Page:United States Statutes at Large Volume 102 Part 4.djvu/1001

 PUBLIC LAW 100-670—NOV. 16, 1988

102 STAT. 3971

Public Law 100-670 100th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to authorize abbreviated new animal drug applications and to amend title 85, United States Code, to authorize the extension of the patents for animal drug products.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE AND REFERENCE TO ACT.

(a) SHORT TITLE.—This Act may be cited as the "Generic Animal Drug and Patent Term Restoration Act". (b) REFERENCE.—

(1) Whenever in title I (other than in section 107(b)) 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. (2) Whenever in title II 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 title 35 of the United States Code.

Nov. 16, 1988 [S. 2843]

Generic Animal Drug and Patent Term Restoration Act. Safety. Consumer protection. 21 USC 301 note.

TITLE I—NEW ANIMAL DRUG APPLICATIONS SEC. 101. ABBREVIATED NEW ANIMAL DRUG APPLICATIONS.

(a) GENERAL RULE.—Section 5120)) (21 U.S.C. 360b) is amended— (1) by inserting "(1)" after "(b)", (2) by redesignating clauses (1) through (8) as clauses (A) through (H), respectively, and (3) by adding at the end the following: "(2) Any person may file with the Secretary an abbreviated application for the approval of a new animal drug. An abbreviated application shall contain the information required by subsection (n).". (b) APPLICATION REQUIREMENTS.—Section 512 is amended by strik-

ing out subsection (n) and inserting in lieu thereof the following: "(n)(l) An abbreviated application for a new animal drug shall contain— "(A)(i) except as provided in clause (ii), information to show that the conditions of use or similar limitations (whether in the labeling or published pursuant to subsection (i)) prescribed, recommended, or suggested in the labeling proposed for the new animal drug have been previously approved for a new animal

Labeling.

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