• ICCBBA - APPLICATION  FOR FACILITY REGISTRATION

    ICCBBA - APPLICATION FOR FACILITY REGISTRATION

    FM-025 v26
    • REGISTRATION PROCESSING WILL TAKE APPROXIMATELY 2 – 4 WEEKS
    • If you are unable to submit the completed form online, please submit completed form to ICCBBA, P.O. Box 11309, San Bernardino, CA 92423-1309 USA

    If you need assistance with completing this form, please email our staff registration@iccbba.org or call +1 909 793 6516.

     

  • 4. Legal Business Address of Firm

  • 5. Telephone, Fax, and Website

  • 8. Billing Address

  • 7. Specify Registration type (CHECK ALL THAT APPLY) if multiple only one registration fee will apply.

  • Registration Fee: $250.00
    Initial one-time fee includes the first Facility Identification Number.
    *This applies to all types of facilities, EXCEPT Plasma Fractionators or Further Processing Facilities.

    Additional FIN(s) Fee: $250.00
    For each subsequent Facility Identification Number Requested.

  • Chain of Identity Identifiers:

    For facilities that intend to be identified as an ISBT 128 issuing organization for Chain of Identity Identifiers. Please reference ISBT 128 Standard Chain of Identify (CoI) Identifier (ST-028) for details on the use of the CoI Identifier.

    Annual License Fee: $502.63

  • Blood Collection Facility:

    Will be billed based on the total number of Donation Identification Numbers (DINs) assigned annually.

    • DINs are assigned to each collection/pooling/apheresis event. This excludes cell therapy products. Does not include changes to expiration date.

    Annual License Fee:

    Your facility assigns <= 1,000 DINs per year.
    Annual License Fee is US$327.91

    Your facility assigns <= 20,000 DINs per year.
    Annual License Fee is US$502.63

    Your facility assigns > 20,000 DINs per year.
    Annual License Fee will be US$502.63 plus $0.0215 for each unit over 20,000

  • Transfusion Laboratory:

    You are a hospital transfusion service and you do not collect or pool blood products.

    • You assign ISBT 128 Product Codes.

    Annual License Fee: $269.27

  • Serum Eye Drops Facility:

    Will be billed based on the total number of Donation Identification Numbers (DINs) assigned annually.

    • DINs are assigned to each collection or pooling event.

    Annual License Fee:

    Your facility assigns <= 500 DINs per year.
    Annual License Fee is US$327.91

    Your facility assigns <= 5,000 DINs per year.
    Annual License Fee is US$502.63

    Your facility assigns > 5,000 DINs per year.
    Annual License Fee will be US$502.63 plus $0.0215 for each unit over 5,000

    Manufacturer – Your facility does NOT collect, or pool products and you only assign ISBT 128 product codes.
    Annual License Fee is US$269.27

  • Cellular Therapy Facility:

    Facilities that only perform collections will be billed based on the total number of Donation Identif ication Numbers (DINs) assigned annually.

    • DINs are assigned to each collection/pooling event. Facilities that only process units will be billed based on the total number of f inal ISBT 128 labeled products distributed annually. For facilities that both collect and process, we will bill based on whichever annual total value is greater.

    Your facility collects and/or distributes <= 1,000 DINs per year.
    Annual License Fee is US$327.91

    Your facility collects and/or distributes <= 20,000 DINs per year.
    Annual License Fee is US$502.63

    Your facility collects and/or distributes > 20,000 DINs per year.
    Annual License Fee will be US$502.63, plus $0.0215 for each product over 20,000

  • Reproductive Tissues and/or Cell Facility:

    Will be based on the number of ART products distributed annually that are labeled with ISBT 128.

    Annual License Fee:

    Your facility distributes <= 1,000 final labeled products per year.
    Annual License Fee is US$327.91

    Your facility distributes <= 5,000 final labeled products per year.
    Annual License Fee is US$502.63

    Your facility distributes > 5,000 final labeled products per year.
    Annual License Fee will be US$502.63, plus $0.1615 for each product over 5,000

  • Organ Transplant Facility:

    Will be billed based on the number of final labeled products produced annually that are labeled with ISBT 128.

