Federal Register #FDA2011N0656

FDA Seeks Stakeholder Participation for Animal Drug User Fee Act Reauthorization Meetings

The Food and Drug Administration (FDA) is inviting stakeholders to participate in consultation meetings for the reauthorization of the Animal Drug User Fee Act (ADUFA): - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are involved, as this is not a procurement opportunity - No products or services are being requested; this is a regulatory consultation process - Stakeholders include: - Patient and consumer advocacy groups - Veterinary professionals - Scientific and academic experts - Meetings will be held: - In person at the FDA Harvey W. Wiley Federal Building in College Park, MD - Virtually via Microsoft Teams - Notable requirements: - Stakeholders must notify the FDA of their intent to participate, providing contact information and any special accommodation needs - Meetings will occur at least once every four months during the negotiation period for ADUFA reauthorization

Description

The Food and Drug Administration (FDA) is requesting public stakeholders to notify their intent to participate in periodic consultation meetings regarding the reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires on September 30, 2028. FDA is required by law to consult with a range of stakeholders including patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts to develop recommendations for the next ADUFA program. These meetings will occur at least once every four months during FDA's negotiations with the regulated industry to ensure consistent stakeholder representation.

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