Public Input Sought on Rare Disease Drug Reporting Rules
Published Date: 9/21/2026
Notice
Summary
The FDA is asking for public feedback on their plan to keep collecting info about orphan drugs—special medicines for rare diseases. This helps make sure drug makers follow rules and get the right approvals, keeping the process smooth and fair. Comments are open until October 21, 2026, and this review won’t cost anyone extra but keeps important protections in place.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
Orphan Drug Reporting — Big Time Burden
If you sponsor drugs for rare diseases, FDA will continue collecting required records and forms under OMB Control Number 0910-0167. FDA estimates this collection generates 6,744 annual records and a total of 193,830 hours of burden each year (for example, 2,210 annual-report records at 3 hours each and 864 designation-related records at 32 hours each). Comments are due by October 21, 2026.
Electronic Submission & Secure Email Fee Risk
If you submit orphan designation materials, you may need to register for the CDER NextGen portal or send encrypted email; FDA notes new NextGen users must register and that there may be a fee for a commercial enterprise to obtain a digital certificate for encrypted email. This could create a small upfront cost and extra steps when sending confidential or proprietary information.
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Key Dates
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