[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: 21CFR5.106]

[Page 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. 5.106  Submission of and effective approval dates for abbreviated 
new drug applications and certain new drug applications.

    (a) The following officials are authorized to perform all of the 
functions of the Commissioner of Food and Drugs with regard to decisions 
made under section 505(c)(3)(D), (j)(4)(B)(iv), and (j)(4)(D) and 
section 505A of the Federal Food, Drug and Cosmetic Act (the act) (21 
U.S.C. 355(c)(3)(D), (j)(4)(B)(ii) and (j)(4)(D) and 355a) concerning 
the date of submission or the date of effective approval of abbreviated 
new drug applications including supplements thereto submitted under 
section 505(j) of the act (21 U.S.C. 355(j)) and of new drug 
applications including supplements thereto submitted under section 
505(b)(1) (21 U.S.C. 355(b)(1)) of the act and described under section 
505(b)(2) of the act (21 U.S.C. 355(b)(2)):

    (1) The Director, the Deputy Director, and the Directors, Office of 
Review Management and Office of Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).

    (2) The Director and Deputy Director, Office of Generic Drugs, 
Office of Pharmaceutical Science, CDER.

    (b) These officials may not further redelegate this authority.