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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 a number of functions to CVM. Among these redelegated functions are:
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 functions of the Office of the Director are as follows:
Directs overall Center activities and coordinates and establishes Center policy in the areas of research, management, scientific evaluation, compliance, and surveillance.
Directs systems for planning, programming, and budgeting and provides administrative and information support for the Center.
Plans and coordinates the Center's Equal Employment Opportunity Program.
Approves 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.
Authorizes, for use as edible products, animals treated with investigational drugs and terminates exemptions for investigational trials.
Approves the use of animal food additives.
Ensures that industry submitted NADAs for food-producing animals are reviewed and evaluated with respect to possible effects on human health. The Director also serves as the Center's representative and spokesperson concerning CVM activities. The Director's contacts include the general public, industry, other government agencies, and national and international organizations.
Through the CVM Ombudsman, investigates and seeks to resolve issues related to science and science-based policy decisions for products under the jurisdiction of CVM.
