FDA Seeks Comments on Minor Animal Drug Data Collection
Published Date: 6/29/2026
Notice
Summary
The FDA is asking for public feedback on their plan to keep collecting info about new animal drugs for rare uses and less common species. This affects drug makers who want special approval and incentives for these unique animal medicines. Comments are open until July 29, 2026, and the process helps keep these important drugs safe and available without extra costs.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
7-Year Marketing Exclusivity Incentive
If you obtain a MUMS (Minor Use/Minor Species) drug designation, you become eligible for incentives under sections 572 and 573 of the FD&C Act, including a 7-year period of exclusive marketing rights for the designated use. The designation is optional and requires sponsors to apply and demonstrate due diligence through annual reports.
Annual Reporting and Recordkeeping Burden
If you are a company that sponsors new animal drugs for minor uses or minor species, you must submit reports and keep records under 21 CFR part 516. FDA estimates the total annual reporting burden is 5,562 hours and the annual recordkeeping burden is 80 hours across respondents; these cover specific activities (for example, 516.30 annual reports and 516.165 drug experience reports).
Guidance and Small Business Resources Provided
FDA acknowledges concerns about administrative and financial burdens on smaller companies and points to resources to help them, including the FDA Small Business Guide and Guidance for Industry documents (CVM GFI #61, #170, #200, #201) and a planned revision of CVM GFI #210. These materials are intended to help sponsors navigate designation and indexing processes.
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