HR1683-118

1. Short title This Act may be cited as the Generic Animal Drug Advancement Act.

2. Changes to process for approval of abbreviated applications for the approval of new animal drugs Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) is amended— in subsection (d)(4), in the matter preceding subparagraph (A), by striking section 512(b)(1) and inserting paragraph (1) or (2) of subsection (b); in subsection (n)(1)(F)— by striking or because the new animal drug and inserting because the new animal drug; and by striking manufacturers; and inserting manufacturers, or because the new animal drug is not shown to be bioequivalent to all of the species for which the approved new animal drug is approved for use;; and by amending subsection (o) to read as follows: For purposes of this section— the term bioequivalent means, in establishing whether a new animal drug is bioequivalent to an approved new animal drug— demonstrating bioequivalence in at least one major species for which the approved new animal drug is approved for use; or in the case that an approved new animal drug is not approved for use in any major species, demonstrating bioequivalence in at least one species for which the approved new animal drug is approved for use; and the term patent means a patent issued by the United States Patent and Trademark Office; (o)For purposes of this section— (1)the term bioequivalent means, in establishing whether a new animal drug is bioequivalent to an approved new animal drug— (A)demonstrating bioequivalence in at least one major species for which the approved new animal drug is approved for use; or (B)in the case that an approved new animal drug is not approved for use in any major species, demonstrating bioequivalence in at least one species for which the approved new animal drug is approved for use; and (2)the term patent means a patent issued by the United States Patent and Trademark Office;.