21 CFR § 1309.34 - Acceptance for filing; defective applications.

(a) Applications submitted for filing are dated upon receipt. If the application is found to be complete, the application will be accepted for filing. Applications failing to comply with the requirements of this part will not be accepted for filing.

(b) Accepting an application for filing does not preclude any subsequent request for additional information pursuant to § 1309.35 and has no bearing on whether the application will be granted.

[60 FR 32454, June 22, 1995, as amended at 87 FR 21023, Apr. 11, 2022]