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e-CFR data is current as of March 3, 2021

Title 21Chapter ISubchapter JPart 1003Subpart D → §1003.30


Title 21: Food and Drugs
PART 1003—NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
Subpart D—Exemptions From Notification Requirements


§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.

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