FDA Extends Paperwork for Animal Drug Side Effects
Published Date: 5/21/2026
Notice
Summary
The FDA is asking for approval to keep collecting info about problems with approved new animal drugs, like side effects or manufacturing issues. This helps make sure animal medicines stay safe and effective. Drug companies need to keep reporting these issues, and the public can comment until June 22, 2026. There’s no new cost, just a continuation of current rules.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Estimated reporting and recordkeeping burden rose
FDA estimates the collection now requires about 139,561 annual reporting responses taking 194,349.5 hours and about 124,443 recordkeeping records taking 1,742,132 hours. FDA says its estimate reflects an overall increase of 22,073.50 hours and 15,117 responses due to more submissions in recent years.
Adverse-event reporting stays required
If you make or hold an approved new animal drug application, you must keep submitting adverse event and product/manufacturing defect reports under section 512(l) and 21 CFR 514.80 using Forms FDA 1932, 1932a, and 2301. The collection continues under OMB Control Number 0910-0284 and is a continuation of current reporting rules.
Limited waivers allowed for electronic filing
FDA requires electronic submission of postmarketing safety reports under Sec. 514.80 but allows a temporary waiver on a limited basis for good cause. An initial waiver request may be made by telephone or email to CVM's Division of Pharmacovigilance and Surveillance, followed promptly by a written letter, and any granted waiver will include specific reporting conditions.
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