Page:United States Statutes at Large Volume 102 Part 4.djvu/1017

 PUBLIC LAW 100-670—NOV. 16, 1988

102 STAT. 3987

"(A) a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), or "(B) a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Virus-Serum-Toxin Act) which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.", (2) by amending subparagraphs (B) and (C) of paragraph (4) to read as follows: "(B) Any reference to section 503, 505, 507, 512, or 515 is a reference to section 503, 505, 507, 512, or 515 of the Federal Food, Drug, and Cosmetic Act. "(C) Any reference to the Virus-Serum-Toxin Act is a reference to the Act of March 4, 1913 (21 U.S.C. 151-158).", and (3) by adding at the end the following: "(7) The term 'date of enactment as used in this section means September 24, 1984, for a human drug product, a medical device, food additive, or color additive. "(8) The term 'date of enactment' as used in this section means the date of enactment of the Generic Animal Drug and Patent Term Restoration Act for an animal drug or a veterinary biological product.", (h) SECTION 156(g).—

(1) Paragraph (1) of section 156(g) is amended— 35 USC 156. (A) in subparagraph (A), by striking out "human drug product" and inserting in lieu thereof '^lew drug, antibiotic drug, or human biological product", (B) in subparagraph (B)— (i) by striking out "human drug product" in the matter before clause (i) and inserting in lieu thereof "new drug, antibiotic drug, or human biological product", and (ii) by striking out "human drug product" in clauses (i) and (ii) and inserting in lieu thereof "product". (2) Paragraph (I)(A) of section 156(g) is amended by striking out "paragraph (4)" and inserting in lieu thereof "paragraph (6)". (3) Paragraphs (2)(A) and (3)(A) are each amended by striking out "paragraph (4)" and inserting in lieu thereof "paragraph (6)". (4) Section 156(g) is amended by redesignating paragraph (4) as paragraph (6) and by inserting after paragraph (3) the following: "(4)(A) In the case of a product which is a new animal drug, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies. "(B) The regulatory review period for a new animal drug product is the sum of^ "(i) the period beginning on the earlier of the date a major health or environmental effects test on the drug was initiated or the date an exemption under subsection (j) of section 512 became effective for the approved new animal drug product and ending on the date an application was

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