PUBLIC LAW 104-250—OCT. 9, 1996 110 STAT. 3151 Public Law 104-250 104th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to provide for improvements Oct. 9, 1996 in the process of approving and using animal drugs, and for other purposes. [H.R. 2508] Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled. Animal Drug Availability Act SECTION 1. SHORT TITLE; REFERENCE. of 1996. (a) SHORT TITLE. —Th is Act may be cited as the "Animal Drug ^^ ^^^ ^°^ °*®- Availability Act of 1996". (b) REFERENCE.— Whenever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). SEC. 2. EVIDENCE OF EFFECTIVENESS. (a) ORIGINAL APPLICATIONS.—Paragraph (3) of section 512(d) (21 U.S.C. 360b(d)) is amended tp read as follows: "(3) As used in this section, the term 'substantial evidence' means evidence consisting of one or more adequate and well controlled investigations, such as— "(A) a study in a target species; "(B) a study in laboratory animals; "(C) any field investigation that may be required under this section and that meets the requirements of subsection (b)(3) if a presubmission conference is requested by the applicant; "(D) a bioequivalence study; or "(E) an in vitro study; by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof". (b) CONFORMING AMENDMENTS. — (1) Clauses (ii) and (iii) of section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F)) are each amended— (A) by striking "reports of new clinical or field investigations (other than bioequivalence or residue studies) and," and inserting "substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or,"; and (B) by striking "essential to" and inserting "required for".
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