BER Instructions for Completing the 

Electronic Blood Establishment 

Registration and Product Listing Form

PRINT 

The FDA requires all blood establishments that collect, manufacture, prepare, store 

under controlled conditions for further distribution, or process blood and blood products 

to register under Title 21, CFR, Part 607. Hospital Transfusion Services certified under 

the Medicare program are exempt from registration (see 21 CFR 607.65(f)).

Establishments that perform certain manufacturing steps are considered to be Hospital 

Blood Banks, which are required to register. See instructions for Item 10.2 for these 

manufacturing steps.

The Paperwork Reduction Act Statement is at the end of these instructions.

Please review all pre-populated data for accuracy and completeness. Correct any 

incorrect items as you navigate through the application.

Note the following: YOU MUST NOTIFY FDA WITHIN 5 DAYS IF YOU CHANGE 

LOCATION.

The Electronic Blood Establishment Registration and Product Listing system is referred 

to as eBER. The blood establishment and product listing process is referred to as 

registration and listing. To view a list of frequently asked questions and their answers, 

please visit the eBER FAQ page.

Table of Contents

• General Instructions

• Navigation

• Saving Information

• Individual Page Descriptions

• Select Establishment Page

• Registration Profile Page

• Active Users Page

• Other Submissions Pending Page

• Status Page

• Legal Name/Location Page

• Other Names Page

• Reporting Official Page

• U.S. Agent Page

• Owner Type Page

• Type of Establishment Page

• Products Page

• Additional Products Page

• Report Page

• Validation Errors Page

• Reporting Problems
• Paperwork Reduction Act Statement

General Instructions:

• Complete a separate eBER record for each establishment.

• Complete all sections. The U.S. Agent section applies only to non-U.S. military 

blood establishments.

• Click the associated links located at the bottom of each page for:

• Log Out - returns you to the CBER On Line Log In page.

• Help with filling out this form - provides on-line instructions for 

completing the form.

• Contact CBER - opens a web email form for users to send comments and 

questions to CBER.

• Release Notes - displays latest release notes for the eBER system.

• FAQ - displays a collection of frequently asked questions and answers 

regarding the eBER system. 

• Enter dates as month/day/year (e.g. December 1, 2001 = 12/01/2001).

• Enter US phone numbers as 10 digit numbers (area code + phone number) 

separated by dashes. Example: 123-555-1212

• Enter US zip codes as five digit zip code + four digit extension separated by a 

dash. Example: 12345-1234. If you do not know the four-digit extension, just enter the 

five-digit zip code.

• All fields marked with an asterisk (*) and written in blue are required fields. You 

must complete these fields before you submit your registration to CBER.

• When available, please provide the reporting official's (and US Agent's) email 

address to facilitate our contacting you for additional information when necessary.

• DO NOT use this form to report biological product deviations, fatalities, or 

adverse events.

• We recommend you print these general instructions for reference when 

completing the electronic form.

Return to Table of Contents

Navigation

There is a continue button on nearly every page of eBER. Clicking this button will take 

you to the next page of the application.

Use the TAB key or mouse for screen navigation. When you press the Enter key, the 

system will check the page for required fields and valid information as if you had hit the 

Continue button on the bottom of the page.

There is a 'Speed Bar' at the top of nearly every page. By clicking the buttons on it you 

may move from one page of eBER to any other. Example: If you are on the Legal 

Name/Location Page you may click on the Report button on the Speed Bar, and you will 
go directly to the Report page. You could then click the Location button on the Speed 

Bar to go directly to the Legal Name/Location page.

Return to Table of Contents

Saving Information

Whenever you begin viewing, entering information, or updating information for an 

establishment, eBER saves your changes in a temporary file. If you have to leave eBER 

for any reason, you will not lose the information you have entered so far.

When you open an establishment in eBER, eBER gives you a Pre-Confirmation Number 

(or Pre-Confirm Number). This Pre-Confirmation number appears on the left side of the 

header of every page in eBER. If you make changes to an establishment's information 

you can get back to those changes after leaving eBER by providing your PreConfirmation Number on the Select Establishment page.

Important: To submit changes you make to your establishment's information to us in 

eBER, you must click the Submit to FDA for Review button on the Report page of 

eBER. If you do not click the Submit to FDA for Review button, eBER will save your 

changes, but not submit them to us.

