Ocular Products FAQs

  1. What are the registration fees?
  2. How are annual license fees calculated?
  3. How do I complete the Facility Annual Return form?
  4. What does the note, “for tissues collected with intent of being processed into cellular therapy products, please fill out section 7.2 Cellular Therapy collections” on the Registration Form mean?
  5. My organization has multiple recovery locations. Does each recovery location need its own Facility Identification Number (FIN)?
  6. My organization has multiple processing locations. Does each processing location need its own Facility Identification Number (FIN)?
  7. Do I assign the same Donation Identification Number (DIN) to all tissues from the same donation event? If so, how would I differentiate between these tissues?
  8. How can I contact ICCBBA for other questions?

 

 Need to ask a specific question? Email us at iccbba@iccbba.org.


1. What are the registration fees?

The registration fee for facilities is a one-time charge of $200.00. This includes one Facility Identification Number (FIN).

In addition, an annual license fee will be assessed based on the type of activity at your facility (based on a tiered structure). See FAQ #2 "How are annual license fees calculated" (below).

If your organization would like more than one FIN, each additional FIN is a one-time fee of $161.00.

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2. How are annual license fees calculated?

License fees are based on the Annual Return Form sent out with your invoice each year. The numbers reported on this form are used to generate the license fees based on a tiered structure. For more information on the tiered structure, visit http://www.iccbba.org/registration-licensing/isbt-128-fees#ocular.

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3. How do I complete the Facility Annual Return form?

Annual returns for tissues are based on the number of individual labeled tissues distributed in the previous year for tissue intended to be released for transplant as well as those meant for interorganizational research. This means that if there were two tissues from a single donor that were distributed, it would count as two, even if both tissues had the same Donation Identification Number.

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4. What does the note, "for tissues collected with intent of being processed into cellular therapy products, please fill out section 7.2 Cellular Therapy collections", on the Registration Form mean?

This note pertains to facilities that collect products like umbilical cord or placenta, which are tissues, with the intent of making stem cell products (e.g., mesenchymal cells). These facilities should register as cell therapy facilities rather than tissue facilities. If you are unsure about what type of facility to register as, contact our help desk at iccbba@iccbba.org.

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5. My organization has multiple recovery locations. Does each recovery location need its own Facility Identification Number (FIN)?

No. If all tissues come back to the same location for processing, a single FIN is appropriate. However, if it is important for your organization to identify where the collection took place at a glance by using the Donation Identification Number, multiple FINs is an option you may consider.

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6. My organization has multiple processing locations. Does each processing location need its own Facility Identification Number (FIN)?

Yes, it is highly recommended. In this case, there are two ways to handle registration:

The organization can register at the "corporate" level and purchase an additional FIN for each processing location at $161.00 per FIN (a one-time charge). The annual license invoice is sent to the headquarters’ location and represents the total volume for the organization and its processing sites.

Each processing location can register separately. In this case, each processing location will pay the $200.00 one-time registration fee, which includes one FIN. Each location will manage its own registration and annual license invoice.

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7. Do I assign the same Donation Identification Number (DIN) to all tissues from the same donation event? If so, how would I differentiate between these tissues?

All tissues from the same donation event must be given the same DIN. This DIN, in addition to the Product Code, is what distinguishes each tissue uniquely. For example, a left and right cornea collected from the same patient will have the same DIN, but different Product Codes. DINs can be assigned at the time of recovery or after the tissues are back in the lab.

 


8. How can I contact ICCBBA for other questions?

Inquires can be sent via e-mail to our help desk at iccbba@iccbba.org. Additionally, we can be reached via telephone at +1 909 793 6516.


 

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