[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.38]

[Page 151-152]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 12_FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
 
                   Subpart B_Initiation of Proceedings
 
Sec. 12.38  Effective date of an order.

    (a) If a person who is subject to a notice of opportunity for 
hearing under Sec. 12.21(b) does not request a hearing, the 
Commissioner will--
    (1) Publish a final order denying or withdrawing approval of an NDA,

[[Page 152]]

NADA, device premarket approval application, or biologics license, in 
whole or in part, or revoking a device product development protocol or 
notice of completion, or declaring that such a protocol has not been 
completed, and stating the effective date of the order; and
    (2) If the order involves withdrawal of approval of an NADA, 
forthwith revoke, in whole or in part, the applicable regulation, under 
section 512(i) of the act.
    (b) If a person who is subject to a notice of opportunity for 
hearing under Sec. 12.21(b) requests a hearing and others do not, the 
Commissioner may issue a final order covering all the drug or device 
products at once or may issue more than one final order covering 
different drug or device products at different times.