Federal agencies must periodically apply to the US Office of Management and Budget (OMB) for continued clearance of forms that collect information from the public. The process is intended to ensure that forms are appropriately designed and are not unduly burdensome to complete.
OMB approval of Form FDA 1572 expired on May 31, 2009, and an extension to continue using the current version expired on August 31, 2011. FDA’s Division of Drug Information recently clarified in an email that the form posted online is still valid for use by investigators and sponsors:
The most recent version of the Form FDA 1572 (1572) is the one available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf. A sponsor can use this version to obtain signed agreements from clinical investigators in their studies. The expiration date merely reflects the U.S. government’s Office of Management and Budget’s (OMB’s) clearance/reclearance of the form as an FDA form that meets the requirements of the Paperwork Reduction Act. FDA is required to submit a request for renewal of all forms no later than the expiration date on the most current form. However, the review and reapproval process as well as issuance and posting of a new form can often be delayed. In any case, as noted above, there is no reason that the form cannot be used as intended, despite the fact that it bears an expired date, and there is no need to update the form after one with an updated expiration date is issued.
Note that FDA does not require the routine submission of updated forms in this situation.