[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1309.46]

[Page 118]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1309_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND 
EXPORTERS OF LIST I CHEMICALS--Table of Contents
 
Sec.  1309.46  Order to show cause.

    (a) If, upon examination of the application for registration from 
any applicant and other information gathered by the Administration 
regarding the applicant, the Administrator is unable to make the 
determinations required by the applicable provisions of section 303 of 
the Act (21 U.S.C. 823) to register the applicant, the Administrator 
shall serve upon the applicant an order to show cause why the 
application for registration should not be denied.
    (b) If, upon information gathered by the Administration regarding 
any registrant, the Administrator determines that the registration of 
such registrant is subject to suspension or revocation pursuant to 
section 304 of the Act (21 U.S.C. 824), the Administrator shall serve 
upon the registrant an order to show cause why the registration should 
not be revoked or suspended.
    (c) The order to show cause shall call upon the applicant or 
registrant to appear before the Administrator at a time and place stated 
in the order, which shall not be less than 30 days after the date of 
receipt of the order. The order to show cause shall also contain a 
statement of the legal basis for such hearing and for the denial, 
revocation, or suspension of registration and a summary of the matters 
of fact and law asserted.
    (d) Upon Receipt of an order to show cause, the applicant or 
registrant must, if he desires a hearing, file a request for a hearing 
pursuant to Sec.  1309.54. If a hearing is requested, the Administrator 
shall hold a hearing at the time and place stated in the order, pursuant 
to Sec.  1309.51.
    (e) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.

                                Hearings