Return to Table of Contents

INDIVIDUAL PAGE DESCRIPTIONS FOR eBER

Select Establishment Page

On this page you may initiate three activities:

1. You may begin an initial registration of an establishment for which we do not yet 

have a record.

2. Click on the 'Initial Registration' button to begin entering information for a new 

establishment.

3. You may associate one or more existing establishments with you.

4. Click on the 'Edit User Establishments Profile' button to identify your 

establishment(s) (so you may view and update your registration and listing 

information).

5. You may access a record of your establishment in order to view or update it.

If you have previously associated an establishment with your account (see #2 

above), you may enter your FDA registration number in the appropriate field and 

click the 'Edit this Establishment' button to view/update your record. If you have 

already started making changes to an establishment's information through eBER or 

have recently submitted changes being reviewed by the FDA, the system will 

display the Other Submissions Pending page.
There are two types of registration numbers you may use to identify your 

establishment. You may have one or both types of numbers. If you have both, you 

need to enter only one to access your data.

Central File Number (CFN): 7-digit number assigned by FDA.

FDA Establishment Identifier number (FEI): 7 to 10-digit number assigned by 

FDA.

If you have already made changes to an establishment's information through eBER, 

you can access the establishment's information (including your changes) and 

continue updating it by supplying the Pre-Confirmation Number eBER assigned you 

when you initially updated the establishment's information.

Buttons

Edit this establishment: See above.

Initial Registration: See above.

Clear: Clears any text you have entered onto this page.

Edit User Establishments Profile: See above.

View All Active Users: Takes you to the Active Users page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Return to Table of Contents

Registration Profile Page

On this page you may identify the establishment(s) to which you wish to have access (to 

view or update) through the eBER system.

In the upper portion of the screen you may enter the registration number of the 

establishment with which you wish to be associated (either an FEI or a CFN) and the 

most recent 'Validated by FDA’ date for this establishment. The most recent validated 

date is in the upper right corner of the last Blood Establishment Registration and 

Product Listing Summary Report we sent you.

Once you have entered a registration number and a ‘Validated by FDA’ date, click on 

the 'Add This Establishment' button to submit your request for access to this 

establishment. If your registration number and ‘Validated by FDA’ date are accurate, 

eBER will grant you access to the establishment immediately. If your registration 

number and ‘Validated by FDA’ date do not match our records, eBER will notify you 

immediately. If you feel that the information you supplied is correct and eBER should 

have accepted it, use the contact CBER link located at the bottom of the web page to 

notify us.

Once you have supplied a valid registration number and ‘Validated by FDA’ date, eBER 

will associate you with the establishment, and the establishment name will appear in the 

lower portion of this screen.

The lower portion of the screen lists the establishments you may access. Each 

establishment listing is prefaced with two buttons 'Edit' and 'Delete'.

To view and/or update an establishment click on the 'Edit' button next to the 

establishment name. If you have already started making changes to an 
establishment's information through eBER or have recently submitted changes for 

review by the FDA, the system will display the Other Submissions Pending page.

To revoke your access to an establishment, click on the 'Delete' button next to the 

establishment name. This will NOT delete any information about this establishment. 

It will simply remove your rights to view or update that establishment's information.

Buttons

Add this Establishment: See above.

Return to Form Entry: Returns you to the Select Establishment page.

Clear Screen: Clears any text you have entered onto this page.

Return to Table of Contents

Active Users Page

This page displays a list of all users associated with the same facilities as the current 

user. For each establishment listed you will see; Establishment Name, FEI, CFN, User 

Names associated with the establishment, and the First and Last name of those users.

Button

Return to Select Establishment page: Returns you to the Select Establishment 

page.

Return to Table of Contents

Other Submissions Pending Page

This page is a notice to you that other electronic submissions are pending for the 

establishment you are attempting to access. A Pending Submission is:

• An electronic (eBER) record that has been created within the last 30 days but not 

submitted to the FDA.

• An electronic (eBER) record that has been submitted and is currently awaiting 

action by the FDA.

To edit a submission listed that has been created but not submitted to the FDA, click the 

'Edit' button next to the record.

To view a submitted record currently awaiting action by the FDA, click the 'View' button 

next to the record.

Please note that the list of Other Submissions Pending contains only records that have 

been created using the eBER system.

