Vaccines, Blood & Biologics
Instructions for Completing the Electronic Human Cell and Tissue Establishment Registration Form
Completion of Form FDA 3356 is required under 21 CFR Part 1271, 207.20 and 807.20 for all establishments engaged in the recovery, processing, storage, labeling, packaging, or distribution of any Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), or the screening or testing of a cell or tissue donor. After we receive your form, we will update our records and send a validated form to the reporting official.
User Establishments Screen
Active Users Screen
Submissions Pending Screen
Initial Establishment Registration Information Screen
Edit Establishment Registration Information Screen
Establishment Registration Address Information Screen
Establishment Reporting Official Information Screen
Establishment U.S. Agent Information Screen
HCT/P Listing Information Screen
Function Information Screen
Donor Information Screen
Additional Information to Complete HCT/P Information Listing Screen
Preview your Establishment Registration Information Screen
Reporting Official Signature Screen
Submitted Establishment Registration Information Screen
You are required to register and list your HCT/Ps by submitting this form if you recover, process, store, label, package, or distribute any HCT/P, or screen or test the HCT/P donor unless one of the following exceptions applies. You are not required to submit this form if:
- You use HCT/Ps solely for nonclinical scientific or educational purposes,
- You remove and then implant HCT/Ps solely for autologous use during the same surgical procedure,
- You are a carrier who accepts, receives, carries, or delivers HCT/Ps in the usual course of business as a carrier,
- You only receive or store HCT/Ps solely for implantation, transplantation, infusion, or transfer within your facility,
- You only recover reproductive cells or tissue and immediately transfer them into a sexually intimate partner of the cell or tissue donor, or
- You are an individual under contract, agreement, or other arrangement with a registered establishment and only recover and send HCT/Ps to the registered establishment.
- It is recommended that you print these instructions for reference when completing the report.
- Complete all sections that apply to your establishment.
- Dates should be entered as month/day/year (e.g., March 1, 2000 = 03/01/2000).
- All fields marked with an asterisk (*) are required fields and must be completed or you will not be allowed to move to the next page or submit the form.
- The reporting official e-mail address is desired to facilitate obtaining additional information when necessary.
- Complete a separate form for each establishment. If an establishment manufactures more than one product, only one form needs to be completed listing all products affected.
- The Tab key or mouse is used for screen navigation. Other keys are enabled to ensure that the system is totally navigable via keyboard. Please contact us if you have any accessibility problems.
- The following are buttons located on the majority of screens:
- Next: Go to next screen
- Previous: Go to previous screen
- CBER On-Line Main Menu: returns to CBER's listing of on-line applications
- Select New Establishment: exits the current registration and returns to the Activity Selection screen
- At the top of most screens is a 'speed' bar that will allow you to go directly to a screen in the application.
- Click the associated links located at the bottom of each page for:
- To log off the system
- Help with filling out this form - provides on-line instructions to aid in completing the form
- For email help from the eHCTERS Registration Coordinator - Contact
- After logging into the system you have 20 minutes to enter information and continue onto the next page (using the Continue button located at the bottom of each page). When you have been on a page for 17 minutes, a window will open and ask if you need more time. If you click 'yes' you will be given an additional 20 minutes. If you do not respond when the window opens, and you have been on the page for more than 20 minutes, your session will be lost (If you have a pre-confirmation number you can re-log in and continue entering data).
- It is highly recommended that you do not use the back and forward buttons on your browser. Unexpected results may occur. Use the buttons on each page for form navigation.
Select one of the following:
Initial Registration - Select this if your establishment is submitting Form FDA-3356 for the first time. When the Initial Registration radio button is selected, the system will display a page to help confirm that "initial registration" is the appropriate selection.
Press Continue to confirm that your establishment has never submitted FORM FDA 3356 by mail, fax, or electronically.
Press Search to see if your establishment has previously registered or to check your registration status.
Press Cancel if you have already registered. On the Activity Selection page, you need to select "Edit Validated Form" to edit your registration information.
- Edit Validated Form - Select this if you have previously submitted and had validated a Form FDA-3356. You also will need to select a Reason for Submission (annual registration/listing, to change information, or to inactivate your registration) and select the establishment you wish to edit, from your existing user establishments. If your establishment does not appear in the 'Select from your existing user establishments' drop down list, press the User Establishments button to add your establishment to the list.
- Complete Unfinished Form FDA-3356 - Enter an eHCTERS assigned pre-confirmation number if you are completing an unfinished (not submitted) entry that you saved earlier (less than 30 days)
When you have made your selection and entered the requested information, press the Continue button to proceed.
