Page:United States Statutes at Large Volume 98 Part 2.djvu/437

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PUBLIC LAW 98-000—MMMM. DD, 1984

PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1597

drug for which the subsection (b) application was submitted effective before the expiration of two years from the date of enactment of this clause.". SEC. 104. Section 505 of such Act is amended by adding at the end the following: "(1) Safety and effectiveness data and information which has been submitted in an application under subsection (b) for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown— "(1) if no work is being or will be undertaken to have the application approved, "(2) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted, "(3) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted, "(4) if the Secretary has determined that such drug is not a new drug, or "(5) upon the effective date of the approval of the first application under subsection (j) which refers to such drug or upon the date upon which the approval of an application under subsection (j) which refers to such drug could be made effective if such an application had been submitted. "(m) For purposes of this section, the term 'patent' means a patent issued by the Patent and Trademark Office of the Department of Commerce.". SEC. 105. (a) The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by sections 101, 102, and 103 of this Act, within one year of the date of enactment of this Act. (b) During the period beginning sixty days after the date of the enactment of this Act and ending on the date regulations promulgated under subsection (a) take effect, abbreviated new drug applications may be submitted in accordance with the provisions of section 314.2 of title 21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 505(c) of the Federal Food, Drug, and Cosmetic Act before the date of the enactment of this Act. If any such provision is inconsistent with the requirements of section 505(j) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall consider the application under the applicable requirements of such section. The Secretary of Health and Human Services may not approve such an abbreviated new drug application which is filed for a drug which is described in sections 505(c)(3)(D) and 505(j)(4)(D) of the Federal Food, Drug, and Cosmetic Act except in accordance with such section. SEC. 106. Section 2201 of title 28, United States Code, is amended by inserting "(a)" before "In a case" and by adding at the end the following: "(b) For limitations on actions brought with respect to drug patents see section 505 of the Federal Food, Drug, and Cosmetic Act.".

Ante, p. 1585. Public availability.

Regulations. 21 USC 355 note.

Ante, pp. 1592-1594. Ante, p. 1592.

Ante, p. 1594.

Ante, p. 1585.