Lot Distribution Data (LDD) Electronic Submission

Quick Links and Instructions	Background and Project Status
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. 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 (PDF) (HTML) 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 Help Desk LDD Coordinator Bridget Davis Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research, FDA 1401 Rockville Pike, 200S/HFM-220 Rockville, MD 20852-1448 Phone: (301)827-9426---Fax: (301) 827-5218 LDDDistribution@fda.hhs.gov Preparation/Registration/Policy Questions Email: LDDDistribution@fda.hhs.gov	This procedure is intended to assist manufacturers of vaccines and other biological products to electronically submit post marketing lot distribution data to CBER's Lot Distribution Database (LDD). In the past, these data primarily came to CBER under 21 CFR 600.81 as paper reports. Conversion to uniform electronic submissions will improve accuracy, efficiency, and timeliness. Most manufacturers have submitted biological product lot distribution reports required under 21 CFR 600.81 in the form of printed paper reports, sometimes accompanied by electronic data files as American Standard Code for Information Interchange (ASCII) flat files or in other formats. CBER staff members then manually compiled the data into the LDD system for use in post marketing safety surveillance. In accordance with current automation initiatives, the FDA is moving toward electronic submission of all regulatory data in computer-readable formats. Although establishing electronic reporting will initially require additional effort by both FDA and regulated industry, the resultant process will increase efficiency and the accuracy and timeliness of data. The improved data file format provides a standardized and consistent presentation of lot distribution information that can be automatically transferred and validated against CBER's Regulatory Management system, which tracks licensed CBER products and manufacturers. We anticipate expansion to electronic data submission of post marketing lot distribution data for all vaccine and other biological products marketed for human use with biologic license applications (BLAs) regulated by CBER. (Electronic Lot Distribution Data submission is only for biological products regulated by CBER. It does not apply to therapeutic biologics transferred to the Center for Drug Evaluation and Research (CDER) on June 30, 2003. The FDA CBER website http://www.fda.gov/cber/ lists these products.) Because FDA authority is limited to the United States, the scope of LDD submissions should similarly focus on product lots intended for "domestic" distribution, i.e., distribution within the U.S. or to U.S. military bases abroad. Lots intended for distribution to other countries should not be included. However, we retain a field to distinguish between domestic and foreign distribution for consistency with previous file formats and in case special circumstances might warrant tracking of non-domestic lots. Related Documents Electronic Submission Instructions for Lot Distribution Data (PDF, 66 KB) Cover Letter for Lot Distribtuion Data Report (PDF, 531 KB) Electronic Submission Instructions for Biological Lot Distribution Data (PDF, 33 KB) Electronic Submission Instructions for Biological Lot Distribution Data in ASCII File Format (PDF, 225 KB) Electronic Submission Instructions for Biological Lot Distribution Data in XML File Format (PDF, 103 KB)

Quick Links and Instructions

Background and Project Status

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.

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 (PDF) (HTML) 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

Help Desk

LDD Coordinator
Bridget Davis
Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research, FDA
1401 Rockville Pike, 200S/HFM-220
Rockville, MD 20852-1448
Phone: (301)827-9426---Fax: (301) 827-5218
LDDDistribution@fda.hhs.gov

Preparation/Registration/Policy Questions
Email: LDDDistribution@fda.hhs.gov

This procedure is intended to assist manufacturers of vaccines and other biological products to electronically submit post marketing lot distribution data to CBER's Lot Distribution Database (LDD). In the past, these data primarily came to CBER under 21 CFR 600.81 as paper reports. Conversion to uniform electronic submissions will improve accuracy, efficiency, and timeliness.

Most manufacturers have submitted biological product lot distribution reports required under 21 CFR 600.81 in the form of printed paper reports, sometimes accompanied by electronic data files as American Standard Code for Information Interchange (ASCII) flat files or in other formats. CBER staff members then manually compiled the data into the LDD system for use in post marketing safety surveillance. In accordance with current automation initiatives, the FDA is moving toward electronic submission of all regulatory data in computer-readable formats. Although establishing electronic reporting will initially require additional effort by both FDA and regulated industry, the resultant process will increase efficiency and the accuracy and timeliness of data. The improved data file format provides a standardized and consistent presentation of lot distribution information that can be automatically transferred and validated against CBER's Regulatory Management system, which tracks licensed CBER products and manufacturers.

We anticipate expansion to electronic data submission of post marketing lot distribution data for all vaccine and other biological products marketed for human use with biologic license applications (BLAs) regulated by CBER. (Electronic Lot Distribution Data submission is only for biological products regulated by CBER. It does not apply to therapeutic biologics transferred to the Center for Drug Evaluation and Research (CDER) on June 30, 2003. The FDA CBER website http://www.fda.gov/cber/ lists these products.)

Because FDA authority is limited to the United States, the scope of LDD submissions should similarly focus on product lots intended for "domestic" distribution, i.e., distribution within the U.S. or to U.S. military bases abroad. Lots intended for distribution to other countries should not be included. However, we retain a field to distinguish between domestic and foreign distribution for consistency with previous file formats and in case special circumstances might warrant tracking of non-domestic lots.

Related Documents