- Continue - Navigates to the next screen based on the Activity selected (Initial Registration, Edit Validated Form, Complete Unfinished Form)
- User Establishments - Navigates to the User Establishments screen where you associate your account to one or more establishments
- Active Users - Navigates to the Active Users screen, which displays a list of all users associated with the same establishments as the current user
- CBER On-Line Main Menu - Exits the eHCTERS, returns to CBER's listing of on-line applications
On this page you may identify the establishment(s) to which you wish to have access (to view or update) through the eHCTERS system.
In the upper portion of the screen you may enter the FDA Establishment Identifier number (FEI) of the establishment with which you wish to be associated and the most recent 'Validated Date' for this establishment. The most recent validated date is in the upper right corner of the last validated Form 3356 we sent you.
Once you have entered an FEI number and a Validated Date, press the 'Add This Establishment' button. If your registration number and Validated Date are accurate, eHCTERS will grant you access to the establishment immediately. If your registration number and Validated Date do not match our records, eHCTERS will notify you immediately. If you feel that the information you supplied is correct and eHCTERS 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 Date, eHCTERS will associate your user account 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 'Remove'.
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 eHCTERS or have recently submitted changes being reviewed by the FDA, the system will display the Submissions Pending page.
To revoke your access to an establishment click on the 'Remove' 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.
This page displays a list of all facilities you have access to as the current user. For each establishment listed you will see; Establishment Name, FEI, User Names associated with the establishment, and the First and Last name of those users.
The Submissions Pending screen will appear when you attempt to create an electronic registration record and the system finds recently created or submitted records for that establishment.
The screen will display:
- eHCTERS records created for your establishment within the last 30 days but not submitted to the FDA
- eHCTERS records submitted for your establishment within the 7 days
Your options for proceeding are as follows:
- To edit a record you have created but not yet submitted to the FDA, click the 'Edit' button next to the record
- To view a recently submitted record, click the 'View' button next to the record
- To create a new record based on your last validated registration, click the button 'Create a New Form FDA-3356'
- To return to the main eHCTERS screen, click the button 'Return to Activity Selection Screen'
Please note that the list of Submissions Pending contains only records that have been created using the eHCTERS system
If this is the first time you have registered with FDA press the Next button and continue to fill out information as the subsequent screens indicate.
If your establishment is already registered with FDA as a Blood, Medical Device, or Drug establishment provide your FEI number. Your establishment will not be given a new registration number and you are not required to fill in registration information such as physical location, mailing address of the reporting official, and US Agent, if the information is the same as provided on your previous registration for Blood, Medical Devices or Drugs. However an electronic signature will be required. This will require you to re-enter your password. By providing this signature, you are certifying that you are the reporting official for this establishment.
Reminder: FDA's Office of Regulatory Affairs (ORA) districts no longer assign Central File numbers (CFN's) to new facilities (as of October 1, 2001). Instead, only FEI numbers are assigned. You may contact your local FDA district office to obtain your registration number from the appropriate Registration Monitor (Blood, Device, or Drug). A listing of the Registration Monitors is available at http://www.fda.gov/ora/inspect_ref/iom/iomoradir_monitors.html. Foreign establishments may contact the Office of Regional Operations, Division of Emergency and Investigational Operations (ORA/ORO/DEIO) at 301-827-5653.
Reason for Submission: Select the reason for your submission, Annual Registration or Change in Information. Please note that the annual registration period begins November 15th and you must complete your annual registration by December 31st.
Other FDA Registrations: If your establishment is registered with FDA as a Blood, Medical Device, or Drug establishment provide the FEI number in the appropriate field.
Physical Location: Provide the physical location of the establishment such as legal name, street address, city, phone number etc. If you did not provide an FEI number or one does not display on the Registration tab, all address information fields are required. Note that State and Postal Code fields are not required for non-U.S. establishments. Please use dashes per the format on the screen when entering the phone numbers.
Satellite Recovery Establishment: Indicate (with a check) if you are a satellite recovery establishment that supports recovery personnel in the field by providing temporary storage for recovered HCT/Ps for shipment to your parent manufacturing establishment, but do not perform any other activities or manufacturing steps.
Manufacturing Establishment FEI Number: Provide the FEI Number of your parent manufacturing establishment. This is required only when Satellite Recovery Establishment is selected.
Testing For Micro-Organisms Only: Indicate (with a check) if you are an establishment that performs testing of HCT/Ps for micro-organisms if that is the only HCT/P processing function that you perform. You must also list the HCT/Ps that you perform microbiological testing for on the HCT/P listing information screen.
Reporting Official Information: The reporting official is the person appointed by the owner or operator to register the firm and answer all the correspondence and inquiries relative thereto. Provide the first name, last name, title, email address and the phone number.
Mailing Address: Provide the establishment's name, street address, city, state, postal code, and country. Note that State and Postal Code fields are not required for non-U.S. establishments. You may copy your entries from the Establishment Registration Address Information screen to the Reporting Official screen by pressing the 'Copy From Address Info Screen' button.
