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Blood Establishment Registration - Latest System Changes

The Electronic Blood Establishment Registration (eBER) web site is in use and is being upgraded continuously. CBER reviews the site periodically to ensure reliable access for data entry and retrieval of saved data. To facilitate user understanding of recent changes, the upgrades made to the system are outlined below. The system consists of the eBER submission module to enter Blood Establishment and Product Listing data required for submission and the eBER Public Query which is used to review non-confidential blood establishment registration information for active, inactive, and pre-registered firms.

eBER Version 1.19.01 Release Information - Release Date 07/23/2021
Modifications made to enhance system stability

eBER Version 1.19.00 Release Information - Release Date 11/20/2020
Blood Establishment Registration and Product Listing (Link to eBER)
Updated application to utilize the Geopolitical Entities, Names, and Codes (GENC) data standard.
eBER Public Query (Link to Public Query)
Updated application to utilize the Geopolitical Entities, Names, and Codes (GENC) data standard.

eBER Version 1.18.00 Release Information - Release Date 06/19/2020
Blood Establishment Registration and Product Listing (Link to eBER)
Added "Research Blood Products for Sale" as a selectable Other Product during registration.
Corrected hyperlinks in the eBER footer.
Implemented changes to enhance eBER system security.
eBER Public Query (Link to Public Query)
Updated system to allow display of new product "Research Blood Products for Sale" on the "Detailed Record" page.
Implemented changes to enhance eBER Public Query system security.

eBER Version 1.17.00 Release Information - Release Date 03/15/2019
Blood Establishment Registration and Product Listing (Link to eBER)
Updated the allowable establishment functions for eBER products.
eBER Public Query (Link to Public Query)
Updated the allowable establishment functions for eBER products.

eBER Version 1.16.01 Release Information - Release Date 10/26/2018
Blood Establishment Registration and Product Listing (Link to eBER)
Updated DUNS to display leading zeros.
Updated logic to prevent duplicate DUNs from being entered in the case a pre-registered facility submits first.

eBER Version 1.16.00 Release Information - Release Date 09/21/2018
Blood Establishment Registration and Product Listing (Link to eBER)
Updated the OMB Control number 0910-0052 expiration date to 06/30/2021.
Added a new required field for Data Universal Numbering System (DUNS) number.
Added additional fields and available values for establishment types, blood products, and processes.
Updated various screens and buttons to refer to the Blood Establishment Registration and Product Listing form instead of Form FDA 2830.
Updated the FDA logo.
Removed the fillable form on the Blood Establishment Registration and Product Listing - Contact page.
eBER Public Query (Link to Public Query)
Added a DUNS number field to the Establishment Details page to display the DUNS numbers submitted by registering establishments.
Updated the eBER Public Query Establishment Details page to include updated fields and values for establishment types, blood products, and processes.
Updated the FDA logo.
Removed the fillable form on the Blood Establishment Registration and Product Listing - Contact page.

eBER Version 1.14.00 Release Information - Release Date 01/08/2016
Blood Establishment and Product Listing (Link to eBER)
Updated the Blood Establishment and Product Listing expiration date to 05/31/2018.
Modified the eBER Select Establishment page to display the date and time of the last session where the user accessed the eBER Registration Module.
Removed obsolete header and footer links from the eBER Registration Module.
Incorporated usability updates to the eBER Legal Name and Location page.
Incorporated usability updates to the eBER Type of Ownership page.
eBER Public Query (Link to Public Query)
Removed obsolete header and footer links from the eBER Public Query.
Modified the Query Results page to display the State/Province “Name” instead of the State/Province “Code” for Non-US establishments.
Incorporated system improvements to the Enter Query Criteria page when searching on the “Country” field.

eBER Version 1.13.00 Release Information - Release Date 11/14/2014
Modifications made on the Status page to limit the reasons for inactivating a registration to: exempt, closed, or temporary.

eBER Version 1.12.00 Release Information - Release Date 08/13/2014
Modifications made to adjust data entry restrictions.

eBER Version 1.11.00 Release Information - Release Date 06/27/2014
Modifications made to enhance system security.

eBER Version 1.10.0 Release Information - Release Date 05/02/2014
Blood Establishment and Product Listing (Link to eBER)
An update was made to improve maintainability of contact information on the Contact page.

