Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act; Draft Guidance for Industry; Availability

The ANIMAL HEALTH INSTITUTE (AHI) appreciates the opportunity to provide additional comments and presentation slides on the Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. We thank CVM for the opportunity to present the industry perspective on the reporting provisions under the CARES Act. Slides from the presentation are included as an addendum. The presentation reflected key concepts outlined in AHI's initial input to FDA, which can be found in the public docket at https://www.regulations.gov/comment/FDA-2021-D-1031-0017. AHI's primary ask related to CARES Act remains to exempt animal health drugs from the reporting requirements.

The ANIMAL HEALTH INSTITUTE (AHI) appreciates the opportunity to comment on the Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. AHI's comments are attached.