[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1003.30]

[Page 580]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1003--NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY--Table of Contents
 
          Subpart D--Exemptions From Notification Requirements
 
Sec. 1003.30  Application for exemption from notification requirements.


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