Buttons

Return To Select Establishment page: Returns you to the Select Establishment 

page.

Create a Blood Establishment Registration and Product Listing: Creates a 

new eBER record pre-filled with the most recent FDA received Blood Establishment 

Registration and Product Listing data for that establishment.

Return to Table of Contents
Status Page

This page allows you to enter the current status of the Blood Establishment 

Registration. Only an Active Status will allow you to modify Establishment information. 

Inactive Status will only allow review and submission of the Blood Establishment and 

Product Listing. You may not continue with the registration process until a status has 

been entered.

Buttons

Continue: Takes you to the next page of the application.

Refresh: Refreshes your browser window.

Change Facility: Returns you to the Select Establishment page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Return to Table of Contents

Legal Name/Location Page

This page allows you to view and/or update your establishment's name and location.

License Number: We issue U.S. License Numbers under section 351 of the Public 

Health Service Act to firms that apply for licensure and otherwise qualify. Licenses are 

appropriate only for firms engaged in interstate commerce. We assign unique license 

numbers only to Blood Banks, Plasmapheresis Centers, Product Testing Laboratories, 

and other biologic product manufacturers.

Parent License Number (Parent Lic No.): Establishments such as Component 

Preparation Facilities, Collection Facilities, and Distribution Centers that operate under 

the license of a parent establishment have the parent U.S. License Number in this field.

FEI and CFN: If this is an initial submission for an establishment, the user will be able to 

enter the FEI or CFN number if known. The system will check if the entered FEI/CFN 

number already exists and if so, direct the user to select the establishment using the 

establishment selection screen to modify data for an existing establishment.

Establishment DUNS: Starting October 1, 2018, the entry of an Establishment DUNS 

is required for all Blood Establishment Registrations. The DUNS number is a unique 

nine-digit identifier for businesses which is generated by Dun & Bradstreet. DUNS 

number is the required Unique Facility Identifier in accordance with the system specified 

under section 510 of the Federal Food, Drug, and Cosmetic Act (see 21 CFR 

607.25(a)). For more information on DUNS numbers, including methods for obtaining a 

DUNS, please visit the Dun & Bradstreet website.

Legal Name and Location: Provide the legal name (not the "doing-business-as" or 

other names in Item 5), street address, and telephone number of the actual location. 

NOTE: If blood collection and laboratory facilities are separated, but register as one 

establishment because of their close proximity, use the laboratory address.

Buttons
Add other names used at this location: Takes you to the Other Names page 

where you may provide other names for your facility.

Continue: Takes you to the next page of the application.

Clear: Clears any text you have entered onto this page.

Refresh: Refreshes your browser window.

Change Facility: Returns you to the Select Establishment page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Return to Table of Contents

Other Names Page

This page allows you to provide any other name by which your facility is commonly 

known, including any name not shown in the Legal Name Field of the Legal 

Name/Location Page that is or was used at this location. This includes trade, doingbusiness-as, and previous names, and names of unaffiliated corporations at the same 

location. If registered with FDA, include the registration number in parentheses.

You must also provide the effective date of the Other Name's first use.

Buttons

Add This Name: Adds the Other Name and the date you entered in the text boxes 

of this page to your establishment's record.

Return to Establishment Location Form [does not save]: Returns you to the 

Legal Name/Location page. Note: eBER will not save any text you entered into the 

two text boxes.

Return to Table of Contents

Reporting Official Page

This page allows you to view and/or edit the Reporting Official name, institution name if 

applicable, street address, e-mail address, and telephone number.

Buttons

Continue: Takes you to the next page of the application.

Clear: Clears any text you have entered onto this page.

Refresh: Refreshes your browser window.

Change Facility: Returns you to the Select Establishment page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Return to Table of Contents

U.S. Agent Page
This page allows you to view and/or edit the U.S. agent name, institution name if 

applicable, street address, e-mail address, and telephone number.

Note: U.S. Agent information is required for non-U.S. establishments.

Buttons

Continue: Takes you to the next page of the application.

Clear: Clears any text you have entered onto this page.

Refresh: Refreshes your browser window.

Change Facility: Returns you to the Select Establishment page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Return to Table of Contents

Owner Type Page

This page allows you to view and/or update the type of ownership under which your 

establishment operates.

