New Animal Drugs for Investigational Use

This information collection request supports FDA's regulations regarding new animal drugs for investigational uses. Respondents to this collection of information are persons who use new animal drugs for investigational purposes, such as drug industry firms, academic institutions, and the government. Investigators may include individuals from these entities, as well as research firms and members of the medical professions. Our regulations require that certain information be submitted to us in a “Notice of Claimed Investigational Exemption for a New Animal Drug” (NCIE) to qualify for the exemption and to control shipment of the new animal drug and prevent potential abuse. Our regulations also require recordkeeping. We use the reported information to determine that investigational animal drugs are distributed only to qualified investigators, adequate drug accountability records are maintained, and edible food products from treated food-producing animals are safe for human consumption. We also use the information collected to monitor the validity of the studies submitted to us to support new animal drug approval.

The latest form for New Animal Drugs for Investigational Use expires 2021-08-31 and can be found here.

Reporting: NAD for Investigational Use

Federal Enterprise Architecture: Health - Consumer Health and Safety