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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Failure to Register Notice

Notice: Failure to update FDA annual registration Form 3356

FDA has noticed an increase in "Failure to Register," where reporting officials did not update their annual registration. This is a reminder as required in 21 CFR 1271.21, that Annual update of your registration is required every year in December.

  • Changes to your HCT/P listing is required within 6 months of the change.
  • If the ownership or location of the establishment changes, an amendment to the establishment registration must be submitted within 5 days of the change.
  • If the facility is no longer in operation, check box 2 (d).
  • Remember to always sign and date your Form 3356 in box # 9. Unsigned forms will not be processed.

Questions can be addressed to Rosemarie Wiseman 301-827-6176 or email tissuereg@fda.hhs.gov.


Contact FDA

Tissue Registration Coordinator