FDA Review of Information Collection for Minor Use and Minor Species Animal Drugs
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This notice keeps FDA’s paperwork process moving for animal drug sponsors that seek special status for drugs used in minor species or for limited uses in major species. The FDA has sent the information collection tied to these programs to the Office of Management and Budget for review under the Paperwork Reduction Act. Companies developing these animal drugs may continue to face reporting and recordkeeping requirements under 21 CFR part 516. Interested parties can submit comments on the collection by July 29, 2026, especially if they believe the paperwork burden should be changed.
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Key Changes
- FDA submitted the existing information collection for OMB review and clearance.
- The notice covers paperwork tied to minor use and minor species new animal drug designation and indexing programs.
- Public comments on the information collection are due by July 29, 2026.
Obligations
What this law requires
Parties submitting written comments on FDA’s information collection for new animal drugs for minor use or minor species must submit them through OMB’s reginfo.gov review process by the stated comment deadline.
Comment submissions on this information collection must reference OMB control number 0910-0605 and include FDA docket number FDA-2026-N-1305.
Sponsors seeking designation of a minor use or minor species new animal drug or listing in the index of legally marketed unapproved new animal drugs for minor species must comply with the reporting and recordkeeping requirements codified in 21 CFR part 516.