[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.38]
[Page 120]
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,
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.
Back to Top
© 2007 Betterchem Corp.
|
