SMG 1410.104

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - HUMAN DRUGS

APPROVAL OF NEW DRUG APPLICATIONS AND THEIR SUPPLEMENTS

Effective Date: 04/29/2009

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED

A. 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 for drugs for human use that have been submitted under section 505 of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 355), and regulatory actions for drugs for human use for which approved applications, submitted under section 505 of the act, are in effect:

1. The Director, the Deputy Director, and the Directors and Deputy Directors, Office of New Drugs, Office of Pharmaceutical Science, and Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER).

2. The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP), and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER, for drugs under their jurisdiction.

This delegation does not apply to those drug products listed in 21 CFR Part 300, Section 314.440(b), for which applications or supplements have been submitted under section 505 of the act.

B. The Director and Deputy Directors, Center for Biologics Evaluation and Research, for drugs listed in 21 CFR Part 300, Section 314.440(b), are authorized to perform all the functions of the Commissioner with regard to approval of new drug applications and supplements for drugs for human use that have been submitted under section 505 of the act, and regulatory actions for drugs for human use for which approved applications, submitted under section 505 of the act, are in effect.

C. The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP) and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER, for drugs under their jurisdiction, are authorized to perform all functions of the Commissioner with regard to: (1) approval of supplemental applications to approved new drug applications for drugs for human use that have been submitted under 21 CFR Part 300, Section 314.70 and of new drug applications for drug products other than those that contain new molecular entities (new chemical entities), and (2) regulatory actions related to drugs for human use for which approved applications, submitted under 21 CFR Part 300, Section 314.70, other than those that contain new molecular entities (new chemical entities), are in effect.

The applications to which this authorization applies may, in appropriate circumstances, continue to be acted upon by the officials so authorized in SMG 1410.10 and paragraphs A. and B. of this SMG.

D. The following officials are authorized to perform all the functions of the Commissioner with regard to: (1) approval of abbreviated new drug applications and supplements 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, and (2) regulatory actions related to these drugs for human use for which approved applications are in effect.

The applications to which this authorization applies may, in appropriate circumstances, continue to be acted upon by the officials so authorized in Section 1410.10 and paragraphs A. and B. of this SMG.

1. For drugs submitted under Secs. 314.50, 314.70, and 314.94 of 21 CFR, Part 300, except for those drug products listed in Sec. 314.440(b):

a. 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.

b. The Directors and Deputy Directors of the divisions in Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP) and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER.

2. For drug products listed in 21 CFR, Part 300, Section 314.440(b) and submitted under 21 CFR, Part 300, sections 314.50, 314.70, and 314.94: The Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Cellular, Tissue and Gene Therapies, Office of Compliance and Biologics Quality, CBER, the Director and Deputy Director, Office of New Drugs, CDER, and the Director and Deputy Director, Office of Cellular, Tissue and Gene Therapies, CBER.

E. The following officials are authorized to perform all functions of the Commissioner with respect to: (1) 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 21 CFR, Part 300, Sections 314.70(b)(1), (b)(2)(i) through (b)(2)(iv), (b)(2)(vi) through (b)(2)(viii), (c)(1), (c)(2), and (c)(6)(i) through (c)(6)(ii) (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), and (2) regulatory actions related to these drugs for human use for which approved applications are in effect:

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. The Director and Deputy Director, Division of Chemistry III, Office of Generic Drugs, Office of Pharmaceutical Science, CDER.

F. 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: (1) 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 21 CFR, Part 300, Sections 314.70(b)(2)(v) and (c)(6)(iii), and (2) regulatory actions related to these drugs for human use for which approved applications are in effect.

Authority to approve supplements that require in vivo bioavailability studies or in vivo study waiver requests is not included in this delegation.

G. The following officials are authorized to perform all functions of the Commissioner with respect to: (1) approval of supplemental applications to new drug applications for drugs for human use that are described in 21 CFR, Part 300, sections 314.70(b)(1), (b)(2)(i) through (b)(2)(iv), (b)(2)(vi) through (b)(2)(viii), (c)(1), (c)(2), and (c)(6)(i) through (c)(6)(ii), and (2) regulatory actions related to these drugs for human use for which approved supplemental applications to new drug applications are in effect.

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 delegation.

The supplemental applications to which this authorization applies may continue to be acted upon by the officials so authorized in SMG 1410.10 and paragraphs A., B., and C. of this SMG.

1. The Director and Deputy Director, Office of New Drug Quality Assessment, Office of Pharmaceutical Science, CDER.

2. The Director, Division of Post-Marketing Evaluation, Office of New Drug Quality Assessment, Office of Pharmaceutical Science, CDER.

3. The Branch Chief of Branch I and II in the Division of Post-Marketing Evaluation, Office of New Drug Quality Assessment, Office of Pharmaceutical Science, CDER.

H. The following officials are authorized to take regulatory actions related to the approval of drugs for human use that are the subject of an investigational new drug application (IND), new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA) for biologics under their jurisdiction, and supplements submitted or approved under the act:

1. The Director and Deputy Director, Office of Surveillance and Epidemiology.

2. The Directors and Deputy Directors of the Division of Risk Management, Division of Epidemiology, Division of Medication Error Prevention, Division of Adverse Event Analysis 1, and Division of Adverse Event Analysis 2, Office of Surveillance and Epidemiology, CDER.

I. The following officials are authorized to take regulatory actions related to the review of proprietary names for drugs for human use that are the subject of an investigational new drug application (IND), new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA) for biologics under their jurisdiction, and supplements submitted or approved under the act:

1. The Director and Deputy Director, Office of Surveillance and Epidemiology.

2. The Director and Deputy Director, Division of Medication Error Prevention, Office of Surveillance and Epidemiology, CDER.

2. REDELEGATION.

These officials may not further redelegate these authorities.

3. EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation, via memorandum, on April 29th, 2009.