If your establishment's ownership type is not listed, you may choose 'Not Listed' from 

the 'Other' pull down menu at the bottom of the selections, and type in your ownership 

type in the text box to the right of the pull down.

Buttons

Continue: Takes you to the next page of the application.

Clear: Clears any text you have entered onto this page.

Refresh: Refreshes your browser window.

Change Facility: Returns you to the Select Establishment page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Return to Table of Contents

Type of Establishment Page

This page allows you to view and or update your type(s) of establishment.

Check all applicable boxes that describe your routine operations. If you check Hospital 

Transfusion Service do not check any other block.

Descriptions of Establishment Types:

Community (Non-hospital) Blood Bank: A commercial or non-profit blood 

collection/processing establishment, not located in a hospital, that may perform 

product testing and routinely distributes blood and/or blood products to one or more 

hospitals. We consider an independent blood bank located inside a hospital, but 

separately operated and owned, to be a Hospital Blood Bank.

Hospital Blood Bank: A hospital (or establishment located within a hospital) that 

routinely collects or processes Whole Blood or blood components. A Hospital Blood 

Bank may collect components by apheresis or prepare them from Whole Blood. 

Processing includes freezing, deglycerolizing, washing, irradiating, rejuvenating, or 

leukocyte-reducing Red Blood Cells. We include hospitals that perform autologous 
or directed collections in this category. Hospital Blood Banks usually perform 

product testing (such as blood grouping and hepatitis testing), as well as 

compatibility testing. We consider hospitals that solely prepare Red Blood Cells or 

Recovered Plasma, pool Platelets or Cryoprecipitated AHF for ease of transfusion, 

or issue bedside leukocyte-reduction filters with blood components to be Hospital 

Transfusion Services. A hospital that collects Source Plasma under licensure 

should also check "Plasmapheresis Center."

Plasmapheresis Center: An establishment licensed by FDA/CBER that collects 

Source Plasma or Therapeutic Exchange Plasma for commercial distribution. If you 

also collect Whole Blood for a licensed establishment, check "Collection Facility" 

and include the license number of the parent firm. Hospitals that perform 

plasmapheresis for research purposes only or to prepare transfusion products such 

as Plasma or Platelets, Pheresis, should NOT check this box.

Product Testing Laboratory: A separate establishment that performs routine 

blood and plasma donor testing. You must also indicate whether you are 

independent or associated with a Blood Bank.

Hospital Transfusion Service: A hospital that performs compatibility testing (cross 

matching) for blood or blood components but does NOT routinely collect allogeneic 

or autologous blood, or process Whole Blood into components (except Red Blood 

Cells and Recovered Plasma). We consider hospitals that freeze, deglycerolize, 

wash, irradiate, rejuvenate, or reduce the number of leukocytes from Red Blood 

Cells to be Hospital Blood Banks. You must also indicate your Medicare approval 

status.

Component Preparation Facility: An intermediate processing establishment that 

prepares components from blood collected by a mobile or fixed collection site but 

does not perform product testing.

Collection Facility: An establishment that performs blood collections or apheresis, 

but does not test. If you also redistribute the final product after the parent blood 

bank has processed and returned products to you, then also check Distribution 

Center.

Distribution Center: An establishment that stores blood or blood products FOR 

TRANSFUSION under specific controlled conditions prior to shipping it to the final 

user. We do not consider a transfusion service to be a "distribution center" since it 

holds the product over a relatively short period of time and does not intend to 

redistribute. If you are a transfusion service operating as a depot or distribution 

center for a blood bank, register as a Distribution Center and include the license 

number of the blood bank, if licensed.

Broker/Warehouse: A broker, distributor, or warehouse that stores and 

redistributes source material for further manufacture, such as Recovered Plasma, 

Source Plasma, and whole blood, red blood cells, or platelets for diagnostic product 

use.

Non-Hospital Transfusion Service: A commercial or non-profit establishment, 

not located within a hospital, that routinely performs product testing and distribution 

of blood and blood products to one or more hospitals. Procedures may include 

compatibility testing (crossmatching), distribution of crossmatched blood products, 
red blood cell phenotyping and genotyping, antibody screening and identification, 

and advanced serologic problem solving.

Manufacturer of Licensed Devices: A biologic licensed establishment responsible 

for production and distribution of medical devices intended for use in the US.

