FDA Proposed Information Collection on Animal Drug and Animal Generic Drug User Fee Reporting

The U.S. Food and Drug Administration (FDA) is publishing a notice in the Federal Register to invite public comment on a proposed extension of an existing information collection related to its animal drug and animal generic drug user fee programs. This action is required under the Paperwork Reduction Act of 1995 (PRA), which mandates that federal agencies publish such notices and allow a minimum 60-day public comment period before collecting or extending collection of information from regulated entities. The user fee programs in question require pharmaceutical companies and sponsors involved in animal drug development to submit specific financial and program-related reporting data to the FDA. These fees fund the Agency's review activities for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs), helping to ensure timely regulatory review of veterinary medicines. This notice does not introduce new regulatory requirements but seeks to reauthorize and continue the existing reporting obligations tied to the user fee structure. Stakeholders in the animal pharmaceutical industry, including drug sponsors and manufacturers, are encouraged to submit comments within the 60-day window regarding the burden, necessity, and accuracy of the information collection.

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