[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: 21CFR5.105]

[Page 70-71]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5_DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
            Subpart C_Human Drugs; Redelegations of Authority
 
Sec. 5.105  Issuance of notices relating to proposals to refuse approval 
or to withdraw approval of new drug applications and their supplements.

    (a) The Director, the Deputy Director, and the Directors, Office of 
Review Management and Office of Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER), are authorized to issue notices of an 
opportunity for a hearing on proposals to refuse approval or to withdraw 
approval of new drug applications and abbreviated new drug applications 
and supplements thereto on drugs for human use, except for those drugs 
listed in Sec. 314.440(b) of this chapter, that have been submitted 
under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 355) and subpart B of part 314 of this chapter and to issue 
notices refusing approval

[[Page 71]]

or withdrawing approval when opportunity for hearing has been waived.

    (b) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research, for those drugs listed in Sec. 314.440(b) of 
this chapter, are authorized to issue notices of an opportunity for a 
hearing on proposals to refuse approval or to withdraw approval of new 
drug applications and abbreviated new drug applications and supplements 
thereto on drugs for human use that have been submitted under section 
505 of the act and subpart B of part 314 of this chapter and to issue 
notices refusing approval or withdrawing approval when opportunity for 
hearing has been waived.

    (c) These officials may not further redelegate these authorities.