Lot Distribution Data (LDD) Electronic Submission

Complete Set of Instructions for LDD eSubmission

Please follow these steps to begin submitting LDD reports electronically:

Step 1
- Contact the LDD Electronic Submission Coordinator to advise the FDA of your intent to begin submitting LDD reports electronically.  See contact information at the bottom of this page.

Step 2
- Review FDA's technical requirements for Lot Distribution Data.

Step 3
- Submit a test file to the LDD Electronic Submission Coordinator via email.
- If test file complies with technical requirements, the LDD system will return an email test acknowledgment receipt with notification for data acceptance.
- If test file is NOT successful, review Step 2.
- Once the test file is processed successfully, you may begin submitting electronic reports via the FDA Electronic Submission Gateway (ESG) or on physical media.

Step 4
- Prepare the LDD submission package, which should contain:

A. Cover Letter should be filled out and saved with a designated naming convention, such as prefix LDD, company name, and reporting period.

B. Electronic file(s) with Lot Distribution Data per technical requirements.

For data submitted in XML format: - Validation should be done against LDD XML Schema (any appropriate program can be used).
- XML Style Sheet can be used for viewing data summary and detail.
- All files should be packaged together under the folder name "LDD_MM_DD_YYYY" and sent as a single submission. A folder named "LDD_MM_DD_YYYY" should be created on the client site and all files should be copied into this folder before they are submitted to the FDA.

Step 5

For Electronic Submission via FDA ESG:

First time users should review FDA's Electronic Submission Gateway (ESG) User Guide that provides industry participants with information and guidance on how to use the FDA ESG.

- Setup an FDA ESG test Account.

- Submit the LDD prepared package (Step 4) through the test gateway during the gateway hours of operation. See the status page for the current status of the gateway.
- When sending an LDD package (folder), select "CBER" from the Center drop-down list and "LDD" for the Submission Type.
- The gateway will return an acknowledgment of receipt of the transmission when the submitted package is successfully received and decrypted. The LDD system will return an ICH M2 compliant acknowledgment test message when the LDD Report has been processed and loaded into the FDA database.
- If the test is successful, then you can Setup an FDA ESG production Account.
- Submit the production package using your FDA ESG production account.
- The gateway will return an acknowledgment of receipt of the transmission when the submitted package is successfully received and decrypted. The LDD system will return an ICH M2 compliant acknowledgment production message when the LDD report has been processed and loaded into the FDA database.

For Electronic Submission using Physical Media:

Mail the submission package to the address below.
Two copies of the electronic files should be submitted on CD-ROM to:

Bridget Davis
Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research, FDA
1401 Rockville Pike, 200S/HFM-220
Rockville, MD 20852-1448