eBER - Frequently Asked Questions

Blood Establishment Registration - Frequently Asked Questions
Table of Contents General Registration Questions Instructions for Electronic Submission Registration Numbers Exemptions Establishment Type Product Listing Annual Registration Contact FDA

GENERAL REGISTRATION QUESTIONS Why do blood establishments have to register? Section 510 of the Federal Food, Drug, and Cosmetic Act requires that “On or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices shall register with the Secretary his name, places of business, and all such establishments. What can I expect after I register? Once you submit your initial registration to us, we will send a copy of the summary report to your local district office. The Blood Registration Monitor in the district office will contact you to confirm that you are in operation and are registering appropriately. The Monitor will assign your establishment an FEI, and will notify us of your FEI. We will print a summary report and email it to you to keep for your records. We will inspect your blood manufacturing operations periodically to ensure that you are following applicable regulations and recommendations. Refer to Title 21 of the Code of Federal Regulations (21 CFR), parts 600 through 660 for regulations related to manufacturing blood products. Our recommendations are available on the Internet at https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances. We have just changed Medical Directors. Do I need to report this change to you? You are required to report changes in Medical Directors annually. You are required to report changes in ownership, corporate, or partnership structure within 5 days of such change. I just found out that we should have registered years ago. We haven’t ever registered. What should I do? You must register as soon as possible. The regulations require that you register within 5 days of beginning blood manufacturing operations. I am a medical device manufacturer. I would like to collect blood products myself, to use in manufacturing my in vitro diagnostic devices. Does Part 607 apply to me? Yes. How do I register? You register by submitting your Blood Establishment Registration and Product Listing information. You must submit this information electronically. To submit electronically, please follow the instructions below.
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INSTRUCTIONS FOR ELECTRONIC SUBMISSION On the Internet, go to the FDA Center for Biologics Evaluation and Research home page https://www.fda.gov/cber. Scroll down to and click on the Blood Registration link in the shaded panel. You may also go directly to the Blood Registration page by typing https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing in your browser address box. Scroll down and click on the link titled "CBER On-Line: Establishment Registration and Biological Product Deviation Reporting." This will take you to the Login page for CBER On-Line. On the Login page, if it is the first time you have used CBER On-Line, you will need to create a new account. Click on the “Create a New Account” link, and follow the on-screen instructions to enter information such as your name, e-mail address, and a username. After you submit your account request, the electronic blood establishment registration (eBER) system will send you separate e-mails with your username and a system-generated password (Please write down your user name and password, keep it in a safe place for future use.) Depending on your Internet Service Provider, it may take five minutes to several hours for you to receive your password. If you do not receive your password within four hours, either try the “Forgot Password” link on the log-in page, or e-mail CBERWebAppSupport@fda.hhs.gov with your username, facility, and the problem you encountered. When you have your user name and password, enter them on the Login page. Click on “Enter CBER On Line.” User Name and Password fields are case sensitive. The eBER will prompt you to change your password on initial login (brand new user) or if you have not changed your password in the last 90 days. Click on the Blood Establishment Registration link. First time users please go directly to instruction number 8. Returning users may click on Edit User Establishments Profile, to access their establishment listing(s). The first time you use eBER, you need to add your establishments to your account. Click on Edit User Establishments Profile. Enter the registration number (FEI) and validated date (located in the top right corner of your last validated registration summary report, “Validated by FDA:”) for each establishment, and then click “Add This Establishment.” If you cannot locate your last validated summary report, or if eBER does not accept the date you are entering, email the Blood Registration Coordinator. If the establishment you are registering has never been submitted to the FDA for registration, please select “Initial Registration.” Once your establishment(s) is/are added to your account, you may view or edit the information from the Select Establishments screen. Either enter your registration number in the appropriate box, or click on the Edit User Establishments Profile button. The Profile screen will list all establishments linked to your account. You may edit your establishment information, or remove the establishment from your account. When you edit your establishment information, you will need to enter the current status. During Annual Registration, use “Active – Annual Registration” ONLY. There are tabs or buttons you may use to move from page to page of your registration. They are located at the top of the pages. Make any needed changes to your registration and product listing. If you do not need to make any changes, you may proceed directly to the report tab. On the report screen, verify that your information is correct. From this screen you may: Use the tabs near the top of the page to go to previous screens to make changes Submit your registration. To submit your registration, you must click on the Submit to FDA for Review button at the bottom of the Report page. The eBER will display a message that you submitted your information, provide you with a confirmation number, and give you an opportunity to print a report. If you would like to save your registration without submitting. The eBER system will hold your registration information for 30 days before deleting. Write down your pre-confirmation number so that you may access your information later. Print a report with your information If, after you submit the form, you determine that you need to make changes, contact us and we will provide instructions. Log out by clicking on the log out link near the top of the page. I submitted my registration electronically, when will I get my validated summary report? It may take a week to several months, depending on the registration status (e.g., registration update, or initial registration) and our workload. Can I view my registration on the Internet? Yes, if you have a CBER On-Line account, and link your establishment(s) to your On-Line account. You may also view your information on the Public Query screen at https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/find-blood-establishment. Can the public view registration information on the Internet? Yes, at https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/find-blood-establishment. Is electronic registration secure? Yes. Validated date should be available only to personnel at your establishment that have access to the validated registration summary report. We review all changes in reporting officials as a way to screen out fraudulent reporters. The CBER On-Line menu has tissue registration and biological product deviations. Can I use the same User Name and Password to use all three systems? Yes. I am trying to register electronically. I get a message that my registration number or validated date is invalid. What does this mean? Make sure that you have selected the appropriate registration number type (FEI or CFN), are using the correct date (“Validated by FDA” date, not any other date on the form) in the correct format (with the slashes: 01/01/2004). I am trying to register electronically. I get a message that a submission is pending, what does this mean? This means that someone has submitted an electronic registration for your establishment, and our electronic system has not imported the submission into our database yet. I'm doing our annual registrations on-line, but I do not have a validation date for one site. Contact the Blood Registration Coordinator by sending an e-mail to bloodregis@fda.hhs.gov. Provide your name, title, name of your establishment and registration number (FEI number), and ask for your validated date. When I click on View All Users, a name that I don’t recognize is associated with my establishment. What do I do? Please click on the “Contact eBER Technical Support” link and request that we remove the link between your establishment and the user. Must the Reporting Official be the same person that registers electronically? No. I have closed one of my donor centers. How do I report this electronically? Edit your registration for the donor center. On the initial screen, enter a status of “Inactive closed,” and submit the summary report to us. After you have submitted the summary report, you may go to your Registration Profile and use the “Remove” button to unlink the establishment from your account.
