Page:United States Statutes at Large Volume 98 Part 2.djvu/425

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PUBLIC LAW 98-000—MMMM. DD, 1984

PUBLIC LAW 98-417—SEPT. 24, 1984 Public Law 98-417 98th Congress

98 STAT. 1585

An Act

To amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug appHcations, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may be cited as the "Drug Price Competition and Patent Term Restoration Act of 1984". TITLE I—ABBREVIATED NEW DRUG APPLICATIONS SEC. 101. Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by redesignating subsection (j) as subsection (k) and inserting after subsection (i) the following: "(j)(1) Any person may file with the Secretary an abbreviated application for the approval of a new drug. "(2)(A) An abbreviated application for a new drug shall contain— "(i) information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a drug listed under paragraph (6) (hereinafter in this subsection referred to as a 'listed drug'); "(ii)(I) if the listed drug referred to in clause (i) has only one active ingredient, information to show that the active ingredient of the new drug is the same as that of the listed drug; "(II) if the listed drug referred to in clause (i) has more than one active ingredient, information to show that the active ingredients of the new drug are the same as those of the listed drug, or "(III) if the listed drug referred to in clause (i) has more than one active ingredient and if one of the active ingredients of the new drug is different and the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that the other active ingredients of the new drug are the same as the active ingredients of the listed drug, information to show that the different active ingredient is an active ingredient of a listed drug or of a drug which does not meet the requirements of section 201(p), and such other information respecting the different active ingredient with respect to which the petition was filed as the Secretary may require; "(iii) information to show that the route of administration, the dosage form, and the strength of the new drug are the same as those of the listed drug referred to in clause (i) or, if the route of administration, the dosage form, or the strength of the new drug is different and the application is filed pursuant to the approval of a petition filed under subparagraph (C), such information respecting the route of administration, dosage form, or strength with respect to which the petition was filed as the Secretary may require;

Sept. 24, 1984 [S. 1538]

Drug Price Competition and Patent Term Restoration Act of 1984. 21 USC 301 note.

Labeling.

21 USC 321.