SMG 1114.9

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF THE CHIEF SCIENTIST

OFFICE OF PEDIATRIC THERAPEUTICS

Effective Date: 01/13/2009

1. OFFICE OF PEDIATRIC THERAPEUTICS (DAEE).

A. Coordinates and facilitates all activities of the Food and Drug Administration that may have any effect on the population, the practice of pediatrics, or may in any way involve pediatric issues.

B. Coordinates the review of and communicates internally and externally any report of an adverse event of a drug which received pediatric exclusivity.

C. Provides for the review of adverse event reports and other new safety information and obtains recommendations whether FDA should take action.

D. Coordinates with all Department of Health and Human Service and FDA employees who exercise responsibilities relating to pediatric therapeutics.

E. Serves as the FDA focal point for all issues involving ethics with respect to the pediatric populations.

F. Coordinates with the Office of International Programs while serving as the Agency focal point for international pediatric activities.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Commissioner, Food and Drug Administration effective January 13, 2009. Additionally, this component was established in accordance with Sections 6 & 17 of the 2002 Best Pharmaceuticals for Children Act.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	01/13/2009	N/a	OC/OO/OM/OMP	Commissioner of the Food and Drug Administration