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REGISTRATION NUMBERS The summary report has two registration numbers, FEI and CFN. What do these mean? The FEI stands for FDA Establishment Identifier. It’s the inventory number the FDA uses to keep track of all the establishments we regulate. All drug, food, biologic, device, radiology, veterinary medicine facilities, and importers of these products have FEIs. They are up to 10 digits long. CFN stands for Central File Number. It was the inventory number from an old FDA database. My FEI and CFN don’t match, is that okay? Yes. We assigned Central File Numbers (CFNs) up until September 30, 2001. When we rolled out our new database, we had the FDA Establishment Identifier (FEI) stay the same number as the CFN. We gave some establishments a new, different FEI. I have an FEI, but no CFN. Is that okay? Yes. We stopped assigning CFNs after October 1, 2001. Establishments that registered after this date will have only a FEI. An Establishment DUNS number is required to submit my registration. What is a DUNS number and how do I obtain one? 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.
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EXEMPTIONS Does FDA exempt any blood establishments from registration? Yes. See 21 CFR 607.65 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=607). I have a hospital transfusion service. What blood banking activities can I conduct and still maintain my exemption? Compatibility testing Divide or aliquot blood components for pediatric or small patient transfusions Therapeutic plasma exchanges, if product destroyed immediately Thawing frozen Plasma and Cryoprecipitated AHF Pooling Platelets and Cryoprecipitated AHF What activities will trigger the requirement for my transfusion service to register? Blood Collection Irradiation Pre-storage leukocyte reduction Washing, freezing, deglycerolizing red blood cells
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ESTABLISHMENT TYPE What’s the difference between Hospital Blood Bank and Hospital Transfusion Service? A Hospital Blood Bank routinely collects or processes Whole Blood or blood components. Processing includes irradiation, rejuvenation, or pre-storage leukocyte-reduction of any blood component, or freezing, deglycerolizing or washing Red Blood Cells. A Hospital Transfusion Service performs compatibility testing for blood or blood components but does NOT collect allergenic or autologous blood, or process Whole Blood or blood components (except Red Blood Cells and Recovered Plasma). You must also answer Item 10.5a concerning Medicare program reimbursement. 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 are Hospital Transfusion Services. I have always registered as a Hospital Transfusion Service. Now my summary report says I’m a Hospital Blood Bank. Why has it changed? If your product listing includes manufacturing processes or irradiating blood components that require you to register, we changed your establishment type from Hospital Transfusion Service to Hospital Blood Bank.
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PRODUCT LISTING I make several blood derivatives. The registration form never includes all my products, even though I write them in every year. What gives? Our previous paper form had very limited space; with the summary report, you should be able to view all of your products. Or, if you view your information on the Internet, either through our electronic registration system or the Public Query (https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/find-blood-establishment), you may view all your products. We perform therapeutic plasma exchanges. Am I supposed to list the plasma as Therapeutic Exchange Plasma? We define Therapeutic Exchange Plasma (TEP) as a product collected during a therapeutic plasma exchange, intended for further manufacturing into a licensed product. If you make TEP, you may not distribute this product without a US License for TEP. If you are destroying the plasma you collect after a therapeutic plasma exchange, you should not list it, because you are not really manufacturing a product. We perform laboratory tests for patients, such as ABO/Rh, antibody screens, direct antiglobulin tests, and tests for hepatitis and AIDS. Do I list these tests as products? Do not list laboratory tests as separate blood products. If you perform compatibility testing (and you are required to register), put a check mark in the Test column for the products for which you perform the compatibility testing (e.g., Red Blood Cells). If you perform testing on blood donors, then put a check mark in the “test” column for Whole Blood, Source Plasma, or whatever other donor type you are testing. How do I list washed red cells? Washed red cells have been added to the Product screen in the eBER application using the name “RBC Washed”. Please select “Prepare” and/or “Irradiated” when adding washed red cells to your product listing. We are anticipating starting an allogeneic blood donor program by May. We will be using an automated apheresis instrument to collect leukoreduced red cells. Our current registration allows for autologous donation only. Can we submit the amended form now or should we wait until actual "go live" date? You need to update your product listing either at the time you initiate manufacturing. [21CFR 607.30(a)] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=607. You may request a revised, revalidated registration summary report after you submit your update. How do I list Plasma Frozen within 24 Hours? Please use the newly added “PF24 Plasma” product on the eBER Product screen. I don’t collect blood. Should I check off a donor type? No, please check donor types only if you collect blood products. I can’t update my product listing, nothing happens when I click on the rectangles in the product table. Please make sure that you are on the Products screen and not the Report screen. The Report screen will have your pre-confirmation number at the top of the report, and all of your establishment and Reporting Official information. The Product screen will have only product information on it.
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ANNUAL REGISTRATION It’s December now, and I haven’t gotten a registration reminder. Do I still have to register? If you are required to register, then you still have to register by December 31. Reminders for annual registration are sent electronically in October. You require us to register every year. Will you send a reminder? Reminders for annual registration are sent electronically each year on October 1st.
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CONTACT FDA You may e-mail the Blood Registration Coordinator at bloodregis@fda.hhs.gov I have a suggestion to improve the registration summary report, process, or electronic registration system. Will someone at FDA listen to me? Absolutely. We will consider all suggestions, and will take all suggestions as an opportunity for improving our registration program.
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Blood Establishment Registration - Frequently Asked Questions

