The owner, operator, or agent in charge of a facility is required to submit an update to a facility’s
registration to FDA within 60 calendar days of a change to any of the required registration
information previously submitted under 21 CFR 1.232 (21 CFR 1.234(a)). If a change occurs to
a facility’s previously submitted required registration information before the start of or during the
biennial registration renewal period, a registrant may submit an update for such change as part of
the facility’s registration renewal by including the update information in the registration renewal,
provided that such update is submitted within 60 calendar days of the change. If a facility
submits an update to FDA before the start of the next biennial registration renewal period, which
takes place from October 1 – December 31 of each even-numbered year, the facility will still be
required to submit a registration renewal to FDA during the biennial registration renewal period.