eBER Version 1.9.3 Release Information - Release Date 01/24/2014
Blood Establishment and Product Listing (Link to eBER)
The system was modified to remove unnecessary files. No functional changes were made in this release.

eBER Version 1.9.2 Release Information - Release Date 10/26/2012
Blood Establishment and Product Listing (Link to eBER)
Updated the Blood Establishment and Product Listing expiration date to 3/31/2015.
Corrected the display timing of the annual registration reminder message.
eBER Public Query (Link to Public Query)
Corrected the version number to match the eBER registration module.

eBER Version 1.9.1 Release Information - Release Date 9/25/2009
Blood Establishment and Product Listing (Link to eBER)
Updated the Blood Establishment and Product Listing expiration date to 2/29/2012.

eBER Version 1.9.0 Release Information - Release Date 10/03/2008
Blood Establishment and Product Listing (Link to eBER)
Added a new page providing answers to Frequently Asked Questions (FAQ).
Added an automatic submission confirmation email. Upon successfully submitting a registration record, the system will send a confirmation email to the Reporting Official email address.
Added a reminder message on the Select Establishment page to inform users when annual registration is near.
Expanded the Phone Extension field to 5 digits on both Location and U.S. Agent pages

eBER Version 1.8.0 Release Information - Release Date 03/16/2007
Blood Establishment and Product Listing (Link to eBER)
Disallow use of the Initial Registration button when P # has been entered on the main page.
eBER Public Query (Link to Public Query)
Added the ability to search for establishments by City, FEI, and ‘Other’ Names.
Changed the country field to allow selection of more than one country and added the value ‘non-us’ to search for foreign establishments.
Added the ability to sort by FEI and changed “Corporate Name” to “Applicant Name” in the Sort By drop-down field.
Added the ability to navigate to the first or last page of query results.
Added a "New Query" button to query results screen which will return to the criteria screen and clear previously entered / selected values.
Modified the detailed record to display province name instead of abbreviation in the State field and moved FEI above CFN in the Legal Name and Location section.

eBER Version 1.7.1 Release Information - Release Date 11/01/2006

Blood Establishment and Product Listing (Link to eBER)

The report page that displays prior to submitting to FDA was updated to clearly show the report has not been submitted.

eBER Version 1.7.0 Release Information - Release Date 07/31/2006

Blood Establishment and Product Listing (Link to eBER) / eBER Public Query (Link to Public Query)

The system was modified to allow compatibility with upgraded development software. No functional changes were made in this release.
The Blood Establishment and Product Listing expiration date was updated to March 31, 2009.

eBER Version 1.6.0 Release Information - Release Date 03/11/2006

Blood Establishment and Product Listing (Link to eBER) / eBER Public Query (Link to Public Query)

The system was modified to allow compatibility with upgraded development software. No functional changes were made in this release.

eBER Version 1.5.0 Release Information - Release Date 10/03/2005

Blood Establishment and Product Listing (Link to eBER)

User Establishments – CFN field should accept numbers only. Added an error message to appear when non-numeric characters are entered in the CFN field.
User Establishments – Updated error messages to differentiate between user entries of incorrect date formats versus incorrect registration number / date combinations.
Establishment Location and RO Addresses - Zip Code is not required for foreign locations.
Reporting Official page – Telephone extension field is increased to 5 digits.
US Agent – Foreign Phone field has been removed.
US agent telephone field in mandatory when US Agent information is required.

eBER Public Query (Link to Public Query)

Corrected the retrieval and display of available license information.

eBER Version 1.4.2 Release Information - Release Date 4/27/2004

Initial release of Electronic Blood Establishment Registration Intranet Query Module

eBER Version 1.4.1 Release Information - Release Date 4/05/2004

Initial release of Electronic Blood Establishment Registration Public Query Module

