Office of the Director
The Federal Food, Drug, and Cosmetic Act allows the Secretary of Health and Human Services to delegate his or her authority to others, such as the Commissioner of Food and Drugs. The Commissioner has redelegated his or her authority for several functions to CVM. These functions include:
- Authority to approve New Animal Drug Applications and their supplements and Abbreviated New Animal Drug Applications (for generic drugs).
- Authority to issue proposals, notices, and orders relating to refusal to approve and withdrawal of approval of New Animal Drug Applications and corresponding new animal drug regulations.
- Authority to approve the use of certain food additives.
The Office of the Director's functions are:
- Directing overall Center activities and coordinates and establishes Center policy in the areas of research, management, scientific evaluation, compliance, and surveillance.
- Directing systems for planning, programming, and budgeting and provides administrative and information support for the Center.
- Planning and coordinating the Center's Equal Employment Opportunity Program.
- Approving New Animal Drug Applications (NADAs) and Abbreviated New Animal Drug Applications (ANADAs), and issues notices of withdrawal of new animal drug approvals when opportunities for hearings have been waived.
- Authorizing, for use as edible products, animals treated with investigational drugs and terminates exemptions for investigational trials.
- Approving the use of animal food additives.
- Ensuring that industry submitted NADAs for food-producing animals are reviewed and evaluated with respect to possible effects on human health.
- Investigating and resolving issues related to science and science-based policy decisions for products under the jurisdiction of CVM through the CVM Ombudsman.
- Leading, coordinating, and managing CVM’s international activities in collaboration with relevant FDA Centers and Offices, as well as FDA’s international regulatory counterparts.
The Director also serves as the Center's representative and spokesperson concerning CVM activities. The Director's contacts include the public, industry, other government agencies, and national and international organizations.