GENERAL REGISTRATION QUESTIONS

Why do blood establishments have to register?

What can I expect after I register?

We have just changed Medical Directors. Do I need to report this change to you?

I just found out that we should have registered years ago. We haven’t ever registered. What should I do?

I am a medical device manufacturer. I would like to collect blood products myself, to use in manufacturing my in vitro diagnostic devices. Does Part 607 apply to me?

How do I register?

INSTRUCTIONS FOR ELECTRONIC SUBMISSION

I submitted my registration electronically, when will I get my validated summary report?

Can I view my registration on the Internet?

Can the public view registration information on the Internet?

Is electronic registration secure?

The CBER On-Line menu has tissue registration and biological product deviations. Can I use the same User Name and Password to use all three systems?

I am trying to register electronically. I get a message that my registration number or validated date is invalid. What does this mean?

I am trying to register electronically. I get a message that a submission is pending, what does this mean?

I'm doing our annual registrations on-line, but I do not have a validation date for one site.

When I click on View All Users, a name that I don’t recognize is associated with my establishment. What do I do?

Must the Reporting Official be the same person that registers electronically?

I have closed one of my donor centers. How do I report this electronically?

REGISTRATION NUMBERS

The summary report has two registration numbers, FEI and CFN. What do these mean?

My FEI and CFN don’t match, is that okay?

I have an FEI, but no CFN. Is that okay?

An Establishment DUNS number is required to submit my registration. What is a DUNS number and how do I obtain one?

EXEMPTIONS

Does FDA exempt any blood establishments from registration?

I have a hospital transfusion service. What blood banking activities can I conduct and still maintain my exemption?

What activities will trigger the requirement for my transfusion service to register?

ESTABLISHMENT TYPE

What’s the difference between Hospital Blood Bank and Hospital Transfusion Service?

I have always registered as a Hospital Transfusion Service. Now my summary report says I’m a Hospital Blood Bank. Why has it changed?

PRODUCT LISTING

I make several blood derivatives. The registration form never includes all my products, even though I write them in every year. What gives?

We perform therapeutic plasma exchanges. Am I supposed to list the plasma as Therapeutic Exchange Plasma?

We perform laboratory tests for patients, such as ABO/Rh, antibody screens, direct antiglobulin tests, and tests for hepatitis and AIDS. Do I list these tests as products?

How do I list washed red cells?

How do I list Plasma Frozen within 24 Hours?

I don’t collect blood. Should I check off a donor type?

I can’t update my product listing, nothing happens when I click on the rectangles in the product table.

ANNUAL REGISTRATION

It’s December now, and I haven’t gotten a registration reminder. Do I still have to register?

You require us to register every year. Will you send a reminder?

CONTACT FDA

I have a suggestion to improve the registration summary report, process, or electronic registration system. Will someone at FDA listen to me?