SMG 1114.73

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF SCIENTIFIC AND MEDICAL PROGRAMS

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

OFFICE OF THE CENTER DIRECTOR

OFFICE OF REGULATORY COMPLIANCE AND RISK MANAGEMENT

Effective Date: 01/13/2009

1. OFFICE OF REGULATORY COMPLIANCE AND RISK MANAGEMENT (DAECD).

A. Identifies and evaluates all risks with the potential to adversely impact the NCTR in the areas of physical security and regulatory compliance, and develops measures to control, reduce, or eliminate those risks. Specific risks would include natural disasters, workplace accidents or illnesses, toxic or hazardous materials spills, or waste, fraud or abuse of resources.

B. Assures compliance with local, state and federal regulations including those promulgated by the Occupational Safety and Health Administration, Environmental Protection Agency, and the Nuclear Regulatory Commission. Ensures Center’s compliance with Executive Orders, HHS and FDA regulations, policies and guidelines.

C. Executes/Administers quality assurance programs to ensure compliance with FDA Good Laboratory Practice regulations and HHS Human Subjects Research regulations.

D. Maintains the physical and personnel security program for the Center to ensure the protection of NCTR’s personnel, equipment, and physical plant; as well as employee’s background investigations and suitability requirements in accordance with the provisions of Executive Order 10450 and the Code of Federal Regulations, parts 731, 732, and 736.

E. Provides oversight to ensure Center’s compliance with the Federal Manager’s Financial Integrity Act and maintains NCTR records (research and administrative) in accordance with Department, Agency, and National Archives and Records Administration (NARA) regulations.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Deputy Commissioner, Food and Drug Administration effective January 13, 2009.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	07/29/2008	N/a	OC/OO/OM/OMP	Associate Director, Office of Executive Programs and Services, NCTR
Revision	01/13/2009	N/a	OC/OO/OM/OMP	Commissioner of the Food and Drug Administration