Page:United States Statutes at Large Volume 102 Part 4.djvu/1014

 102 STAT. 3984

Fraud.

21 USC 360b note.

PUBLIC LAW 100-670—NOV. 16, 1988

"(3) The Secretary may by regulation exempt drugs for animals other than man subject to section 512 from the requirements of paragraph (1) when such requirements are not necessary for the protection of the public health. "(4) A drug which is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to d^pensing its label fails to bear the statement 'Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.'. A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the statement specified in the preceding sentence.". SEC. 106. DRUGS PRIMARILY iMANUFACTURED USING BIOTECHNOLOGY.

Notwithstanding section 512ft)X2) of the Federal Food, Drug, and Cosmetic Act, the Secretary of Health and Human Services may not approve an abbreviated application submitted under such section for a new animal drug which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques. SEC. 107. CONFORMING AMENDMENTS. (a) BATCH CERTIFICATION.—

(1) Section 201(w) (21 U.S.C. 321(w)) is amended by striking out "; or" at the end of paragraph (2) and inserting in lieu thereof a period and by striking out paragraph (3). (2) Section 512(a)(l) (21 U.S.C. 360b(a)(l)) is amended by inserting "and" at the end of subparagraph (A), by striking out ", and" at the end of subparagraph (B) and inserting in lieu thereof a period, and by striking out subparagraph (C). (b) TITLE 28.—Section 2201(b) of title 28, United States Code, is amended by inserting "or 512" after "505". 21 USC 360b note.

SEC. 108. EFFECTIVE DATE.

The Secretary of Health and Human Services may not make an approval of an application submitted under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.a 360b(b)(2)) effective before January 1, 1991.

TITLE II—PATENT TERMS 35 USC 156.

Marketing.

SEC. 201. EXTENSION OF PATENT TERM. (a) SECTION 156(a)(5).—Section 156(a)(5) is amended— (1) by inserting "or (C)" after "subparagraph (B)" in subparagraph (A), (2) by striking out "or" at the end of subparagraph (A), and (3) by striking out the period at the end of subparagraph (B) and inserting "; or" and the following: "(Q for purposes of Subparagraph (A), in the case of a patent which— "(i) claims a new animal drug or a veterinary biological product which (I) is not covered by the claims in any other patent which has been extended, and (II) has received permission for the commercial marketing or use in nonfood-producing animals and in food-producing animals, and "(ii) was not extended on the basis of the regulatory review period for use in non-food-producing emimals.

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