The dated signature by the reporting official affirms that all information contained on the form is true and accurate, to the best of his or her knowledge. You will electronically sign at the end of this process.
This section should be filled out for non-U.S. establishments only; Provide your U.S. agent's first name, last name, title, email address and phone number. United States agent means a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent.
Mailing Address: Provide the U.S. Agent's mailing address. Note that the institution name, street address line 1, city, state, postal code and country is required. Please use dashes per the format on the screen when entering the phone numbers.
In the first column titled "HCT/P's Described in 21 CFR 1271.10" indicate (with an X) each HCT/P that fulfills all of the following criteria:
- The HCT/P is minimally manipulated,
- The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent,
- The manufacture of the HCT/P does not involve the combination of the cell or tissue component with a drug or a device, except for a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the HCT/P, and either
- The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or the HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and (i) is for autologous use, (ii) is for allogeneic use in a first-degree or second-degree blood relative, or (iii) is for reproductive use.
If your HCT/P type is not listed on the screen, click the Add Other HCT/Ps button.
In the second column titled "HCT/P's Regulated as Medical Devices", indicate (with an X) each HCT/P that is regulated as a medical device under the Federal Food, Drug, and Cosmetic Act.
In the third column titled "HCT/P's Regulated as Drugs, or Biological Drugs", indicate (with an X) each HCT/P that is regulated as a drug or biological drug under the Federal Food, Drug, and Cosmetic Act and/or section 351 of the Public Health Service Act.
For changes to HCT/P listing such as discontinuance (indicate with a D), or resumption (indicate with an R) of a HCT/P into commercial distribution in June and December or at the time the change occurs as directed under 21 CFR Part 1271.21. Dates of HCT/P discontinuance / resumption should be provided on the additional information screen.
Proprietary Names: Indicate any applicable proprietary names used for the HCT/Ps listed, such as a trademark.
Function Information: Indicate (with a check) the activity(ies) performed by the registered establishment in conjunction with the type of HCT/P that the registered establishment manufactures. Test and screen refer to the donor, not the HCT/P. Check boxes will display only for HCT/Ps which have a regulation selected on the HCT/P Listing Information screen.
Donor Information: For reproductive HCT/Ps, indicate whether the HCT/Ps are from sexually intimate partners (SIP), directed, or anonymous. For hematopoietic stem/progenitor cells and somatic cells, indicate whether the HCT/Ps are autologous, family related, or allogeneic. Family related means allogeneic use in a first degree or second degree relative.
NOTE: If necessary, this screen exists to add additional information in completing the HCT/P Information Listing. Information included on this screen may include Proprietary Names that are too long or numerous for the HCT/P Listing screen and dates of discontinuance or resumption, or additional HCT/Ps that are not indicated on the screen.
The purpose of this report is to review your information prior to submitting the information to FDA/CBER. You may also note your Pre-Confirmation Number and return to this data within 30 days of creating the record.
Submit to FDA button: Once you have completed a review, press the Submit to FDA button to send the data to FDA/CBER.
The reporting official is the person appointed by the owner or operator to register the firm and answer all the correspondence and inquiries relative thereto. By entering your password and reporting official email address and then continuing with your submission of this information to FDA/CBER, you are certifying that:
- You are the Reporting Official as listed in this form
- As a Reporting Official, you are the person appointed by the owner or operator to register the firm and answer all correspondence and inquiries relative there to.
- All information contained in this form is true and accurate to the best of your knowledge.
Under 21 CFR 1271.25 (a)(4), a dated signature by the reporting official affirms that all information contained in the establishment registration and HCT/P listing form is true and accurate, to the best of his or her knowledge.
Under 18 USC 1030, anyone who intentionally accesses a protected computer without authorization and, as a result of such conduct, causes damage and a threat to public health or safety is subject to criminal penalties.
Under 18 USC 1001, anyone who knowlingly and willfully makes a materially false, fictitious, or fraudulent statement or representation to the U.S. Government is subject to criminal penalties.
If you understand and agree to the above statements, re-enter your user password and reporting official email address and then press the Continue button.
You may press the Cancel button if you do not wish to continue.
The purpose of this screen is for you to print the report information so you can have a copy of what you submitted should any questions arise. You will not be able to make any other changes until FDA/CBER has approved the submitted changes. The reporting official will receive by mail a new validated Form FDA - 3356 once FDA has approved the changes. You may then make additional changes if needed.
If for any reason you are unable to utilize the online system, you may manually submit your report by downloading the PDF form. After downloading the form, print it out, complete it using the instructions and return to the following address:
Food and Drug Administration
Center for Biologics Evaluation and Research (HFM-775)
1401 Rockville Pike, Rockville, MD 20852-1448
ATTENTION: Tissue Establishment Registration Coordinator
FAX No. (301) 827-2844