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Interim Final Rule

A type of rule issued by a government agency that takes effect immediately, often without the usual period for public comments beforehand. Comments are usually accepted after the rule is in effect.

Nonclinical Testing Methods

Drug testing approaches that do not use living animals. This can include tests using human cells in a lab (in vitro), computer models, or other advanced scientific techniques.

Secretary of Health and Human Services

The head of the U.S. Department of Health and Human Services (HHS), a cabinet-level position responsible for protecting the health of all Americans and providing essential human services.

Commissioner of Food and Drugs

The head of the U.S. Food and Drug Administration (FDA), the agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, among other things.

Federal Food, Drug, and Cosmetic Act

The main law that gives the Food and Drug Administration (FDA) its authority to regulate food, drugs, cosmetics, and medical devices in the United States.

Code of Federal Regulations (CFR)

A collection of all the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. It is organized into 50 titles covering broad areas subject to Federal regulation.