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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Biologics Export Certification Application and Tracking System (BECATS) Frequently Asked Questions

BECATS Questions

We will implement Phase 2 on June 28, 2014 for Certificates of Pharmaceutical Product.

What is BECATS?

BECATS is CBER’s web-based application for accepting requests, reviewing, processing, managing, tracking, and administering export certificates. In the first phase, which begins on October 1, 2013, firms will be able to submit requests for a Certificate to Foreign Government electronically through BECATS.

At this time, BECATS will be available only for Certificates to Foreign Government. Subsequent releases of this application are in development for inclusion of the other certificates issued by CBER.

We hope to implement Phase 2 in 2014 for Certificates of Pharmaceutical Product.

Is it mandatory to use BECATS? Can paper requests be mailed to the FDA?

It is not mandatory to submit applications through BECATS. The advantage of using BECATS is that it allows for immediate submission and immediate notification via e-mail, as well as status updates via the Internet. The FDA will continue to accept paper applications.

Firms may choose to request a certificate through BECATS or through a mailed request, but not both. If a firm submits a BECATS request and a mail request for the same certificate, the FDA will process and charge for both applications.

How do I access BECATS and who do I contact if I have a problem accessing the system?

You can access BECATS after logging into the FDA Unified Registration and Listing Systems (FURLS). You must have a FURLS account ID and password to access this system. If you do not have one, please see the instructions on the FURLS website.

Should you need assistance while in FURLS, please use the “Help Desk” link. If you require further assistance with your FURLS account, please call 1-800-216-7331. If you need assistance on an export specific matter, please send an email to CBERBECATS@fda.hhs.gov.

Why should I use BECATS?

BECATS offers several benefits, including a reduction in certificate processing time, real-time validation and status updates.

Do I have to pay more for a Certificate if I use BECATS?

No, there is no additional fee for using BECATS, The first two certificates are $175 and additional copies are $85 per copy.

If we use BECATS, is our company information going to remain confidential?

Yes, company information is kept confidential for both BECATS and mailed requests.

Can I still utilize our current format for the product listings?

Yes. BECATS will also provide an option to upload the product list from a Microsoft Excel spreadsheet. This will allow you to list the catalog number and product name as you would like to see it on the certificate.

Do I need a special account to use BECATS?

No, all registered firms should use their existing FURLS account to access BECATS. To create a FURLS account please follow the instructions on the FURLS homepage disclaimer icon .

Can multiple individuals at one firm access BECATS to apply for certificates?

Yes, firms can create sub-accounts for multiple individuals to use BECATS.

If I submit a request through BECATS will I receive the certificate instantly?

No. The FDA will review and validate the information provided and issue the certificate within 20 business days. We anticipate that processing time will be reduced significantly for requests submitted through BECATS.

Will I be able to electronically submit a return slip for mailing processed certificates?

Yes, you will be able to upload a prepaid mailing RETURN SLIP for UPS or FedEx.