What is the effective date of the final rule and, by what date, must IRBs complete an initial registration or submit additional information as required by the FDA rule?

This rule is effective July 14, 2009. However, in order to allow IRBs to submit their initial
registrations or the additional information required by the rule, FDA will not enforce the rule
until September 14, 2009, the compliance date. Therefore, as stated above, IRBs that are not
already in the OHRP system must submit an initial registration by September 14, 2009. For
IRBs that are already in the OHRP system and are reviewing FDA-regulated research, the
required additional information must be added to the database by this compliance date. After
September 14, 2009, if an IRB that is not reviewing FDA-regulated research decides to do so,
this additional information must be submitted before the IRB reviews research involving FDA regulated
products.