Other (specify): This includes independent establishments that irradiate blood 

products. If your establishment type is not on the list, select 'Other' and enter your 

establishment type in the adjoining box.

Buttons

Continue: Takes you to the next page of the application.

Clear: Clears any text you have entered onto this page.

Refresh: Refreshes your browser window.

Change Facility: Returns you to the Select Establishment page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Return to Table of Contents

Products Page

This page allows you to view and/or update all products that you manufacture for 

commercial distribution. This includes allogeneic, autologous, and directed collections, 

or products prepared, tested, or stored for distribution to other firms. See the Product 

Definition section for information on products.

If one of your manufactured products is not on the list, enter the product on the Other 

Products page. Navigate to this page by clicking on the 'Add Other Products' button. 

Check the list of values for your product. If your product is not on the list, select 'Other' 

and enter your product name in the lower box.

Do not list products you do not manufacture, but only hold for final use, such as 

albumin, reagents, immune globulins, etc. Do not list clinical laboratory services as a 

product. We do not consider this to be blood product manufacturing. Record 

compatibility testing in the testing column for the appropriate product.

Do not list any products you collect as a by-product of a therapeutic procedure and 

immediately destroy. Similarly, exclude products prepared under emergency conditions. 

We define an emergency as a situation that demands immediate action that a 

responsible person has suitably documented in writing. Do not list products that you 

pool or divide into pediatric aliquots. 

Indicate Allogeneic, Autologous, or Directed donor types only if you collect blood 

products for transfusion (Product lines 1-14, columns 1 or 3). Allogeneic donors 

donate blood intended for transfusion to other than the donor or a known recipient. 

Autologous donors donate blood intended for transfusion at a later time to the donor. 

Directed donors donate blood intended for transfusion to a known recipient. If you do 

not collect blood products for transfusion, do not check donor types.

Process Definitions:

Collect: refers to collection of whole blood or blood products for transfusion or 

further manufacturing into injectable or non-injectable products.
Manual Apheresis: refers to procedures such as plasmapheresis, plateletpheresis, 

and leukapheresis, in which you return unneeded portions of the whole blood to the 

donor.

Automated Apheresis: refers to the collection of Red Blood Cells, Platelets, 

Leukocytes, Granulocytes, or Plasma by automated equipment.

Prepare: refers to functions such as component preparation from Whole Blood. 

Leukocytes Reduced: refers to blood products that you process to remove 

leukocytes before issue. Leukocyte-reduced products should meet the criteria for 

residual leukocyte count and product recovery described in FDA recommendations. 

Do not include products leukocyte reduced during transfusion.

Irradiated: refers to irradiation of blood products before transfusion. Check this 

only if you are performing the irradiation step, or have a contract manufacturing 

agreement for another establishment to perform the irradiation for you.

Donor Retested: refers to storage of products for a minimum of 112 days, until the 

donor returns for subsequent donation or testing, and all infectious disease markers 

are negative at the subsequent testing.

Test: refers to product testing such as blood grouping, syphilis, hepatitis, HIV, and 

protein electrophoresis, as well as compatibility testing (cross matching). It does not 

include daily quality control tests of reagents.

Store and Distribute to Others: refers to storage of products under controlled 

conditions for distribution to other firms.

Pathogen Reduced: refers to exposure to a chemical and/or radiation based 

processing system intended to reduce the risk of transfusion-transmitted infections 

in blood and blood components.

Pooled: individual components, e.g. Cryoprecipitated AHF, Whole Blood-derived 

platelet concentrates, combined using an aseptic technique. The shelf life is 

specified in the directions for use for the blood collection, processing, and storage 

system.

Bacterial Testing: is a qualitative immunoassay for the detection of aerobic and 

anaerobic Gram-positive and Gram-negative bacteria in leukocyte reduced 

apheresis platelets or pre-storage pools of up to six (6) leukocyte reduced whole 

blood derived platelets within 24 hours prior to transfusion as a safety measure 

following testing with a growth-based quality control test cleared by the FDA for 

platelet components.

Product Definitions:

Whole Blood: All blood collected from human donors for transfusion to human 

recipients using an approved anticoagulant preservative solution.

Red Blood Cells: Red Blood Cells remaining after separating plasma from human 

blood, or collected by apheresis.

RBC Frozen: Red Blood Cells stored at ultra-low temperature in the presence of a 

cryoprotective agent, and preserved for potentially long periods of time.

