Firms that send their initial or annual registrations from October 1st to December 31st period are considered registered until the end of the following year. If a firm submits its initial, updated or annual registration outside this time frame, it is considered registered until the end of the current year and shall renew before December 31.
Example 1: a new, updated or annual establishment registration Structured Product Labeling (SPL) is received on October 1. Registration is current through December 31, of the following year.
Example 2: a new, updated or annual establishment registration SPL is received on September 30, 2013. Registration is current through December 31, that same year. The renewal for the next period must be submitted between October 1 and December 31.
Regarding the effective time field in the annual establishment registration SPL, it should contain a reference to the year that is the same as the year you are submitting your SPL file.
For example, if a firm sends in an Establishment Registration SPL for 2014 on November 1, 2013 then the effective time field should be “20131101”.
21 Code of Federal Regulations (CFR) 207.21(a) and 207.40 and the United States Federal Food, Drug, and Cosmetic (FD&C) Act sections 510(c), (d), & (i)). In addition, establishments must renew registration annually between October 1st and December 31st of each year. (FD&C Act sections 510(b) & (i).