21 CFR 1003.30 - Application for exemption from notification requirements.

Regulations last checked for updates: Oct 18, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart D [§ 1003.30 - § 1003.31]

§ 1003.30 - Application for exemption from notification requirements.

(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.

authority: 21 U.S.C. 360hh-360ss.

source: 38 FR 28628, Oct. 15, 1973, unless otherwise noted.

cite as: 21 CFR 1003.30