StacksVerified U.S. regulatory reference

21 CFR §1309.34

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.