Fast-breaking News from AABB PulsePoints The following has been reproduced from the November 1, 2006 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

November 1, 2006
No. 756

FDA Notifies Tissue Establishments of Changes to Annual Registration Process

AABB PulsePoints

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) today released a notice advising tissue establishments that it will not be mailing the annual registration form to facilities that register electronically. Instead of mailing Form 3356, the agency will issue a registration e-mail reminder to each establishment’s reporting official.

All establishments are required to submit annual updates to FDA by Dec. 31 regardless of changes. Tissue establishments — which are encouraged to send their annual registration forms electronically — should take steps to ensure that FDA has the correct reporting official's e-mail address and that e-mail received from tissreg@fda.hhs.gov will not be blocked. Reporting officials should also remember to select the "submit to FDA" button in order to make certain that the agency electronically receives the establishment’s registration.

For more information, visit http://www.fda.gov/cber/tissue/annreg.htm.