RBC Deglycerolized: Red Blood Cells washed free of the glycerol in which they 

have been stored.
RBC Reconstituted: Red Blood Cells to which plasma is added to prepare a 

Whole Blood product, often with a specific hematocrit, used primarily for pediatric 

transfusions.

RBC Washed: Red Blood Cells typically washed using 0.9% Sodium Chloride, 

Injection (USP) with or without small amounts of dextrose using manual or 

automated methods. The washed Red Blood Cells are stored at 1-6° C for up to 24 

hours.

RBC Rejuvenated: Red Blood Cells treated with a rejuvenating solution, such as 

pyruvate inosine, to restore cell integrity.

RBC Rejuvenated Frozen: Red Blood Cells treated with a rejuvenating solution, 

then frozen and stored at ultra-low temperatures in the presence of a cryoprotective 

agent.

RBC Rejuvenated Deglycerolized: Red Blood Cells treated with a rejuvenating 

solution, frozen using a cryoprotective agent, and then washed free of the 

rejuvenating solution and glycerol.

Cryoprecipitated AHF: A preparation containing antihemophilic factor obtained 

from a single unit of plasma.

Platelets: Platelets collected from a single donor and suspended in a specified 

volume of original plasma.

Platelets PAS (Platelet Additive Solution): Isotonic crystalloid nutrient media 

solution designed to replace a portion of plasma for the storage of apheresis 

platelet products, allowing the volume of plasma transfused to be decreased.

Platelets Extended Dating: Platelets that have been tested for bacteria using an 

FDA-cleared bacterial detection device labeled as a “safety measure”, following 

testing with a growth-based quality control test cleared by the FDA for platelet 

components, that can support extending the expiration date of platelets past 5 

days. Platelets shall be stored in a container that is approved or cleared to store 

platelets up to 7 days.

Platelets Washed: Whole Blood derived or apheresis collected platelets washed 

with 0.9& Sodium Chloride, Injection (USP) or saline-buffered with ACD-A or citrate 

using manual or automated methods. The washed platelets are stored at 20-24° C 

for up to 4 hours.

Granulocytes: White Blood Cells (leukocytes) collected from a single donor and 

suspended in a specific volume of original plasma intended for patient infusion.

Plasma: The fluid portion of one unit of human blood intended for transfusion 

which, in a closed system, has been collected, stabilized against clotting, and 

separated from red cells within 26 days after phlebotomy (40 days when CPDA-1 is 

used as the anticoagulant) and stored at -18°C or colder.

PF24 Plasma: The fluid portion of one unit of human blood intended for transfusion 

which has been separated from Whole Blood and placed at -18° C or colder within 

24 hours from Whole Blood collection. When prepared by automated apheresis the 

product is stored at 1° to 6° C within 8 hours of collection and frozen at -18° C or 

colder within 24 hours of collection.

PF24RT24 Plasma: Plasma Frozen Within 24 Hours After Phlebotomy Held At 

Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24) – Prepared 
from automated apheresis collections , can be held at room temperature for up 24 

hours after collection and then frozen at -18° C or colder.

Fresh Frozen Plasma: Single donor plasma prepared from Whole Blood within 8 

hours of collection, or collected by automated apheresis, and stored at -18°C or 

colder.

Plasma Cryoprecipitate Reduced: Plasma from which Cryoprecipitated AHF has 

been removed.

Liquid Plasma: Single donor plasma separated from red cells within 26 days after 

phlebotomy (40 days when CPDA-1 is used as the anticoagulant) and stored at 1-

6°C.

Therapeutic Exchange Plasma (TEP): Plasma obtained from a patient who 

undergoes plasma exchange (also called therapeutic plasmapheresis). Do not list 

TEP that you immediately destroy. We consider TEP to be source material for 

further manufacturing use subject to licensure.

Source Leukocytes: White Blood Cells intended as source material for further 

manufacturing use.

Source Plasma: The fluid portion of human blood collected by plasmapheresis 

(except plasma derived by therapeutic plasma exchange) and intended as a source 

material for further manufacturing use. This includes source material intended for 

injectable and non-injectable products.

Recovered Plasma: Plasma derived from single units of Whole Blood, Plasma, or 

as a by-product in the preparation of blood components from Whole Blood, for use 

in the manufacturing of licensed or unlicensed products.

