SMG 1261.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF THE CENTER DIRECTOR

Effective Date: 07/08/2011

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1. OFFICE OF THE CENTER DIRECTOR (DKKNA)

A. Promulgates, plans, administers, coordinates, and evaluates overall Center scientific, management, and regulatory programs, plans, and policies

B. Provides leadership and direction for all Center activities

C. Coordinates and directs the Center management, planning, and evaluation systems, to assure optimum utilization of Center Manpower, financial resources, and facilities

2. CONTROLLED SUBSTANCE STAFF (DKKNA6)

A. Serves as the CDER, FDA and DHHS focus for all activities regarding drug scheduling, abuse and dependence including international drug scheduling and control. This is a DHHS function under the Controlled Substances Act (CSA) and performed by CSS within CDER. Responsibilities include writing the "8-Factor Analysis" (scientific and medical assessments and drug scheduling recommendations to the DEA) required of DHHS under the CSA

B. Consults with CDER drug review division regarding and performing the scientific abuse liability review of Investigational New Drug Applications (INDs) and New Drug Applications (NDA) of Central Nervous System (CNS) active drugs with known or potential abuse liability

C. Consults with CDER drug review divisions and sponsors regarding and performing review of pre-clinical and clinical protocol submissions on controlled substances in CDER

D. Serves as FDA and CDER liaison with other government agencies including Drug Enforcement Administration (DEA), Office of National Drug Control Policy, Substance Abuse and Mental Health Services Administration, and National Institute of Drug Abuse regarding all matters of drug scheduling and identification of new trends in abuse and dependence

E. Serves as FDA and CDER liaison with DEA in determination of Schedule I and II drug quotas and in the DEA licensure of Schedule I drug researchers

F. Consults to other FDA centers including the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, and the Center for Food Safety and Applied Nutrition regarding abuse liability and drug scheduling matters

DRUG SAFETY OVERSIGHT BOARD

a. Identifies, tracks, and oversees the management of important drug safety issues

b. Adjudicates organizational disputes concerning the management of drug safety issues

c. Establishes policies regarding management of drug safety issues in CDER

d. Selects drugs to be placed on Drug Watch and updates their status (including deciding to remove drugs from Drug Watch) as appropriate

e. Oversees the development of patient and professional information sheets in CDER

f. Tracks important emerging safety issues and ensures that they are resolved in a timely manner

g. Ensures that CDER decisions about a drug’s safety benefit from the input and perspective of experts within and outside FDA who have not been directly involved in the ongoing premarket evaluation or post-market surveillance activities with respect to that drug

3. SAFE USE STAFF (DKKNA7)

A.Provides overall leadership, direction, planning, and policy formulation for safe use. Develops safety policy regarding the development and implementation of guidance related to safe use in coordination with other coordinating committees and offices as appropriate; establishes and maintains safe use liaison with Congress, with other Federal Agencies, within the Agency and with outside groups

B.Maintains and tracks safe use issues throughout the Center, and provides oversight and direction to the staff

C.Provides leadership and direction for the staff as it pertains to external communication of safe use information

D.Plans, coordinates, and evaluates safe use related policies, procedures, programs and communication for the Center

4. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Office were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	03/02/2010	N/a	OC/OA/ OM/OMP	Commissioner of Food and Drugs
Revision	02/25/2011	N/a	OC/OA/ OM/OMP	Commissioner of Food and Drugs
Revision	07/08/2011	N/a	CDER/OM	Secretary of the Department of Health and Human Services