    Annual License Fee:

    Your facility distributes <= 250 final labeled products per year.
    Annual License Fee is US$327.91

    Your facility distributes > 250 final labeled products per year.
    Annual License Fee will be US$327.91, plus US$1.00 for each product over 250

  • Regenerative Medicine Facility:

    Will be billed based on the number of final labeled products produced annually that are labeled with ISBT 128.

    Annual License Fee:

    Your facility distributes <= 500 final labeled products per year.
    Annual License Fee is US$327.91

    Your facility distributes <= 1,000 final labeled products per year.
    Annual License Fee is US$502.63

    Your facility distributes > 1,000 final labeled products per year.
    Annual License Fee will be US$502.63, plus $0.0215 for each product over 1,000

  • Tissue – Non-Ocular Facility:

    Will be billed based on the number of tissue products distributed annually that are labeled with ISBT 128.

    Annual License Fee:

    Your facility distributes <= 1,000 final labeled products per year.
    Annual License Fee is US$327.91

    Your facility distributes <= 5,000 final labeled products per year.
    Annual License Fee is US$502.63

    Your facility distributes > 5,000 final labeled products per year.
    Annual License Fee will be US$502.63, plus $0.1615 for each product over 5,000

    • Note: For tissues collected with intent of being processed into a cellular therapy product, please mark cellular therapy collection facility.
  • Tissue – Ocular Facility:

    Will be billed based on the number of ocular tissue products distributed annually that are labeled with ISBT 128.

    Annual License Fee:

    Your facility distributes <= 1,000 final labeled products per year.
    Annual License Fee is US$327.91

    Your facility distributes <= 5,000 final labeled products per year.
    Annual License Fee is US$502.63

    Your facility distributes > 5,000 final labeled products per year.
    Annual License Fee will be US$502.63, plus $0.1615 for each product over 5,000

    • Note: For tissues collected with intent of being processed into a cellular therapy product, please mark cellular therapy collection facility.
  • Human Milk Bank Facility:

    Will be billed based on the number of liters distributed annually that are labeled with ISBT 128.

    Annual License Fee:

    Your facility distributes <= 4,000 liters per year.
    Annual License Fee is US$327.91

    Your facility distributes <= 8,000 liters per year.
    Annual License Fee is US$502.63

    Your facility distributes > 8,000 liters per year.
    Annual License Fee will be US$502.63, plus $0.1615 for liters over 8,000

  • HCT/P Medical Device Manufacturer:

    *HCT/P is defined as Human Cells, tissues, and cellular and tissue-based products
    Will be billed based on the number of final labeled products produced annually that are labeled with ISBT 128.

    Annual License Fee:

    Your facility labels <= 1,000 HCT/P Medical Devices per year.
    Annual License Fee is US$327.91

    Your facility labels <= 5,000 HCT/P Medical Devices per year.
    Annual License Fee is US$502.63

    Your facility labels > 5,000 HCT/P Medical Devices per year.
    Annual License Fee will be US$502.63, plus $0.1615 for each product over 5,000

  • Proficiency Testing Facility:

    • Your facility develops proficiency testing.
  • Fecal Microbiota Facility:

    Will be billed based on the number of final labeled products (treatments) produced annually that are labeled with ISBT 128.

    Annual License Fee:

    Your facility produces <= 500 products per year.
    Annual License Fee is US$327.91

    Your facility produces <= 2,000 products per year.
    Annual License Fee is US$502.63

    Your facility produces > 2,000 products per year.
    Annual License Fee will be US$502.63, plus $0.1615 for each product over 2,000

  • Registration Fee: Please see below for fees.

  • Additional FIN(s) Fee: $250.00

    For each subsequent Facility Identification Number Requested.

  • Plasma Fractionator or Further Processing Facilities

    *Please check the type that applies to you.