Blood Products for Diagnostic Use: Whole Blood, Red Blood Cells, or Platelets 

shipped for further manufacture into non-injectable products.

Blood Bank Reagents: Diagnostic substances manufactured for commercial 

distribution used to characterize and determine the acceptability of blood products 

for transfusion purposes. These include reagent red blood cells, blood grouping 

reagents and anti-human globulin (AHG).

Donor Screening IVDs: In-vitro diagnostic medical devices used in screening 

blood donors for transfusion-transmitted infections.

Freeze Dried Plasma: Dehydrated version of plasma that when reconstituted, is 

used to replace coagulations factors in bleeding patients.

Other: Other products not listed above that you manufacture for commercial 

distribution. 

Blood Components for Research: Any blood products which are not for sale, 

rather are solely for use in clinical or non-clinical studies, teaching, or analysis, 

including laboratory samples.

Pooled Plasma SD: Solvent-detergent (SD) treated, pooled, human plasma.

Not Listed: Creates a free-text box for custom product entry.

Buttons

Add Other Products: Takes you to the Additional Products page.

Continue: Takes you to the next page of the application.

Clear: Clears any text you have entered onto this page.
Refresh: Refreshes your browser window.

Change Facility: Returns you to the Select Establishment page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Return to Table of Contents

Additional Products Page

This page allows you to enter additional products that your establishment manufactures 

for commercial distribution and indicate what processes you perform for each additional 

product. Check the list of values for your additional product. If your product is there, 

select it. If your product is not on the list, select 'Not Listed' and enter your product 

name in the lower box.

Buttons

Add This Product and Reset Screen: Adds to your establishment's record the 

additional product and processes you have entered.

Clear This Form and Return to Product Form: Returns you to the Product page. 

Note: eBER will not save any product and process information displayed in the 

textbox and checkboxes of this page unless you click on 'Add Product' first.

Return to Table of Contents

Report Page

This page displays all of the information available for your establishment. This page will 

display any updates you have made to your establishment's registration and product 

listing.

You may submit your updates to us by clicking on the 'Submit to FDA for Review' 

button. eBER will review all of the information entered for your establishment to ensure 

that you provided all the required information. If all of the required information is 

present, eBER will send your request to update your establishment's information to us. 

eBER will display a notification on the screen that it has submitted your update, and you 

may print a copy of your submitted information for your records.

Remove Establishment Dialog: If a user submits an establishment with a status of 

"Inactive" then the user will be asked if they wish to remove the establishment from their 

user profile. The user will select "OK" to remove the establishment or "Cancel" to retain 

the establishment in their user profile.

Buttons

Submit to FDA for Review: See above. This button does not appear if viewing a 

submitted report.

New Facility: Returns you to the Select Establishment page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Print Form: Prints a report of your establishment's information (including any 

updates you have made).
Return to Table of Contents

Validation Errors Page

This page appears when you have attempted to submit an incomplete registration and 

will display what required data is missing.

Enter data in the fields provided then click the 'Submit Form' button to save the 

information you entered.

If no data entry field is provided, return to the data entry form by clicking the appropriate 

button in the Return to Data Form column.

Buttons

Submit Form: Submits your record to the FDA (if all required information has been 

entered) or Saves your changes and displays any remaining required data that is 

missing.

Refresh: Refreshes your browser window.

Change Facility: Returns you to the Select Establishment page.

CBER On-Line Main Menu: Returns you to the CBER On-Line Main Menu.

Return to Table of Contents

Reporting Problems

If for any reason you are unable to use the online system, please contact 

bloodregis@fda.hhs.gov.

Paperwork Reduction Act Statement

An Agency may not conduct or sponsor, and a person is not required to respond to, a 

collection of information unless it displays a currently valid OMB control number. Public 

reporting burden for this collection of information is estimated to average 1 hour per 

response for initial registration, and 30 minutes for re-registration, including time for 

reviewing instructions, searching existing data sources, gathering and maintaining the 

necessary data, and completing and reviewing the collection of information. Send 

comments regarding this burden estimate or any other aspect of this collection of

information to:

Food and Drug Administration

Center for Biologics Evaluation and Research 

Document Control Center

10903 New Hampshire Avenue
WO71 - G112

Silver Spring, MD 20993-0002

Return to Table of Contents