21 CFR § 1003.30
Application for exemption from notification requirements
June 25, 2020
(a) A manufacturer may at the time of giving the written confirmation required by §1003.20 or within 15 days of the receipt of any notice from the Secretary pursuant to §1003.11(a), apply for an exemption from the requirement of notice to the persons specified in §1003.10(b).
(b) The application for exemption shall contain the information required by §1003.20 and in addition shall set forth in detail the grounds upon which the exemption is sought.