  • Registration Fee: None

    Annual License Fee: $9,014.12

    Plasma fractionators who read and interpret ISBT 128 donation identification numbers and/or product codes, whether originating from their own collection or from a third-party supplier, are required to register with ICCBBA and pay an annual license fee.

  • Registration Fee: $250.00

    Annual License Fee: Will be billed based on the total number of Donation Identification Numbers (DINs) assigned annually. For facilities that label final products, indicate the number of final products labeled annually with ISBT 128. The fee is US$0.0215 per unit, with a minimum license fee of $502.63.

    Plasma fractionators who want to use ISBT 128 donation numbers on the plasma that they collect will need to register as collection facilities and be assigned a facility identification number.

  • Registration Fee: None

    Annual License Fee: Will be billed based on the total number of Donation Identification Numbers (DINs) assigned annually. For facilities that label final products, indicate the number of final products labeled annually with ISBT 128. The fee is US$502.63, plus $0.0215 for each unit over 20,000.

    Plasma fractionators or Further Processing Facilities who supply final product labeled with ISBT 128 are required to register with ICCBBA and pay an annual license fee.

    The annual bill is calculated as follows:

    For plasma derivatives other than solvent detergent plasma, the fee has not yet been determined (contact the ICCBBA of f ice for more information).

  • 11. Signature of authorized person:

    I request registration of the above-named facility by ICCBBA. I agree to the terms and conditions of the License Agreement and understand that an annual license fee (payable when invoiced) will be required to maintain this registration. I represent and warrant that I have full authority to bind my organization to the terms and conditions of the License Agreement.

     

     

  • *    Pick a Date*     

  • World Bank Classification

    • If your facility is in a country classified as Upper-Middle Gross National Income per capita, your license fee will be reduced by 10%.
    • If your facility is in a country classified as Lower-Middle Gross National Income per capita, your license fee will be reduced by 33% and the registration fee will be waived.
    • If your facility is in a country classified as Low Gross National Income per capita, your license fee will be reduced by 66% and the registration fee will be waived..

    Information on country classification is available from the World Bank at: 
    https://data.worldbank.org/

  • 12. Payment Options:

    We accept credit cards (Visa and Mastercard only), wire transfers and ACH payments. Please submit your completed registration form to us for review and we will reach out to you with an invoice with the appropriate amount due at the time of registration. Please do not send any payments before your registration form is submitted.

    NO PURCHASE ORDERS

    Credit Card (VISA or MasterCard only)

    For credit card payments, we will email you your invoice. Once you receive the invoice, please visit our online payment portal at: https://www.ICCBBA.org/payment-portal/. No telephone orders accepted.

    Bank Draft/Wire

    Transfer appropriate amount to: Bank of America, NA
    222 Broadway, New York, New York, 10038
    Bank Number 053000196 BIC/SWIFT: BOFAUS3N

    Payable to: ICCBBA, Account Number 000683127591

     

     

  • PART B:

  • Information from this form will be used to assign Facility Identification Numbers (FIN) and create entries in the official ICCBBA Facility Identification Number database that is maintained on the ICCBBA Website.

    It is left to the discretion of the organization registering how many FINs are requested, and how they are assigned within the organization. The additional FIN section must be filled out for each FIN requested.

    Complete the following section identifying the CONTACT LOCATION for the facility. This contact location will be associated with the Facility Identification Number in the ICCBBA database and should provide the information necessary to contact the facility if any questions arise about a product bearing the particular Facility Identification Number.

    Note: Information provided to ICCBBA will be used for billing and registration purposes, and to assist ICCBBA in its operations – this may include periodic surveys or any other type of announcement. If you wish to opt -out of surveys or announcements, please contact us. To view our full privacy policy, visit the following URL: https://www.ICCBBA.org/privacy-policy

     

  • Fee for each additional FIN: $250

    Note: If you require more than 4 additional FINs, please reach out to our office at registration@iccbba.org.

  • Additional FIN #1

  • Additional FIN #2

  • Additional FIN #3

  • Additional FIN #4

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  • Should be Empty: