[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: 21CFR5.103]

[Page 69-70]
 
                        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. 5.103  Approval of new drug applications and their supplements.

    (a)(1) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs (Commissioner) with 
regard to approval of 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):
    (i) The Director, the Deputy Director, and the Directors, Office of 
Review Management and Office of Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The Directors and Deputy Directors of the Offices of Drug 
Evaluation I, II, III, IV, and V, Office of Review Management, CDER, for 
drugs under their jurisdiction.
    (2) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research, for drugs listed in Sec. 314.440(b) of this 
chapter, are authorized to perform all the functions of the Commissioner 
with regard to approval of new drug applications and supplements thereto 
on drugs for human use that have been submitted under section 505 of the 
act.
    (b) The Directors and Deputy Directors of the divisions in the 
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review 
Management, CDER, for drugs under their jurisdiction, are authorized to 
perform all functions of the Commissioner with regard to approval of 
supplemental applications to approved new drug applications for drugs 
for human use that have been submitted under Sec. 314.70 of this 
chapter and of new drug applications for drug products other than those 
that contain new molecular entities (new chemical entities). The 
applications to which this authorization applies may, in appropriate 
circumstances, continue to be acted upon by the officials so authorized 
in Sec. 5.10(a) and paragraph (a) of this section.
    (c) The following officials are authorized to perform all the 
functions of the Commissioner with regard to approval of abbreviated new 
drug applications and supplements thereto for drugs for human use and 
new drug applications for drugs with a 5S classification whose clinical 
safety and efficacy may be supported by appropriate literature citations 
in lieu of submission of data from original proprietary studies, or 
section 505(b)(2) of the act (21 U.S.C. 355(b)(2)) applications under 
their jurisdiction. The applications to which this authorization applies 
may, in appropriate circumstances, continue to be acted upon by the 
officials so authorized in Sec. 5.10(a) and paragraph (a) of this 
section.
    (1) For drugs submitted under Sec. Sec. 314.50, 314.70, and 314.94 
of this chapter, except for those drug products listed in Sec. 
314.440(b):
    (i) The Director and Deputy Director, Office of Generic Drugs (OGD), 
Office of Pharmaceutical Science, CDER, except that the Director and 
Deputy Director, OGD are not authorized to approve new drug applications 
with a 5S classification if clinical studies are needed.
    (ii) The Directors and Deputy Directors of the divisions in Offices 
of Drug

[[Page 70]]

Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
    (2) For drug products listed in Sec. 314.440(b) of this chapter and 
submitted under Sec. Sec. 314.50, 314.70, and 314.94 of this chapter: 
The Directors and Deputy Directors, Office of Blood Research and Review, 
Office of Vaccines Research and Review, Office of Therapeutics Research 
and Review, and Office of Compliance and Biologics Quality, CBER.
    (d) The following officials are authorized to perform all functions 
of the Commissioner with respect to approval of supplemental 
applications to abbreviated new drug applications, 5S applications, or 
section 505(b)(2) applications for drugs for human use that are 
described in Sec. Sec. 314.70(b)(1), (b)(2)(ii) through (b)(2)(x), 
(c)(1), and (c)(3) of this chapter. (Authority to approve supplements 
that require in vivo bioavailability studies or that include in vivo 
bioavailability study waiver requests are not included in this 
paragraph.)
    (1) The Director and Deputy Director, Division of Chemistry I, 
Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
    (2) The Director and Deputy Director, Division of Chemistry II, 
Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
    (3) Associate Director for Chemistry, Office of New Drug Chemistry, 
Office of Pharmaceutical Science, CDER.
    (e) The Director, Division of Labeling and Program Support, Office 
of Generic Drugs, Office of Pharmaceutical Science, CDER, are authorized 
to perform all the functions of the Commissioner with respect to 
approval of supplemental applications to abbreviated new drug 
applications, 5S applications, or section 505(b)(2) applications for 
drugs for human use that are described in Sec. Sec. 314.70(b)(3) and 
(c)(2)(i) through (c)(2)(iv) of this chapter. Authority to approve 
supplements that require in vivo bioavailability studies or in vivo 
study waiver requests is not included in this paragraph.
    (f) The supervisory and team leader chemists in the Divisions of New 
Drug Chemistry I, II, and III, Office of New Drug Chemistry, Office of 
Pharmaceutical Science, CDER, are authorized to perform all functions of 
the Commissioner with respect to approval of supplemental applications 
to new drug applications for drugs for human use that are described in 
Sec. Sec. 314(b)(1), (b)(2)(ii) through (b)(2)(x), (c)(1), and (c)(3) 
of this chapter. Authority to approve supplements that require in vivo 
bioavailability information or that require a change in the labeling of 
the drug, except changes that reflect only the use of a different 
facility or establishment, are not included in this paragraph. The 
supplemental applications to which this authorization applies may 
continue to be acted upon by the officials so authorized in Sec. 
5.10(a) and paragraphs (a) and (b) of this section.
    (g) These officials may not further redelegate these authorities.