          Electronic Submissions Gateway
          About ESG
          Appendix K: Sample Authorization LetterAbout ESG Appendix K: Sample Authorization Letter
  
  	
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    PrintESG User Guide - Table of Contents

Clients must submit a Letter of Authorization to the FDA for CROs, U.S. Agents or Consultants. The Letter of Authorization must be submitted on company letterhead and signed with a traditional handwritten signature. Clients who have WebTrader ESG user accounts must upload an electronic copy of their Letter of Authorization via the FDA ESG User Portal (https://esgportal.fda.gov/). All other clients must send an electronic copy of their Letter of Authorization to the ESG Help Desk at ESGHelpDesk@fda.hhs.gov. Clients are no longer required to submit a physical copy to the FDA. Submitting a physical copy is now optional. Clients who would like to continue to send a physical copy to the FDA can do so by sending the letter to:

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Samples: Letter of Authorization

The following letter is provided as a sample for an Authorization Letter. The information in square brackets [ ] will be provided by the submitter.

**SAMPLE LETTER**

[Company Letterhead]

[Today's Date]

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Re: Authorization Letter

To whom it may concern:

Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, please accept this Authorization Letter. This letter is to certify that [Client Company Name] authorizes [Your Company Name] to submit in the Electronic Submissions Gateway on behalf of [Client Company Name].

Sincerely yours,

[Hand-written signature]
[Company Representative Title]

                                                                                  Content current as of:
      03/02/2023About ESG

          
                        User Guide
          Account Management Portal User Guide
          Submission Statistics
          Impact of the Gateway
          Center Submission Types
          Submission Acknowledgements
          ESG Submission Process
          Planned Maintenance and Status History
          Submission Times
 
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