small business

(A)In paragraph (1)(E), the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates. (B)The Secretary shall waive under paragraph (1)(E) the application fee for the first animal drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent animal drug applications and supplemental animal drug applications for which safety or effectiveness data are required in the same manner as an entity that does not qualify as a small business. (C)The Secretary shall require any person who applies for a waiver under paragraph (1)(E) to certify their qualification for the waiver. The Secretary shall periodically publish in the Federal Register a list of persons making such certifications.


21 USC § 379j-12(d)(3)(A)

Scoping language

None: Default is title Scope
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