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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Letter to Industry about BECATS

October 1, 2013

Dear Biological Product Establishments:

Biologics Export Certificate Application and Tracking System (BECATS) is CBER’s web-based application for accepting requests, reviewing, processing, managing, tracking, and administering export certificates. Beginning 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 certificate types issued by CBER.

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

BECATS automates many of the steps that exporters and CBER perform when submitting and processing export document requests. The advantages to exporters include:

  • Reduction in certificate processing time;
  • Real-time validation that eliminates the need to return submissions;
  • Certificate print preview
  • Elimination of the cost of mailing the request; and
  • Real-time status updates available via email.

CBER looks forward to continuing to improve the processing of all export document requests, with a goal of providing the best service possible. If you have any questions or concerns, please email CBERBECATS@fda.hhs.gov.

Sincerely yours,

Maria C.H. Anderson, Branch Chief

Biological Drug and Device Compliance Branch

Division of Case Management

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research