BER Version 1.4.0 Release Information - Release Date 2/13/2004

After submitting a registration to the FDA for review, the user will not be able to browse back and edit the registration. Instead the user will be redirected to the eBER Select Establishment screen.
For Initial Registrations, license number fields now accept only positive integers as input.
For the Netscape 4.7+, the application now requires the entry of establishment type if the user selects the establishment type 'not listed'.
For the Netscape 6 and 7 users, the application now notifies the user when 'Donor Type' selection is required on the Products screen.
On Establishment Type screen if the 'Other' checkbox is disabled, the user is not able to enter any text in the establishment type text box.
U.S. Agent information is not needed for the establishments located within U.S. or U.S. territories. But for the establishments outside U.S. with the owner type Military U.S. Agent information is required.
The Registration Profile screen provides two more columns and sort functionality.
Clear button functionality was corrected on the Location and Owner Type screens.
On 'Owner Type' and 'Establishment Type' screen, if the user selects 'Other' type and presses the refresh button, and navigates to the other screen, then on the validation error page the user requires to enter the other owner type as well as other establishment type.
The pre-confirmation report page and confirmation report page displaying the number(##) along with the additional product names.
The popup message on the products screen has been changed to:
"Indicate donor type only if you collect Whole Blood or collect apheresis products for transfusion.
Indicate Allogeneic, Autologous, or Directed donor type for Collect or Automated Apheresis (products 1-14).

Version 1.3.2 Release Information - Release Date 12/10/2003

For Other Products, a donor type is not required unless a firm selects any combination of product 1-14 and process 1 or 3.

Version 1.3.1 Release Information - Release Date 12/4/2003

A donor type is required if a firm selects any combination of product 1-14 and process 1 or 3. A donor type is not required (and is prohibited) if the firm does not select at least one combination of product 1-14 and process 1 or 3.

Version 1.3.0 Release Information - Release Date 7/2/2003

Eliminated Javascript errors that displayed on the Products screen when the Clear function was used and when certain Process/Product/Donor Type combinations were selected. For Netscape 4.7 and 4.8 users, the system now displays popup messages to notify users when valid Process/Product/Donor Type combinations are required.
For Netscape 4.7 and 4.8 users, the system now displays popup messages to notify users when invalid establishment type combinations are selected.
Corrected the display of text field data containing double quotes. Previously, text appearing after a double quote would save but not display.
Eliminated possible unexpected results experienced by users having an apostrophe in their user name.
Corrected an issue occurring when a user session expired. After timing out, the user cannot user their browsers’ back button to access previously displayed eBER screens.
Increased the field length of the “Comments” field on the Status screen to 50 characters.
Improved formatting for report printing.
Corrected message text on the Contact CBER screen.

Version 1.2.0 Release Information - Release Date 4/3/2003

For Initial Registrations, added CFN and FEI input fields that allow user to change their entries prior to submission.
When creating an Initial Registration, the application will save any supplied FEI or CFN provided the FEI or CFN is not already assigned to another establishment.
Updated the legitimate values for States to include only US states and provinces. States that are not US States or Military designations will not be saved.
Added confirmation pop-up window when a user presses the 'Change Facility' button. The user may confirm that they want to change the facility, or return to the report they were editing.
Users are now asked if they want to remove their association with an establishment that they make 'inactive'.
The 'Contact Us' link on the Report Screen and the Confirm Submission Window takes the user to the main contact page rather than initiating an email.
Fixed an intermittent problem where the Report screen was not changing when a new facility was selected.
Moved the FDA Logo and text image from the bottom to the top of all pages. Added the text "Center for Biologics Evaluation and Research (CBER)" below the image.
Fixed a problem where some browsers were not displaying 'other products' on the Products page.
Fixed a problem that caused the Submission Pending Screen to display even when there were no submissions for the chosen facility.
Renamed the 'Return To Form Entry' button to 'Return To Select Establishment page'.
Fixed an error that prevented users from deleting 'Other Names'.

Version 1.1.2 Release Information - Release Date 2/28/2003

Change the expiration date of the form from February 28, 2003 to February 28, 2006.

Version 1.1.1 Release Information - Release Date 01/10/2003

Removed Javascript errors on Location, Reporting Official and Validation Error pages.
Limited input characters on Establishment Type Other text field and Establishment Owner Other Text field.
Limited input characters on US Agent Last Name Text field.
Corrected count down timer on the Refresh warning page.
Removed several old (not used) files.
Non-Specific code optimization.

Version 1.1.0 Release Information - Release Date 12/9/2002

Added the Pre-Confirmation Number (P#) to the Report Page (so when the user prints the information they submitted, the P#/confirmation number will print as well).
Corrected various grammar/spelling mistakes.